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In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) can i buy avelox for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may can i buy avelox act on HRSA's ICR only after the 30 day comment period for this notice has closed.

Comments on this ICR should be received no later than October 8, 2020. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by can i buy avelox selecting “Currently under Review—Open for Public Comments” or by using the search function. Start Further Info To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-1984.

End Further Info End Preamble Start Supplemental Information Information Collection Request Title. Substance Use Disorder Treatment and Recovery Loan Repayment Program OMB can i buy avelox No. 0906-xxxx—New Abstract. The Further Consolidated Appropriations Act, 2020 included no less than $12,000,000 for HRSA to establish the Loan Repayment Program for Substance Use Disorder Treatment Workforce.

This funding can i buy avelox will allow HRSA to provide the repayment of education loans for individuals working in either a full-time substance use disorder treatment job that involves direct patient care in a Health Professional Shortage Area (HPSA) designated for Mental Health or a county where the average drug overdose death rate exceeds the national average. Eligible disciplines include but are not limited to behavioral health paraprofessionals, occupational therapists and counselors. Eligible treatment facilities include but are not limited to inpatient psychiatric facilities, recovery centers, detox facilities, emergency department and local community jails and detention centers. The Department of Health and Human Services agrees to can i buy avelox repay the qualifying educational loans up to $250,000.00 in return for six years of service obligation.

The forms utilized by the Substance Use Disorder Treatment and Recovery (STAR) Loan Repayment Program (LRP) include the following. The STAR LRP Application, the Authorization for Disclosure of Loan Information form, the Privacy Act Release Authorization form, the Employment Verification form, and the Site Application form, if applicable. The aforementioned forms can i buy avelox collect information that is needed for selecting participants and repaying qualifying educational loans. Eligible facilities for the STAR LRP are facilities that provide in-patient and outpatient, ambulatory, primary and mental/behavioral health care services to populations residing in a mental health HPSA or a county where the average drug overdose death rate exceeds the national average.

The facilities that may provide related in-patient services may include, but are not limited to Centers for Medicare &. Medicaid Services-approved Critical Access Hospitals, American Indian Health Facilities (Indian Health Service can i buy avelox Facilities, Tribally-Operated 638 Health Programs, and Urban Indian Health Programs), inpatient rehabilitation centers and psychiatric facilities. HRSA will recruit facilities for approval. New facilities must submit an application for review and approval.

The application requests will contain supporting information on the clinical service site, recruitment contact can i buy avelox and services provided. Assistance in completing this application may be obtained through the appropriate HRSA personnel. HRSA will use the information collected on the applications to determine eligibility of the facility for the assignment of health professionals and to verify the need for clinicians. Despite can i buy avelox the similarity in the titles, the STAR LRP is not the existing NHSC Substance Use Disorder LRP (OMB #0915-0127), which is authorized under Title III of the Public Health Service Act.

The STAR LRP is a newly authorized Title VII program that has different service requirements, loan repayment protocols, and authorized employment facilities. A 60-day notice published in the Federal Register on June 4, 2020, vol. 85, No can i buy avelox. 108.

Pp. 34454-34456. There were no public comments. Need and Proposed Use of the Information.

The need and purpose of this information collection is to obtain information that is used to assess a STAR LRP applicant's eligibility and qualifications for the program, and to obtain information for eligible site applicants. Clinicians interested in participating in the STAR LRP must submit an application to the program in order to participate, and health care facilities located in a high overdose rate or Mental Health HPSAs must submit a Site Application to determine the eligibility of sites to participate in the STAR LRP. The STAR LRP application asks for personal, professional and financial information needed to determine the applicant's eligibility to participate in the STAR LRP. In addition, applicants must provide information regarding the loans for which repayment is being requested.

Likely Respondents. Likely respondents include. Licensed primary care medical, mental and behavioral health providers, and other paraprofessionals who are employed or seeking employment, and are interested in serving underserved populations. Health care facilities interested in participating in the STAR LRP, and becoming an approved service site.

STAR LRP sites providing behavioral health care services directly, or through a formal affiliation with a comprehensive community-based primary behavioral health setting, facility providing comprehensive behavioral health services, or various substance abuse treatment facility sub-types. Burden Statement. Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions.

To develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying Start Printed Page 55466information, processing and maintaining information, and disclosing and providing information. To train personnel and to be able to respond to a collection of information. To search data sources. To complete and review the collection of information.

And to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. Total Estimated Annualized Burden—HoursForm nameNumber of respondentsNumber of responses per respondentTotal responsesAverage burden per response (in hours)Total burden hoursSTAR LRP Application3001300.50150Authorization for Disclosure of Loan Information Form3001300.50150Privacy Act Release Authorization Form3001300.50150Employment Verification Form3001300.50150Site Application40014001.00400Total1,6001,6001000 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Start Signature Maria G.

Button, Director, Executive Secretariat. End Signature End Supplemental Information [FR Doc. 2020-19776 Filed 9-4-20. 8:45 am]BILLING CODE 4165-15-PStart Preamble Centers for Medicare &.

Medicaid Services (CMS), HHS. Extension of timeline for publication of final rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule. As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021.

Start Further Info Lisa O. Wilson, (410) 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &.

Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician. A new exception for donations of cybersecurity technology and related services.

And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations. This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation.

In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances.

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Here I address some questions raised by the current news reports.Why wasn’t the man immune to reinfection?. Immunity to can i buy avelox endemic coronaviruses – those that cause symptoms of the common cold – is relatively short-lived, with reinfections occurring even within the same season. So it isn’t completely surprising that reinfection with SARS-CoV-2, the virus that causes COVID-19, might be possible.Immunity is complex and involves multiple mechanisms in the body.

That includes the generation of antibodies – through what’s known as the adaptive immune response – and through the actions of can i buy avelox T-cells, which can help to educate the immune system and to specifically eliminate virus-infected cells. However, researchers around the world are still learning about immunity to this virus and so can’t say for sure, based on this one case, whether reinfection will be a cause for broad concern.[Get the best of The Conversation, every weekend. Sign up can i buy avelox for our weekly newsletter.]How different is the second strain that infected the Hong Kong man?.

“Strain” has a particular definition when referring to viruses. Often a different can i buy avelox “strain” is a virus that behaves differently in some way. The coronavirus that infected this man in Europe is likely not a new strain.A STAT News article reports that the genetic make up of the sequenced virus from the patient’s second infection had 24 nucleotides – building blocks of the virus’s RNA genome – that differed from the SARS-CoV-2 isolate that infected him the first time.SARS-CoV-2 has a genome that is made up of about 30,000 nucleotides, so the virus from the man’s second infection was roughly 0.08% different than the original in genome sequence.

That shows that the virus that caused the second infection was new. Not a can i buy avelox recurrence of the first virus.The man was asymptomatic – what does that mean?. The man wasn’t suffering any of the hallmark COVID-19 symptoms which might mean he had some degree of protective immunity to the second infection because he didn’t seem sick.

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Finally, sometimes infections with SARS-CoV-2 are asymptomatic – at the moment it is difficult to determine whether this was due to the differences in the virus or in the host.What can we say about reinfection based on this one case?. Only that it seems to can i buy avelox be possible after enough time has elapsed. We do not know how likely or often it is to occur.Should people who have recovered from COVID-19 still wear a mask?.

As we are still learning about how humans develop immunity to SARS-CoV-2 after infection, my recommendation is for continued masking, hand hygiene and distancing practices, can i buy avelox even after recovery from COVID-19, to protect against the potential for reinfection.Megan Culler Freeman is a Pediatric Infectious Diseases Fellow at the University of Pittsburgh. This article originally appeared on The Conversation and is republished under a Creative Commons license. Read the original here..

