Department of Health and Human Services December 26, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Monterey Mushrooms, LLC; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Monterey Mushrooms, LLC, proposing that the food additive regulations for vitamin D2 mushroom powder be amended to provide for an additional method for producing the additive.
Statement of Organization, Functions, and Delegations of Authority
The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research's (CDER), Office of Surveillance and Epidemiology (OSE) and Office of New Drugs (OND) has modified their organizational structure. The new organizational structure was approved by the Secretary of Health and Human Services on November 20, 2014.
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). A nonprescription drug product with an ACNU is a drug product that could be marketed without a prescription if an applicant implements an additional condition to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a practitioner licensed by law to administer such drug. The final rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products and increase consumer access to appropriate, safe, and effective drug products, which could improve public health.
Office of Child Care; Statement of Organization, Functions, and Delegations of Authority; Correction
The Administration for Children and Families (ACF) published a document in the Federal Register on December 4, 2024, concerning minor adjustments made to the organization of the Office of Child Care (OCC) in adding a Regional Operations Division. The document contained an incorrect code.
Select Agent: Modified Junín Virus Vaccine Strain
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), has determined that a previously excluded attenuated strain, Jun[iacute]n virus vaccine strain Candid No.1, has key attenuating mutations in the glycoprotein envelope at GP1 T168A and GP2 F427I. Revertants at either of these positions have increased pathogenicity and virulence. Therefore, Jun[iacute]n virus vaccine strain Candid No. 1 containing GP1 168T and/or GP2 427F is a select agent and is subject to the select agent and toxin regulations.
Agency Information Collection Request; 60-Day Public Comment Request
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.
Export Lists for Human Food: Request for Information; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the request for information, published in the Federal Register of November 8, 2024. In that notice, FDA invited comment relating to the listing requirements of other countries and FDA's approach to facilitating U.S. industry compliance with these requirements through the issuance of export certification for human food products provided in the form of lists (export lists). We are extending the comment period to allow interested persons additional time to submit comments on FDA's approach.
Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing departmentwide system of records, "Federal Advisory Committee Membership Files," System No. 09-90-0059. The modifications include, among other things, adding records about any prospective guest speakers at Federal advisory committee meetings who disclose financial interests and professional relationships related to the matter they will be speaking on, and changing the name of the system of records to "Federal Advisory Committee/Subgroup Member, Subscriber/Registrant, and Guest Speaker Records."
Medicare Program; Rural Community Hospital Disemonstration Program: Solicitation of Additional Participants
This notice announces a solicitation for up to 10 additional eligible hospitals to participate in the Rural Community Hospital Demonstration program, to run through June 30, 2028.
Proposed Information Collection Activity; Sexual Risk Avoidance Education (SRAE) National Evaluation Overarching Generic (New Collection)
The Administration for Children and Families' (ACF) Office of Planning, Research, and Evaluation (OPRE) requests Office of Management and Budget (OMB) approval for an overarching generic clearance to collect data from programs delivered by Sexual Risk Avoidance Education (SRAE) grant recipients on behalf of the SRAE National Evaluation. The generic mechanism will allow ACF to rapidly respond to research and evaluation opportunities that would not otherwise be feasible under the timelines associated with the Paperwork Reduction Act of 1995. The opportunities may relate to innovative implementation strategies and program components in use by SRAE grant recipients as they arise, and in particular, for youth subpopulations served by grant recipients. The purpose of the data collections submitted under the generic will be to inform ACF programming by building evidence about what innovations work to improve programming and outcomes across the SRAE grant recipients and the youth they serve.
Investigations of Child Abuse and Neglect Rule; Correction
ORR is correcting an interim rule (IFR) that was published in the Federal Register on November 27, 2024 with an effective date of December 27, 2024. The Investigations of Child Abuse and Neglect IFR provides standards and processes for ORR to apply when it conducts investigations into allegations of child abuse and neglect that occur in certain care provider facilities funded by ORR to provide residential and other services for unaccompanied children; describes a process for appeal and review of substantiated allegations; and establishes an ORR Central Registry to list individuals with certain findings of child abuse and neglect that have been substantiated and sustained after exhausting the appeal and review process.
Proposed Information Collection Activity; Data Collection for the NextGen Project's Well-Being Storytelling Exhibit (New Collection)
The Office of Planning, Research, and Evaluation (OPRE) in the Administration for Children and Families (ACF) is conducting additional data collection activities for the Next Generation of Enhanced Employment Strategies Project (NextGen Project) that provides an in- depth look at participant experiences. This effort includes photo elicitation methods and will be referred to as the Well-Being Storytelling Exhibit. The study team will use photo elicitation and human-centered design methods to explore how NextGen participants, staff, and community members conceptualize well-being. This data will help the study team explore the factors that may enhance or explain impact study findings.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
