Drawbridge Operation Regulations; China Basin, San Francisco, CA, 19585-19586 [2013-07572]
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19585
Rules and Regulations
Federal Register
Vol. 78, No. 63
Tuesday, April 2, 2013
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
under the Administrative Procedure Act
(5 U.S.C. 553). FDA has determined that
notice and public comment are
unnecessary because this amendment to
the regulations provides only technical
changes to update an address for the
submission of BLAs and BLA
amendments and supplements.
List of Subjects for 21 CFR Part 600
Biologics, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 600 is
amended as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 600
[Docket No. FDA–2013–N–0011]
PART 600—BIOLOGICAL PRODUCTS:
GENERAL
Change of Address; Biologics License
Applications; Technical Amendment
■
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
1. The authority citation for 21 CFR
part 600 continues to read as follows:
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 360i, 371, 374; 42 U.S.C. 216, 262,
263, 263a, 264, 300aa–25.
§ 600.2
The Food and Drug
Administration (FDA) is amending its
regulations to update the address for
applicants to submit biologics license
applications (BLAs) and BLA
amendments and supplements regulated
by the Center for Drug Evaluation and
Research (CDER). This action is being
taken to ensure accuracy and clarity in
the Agency’s regulations.
DATES: This rule is effective April 2,
2013.
[Amended]
■
FOR FURTHER INFORMATION CONTACT:
tkelley on DSK3SPTVN1PROD with RULES
SUMMARY:
Dated: March 27, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
Scott E. Zeiss, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 1120,
Silver Spring, MD 20993–0002, 301–
796–0639.
SUPPLEMENTARY INFORMATION: FDA is
amending 21 CFR 600.2(b) to update the
address for applicants to submit BLAs
and BLA amendments and supplements
regulated by CDER. The new address for
all these submissions is CDER Central
Document Room, Center for Drug
Evaluation and Research, Food and
Drug Administration, 5901B
Ammendale Rd., Beltsville, MD 20705.
This action is being taken to ensure
accuracy and clarity in the Agency’s
regulations.
Publication of this document
constitutes final action on these changes
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16:10 Apr 01, 2013
Jkt 229001
2. Section 600.2 is amended in the
first sentence of paragraph (b) by
removing ‘‘CDER Therapeutic Biological
Products Document Room’’ and adding
in its place ‘‘CDER Central Document
Room’’, and by removing ‘‘12229
Wilkins Ave., Rockville, MD 20852’’
and adding in its place ‘‘5901B
Ammendale Rd., Beltsville, MD 20705’’.
[FR Doc. 2013–07578 Filed 4–1–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2013–0142]
Drawbridge Operation Regulations;
China Basin, San Francisco, CA
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
SUMMARY:
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schedule that governs the Third Street
Drawbridge across the China Basin, mile
0.0, at San Francisco, CA. The deviation
is necessary to allow the public to cross
the bridge to participate in the
scheduled CycleSF, a community event.
This deviation allows the bridge to
remain in the closed-to-navigation
position during the deviation period.
DATES: This deviation is effective from
6 a.m. until 10 a.m. on April 28, 2013.
ADDRESSES: The docket for this
deviation, [USCG–2013–0142], 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. You may
also visit the Docket Management
Facility in Room W12–140 on the
ground floor of the Department of
Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email David H.
Sulouff, Chief, Bridge Section, Eleventh
Coast Guard District; telephone 510–
437–3516, email
David.H.Sulouff@uscg.mil. If you have
questions on viewing the docket, call
Barbara Hairston, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION: The City
of San Francisco requested a temporary
change to the operation of the Third
Street Drawbridge, mile 0.0, over China
Basin, at San Francisco, CA. The Third
Street Drawbridge navigation span
provides a vertical clearance of 7 feet
above Mean High Water in the closedto-navigation position. The draw opens
on signal if at least one hour notice is
given as required by 33 CFR 117.149.
Navigation on the waterway is
recreational.
The drawspan will be secured in the
closed-to-navigation position 6 a.m.
until 10 a.m. on April 28, 2013, to allow
participants in the CycleSF to cross the
bridge during the event. This temporary
deviation has been coordinated with the
waterway users. No objections to the
proposed temporary deviation were
raised. The drawspan can be operated
upon one hour advance notice for
emergencies requiring the passage of
waterway traffic.
