Safety Zone; Delaware River, Philadelphia, PA, 75694-75695 [2016-26342]
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Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Rules and Regulations
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 Docket No. FDA–
2011–N–0922 for ‘‘What You Need to
Know About the FDA Regulation:
Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Food for
Animals.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. 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
VerDate Sep<11>2014
15:21 Oct 31, 2016
Jkt 241001
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the SECG to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT:
Jeanette Murphy, Center for Veterinary
Medicine (HFV–200), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20800, 240–402–6246.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September
17, 2015 (80 FR 56170), we issued a
final rule entitled ‘‘Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals’’ (the
final rule) in which we established
requirements for facilities subject to
food registration to implement current
good manufacturing practices and
establish and implement hazard
analysis and risk-based preventive
controls for food for animals. The final
rule, which is codified at part 507 (21
CFR part 507), became effective
November 16, 2015 (except for
paragraph (2) of the definition of
‘‘qualified auditor’’ in § 507.3, and
§§ 507.12(a)(1)(ii), 507.105(a)(2),
507.105(c), 507.110(d)(2)(ii), 507.130(d),
507.135(d), 507.175(c)(2), and
507.175(c)(13)) but has compliance
dates staggered over several years after
publication of the final rule.
We examined the economic
implications of the final rule as required
by the Regulatory Flexibility Act (5
U.S.C. 601–612) and determined that
the final rule will have a significant
economic impact on a substantial
number of small entities. In compliance
with section 212 of the Small Business
Regulatory Enforcement Fairness Act
(Pub. L. 104–121, as amended by Pub.
L. 110–28), we are making available the
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SECG to explain the actions that a small
entity must take to comply with the
rule.
We are issuing the SECG consistent
with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The
SECG 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.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information 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 part 507 have been
approved under 0910–0789.
III. Electronic Access
Persons with access to the Internet
may obtain the SECG at https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm,
https://www.fda.gov/Food/
GuidanceRegulation/FSMA/
ucm253380.htm, or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
Dated: October 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–26314 Filed 10–31–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2016–0936]
Safety Zone; Delaware River,
Philadelphia, PA
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
regulations for a safety zone for an
annual fireworks event in the Captain of
the Port Delaware Bay zone from 6 p.m.
to 8 p.m. on November 19, 2016.
Enforcement of this zone is necessary
and intended to ensure safety of life on
SUMMARY:
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01NOR1
jstallworth on DSK7TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Rules and Regulations
the navigable waters immediately prior
to, during, and immediately after this
fireworks event. During the enforcement
period, no vessel may transit this
regulated area without approval from
the Captain of the Port or a designated
representative.
DATES: The regulations in 33 CFR
165.506 will be enforced from 6 p.m. to
8 p.m. on November 19, 2016, for the
safety zone identified in row (a)(16) of
Table to § 165.506.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice of
enforcement, call or email MST1
Thomas Simkins, Sector Delaware Bay
Waterways Management Division, U.S.
Coast Guard; telephone 215–271–4889,
email Tom.J.Simkins@uscg.mil.
SUPPLEMENTARY INFORMATION:
From 6 p.m. to 8 p.m. on November
19, 2016, the Coast Guard will enforce
regulations in 33 CFR 165.506 for the
safety zone in the Delaware River in
Philadelphia, PA listed in row (a)(16) in
the table in that section. This action is
being taken to provide for the safety of
life on navigable waterways during the
fireworks display.
Our regulations for recurring firework
events in Captain of the Port Delaware
Bay Zone, appear in § 165.506, Safety
Zones; Fireworks Displays in the Fifth
Coast Guard District, which specifies
the location of the regulated area for this
safety zone as all waters of Delaware
River, adjacent to Penn’s Landing,
Philadelphia, PA, bounded from
shoreline to shoreline, bounded on the
south by a line running east to west
from points along the shoreline at
latitude 39°56′31.2″ N., longitude
075°08′28.1″ W.; thence to latitude
39°56′29″ .1 N., longitude 075°07′56.5″
W., and bounded on the north by the
Benjamin Franklin Bridge.
