[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)]
[Notices]
[Pages 1618-1619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00405]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5974]


Determining Whether To Submit an Abbreviated New Drug Application 
or 505(b)(2) Application; Draft Guidance for Industry; Availability; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the notice of availability, published 
in the Federal Register of October 13, 2017. In that document, FDA 
requested comments on the draft guidance for industry entitled 
``Determining Whether to Submit an ANDA or 505(b)(2) Application.'' The 
Agency is taking this action in response to a request for an extension 
to allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period on the notice of 
availability published October 13, 2017 (82 FR 47749). Submit either 
electronic or written comments on the draft guidance by February 12, 
2018 to ensure that the Agency considers your comment on this draft 
guidance before it begins work on the final version of the guidance.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:
    <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-2017-D-5974 for ``Determining Whether to Submit an ANDA or 
505(b)(2) Application; Draft Guidance for Industry.'' 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: Elizabeth Giaquinto Friedman, Office 
of Generic Drugs, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, 
Silver Spring, MD 20993-0002, 240-402-7930.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of October 13, 2017, FDA published a notice 
of availability with a 60-day comment period to request comments on the 
draft guidance for industry entitled ``Determining Whether to Submit an 
ANDA or 505(b)(2) Application.''
    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 factors for 
applicants to consider when determining which one of the abbreviated 
approval pathways under the Federal Food, Drug, and Cosmetic Act is 
appropriate for the submission of a marketing application to FDA. 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.
    The Agency has received a request for a 30-day extension of the 
comment period for the draft guidance. The request conveyed concern 
that the requestor did not have sufficient time to develop a meaningful 
or thoughtful response to the draft guidance.

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    FDA has considered the request and is reopening the comment period 
for the draft guidance for 30 days, until February 12, 2018. The Agency 
believes that a 30-day reopening of the comment period allows adequate 
time for interested persons to submit comments to ensure that the 
Agency can consider the comments on this draft guidance before it 
begins work on the final version of the guidance.

II. 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: January 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00405 Filed 1-11-18; 8:45 am]
 BILLING CODE 4164-01-P