[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repealed, or replaced, consistent with the law, to achieve meaningful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]
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