Department of Health and Human Services 2021 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the National Hospital Care Survey (NHCS). The goal of the project is to assess patient care in hospital- based settings, and to describe patterns of health care delivery and utilization in the United States.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) seeks input from Asian American and Pacific Islander (AAPI) communities and AAPI-serving organizations to inform the development of guidance describing best practices for advancing cultural competency, language access, and sensitivity toward Asian Americans and Pacific Islanders in the context of the Federal Government's COVID-19 response. This is NOT a solicitation for proposals or proposal abstracts. Please note: This request is for information (RFI) and is for planning purposes only. It is not a notice for a proposal and does not commit the federal government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the federal government and will not be returned. All responses will become part of the public record and will not be held confidential. The federal government reserves the right to use information provided by respondents for purposes deemed necessary and legally appropriate. Respondents are advised that the federal government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Responses will not be accepted after the due date. After a review of the responses received, a notice of funding opportunity or pre-solicitation synopsis and solicitation may be published.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the General Services Administration (GSA), announces the availability of a Final Environmental Impact Statement (FEIS) for the proposed acquisition of a site in Mace, West Virginia, and the development of this site into a replacement for the National Institute for Occupational Safety and Health (NIOSH) Underground Safety Research Program facility (Proposed Action). The proposed acquisition and development would replace the former Lake Lynn Experimental Mine in Fayette County, Pennsylvania and would support research programs focused on miner health and safety issues. The site being considered for acquisition and development includes 461.35 acres located off U.S. Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia (Site). The Final EIS and this notice are published pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). In parallel with the NEPA process, CDC also completed consultation with the West Virginia State Historic Preservation Office under Section 106 of the National Historic Preservation Act to evaluate the potential effects, if any, of the Proposed Action on historic properties.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the information collection requirements for the current PPR data collection necessary to determine grantee compliance with Part B of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act).

The Administration for Community Living (ACL) announces the intent to award 54 administrative supplements in the form of cooperative agreements to existing SMP project grantees to support the expansion and enhancement of virtual capacity of the program. This effort will benefit the SMP programs in each state, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands. The purpose of existing grantees' work is to empower and assist Medicare beneficiaries, their families, and caregivers to prevent, detect, and report health care fraud, errors, and abuse through outreach, counseling, and education with an emphasis on reaching Medicare beneficiaries with limited income and those residing in rural areas. As a result of the COVID-19 pandemic and related travel and congregation limitations and public health concerns, it has been identified that focus on expansion of virtual capacity is crucial at this time. The administrative supplements for FY 2021 will be distributed at a flat rate of $18,000 to each of the existing 54 state grantees, bringing the total for the supplement awards to $972,000.

The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of guanidinoacetic acid as a precursor of creatine in poultry feeds. This action is in response to a food additive petition filed by Alzchem Trostberg GmbH.

The Food and Drug Administration (FDA or Agency) is announcing the availability of final guidance for industry (GFI) #261 entitled ``Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.'' This guidance is intended for sponsors and potential sponsors who may be interested in pursuing conditional approval of new animal drugs for certain major uses in major species. Eligibility for conditional approval has been expanded beyond minor uses in major species and use in minor species (MUMS) to include certain major uses in major species. The Center for Veterinary Medicine (CVM or we) refers to the process for conditionally approving new animal drugs that are not intended for MUMS indications as ``expanded conditional approval.'' The purpose of expanded conditional approval is to incentivize development of new animal drugs for serious or life-threatening conditions or unmet animal or human health needs under circumstances where a demonstration of effectiveness would require a complex or particularly difficult study or studies. This guidance defines certain terms, clarifies the eligibility criteria for expanded conditional approval, and describes the criteria CVM intends to consider when determining expanded conditional approval eligibility.

The Food and Drug Administration (FDA or Agency) has determined that STROMECTOL (ivermectin) tablets, 6 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for STROMECTOL (ivermectin) tablets, 6 mg, if all other legal and regulatory requirements are met.

The Centers for Medicare & Medicaid Services (CMS) is requesting that this information collection request (ICR), for revisions to the form CMS-2567 be processed under the emergency Paperwork Reduction Act of 1995 (PRA) clearance process.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

NIOSH announces the availability of a draft technical report entitled Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials: User Guide and Technical Report now available for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2021-0067 in the search field and click ``Search.''

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with medical device labeling regulations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for FDA staff entitled ``FDA Oversight of Food Products Covered by Systems Recognition Arrangements.'' This draft guidance provides recommendations related to the FDA's regulatory oversight activities for food products imported from countries whose food safety systems the FDA has recognized in Systems Recognition Arrangements (SRAs).

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Energy Employees Occupational Illness Compensation Program Act (EEOICPA) Dose Reconstruction Interviews and Forms. This data collection permits claimants under EEOICPA to provide information potentially useful in reconstructing radiation doses, and to confirm that they have no further information to submit.

ACF, ORR, announces the issuance of one OPDIV-Initiated Supplement to BCFS HHS, San Antonio, Texas in the amount of up to $475,868,102. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of UAC at the Southwest Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for UAC referred to its care by the Department of Homeland Security. To ensure sufficient capacity to provide shelter to UAC referred to HHS, ORR is requesting that BCFS HHS continue the use of up to 1008 hard-sided beds at Carrizo Springs, Texas.

As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID-19 Health Equity Task Force (Task Force) will hold a virtual meeting on July 30, 2021. The purpose of this meeting is to consider interim recommendations addressing future pandemic preparedness, mitigation, and resilience needed to ensure equitable response and recovery in communities of color and other underserved populations. This meeting is open to the public and will be live- streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website: www.minorityhealth.hhs.gov/healthequitytaskforce/ prior to the meeting.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to a Grantee Survey and a Local Implementation Organization Survey that will be used by ACL to evaluate the fidelity with which ACL and its grantee organizations, under the Older Americans Act, implement the required evidence-based programs.

The Interagency Coordinating Committee on Fetal Alcohol Spectrum Disorders (ICCFASD) is developing an updated strategic plan to guide its efforts over the next five years. As sponsor and chair of the ICCFASD, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) will be issuing a Request for Information to seek comments on the draft outline of the ICCFASD's 2022-2026 Strategic Plan from diverse stakeholders, including scientific experts, health care providers, patients and family members, advocacy groups, other federal agencies, and non-governmental scientific, professional, and healthcare organizations.

In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, limited only by the space available. The are 200 spaces for the audio conference and computer lines combined. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining a teleconference line and/or computer connection (information below).

The National Cancer Institute (NCI), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Yeda Research & Development Co, Ltd (``YEDA''), the technology transfer company of the Weizmann Institute of Science, a non-profit research institution located in Rehovot, Israel for NCI's rights to the patent applications listed in the Supplementary Information section of this notice.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled ``Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised).'' This is a revision to the third edition of this final guidance, which issued in February 2021, and is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. FDA is revising this guidance to reflect the May 21, 2021, court order that postponed the effective date of the final rule entitled ``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements'' to July 13, 2022. Pursuant to the court order, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event, by the recommended submission date, which is currently September 13, 2021.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AJOVY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Department of Health and Human Services (Department or HHS) is announcing the withdrawal of a notice published in the Federal Register on January 21, 2021, entitled ``Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation.'' HHS also withdraws the requests for proposals issued on its website on September 24, 2020, and revised on January 13, 2021, and ends the period for submission of proposals in response to the requests for proposals.

