[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4257-4258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01605]



[[Page 4257]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Information Requests and Discipline Review Letters Under Generic 
Drug User Fee Amendments; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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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finalizes the draft guidance of the same title issued on December 18, 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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, <a href="/cdn-cgi/l/email-protection#5d393c2b3439733e322d2d382f2e303429351d3b393c7335352e733a322b"><span class="__cf_email__" data-cfemail="b7d3d6c1ded399d4d8c7c7d2c5c4dadec3dff7d1d3d699dfdfc499d0d8c1">[email protected]</span></a>; 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\
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    \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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[[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.
[FR Doc. 2022-01605 Filed 1-26-22; 8:45 am]
BILLING CODE 4164-01-P


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