Department of Health and Human Services October 2022 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the availability of the Final Supplemental Environmental Impact Statement (SEIS) for CDC's Roybal Campus in Atlanta, Georgia. The Final SEIS was prepared to address changes proposed since completing the 2014 Final Environmental Impact Statement (EIS) for the CDC Roybal Campus 2025 Master Plan (2014 Final EIS) and issuing a Record of Decision (ROD) dated November 7, 2014. This announcement follows the requirements of the National Environmental Policy Act (NEPA) as implemented by the Council on Environmental Quality (CEQ) regulations and HHS environmental procedures.

The Food and Drug Administration (FDA or Agency) is announcing publication of a discussion paper providing information for stakeholders and soliciting public comments on specific areas of emerging and advanced manufacturing technologies. The discussion paper presents areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with distributed manufacturing (DM) and point-of-care (POC) manufacturing for drugs, including biological products regulated by CDER and the Center for Biologics Evaluation and Research (CBER). FDA recognizes that regulatory policies and programs may need to evolve to enable the timely adoption of these technologies. The discussion paper includes a series of questions for each technology to stimulate feedback from the public.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the Statement of Work to assess communication between FDA and sponsors through product quality information requests during application review and to identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA). The independent assessment of FDA and sponsors in communicating through product quality information requests is described in detail in the document entitled ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027.'' As part of FDA performance commitments described in this document, the assessment will be conducted by an independent contractor. FDA is providing for public comment on the statement of work before revising as needed and requesting contractor proposals.

The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.

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.

Establish the Medicare Drug Rebate and Negotiations Group within the Center for Medicare (CM) to implement the Drug Price Negotiation Program and the Inflation Rebate Program in Medicare Part B and Part D as authorized under the Inflation Reduction Act of 2022. CMS is responsible for implementing these new programs.

The Biomedical Advanced Research and Development Authority (BARDA) annually hosts BARDA Industry Day (BID), a two-day conference with our industry and government partners to share BARDA's goals and objectives, increase awareness of U.S. government medical countermeasure (MCM) priorities, and facilitate coordination and collaboration between public and private sectors within the health security space.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC). This is a hybrid meeting, accessible both in person and virtually (webcast live via the World Wide Web). It is open to the public and limited only by the space available. Time will be available for public comment.

The Centers for Disease Control and Prevention (CDC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010 (42 U.S.C. 300mm-1(a)(2)), is seeking nominations for membership on the World Trade Center (WTC) Health Program Scientific/Technical Advisory Committee (WTCHP-STAC). The WTCHP-STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, and mental health, and representatives of WTC responders as well as representatives of certified-eligible WTC survivors.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health and National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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.

The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2023 rates for GDUFA III fees. These fees are effective on October 1, 2022, and will remain in effect through September 30, 2023.

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.

Notice is hereby given for the meeting on November 15-17, 2022 of the Substance Abuse and Mental Health Services Administration's Tribal Technical Advisory Committee (TTAC). The meeting is open to the public and will be held in person. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/ meetings. The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities; follow up on topics related to the previous TTAC meetings; and council discussions.

This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, December 7, 2022. National Coverage Determinations resulting in coverage with evidence development (CED) can expedite earlier Medicare beneficiary access to innovative technology while ensuring that systematic patient safeguards are in place to reduce the risks inherent to new technologies, or to new applications of older technologies. This meeting will examine the general requirements for clinical studies submitted for CMS coverage requiring CED. The MEDCAC will evaluate the CED criteria to assure that CED studies are evaluated with consistent, feasible, transparent and methodologically rigorous criteria and advise CMS on whether the criteria are appropriate to ensure that CED-approved studies will produce reliable evidence that CMS can rely on to help determine whether a particular item or service is reasonable and necessary. This meeting is open to the public in accordance with the Federal Advisory Committee Act.

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 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 Public Health Laboratory Testing for Emerging Antibiotic Resistance and Fungal Threats. This collection will allow CDC to partner with public health laboratories and will help equip them to detect and characterize isolates.

The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a supplemental new drug application (sNDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Infant Formula Transition Plan for Exercise of Enforcement Discretion: Guidance for Industry.'' We are issuing this guidance document to protect public health by helping to stabilize the supply of infant formula in the United States and to maintain a consistent supply of a variety of infant formula products. Under the guidance, we intend to exercise enforcement discretion until January 6, 2023, for infant formula products that are listed in letters of enforcement discretion that FDA has issued or will issue to specific manufacturers, in response to information provided under our May 2022 ``Infant Formula Enforcement Discretion Policy: Guidance for Industry,'' which remains in effect until November 14, 2022. For those manufacturers that wish to continue to market specific products in the United States under enforcement discretion after January 6, 2023, the guidance further details additional steps that manufacturers can take toward lawful marketing of such productsand the timeline under which such steps should be takenfor FDA to consider the continued exercise of enforcement discretion. This guidance document will help infant formula manufacturers meet applicable regulatory requirements while ensuring that consumers have continued access to formulas that are currently fulfilling the needs of infants consuming such products. We are also 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 (PRA). The proposed collection pertains to the submission of information necessary to facilitate FDA's exercise of enforcement discretion, as discussed in the guidance document.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.