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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Study of Sex Differences in the Clinical Evaluation of Medical Products." Clinical trials and non-interventional studies of medical products should be designed to enroll sufficient numbers of females and males to reflect the prevalence of the disease or condition for which the medical product is being investigated to help ensure the generalizability of results and facilitate exploration of potential differences in effects by sex. This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products. When finalized, this guidance will replace the guidance entitled "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs" issued in July 1993.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Labeling of Plant-Based Alternatives to Animal-Derived Foods." This draft guidance, when finalized, will provide our recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for animal-derived foods (plant-based alternative foods), especially in the absence of a common or usual name for the product. This draft guidance does not address the naming and labeling of plant-based milk alternatives; FDA is providing recommendations regarding these products in a separate guidance document.

The Food and Drug Administration (FDA or we) is announcing the availability of a revised final guidance for industry entitled "Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry." The guidance explains FDA's current thinking on a number of issues related to the labeling of food allergens, including requirements in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act).

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." This draft guidance, when finalized, will describe FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs). Type VII VMFs are appropriate for research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), gene therapies, and heritable intentional genomic alterations (IGAs) in animals.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for FDA staff and interested parties entitled "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act." This guidance document provides our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than one of the major food allergens (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame) listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Department of Health and Human Services (HHS or "Department") is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Security Standards for the Protection of Electronic Protected Health Information ("Security Rule") under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The proposed modifications would revise existing standards to better protect the confidentiality, integrity, and availability of electronic protected health information (ePHI). The proposals in this NPRM would increase the cybersecurity for ePHI by revising the Security Rule to address: changes in the environment in which health care is provided; significant increases in breaches and cyberattacks; common deficiencies the Office for Civil Rights has observed in investigations into Security Rule compliance by covered entities and their business associates (collectively, "regulated entities"); other cybersecurity guidelines, best practices, methodologies, procedures, and processes; and court decisions that affect enforcement of the Security Rule.

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 requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective February 1, 2025, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

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 (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.

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 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's (FDA, Agency, or we) Office of Pediatric Therapeutics, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research are announcing a public meeting entitled "Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act." The purpose of the public meeting is to seek input from interested parties, including patient/parent/ caregiver groups, consumer groups, regulated industry, academia, and others. This input will enable FDA to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatric drug and biologic development and labeling, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA).

Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA), that a meeting of the National Advisory Committee on the Trafficking of Children and Youth in the United States (Committee) will be held on January 13, 2025. The purpose of the meeting is for the Committee to discuss its plans and responsibilities over its 24-month extension to advise on the development and implementation of successful interventions with children and youth who have been impacted by labor and sex trafficking, make recommendations for administrative and legislative changes regarding the trafficking of children and youth, and publish information on best practices regarding the labor and sex trafficking of children and youth.

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

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments notice entitled "Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products," published in the Federal Register of July 25, 2024. FDA is reopening the comment period to update comments and to receive any new information.

The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Dermatologic and Ophthalmic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 7, 2026, expiration date.

The Office of Child Support Services (OCSS) is requesting a review by the Office of Management and Budget (OMB) of revisions to the Tribal Child Support Direct Funding Request: (OMB #0970-0218). These revisions are necessary to align this collection with updates resulting from a final rule: Employment and Training Services for Noncustodial Parents in the Child Support Program, which will require tribes to amend tribal plans if they elect to participate in employment and training services for non-custodial parents in the child support program.

The Food and Drug Administration (FDA or we) is establishing January 1, 2028, as the uniform compliance date for food labeling regulations that are published on or after January 1, 2025, and on or before December 31, 2026. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of labeling changes.