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There aren’t many hospital visitors amid best time of day to take cialis for bph the erectile dysfunction treatment cialis how much does generic cialis cost. But, if you were to walk through intensive-care units at one New York City hospital, you’d see internet-connected speakers—about the size of how much does generic cialis cost a stack of Post-it Notes—affixed to the bedrails of some patient beds.It’s part of a project by two Weill Cornell Medicine doctors to help family members speak with ICU patients, often intubated or otherwise not able to hold up a phone themselves, from afar.“The patients could be completely sedated, they could be in a coma,” but families still want to be there with them, said Dr. Marc Schiffman, an interventional radiologist and one of the doctors who spearheaded bringing the devices into ICUs.The speakers, now in 11 units at Weill Cornell, are part of a two-way communication system from company Relay, originally developed as a walkie-talkie system of sorts for children to stay in touch with their parents throughout the day.

Users on one end record snippets of conversation using a mobile app, which are automatically played out loud through the how much does generic cialis cost small speaker.Users on the other end push a button on the device to record a response.“Whenever (families) have a story they want to recount, they can just talk into their phone,” Schiffman said. €œIt gives the families a sense of autonomy (and) connection,” even when the patient can’t respond.The effort, dubbed the VoiceLove Project, began about four months ago, at the height of the erectile dysfunction treatment cialis in New York City.Families and other visitors were no longer allowed inside Weill Cornell, but still wanted a way to connect with patients who were sick with erectile dysfunction treatment. Initially, that involved a nurse how much does generic cialis cost standing in the ICU and holding up a phone or tablet so families could see the patient—a task that took time out of their already busy day, potentially exposed them to erectile dysfunction treatment and often meant using scarce personal protective equipment.“It really wasn’t a practical solution,” said Dr.

Tamatha Fenster, a minimally invasive gynecologic surgeon.So Fenster and Schiffman began how much does generic cialis cost brainstorming hands-free technologies they could install directly at the bedside. Schiffman drove to a local Target store and bought a few Relay walkie-talkie devices. After testing it with families and patients in the ICU, the two decided it was a “grand slam,” Schiffman said.Since March, hospitals have been trying new ways how much does generic cialis cost to keep patients connected to families at home, said Bill Flatley, senior service delivery manager at consulting firm OST.

He said he’s mainly seen hospitals repurpose technology usually used for telemedicine, like tablets and cameras mounted on telemedicine carts.It’s likely hospitals will have to continue to restrict visitors, at least as long as there’s uncertainty around erectile dysfunction treatment. So it’s integral how much does generic cialis cost for staff to figure out processes that make it easy for families to talk to patients—without putting an additional burden on clinicians or expecting them to serve as tech support.For Fenster and Schiffman, deploying walkie-talkies in the ICU for the first time took some leg work.To scale the walkie-talkie system, Schiffman reached out to Relay’s team via the company’s website, and the company agreed to donate roughly 130 devices and waived the per-user subscription fee. The doctors and Relay have continued to work together on best practices for using the devices in ICUs, a use case Relay is marketing and could how much does generic cialis cost sell to other hospitals, according to Jon Schniepp, Relay’s senior vice president of marketing.But Fenster and Schiffman couldn’t just bring walkie-talkies into the ICU.

In the hospital setting, there are additional quality and privacy concerns. To address those, the doctors how much does generic cialis cost created a disposable case, which made it easier to keep the device sterile and blocked passersby from accidentally pressing the button that would transmit sounds to a family’s Relay app.The two spent thousands of dollars out of their own pockets to devise the best case design, Fenster said, working with an industrial designer in New Jersey to 3D print different models. The final plastic case, customized with the phrase “VoiceLove” on the front, costs about $10 per case to print and ship.

They’ve started reaching out to acute-care and post-acute facilities in California, Texas and other erectile dysfunction treatment how much does generic cialis cost hot spots to explain how the VoiceLove Project works, hoping to connect other groups with Relay and share the case design. But the doctors say they’re still working out the logistics of getting the equipment to interested organizations.

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Start Preamble Notice how to get cialis discount of Amendment cheap cialis and Republished Declaration. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to amend his March 10, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against erectile dysfunction treatment. The amendments to the Declaration are applicable as of February 4, 2020, how to get cialis discount except as otherwise specified in Section XII. Start Further Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue Start Printed Page 79191SW, Washington, DC 20201.

Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C. 247d-6d et. Seq., authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct,” as defined in the PREP Act.

Such declarations are subject to amendment as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2. It amended the Public Health Service (PHS) Act, adding Section 319F-3, which addresses liability immunity, and Section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C.

247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the cialis and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the erectile dysfunction Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response to the erectile dysfunction Disease 2019 (erectile dysfunction treatment) outbreak, which subsequently became a global cialis. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 21, 2020, July 23, 2020, and October 2, 2020.

On March 10, 2020, the Secretary issued a declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment.[] On April 10, the Secretary amended the Declaration to extend liability protections to Covered Countermeasures authorized under the CARES Act.[] On June 4, the Secretary amended the Declaration to clarify that Covered Countermeasures under the Declaration include qualified cialis and epidemic products that limit the harm that erectile dysfunction treatment might otherwise cause.[] On August 19, the Secretary amended the Declaration to add additional categories of Qualified Persons and to amend the category of disease, health condition, or threat for which he recommends the administration or use of Covered Countermeasures.[] The Secretary now further amends the Declaration pursuant to section 319F-3 of the Public Health Service Act. This Fourth Amendment to the Declaration. (a) Clarifies that the Declaration must be construed in accordance with the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) Advisory Opinions on the Public Readiness and Emergency Preparedness Act and the Declaration (Advisory Opinions).[] The Declaration incorporates the Advisory Opinions for that purpose. (b) Incorporates authorizations that the HHS Office of the Assistant Secretary for Health (OASH) has issued as an Authority Having Jurisdiction.[] (c) Adds an additional category of Qualified Persons under Section V of the Declaration and 42 U.S.C. 247d-6d(i)(8)(B), i.e., healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.[] (d) Modifies and clarifies the training requirements for certain licensed pharmacists and pharmacy interns to administer certain routine childhood or erectile dysfunction treatment vaccinations.

(e) Makes explicit that Section VI covers all qualified cialis and epidemic products under the PREP Act. (f) Adds a third method of distribution under Section VII of the Declaration and 42 U.S.C. 247d-6d(a)(5) that would provide liability protections for, among other things, additional private-distribution channels. (g) Makes explicit in Section IX that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. (h) Makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests, in having a unified, whole-of-nation response to the erectile dysfunction treatment cialis among federal, state, local, and private-sector entities.

The world is facing an unprecedented cialis. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.Start Printed Page 79192 (i) Revises the effective time period of the Declaration in light of the amendments to the Declaration.[] The Secretary republishes the Declaration, as amended, in full. Unless otherwise noted, all statutory citations are to the U.S. Code. Description of This Amendment Declaration The Declaration has fifteen sections describing PREP Act coverage for medical countermeasures against erectile dysfunction treatment.

OGC has issued Advisory Opinions interpreting the PREP Act and reflecting the Secretary's interpretation of the Declaration.[] The Secretary now amends the Declaration to clarify that the Declaration must be construed in accordance with the Advisory Opinions. The Secretary expressly incorporates the Advisory Opinions for that purpose. Section V. Covered Persons Section V of the Declaration describes Covered Persons, including additional qualified persons identified by the Secretary, as required under the PREP Act. The Secretary amends Section V to specify an additional category of qualified persons.

Specifically, healthcare personnel who are permitted to order and administer a Covered Countermeasure through telehealth in a state may do so for patients in another state so long as the healthcare personnel comply with the legal requirements of the state in which the healthcare personnel are permitted to order and administer the Covered Countermeasure by means of telehealth. Telehealth is widely recognized as a valuable tool to promote public health during this cialis. According to the Centers for Disease Control and Prevention (CDC), Telehealth services can facilitate public health mitigation strategies during this cialis by increasing social distancing. These services can be a safer option for [healthcare personnel (HCP)] and patients by reducing potential infectious exposures. They can reduce the strain on healthcare systems by minimizing the surge of patient demand on facilities and reduce the use of [personal protective equipment (PPE)] by healthcare providers.

