Department of Health and Human Services December 13, 2021 – Federal Register Recent Federal Regulation Documents

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting the federal 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 use the EDE to improve case processing. The current OMB approval expires on June 30, 2022.

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 announcing the availability of a final guidance for industry entitled ``Q3C(R8) Impurities: Guidance for Residual Solvents.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance provides recommendations for permitted daily exposures (PDEs) for three additional residual solvents: 2-Methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol. The PDEs were developed according to the methods for establishing exposure limits included in the guidance for industry ``Q3C: Impurities Residual Solvents'' (Q3C guidance). The Q3C PDE levels are added and revised as new toxicological data for solvents become available. This guidance finalizes the draft guidance entitled ``Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl AlcoholAccording to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents'' issued on May 27, 2020.

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 titled, ``Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions,'' Office of Management and Budget (OMB) Control Number 0917-0028. A copy of the supporting statement is available at www.regulations.gov (see Docket ID: IHS_FRDOC_0001).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products.'' The purpose of this draft guidance is to provide FDA's current thinking regarding the necessary attributes of patients for enrollment in clinical trials, efficacy assessments, and safety assessments. The draft guidance is intended to serve as a focus for continued discussion among FDA's Division of Gastroenterology, pharmaceutical sponsors, the academic community, and the public.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting the federal Office of Management and Budget (OMB) to approve the Federal Tax Refund Offset, Administrative Offset, and Passport Denial with minor edits to the ``Comments'' section of the record specifications to clarify the corresponding fields for an additional three years. The current OMB approval expires on June 30, 2022.

The Administration for Children and Families' (ACF) Administration for Native Americans (ANA) is requesting a 2-year extension to the following information collection: Annual Data Report (ADR) (OMB #0970-0475; expiration date: 2/28/2022). There are no changes requested to the form.