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

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the "generic" clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are "usually voluntary, low-burden, and uncontroversial collections," do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.

This final rule adopts updated versions of the retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These updated versions are modifications to the currently 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. This final rule also adopts a modification to the standard for the Medicaid pharmacy subrogation transaction.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Registration and Listing of Cosmetic Product Facilities and Products." The guidance 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 guidance includes three new draft frequently asked questions and answers about cosmetic product facility registrations and product listing submissions, in Appendix B, for comment purposes only. Aside from the three new draft frequently asked questions and answers, this guidance finalizes the draft Appendix B published in an otherwise final guidance on December 19, 2023. This guidance also includes minor changes to the final guidance for clarity.

This document revises and restates the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Office of the General Counsel (OGC). Issuance of this Statement of Organization rescinds all prior Statements of Organization.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Leprino Nutrition, proposing that the food additive regulations be amended to provide for the safe use of ultraviolet light for the reduction of microorganisms in whey products.

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.

The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to extend the duration of the Declaration to December 31, 2029, and to republish the Declaration in full.

This notice acknowledges the approval of an application by the DNV Healthcare USA, Inc., for continued recognition as a national accrediting organization for Critical Access Hospitals that wish to participate in the Medicare or Medicaid programs.

This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Sac and Fox Nation of Missouri in Kansas and Nebraska (Sac and Fox Nation of Missouri, or Tribe) to include the counties of Doniphan and Jackson in the State of Kansas, and Holt in the State of Missouri. The current PRCDA for the Sac and Fox Nation of Missouri includes Brown County, Kansas, and Richardson County, Nebraska. The Sac and Fox Nation of Missouri Tribal members who reside outside of the PRCDA are eligible for direct care services; however, they are not eligible for Purchased/Referred Care (PRC) services. The sole purpose of this expansion would be to authorize additional Sac and Fox Nation of Missouri members and beneficiaries to receive PRC services.

The Departments of Health and Human Services and Agriculture invite the public to provide written comments and virtual oral comments on the Scientific Report.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicaid, Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, drug coverage, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This proposed rule also includes proposals to codify existing subregulatory guidance in the Part C and Part D programs.

The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the Office of Management and Budget (OMB) to approve the Electronic Document Exchange (EDE), with minor revisions, for an additional three years. State child support agencies (CSAs) use the EDE to improve case processing. The current OMB approval expires on June 30, 2025.

OCSS is requesting the Office of Management and Budget (OMB) to approve the "State SNAP Agency NDNH Matching Program Performance Report," with minor revisions, for an additional three years. State agencies administering their Supplemental Nutrition Assistance Program (SNAP) provide the annual performance report to OCSS in accordance with the computer matching agreement between state SNAP agencies and OCSS. The current OMB approval expires on February 28, 2025.

This final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for, the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; updates to the Medicare Diabetes Prevention Program expanded model; payment for dental services inextricably linked to specific covered medical services; updates to drugs and biological products paid under Part B including immunosuppressive drugs and clotting factors; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or a Medicare Advantage Prescription Drug (MA-PD) plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the diabetes payment structure and PHE flexibilities; expansion of colorectal cancer screening and Hepatitis B vaccine coverage and payment; establishing payment for drugs covered as additional preventive services; Medicare Parts A and B Overpayment Provisions of the Affordable Care Act and Medicare Parts C and D Overpayment Provisions of the Affordable Care Act.

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 Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Medical Care for Adults with Down Syndrome, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.