[Federal Register Volume 82, Number 233 (Wednesday, December 6, 2017)]
[Proposed Rules]
[Pages 57560-57561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket Nos. FDA-2017-N-5092, FDA-2017-N-5093, FDA-2017-N-5094, FDA-
2017-N-5095, FDA-2017-N-5101, FDA-2017-N-5104, and FDA-2017-N-5105]


Review of Existing Regulatory and Information Collection 
Requirements; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Requests for comments and information; extension of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the Requests for Comments and 
Information that appeared in the Federal Register of September 8, 2017. 
In the Requests for Comments and Information, FDA requested comments 
and information from interested parties to help FDA identify existing 
regulations and related paperwork requirements that could be modified, 
repealed, or replaced, consistent with the law, to achieve meaningful 
burden reduction while allowing us to achieve our public health mission 
and fulfill statutory obligations. The Agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the Requests for Comments 
and Information documents published September 8, 2017 (82 FR 42492, 82 
FR 42494, 82 FR 42497, 82 FR 42499, 82 FR 42501, 82 FR 42503, and 82 FR 
42506). Submit either electronic or written comments by February 5, 
2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 5, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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 document 
number and title (see SUPPLEMENTARY INFORMATION). Received comments, 
those filed in a timely manner (see ADDRESSES), 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 a 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.

FOR FURTHER INFORMATION CONTACT: Megan Velez, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 
20993, 301-796-4830, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 8, 
2017, FDA published seven Requests for Comments and Information with a 
90-day comment period to request comments and information from 
interested parties to help FDA identify existing regulations and 
related paperwork requirements that could be modified, repealed, or 
replaced, consistent with the law, to achieve meaningful burden 
reduction while allowing us to achieve our public health mission and 
fulfill statutory obligations.

[[Page 57561]]



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              Docket No.                       Title of document
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FDA-2017-N-5092......................  Review of Existing Center for
                                        Biologics Evaluation and
                                        Research Regulatory and
                                        Information Collection
                                        Requirements.
FDA-2017-N-5093......................  Review of Existing General
                                        Regulatory and Information
                                        Collection Requirements of the
                                        Food and Drug Administration.
FDA-2017-N-5094......................  Review of Existing Center for
                                        Food Safety and Applied
                                        Nutrition Regulatory and
                                        Information Collection
                                        Requirements.
FDA-2017-N-5095......................  Review of Existing Center for
                                        Tobacco Products Regulatory and
                                        Information Collection
                                        Requirements.
FDA-2017-N-5101......................  Review of Existing Center for
                                        Drug Evaluation and Research
                                        Regulatory and Information
                                        Collection Requirements.
FDA-2017-N-5104......................  Review of Existing Center for
                                        Veterinary Medicine Regulatory
                                        and Information Collection
                                        Requirements.
FDA-2017-N-5105......................  Review of Existing Center for
                                        Devices and Radiological Health
                                        Regulatory and Information
                                        Collection Requirements.
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    The Agency has received requests for a 60-day extension of the 
comment period for the Requests for Comments and Information. Each 
request conveyed concern that the current 90-day comment period does 
not allow sufficient time to develop a meaningful or thoughtful 
response to the Requests for Comments and Information.
    FDA has considered the requests and is extending the comment period 
for the Requests for Comment and Information for 60 days, until 
February 5, 2018. The Agency believes that a 60-day extension allows 
adequate time for interested persons to submit comments without 
significantly delaying work on these important issues.

    Dated: November 30, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26199 Filed 12-5-17; 8:45 am]
 BILLING CODE 4164-01-P