Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
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Request for Information Regarding Diagnostic Excellence Measurement; Reopening of Comment Period
The Agency for Healthcare Research and Quality (AHRQ) invites public comment in response to this Request for Information (RFI) on the development of measures of diagnostic excellence that may be calculated using administrative data or electronic health record (EHR) data. The purpose of diagnostic excellence measurement is to identify potential opportunities to improve the diagnostic process at a health system or geographic level. AHRQ welcomes comments on the importance and usability of existing measures and those that may be under development.
Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
The Food and Drug Administration (FDA) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677- 012, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of insomnia characterized by difficulties with sleep initiation. The decision, which also refuses approval of sNDA 205677-012, is available in the docket identified by the number in the heading of this document.
National Vaccine Injury Compensation Program; List of Petitions Received
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 (Secretary) 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.
Request for Public Comment: 30-Day Notice for Extension of the Indian Health Service Loan Repayment Program
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 Office of Management and Budget (OMB) Control Number 0917-0014, titled, "IHS Loan Repayment Program (LRP)."
Advisory Committee on Immunization Practices; Cancellation of Meeting
This is to notify the public that the February 26-28, 2025, meeting of the Advisory Committee on Immunization Practices (ACIP) was cancelled and will be rescheduled.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
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.
Request for Public Comment: 30-Day Notice for Extension of Fast Track Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery: Indian Health Service Customer Service Satisfaction and Similar Surveys
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 Office of Management and Budget (OMB) Control Number 0917-0036, "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery." This notice announces our intent to submit this previously approved information collection, which expires February 28, 2025, to the OMB for approval of an extension and solicit comments on specific aspects for the proposed information collection.
Policy on Adhering to the Text of the Administrative Procedure Act
The Department of Health and Human Services' (the Department) Immediate Office of the Secretary is rescinding the policy on Public Participation in Rule Making (Richardson Waiver) and re-aligning the Department's rule-making procedures with the Administrative Procedure Act.
Name Change From Office of Child Support Enforcement to Office of Child Support Services; Reopening of Comment Period and Delaying Effective Date
The Department of Health and Human Services (HHS or Department) published a direct final rule entitled "Name Change From Office of Child Support Enforcement to Office of Child Support Services" in the Federal Register on December 31, 2024, which was to become effective March 3, 2025. HHS is reopening the public comment period and delaying the effective date for the purpose of reviewing any questions of fact, law, and policy that the rule may raise.
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule entitled "Food Labeling: Nutrient Content Claims; Definition of Term `Healthy,' " is delayed until April 28, 2025.
Notice of Hearing: Reconsideration of Disapproval Idaho Medicaid State Plan Amendment (SPA) 24-0015
This notice announces an administrative hearing to be held on April 2, 2025, by way of video, or at the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, 701 Fifth Avenue, Suite 1600, Seattle, WA 98104 to reconsider CMS' decision to disapprove Idaho's Medicaid SPA 24-0015.
Medicare and Medicaid Programs; Application From the Accreditation Commission for Health Care Inc. for Continued Approval of Its Home Health Agency Accreditation Program
This notice announces our decision to approve the Accreditation Commission for Health Care Inc. (ACHC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs: Approval of Application From the American Association for Accreditation of Ambulatory Surgery Facilities dba QUAD A for Continued CMS-Approval of Its Outpatient Physical Therapy (OPT) Accreditation Program
This notice acknowledges the approval of an application from the American Association for Accreditation of Ambulatory Surgery Facilities dba QUAD A for continued recognition as a national accrediting organization for Outpatient Physical Therapy programs that wish to participate in the Medicare or Medicaid programs.
Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients
In the January 17, 2025, issue of the Federal Register, the Drug Enforcement Administration and the Department of Health and Human Services published two final rules related to the practice of telemedicine, titled "Expansion of Buprenorphine Treatment via Telemedicine Encounter" and "Continuity of Care via Telemedicine for Veterans Affairs Patients." These final rules were scheduled to become final on February 18, 2025. In accordance with the Presidential Memorandum of January 20, 2025, titled "Regulatory Freeze Pending Review," the Drug Enforcement Administration and the Department of Health and Human Services are delaying the effective dates of these two final rules to March 21, 2025, and are soliciting public comments specifically regarding this delayed effective date.
