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

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic ActCompliance Policies.'' This guidance describes FDA's compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing (referred to as enhanced drug distribution security requirements) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that will go into effect on November 27, 2023. FDA believes the compliance policies outlined in this guidance will help supply chain stakeholders, particularly trading partners, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the Drug Supply Chain Security Act (DSCSA) while helping ensure continued patient access to prescription drugs.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. 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 the audio conference (information below). The audio conference line has 150 ports for callers.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). The BSC, CPR consists of 11 experts in fields associated with business, crisis leadership, emergency response and management, informatics, laboratory science, medicine, mental and behavioral health, public health law, public health practice, risk communication, and social science.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). This is a hybrid meeting, accessible both in person and virtually. It is open to the public, limited only by the in-person space available. The public is also welcome to view the meeting by joining the audio conference (information below). Time will be available for public comment, and the public is also welcome to submit written comments in advance of the meeting (see the public participation section below).

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.

The Food and Drug Administration (FDA or we) is proposing to amend the standard of identity and standard of fill of container for canned tuna. This action partially responds to a citizen petition submitted by Bumble Bee Foods, LLC, StarKist Co., and Tri Union Seafoods, LLC (doing business as Chicken of the Sea International). We tentatively conclude that this action, if finalized, will promote honesty and fair dealing in the interest of consumers.

In accordance with regulatory provisions, 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 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 funding to icddr,b. The award will support high quality public health research and surveillance activities to further strengthen the ability of the Government of Bangladesh and other global partners to detect, prevent, and respond to disease threats. 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 Program Evaluation for PS22-2208 Component 2. This information collection request is designed to monitor and evaluate the PS22-2208 Component 2 funding opportunity's overall goal of supporting syringe services program (SSP) subrecipients in meeting the needs of people who use drugs (PWUD) and reducing infectious disease and other harms related to drug use during the 5- year PS22-2208 Cooperative Agreement.

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.

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

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 convene the 78th full council meeting on Wednesday, September 20, 2023. The meeting will convene in Charleston, West Virginia and it will also utilize virtual technologies. The meeting will be open to the public. Due to limited space, pre-registration is encouraged for members of the public who wish to attend the meeting in-person. Please email your name to PACHA@hhs.gov by close of business Wednesday, September 13, 2023 to pre-reigster. There will be a public comment session during the meeting; pre-registration is required to provide public comment. To pre-register to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Wednesday, September 13, 2023. 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 September 27, 2023. 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 Office of the Assistant Secretary for Health (OASH) is seeking nominations for membership on the Presidential Advisory Council on HIV/AIDS (referred to as PACHA and/or the Council). The PACHA is a federal advisory committee within the U. S. Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve for overlapping terms of up to four-year; terms of more than two years are contingent upon the authorized continuation of the Council. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs, policies, and research to promote effective treatment, prevention and cure of HIV and AIDS, including considering common co-morbidities, as needed to promote effective HIV diagnosis, treatment, prevention, and quality care services. The functions of the Council are solely advisory in nature.

The Food and Drug Administration (FDA, 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 an alternative form of hearing regarding the Center for Drug Evaluation and Research's (CDER's) proposal to refuse to approve ITCA 650 (exenatide in DUROS device), a drug-device combination product that is the subject of a new drug application (NDA) submitted by Intarcia Therapeutics, Inc. (Intarcia). CDER is holding a public hearing before an advisory committee under FDA regulations as an alternative form of hearing.

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

The Substance Abuse and Mental Health Services Administration (SAMHSA) within the Department of Health and Human Services (HHS), is soliciting applications from qualified individuals or organizations to be considered for non-voting representative positions on the Maternal Mental Health Task Force subcommittee of the Advisory Committee for Women's Services (ACWS) (ACWS Subcommittee), as authorized in the Consolidated Appropriations Act. This notice solicits additional representatives.

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, the Agency, or we) is announcing a public workshop entitled ``Workshop To Enhance Clinical Study Diversity.'' This public workshop will satisfy a mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) for FDA to convene one or more public workshops to solicit input from various stakeholders on enhancing diversity in clinical studies.The public workshop will be convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative and will solicit input from interested parties on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence or incidence of the disease or condition among demographic subgroups, where appropriate.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the 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.

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.

HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Commission on Childhood Vaccines (ACCV). ACCV advises the Secretary of HHS (the Secretary) on issues related to the implementation of the National Vaccine Injury Compensation Program (VICP).

