Department of Health and Human Services December 17, 2020 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) is updating the organizational structure of the Office of Grants in the Office of the Assistant Secretary for Financial Resources (ASFR), which is located within the Office of the Secretary. ASFR is modifying the Office of Grants organizational structure to further improve and streamline its operation and to assume responsibility for maintaining and operating the GrantSolutions System currently aligned to the National Grant Center of Excellence (COE) in the Administration for Children and Families (ACF). The changes proposed affect HHS organizational Chapter AM Section AMU1 and AMU2 and Chapter KP Section KPA.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA's controlled correspondence response and the Agency's process for responding to those requests. This guidance finalizes the draft guidance announced in the Federal Register on November 3, 2017, and replaces the guidance for industry ``Controlled Correspondence Related to Generic Drug Development'' issued in September 2015.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ZOKINVY (lonafarnib), manufactured by Eiger BioPharmaceuticals, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Dry Eye: Developing Drugs for Treatment.'' The purpose of this draft guidance is to foster greater efficiency in drug development for this disease, which currently has few effective treatment options. The goal is to enhance clinical trial data quality and to support the development of treatments for dry eye conditions. Specifically, the draft guidance provides the Agency's current recommendations regarding eligibility criteria, trial design considerations, and efficacy endpoints for use in clinical development programs of investigational drugs to treat dry eye conditions.

The Food and Drug Administration (FDA, we, 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 reporting requirements contained in existing FDA regulations governing State enforcement notifications.

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 (the 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 Extension of a Currently Approved Collection (ICR Rev) solicits comments on the information collection requirements related to the Independent Living Services (ILS) Program Performance Report (PPR).

The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on November 16, 2020. This document had incorrectly designated footnotes and typographical errors.