[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48093-48095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22288]


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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 
the Generic Drug User Fee Act; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Post-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 time frames set forth in the GDUFA Reauthorization Performance 
Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals 
or Commitment Letter).

DATES: Submit either electronic or written comments on the draft 
guidance by December 15, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
    <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

[[Page 48094]]

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-5928 for ``Post-Complete Response Letter Meetings Between 
FDA and ANDA Applicants Under GDUFA; Draft Guidance for Industry; 
Availability.'' 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.
    <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.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: Tamara R. Coley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Building 75, Rm. 1668, Silver Spring, MD 20903, 240-
402-6903.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Post-Complete Response Letter Meetings Between FDA and ANDA 
Applicants Under GDUFA.'' The Generic Drug User Fee Amendments of 2017 
(GDUFA II), reauthorizing generic drug user fees for Fiscal Years 2018-
2022, was signed into law on August 18, 2017, to facilitate timely 
access to quality, affordable generic medicines. In accordance with the 
GDUFA II Commitment Letter \1\ that accompanied the legislation, FDA 
agreed to certain review goals and procedures for the review of post-
CRL meetings received on or after October 1, 2017.
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    \1\ Available at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf.
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    The GDUFA II Commitment Letter adds time frames within which FDA 
will provide a scheduled date for, and will conduct, post-CRL meetings. 
Under GDUFA I, FDA committed to close out a certain number of 
teleconference requests in fiscal year (FY) 2015 through FY 2017. In 
accordance with the GDUFA II Commitment Letter, FDA committed to 
schedule and conduct 90 percent of post-CRL meetings within prescribed 
time frames.
    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. 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 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 ``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 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 
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 draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.


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    Dated: October 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22288 Filed 10-13-17; 8:45 am]
 BILLING CODE 4164-01-P