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 Overdose Response Strategy Data Collection. This data collection focuses on a survey

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

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 to take this opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Health Interview Survey (NHIS). This Extension is designed to include the continuation of current questionnaire

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

The Department of Health and Human Services (HHS) is delaying the effective date of the new routine use under the modified system of records maintained by the Office of Family Assistance (OFA) within HHS' Administration for Children and Families (ACF), System No. 09-80-0375, Temporary Assistance for Needy Families (TANF) Data that appeared in the Federal Register of June 23, 2026.

Original title: “Privacy Act of 1974; System of Records”

If confirmed by the Senate, Heidi Overton—officially revealed Wednesday as President Donald Trump’s choice for FDA commissioner—is expected to be a boon for developers of psychedelic therapeutics and non-opioid pain drugs, but could tow the party line on vaccines.

Original title: “Trump's FDA pick Overton good for psychedelics, new pain meds but bad for vaccines: analysts”

Heidi Overton, a medical doctor and veteran of the America First think tank, currently serves as deputy director of the White House Domestic Policy Council.

Original title: “Trump reportedly plans to tap policy aide Overton to lead FDA”

If Heidi Overton clears the Senate nomination process, analysts say she will have a tough job ahead to “restore predictability” to an agency battered by layoffs and controversial policies.

Original title: “Trump picks White House aide Heidi Overton as FDA chief: Reports”

Information about Shigella surveillance

Original title: “<em>Shigella</em> Surveillance”

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o Exponent, Inc., proposing that we amend our color additive regulations to expand the safe use of gardenia (genipin) blue in various foods at levels consistent with good manufacturing practice. The petition also proposes to lower the specification for arsenic in gardenia (genipin) blue.

Original title: “Gardenia Blue Interest Group; Filing of Color Additive Petition”

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.

Original title: “GNT USA, LLC.; Filing of Color Additive Petition”

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 chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.

Original title: “Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate”

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the World Trade Center (WTC) Health Program Scientific/Technical Advisory Committee (STAC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010, as amended. The STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine, environ

Original title: “Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee”

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the International Association of Color Manufacturers, proposing that we amend our color additive regulations to provide for the safe use of acetone as a solvent in the manufacture of carrot oil. The petition also proposes to add heavy metal limits and secondary names for carrot oil. FDA may also consider other changes to the regulation, as appropriate, during the course of our review.

Original title: “International Association of Color Manufacturers; Filing of Color Additive Petition”

The U.S. Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics

Original title: “FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application." This draft guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA. This draft guidance revises the gu

Original title: “Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability”

The Food and Drug Administration's (FDA) Office of Women's Health and the Center for Drug Evaluation and Research are announcing a public workshop titled "Testosterone Use in Menopausal Women." The purpose of the public workshop is to examine the current scientific evidence and critical knowledge gaps related to testosterone use in menopausal women to help inform future research and potential drug development of testosterone products for menopausal women. Researchers, educators, industry, clinic

Original title: “Testosterone Use in Menopausal Women; Public Workshop; Request for Comments”

Pursuant to the Head Start Act, notice is hereby given of one Tribal Consultation session to be held between HHS/ACF OHS leadership and the leadership of Tribal governments operating Head Start and Early Head Start programs. The purpose of this consultation session is to discuss ways to better meet the needs of American Indian and Alaska Native (AIAN) children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head

Original title: “Tribal Consultation Meeting”

The Administration for Children and Families (ACF) is requesting to reinstate approval of the ACF-700: Tribal Annual Report (Office of Management and Budget (OMB) #: 0970-0430) with proposed revisions. ACF requests changes to the form that reduce annual burden hours.

Original title: “Submission for Office of Management and Budget Review; ACF-700 Tribal Annual Report”

Original title: “National Institute of Neurological Disorders and Stroke; Notice of Partially Closed Meeting”

As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, suggests clinical considerations for medical device developers and anticipates AI-enabled SaMDs’ future progress.

Original title: “How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine”