Department of Health and Human Services 2022 – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families (ACF), Children's Bureau is requesting a 3-year extension of the Prevention Services Data Collection (OMB #0970-0529, expiration 7/31/2022). There are no changes requested to the form.

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.

The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests regarding POTABA (potassium aminobenzoate) Tablets, Capsules, Powder, and Envules under Docket No. FDA-1977-N-0015 (formerly 77N-0187) (this Drug Efficacy Study Implementation (DESI) 7663) have been withdrawn. Therefore, as proposed in the notice of opportunity for hearing (NOOH), FDA finds that the products subject to the application identified in this docket, or any identical, related, or similar (IRS) products, have not been shown to be effective for use under the conditions of use prescribed, recommended, or suggested in the labeling, and hereby withdraws approval of the application under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $1,000,000, for Year 1 of funding to the IPCI to sustain decentralization of HIV-associated microbiology at regional hospitals and to expand interventions to additional regional hospitals. The award will improve support to and the coordination of the TB and OIs laboratory network for quality assured diagnosis of TB/DR-TB, including smear microscopy (LED), Lipoarabinomannan Assay (LF-LAM) for the diagnosis and screening of active tuberculosis in people with HIV, solid and liquid culture, and molecular WHO-recommended diagnostic tests (LIPA, Xpert Ultra). Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $3,000,000 for Year 1 of funding to the National AIDS Control Committee (NACC), Cameroon. The award will strengthen national policies, build capacity, and define high-level high-impact interventions and key strategies for HIV/TB prevention, treatment and care in Cameroon. Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $57,500,000 for total year 1 of funding, and an average 1-year award amount of $14,375,000, to the Southern Provincial Health Office (SPHO), Lusaka Provincial Health Office (LPHO), Western Provincial Health Office (WPHO), and Eastern Provincial Health Office (EPHO)in Zambia. The awards will provide the Provincial Health Offices (PHOs) with CDC technical assistance and financial support to maintain and sustain the provinces' overall leadership and oversight for implementing high-impact HIV combination prevention, treatment and support services, including clinical, surveillance, and laboratory services as well as to identify and mitigate emerging disease threats for people living with HIV (PLHIV). Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $3,000,000 for Year 1 of funding to the Ministry of Women, Families and Children (MFFE). The award will continue to build a sustainable national response to address the needs of Orphans and Vulnerable Children (OVC) and their families and others highly affected by HIV/AIDS. Annual award amounts for years 2-5 will be set at continuation.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $6,000,000 for Year 1 of funding to the Southern Nations, Nationalities, and Peoples Regional Health Bureaus (SNNPRHB). The award will ensure continuity of quality comprehensive HIV/AIDS prevention, care, and treatment services for controlling the HIV epidemic in SNNPR in Ethiopia. Funding amounts for years 2-5 will be set at continuation.

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 Intimate Partner and Sexual Violence Survey (NISVS). NISVS is a surveillance system used to monitor the magnitude of sexual violence, stalking, and intimate partner violence victimization among adults in the U.S.

The Office of the Surgeon General requests input from interested parties on the impact and prevalence of health misinformation in the digital information environment during the COVID- 19 pandemic. The purpose of this RFI is to understand the impact of COVID-19 misinformation on healthcare infrastructure and public health more broadly during the pandemic including (but not limited to) quality of care, health decisions and outcomes, direct and indirect costs, trust in the healthcare system and providers, and healthcare worker morale and safety, understand the unique role the information environment played in the societal response to the COVID-19 pandemic and implications for future public health emergencies, understand the impact of exposure to health misinformation and how access to trusted and credible health information, particularly during a public health emergency, impacts lifesaving health decisions such as an individual's likelihood to vaccinate; and use the information requested to prepare for and respond to future public health crises. HHS will consider the usability, applicability, and rigor of submissions in response to this RFI and share learnings from these responses with the public. Public comments and submissions will also be made available to the public and can be used for research purposes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.