As specified in § 165.506, during the
enforcement period no vessel may
transit this safety zone without approval
from the Captain of the Port Delaware
Bay. If permission is granted, all persons
and vessels shall comply with the
instructions of the COTP or designated
representative.
This notice of enforcement is issued
under authority of 33 CFR 165.506 and
5 U.S.C. 552(a). In addition to this
notice of enforcement in the Federal
Register, the Coast Guard will provide
the maritime community with advanced
notification of this enforcement period
via Broadcast Notice to Mariners (BNM).
If the Captain of the Port Delaware
Bay determines that the regulated area
need not be enforced for the full
duration, a BNM to grant general
permission to enter the safety zone may
be used.
VerDate Sep<11>2014
15:21 Oct 31, 2016
Jkt 241001
Dated: October 27, 2016.
Benjamin A. Cooper,
Captain, U.S. Coast Guard, Captain of the
Port Delaware Bay.
[FR Doc. 2016–26342 Filed 10–31–16; 8:45 am]
BILLING CODE 9110–04–P
U.S. Copyright Office
37 CFR Part 201
[Docket No. RM 2011–6]
Designation of Agent To Receive
Notification of Claimed Infringement
U.S. Copyright Office, Library
of Congress.
ACTION: Final rule.
AGENCY:
Under the Digital Millennium
Copyright Act (‘‘DMCA’’), the U.S.
Copyright Office is required to maintain
a ‘‘current directory’’ of agents that have
been designated by online service
providers to receive notifications of
claimed infringement. Since the
DMCA’s enactment in 1998, online
service providers have designated
agents with the Copyright Office using
the Office’s or their own paper form,
and the Office has made scanned copies
these filings available to the public by
posting them on the Office’s Web site.
Although the DMCA requires service
providers to update their designations
with the Office as information changes,
an examination of the Office’s current
directory reveals that many have failed
to do so, and that much of the
information currently contained in the
directory has become inaccurate and out
of date. On September 28, 2011, the
Office issued a notice of proposed
rulemaking to update relevant
regulations in anticipation of creating a
new electronic system through which
service providers would be able to more
efficiently submit, and the public would
be better able to search for, designated
agent information. On May 25, 2016,
with the electronic system in its final
stages of development, the Office issued
a notice of proposed rulemaking
proposing significantly lower fees for
designating agents through the
forthcoming online system. As the next
step in implementation, the Office today
announces the adoption of a final rule
to govern the designation and
maintenance of DMCA agent
information under the new electronic
system and to establish the applicable
fees.
SUMMARY:
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Effective December 1, 2016.
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FOR FURTHER INFORMATION CONTACT:
Sarang V. Damle, General Counsel and
Associate Register of Copyrights, by
email at sdam@loc.gov, or Jason E.
Sloan, Attorney-Advisor, by email at
jslo@loc.gov. Each can be contacted by
telephone by calling (202) 707–8350.
SUPPLEMENTARY INFORMATION:
I. Background
LIBRARY OF CONGRESS
DATES:
75695
In 1998, Congress enacted section 512
of title 17, United States Code, as part
of the Digital Millennium Copyright Act
(‘‘DMCA’’).1 Among other things,
section 512 provides safe harbors from
copyright infringement liability for
online service providers that are
engaged in specified activities and that
meet certain eligibility requirements.2 A
service provider seeking to avail itself of
the safe harbor in section 512(c) (for
storage of material at the direction of a
user) is required to designate an agent
to receive notifications of claimed
copyright infringement by making
contact information for the agent
available to the public on its Web site,
and by providing such information to
the Copyright Office.3 The safe harbors
in subsections 512(b) (for system
caching) and (d) (for information
location tools) incorporate the notice
provisions of section 512(c) and thus
also require that notices of infringement
be sent to ‘‘the designated agent of a
service provider’’ 4—that is, an agent
that has been designated by the service
provider as described above.5
The language of section 512(c)(2)
makes clear that a service provider must
maintain the same contact information
required under section 512(c)(2)(A) and
(B) both on its Web site and at the
Copyright Office.6 A service provider
that fails to maintain current and
accurate information, both on its Web
site and with the Office, may not satisfy
the statutory requirements necessary for
1 Public
Law 105–304, 112 Stat. 2860 (1998).
U.S.C. 512.