Privacy Act; Implementation
On January 16, 2025, the Department of Health and Human Services published a final rule to make effective the exemptions that were previously proposed for a new Privacy Act system of records, "NIH Police Records," maintained by the National Institutes of Health (NIH), from certain requirements of the Act. That final rule was originally scheduled to take effect on February 18, 2025. This document announces that the effective date is delayed until March 21, 2025, in response to the memorandum titled "Regulatory Freeze Pending Review," issued by the President on January 20, 2025.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2024
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
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.
Medicare Program; Announcement of Request for an Exception From the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
The Social Security Act prohibits a hospital with physician ownership that relies on the exception to the physician self-referral law for hospitals outside of Puerto Rico or for rural providers from expanding its facility capacity unless the Secretary of the Department of Health and Human Services grants the hospital's request for an exception from that prohibition after considering input on the request from individuals and entities in the community where the hospital is located. The Centers for Medicare & Medicaid Services has received a request from a hospital with physician ownership for an exception from the prohibition on expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the hospital is located. Community input may inform our decision to approve or deny the hospital's request for an exception from the prohibition on expansion of facility capacity.
Medicare and Medicaid Programs: Application From The Joint Commission for Continued CMS-Approval of Its Hospital Accreditation Program
This proposed notice acknowledges the receipt of an application from The Joint Commission for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard; Delay of Effective Date
In accordance with the Presidential memorandum of January 20, 2025, titled "Regulatory Freeze Pending Review," the effective date of the final rule titled "Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard" is delayed until April 14, 2025. That final rule adopted updated versions of the retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of HIPAA, which constitute modifications to the adopted standards for the following retail pharmacy transactions: health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits. It also adopted a modification to the standard for the Medicaid pharmacy subrogation transaction.
Submission for Office of Management and Budget (OMB) Review; Child Care Improper Payments Data Collection Instructions (OMB #0970-0323)
The Administration for Children and Families is proposing revisions to an approved information collection, the Child Care Improper Payments Data Collection Instructions (OMB #0970-0323, expiration 1/31/2025). In addition to the proposed changes, we are requesting a 3-year extension.
Announcement of the Advisory Panel on Outreach and Education (APOE) Virtual Meeting; Cancellation of the February 6, 2025, Virtual Meeting
This notice announces the cancellation of the February 6, 2025, virtual public meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) that was announced in the January 10, 2025, Federal Register (90 FR 2003 through 2005). CMS will publish a notice in the Federal Register announcing the date on which the next meeting of the APOE will take place no less than 15 calendar days before the meeting date. The meeting will be open to the public in accordance with the Federal Advisory Committee Act (FACA) (Pub. L. 92- 463), as amended (5 U.S.C. Appendix 2).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling Requirements for Prescription Drugs
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Program
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Guidance for Industry; Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products
The final guidances entitled "Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and "Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps)" are being revised to change the time by which FDA recommends implementation of the recommendations in the guidances.
Privacy Act; Implementation
The Department of Health and Human Services (HHS or Department) published a direct final rule in the Federal Register on December 23, 2024, which was to become effective February 6, 2025. As a result of administrative technical issues, including an incorrect email address, HHS is reopening the public comment period with a new email address for the public to submit comments and delaying the effective date to March 21, 2025. The purpose of the direct final rule was to exempt a new Privacy Act system of records maintained by the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), Unaccompanied Children Bureau (UCB), System No. 09- 80-0323, "ORR Unaccompanied Children Bureau (UCB) Child Abuse or Neglect Investigation Records and Central Registry," from certain requirements of the Privacy Act, in accordance with subsection (k)(2) of the Privacy Act.
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule, entitled "Nonprescription Drug Product With an Additional Condition for Nonprescription Use," (ACNU) is delayed until March 21, 2025.
World Trade Center Health Program; Petitions 031, 036, 039, and 053-Amyotrophic Lateral Sclerosis; Finding of Insufficient Evidence
The Administrator of the World Trade Center (WTC) Health Program received four petitions (Petitions 031, 036, 039, and 053) to add amyotrophic lateral sclerosis (ALS) to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by petitioners, the Administrator determined that there is insufficient evidence to support taking further action at this time regarding ALS. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting 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 listed in the Addresses section below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below), limited only by the number of audio conference lines available (150).
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