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The survey won't have the CAHPS logo because drug avelox it hasn't gone through the long approval process including field testing, but Ginsberg said AHRQ leaders thought it was important providers had access to the survey soon given the expanded use of telehealth. "We think it will be very useful for organizations right now to understand how they are doing," she said. Providers have developed their own surveys to assess patient experience with telehealth or used ones developed by vendors such as Press Ganey. Most reports show patients are satisfied with telehealth although there are concerns the platform isn't improving access for everyone, particularly those who don't have reliable access to broadband or devices drug avelox. AHRQ received feedback from patients, providers and accreditation organizations about the beta version of the survey.

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Novant, similar to other large health systems, has drug avelox developed its own survey to assess patient's experience with its telehealth platform. Patients receive the survey immediately after a telehealth visit through the patient portal and it can be completed on the moblie app or the web. Capps said Novant would continue to use its own survey even with the existence of a CAHPS telehealth survey because the information can be accessed right away and acted upon immediately."We are making real-time decisions based on the kind of responses that we get from our patients," he said..

The Agency for Healthcare Research and can i buy avelox Quality plans to release a survey next month that providers can use to assess patient experience with telehealth visits. AHRQ, which oversees and funds a suite of widely used patient experience surveys called Consumer Assessment of Healthcare Providers and Systems (CAHPS), will release the survey sometime in October as a beta version to any providers who want to use it, according to Caren Ginsberg, director of the CAHPS program at AHRQ during a recent call with Modern Healthcare. AHRQ became interested in offering a survey with can i buy avelox telehealth-related questions after the technology became more popular amid COVID-19.

AHRQ's 25-year-old CAHPS program has a survey for doctor's office visits but it doesn't ask questions relevant to telehealth, including asking patients if the format was easy to use.The survey targets ambulatory care patients after in-person, video, or phone call visits with a clinician. Email or text interactions through a patient portal aren't suitable for the survey. The survey won't have the CAHPS logo because it hasn't gone through the long approval process including field testing, but Ginsberg said AHRQ leaders thought it was important providers had access to the survey soon given the can i buy avelox expanded use of telehealth.

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AHRQ received feedback from patients, providers and accreditation organizations about the beta version of the survey. Patients underwent cognitive testing to ensure the questions were interpreted as intended and the order of the survey made sense. Additionally, stakeholders were asked what information they can i buy avelox would like to get from a telehealth survey.

The beta version includes questions about the value of instructions for accessing telehealth visits, ease of use. There are also questions similar to what's in other CAHPS surveys related to communication and respect. "All of that is going to be important in any survey for any encounter regardless of the format of that encounter," Ginsberg can i buy avelox said.

The results from the survey won't be released publicly as is done for some of AHRQ's other surveys because it's not officially a CAHPS survey, Ginsberg said. Right now, can i buy avelox doctor's offices and health plans can voluntarily submit their survey data to AHRQ in order to compare themselves to their peers. Dr.

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Responding to those complaints, CMS plans to test in the spring a "web mode" version of multiple patient experience surveys and for HCAHPS, it will ask a nationally representative group of hospitals to participate, according to an agency spokeswoman. The testing can i buy avelox is scheduled to begin in April 2021, but the spokeswoman said COVID-19 may cause delays. Ginsberg said AHRQ releases guidance on its surveys but doesn't require them to be administered in particular ways, rather regulators such as CMS make those rules.

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Capps said Novant would continue to use its own survey even with the existence of a CAHPS telehealth survey because the information can be accessed right away and acted upon immediately."We are making real-time decisions based on the kind of responses that we get from our patients," he said..

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Johnson and explain why experts say they offer more good news than bad. Then, STAT Washington correspondent Lev Facher calls in to talk about his first-of-its-kind analysis of avelox dosage for sinus infection the drug industry’s spending to influence policy at the state level. Finally, our STAT colleague Nicholas St. Fleur joins us to tell the story of two Black university leaders who urged their campuses to join a Covid-19 vaccine trial — and the backlash that ensued. For more on what we cover, avelox dosage for sinus infection here’s the latest paused study.