3 Id. at 512(c)(2).
4 Id. at 512(c)(3)(A).
5 See id. at 512(b)(2)(E), (d)(3).
6 63 FR 59233, 59234 (Nov. 3, 1998) (‘‘[A] service
provider designates an agent by providing
information required by Copyright Office
regulations both on its publicly available Web site
and in a filing with the Copyright Office.’’); see also
BWP Media USA Inc. v. Hollywood Fan Sites LLC,
115 F. Supp. 3d 397, 403 (S.D.N.Y. 2015) (‘‘[T]he
statutory scheme expressly requires two publicly
available, parallel sources of a service provider’s
DMCA agent information (the service provider’s
Web site and the [Copyright Office] directory) in
order for that provider to be shielded by the § 512(c)
safe harbor.’’); 4 Melville Nimmer & David Nimmer,
Nimmer on Copyright 12B.04[B][3] (2015)
(‘‘Nimmer on Copyright’’) (‘‘In addition to
providing the foregoing information to the
Copyright Office, the service provider must provide
the same information to the public.’’).
2 17
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Agencies
[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)]
[Rules and Regulations]
[Pages 75694-75695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26342]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG-2016-0936]
Safety Zone; Delaware River, Philadelphia, PA
AGENCY: Coast Guard, DHS.
ACTION: Notice of enforcement of regulation.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard will enforce regulations for a safety zone for
an annual fireworks event in the Captain of the Port Delaware Bay zone
from 6 p.m. to 8 p.m. on November 19, 2016. Enforcement of this zone is
necessary and intended to ensure safety of life on
[[Page 75695]]
the navigable waters immediately prior to, during, and immediately
after this fireworks event. During the enforcement period, no vessel
may transit this regulated area without approval from the Captain of
the Port or a designated representative.
DATES: The regulations in 33 CFR 165.506 will be enforced from 6 p.m.
to 8 p.m. on November 19, 2016, for the safety zone identified in row
(a)(16) of Table to Sec. 165.506.
FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email MST1 Thomas Simkins, Sector
Delaware Bay Waterways Management Division, U.S. Coast Guard; telephone
215-271-4889, email Tom.J.Simkins@uscg.mil.
SUPPLEMENTARY INFORMATION:
From 6 p.m. to 8 p.m. on November 19, 2016, the Coast Guard will
enforce regulations in 33 CFR 165.506 for the safety zone in the
Delaware River in Philadelphia, PA listed in row (a)(16) in the table
in that section. This action is being taken to provide for the safety
of life on navigable waterways during the fireworks display.
Our regulations for recurring firework events in Captain of the
Port Delaware Bay Zone, appear in Sec. 165.506, Safety Zones;
Fireworks Displays in the Fifth Coast Guard District, which specifies
the location of the regulated area for this safety zone as all waters
of Delaware River, adjacent to Penn's Landing, Philadelphia, PA,
bounded from shoreline to shoreline, bounded on the south by a line
running east to west from points along the shoreline at latitude
39[deg]56'31.2'' N., longitude 075[deg]08'28.1'' W.; thence to latitude
39[deg]56'29'' .1 N., longitude 075[deg]07'56.5'' W., and bounded on
the north by the Benjamin Franklin Bridge.
As specified in Sec. [thinsp]165.506, during the enforcement
period no vessel may transit this safety zone without approval from the
Captain of the Port Delaware Bay. If permission is granted, all persons
and vessels shall comply with the instructions of the COTP or
designated representative.
This notice of enforcement is issued under authority of 33 CFR
165.506 and 5 U.S.C. 552(a). In addition to this notice of enforcement
in the Federal Register, the Coast Guard will provide the maritime
community with advanced notification of this enforcement period via
Broadcast Notice to Mariners (BNM).
If the Captain of the Port Delaware Bay determines that the
regulated area need not be enforced for the full duration, a BNM to
grant general permission to enter the safety zone may be used.
Dated: October 27, 2016.
Benjamin A. Cooper,
Captain, U.S. Coast Guard, Captain of the Port Delaware Bay.
[FR Doc. 2016-26342 Filed 10-31-16; 8:45 am]
BILLING CODE 9110-04-P