Department of Health and Human Services March 2023 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' initial guidance for the Medicare Drug Price Negotiation Program for the implementation of the Inflation Reduction Act. CMS will be releasing additional Inflation Reduction Act-related guidance; all can be viewed on the dedicated Inflation Reduction Act section of the CMS website at https://www.cms.gov/inflation-reduction-act-and-medicare/.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #106 entitled ``The Use of Published Literature in Support of New Animal Drug Approvals.'' This guidance replaces existing guidance #106, ``The Use of Published Literature in Support of New Animal Drug Approvals,'' which FDA published in August 2000. It addressed the use of a single scientific article to support drug approval. This revision of the guidance document considers multiple uses of the scientific literature, including narrative reviews, systematic reviews, and meta-analyses to support approval of a new animal drug.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the Developmental Disabilities State Plan OMB control number 0985-0029.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements contained in regulations governing the use of radioactive drugs for basic informational research.

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 or Agency) is announcing the availability of a draft guidance for industry entitled ``Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.'' The draft guidance provides information for sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs under FDA regulations. This draft guidance revises the draft guidance for industry issued in June 2017 entitled ``Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR part 11 Questions and Answers'' and, when finalized, will supersede the guidance for industry entitled ``Computerized Systems Used in Clinical Investigations'' (May 2007).

The Food and Drug Administration (FDA or Agency) is withdrawing approval of six abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee (BPAC) for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the BPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

The National Biodefense Science Board (NBSB or the Board), authorized under the Public Health Service (PHS) Act, as added by the Pandemic and All-Hazards Preparedness Act of 2006 and amended by the Pandemic and All-Hazards Preparedness Reauthorization Act, will hold a virtual, public meeting on May 4, 2023, at 2:00 p.m. ET. The NBSB, managed and operated by the ASPR, provides expert advice and guidance to the Secretary of HHS regarding current and future chemical, biological, radiological, and nuclear threats, and other disaster preparedness and response matters. A detailed agenda and Zoom registration instructions will be available on the ASPR/NBSB public meeting web page at least 10 days in advance of the meeting.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $5,000,000, for Year 1 funding to the Ministry of Health Zanzibar (MOHZ). The award will provide rapid and flexible support to Zanzibar to accelerate evidence- based, person-centered HIV prevention and treatment program implementation at both facility and community levels, align HSS strengthening activities towards epidemic control, and ensure a comprehensive, coordinated, and strategic approach to the HIV response by organizing policies and interventions supported by reliable epidemiologic and program data. Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the award of approximately $15,000,000, for Year 1 funding to the Haitian Ministry of Health and Population (MSPP). The award will strengthen the public health system in Haiti by building the capacity of MSPP and partners to sustain governance of public health programs and, laboratory quality systems, monitor and evaluate programs, conduct surveillance for priority diseases and conditions (including, but not limited to, HIV, TB, cholera, VPDs, malaria, AFP, LF, rabies, COVID), and provide high quality health services. Funding amounts for years 2-5 will be set at continuation.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the number of webcast lines available. Time will be available for public comment.

Notice is hereby given for the meeting on April 25, 2023, 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 (hybrid). 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.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the awards of approximately $6,000,000 for Year 1 funding to FIOTEC, Brazil; approximately $13,000,000 for Year 1 to the Lighthouse Trust, Malawi; and approximately $300,000 for Year 1 funding to GAC, Ghana. These awards will support implementation of a comprehensive combination of HIV prevention, monitoring, diagnosis, and treatment systems; emergency preparedness and response; and a reduction of infectious disease burden in Brazil, Malawi, and Ghana. Funding amounts for years 2-5 will be set at continuation.

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 (the 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 Administration for Children and Families (ACF) is proposing to collect information to support state planning, training, and exercise activities and training and technical assistance for the United States (U.S.) Repatriation Program through six new forms in addition to the currently approved forms.

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.