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 Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry and FDA staff entitled ``Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.'' The guidance for industry and FDA staff provides guidance on timely initiation of voluntary recalls of FDA-regulated products. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication. In addition, the guidance discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA. This guidance finalizes the draft guidance of the same title issued on April 24, 2019.

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 of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) 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 act on HRSA's ICR only after the 30-day comment period for this notice has closed.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Patrick Charles Bishop for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Bishop was convicted of one felony count under Federal law for conspiracy to commit fraud. The factual basis supporting Mr. Bishop's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Bishop was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. Mr. Bishop provided notice to FDA that he acquiesced to the debarment; FDA received that notice on January 4, 2022. As such, his debarment commenced on the date FDA was notified of acquiescence.

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 Authorization for Medical Products for Use in Emergencies.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Pre-Launch Activities Importation Requests (PLAIR).'' This guidance finalizes and updates the draft guidance of the same title issued on July 24, 2013. This guidance finalizes FDA's approach for overseeing requests regarding the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This guidance further describes the procedures for making these requests and FDA's actions on such requests. Finalizing this policy will help increase efficiencies in ensuring timely access to drug products upon approval.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) requests a three-year extension of the State Self-Assessment Review and Report with minor revisions. The information collected in the reports assists state child support enforcement agencies and OCSE in determining whether the agencies meet federal child support performance requirements. The current Office of Management and Budget (OMB) approval expires April 30, 2022.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Inclusion of Older Adults in Cancer Clinical Trials.'' This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this final guidance, older adults are those age 65 years and older. The final guidance emphasizes the particular importance of including adults over age 75 years in cancer clinical trials. Specifically, this final guidance includes recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population. This guidance finalizes the draft guidance of the same title issued on March 6, 2020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.'' The purpose of this guidance is to provide advice to sponsors regarding the design and conduct of first- in-human (FIH) clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs. This guidance finalizes the draft guidance of the same name issued in August 2018.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the form OCSE-75 Tribal Child Support Enforcement Annual Data Report (OMB #0970-0320, expiration 01/31/2023). There are changes requested to the form.

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.

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 Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS). Data from BD-STEPS will play an important part in the decision-making process that determines federal research agendas, birth defect prevention activities, and the direction of funding programs such as cooperative agreements.

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.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Syncopation Life Sciences Inc., (``Syncopation''), located in Palo Alto, California.

As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020. The new effective date is April 9, 2023.

This is to notify the public that the March 3, 2022, meeting of the Advisory Commission on Childhood Vaccines (ACCV) is canceled and will be rescheduled. This meeting was announced in the Federal Register, Vol. 87, No. 20 on Monday, January 31, 2022 (FR Doc. 2022- 01848 Filed 1-28-22). Future meetings will occur in June, September, and December of calendar year 2022 and were announced through the same Federal Register notice.

The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), proposes to amend the existing regulation for the conduct of persons and traffic on the NIH enclave in Bethesda, Maryland, in order to update certain provisions of the regulation.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of five 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 we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and a conditionally approved new animal drug application (cNADA) during July, August, and September 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations.

The Office of Child Care (OCC), Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF- 801: CCDF Quarterly Case-Level Report (OMB #0970-0167, expiration 2/28/ 2022). OCC proposes minor changes to the response categories under the following three data elements: Child's gender, ethnicity, and race.

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 exemptions from substantial equivalence requirements for tobacco products.

This document corrects technical errors that appeared in the proposed rule published in the Federal Register on January 12, 2022 entitled ``Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs.''

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements associated with the sanitary transportation of human and animal food.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low- burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS- 10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Lead Exposure and Prevention Advisory Committee (LEPAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through January 17, 2024.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection titled, ``Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions,'' Office of Management and Budget (OMB) Control Number 0917-0028. The IHS is requesting OMB to approve an extension for this collection, which expires on February 28, 2022. Notice regarding the information collection was last published in the Federal Register on December 13, 2021, and allowed 60 days for public comment. The purpose of this notice is to announce the IHS' intent to submit this collection to OMB and to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID: IHS_FRDOC_0001).