Here’s the analysis of pharma’s statehouse spending. Here’s the story on HBCUs and clinical trials.

How does racism in medicine loom over Covid-19 can i buy avelox studies?. And who decides when a clinical trial goes on pause?. We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss can i buy avelox two high-profile pauses to Covid-19 clinical trials from Eli Lilly and Johnson &.

Johnson and explain why experts say they offer more good news than bad. Then, STAT Washington correspondent Lev Facher calls in to talk about his first-of-its-kind analysis of the drug industry’s spending to influence policy at the state level. Finally, our can i buy avelox STAT colleague Nicholas St. Fleur joins us to tell the story of two Black university leaders who urged their campuses to join a Covid-19 vaccine trial — and the backlash that ensued.

For more on what we cover, here’s the latest paused study. Here’s the analysis of pharma’s can i buy avelox statehouse spending. Here’s the story on HBCUs and clinical trials. And here’s STAT’s complete coverage of the coronavirus pandemic.advertisement We’ll be back next Thursday evening — and every Thursday evening — so be sure to sign up on Apple Podcasts, Stitcher, Google Play, or wherever you get your podcasts.And if you have any feedback for us — topics to cover, guests to invite, vocal tics to cease — you can email readoutloud@statnews.com.advertisement Interested in sponsoring a future episode of “The Readout LOUD”?.

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REDWOOD CITY, avelox for sinus infection Calif., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc avelox for sinus infection. (Nasdaq.

GH) today announced the company will be participating in the upcoming Morgan Stanley Virtual Healthcare Conference.Guardant Health’s avelox for sinus infection management is scheduled for a fireside chat on Tuesday, September 15 at 8:45 a.m. Pacific Time / 11:45 a.m. Eastern Time avelox for sinus infection.

Interested parties may access a live and archived webcast of the presentation on the “Investors” section of the company website at. Www.guardanthealth.com.About Guardant HealthGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its avelox for sinus infection proprietary blood tests, vast data sets, and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum.

Guardant Health has launched liquid avelox for sinus infection biopsy-based Guardant360® and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.Investor Contact:Carrie Mendivilinvestors@guardanthealth.comMedia Contact:Anna Czenepress@guardanthealth.comCourtney Carrollcourtney.carroll@uncappedcommunications.com Source. Guardant Health, Inc.COVID-19 diagnostic expands testing supply, protects the continuity of essential cancer work at Guardant Health, and helps with reopening at Delaware State UniversityREDWOOD CITY, Calif., avelox for sinus infection Aug.

24, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq. GH) announces that the U.S.

Food and Drug Administration (FDA) has granted the Guardant-19 test emergency use authorization (EUA) for use in the detection of the novel coronavirus, SARS-CoV-2. The test is being offered to Guardant Health employees and select partner organizations through the company’s CLIA-certified clinical laboratory.The Guardant-19 test is a reverse transcriptase polymerase chain reaction next generation sequencing (rt-PCR-seq) test that detects coronavirus SARS-CoV-2 nucleic acid from upper respiratory nasal specimens including nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, interior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal aspirates, and nasal washes. The test has a validated limit of detection (LoD) of 125 copies per mL and results are typically returned the next day.

The heavily multiplexed testing workflow used has the ability to scale to over 10,000 tests per day.“While serving cancer patients remains our top priority, we are proud to be able to leverage our expertise in liquid biopsy testing to contribute to battling the COVID-19 pandemic by offering a highly accurate test that is truly additive to the testing options available today,” said AmirAli Talasaz, Guardant Health president. €œSince the beginning of the pandemic we believed it was our social responsibility to not only protect the health and safety of our employees, but to also help our greater community with return to work and school initiatives. It gives me great pride knowing that Guardant Health is able to deliver.”The Guardant-19 test is being used to help Delaware State University, a Historically Black College &.