Maintaining continuity of care to the extent possible can avoid additional negative consequences from delayed preventive, chronic, or routine care. Remote access to healthcare services may increase participation for those who are medically or socially vulnerable or who do not have ready access to providers. Remote access can also help preserve the patient-provider relationship at times when an in-person visit is not practical or feasible. Telehealth services can be used to. Screen patients who may have symptoms of erectile dysfunction treatment and refer as appropriate Provide low-risk urgent care for non-erectile dysfunction treatment conditions, identify those persons who may need additional medical consultation or assessment, and refer as appropriate Access primary care providers and specialists, including mental and behavioral health, for chronic health conditions and medication management Provide coaching and support for patients managing chronic health conditions, including weight management and nutrition counseling Participate in physical therapy, occupational therapy, and other modalities as a hybrid approach to in-person care for optimal health Monitor clinical signs of certain chronic medical conditions (e.g., blood pressure, blood glucose, other remote assessments) Engage in case management for patients who have difficulty accessing care (e.g., those who live in very rural settings, older adults, those with limited mobility) Follow up with patients after hospitalization Deliver advance care planning and counseling to patients and caregivers to document preferences if a life-threatening event or medical crisis occurs Provide non-emergent care to residents in long-term care facilities Provide education and training for HCP through peer-to-peer professional medical consultations (inpatient or outpatient) that are not locally available, particularly in rural areas.[] Similarly, CMS has stressed the importance of telehealth during this cialis.

Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient's health. Innovative uses of this kind of technology in the provision of healthcare is increasing. And with the emergence of the cialis causing the disease erectile dysfunction treatment, there is an urgency to expand the use of technology to help people who need routine care, and keep vulnerable beneficiaries and beneficiaries with mild symptoms in their homes while maintaining access to the care they need. Limiting community spread of the cialis, as well as limiting the exposure to other patients and staff members will slow viral spread.[] Accordingly, CMS and other HHS components has substantially expanded the scope of services paid under Medicare when furnished using telehealth technologies during this cialis. Other HHS components have also taken steps to expand the use of telehealth during the cialis.[] Moreover, to expand the use of telehealth during this cialis, the Office for Civil Rights (OCR) at HHS is exercising enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA) Rules against covered healthcare providers that serve patients through everyday communications technologies during the erectile dysfunction treatment nationwide public health emergency.[] This exercise of discretion Start Printed Page 79193applies to widely available communications apps, such as FaceTime or Skype, when used in good faith for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to erectile dysfunction treatment.[] Many states have authorized out-of-state healthcare personnel to deliver telehealth services to in-state patients, either generally or in the context of erectile dysfunction treatment.[] To help maximize the utility of telehealth, the Secretary declares that the term “qualified person” under 42 U.S.C.

247d-6d(i)(8)(B) includes healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice. When ordering and administering Covered Countermeasures through telehealth to patients in a state where the healthcare personnel are not already permitted to do so, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients through telehealth in the state where the healthcare personnel are licensed or otherwise permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. The Secretary also amends Section V to include several examples of Covered Persons who are Qualified Persons, because they are authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures. Those examples include certain pharmacists, pharmacy interns, and pharmacy technicians who order or administer certain erectile dysfunction treatment tests and certain treatments.[] These examples are not an exclusive or exhaustive list of persons who are qualified persons identified by the Secretary in Section V.

The Secretary also amends Section V to make explicit that the requirement in that section for certain qualified persons to have a current certificate in basic cardiopulmonary resuscitation is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education (ACPE), or the Accreditation Council for Continuing Medical Education. The Secretary also amends Section V's training requirements for licensed pharmacists to order and administer certain childhood or erectile dysfunction treatments. To order and administer treatments, the licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

Other than the basic cardiopulmonary resuscitation requirement and the practical training program requirement, this Amendment does not change the requirements for a pharmacist, pharmacy intern, or pharmacy technician to be a “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) who can order or administer childhood or erectile dysfunction treatments pursuant to the Declaration. Section VI. Covered Countermeasures The Secretary amends Section VI to make explicit that Section VI covers all qualified cialis and epidemic products under the PREP Act.Start Printed Page 79194 Section VII. Limitations on Distribution The Secretary may specify that liability protections are in effect only for Covered Countermeasures obtained through a particular means of distribution.

The Declaration previously stated that liability immunity is afforded to Covered Persons only for Recommended Activities related to (a) present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements. Or (b) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a declaration of an emergency. erectile dysfunction treatment is an unprecedented global challenge that requires a whole-of-nation response that utilizes federal-, state-, and local- distribution channels as well as private-distribution channels. Given the broad scale of this cialis, the Secretary amends the Declaration to extend PREP Act coverage to additional private-distribution channels, as set forth below. The amended Section VII adds that PREP Act liability protections also extend to Covered Persons for Recommended Activities that are related to any Covered Countermeasure that is.

(a) Licensed, approved, cleared, or authorized by the Food and Drug Administration (FDA) (or that is permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the Federal Food, Drug, and Cosmetic (FD&C) Act or Public Health Service (PHS) Act to treat, diagnose, cure, prevent, mitigate or limit the harm from erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom. Or (b) a respiratory protective device approved by the National Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from, erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom. To qualify for this third distribution channel (but not necessarily to qualify for the other distribution channels), a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval. This third distribution channel may extend PREP Act coverage when there is no federal agreement or authorization in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency. For example, a manufacturer, distributor, program planner, or qualified person engages in manufacturing, testing, development, distribution, administration, or use of a erectile dysfunction treatment test pursuant to an FDA Emergency Use Authorization for that erectile dysfunction treatment test.

If the Covered Person satisfies all other requirements of the PREP Act and Declaration, there will be PREP Act coverage even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction. Section IX. Administration of Covered Countermeasures The Secretary amends Section IX to make explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. Section XI. Geographic Area The Secretary makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &.

Sons Metal Products, Inc. V. Darue Eng'g. &. Mf'g., 545 U.S.

308 (2005), in having a unified, whole-of-nation response to the erectile dysfunction treatment cialis among federal, state, local, and private-sector entities. The world is facing an unprecedented global cialis. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc.

V. Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.

Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons is an exclusive Federal cause of action against a Covered Person for death or serious physical injury proximately caused by willful misconduct by such Covered Person. In all other cases, an injured party's exclusive remedy is an administrative remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations. Section XII. Effective Time Period The Secretary amends Section XII to provide that liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begins with a “Declaration of Emergency,” as defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, PREP Act coverage began on August 24, 2020), and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

This change is to conform the text of the Declaration to the Third Amendment.[] The Secretary also amends Section XII to provide that liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begins on the date of this amended Declaration and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Because the Secretary is adding Section VII(c) to the Declaration in this Amendment, Section XII provides that Section VII(c) is effective as of the date this amended Declaration is published. Additional Amendments The Secretary also makes other, non-substantive amendments. Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Medical Countermeasures Against erectile dysfunction treatment To the extent any term previously in the Declaration, including its amendments, is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling. This Declaration must be construed in accordance with the Advisory Opinions Start Printed Page 79195of the Office of the General Counsel (Advisory Opinions).

I incorporate those Advisory Opinions as part of this Declaration.[] This Declaration is a “requirement” under the PREP Act. I. Determination of Public Health Emergency 42 U.S.C. 247d-6d(b)(1) I have determined that the spread of erectile dysfunction or a cialis mutating therefrom and the resulting disease erectile dysfunction treatment constitutes a public health emergency. I further determine that use of any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, is a priority for use during the public health emergency that I declared on January 31, 2020 under section 319 of the PHS Act for the entire United States to aid in the response of the nation's healthcare community to the erectile dysfunction treatment outbreak.

II. Factors Considered 42 U.S.C. 247d-6d(b)(6) I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures. III. Recommended Activities 42 U.S.C.

247d-6d(b)(1) I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures. IV. Liability Protections 42 U.S.C. 247d-6d(a), 247d-6d(b)(1) Liability protections as prescribed in the PREP Act and conditions stated in this Declaration are in effect for the Recommended Activities described in Section III. V.

Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability protections under this Declaration are “manufacturers,” “distributors,” “program planners,” and “qualified persons,” as those terms are defined in the PREP Act. Their officials, agents, and employees. And the United States. In addition, I have determined that the following additional persons are qualified persons.

(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of Emergency, as that term is defined in Section VII of this Declaration; [] (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), [] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) FDA-authorized or FDA-licensed erectile dysfunction treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. I.

The treatment must be authorized, approved, or licensed by the FDA. Ii http://www.soilplus.ro/member/mark-rupert/. In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

Iv. The licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Start Printed Page 79196Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. V.

The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vi. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; [] vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

Viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. And ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. X.

The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s). (e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered Countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such Covered Countermeasures. VI.

Covered Countermeasures 42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7) Covered Countermeasures are. (a) Any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any treatment manufactured, used, designed, developed, modified, licensed, or procured. I.

To diagnose, mitigate, prevent, treat, or cure erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom. Or ii. To limit the harm that erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom, might otherwise cause. (b) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in paragraph (a) above. (c) a product or technology intended to enhance the use or effect of a product described in paragraph (a) or (b) above.

Or (d) any device used in the administration of any such product, and all components and constituent materials of any such product. To be a Covered Countermeasure under the Declaration, a product must also meet 42 U.S.C. 247d-6d(i)(1)'s definition of “Covered Countermeasure.” VII. Limitations on Distribution 42 U.S.C. 247d-6d(a)(5) and (b)(2)(E) I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving.

(a) Covered Countermeasures that are related to present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements. (b) Covered Countermeasures that are related to activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of Emergency. Or (c) Covered Countermeasures that are. I. Licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit the harm from erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom.

OrStart Printed Page 79197 ii. A respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom. To qualify for this third distribution channel, a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval. As used in this Declaration, the terms “Authority Having Jurisdiction” and “Declaration of Emergency” have the following meanings. (a) The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.

(b) A Declaration of Emergency means any declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal declaration in support of an Emergency Use Authorization under Section 564 of the FD&C Act unless such declaration specifies otherwise. I have also determined that, for governmental program planners only, liability protections are afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (a) donation. (b) commercial sale. (c) deployment of Covered Countermeasures from federal stockpiles. Or (d) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only erectile dysfunction treatment caused by erectile dysfunction, or a cialis mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a cialis mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. IX. Administration of Covered Countermeasures 42 U.S.C.

247d-6d(a)(2)(B) Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures. Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to. . . The administration to.

. . An individual” under 42 U.S.C. 247d-6d. For example, consider a situation where there is only one dose [] of a erectile dysfunction treatment, and a person in a vulnerable population and a person in a less vulnerable population both request it from a healthcare professional.

In that situation, the healthcare professional administers the one dose to the person who is more vulnerable to erectile dysfunction treatment. In that circumstance, the failure to administer the erectile dysfunction treatment to the person in a less-vulnerable population “relat[es] to. . . The administration to” the person in a vulnerable population.

The person in the vulnerable population was able to receive the treatment only because it was not administered to the person in the less-vulnerable population. Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority's directive, can fall within the PREP Act and this Declaration's liability protections. X. Population 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C) The populations of individuals to whom the liability protections of this Declaration extend include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration.

Liability protections are afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population. XI. Geographic Area 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D) Liability protections are afforded for the administration or use of a Covered Countermeasure without geographic limitation.

Liability protections are afforded to manufacturers and distributors without regard to whether the Covered Countermeasure is used by or administered in any designated geographic area. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area. erectile dysfunction treatment is a global challenge that requires a whole-of-nation response. There are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc.

V. Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the erectile dysfunction treatment cialis among federal, state, local, and private-sector entities.

The world is facing an unprecedented cialis. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act. Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person.

In all other cases, an injured party's exclusive remedy is an administrative Start Printed Page 79198remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations.[] XII. Effective Time Period 42 U.S.C. 247d-6d(b)(2)(B) Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024. Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024.

Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on the date of this amended Declaration and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C) I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.

Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS. XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d-6e The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services.

Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/​cicp/​. XV. Amendments 42 U.S.C. 247d-6d(b)(4) Amendments to this Declaration will be published in the Federal Register, as warranted. Start Authority 42 U.S.C.

247d-6d. End Authority Start Signature Dated. December 3, 2020. Alex M. Azar II, Secretary of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-26977 Filed 12-8-20. 8:45 am]BILLING CODE 4150-37-P.

Start Preamble Notice how much does generic cialis cost of Amendment and Republished Declaration. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to amend his March 10, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against erectile dysfunction treatment. The amendments to the Declaration are applicable how much does generic cialis cost as of February 4, 2020, except as otherwise specified in Section XII. Start Further Info Robert P.

Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue Start Printed Page 79191SW, Washington, DC 20201. Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C.

247d-6d et. Seq., authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct,” as defined in the PREP Act. Such declarations are subject to amendment as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2.

It amended the Public Health Service (PHS) Act, adding Section 319F-3, which addresses liability immunity, and Section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

Section 319F-3 of the PHS Act has been amended by the cialis and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the erectile dysfunction Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response to the erectile dysfunction Disease 2019 (erectile dysfunction treatment) outbreak, which subsequently became a global cialis. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 21, 2020, July 23, 2020, and October 2, 2020.

On March 10, 2020, the Secretary issued a declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment.[] On April 10, the Secretary amended the Declaration to extend liability protections to Covered Countermeasures authorized under the CARES Act.[] On June 4, the Secretary amended the Declaration to clarify that Covered Countermeasures under the Declaration include qualified cialis and epidemic products that limit the harm that erectile dysfunction treatment might otherwise cause.[] On August 19, the Secretary amended the Declaration to add additional categories of Qualified Persons and to amend the category of disease, health condition, or threat for which he recommends the administration or use of Covered Countermeasures.[] The Secretary now further amends the Declaration pursuant to section 319F-3 of the Public Health Service Act. This Fourth Amendment to the Declaration. (a) Clarifies that the Declaration must be construed in accordance with the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) Advisory Opinions on the Public Readiness and Emergency Preparedness Act and the Declaration (Advisory Opinions).[] The Declaration incorporates the Advisory Opinions for that purpose. (b) Incorporates authorizations that the HHS Office of the Assistant Secretary for Health (OASH) has issued as an Authority Having Jurisdiction.[] (c) Adds an additional category of Qualified Persons under Section V of the Declaration and 42 U.S.C.

247d-6d(i)(8)(B), i.e., healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.[] (d) Modifies and clarifies the training requirements for certain licensed pharmacists and pharmacy interns to administer certain routine childhood or erectile dysfunction treatment vaccinations. (e) Makes explicit that Section VI covers all qualified cialis and epidemic products under the PREP Act. (f) Adds a third method of distribution under Section VII of the Declaration and 42 U.S.C. 247d-6d(a)(5) that would provide liability protections for, among other things, additional private-distribution channels.

(g) Makes explicit in Section IX that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. (h) Makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests, in having a unified, whole-of-nation response to the erectile dysfunction treatment cialis among federal, state, local, and private-sector entities. The world is facing an unprecedented cialis. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.Start Printed Page 79192 (i) Revises the effective time period of the Declaration in light of the amendments to the Declaration.[] The Secretary republishes the Declaration, as amended, in full.

Unless otherwise noted, all statutory citations are to the U.S. Code. Description of This Amendment Declaration The Declaration has fifteen sections describing PREP Act coverage for medical countermeasures against erectile dysfunction treatment. OGC has issued Advisory Opinions interpreting the PREP Act and reflecting the Secretary's interpretation of the Declaration.[] The Secretary now amends the Declaration to clarify that the Declaration must be construed in accordance with the Advisory Opinions.

The Secretary expressly incorporates the Advisory Opinions for that purpose. Section V. Covered Persons Section V of the Declaration describes Covered Persons, including additional qualified persons identified by the Secretary, as required under the PREP Act. The Secretary amends Section V to specify an additional category of qualified persons.