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $200,000, with an expected total funding of approximately $1,000,000 over a five-year period to the International Agency for Research on Cancer (IARC). The award will support the IARC Handbooks on Cancer Prevention program which provide comprehensive reviews and consensus evaluations evidence on the effectiveness of preventive interventions that may reduce cancer incidence or mortality in the United States and other countries.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $2,000,000 for Year 1 of funding to the Ho Chi Minh City Department of Health (HCMC DOH). The award will strengthen the capacity of the HCMC DOH to provide sustainable evidence-based effective HIV prevention, care and treatment services. As Ho Chi Minh City contributes to 22.6% of the HIV burden, HCMC DOH remains critical to the success of HIV program in Vietnam. This NOFO will contribute directly to the national HIV prevention, care and treatment goals by supporting direct services and will support long-term sustainability of the HIV response through capacity building and technical assistance (TA). Funding amounts for years 2-5 will be set at continuation.

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 Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $1,000,000 for Year 1 of funding to the Servicos Provinciais de Sa[uacute]de de Inhambane (SPS Inhambane), Mozambique. The award will strengthen the institutional capacity of SPS Inhambane to plan, coordinate, and supervise HIV-related activities to contribute to accelerated progress towards the 95-95-95 goals (95% of HIV-positive individuals knowing their status, 95% of those receiving ART [Antiretroviral therapy], and 95% of those achieving viral suppression) and ensure sustainable control of the epidemic in Mozambique. Funding amounts for years 2-5 will be set at continuation.

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 Homeless Service Providers Knowledge, Attitudes, and Practices Regarding Body Lice, Fleas and Associated Diseases. This proposed study is designed to improve CDC's understanding of homeless service providers knowledge, attitudes, and practices regarding vector-borne diseases that can affect persons experiencing homelessness.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

The Food and Drug Administration (FDA, Agency, or we) is classifying the integrated continuous glucose monitoring system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the integrated continuous glucose monitoring system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension with minor changes to the approved information collection: Regional Partnership Grants National Cross-Site Evaluation and Evaluation Technical Assistance (OMB #0970-0527). The proposed information collection will be used in a national cross-site evaluation of the fifth and sixth cohorts of CB's Regional Partnership Grants (RPG). The cross-site evaluation will use surveys, interviews, progress reports, and data on participant enrollment, services, and outcomes.

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 certain Center for Devices and Radiological Health (CDRH) appeals processes.

The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension of approval for an information request to collect data from Low Income Household Water Assistance Program (LIHWAP) grant recipients. This information collection was originally approved for 6 months as an emergency approval. OCS is proposing revisions to the information collection based on feedback received to date.

The Department of Health and Human Services (HHS or Department) is issuing this final rule to make effective the exemptions that were previously proposed for a subset of records covered in a new Privacy Act system of records, No. 09-25-0165, NIH Loan Repayment Records, which is maintained by the National Institutes of Health (NIH). The system of records covers records used to manage and evaluate the Loan Repayment Programs (LRPs) at NIH. The exemptions are necessary to maintain the integrity of the NIH peer review and award processes by enabling NIH to protect the identities of reviewers.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, Office of Policy and Extramural Research Administration (OPERA), Office of Extramural Research (OER) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA, the Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that SPIKEVAX (COVID-19 Vaccine, mRNA), meets the criteria for a material threat priority review voucher, which has been issued to ModernaTX, Inc., the holder of the biologics license application.

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 Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2022. This notice is issued under the Controlled Substances Act (CSA).

The Food and Drug Administration (FDA or we) is announcing the withdrawal of three compliance policy guides (CPG) entitled ``Compliance Policy Guide Sec. 510.800 BeveragesServing Size Labeling,'' ``Compliance Policy Guide Sec. 540.420 Raw Breaded Shrimp Microbiological Criteria for Evaluating Compliance with Current Good Manufacturing Practice Regulations,'' and ``Compliance Policy Guide Sec. 562.800 Vending Machine FoodLabeling.'' We are withdrawing these CPGs because they have become outdated or have been superseded by subsequent FDA actions.