Drawbridge Operation Regulation; James River, Isle of Wight and Newport News, VA, 46879-46880 [2018-20067]
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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations
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INFORMATION section for electronic
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FOR FURTHER INFORMATION CONTACT: For
questions relating to the guidance as it
applies to human food: Jenny Scott,
Center for Food Safety and Applied
Nutrition (HFS–300), Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2166.
For questions relating to the guidance
as it applies to animal food: Jeanette
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Murphy, Center for Veterinary Medicine
(HFV–200), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6246.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a guidance for industry entitled
‘‘Determination of Status as a Qualified
Facility Under Part 117: Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human Food and Part 507:
Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Food for
Animals; Guidance for Industry.’’ We
are issuing this guidance consistent
with our good guidance practices
regulation (21 CFR 10.115). This
guidance represents the current thinking
of FDA on this topic. 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.
In the Federal Register of May 16,
2016 (81 FR 30219), we made available
a draft guidance for industry entitled
‘‘Qualified Facility Attestation Using
Form FDA 3942a (for Human Food) or
Form FDA 3942b (for Animal Food)’’
and gave interested parties an
opportunity to submit comments by
November 14, 2016, for us to consider
before beginning work on the final
version of the guidance. We received a
couple of comments on the draft
guidance and have modified the final
guidance where appropriate. Changes to
the guidance include: (1) Clarification
regarding recordkeeping and FDA
review of records, (2) clarification
regarding how a facility can meet the
definition of a ‘‘very small business,’’ (3)
addition of new examples of
calculations, and (4) explanation of a
simpler method for determining
whether a facility’s 3-year average of
food sales and food market value is
below the inflation adjusted threshold
for a ‘‘very small business.’’ In addition,
editorial changes were made to improve
clarity. The guidance announced in this
notice finalizes the draft guidance dated
May 16, 2016.
II. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
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46879
21 CFR 117.201 and 507.7 have been
approved under 0910–0854.
The guidance also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in part 117
have been approved under OMB control
number 0910–0751. The collections of
information in part 507 have been
approved under OMB control number
0910–0789.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
IV. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. FDA 2016: Qualified Facility Attestation
Using Form FDA 3942a (for Human
Food) or Form FDA 3942b (for Animal
Food): Instructions for Submitting Your
Attestation. Accessible at: https://
www.fda.gov/Food/GuidanceRegulation/
FoodFacilityRegistration/default.htm.
2. FDA 2017: Form FDA 3942a. Accessible at:
https://www.fda.gov/AboutFDA/
ReportsManualsForms/Forms/
ListFormsAlphabetically/default.htm.
3. FDA 2017: Form FDA 3942b. Accessible at:
https://www.fda.gov/AboutFDA/
ReportsManualsForms/Forms/
ListFormsAlphabetically/default.htm.
Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20109 Filed 9–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2018–0761]
Drawbridge Operation Regulation;
James River, Isle of Wight and
Newport News, VA
AGENCY:
E:\FR\FM\17SER1.SGM
Coast Guard, DHS.
17SER1
46880
Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations
Notice of deviation from
drawbridge regulation.
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the US 17/US
258/SR 32/James River Bridge, which
carries US 17, US 258, and SR 32, across
the James River, mile 5.0, between Isle
of Wight and Newport News, VA. The
deviation is necessary to facilitate
bridge maintenance. This deviation
allows the bridge to remain in the
closed-to-navigation position.
DATES: The deviation is effective from 7
a.m. on September 26, 2018, through
12:01 a.m. on September 28, 2018.
ADDRESSES: The docket for this
deviation, USCG–2018–0761 is available
at https://www.regulations.gov. Type the
docket number in the ‘‘SEARCH’’ box
and click ‘‘SEARCH’’. Click on Open
Docket Folder on the line associated
with this deviation.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Mr. Michael
Thorogood, Bridge Administration
Branch Fifth District, Coast Guard;
telephone 757–398–6557, email
Michael.R.Thorogood@uscg.mil.
SUPPLEMENTARY INFORMATION: The
Virginia Department of Transportation,
owner and operator of the U.S. 17/U.S.
258/SR 32/James River Bridge which
carries U.S. 17, U.S. 258, SR 32, across
the James River, mile 5.0, between Isle
of Wight and Newport News, VA, has
requested a temporary deviation from
the current operating schedule to
facilitate replacement of a rotary cam
limit switch in the span drive system of
the vertical lift span of the drawbridge.
The bridge has a vertical clearance of 60
feet above mean high water in the
closed position and 145 feet above mean
high water in the open position.
The current operating schedule is set
out in 33 CFR 117.5. Under this
temporary deviation, the bridge will be
in the closed-to-navigation position
from 7 a.m. on September 26, 2018,
through 12:01 a.m. on September 28,
2018.
The James River is used by a variety
of vessels including deep draft oceangoing vessels, U.S. government and
public vessels, small commercial
vessels, tug and barge traffic, and
recreational vessels. The Coast Guard
has carefully coordinated the
restrictions with waterway users in
publishing this temporary deviation.
Vessels able to pass through the
bridge in the closed-to-navigation
position may do so at any time. The
bridge will not be able to open for
emergencies and there is no immediate
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SUMMARY:
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alternative route for vessels unable to
pass through the bridge in the closed
position. The Coast Guard will also
inform the users of the waterway
through our Local Notice and Broadcast
Notices to Mariners of the change in
operating schedule for the bridge so that
vessel operators can arrange their
transits to minimize any impact caused
by the temporary deviation.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: September 11, 2018.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard
District.
