82 FR 57560 - Review of Existing Regulatory and Information Collection Requirements; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 233 (December 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 233 (December 6, 2017)
| Page Range | 57560-57561 | |
| FR Document | 2017-26199 |
[Federal Register Volume 82, Number 233 (Wednesday, December 6, 2017)] [Proposed Rules] [Pages 57560-57561] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26199] ======================================================================= ----------------------------------------------------------------------- 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interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory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.thefederalregister.org/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]] ------------------------------------------------------------------------ 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
![57560 Federal Register / Vol. 82, No. 233 / Wednesday, December 6, 2017 / Proposed Rules
Perce County Airport, and within 24 miles comments until midnight Eastern Time • Confidential Submissions—To
each side of the 056° bearing from the airport at the end of February 5, 2018. submit a comment with confidential
extending from the 62-mile radius to 92 miles Comments received by mail/hand information that you do not wish to be
northeast of the airport.
delivery/courier (for written/paper made publicly available, submit your
Issued in Seattle, Washington, on submissions) will be considered timely comments only as a written/paper
November 21, 2017. if they are postmarked or the delivery submission. You should submit two
Brian J. Johnson, service acceptance receipt is on or copies total. One copy will include the
Acting Group Manager, Operations Support before that date. information you claim to be confidential
Group, Western Service Center. with a heading or cover note that states
Electronic Submissions
[FR Doc. 2017–26206 Filed 12–5–17; 8:45 am] ‘‘THIS DOCUMENT CONTAINS
BILLING CODE 4910–13–P Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
• Federal eRulemaking Portal: the claimed confidential information, in
DEPARTMENT OF HEALTH AND https://www.regulations.gov. Follow the its consideration of comments. The
HUMAN SERVICES instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information
Food and Drug Administration including attachments, to https:// redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on
21 CFR Chapter I the docket unchanged. Because your https://www.regulations.gov. Submit
[Docket Nos. FDA–2017–N–5092, FDA– comment will be made public, you are both copies to the Dockets Management
2017–N–5093, FDA–2017–N–5094, FDA– solely responsible for ensuring that your Staff. If you do not wish your name and
2017–N–5095, FDA–2017–N–5101, FDA– comment does not include any contact information to be made publicly
2017–N–5104, and FDA–2017–N–5105] confidential information that you or a available, you can provide this
third party may not wish to be posted, information on the cover sheet and not
Review of Existing Regulatory and such as medical information, your or in the body of your comments and you
Information Collection Requirements; anyone else’s Social Security number, or must identify this information as
Extension of Comment Period confidential business information, such ‘‘confidential.’’ Any information marked
AGENCY: Food and Drug Administration, as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
HHS. that if you include your name, contact except in accordance with 21 CFR 10.20
ACTION: Requests for comments and information, or other information that and other applicable disclosure law. For
information; extension of comment identifies you in the body of your more information about FDA’s posting
period. comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
SUMMARY: The Food and Drug • If you want to submit a comment the information at: https://www.gpo.gov/
Administration (FDA or the Agency) is with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
extending the comment period for the do not wish to be made available to the 23389.pdf.
Requests for Comments and Information public, submit the comment as a Docket: For access to the docket to
that appeared in the Federal Register of written/paper submission and in the read background documents or the
September 8, 2017. In the Requests for manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Comments and Information, FDA Submissions’’ and ‘‘Instructions’’). received, go to https://
requested comments and information www.regulations.gov and insert a docket
from interested parties to help FDA Written/Paper Submissions
number, found in brackets in the
identify existing regulations and related Submit written/paper submissions as heading of this document, into the
paperwork requirements that could be follows: ‘‘Search’’ box and follow the prompts
modified, repealed, or replaced, • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
consistent with the law, to achieve written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
meaningful burden reduction while Management Staff (HFA–305), Food and Rockville, MD 20852.
allowing us to achieve our public health Drug Administration, 5630 Fishers
mission and fulfill statutory obligations. FOR FURTHER INFORMATION CONTACT:
Lane, Rm. 1061, Rockville, MD 20852.
