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

The Food and Drug Administration (FDA or we) is proposing to replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on review and approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions. FDA is also proposing an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution. FDA is proposing these revisions to streamline the IRB review process and decrease administrative burdens and inefficiencies for investigators and IRBs without compromising human subject protections. This proposed rule would harmonize FDA's requirements for cooperative research and IRB records, to the extent practicable and consistent with statutory provisions, with the ``Federal Policy for the Protection of Human Subjects'' (revised Common Rule) and is being issued in accordance with a provision of the 21st Century Cures Act (Cures Act).

The Administration for Children and Families (ACF) has redelegated the authorities for the Preschool Development Grants Birth Through Five (PDG B-5) and Tribal Maternal Infant and Early Childhood Home Visiting (MIECHV) Program from the Office of Child Care to the Office of Early Childhood Development.

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Headquarters (HQ) and Field Offices (RFO) have modified its structure.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Clinical Decision Support Software.'' This final guidance provides clarity on FDA's oversight of clinical decision support (CDS) software intended for health care professionals with the purpose of describing FDA's regulatory approach to CDS software functions. This guidance clarifies the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Over-the-Counter Monograph Submissions in Electronic Format.'' This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA) is announcing a correction to the notice of meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of September 2, 2022. The correction is being made to reflect a change to the sponsor's name. There are no other changes.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee, in the Center for Tobacco Products. Nominations will be accepted for upcoming vacancies effective January 31, 2023, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

On November 6, 2020, CMS published an interim final rule with request for comments (IFR) entitled ``Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency.'' The IFR set forth certain requirements in CMS regulations that States must follow in order to claim a temporary increase in Federal matching funds for their Medicaid programs under the Families First Coronavirus Response Act (FFCRA). In light of the possibility of changed circumstances since publication of the IFR and other policy considerations, CMS is considering modifying those requirements. CMS is soliciting additional information from the public on any issues that may be pertinent to these potential modifications by reopening the public comment period for an additional 30 days.

The U.S. Department of Health and Human Services' (HHS) Office of Disease Prevention and Health Promotion (ODPHP) invites public and private sector organizations that support Healthy People 2030, the nation's disease prevention and health promotion plan, to become a Healthy People 2030 Champion. The selected Healthy People 2030 Champions will be recognized for their commitment and work toward achieving Healthy People 2030's vision of a society in which all people can achieve their full potential for health and well-being across the lifespan.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, sponsors, and institutional review boards (IRBs) entitled ``Ethical Considerations for Clinical Investigations of Medical Products Involving Children.'' This draft guidance describes FDA's current thinking regarding ethical considerations for clinical investigations of drugs, biological products, and medical devices (collectively referred to as ``medical products'' in this notice) involving children. The draft guidance is intended to assist industry, sponsors, and IRBs when considering the enrollment of children in clinical investigations of medical products.

The Administration for Children and Families' (ACF) Office of Refugee Resettlement (ORR) intends to collect demographic, programmatic, and outcome data on Services for Survivors of Torture (SOT) grant recipients and the clients they serve. This data collection will allow ORR to learn more about the populations served; the types and effectiveness of services provided; methods, challenges, and facilitators of implementing services; and grant recipients' progress towards programmatic goals. ORR will collect these data on the new cohort of Services for SOT grant recipients; ORR collected information from the previous grantee cohort under the Generic Performance Progress Report (OMB #0970-0490). ORR has made changes to the data collection instruments for use in the new cohort.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 Information Collection (IC) Revision solicits comments on the information collection requirements relating to the State Councils on Developmental Disabilities (Councils) OMB control number 0985-0033.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Roy Tuccillo, Sr. for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Tuccillo was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Tuccillo was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 17, 2022 (30 days after receipt of the notice), Mr. Tuccillo has not responded. Mr. Tuccillo's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency.'' Combating the opioid overdose epidemic is an urgent public health priority for FDA. Naloxone hydrochloride (``naloxone'') is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. FDA understands that naloxone is being made available to underserved communities through entities such as harm reduction programs and is aware of concerns that harm reduction programs are having difficulty acquiring naloxone. FDA is issuing this guidance to clarify the scope of the public health emergency exclusion and exemption under the Drug Supply Chain Security Act as they apply to the distribution of FDA-approved naloxone products indicated for the emergency treatment of opioid overdose to harm reduction programs during the opioid public health emergency. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.

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.

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 Customer Surveys Generic Clearance for the National Center for Health Statistics. The goal of this project is to conduct voluntary customer surveys to assess strengths in agency products and services, and to evaluate how well it addresses the emerging needs of its data users.