The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies two bulk drug substances that FDA has considered and is not including on the list at this time: ephedrine sulfate and hydroxychloroquine sulfate. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.

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 mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings. The collection is part of a research study designed to implement and evaluate the effectiveness of an intervention that utilizes evidence-based education and support tools to improve preexposure prophylaxis (PrEP) adherence among young men who have sex with men (YMSM).

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) Survey. This data collection will evaluate fire department implementation of the NIOSH FFFIPP recommendations, and assess whether NIOSH FFFIPP recommendations are utilized by fire departments to identify barriers to implementation of recommendations and to identify areas for potential intervention projects.

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Healthcare Safety Network (NHSN). NHSN provides facilities, States, regions, and the nation with data necessary to identify problem areas, measure the progress of prevention efforts, and ultimately eliminate healthcare-associated infections (HAIs) nationwide.

HRSA is providing approximately $600,000 in supplemental award funds in federal fiscal year 2023 to the recipient of the Family Engagement and Leadership in Systems of Care award to support technical assistance and provide subawards to Family-to-Family Health Information Centers (F2F HIC) to support Medicaid redetermination education, guidance, and support to children with special health care needs and their families, particularly those receiving services through Medicaid Home and Community Based Services waivers.

The Food and Drug Administration (FDA, Agency, or we) has determined that BORTEZOMIB (bortezomib) solution, 2.5 milligrams (mg)/ milliliter (mL) and 3.5 mg/1.4 mL (2.5 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for BORTEZOMIB (bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5 mg/ mL), if all other legal and regulatory requirements are met.

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.

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.

CDC's National Institute for Occupational Safety and Health (NIOSH) is extending the public comment period for a request for information (RFI) that published April 26, 2023, regarding a World Trade Center (WTC) Health Program research cohort for future studies on health, social, and educational impacts among persons exposed to the September 11, 2001, terrorist attacks who were aged 21 years or younger at the time of their exposures. An organization interested in responding to the RFI asked CDC to extend the comment period to allow more time to submit comments. With this notice, the comment period is extended an additional 60 days, to allow interested parties additional time to respond.

HRSA is providing supplemental funds not to exceed $449,000 to the Women's Preventive Services Initiative (WPSI) in fiscal year 2023.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Optimizing the Use of Postapproval Pregnancy Safety Studies'' convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis. This workshop will include discussions of designs of postapproval pregnancy safety studies for drug and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and experiences with implementing these studies. The workshop also will include discussion of considerations for further development of a framework that describes how data from different types of postapproval pregnancy safety studies might optimally be used when it has been determined that this data should be collected.

The invention listed below is directed to potential peptidyl therapeutics that counteract with amyloid forming IAPP and amyloid- [beta] in treatments of diabetes and Alzheimer's disease and serve as blood-based biomarkers for Alzheimer's disease. This technology was discovered and is being developed by the National Institute on Aging (NIA). The NIA is currently seeking a licensee and/or collaborator to further develop this technology.

In compliance with the Paperwork Reduction Act of 1995, HRSA 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 or the Agency) is reopening the comment period for the notice of availability that published in the Federal Register of June 8, 2023. In that notice, FDA requested comments on the draft guidance for industry (GFI) #279 entitled ``Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to develop and submit comments.

The Food and Drug Administration (FDA or we) is announcing that the Florida Citrus Processors Association (FCPA) and Florida Citrus Mutual (FCM) have filed a citizen petition requesting that we amend the standard of identity (SOI) for pasteurized orange juice (POJ) by adjusting the minimum soluble solids content from 10.5[deg] to 10[deg] Brix. We are issuing this document to request comments, data, and information about the issues presented in the petition.

The Department of Health and Human Services (HHS) is issuing a Notice of Proposed Rule Making (NPRM) to establish standards and procedures by which it may require acceptance and priority performance of certain contracts or orders to promote the national defense over other contracts or orders with respect to health resources. This proposed rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisory-committees/ rural-health/.

This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

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 Possession, Use, and Transfer of Select Agents and Toxins. This data collection allows CDC to continue to collect information and ensure compliance under the Select Agent regulations.

The Food and Drug Administration (FDA, 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 National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) has developed a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principle of this initiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence.

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 the information collection provisions of existing FDA regulations concerning FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle.

The Food and Drug Administration (FDA, 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 or Agency) is announcing the availability of a draft guidance for industry entitled ``Classification Categories for Certain Supplements Under BsUFA III.'' This draft guidance provides recommendations for applicants and FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This draft guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.