This document corrects technical errors in the final rule that appeared in the May 5, 2021, Federal Register entitled, ``Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards''.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 71st full Council meeting utilizing virtual technology on Tuesday, August 3-Wednesday, August 4, 2021 from 1:00-5:00 p.m. (ET) on both days. The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required to provide public comment during the meeting. To pre-register to attend or to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Monday, July 26, 2021. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing PACHA@hhs.gov by close of business Wednesday, August 11, 2021. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/federal-response/pacha/about-pacha prior to the meeting.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Zephyr Endobronchial Valve Implant and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Biomin Holding GmbH, proposing that the food additive regulations be amended to provide for the safe use of fumonisin esterase to degrade fumonisins in poultry feed.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BARHEMSYS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Administration for Children and Families (ACF), Office on Trafficking in Persons (OTIP) is requesting a three-year extension of the form: Request for Assistance (RFA) for Child Victims of Human Trafficking (OMB #0970-0362, expiration 07/31/2021). Minor revisions have been made to the form, including the addition of a few fields that will enable the OTIP Child Protection Specialist team to better understand the child's specific needs, connect the child to appropriate services, and help ensure the safety of the child.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This document finalizes the methodology and data sources necessary to determine federal payment amounts to be made for program year 2022 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Health Insurance Exchanges, and incorporates the effects on such payment amounts the American Rescue Plan Act of 2021 (ARP).

This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is a virtual meeting and is open to the public. Written comments will be accepted and registration is required to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Performance Monitoring of CDC's Core State Injury Prevention Program. The proposed study is designed to collect performance monitoring data, via a web-based tool, from recipients funded under the Core State Injury Prevention Program cooperative agreement (Core SIPP).

The Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and Disease Registry (ATSDR), announces the 2021 CDC/ATSDR Tribal Consultation Session. CDC/ATSDR will host American Indian and Alaska Native (AI/AN) Federally Recognized Tribes for the virtual tribal consultation session. The proceedings will be open to the public.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Providing Regulatory Submissions in Alternate Electronic Format.'' Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress granted FDA the authority to implement the statutory electronic submission requirements in guidance. In response, FDA implemented binding guidance requiring that new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) be submitted to the Agency in electronic common technical document format. Recognizing that some submissions are exempt from this requirement and that waivers of the requirement may be granted on a case-by-case basis, the Agency is issuing this guidance to provide recommendations on an alternate electronic format for submissions covered under such exemptions and waivers. This guidance replaces the draft guidance of the same title issued on March 11, 2020.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that RYPLAZIM (plasminogen, human-tvmh), manufactured by Prometic Bioproduction, Inc., meets the criteria for a priority review voucher.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The National Institutes of Health (NIH) Office of Research on Women's Health (ORWH) is planning a Women's Health Consensus Conference (WHCC) in October 2021, in response to a Congressional request to address NIH research efforts related to women's health research as well as the following specific conditions, rising maternal morbidity and mortality rates, increasing rates of chronic debilitating conditions in women, and stagnant cervical cancer survival rates. The ORWH is seeking comments and testimonies from the extramural scientific community, professional societies, and the general public regarding the topics mentioned above to assist with identifying research gaps, pitfalls in clinical practices, and obtaining real-life testimonial experiences (direct or indirect) caused by any or all of the listed public health issues.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Office of the Secretary has extended the application period for accepting application submissions from qualified individuals who wish to be considered for membership on the National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD). Up to seven new voting members with expertise disability accessibility, medical disaster planning, preparedness, response, or recovery will be selected for the Committee. Please visit the NACIDD website at www.phe.gov/nacidd for all application submission information and instructions. Application submissions will be accepted until July 12, 2021.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by audio and web conference lines (300 audio and web conference lines are available). Registration is required. To register for this web conference, please go to: www.cdc.gov/hicpac. All registered participants will receive the meeting link and instructions shortly before the meeting.

