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HHS/FDA RIN: 0910-AI56 Publication ID: Fall 2023 
Title: Revisions to Regulation for Receiving an Abbreviated New Drug Application 

FDA is taking this action to revise 21 CFR 314.101 Filing an NDA and Receiving an ANDA in order to ensure the submission of high-quality, sufficiently complete abbreviated new drug applications (ANDAs) for technical assessment and approval. FDA’s regulations at 21 CFR 314.101(b), (d), and (e) set forth general criteria for the receipt or refusal of an ANDA for assessment. Specifically, 21 CFR 314.101(d)(3) states that in determining whether to receive or refuse to receive (RTR) an ANDA, FDA considers the nature of the deficiency (i.e., whether the deficiency is major or minor) and the number of deficiencies that have been identified during the filing review. The current regulations, while providing examples of deficiencies for which FDA will or may RTR an ANDA, do not specify whether the deficiencies are major or minor, nor do the regulations establish the number of deficiencies that will result in an RTR determination. In the absence of these specifics, FDA has issued a series of guidance documents over the last several years identifying more specific examples of what we have considered to be major or minor deficiencies. To improve the clarity and predictability of the ANDA assessment process and facilitate the submission of sufficiently complete applications, we intend to describe what we consider to be major and minor deficiencies, provide examples of such deficiencies, and establish the number of deficiencies that will cause FDA to RTR an ANDA (e.g., one major deficiency or 10 or more minor deficiencies) in ways that generally are consistent with current Agency practices. We will also establish a timeframe in which an applicant may respond to an information request from FDA to resolve minor deficiencies and ensure receipt of the ANDA consistent with current Agency practices. For example, we have permitted ANDAs for which we have identified a few minor deficiencies a limited period of time to address those minor deficiencies.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 314.101   
Legal Authority: 21 U.S.C. 355    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  08/00/2024 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Lisa Bercu
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 75, Room 1672,
Silver Spring, MD 20993
Phone:240 402-6902