[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60018-60019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27124]


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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 the 
Generic Drug User Fee Amendments; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled 
``Information Requests and Discipline Review Letters Under GDUFA.'' 
This draft guidance explains how FDA will issue and use an information 
request (IR) and/or a discipline review letter (DRL) during the review 
of an original abbreviated new drug application (ANDA).

DATES: Submit either electronic or written comments on the draft 
guidance by February 16, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft 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. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Philip Bonforte, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993-0002, 240-
402-9871, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Information Requests and Discipline Review Letters Under 
GDUFA.''
    Under the first iteration of the Generic Drug User Fee Amendments 
of 2012

[[Page 60019]]

(GDUFA I), beginning October 1, 2012, FDA agreed to act on received 
ANDAs within established time frames. As part of this undertaking, the 
Agency instituted the use of multiple forms of communicating with an 
applicant regarding the review of an application, including issuance of 
Complete Response Letters (CRLs) and IRs.\1\
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    \1\ Food and Drug Administration Safety and Innovation Act of 
2012 (FDASIA), Public Law 112-144 (2012). FDASIA includes GDUFA I, 
and by reference, the Generic Drug User Fee Act Program Performance 
Goals and Procedures (GDUFA I Commitment Letter).
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    Under GDUFA I, FDA issued a CRL after completing a review of an 
ANDA. The CRL described all the deficiencies identified in the ANDA 
that must be satisfactorily addressed before the ANDA can be approved. 
Issuance of a CRL also completed the ANDA's review cycle, with the next 
review cycle beginning when the applicant amended the ANDA by 
submitting a complete response to all deficiencies listed in the CRL.
    FDA used IRs to ask for information that would assist reviewers 
during the course of the review or to convey deficiencies identified in 
the application in advance of a CRL. IRs did not stop the review clock, 
did not signal the completion of a review cycle, and were not always 
used consistently across divisions or offices.
    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 review 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 
reviewer and/or review team for its or their portion of the application 
under review at the conclusion of a discipline review.\2\
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    \2\ 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 draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information has been approved under OMB control number 
0910-0797.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27124 Filed 12-15-17; 8:45 am]
 BILLING CODE 4164-01-P