Specifically, healthcare personnel who are permitted to order and administer a Covered Countermeasure through telehealth in a state may do so for patients in another state so long as the healthcare personnel comply with the legal requirements of the state in which the healthcare personnel are permitted to order and administer the Covered Countermeasure by means of telehealth. Telehealth is widely recognized as a valuable tool to promote public health during this cialis. According to the Centers for Disease Control and Prevention (CDC), Telehealth services can facilitate public health mitigation strategies during this cialis by increasing social distancing. These services can be a safer option for [healthcare personnel (HCP)] and patients by reducing potential infectious exposures.

They can reduce the strain on healthcare systems by minimizing the surge of patient demand on facilities and reduce the use of [personal protective equipment (PPE)] by healthcare providers. Maintaining continuity of care to the extent possible can avoid additional negative consequences from delayed preventive, chronic, or routine care. Remote access to healthcare services may increase participation for those who are medically or socially vulnerable or who do not have ready access to providers. Remote access can also help preserve the patient-provider relationship at times when an in-person visit is not practical or feasible.

Telehealth services can be used to. Screen patients who may have symptoms of erectile dysfunction treatment and refer as appropriate Provide low-risk urgent care for non-erectile dysfunction treatment conditions, identify those persons who may need additional medical consultation or assessment, and refer as appropriate Access primary care providers and specialists, including mental and behavioral health, for chronic health conditions and medication management Provide coaching and support for patients managing chronic health conditions, including weight management and nutrition counseling Participate in physical therapy, occupational therapy, and other modalities as a hybrid approach to in-person care for optimal health Monitor clinical signs of certain chronic medical conditions (e.g., blood pressure, blood glucose, other remote assessments) Engage in case management for patients who have difficulty accessing care (e.g., those who live in very rural settings, older adults, those with limited mobility) Follow up with patients after hospitalization Deliver advance care planning and counseling to patients and caregivers to document preferences if a life-threatening event or medical crisis occurs Provide non-emergent care to residents in long-term care facilities Provide education and training for HCP through peer-to-peer professional medical consultations (inpatient or outpatient) that are not locally available, particularly in rural areas.[] Similarly, CMS has stressed the importance of telehealth during this cialis. Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient's health. Innovative uses of this kind of technology in the provision of healthcare is increasing.

And with the emergence of the cialis causing the disease erectile dysfunction treatment, there is an urgency to expand the use of technology to help people who need routine care, and keep vulnerable beneficiaries and beneficiaries with mild symptoms in their homes while maintaining access to the care they need. Limiting community spread of the cialis, as well as limiting the exposure to other patients and staff members will slow viral spread.[] Accordingly, CMS and other HHS components has substantially expanded the scope of services paid under Medicare when furnished using telehealth technologies during this cialis. Other HHS components have also taken steps to expand the use of telehealth during the cialis.[] Moreover, to expand the use of telehealth during this cialis, the Office for Civil Rights (OCR) at HHS is exercising enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA) Rules against covered healthcare providers that serve patients through everyday communications technologies during the erectile dysfunction treatment nationwide public health emergency.[] This exercise of discretion Start Printed Page 79193applies to widely available communications apps, such as FaceTime or Skype, when used in good faith for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to erectile dysfunction treatment.[] Many states have authorized out-of-state healthcare personnel to deliver telehealth services to in-state patients, either generally or in the context of erectile dysfunction treatment.[] To help maximize the utility of telehealth, the Secretary declares that the term “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) includes healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.

When ordering and administering Covered Countermeasures through telehealth to patients in a state where the healthcare personnel are not already permitted to do so, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients through telehealth in the state where the healthcare personnel are licensed or otherwise permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. The Secretary also amends Section V to include several examples of Covered Persons who are Qualified Persons, because they are authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures. Those examples include certain pharmacists, pharmacy interns, and pharmacy technicians who order or administer certain erectile dysfunction treatment tests and certain treatments.[] These examples are not an exclusive or exhaustive list of persons who are qualified persons identified by the Secretary in Section V.

The Secretary also amends Section V to make explicit that the requirement in that section for certain qualified persons to have a current certificate in basic cardiopulmonary resuscitation is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education (ACPE), or the Accreditation Council for Continuing Medical Education. The Secretary also amends Section V's training requirements for licensed pharmacists to order and administer certain childhood or erectile dysfunction treatments. To order and administer treatments, the licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Other than the basic cardiopulmonary resuscitation requirement and the practical training program requirement, this Amendment does not change the requirements for a pharmacist, pharmacy intern, or pharmacy technician to be a “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) who can order or administer childhood or erectile dysfunction treatments pursuant to the Declaration. Section VI.

Covered Countermeasures The Secretary amends Section VI to make explicit that Section VI covers all qualified cialis and epidemic products under the PREP Act.Start Printed Page 79194 Section VII. Limitations on Distribution The Secretary may specify that liability protections are in effect only for Covered Countermeasures obtained through a particular means of distribution. The Declaration previously stated that liability immunity is afforded to Covered Persons only for Recommended Activities related to (a) present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements. Or (b) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a declaration of an emergency.

erectile dysfunction treatment is an unprecedented global challenge that requires a whole-of-nation response that utilizes federal-, state-, and local- distribution channels as well as private-distribution channels. Given the broad scale of this cialis, the Secretary amends the Declaration to extend PREP Act coverage to additional private-distribution channels, as set forth below. The amended Section VII adds that PREP Act liability protections also extend to Covered Persons for Recommended Activities that are related to any Covered Countermeasure that is. (a) Licensed, approved, cleared, or authorized by the Food and Drug Administration (FDA) (or that is permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the Federal Food, Drug, and Cosmetic (FD&C) Act or Public Health Service (PHS) Act to treat, diagnose, cure, prevent, mitigate or limit the harm from erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom.

Or (b) a respiratory protective device approved by the National Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from, erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom. To qualify for this third distribution channel (but not necessarily to qualify for the other distribution channels), a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval. This third distribution channel may extend PREP Act coverage when there is no federal agreement or authorization in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency. For example, a manufacturer, distributor, program planner, or qualified person engages in manufacturing, testing, development, distribution, administration, or use of a erectile dysfunction treatment test pursuant to an FDA Emergency Use Authorization for that erectile dysfunction treatment test.

If the Covered Person satisfies all other requirements of the PREP Act and Declaration, there will be PREP Act coverage even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction. Section IX. Administration of Covered Countermeasures The Secretary amends Section IX to make explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. Section XI.

Geographic Area The Secretary makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V. Darue Eng'g.

&. Mf'g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the erectile dysfunction treatment cialis among federal, state, local, and private-sector entities. The world is facing an unprecedented global cialis.

To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.

Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons is an exclusive Federal cause of action against a Covered Person for death or serious physical injury proximately caused by willful misconduct by such Covered Person. In all other cases, an injured party's exclusive remedy is an administrative remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations. Section XII.

Effective Time Period The Secretary amends Section XII to provide that liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begins with a “Declaration of Emergency,” as defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, PREP Act coverage began on August 24, 2020), and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. This change is to conform the text of the Declaration to the Third Amendment.[] The Secretary also amends Section XII to provide that liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begins on the date of this amended Declaration and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Because the Secretary is adding Section VII(c) to the Declaration in this Amendment, Section XII provides that Section VII(c) is effective as of the date this amended Declaration is published. Additional Amendments The Secretary also makes other, non-substantive amendments.

Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Medical Countermeasures Against erectile dysfunction treatment To the extent any term previously in the Declaration, including its amendments, is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling. This Declaration must be construed in accordance with the Advisory Opinions Start Printed Page 79195of the Office of the General Counsel (Advisory Opinions). I incorporate those Advisory Opinions as part of this Declaration.[] This Declaration is a “requirement” under the PREP Act. I.

Determination of Public Health Emergency 42 U.S.C. 247d-6d(b)(1) I have determined that the spread of erectile dysfunction or a cialis mutating therefrom and the resulting disease erectile dysfunction treatment constitutes a public health emergency. I further determine that use of any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, is a priority for use during the public health emergency that I declared on January 31, 2020 under section 319 of the PHS Act for the entire United States to aid in the response of the nation's healthcare community to the erectile dysfunction treatment outbreak. II.