[FR Doc. 2018–20067 Filed 9–14–18; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2017–0542; FRL–9983–
75—Region 4]
Air Plan Approval; Tennessee: Knox
County NSR Reform
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is finalizing approval of
several Tennessee State Implementation
Plan (SIP) revisions submitted by the
Tennessee Department of Environment
& Conservation (TDEC), on behalf of
Knox County’s Air Quality Management
Division, through letters dated March 7,
2017, and April 17, 2017. The SIP
revisions modify the Prevention of
Significant Deterioration (PSD) and
Nonattainment New Source Review
(NNSR) regulations in the Knox County
portion of the Tennessee SIP to address
changes to the federal new source
review (NSR) regulations in recent years
for the implementation of the national
ambient air quality standards (NAAQS).
Additionally, the SIP revisions include
updates to Knox County’s minor source
permitting regulations. This action is
being approved pursuant to the Clean
Air Act (CAA or Act).
DATES: This rule will be effective
October 17, 2018.
ADDRESSES: EPA has established a
docket for this action under Docket
Identification No. EPA–R04–OAR–
2017–0542. All documents in the docket
SUMMARY:
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are listed on the www.regulations.gov
website. Although listed in the index,
some information is not publicly
available, i.e., Confidential Business
Information or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
www.regulations.gov or in hard copy at
the Air Regulatory Management Section,
Air Planning and Implementation
Branch, Air, Pesticides and Toxics
Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street SW, Atlanta,
Georgia 30303–8960. EPA requests that
if at all possible, you contact the person
listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your
inspection. The Regional Office’s
official hours of business are Monday
through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.
FOR FURTHER INFORMATION CONTACT:
Andres Febres of the Air Regulatory
Management Section, Air Planning and
Implementation Branch, Air, Pesticides
and Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street SW, Atlanta,
Georgia 30303–8960. The telephone
number is (404) 562–8966. Mr. Febres
can also be reached via electronic mail
at febres-martinez.andres@epa.gov.
SUPPLEMENTARY INFORMATION:
I. What action is EPA taking?
EPA is finalizing approval of changes
to the Knox County portion of the
Tennessee SIP regarding PSD and NNSR
permitting, as well as updates to minor
NSR, submitted by TDEC on behalf of
Knox County’s Air Quality Management
Division.
On March 7, 2017, Tennessee
submitted two SIP revisions updating
Knox County’s Air Quality Management
Regulations, Section 41.0 entitled
‘‘Regulations for the Review of New
Sources,’’ and Section 45.0 entitled
‘‘Prevention of Significant
Deterioration.’’ 1 On April 17, 2017,
Tennessee submitted two additional SIP
revisions, including additional changes
to Section 41, and updates to Section
25.0 entitled ‘‘Permits.’’ 2 These SIP
revisions are meant to address changes
to the federal NSR regulations, as
1 EPA notes that the Agency may not have
received the submittal on this date, which is the
date of the State submittal’s cover letter.
2 EPA notes that the Agency may not have
received the submittal on this date, which is the
date of the State submittal’s cover letter.
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17SER1
Agencies
[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Rules and Regulations]
[Pages 46879-46880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20067]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG-2018-0761]
Drawbridge Operation Regulation; James River, Isle of Wight and
Newport News, VA
AGENCY: Coast Guard, DHS.
[[Page 46880]]
ACTION: Notice of deviation from drawbridge regulation.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the US 17/US 258/SR 32/James River
Bridge, which carries US 17, US 258, and SR 32, across the James River,
mile 5.0, between Isle of Wight and Newport News, VA. The deviation is
necessary to facilitate bridge maintenance. This deviation allows the
bridge to remain in the closed-to-navigation position.
DATES: The deviation is effective from 7 a.m. on September 26, 2018,
through 12:01 a.m. on September 28, 2018.
ADDRESSES: The docket for this deviation, USCG-2018-0761 is available
at https://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.
FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Michael Thorogood, Bridge
Administration Branch Fifth District, Coast Guard; telephone 757-398-
6557, email [email protected].
SUPPLEMENTARY INFORMATION: The Virginia Department of Transportation,
owner and operator of the U.S. 17/U.S. 258/SR 32/James River Bridge
which carries U.S. 17, U.S. 258, SR 32, across the James River, mile
5.0, between Isle of Wight and Newport News, VA, has requested a
temporary deviation from the current operating schedule to facilitate
replacement of a rotary cam limit switch in the span drive system of
the vertical lift span of the drawbridge. The bridge has a vertical
clearance of 60 feet above mean high water in the closed position and
145 feet above mean high water in the open position.
The current operating schedule is set out in 33 CFR 117.5. Under
this temporary deviation, the bridge will be in the closed-to-
navigation position from 7 a.m. on September 26, 2018, through 12:01
a.m. on September 28, 2018.
The James River is used by a variety of vessels including deep
draft ocean-going vessels, U.S. government and public vessels, small
commercial vessels, tug and barge traffic, and recreational vessels.
The Coast Guard has carefully coordinated the restrictions with
waterway users in publishing this temporary deviation.
Vessels able to pass through the bridge in the closed-to-navigation
position may do so at any time. The bridge will not be able to open for
emergencies and there is no immediate alternative route for vessels
unable to pass through the bridge in the closed position. The Coast
Guard will also inform the users of the waterway through our Local
Notice and Broadcast Notices to Mariners of the change in operating
schedule for the bridge so that vessel operators can arrange their
transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.
Dated: September 11, 2018.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2018-20067 Filed 9-14-18; 8:45 am]
BILLING CODE 9110-04-P