[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47531-47533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5868]


Requests for Reconsideration at the Division Level 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Generic Drug User Fee Act; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Requests 
for Reconsideration at the Division Level Under GDUFA.'' This guidance 
provides recommendations for industry on the procedures for resolving 
scientific and/or regulatory issues or matters between FDA and 
applicants of abbreviated new drug applications (ANDAs) that wish to 
pursue a request for reconsideration within the review discipline at 
the division level or original signatory authority. This guidance also 
provides information for applicants to consider before pursuing a 
request for reconsideration, procedures for submitting a request for 
reconsideration, and the Agency's process for responding to those 
requests.

DATES: Submit either electronic or written comments on the draft 
guidance by December 11, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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-

[[Page 47532]]

2017-D-5868 for ``Requests for Reconsideration at the Division Level 
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: Lisa Bercu, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 1611, Silver Spring, MD 20993-0002, 240-402-6902.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Requests for Reconsideration at the Division Level Under 
GDUFA.'' This guidance provides recommendations for industry on the 
procedures for resolving scientific and/or regulatory issues or matters 
between FDA and applicants of ANDAs that wish to pursue a request for 
reconsideration within the review discipline at the division level or 
original signatory authority. In accordance with ``GDUFA 
Reauthorization Performance Goals and Program Enhancements Fiscal Years 
2018-2022'' (GDUFA II Goals Letter or GDUFA II Commitment Letter; 
https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf), FDA agreed to certain review goals and procedures for 
the review of requests for reconsideration received on or after October 
1, 2017.\1\
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    \1\ The FDA Reauthorization Act of 2017 (Pub. L. 115-52) 
included the reauthorization of generic user fees as Title III, 
Generic Drug User Amendments of 2017 (GDUFA II).
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    As agreed to by FDA and industry in the GDUFA II Commitment Letter, 
applicants may pursue a request for reconsideration within the review 
discipline at the division level. In addition, if an applicant requests 
a teleconference as part of its request to reclassify a major amendment 
or standard review status, FDA will schedule and conduct the 
teleconference and decide 90 percent of such reclassification requests 
within 30 days of the date of FDA's receipt of the request for a 
teleconference. As stated in the GDUFA II Commitment Letter, this goal 
only applies when the applicant accepts the first scheduled 
teleconference date offered by FDA. This guidance provides additional 
details and recommendations concerning considerations for applicants 
before pursuing a request for reconsideration and procedures for 
submitting a request for reconsideration and the Agency's process for 
responding to those requests.
    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 ``Requests for 
Reconsideration at the Division Level 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

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information, including each proposed extension of an 
existing collection of information, before submitting the collection to 
OMB for approval. To comply with this requirement, FDA is publishing 
notice of the proposed collection of information set forth in this 
document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
Applications for FDA Approval To Market a New Drug
OMB Control Number 0910-0001--Revision
    The information collection request supports the Agency's draft 
guidance entitled, ``Requests for Reconsideration at the Division Level 
Under GDUFA.'' As discussed in section I of this notice, this guidance 
provides information to respondents regarding procedures for

[[Page 47533]]

submitting requests for reconsideration, including details on the 
content and format of the submission. Respondents to the collection of 
information are applicants of ANDAs. Based on available data with 
regard to similar information collections, FDA's Center for Drug 
Evaluation and Research will receive approximately 150 requests for 
reconsideration annually from 75 respondents. Because we estimate it 
will take 5 hours to prepare a request for reconsideration, we estimate 
it will take an average of 750 total hours annually for respondents to 
prepare and submit requests for reconsideration. The burden of the 
information collection, therefore, is estimated as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                      Guidance recommendation                           Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Section IV: Procedures for Submitting and Responding to a Request                75                2              150                5              750
 for Reconsideration...............................................
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\1\ There are no capital or operating and maintenance costs associated with the collection of information.

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: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22049 Filed 10-11-17; 8:45 am]
 BILLING CODE 4164-01-P