Factors Considered 42 U.S.C. 247d-6d(b)(6) I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures. III. Recommended Activities 42 U.S.C.

247d-6d(b)(1) I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures. IV. Liability Protections 42 U.S.C. 247d-6d(a), 247d-6d(b)(1) Liability protections as prescribed in the PREP Act and conditions stated in this Declaration are in effect for the Recommended Activities described in Section III.

V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability protections under this Declaration are “manufacturers,” “distributors,” “program planners,” and “qualified persons,” as those terms are defined in the PREP Act. Their officials, agents, and employees.

And the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of Emergency, as that term is defined in Section VII of this Declaration; [] (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

(d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), [] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) FDA-authorized or FDA-licensed erectile dysfunction treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. I. The treatment must be authorized, approved, or licensed by the FDA.

Ii. In the case of a erectile dysfunction treatment, the vaccination must be ordered and administered according to ACIP's erectile dysfunction treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

Iv. The licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Start Printed Page 79196Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

V. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vi.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; [] vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. Viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment.

And ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. X. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) erectile dysfunction treatment vaccination provider agreement and any other federal requirements that apply to the administration of erectile dysfunction treatment(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered Countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such Covered Countermeasures.

VI. Covered Countermeasures 42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7) Covered Countermeasures are.

(a) Any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any treatment manufactured, used, designed, developed, modified, licensed, or procured. I. To diagnose, mitigate, prevent, treat, or cure erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom. Or ii.

To limit the harm that erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom, might otherwise cause. (b) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in paragraph (a) above. (c) a product or technology intended to enhance the use or effect of a product described in paragraph (a) or (b) above. Or (d) any device used in the administration of any such product, and all components and constituent materials of any such product.

To be a Covered Countermeasure under the Declaration, a product must also meet 42 U.S.C. 247d-6d(i)(1)'s definition of “Covered Countermeasure.” VII. Limitations on Distribution 42 U.S.C. 247d-6d(a)(5) and (b)(2)(E) I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving.

(a) Covered Countermeasures that are related to present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements. (b) Covered Countermeasures that are related to activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of Emergency. Or (c) Covered Countermeasures that are. I.

Licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit the harm from erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom. OrStart Printed Page 79197 ii. A respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from erectile dysfunction treatment, or the transmission of erectile dysfunction or a cialis mutating therefrom. To qualify for this third distribution channel, a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval.

As used in this Declaration, the terms “Authority Having Jurisdiction” and “Declaration of Emergency” have the following meanings. (a) The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority. (b) A Declaration of Emergency means any declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal declaration in support of an Emergency Use Authorization under Section 564 of the FD&C Act unless such declaration specifies otherwise. I have also determined that, for governmental program planners only, liability protections are afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (a) donation.

(b) commercial sale. (c) deployment of Covered Countermeasures from federal stockpiles. Or (d) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only erectile dysfunction treatment caused by erectile dysfunction, or a cialis mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a cialis mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. IX. Administration of Covered Countermeasures 42 U.S.C.

247d-6d(a)(2)(B) Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures. Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to. . .

The administration to. . . An individual” under 42 U.S.C.

247d-6d. For example, consider a situation where there is only one dose [] of a erectile dysfunction treatment, and a person in a vulnerable population and a person in a less vulnerable population both request it from a healthcare professional. In that situation, the healthcare professional administers the one dose to the person who is more vulnerable to erectile dysfunction treatment. In that circumstance, the failure to administer the erectile dysfunction treatment to the person in a less-vulnerable population “relat[es] to.

. . The administration to” the person in a vulnerable population. The person in the vulnerable population was able to receive the treatment only because it was not administered to the person in the less-vulnerable population.

Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority's directive, can fall within the PREP Act and this Declaration's liability protections. X. Population 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C) The populations of individuals to whom the liability protections of this Declaration extend include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration.

Liability protections are afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population. XI. Geographic Area 42 U.S.C.

247d-6d(a)(4), 247d-6d(b)(2)(D) Liability protections are afforded for the administration or use of a Covered Countermeasure without geographic limitation. Liability protections are afforded to manufacturers and distributors without regard to whether the Covered Countermeasure is used by or administered in any designated geographic area. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area. erectile dysfunction treatment is a global challenge that requires a whole-of-nation response.

There are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V. Darue Eng'g.

&. Mf'g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the erectile dysfunction treatment cialis among federal, state, local, and private-sector entities. The world is facing an unprecedented cialis.

To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.

Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person. In all other cases, an injured party's exclusive remedy is an administrative Start Printed Page 79198remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations.[] XII. Effective Time Period 42 U.S.C.

247d-6d(b)(2)(B) Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024. Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024. Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on the date of this amended Declaration and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C) I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures. Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS.

XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d-6e The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services.

Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/​cicp/​. XV. Amendments 42 U.S.C. 247d-6d(b)(4) Amendments to this Declaration will be published in the Federal Register, as warranted.

Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated. December 3, 2020.

Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-26977 Filed 12-8-20.

Where should I keep Cialis?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

36 hour cialis reviews

Whether you 36 hour cialis reviews call them feral pigs, boar, swine, hogs, or even razorbacks, wild pigs are one of the most damaging invasive species on Earth, and they’re notorious site for damaging agriculture and native wildlife. A big reason they’re so harmful is because they uproot soil at vast scales, like tractors ploughing a field. Our new research, published today, is the first to calculate the global extent of this and its implications for carbon emissions.

Our findings were 36 hour cialis reviews staggering. We discovered the cumulative area of soil uprooted by wild pigs is likely the same area as Taiwan. This releases 4.9 million tonnes of carbon dioxide each year — the same as one million cars.

The majority of these 36 hour cialis reviews emissions occur in Oceania. A huge portion of Earth’s carbon is stored in soil, so releasing even a small fraction of this into the atmosphere can have a huge impact on climate change. The problem with pigs Wild pigs (Sus scrofa) are native throughout much of Europe and Asia, but today they live on every continent except Antarctica, making them one of the most widespread invasive mammals on the planet.

An estimated three million wild pigs live 36 hour cialis reviews in Australia alone. It’s estimated that wild pigs destroy more than A$100 million (US$74 million) worth of crops and pasture each year in Australia, and more than US$270 million (A$366 million) in just 12 states in the USA. Wild pigs have also been found to directly threaten 672 vertebrate and plant species across 54 different countries.

This includes imperilled Australian ground frogs, tree frogs and multiple orchid species, as pigs destroy their 36 hour cialis reviews habitats and prey on them. [embedded content] Their geographic range is expected to expand in the coming decades, suggesting their threats to food security and biodiversity will likely worsen. But here, let’s focus on their contribution to global emissions.

Their carbon hoofprint Previous 36 hour cialis reviews research has highlighted the potential contribution of wild pigs to greenhouse gas emissions, but only at local scales. One such study was conducted for three years in hardwood forests of Switzerland. The researchers found wild pigs caused soil carbon emissions to increase by around 23% per year.

Similarly, a study in the Jigong 36 hour cialis reviews Mountains National Nature Reserve in China found soil emissions increased by more than 70% per year in places disturbed by wild pigs. To find out what the impact was on a global scale, we ran 10,000 simulations of wild pig population sizes in their non-native distribution, including in the Americas, Oceania, Africa and parts of Southeast Asia. For each simulation, we determined the amount of soil they would disturb using another model from a different study.

Lastly, we used local case studies to calculate the minimum 36 hour cialis reviews and maximum amount of wild pig-driven carbon emissions. And we estimate the soil wild pigs uproot worldwide each year is likely between 36,214 and 123,517 square kilometres — or between the sizes of Taiwan and England. Most of this soil damage and associated emissions occur in Oceania due to the large distribution of wild pigs there, and the amount of carbon stored in the soil in this region.