This proposed rule sets forth proposed revised 2022 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs); proposes repeal of separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services; proposes to expand the annual open enrollment period and Navigator duties; proposes a new monthly special enrollment period for qualified individuals or enrollees, or the dependents of a qualified individual or enrollee, who are eligible for advance payments of the premium tax credit (APTC) and whose household income does not exceed 150 percent of the federal poverty level (FPL); proposes to repeal the recent establishment of a Direct Enrollment option for Exchanges; and proposes to modify regulations and policies related to section 1332 waivers.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OXBRYTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AXONICS SACRAL NEUROMODULATION SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on postmarketing reporting and recordkeeping of adverse experiences for drug and biological products.

The National Advisory Council for Healthcare Research and Quality (the Council) is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven current members' terms will expire in November 2021.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG), proposing that the color additive regulations be amended to provide for the safe use of gardenia blue powder in various foods.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA's MedWatch adverse experience reporting (AER) program.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the July 19, 2021 meeting the Advisory Council will discuss the implications of and opportunities presented by the approval of aducanumab. The Council will also hear updates from federal workgroups on efforts undertaken in the last quarter. The risk reduction subcommittee will present a summary of their work and recommendations. The research, clinical care, and long- term services and supports subcommittees will present recommendations and the Council will vote on adopting them.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the extension of an Order under Section 361 of the Public Health Service Act to temporarily halt residential evictions to prevent the further spread of COVID-19.

The Office of Community Services (OCS) requests a three-year extension of the forms Community Services Block Grant (CSBG) State Plan, CSBG Eligible Entity Master List, and the American Customer Survey Index (ACSI) (OMB #0970-0382, expiration 6/30/2021). There are minimal changes requested to the State Plan and the Master List. No changes are proposed to the ACSI.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Smallpox and Monkeypox Vaccine, Live and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The U.S. Department of Health and Human Services' (HHS) Office of Disease Prevention and Health Promotion (ODPHP) invites public and private sector organizations that support Healthy People 2030 (HP2030), the nation's disease prevention and health promotion plan, to become a Healthy People 2030 Champion (HP2030 Champion). Eligibility: Any organization may apply to be a HP2030 Champion. The selected HP2030 Champions will be recognized for their commitment and work toward achieving HP2030's vision of a society in which all people can achieve their full potential for health and well-being across the lifespan. HP2030 Champions. HP2030 Champions can be public and private organizations such as those at the state, local, county, and tribal levels, non-governmental organizations, non-profit organizations, businesses, academic organizations, organizations that impact health outcomes, philanthropic organizations, and tribal organizations that identify themselves as being aligned with or promoting HP2030, HP2030's vision, and HP2030's overarching goals. All organizations may apply. Applicants for HP2030 Champions shall submit a letter of interest and identify how they address or support health promotion, disease prevention, social determinants of health (SDOH), health disparities, health equity, and/or well-being and work in alignment with HP2030 through activities, donations, or other means. Applicants for HP2030 Champions will be evaluated according to the organization's commitment to support the overarching goals of Healthy People 2030 and the Healthy People 2030 objectives. Individuals are not eligible to be HP2030 Champions. HP2030 Champions will receive recognition from ODPHP on Health.gov/ healthypeople2030, a digital HP2030 Champion badge for their website to highlight their support of HP2030, and HP2030 information, tools and resources for dissemination. The following activities may be considered as an organization's demonstrated commitment to HP2030's overarching goals and objectives: Promoting and increasing access to disease prevention and health promotion activities; Providing access to training or certification programs for disease prevention and health promotion; Addressing SDOH, eliminating disparities, achieving health equity, and/or promoting well-being; Providing training and other necessary resources to adapt or modify disease prevention and health promotion activities to meet the needs of diverse populations, address SDOH, eliminate disparities, achieve health equity, and/or promote well-being; Developing partnerships across a variety of sectors, including business, community, academia, education, faith-based, government, health care, media, public health, and technology; Working across sectors to address SDOH, eliminate disparities, and achieve health equity; Evaluating health promotion and disease prevention programs or partnering with academic institutions or public health organizations to evaluate health promotion and disease prevention activities; Including information in their public facing materials about programs for disease prevention, health promotion, addressing SDOH, eliminating disparities, achieving health equity, and/or promoting well-being in community needs assessments; Adopting or implementing the HP2030 framework (i.e., vision, mission, overarching goals, foundational principles), Leading Health Indicators (LHIs), Overall Health and Well-Being Measures (OHMs) and/or HP2030 objectives in their strategic plan; Promoting HP2030; providing opportunities and venues for disease prevention and health promotion activities; Partnering with national, state, tribal, or local volunteer organizations to provide education, training, or programs regarding health promotion, disease prevention, SDOH, health disparities, health equity, and well-being; Supporting an entity with the responsibility to organize and coordinate efforts within and across sectors to foster health promotion and well-being; Promoting collaboration across all levels, including neighborhoods, communities, tribes, cities, states, counties, and localities, to increase and expand participation in health promotion and disease prevention activities; Disseminating through a variety of platforms messaging about the benefits of and resources available to promote disease prevention, health promotion, well-being and the importance of addressing SDOH, health disparities, and health equity; Supporting the coordination and standardization of data to enable comparisons across national, state, local, county, and/or tribal levels; Providing grants, funding opportunities, and other resources to programs that address disease prevention, health promotion, well-being, SDOH, health equity, and health disparities. Funds: None. Neither HHS nor ODPHP will provide funds to support HP2030 Champions. Applicants and HP2030 Champions will not be expected to contribute funds. Application: Organizations may apply to be an HP2030 Champion. Organizations should submit a letter of interest acknowledging their support of the HP2030 vision of a society in which all people can achieve their full potential for health and well-being across the lifespan and HP2030's overarching goals. Organizations interested in being HP2030 Champions shall identify in their letters of interest those activities from the list noted above that demonstrate commitment to HP2030's overarching goals and objectives and indicate how they address or support health promotion, disease prevention, SDOH, health disparities, health equity, and well-being and work in alignment with HP2030 through activities, donations, or other means.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 36 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or Agency or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on class II special controls for human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests.