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02APR1
19586
Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Rules and Regulations
Vessels that can transit the bridge,
while in the closed-to-navigation
position, may continue to do so at any
time. 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: March 21, 2013.
D.H. Sulouff,
Bridge Section Chief, Eleventh Coast Guard
District.
[FR Doc. 2013–07572 Filed 4–1–13; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AO01
Grants for Transportation of Veterans
in Highly Rural Areas
Department of Veterans Affairs.
Final rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) amends its regulations to
establish a new program to provide
grants to eligible entities to assist
veterans in highly rural areas through
innovative transportation services to
travel to VA medical centers, and to
otherwise assist in providing
transportation services in connection
with the provision of VA medical care
to these veterans, in compliance with
section 307 of title III of the Caregivers
and Veterans Omnibus Health Services
Act of 2010. This final rule establishes
procedures for evaluating grant
applications under the new grant
program, and otherwise administering
the new grant program.
DATES: Effective date: This rule is
effective May 2, 2013.
FOR FURTHER INFORMATION CONTACT:
David Riley, Director, Veterans
Transportation Service, Chief Business
Office (10NB), Veterans Health
Administration, Department of Veterans
Affairs, 2957 Clairmont Road, Atlanta,
GA 30329, (404) 828–5601. (This is not
a toll-free number.)
SUPPLEMENTARY INFORMATION: On
December 30, 2011, VA published in the
Federal Register (76 FR 82212) a
proposal to amend VA regulations to
establish a grant program to provide
innovative transportation options to
veterans in highly rural areas, to comply
with section 307 of title III of the
Caregivers and Veterans Omnibus
Health Services Act of 2010, Public Law
tkelley on DSK3SPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
16:10 Apr 01, 2013
Jkt 229001
111–163. Subsection (a) of section 307
mandates that VA award grants to only
State veterans service agencies (SVSAs)
and Veterans Service Organization
(VSOs) to assist veterans in highly rural
areas to travel to VA medical centers,
and to otherwise assist in providing
transportation in connection with the
provision of VA medical care to these
veterans. This final rule establishes the
grant program in accordance with
subsection (a) of section 307, and
establishes procedures for evaluating
grant applications and otherwise
administering the grant program in
accordance with subsection (b) of
section 307.
Interested persons were invited to
submit comments to the proposed rule
on or before February 28, 2012, and we
received 17 comments. All of the issues
raised by the commenters can be
grouped together by similar topic, and
we have organized our discussion of the
comments accordingly. For the reasons
set forth in the proposed rule and
below, we are adopting the proposed
rule as final, with changes to §§ 17.701,
17.703, 17.705, 17.715, and 17.725 and
the authority citations following the
regulations in this rulemaking.
Comments Regarding the Limitation on
Entities That Are Eligible To Receive
Grants
Multiple commenters objected to the
proposed rule’s limitation that only
VSOs and SVSAs may receive grants.
These commenters contended that this
limitation would block many existing
transportation providers from receiving
grants to expand current veterans’
transportation services, to the detriment
of veterans generally. Commenters
asserted that making grants available to
any existing transportation provider
would ensure that grants would be used
more effectively because VSOs and
SVSAs that receive grants would only
be duplicating transportation services
already offered to veterans by existing
providers, and because VSOs and
SVSAs do not have the expertise of
existing transportation providers to
access a particular area or transport that
area’s veterans. We make no changes to
the rule based on these comments,
because grantees are limited by section
307 to VSOs and SVSAs. Subsection
(a)(2) of section 307 identifies as eligible
grant recipients ‘‘State veterans service
agencies’’ and ‘‘Veterans service
organizations.’’ Subsection (a)(3) of
section 307 further states that ‘‘[a] State
veterans service agency or veterans
service organization’’ may use grant
funds for specified purposes. We
interpret this statutory language to bar
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VA from awarding grants to any entity
other than a VSO or SVSA.
