[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62589-62590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26285]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5928]


Post-Complete Response Letter Meetings Between the Food and Drug 
Administration and Abbreviated New Drug Application Applicants 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 ``Post-
Complete Response Letter Meetings Between FDA and ANDA Applicants Under 
GDUFA.'' This guidance is intended to clarify the criteria for granting 
post-complete response letter (CRL) meeting requests and the scope of 
discussions for granted meeting requests. This guidance provides 
procedures that will promote well-managed post-CRL meetings and help 
ensure that such meetings are scheduled and conducted in accordance 
with the commitments made by FDA in connection with the reauthorization 
of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 
(GDUFA II).

DATES: The announcement of the guidance is published in the Federal 
Register on December 4, 2018.

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-5928 for ``Post-Complete Response Letter Meetings Between 
FDA and ANDA Applicants 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 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. 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: Lisa Bercu, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 240-402-6902.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Post-Complete Response Letter Meetings Between FDA and ANDA 
Applicants Under GDUFA.'' GDUFA was reauthorized (GDUFA II) on August 
18, 2017, in order to facilitate timely access to high quality, 
affordable generic medicines. In accordance with the GDUFA 
Reauthorization Performance Goals and Program Enhancements Fiscal Years 
2018-2022 (GDUFA II Goals or Commitment Letter) that accompanied the 
legislation, FDA committed to schedule and conduct 90 percent of post-
CRL meetings within prescribed time frames.

[[Page 62590]]

    As described in the GDUFA II Commitment Letter, post-CRL meetings 
will be used by applicants ``to seek clarification concerning 
deficiencies identified in a CRL.'' Under GDUFA II, post-CRL meetings 
are available for both major and minor CRLs and for first and 
subsequent review cycles. FDA will grant any complete post-CRL meeting 
request that satisfies the criteria outlined in section IV of this 
guidance. FDA will only grant post-CRL meeting requests that pose 
questions to clarify identified deficiencies. Other issues, including 
questions requiring further Agency review, disputes about 
classification of complete response amendments, or new information 
submitted by the applicant, will not be addressed in a post-CRL 
meeting.
    This guidance finalizes the draft guidance announced in the Federal 
Register on October 16, 2017 (82 FR 48093). The Agency considered 
comments on the draft guidance while finalizing the guidance. 
Generally, we revised the draft guidance to provide clarifying 
information on the process for submitting post-CRL meeting requests and 
the criteria for granting post-CRL meeting requests. Changes from the 
draft guidance include information on the process for an abbreviated 
new drug application (ANDA) applicant to change the list of meeting 
participants and clarification on when a post-CRL meeting request may 
be denied.
    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 ``Post-Complete Response Letter Meetings 
Between FDA and ANDA Applicants 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. This guidance is not subject to 
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This 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 
collections of information in 21 CFR part 314 have been approved under 
OMB control number 0910-0001.

III. Electronic Access

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

    Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26285 Filed 12-3-18; 8:45 am]
 BILLING CODE 4164-01-P