So how exactly does disturbing soil release emissions? 36 hour cialis reviews. Wild pigs use their tough snouts to excavate soil in search of plant parts such as roots, fungi and invertebrates. This “ploughing” behaviour commonly disturbs soil at a depth of about five to 15 centimetres, which is roughly the same depth as crop tilling by farmers.

Because wild pigs are highly social 36 hour cialis reviews and often feed in large groups, they can completely destroy a small paddock in a short period. This makes them a formidable foe to the organic carbon stored in soil. In general, soil organic carbon is the balance between organic matter input into the soil (such as fungi, animal waste, root growth and leaf litter) versus outputs (such as decomposition, respiration and erosion).

This balance is an 36 hour cialis reviews indicator of soil health. When soils are disturbed, whether from ploughing a field or from an animal burrowing or uprooting, carbon is released into the atmosphere as a greenhouse gas. This is because digging up soil exposes it to oxygen, and oxygen promotes the rapid growth of microbes.

These newly invigorated microbes, in turn, break down the organic matter containing 36 hour cialis reviews carbon. Tough and cunning Wild pig control is incredibly difficult and costly due to their cunning behaviour, rapid breeding rate, and overall tough nature. For example, wild pigs have been known to avoid traps if they had been previously caught, and they are skilled at changing their behaviour to avoid hunters.

In Australia, management efforts include coordinated 36 hour cialis reviews hunting events to slow the spread of wild pig populations. Other techniques include setting traps and installing fences to prevent wild pig expansion, or aerial control programs. Some of these control methods can also cause substantial carbon emissions, such as using helicopters for aerial control and other vehicles for hunting.

Still, the long-term benefits of wild pig reduction may far outweigh these 36 hour cialis reviews costs. Working towards reduced global emissions is no simple feat, and our study is another tool in the toolbox for assessing the threats of this widespread invasive species. This article was originally published on The Conversation.

Whether you call them how much does generic cialis cost feral pigs, boar, swine, hogs, or even razorbacks, wild pigs are one of the most damaging invasive species on Earth, and they’re notorious for damaging Buy renova zero agriculture and native wildlife. A big reason they’re so harmful is because they uproot soil at vast scales, like tractors ploughing a field. Our new research, published today, is the first to calculate the global extent of this and its implications for carbon emissions.

Our findings how much does generic cialis cost were staggering. We discovered the cumulative area of soil uprooted by wild pigs is likely the same area as Taiwan. This releases 4.9 million tonnes of carbon dioxide each year — the same as one million cars.

The majority how much does generic cialis cost of these emissions occur in Oceania. A huge portion of Earth’s carbon is stored in soil, so releasing even a small fraction of this into the atmosphere can have a huge impact on climate change. The problem with pigs Wild pigs (Sus scrofa) are native throughout much of Europe and Asia, but today they live on every continent except Antarctica, making them one of the most widespread invasive mammals on the planet.

An estimated three million how much does generic cialis cost wild pigs live in Australia alone. It’s estimated that wild pigs destroy more than A$100 million (US$74 million) worth of crops and pasture each year in Australia, and more than US$270 million (A$366 million) in just 12 states in the USA. Wild pigs have also been found to directly threaten 672 vertebrate and plant species across 54 different countries.

This includes imperilled Australian ground frogs, tree frogs and multiple orchid species, as pigs destroy their habitats and prey on them how much does generic cialis cost. [embedded content] Their geographic range is expected to expand in the coming decades, suggesting their threats to food security and biodiversity will likely worsen. But here, let’s focus on their contribution to global emissions.

Their carbon how much does generic cialis cost hoofprint Previous research has highlighted the potential contribution of wild pigs to greenhouse gas emissions, but only at local scales. One such study was conducted for three years in hardwood forests of Switzerland. The researchers found wild pigs caused soil carbon emissions to increase by around 23% per year.

Similarly, a study how much does generic cialis cost in the Jigong Mountains National Nature Reserve in China found soil emissions increased by more than 70% per year in places disturbed by wild pigs. To find out what the impact was on a global scale, we ran 10,000 simulations of wild pig population sizes in their non-native distribution, including in the Americas, Oceania, Africa and parts of Southeast Asia. For each simulation, we determined the amount of soil they would disturb using another model from a different study.

Lastly, we used local case studies to calculate the minimum how much does generic cialis cost and maximum amount of wild pig-driven carbon emissions. And we estimate the soil wild pigs uproot worldwide each year is likely between 36,214 and 123,517 square kilometres — or between the sizes of Taiwan and England. Most of this soil damage and associated emissions occur in Oceania due to the large distribution of wild pigs there, and the amount of carbon stored in the soil in this region.

So how how much does generic cialis cost exactly does disturbing soil release emissions?. Wild pigs use their tough snouts to excavate soil in search of plant parts such as roots, fungi and invertebrates. This “ploughing” behaviour commonly disturbs soil at a depth of about five to 15 centimetres, which is roughly the same depth as crop tilling by farmers.

Because wild pigs are highly social and often feed in large groups, they can completely destroy a small paddock in a short period how much does generic cialis cost. This makes them a formidable foe to the organic carbon stored in soil. In general, soil organic carbon is the balance between organic matter input into the soil (such as fungi, animal waste, root growth and leaf litter) versus outputs (such as decomposition, respiration and erosion).

This balance is an indicator of soil how much does generic cialis cost health. When soils are disturbed, whether from ploughing a field or from an animal burrowing or uprooting, carbon is released into the atmosphere as a greenhouse gas. This is because digging up soil exposes it to oxygen, and oxygen promotes the rapid growth of microbes.

These newly invigorated microbes, in turn, break down the organic matter containing carbon how much does generic cialis cost. Tough and cunning Wild pig control is incredibly difficult and costly due to their cunning behaviour, rapid breeding rate, and overall tough nature. For example, wild pigs have been known to avoid traps if they had been previously caught, and they are skilled at changing their behaviour to avoid hunters.

In Australia, management efforts how much does generic cialis cost include coordinated hunting events to slow the spread of wild pig populations. Other techniques include setting traps and installing fences to prevent wild pig expansion, or aerial control programs. Some of these control methods can also cause substantial carbon emissions, such as using helicopters for aerial control and other vehicles for hunting.

Still, the long-term benefits of wild pig how much does generic cialis cost reduction may far outweigh these costs. Working towards reduced global emissions is no simple feat, and our study is another tool in the toolbox for assessing the threats of this widespread invasive species. This article was originally published on The Conversation.

Cialis 5 mg tablet

Jorge Salazar cialis 5 mg tablet is the kind of doctor who thrives in diverse environments – he always has cialis 20mg price walmart. Jorge Salazar wins the inaugural award for contributions to equity, diversity and inclusion in Graduate Medical Education.Born in San Luis Potosí, Mexico, he was raised near the University of Alabama at Birmingham, where his parents worked at a research lab.He attended Meharry Medical College, a historically black academic health science center in Nashville that has trained thousands of students to serve the underserved.Coming to UC Davis three years ago for cialis 5 mg tablet an internal medicine residency was a natural match, he said, because he wanted to train in “a diverse and inclusive community.”So perhaps it shouldn’t be all that surprising that Salazar’s enthusiastic desire to influence those around him about the importance of equity, diversity and inclusion in health care has won him special recognition from the UC Davis School of Medicine.Salazar is the inaugural recipient of the Postgraduate Trainee Award in Equity, Diversity and Inclusion (EDI).Honorable mention went to Bethel Essaw, who made significant contributions to EDI in research, clinical care and education. She also helped launch the UC Davis Black Resident Organization.The award was recently created by the Resident Medical Staff Committee with support from Graduate Medical Education and the Office of Student and Resident Diversity.“We hope that this award will help to demonstrate for those in the health system who are not trainees that residents and fellows have been working on EDI in spaces that span education, clinical care, and research,” said Erik Fernández y García, a UC Davis Health pediatrician and director for diversity in the office of Graduate Medical Education.Salazar was selected for a number of reasons, including:His leadership role as chair of the Diversity, Inclusion and Community Engagement Committee within the department of internal medicine (DICE)Helping organize forums for trainees to safely discuss EDI and social justice issuesEnlisting speakers for internal medicine Grand Rounds discussions and executing several events to help recruit trainees from underrepresented backgroundsHis stellar dedication to clinical duties as part of the Transforming Education and Community Heath (TEACH) programEducating the community about erectile dysfunction treatment through public forums in English and Spanish“I feel honored to have been selected for this award,” Salazar said, “especially because there were many amazing individuals who had a tremendous impact on our community and health system in regard to EDI efforts.”Bethel Essaw, who helped launch the UC Davis Black Resident Organization, receives honorable mention.Like many trainees connected to the School of Medicine, Salazar is a fervent believer that institutions that are focused on health equity contribute to better patient outcomes and improve their quality of life.“Diversity, inclusion, and equity must be adopted at all levels to work in synchrony,” he said. €œIt includes our first responders, nurses, discharge planners, physical and occupational therapists, respiratory therapists, primary providers, specialists, and so on.”UC Davis’ commitment to health equity was a major draw for Salazar when he was seeking an internal medicine residency.“One of the main aspects I was cialis 5 mg tablet looking for was a diverse and inclusive community reflected in both the health system and in the patient population,” he said.