To more specifically address
commenter concerns regarding
duplicated services and lack of grantee
expertise, we note that most
commenters seemed to assume that
VSOs and SVSAs that receive grants
would not themselves be existing
transportation providers. However, we
know of several VSOs and SVSAs that
provide transportation services.
Moreover, the rule contains scoring
criteria to reward coordination between
grantees and other transportation
providers (including existing providers
that may not qualify to receive grants),
and rewarding this type of coordination
assists in addressing the general
concerns of duplicated services and lack
of grantee expertise. See § 17.705(a)(3).
Discussion of these coordination
criteria, as well as discussion of why
VSOs and SVSAs would not merely be
duplicating existing transportation
services, are provided in greater detail
in the next section of this document.
Generally, grantees may use grants to
expand or augment the transportation
services offered by transportation
providers that may not qualify as
grantees under the rule, or otherwise
may use such entities to provide the
transportation assistance that is
established in a grantee’s program, as
long as all other criteria of the rule are
met.
One commenter specifically asserted
that section 307 could be interpreted in
an ‘‘innovative’’ manner to allow a grant
award to an organization such as a
county-level agency within a State that
is delegated responsibilities to serve
veterans by an SVSA, based on the
following language from section 307:
‘‘The Secretary of Veterans Affairs shall
establish a grant program to provide
innovative transportation options to
veterans in highly rural areas.’’ Public
Law 111–163, sec. 307(a)(1). We
interpret the term ‘‘innovative’’ in
section 307(a)(1), however, only as a
modifier to describe the types of
transportation options that may be
provided to veterans in highly rural
areas. We do not interpret the term as
having any effect regarding the two
defined eligible entities that may receive
grants under section 307. The plain
meaning of a ‘‘State veterans service
agency’’ considers only State-level
entities, and not a county agency within
a State. However, under the same
rationale provided above, this rule does
not prevent an SVSA from using grant
funds to administer transportation
assistance through a county-level
agency to carry out the objectives of the
SVSA’s grant application.
E:\FR\FM\02APR1.SGM
02APR1
Agencies
[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Rules and Regulations]
[Pages 19585-19586]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07572]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG-2013-0142]
Drawbridge Operation Regulations; China Basin, San Francisco, CA
AGENCY: Coast Guard, DHS.
ACTION: Notice of deviation from drawbridge regulation.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Third Street Drawbridge across the
China Basin, mile 0.0, at San Francisco, CA. The deviation is necessary
to allow the public to cross the bridge to participate in the scheduled
CycleSF, a community event. This deviation allows the bridge to remain
in the closed-to-navigation position during the deviation period.
DATES: This deviation is effective from 6 a.m. until 10 a.m. on April
28, 2013.
ADDRESSES: The docket for this deviation, [USCG-2013-0142], 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. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email David H. Sulouff, Chief, Bridge
Section, Eleventh Coast Guard District; telephone 510-437-3516, email
David.H.Sulouff@uscg.mil. If you have questions on viewing the docket,
call Barbara Hairston, Program Manager, Docket Operations, telephone
202-366-9826.
SUPPLEMENTARY INFORMATION: The City of San Francisco requested a
temporary change to the operation of the Third Street Drawbridge, mile
0.0, over China Basin, at San Francisco, CA. The Third Street
Drawbridge navigation span provides a vertical clearance of 7 feet
above Mean High Water in the closed-to-navigation position. The draw
opens on signal if at least one hour notice is given as required by 33
CFR 117.149. Navigation on the waterway is recreational.
The drawspan will be secured in the closed-to-navigation position 6
a.m. until 10 a.m. on April 28, 2013, to allow participants in the
CycleSF to cross the bridge during the event. This temporary deviation
has been coordinated with the waterway users. No objections to the
proposed temporary deviation were raised. The drawspan can be operated
upon one hour advance notice for emergencies requiring the passage of
waterway traffic.
[[Page 19586]]
Vessels that can transit the bridge, while in the closed-to-
navigation position, may continue to do so at any time. 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: March 21, 2013.
D.H. Sulouff,
Bridge Section Chief, Eleventh Coast Guard District.
[FR Doc. 2013-07572 Filed 4-1-13; 8:45 am]
BILLING CODE 9110-04-P