University, in its efforts to reopen safely. €œGuardant is providing us with an innovative testing technology to help protect the safety of our entire campus community,” said Tony Allen, president of Delaware State University, which is being advised by nonprofit Testing for America on its reopening plans.“Our mission is to permanently and safely reopen schools, business and the US economy by providing affordable, accessible and frequent testing and screening. We believe that a testing option like the one provided by Guardant Health can help achieve the highly accurate and rapid results at a scale that we need,” said Dr.

Joan Coker, surgeon and Advisory Council member of Testing for America.The Healing Grove Health Center in San Jose, California is another partner organization. €œWe are thankful for a high-throughput, fast, accurate COVID-19 test from Guardant Health,” said Brett Bymaster, the center’s executive director. €œOur patients are low-income and high risk, and we are seeing a high positivity rate.

When we catch these positive cases early, we are possibly saving hundreds of people from getting infected with COVID-19 by ensuring that they quarantine. By working closely with Guardant Health, we have gotten results quickly and have been able to keep our COVID-positive patients recovering at home, limiting the severity of the outbreak in this important community.”To learn more about accessing the Guardant-19 test, email. Guardant19support@guardanthealth.com.About Guardant HealthGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets, and advanced analytics.

The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360® and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.Investor Contact:Carrie Mendivilinvestors@guardanthealth.comMedia Contact:Anna Czenepress@guardanthealth.comCourtney Carrollcourtney.carroll@uncappedcommunications.com Source.

REDWOOD CITY, Calif., can i buy avelox Sept. 01, 2020 (GLOBE NEWSWIRE) can i buy avelox -- Guardant Health, Inc. (Nasdaq.

GH) today announced the can i buy avelox company will be participating in the upcoming Morgan Stanley Virtual Healthcare Conference.Guardant Health’s management is scheduled for a fireside chat on Tuesday, September 15 at 8:45 a.m. Pacific Time / 11:45 a.m. Eastern Time can i buy avelox.

Interested parties may access a live and archived webcast of the presentation on the “Investors” section of the company website at. Www.guardanthealth.com.About Guardant HealthGuardant Health is a leading precision oncology company focused can i buy avelox on helping conquer cancer globally through use of its proprietary blood tests, vast data sets, and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum.

Guardant Health has launched liquid biopsy-based Guardant360® and GuardantOMNI® tests for advanced stage can i buy avelox cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.Investor Contact:Carrie Mendivilinvestors@guardanthealth.comMedia Contact:Anna Czenepress@guardanthealth.comCourtney Carrollcourtney.carroll@uncappedcommunications.com Source. Guardant Health, Inc.COVID-19 diagnostic expands testing supply, protects the continuity of essential cancer work at Guardant Health, and helps with can i buy avelox reopening at Delaware State UniversityREDWOOD CITY, Calif., Aug.

24, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq. GH) announces that the U.S.

Food and Drug Administration (FDA) has granted the Guardant-19 test emergency use authorization (EUA) for use in the detection of the novel coronavirus, SARS-CoV-2. The test is being offered to Guardant Health employees and select partner organizations through the company’s CLIA-certified clinical laboratory.The Guardant-19 test is a reverse transcriptase polymerase chain reaction next generation sequencing (rt-PCR-seq) test that detects coronavirus SARS-CoV-2 nucleic acid from upper respiratory nasal specimens including nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, interior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal aspirates, and nasal washes. The test has a validated limit of detection (LoD) of 125 copies per mL and results are typically returned the next day.

The heavily multiplexed testing workflow used has the ability to scale to over 10,000 tests per day.“While serving cancer patients remains our top priority, we are proud to be able to leverage our expertise in liquid biopsy testing to contribute to battling the COVID-19 pandemic by offering a highly accurate test that is truly additive to the testing options available today,” said AmirAli Talasaz, Guardant Health president. €œSince the beginning of the pandemic we believed it was our social responsibility to not only protect the health and safety of our employees, but to also help our greater community with return to work and school initiatives. It gives me great pride knowing that Guardant Health is able to deliver.”The Guardant-19 test is being used to help Delaware State University, a Historically Black College &.