The Food and Drug Administration (FDA or Agency) is reopening the comment period for public scoping on the environmental impact statement (EIS) described in the notice entitled ``Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use'' that appeared in the Federal Register of May 13, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) is proposing a new information collection activity to assess the impact and implementation of LifeSet, a program that provides services and supports to young adults ages 17 to 21 with previous child welfare involvement. Data collection efforts will include accessing administrative data from the child welfare agency, program, and other private and governmental databases; surveys of young adults (participants and those receiving services as usual); interviews and focus groups with program and child welfare agency administrators and staff; interviews and focus groups with young adult program participants; and interviews with other program stakeholders.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``School-Associated Violent Deaths Surveillance System (SAVD).''

The Food and Drug Administration (FDA, we, or the Agency) is soliciting comments on our current policy on eligibility for indexing. Indexing is the process of adding an unapproved drug for a minor species to our index of legally marketed unapproved new animal drugs for minor species (the Index). Except for in some early non-food life stages, members of a food-producing minor species are not eligible for indexing, even if a subset of animals within a food-producing minor species is not intended to be consumed by humans or food-producing animals. Specifically, we are requesting comment on this policy.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.'' FDA is issuing this guidance to assist sponsors developing master protocols for trials evaluating drugs and biological products for the treatment or prevention of COVID-19. This guidance primarily focuses on the trial design and conduct as well as statistical considerations for master protocols intended to generate substantial evidence of effectiveness and adequate characterization of safety for COVID-19. Additionally, this guidance provides administrative and procedural recommendations to sponsors of master protocols for COVID-19. Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Premenopausal Women with Breast Cancer: Developing Drugs for Treatment.'' This guidance provides recommendations regarding the inclusion of premenopausal women in breast cancer clinical trials. The guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials for breast cancer drugs. This guidance finalizes the draft guidance of the same title issued on October 8, 2020.