€œOf all the places I interviewed, UC Davis demonstrated that the best and I ranked UC Davis number one on my cialis 5 mg tablet match list.”Salazar has spent quality time outside clinical hours to help others appreciate diversity.The death of George Floyd in May 2020 prompted the internal medicine DICE group to take a leading role in discussions over Zoom that allowed residents to “reflect and process the traumatic current events we were witnessing,” Salazar said, “and to also share any experiences of injustice or discrimination we had felt in our own lives.”He described the online sessions as “emotional, but therapeutic.”Salazar’s three-year residency comes to an end on June 30. The day after, he’ll start a fellowship in infectious diseases at UCSF where his training no doubt will focus on erectile dysfunction treatment.He is grateful for the invaluable connections and friendships forged with residents and faculty.“There’s nothing quite like residency training,” Salazar said, “especially with the development of a cialis right in the middle of it.”Gabriel “Gabe” Gonzalez thought the summer after his senior year would be spent hanging out with friends. But for the past five weeks, he cialis 5 mg tablet hasn’t seen one of them. Gabriel Gonzalez smiles at former teammates and cialis 5 mg tablet friends.

The 18-year-old is being treated for third-degree burns over 46% of his body.Instead, the Woodcreek High School graduate spends his days undergoing physical therapy (PT) and recovering from third-degree burns over 46% of his body at the Firefighters Burn Institute Regional Burn Center at UC Davis Medical Center.“Overall, he’s doing pretty well,” said Coleen Gonzalez, his mom. €œThe doctors and nurses here have been absolutely cialis 5 mg tablet wonderful. Because he’s young, healthy and strong, everyone has been positive he’ll get through this since day one.”A tragic accidentBefore cialis 5 mg tablet graduating, Gonzalez played right guard for the Woodcreek Timberwolves in Roseville. He was with some of his football teammates and other friends at a post-prom party on May 16 when disaster struck.A firepit accident sparked uncontrollable flames.

Four people cialis 5 mg tablet were rushed to the hospital. Gonzalez and Jackson Allen required treatment at the burn center.“It cialis 5 mg tablet was horrible. Burns all over his hands, arms and legs,” his mom recalled.The two survivors kept tabs on each other while both were in the hospital. Allen was cialis 5 mg tablet discharged in early June.

But for Gonzalez, the summer hanging out with friends was put cialis 5 mg tablet on hold.His parents, Coleen and José, are with him every day. They were there after two surgeries. They are there after daily sessions with the physical therapists.A surprise visitThen, on June 24, cialis 5 mg tablet Gabriel Gonzalez received some new visitors. 40 former teammates and cialis 5 mg tablet friends surprised him at UC Davis Medical Center.

They gathered outside his second-floor window, thinking they would only get to wave to him.Meanwhile inside, Gonzalez thought his therapist was taking him outside for a new PT exercise. When he cialis 5 mg tablet was wheeled out, the shocked faces — from both the teammates and Gonzalez— could not be contained.Not only was it his first time to see friends, but it was also his first trip outside the hospital since May 17. He smiled at a sea of friends cialis 5 mg tablet dressed in pink t-shirts — his favorite color — donning his jersey number — 67 — and holding posters that read, “Stay strong brotha,” “Gabriel u got this” and “Life is tough, but so are you.”“I had no idea there would be so many of his teammates here. It really lifted his spirits and he did not want the time with friends and teammates to end,” said his mom.

€œA huge thank you to everyone at UC Davis cialis 5 mg tablet for making this happen.”Gonzalez’ therapist rolled his wheelchair in front of the team. Then, to everyone’s surprise, Gonzalez stood and walked roughly 20 feet.Encouraged by his PT team, Gabriel Gonzalez shows his recovery progress by standing and walking, while cialis 5 mg tablet well-wishers cheer him on. €œIt was great. It felt good,” Gonzalez cialis 5 mg tablet said.

€œDefinitely surprised.”The moment felt good for his supporters as well.“It was such a surprise to be able to see and cialis 5 mg tablet talk to him in person. The worst is over. It is only going to get better from here,” said graduating cialis 5 mg tablet football teammate Scott Miller. €œGabriel was never in a bad mood during football practice and his same high spirits will help him recover from this.”“The entire Wolf Pack, made up of family and friends, is behind Gabriel and has been keeping him in their thoughts and cialis 5 mg tablet prayers,” added his aunt, Janine Loving.

€œSeeing him for the first time in two months was phenomenal and brought instant tears.”Unexpected supportColleen Gonzalez says this surprise visit is just one more way their family has not felt alone during this ordeal.“All the support from our family and the community has been overwhelming. I’m amazed at how cialis 5 mg tablet much they have come together to help us,” she said. €œAnd the team cialis 5 mg tablet here at UC Davis. I’ve always heard UC Davis is great, but we had never experienced it, thank goodness, until now.

We’re so fortunate to have such a burn unit in our backyard.”Gabriel Gonzalez, third from left, celebrates senior night at Woodcreek High School with his brother, Alexander cialis 5 mg tablet. Mom, Coleen cialis 5 mg tablet. And father, José.“Burn care, similar to football, is a team effort. The UC Davis burn team united to provide him with state-of-the-art cialis 5 mg tablet care that will enable him to rejoin his teammates and return to a normal life,” said Tina Louise Palmieri, chief burn surgeon.The tragedy also offered an opportunity to educate young people on the dangers of fire.“Doesn’t take much for a fire to turn life-threatening,” said Kevin Snider, a retired chief — now senior chaplain — of the Sacramento Metropolitan Fire District.

€œNever pour any flammable liquid, cialis 5 mg tablet including gasoline, on an open fire. Fumes can travel and land on clothing of individuals, catching them instantly on fire.”When Gabriel Gonzalez returns to his normal life, he still has a team behind him. A new support group cialis 5 mg tablet for young adult burn survivors launches in July in collaboration with the Firefighters Burn Institute.“We feel young adults face unique challenges during their healing process,” said Lauren Spink, burn outreach coordinator. €œThis group is where burn survivors can support each other no matter where they are in their recovery.”When he’s discharged in the coming weeks, Gabriel Gonzalez looks forward to going back to the gym, starting Sierra College in the fall and yes, hanging out and playing video games with friends..