University, in its efforts to reopen safely. €œGuardant is providing us with an innovative testing technology to help protect the safety of our entire campus community,” said Tony Allen, president of Delaware State University, which is being advised by nonprofit Testing for America on its reopening plans.“Our mission is to permanently and safely reopen schools, business and the US economy by providing affordable, accessible and frequent testing and screening. We believe that a testing option like the one provided by Guardant Health can help achieve the highly accurate and rapid results at a scale that we need,” said Dr.

Joan Coker, surgeon and Advisory Council member of Testing for America.The Healing Grove Health Center in San Jose, California is another partner organization. €œWe are thankful for a high-throughput, fast, accurate COVID-19 test from Guardant Health,” said Brett Bymaster, the center’s executive director. €œOur patients are low-income and high risk, and we are seeing a high positivity rate.

When we catch these positive cases early, we are possibly saving hundreds of people from getting infected with COVID-19 by ensuring that they quarantine. By working closely with Guardant Health, we have gotten results quickly and have been able to keep our COVID-positive patients recovering at home, limiting the severity of the outbreak in this important community.”To learn more about accessing the Guardant-19 test, email. Guardant19support@guardanthealth.com.About Guardant HealthGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets, and advanced analytics.

The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360® and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.Investor Contact:Carrie Mendivilinvestors@guardanthealth.comMedia Contact:Anna Czenepress@guardanthealth.comCourtney Carrollcourtney.carroll@uncappedcommunications.com Source.

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Start Preamble Notice of amendment allergic reaction to avelox. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures. This amendment to the Declaration published on March allergic reaction to avelox 17, 2020 (85 FR 15198) is effective as of August 24, 2020. 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, allergic reaction to avelox 200 Independence Avenue SW, Washington, DC 20201.

Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity 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 medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 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 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, 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 of the nation's health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration).

On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V.

Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S.

Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed. Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here.

If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks.

The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates. We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience.

What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible.

Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] 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 vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children.

That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule. All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine 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.

Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below.

All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr. 15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with.

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

(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. And (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), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The vaccine must be FDA-authorized or FDA-approved.

The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. 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 vaccines, and the recognition and treatment of emergency reactions to vaccines.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. 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. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered countermeasures that are subject to the National Vaccine 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 Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2.

Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. 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 COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C.

247d-6d. End Authority Start Signature Dated. August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20. 4:15 pm]BILLING CODE 4150-03-PToday, the U.S. Department of Health and Human Services released Healthy People 2030, the nation's 10-year plan for addressing our most critical public health priorities and challenges. Since 1980, HHS's Office of Disease Prevention and Health Promotion has set measurable objectives and targets to improve the health and well-being of the nation.This decade, Healthy People 2030 features 355 core – or measurable – objectives with 10-year targets, new objectives related to opioid use disorder and youth e-cigarette use, and resources for adapting Healthy People 2030 to emerging public health threats like COVID-19.

For the first time, Healthy People 2030 also sets 10-year targets for objectives related to social determinants of health."Healthy People was the first national effort to lay out a set of data-driven priorities for health improvement," said HHS Secretary Alex Azar. "Healthy People 2030 adopts a more focused set of objectives and more rigorous data standards to help the federal government and all of our partners deliver results on these important goals over the next decade."Healthy People has led the nation with its focus on social determinants of health, and continues to prioritize economic stability, education access and quality, health care access and quality, neighborhood and built environment, and social and community context as factors that influence health. Healthy People 2030 also continues to prioritize health disparities, health equity, and health literacy."Now more than ever, we need programs like Healthy People that set a shared vision for a healthier nation, where all people can achieve their full potential for health and well-being across the lifespan," said ADM Brett P. Giroir, MD, Assistant Secretary for Health. "COVID-19 has brought the importance of public health to the forefront of our national dialogue.

