Notice2022-01605
Information Requests and Discipline Review Letters Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
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Published
January 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 This guidance finalizes the draft guidance of the same title issued on December 18, 2017.
Full Text
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<title>Federal Register, Volume 87 Issue 18 (Thursday, January 27, 2022)</title>
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[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4257-4258]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01605]
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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finalizes the draft guidance of the same title issued on December 18,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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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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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
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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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