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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2017-D-6752]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability.

# SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Information Requests and Discipline Review Letters Under GDUFA.” This guidance explains how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the assessment of an original abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance finalizes the draft guidance of the same title issued on December 18, 2017.

# DATES:

                        The announcement of the guidance is published in the                         **Federal Register**                         on January 27, 2022.                    

# ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

### Electronic Submissions

Submit electronic comments in the following way:
      -  Federal eRulemaking Portal: https://www.regulations.gov.                      Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to                      https://www.regulations.gov                      will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on                      https://www.regulations.gov. 
      - If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

### Written/Paper Submissions

Submit written/paper submissions as follows:
      -  Mail/Hand delivery/Courier (for written/paper submissions):                      Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.                
      - For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

*Instructions:*                     All submissions received must include the Docket No. FDA-2017-D-6752 for “Information Requests and Discipline Review Letters Under GDUFA.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at                     *https://www.regulations.gov*                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.                
      - Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.                      Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with  21 CFR 10.20  and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see  80 FR 56469 , September 18, 2015, or access the information at:                      https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. 

*Docket:*                     For access to the docket to read background documents or the electronic and written/paper comments received, go to                     *https://www.regulations.gov*                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.                

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

                    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the                     **SUPPLEMENTARY INFORMATION**                     section for electronic access to the guidance document.                

# FOR FURTHER INFORMATION CONTACT:

                        David Coppersmith, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993-0002, 301-796-9193,                         *david.coppersmith@fda.hhs.gov;*                         or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.                    

# SUPPLEMENTARY INFORMATION:

## I. Background

FDA is announcing the availability of a guidance for industry entitled “Information Requests and Discipline Review Letters Under GDUFA.”

                    In negotiations held as part of the Generic Drug User Fee Amendments of 2017 (GDUFA II), it was agreed that FDA will: (1) Issue an IR to request further information or clarification that is needed or would be helpful to allow completion of a discipline assessment and/or (2) issue a new type of letter for ANDAs, known as a DRL, to convey preliminary thoughts on possible deficiencies found by a discipline assessor and/or assessment team for its or their portion of the application under assessment at the conclusion of a discipline assessment.[1] 
      ( print page 4258)    
This guidance explains how FDA will issue and use an IR and a DRL during the assessment of an original ANDA under section 505(j) of the FD&C Act (21 U.S.C. 355(j)), as contemplated under GDUFA II. This guidance does not apply to an amendment made in response to a Complete Response Letter, a supplement, or an amendment to a supplement.

This guidance identifies the timing of FDA's issuance of an IR or a DRL and the effect FDA's issuance of an IR or a DRL will have on the assessment clock for a given assessment cycle.

This guidance finalizes the draft guidance entitled “Information Requests and Discipline Review Letters Under GDUFA” issued on December 18, 2017 (82 FR 60018). FDA considered comments received on the draft guidance as the guidance was finalized. Minor changes were made from the draft to the final guidance, primarily to reflect current terminology.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Information Requests and Discipline Review Letters Under GDUFA.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

## II. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR 314 for approval of abbreviated new drug applications have been approved under OMB control number 0910-0001. The collections of information that support FDA's guidance for industry on controlled correspondence related to generic drug development have been approved under OMB control number 0910-0797.

## III. Electronic Access

                    Persons with access to the internet may obtain the guidance at                     *https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs, https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-guidances,**https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents,*                     or                     *https://www.regulations.gov.*

Dated: January 21, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

# Footnotes

1.                             FDA Reauthorization Act of 2017 (FDARA), Public Law 115-52 (2017). FDARA includes GDUFA II, and by reference, the GDUFA                                                 Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Commitment Letter).                    
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[FR Doc. 2022-01605 Filed 1-26-22; 8:45 am]

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