Achieving Healthy People 2030's vision would help the United States become more resilient to public health threats like COVID-19."Healthy People 2030 emphasizes collaboration, with objectives and targets that span multiple sectors. A federal advisory committee of 13 external thought leaders and a workgroup of subject matter experts from more than 20 federal agencies contributed to Healthy People 2030, along with public comments received throughout the development process.The HHS Office of Disease Prevention and Health Promotion leads Healthy People in partnership with the National Center for Health Statistics at the Centers for Disease Control and Prevention, which oversees data in support of the initiative.HHS Secretary Alex M. Azar II, ADM Brett P. Giroir, MD, Assistant Secretary for Health, and U.S. Surgeon General Jerome M.

Adams, MD, MPH, and others from HHS and CDC will launch Healthy People 2030 during a webcast on August 18 at 1 pm (EDT) at https://www.hhs.gov/live. No registration is necessary. For more information about Healthy People 2030, visit https://healthypeople.gov..

Start Preamble Notice can i buy avelox of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures. This amendment to the Declaration published on March 17, can i buy avelox 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department can i buy avelox of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201.

Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity 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 medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 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 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, 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 of the nation's health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration).

On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V.

Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S.

Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed. Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here.

If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks.

The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates. We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience.

What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible.

Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] 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 vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children.

That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule. All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine 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.

Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below.

All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr. 15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with.

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

(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. And (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), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The vaccine must be FDA-authorized or FDA-approved.

The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. 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 vaccines, and the recognition and treatment of emergency reactions to vaccines.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. 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. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered countermeasures that are subject to the National Vaccine 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 Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2.

Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. 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 COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C.

247d-6d. End Authority Start Signature Dated. August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20. 4:15 pm]BILLING CODE 4150-03-PToday, the U.S. Department of Health and Human Services released Healthy People 2030, the nation's 10-year plan for addressing our most critical public health priorities and challenges. Since 1980, HHS's Office of Disease Prevention and Health Promotion has set measurable objectives and targets to improve the health and well-being of the nation.This decade, Healthy People 2030 features 355 core – or measurable – objectives with 10-year targets, new objectives related to opioid use disorder and youth e-cigarette use, and resources for adapting Healthy People 2030 to emerging public health threats like COVID-19.

For the first time, Healthy People 2030 also sets 10-year targets for objectives related to social determinants of health."Healthy People was the first national effort to lay out a set of data-driven priorities for health improvement," said HHS Secretary Alex Azar. "Healthy People 2030 adopts a more focused set of objectives and more rigorous data standards to help the federal government and all of our partners deliver results on these important goals over the next decade."Healthy People has led the nation with its focus on social determinants of health, and continues to prioritize economic stability, education access and quality, health care access and quality, neighborhood and built environment, and social and community context as factors that influence health. Healthy People 2030 also continues to prioritize health disparities, health equity, and health literacy."Now more than ever, we need programs like Healthy People that set a shared vision for a healthier nation, where all people can achieve their full potential for health and well-being across the lifespan," said ADM Brett P. Giroir, MD, Assistant Secretary for Health. "COVID-19 has brought the importance of public health to the forefront of our national dialogue.

Achieving Healthy People 2030's vision would help the United States become more resilient to public health threats like COVID-19."Healthy People 2030 emphasizes collaboration, with objectives and targets that span multiple sectors. A federal advisory committee of 13 external thought leaders and a workgroup of subject matter experts from more than 20 federal agencies contributed to Healthy People 2030, along with public comments received throughout the development process.The HHS Office of Disease Prevention and Health Promotion leads Healthy People in partnership with the National Center for Health Statistics at the Centers for Disease Control and Prevention, which oversees data in support of the initiative.HHS Secretary Alex M. Azar II, ADM Brett P. Giroir, MD, Assistant Secretary for Health, and U.S. Surgeon General Jerome M.

Adams, MD, MPH, and others from HHS and CDC will launch Healthy People 2030 during a webcast on August 18 at 1 pm (EDT) at https://www.hhs.gov/live. No registration is necessary. For more information about Healthy People 2030, visit https://healthypeople.gov..