The Food and Drug Administration (FDA 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 Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Cancer Institute, both institutes of the National Institutes of Health, Department of Health and Human Services, are 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 EnZeta Immunotherapies, Inc. of the State of Delaware.

The Administration for Children and Families (ACF) proposes to extend data collection under the existing overarching generic clearance for Formative Data Collections for ACF Research and Evaluation (Office of Management and Budget (OMB) #0970-0356). There are no changes proposed.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), has determined that an excluded attenuated strain, Coxiella burnetii Phase II, Nine Mile Strain, plaque purified clone 4, has, in one instance, been shown to spontaneously mutate when passaged in vivo. The resulting mutant, C. burnetii Phase II, Nine Mile Strain, plaque purified clone 4 with reversion to wildtype cbu0533, has enhanced pathogenicity and virulence. Therefore, C. burnetii Phase II, Nine Mile Strain, plaque purified clone 4 with reversion to wildtype cbu0533 is not an excluded strain but is a select agent and subject to the HHS select agent and toxin regulations.

The National Institutes of Health (NIH) seeks input on a proposal to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to include specific considerations and requirements for conducting research involving gene drive modified organisms (GDMO) in contained research settings. NIH is proposing to update the NIH Guidelines to clarify minimum containment requirements, propose considerations for performing risk assessments, and define additional institutional responsibilities regarding Institutional Biosafety Committees (IBCs) and Biosafety Officers (BSOs). The proposed revisions are specific to GDMO research subject to the NIH Guidelines, conducted in contained settings and are consistent with the recommendations of the NIH Novel and Exceptional Technology Research Advisory Committee report, Gene Drives in Biomedical Research (NExTRAC Report). NIH does not currently support research involving potential field release of GDMOs and the NIH Guidelines pertain to contained research; accordingly, no changes regarding potential field release are being proposed in this Notice. NIH is also proposing revisions to the NIH Guidelines to harmonize with the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th edition regarding the Risk Group (RG) categorization of West Nile Virus (WNV) and Saint Louis Encephalitis Virus (SLEV).

The Food and Drug Administration (FDA, the 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 the information collection provisions of FDA's regulations governing batch certification of color additives manufactured for use in foods, drugs, cosmetics, or medical devices in the United States.

The Food and Drug Administration (FDA) 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, 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) is requesting that any small business tobacco manufacturing industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to be included in a pool of individuals to represent the interests of the small business tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. This position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. Nominations will be accepted for current vacancies effective with this notice.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces availability of the draft document, ``Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies.'' ICCVAM will accept public comments on the document through September 5, 2023; 5:00 p.m. EDT.

The Food and Drug Administration (FDA or we) is proposing to amend our regulations that provide for the use of partially hydrogenated oils (PHOs) in food in light of our determination that PHOs are no longer generally recognized as safe (GRAS). We are proposing to remove PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna. We are also proposing to revise FDA's regulations affirming food substances as GRAS pertaining to menhaden oil and rapeseed oil to no longer include partially hydrogenated forms of these oils, and delete the regulation affirming hydrogenated fish oil as GRAS as an indirect food substance. We are also proposing to revoke prior sanctions (i.e., pre-1958 authorization of certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on our conclusion that these uses of PHOs may be injurious to health.

The Administration for Community Living (ACL) announces the intent to award a one-year supplemental to the current grant held by Independent Living Research Utilization (ILRU) for technical assistance (TA) to Statewide Independent Living Councils (SILCs). The purpose of this grant is to provide TA to SILCs that supports them to operate effective organizations; fulfill their role in developing state plans for independent living; monitor, review, and evaluate the implementation of completed plans; and develop partnerships with designated state entities and other agencies to foster effective independent living programs. The administrative supplement for FY 2023 will be for $246,296, which will be the total award for FY 2023.

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the Women's Health USA Patient Safety Organization PSO, PSO number P0207, of its status as a PSO, and has delisted the PSO accordingly.

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 requirements for the tracking of medical devices.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Registration and Listing of Cosmetic Product Facilities and Products.'' This draft guidance, when finalized, will assist persons submitting cosmetic product facility registrations and product listing submissions to FDA under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This draft guidance is not final nor is it in effect at this time.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection applicable to the Good Laboratory Practice Requirements for Nonclinical Laboratory Studies established in Agency regulations.

The Food and Drug Administration (FDA, 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.