Jorge Salazar is the how much does generic cialis cost kind of doctor who thrives cialis online usa in diverse environments – he always has. Jorge Salazar wins the inaugural award for contributions to equity, diversity and inclusion in Graduate Medical Education.Born in San Luis Potosí, Mexico, he how much does generic cialis cost was raised near the University of Alabama at Birmingham, where his parents worked at a research lab.He attended Meharry Medical College, a historically black academic health science center in Nashville that has trained thousands of students to serve the underserved.Coming to UC Davis three years ago for an internal medicine residency was a natural match, he said, because he wanted to train in “a diverse and inclusive community.”So perhaps it shouldn’t be all that surprising that Salazar’s enthusiastic desire to influence those around him about the importance of equity, diversity and inclusion in health care has won him special recognition from the UC Davis School of Medicine.Salazar is the inaugural recipient of the Postgraduate Trainee Award in Equity, Diversity and Inclusion (EDI).Honorable mention went to Bethel Essaw, who made significant contributions to EDI in research, clinical care and education. She also helped launch the UC Davis Black Resident Organization.The award was recently created by the Resident Medical Staff Committee with support from Graduate Medical Education and the Office of Student and Resident Diversity.“We hope that this award will help to demonstrate for those in the health system who are not trainees that residents and fellows have been working on EDI in spaces that span education, clinical care, and research,” said Erik Fernández y García, a UC Davis Health pediatrician and director for diversity in the office of Graduate Medical Education.Salazar was selected for a number of reasons, including:His leadership role as chair of the Diversity, Inclusion and Community Engagement Committee within the department of internal medicine (DICE)Helping organize forums for trainees to safely discuss EDI and social justice issuesEnlisting speakers for internal medicine Grand Rounds discussions and executing several events to help recruit trainees from underrepresented backgroundsHis stellar dedication to clinical duties as part of the Transforming Education and Community Heath (TEACH) programEducating the community about erectile dysfunction treatment through public forums in English and Spanish“I feel honored to have been selected for this award,” Salazar said, “especially because there were many amazing individuals who had a tremendous impact on our community and health system in regard to EDI efforts.”Bethel Essaw, who helped launch the UC Davis Black Resident Organization, receives honorable mention.Like many trainees connected to the School of Medicine, Salazar is a fervent believer that institutions that are focused on health equity contribute to better patient outcomes and improve their quality of life.“Diversity, inclusion, and equity must be adopted at all levels to work in synchrony,” he said. €œIt includes our first responders, how much does generic cialis cost nurses, discharge planners, physical and occupational therapists, respiratory therapists, primary providers, specialists, and so on.”UC Davis’ commitment to health equity was a major draw for Salazar when he was seeking an internal medicine residency.“One of the main aspects I was looking for was a diverse and inclusive community reflected in both the health system and in the patient population,” he said. €œOf all the places I interviewed, UC Davis demonstrated that the best and I ranked UC Davis number one on my match list.”Salazar has spent quality time outside clinical hours to help others appreciate diversity.The death of George Floyd in May 2020 prompted the internal medicine DICE group to take a leading role in discussions over Zoom that allowed residents to “reflect and process the traumatic how much does generic cialis cost current events we were witnessing,” Salazar said, “and to also share any experiences of injustice or discrimination we had felt in our own lives.”He described the online sessions as “emotional, but therapeutic.”Salazar’s three-year residency comes to an end on June 30.

The day after, he’ll start a fellowship in infectious diseases at UCSF where his training no doubt will focus on erectile dysfunction treatment.He is grateful for the invaluable connections and friendships forged with residents and faculty.“There’s nothing quite like residency training,” Salazar said, “especially with the development of a cialis right in the middle of it.”Gabriel “Gabe” Gonzalez thought the summer after his senior year would be spent hanging out with friends. But for how much does generic cialis cost the past five weeks, he hasn’t seen one of them. Gabriel Gonzalez how much does generic cialis cost smiles at former teammates and friends. The 18-year-old is being treated for third-degree burns over 46% of his body.Instead, the Woodcreek High School graduate spends his days undergoing physical therapy (PT) and recovering from third-degree burns over 46% of his body at the Firefighters Burn Institute Regional Burn Center at UC Davis Medical Center.“Overall, he’s doing pretty well,” said Coleen Gonzalez, his mom. €œThe doctors and nurses how much does generic cialis cost here have been absolutely wonderful.

Because he’s young, healthy and strong, everyone has been positive he’ll get through this since day one.”A tragic accidentBefore how much does generic cialis cost graduating, Gonzalez played right guard for the Woodcreek Timberwolves in Roseville. He was with some of his football teammates and other friends at a post-prom party on May 16 when disaster struck.A firepit accident sparked uncontrollable flames. Four people were rushed to how much does generic cialis cost the hospital. Gonzalez and Jackson Allen required treatment at the how much does generic cialis cost burn center.“It was horrible. Burns all over his hands, arms and legs,” his mom recalled.The two survivors kept tabs on each other while both were in the hospital.

Allen was how much does generic cialis cost discharged in early June. But for Gonzalez, the summer hanging out with friends was put on hold.His parents, Coleen how much does generic cialis cost and José, are with him every day. They were there after two surgeries. They are how much does generic cialis cost there after daily sessions with the physical therapists.A surprise visitThen, on June 24, Gabriel Gonzalez received some new visitors. 40 former how much does generic cialis cost teammates and friends surprised him at UC Davis Medical Center.

They gathered outside his second-floor window, thinking they would only get to wave to him.Meanwhile inside, Gonzalez thought his therapist was taking him outside for a new PT exercise. When he was wheeled out, the shocked faces — from both the teammates and Gonzalez— could not be contained.Not only was it his how much does generic cialis cost first time to see friends, but it was also his first trip outside the hospital since May 17. He smiled at cialis 10mg tablet cost a sea of friends dressed in pink t-shirts — his favorite color — donning his jersey number — 67 — and holding posters that read, “Stay strong brotha,” “Gabriel u got this” and “Life is tough, but so are you.”“I had no idea there would be so many of how much does generic cialis cost his teammates here. It really lifted his spirits and he did not want the time with friends and teammates to end,” said his mom. €œA huge thank you to everyone at UC Davis for making this how much does generic cialis cost happen.”Gonzalez’ therapist rolled his wheelchair in front of the team.

Then, to everyone’s surprise, Gonzalez stood and walked roughly 20 feet.Encouraged by his PT team, Gabriel Gonzalez shows his recovery progress by standing and how much does generic cialis cost walking, while well-wishers cheer him on. €œIt was great. It felt good,” Gonzalez how much does generic cialis cost said. €œDefinitely surprised.”The moment felt good for his supporters as well.“It was such a surprise how much does generic cialis cost to be able to see and talk to him in person. The worst is over.

It is only going to get better from here,” said graduating football teammate Scott how much does generic cialis cost Miller. €œGabriel was never in a bad mood how much does generic cialis cost during football practice and his same high spirits will help him recover from this.”“The entire Wolf Pack, made up of family and friends, is behind Gabriel and has been keeping him in their thoughts and prayers,” added his aunt, Janine Loving. €œSeeing him for the first time in two months was phenomenal and brought instant tears.”Unexpected supportColleen Gonzalez says this surprise visit is just one more way their family has not felt alone during this ordeal.“All the support from our family and the community has been overwhelming. I’m amazed at how much does generic cialis cost how much they have come together to help us,” she said. €œAnd the team here at UC Davis how much does generic cialis cost.

I’ve always heard UC Davis is great, but we had never experienced it, thank goodness, until now. We’re so fortunate to have such a burn unit in our backyard.”Gabriel Gonzalez, third from left, celebrates senior night at Woodcreek how much does generic cialis cost High School with his brother, Alexander. Mom, Coleen how much does generic cialis cost. And father, José.“Burn care, similar to football, is a team effort. The UC Davis burn team united to provide him with state-of-the-art care that will enable him to rejoin his teammates and return to a normal life,” said Tina Louise Palmieri, chief burn surgeon.The tragedy also offered an how much does generic cialis cost opportunity to educate young people on the dangers of fire.“Doesn’t take much for a fire to turn life-threatening,” said Kevin Snider, a retired chief — now senior chaplain — of the Sacramento Metropolitan Fire District.

€œNever pour any flammable liquid, including gasoline, on an open how much does generic cialis cost fire. Fumes can travel and land on clothing of individuals, catching them instantly on fire.”When Gabriel Gonzalez returns to his normal life, he still has a team behind him. A new support group for young adult burn survivors launches in July in collaboration with the Firefighters Burn Institute.“We feel young adults face unique challenges during their healing process,” said Lauren Spink, how much does generic cialis cost burn outreach coordinator. €œThis group is where burn survivors can support each other no matter where they are in their recovery.”When he’s discharged in the coming weeks, Gabriel Gonzalez looks forward to going back to the gym, starting Sierra College in the fall and yes, hanging out and playing video games with friends..