Megan Velez, Office of Policy, Food and
The Agency is taking this action in • For written/paper comments
response to requests for an extension to Drug Administration, 10903 New
submitted to the Dockets Management
allow interested persons additional time Hampshire Ave., Silver Spring, MD
Staff, FDA will post your comment, as
to submit comments. 20993, 301–796–4830, megan.velez@
well as any attachments, except for
fda.hhs.gov.
DATES: FDA is extending the comment information submitted, marked and
period on the Requests for Comments identified, as confidential, if submitted SUPPLEMENTARY INFORMATION: In the
and Information documents published as detailed in ‘‘Instructions.’’ Federal Register of September 8, 2017,
September 8, 2017 (82 FR 42492, 82 FR Instructions: All submissions received FDA published seven Requests for
42494, 82 FR 42497, 82 FR 42499, 82 FR must include: The document number Comments and Information with a 90-
42501, 82 FR 42503, and 82 FR 42506). and title (see SUPPLEMENTARY day comment period to request
Submit either electronic or written INFORMATION). Received comments, comments and information from
jstallworth on DSKBBY8HB2PROD with PROPOSALS
comments by February 5, 2018. those filed in a timely manner (see interested parties to help FDA identify
ADDRESSES: You may submit comments ADDRESSES), will be placed in the docket existing regulations and related
as follows. Please note that late, and, except for those submitted as paperwork requirements that could be
untimely filed comments will not be ‘‘Confidential Submissions,’’ publicly modified, repealed, or replaced,
considered. Electronic comments must viewable at https://www.regulations.gov consistent with the law, to achieve
be submitted on or before February 5, or at the Dockets Management Staff meaningful burden reduction while
2018. The https://www.regulations.gov between 9 a.m. and 4 p.m., Monday allowing us to achieve our public health
electronic filing system will accept through Friday. mission and fulfill statutory obligations.
VerDate Sep<11>2014 14:39 Dec 05, 2017 Jkt 244001 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 E:\FR\FM\06DEP1.SGM 06DEP1](https://thefederalregister.org/doc/82_FR_57793/page/1.svg)
![Federal Register / Vol. 82, No. 233 / Wednesday, December 6, 2017 / Proposed Rules 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 DATES: Comments and related material these deficiencies were submitted to the
a 60-day extension of the comment must reach the Coast Guard on or before docket and provided to the Coast Guard
period for the Requests for Comments January 15, 2018. and bridge owner by representatives
and Information. Each request conveyed ADDRESSES: You may submit comments from the Mariners’ Advisory Committee
concern that the current 90-day identified by docket number USCG– for the Bay and River Delaware.
comment period does not allow 2016–0257 using Federal eRulemaking The bridge owner implemented
sufficient time to develop a meaningful Portal at http://www.regulations.gov. policies and provided training to
or thoughtful response to the Requests See the ‘‘Public Participation and address the procedural and
for Comments and Information. Request for Comments’’ portion of the communications deficiencies, and
FDA has considered the requests and SUPPLEMENTARY INFORMATION section implemented backup systems to
is extending the comment period for the below for instructions on submitting mitigate potential equipment and
Requests for Comment and Information comments. systems failures. These changes were
for 60 days, until February 5, 2018. The FOR FURTHER INFORMATION CONTACT: If
not fully evaluated during the test
Agency believes that a 60-day extension you have questions on this proposed deviation ending October 21, 2017.
allows adequate time for interested rule, call or email Mr. Hal R. Pitts, Fifth Therefore, the Coast Guard has decided
persons to submit comments without Coast Guard District (dpb); telephone to issue a second test deviation to
significantly delaying work on these (757) 398–6222, email Hal.R.Pitts@ complete the evaluation of the changes
important issues. uscg.mil. incorporated into the remote operation
Dated: November 30, 2017. system.
