Review of Existing Regulatory and Information Collection Requirements; Extension of Comment Period, 57560-57561 [2017-26199]

Download as PDF 57560 Federal Register / Vol. 82, No. 233 / Wednesday, December 6, 2017 / Proposed Rules Perce County Airport, and within 24 miles each side of the 056° bearing from the airport extending from the 62-mile radius to 92 miles northeast of the airport. Issued in Seattle, Washington, on November 21, 2017. Brian J. Johnson, Acting Group Manager, Operations Support Group, Western Service Center. [FR Doc. 2017–26206 Filed 12–5–17; 8:45 am] BILLING CODE 4910–13–P 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. Requests for comments and information; extension of comment period. ACTION: 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interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory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 jstallworth on DSKBBY8HB2PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 14:39 Dec 05, 2017 Jkt 244001 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. PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 • 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/201523389.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, megan.velez@ fda.hhs.gov. In the Federal Register of September 8, 2017, FDA published seven Requests for Comments and Information with a 90day 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\06DEP1.SGM 06DEP1 Federal Register / Vol. 82, No. 233 / Wednesday, December 6, 2017 / Proposed Rules Docket No. FDA–2017–N–5092 FDA–2017–N–5093 FDA–2017–N–5094 FDA–2017–N–5095 FDA–2017–N–5101 FDA–2017–N–5104 FDA–2017–N–5105 Title of document Review Review Review Review Review Review Review of of of of of of of Existing Existing Existing Existing Existing Existing Existing Center for Biologics Evaluation and Research Regulatory and Information Collection Requirements. General Regulatory and Information Collection Requirements of the Food and Drug Administration. Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements. Center for Tobacco Products Regulatory and Information Collection Requirements. Center for Drug Evaluation and Research Regulatory and Information Collection Requirements. Center for Veterinary Medicine Regulatory and Information Collection Requirements. Center for Devices and Radiological Health Regulatory and Information Collection Requirements. 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 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG–2016–0257] RIN 1625–AA09 Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ Coast Guard, DHS. Notice of proposed rulemaking; reopening of comment period. AGENCY: ACTION: The Coast Guard is re-opening the comment period for its notice of proposed rulemaking (NPRM), which published on June 30, 2017. The Coast Guard is proposing to change the regulation governing the DELAIR Memorial Railroad Bridge across the Delaware River, mile 104.6, at Pennsauken Township, NJ. Because the bridge owner implemented new polices and training that was not fully evaluated during the previous test deviation, the Coast Guard is providing an additional opportunity for public comment. jstallworth on DSKBBY8HB2PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 57561 14:39 Dec 05, 2017 Jkt 244001 Comments and related material must reach the Coast Guard on or before January 15, 2018. ADDRESSES: You may submit comments identified by docket number USCG– 2016–0257 using Federal eRulemaking Portal at http://www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section below for instructions on submitting comments. FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed rule, call or email Mr. Hal R. Pitts, Fifth Coast Guard District (dpb); telephone (757) 398–6222, email Hal.R.Pitts@ uscg.mil. SUPPLEMENTARY INFORMATION: DATES: I. Background and Purpose On June 30, 2017, we published a notice of proposed rulemaking (NPRM) entitled, ‘‘Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ’’ in the Federal Register (82 FR 29800). The original comment period closed on August 18, 2017. The NPRM proposed changes to the regulation governing the DELAIR Memorial Railroad Bridge across the Delaware River, mile 104.6, at Pennsauken Township, and contains useful background and analysis related to the proposed changes. The installation of the remote capabilities did not change the operational schedule of the bridge.1 The public is encouraged to review the NPRM. On April 12, 2017, we issued a temporary deviation entitled ‘‘Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ’’ in the Federal Register (82 FR 17561). During the initial test deviation performed from 8 a.m. on April 24, 2017, through 7:59 a.m. on October 21, 2017, the bridge owner identified deficiencies in the remote operation center procedures, bridge to vessel communications, and equipment redundancy. Comments concerning 1 A full description of the remote operational system is outlined in the aforementioned publication, which can be found at http:// regulations.gov. (see ADDRESSES for more information). PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 these deficiencies were submitted to the docket and provided to the Coast Guard and bridge owner by representatives from the Mariners’ Advisory Committee for the Bay and River Delaware. The bridge owner implemented policies and provided training to address the procedural and communications deficiencies, and implemented backup systems to mitigate potential equipment and systems failures. These changes were not fully evaluated during the test deviation ending October 21, 2017. Therefore, the Coast Guard has decided to issue a second test deviation to complete the evaluation of the changes incorporated into the remote operation system. On October 18, 2017, we published a second test deviation entitled ‘‘Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ’’ in the Federal Register (82 FR 48419). This second test deviation was issued to complete the evaluation of the changes incorporated into the remote operation system during the test deviation ending October 21, 2017. Comments and related material for the second test deviation must reach the Coast Guard on or before January 15, 2018. Re-Opening the Comment Period The comment period for the NPRM published on June 30, 2017 ended August 18, 2017. This notice re-opening the comment period ensures there is sufficient opportunity to comment on the proposed rule which would allow the bridge to be remotely operated from the Conrail South Jersey dispatch center in Mount Laurel, NJ, instead of being operated by an on-site bridge tender, before the proposed changes become final. II. Public Participation and Request for Comments We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, E:\FR\FM\06DEP1.SGM 06DEP1

Agencies

[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.

-----------------------------------------------------------------------

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, megan.velez@fda.hhs.gov.

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]]



------------------------------------------------------------------------
              Docket No.                       Title of document
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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