SUPPLEMENTARY INFORMATION: On October 18, 2017, we published a
Leslie Kux,
I. Background and Purpose second test deviation entitled
Associate Commissioner for Policy. ‘‘Drawbridge Operation Regulation;
[FR Doc. 2017–26199 Filed 12–5–17; 8:45 am] On June 30, 2017, we published a Delaware River, Pennsauken Township,
BILLING CODE 4164–01–P notice of proposed rulemaking (NPRM) NJ’’ in the Federal Register (82 FR
entitled, ‘‘Drawbridge Operation 48419). This second test deviation was
Regulation; Delaware River, Pennsauken issued to complete the evaluation of the
Township, NJ’’ in the Federal Register changes incorporated into the remote
DEPARTMENT OF HOMELAND
(82 FR 29800). The original comment operation system during the test
SECURITY
period closed on August 18, 2017. The deviation ending October 21, 2017.
Coast Guard NPRM proposed changes to the Comments and related material for the
regulation governing the DELAIR second test deviation must reach the
33 CFR Part 117 Memorial Railroad Bridge across the Coast Guard on or before January 15,
Delaware River, mile 104.6, at 2018.
[Docket No. USCG–2016–0257] Pennsauken Township, and contains
useful background and analysis related Re-Opening the Comment Period
RIN 1625–AA09 to the proposed changes. The The comment period for the NPRM
installation of the remote capabilities published on June 30, 2017 ended
Drawbridge Operation Regulation; did not change the operational schedule
Delaware River, Pennsauken August 18, 2017. This notice re-opening
of the bridge.1 The public is encouraged the comment period ensures there is
Township, NJ
to review the NPRM. sufficient opportunity to comment on
AGENCY: Coast Guard, DHS. On April 12, 2017, we issued a the proposed rule which would allow
ACTION:Notice of proposed rulemaking; temporary deviation entitled the bridge to be remotely operated from
reopening of comment period. ‘‘Drawbridge Operation Regulation; the Conrail South Jersey dispatch center
Delaware River, Pennsauken Township, in Mount Laurel, NJ, instead of being
SUMMARY: The Coast Guard is re-opening NJ’’ in the Federal Register (82 FR operated by an on-site bridge tender,
the comment period for its notice of 17561). During the initial test deviation before the proposed changes become
proposed rulemaking (NPRM), which performed from 8 a.m. on April 24, final.
published on June 30, 2017. The Coast 2017, through 7:59 a.m. on October 21,
Guard is proposing to change the 2017, the bridge owner identified II. Public Participation and Request for
regulation governing the DELAIR deficiencies in the remote operation Comments
jstallworth on DSKBBY8HB2PROD with PROPOSALS
Memorial Railroad Bridge across the center procedures, bridge to vessel We view public participation as
Delaware River, mile 104.6, at communications, and equipment essential to effective rulemaking, and
Pennsauken Township, NJ. Because the redundancy. Comments concerning will consider all comments and material
bridge owner implemented new polices received during the comment period.
1 A full description of the remote operational
and training that was not fully evaluated Your comment can help shape the
system is outlined in the aforementioned
during the previous test deviation, the publication, which can be found at http://
outcome of this rulemaking. If you
Coast Guard is providing an additional regulations.gov. (see ADDRESSES for more submit a comment, please include the
opportunity for public comment. information). docket number for this rulemaking,
VerDate Sep<11>2014 14:39 Dec 05, 2017 Jkt 244001 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\06DEP1.SGM 06DEP1](https://thefederalregister.org/doc/82_FR_57793/page/2.svg)
Document Created: 2017-12-06 00:21:31
Document Modified: 2017-12-06 00:21:31
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Requests for comments and information; extension of comment period. | |
| 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. | |
| Contact | Megan Velez, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4830, [email protected] | |
| FR Citation | 82 FR 57560 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR