30 Day Federal Register Notice

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Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Notices

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compounding that should be primarily
overseen by the States and higher risk
non-traditional pharmacy compounding
that would require compliance with
Federal standards. In addition, there are
open questions about whether, and to
what degree States should enforce
Federal standards, what that oversight
should look like, and the appropriate
level of communication and
coordination required to make the
system of State and Federal oversight
seamless and effective.
FDA recognizes that the States play a
critical role in the oversight of
traditional pharmacy compounding,
which can include compounding a
customized medication in response to a
prescription by a licensed practitioner
based on the identified medical need of
a particular patient for the compounded
product. However, a category of ‘‘nontraditional’’ compounding has evolved
in the last decade that FDA believes
requires additional oversight. The
Agency is working with Congress to
consider new authorities regarding
‘‘non-traditional’’ compounding
pharmacies. In recognition of the States’
role, FDA has also reached out to its
State partners by inviting
representatives from all 50 States to an
intergovernmental meeting.
II. Questions for Comment
The intergovernmental meeting will
be an opportunity for the State officials
to discuss a variety of issues regarding
their views on the role of the FDA and
the States in the oversight of
compounding including:
• Given existing authorities and
resources, are the States currently able
to provide the needed oversight of
pharmacy compounding and consumer
protection?
• What should the Federal role be in
regulating higher risk pharmacy
compounding such as compounding
high-volumes of drugs for interstate
distribution? Is there a way to re-balance
Federal and State participation in the
regulation of pharmacy compounding
that would better protect the public
health? What strategies should be
developed to further strengthen Federal/
State communications?
• Do you see a role for the States in
enforcing a Federal standard for ‘‘nontraditional’’ compounding? If so, what
role? What factors would affect a
decision by your State to take on such
responsibility?
The public meeting announced in this
document will be held after the
intergovernmental meeting described
above. FDA is holding this public
meeting to share the results of the
intergovernmental meeting with

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interested stakeholders. At the public
meeting, FDA representatives and
participants from the intergovernmental
meeting will summarize the results of
the intergovernmental meeting.
III. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but is not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. The Fungal Meningitis Outbreak:
Could It Have Been Prevented?
Statement of Margaret A. Hamburg,
M.D., before the House Committee on
Energy and Commerce, Subcommittee
on Oversight and Investigations (http://
www.fda.gov/NewsEvents/Testimony/
ucm327664.htm), November 14, 2012.
2. Pharmacy Compounding:
Implications of the 2012 Meningitis
Outbreak: Margaret A. Hamburg, M.D.,
before the Senate Committee on Health,
Education, Labor, and Pensions (http://
www.fda.gov/NewsEvents/Testimony/
ucm327667.htm), November 15, 2012.
Dated: November 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28786 Filed 11–27–12; 8:45 am]
BILLING CODE 4160–01–P

respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
includes the actual data collection
instruments FEMA will use.
There has been a change in the
respondents, estimated burden, and
estimated total annual burden hours
from previous 30 day Notice. This
change is a result of including the time,
effort, and resources to collect
information to be used by respondents
as well as the significant decline in
respondents expected.
DATES: Comments must be submitted on
or before December 28, 2012.
ADDRESSES: Submit written comments
on the proposed information collection
to the Office of Information and
Regulatory Affairs, Office of
Management and Budget. Comments
should be addressed to the Desk Officer
for the Department of Homeland
Security, Federal Emergency
Management Agency, and sent via
electronic mail to oira.submission@omb.
eop.gov or faxed to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be made to Director, Records
Management Division, 1800 South Bell
Street, Arlington, VA 20598–3005,
facsimile number (202) 646–3347, or
email address [email protected].
SUPPLEMENTARY INFORMATON:
Collection of Information

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2012–0027; OMB No.
1660–0054]

Agency Information Collection
Activities: Submission for OMB
Review; Comment Request,
Assistance to Firefighters Grant
Program-Grant Application
Supplemental Information
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:

The Federal Emergency
Management Agency (FEMA) has
submitted the following information
collection to the Office of Management
and Budget (OMB) for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
describes the nature of the information
collection, the categories of

SUMMARY:

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Title: Assistance to Firefighters Grant
Program-Grant Application
Supplemental Information.
Type of Information Collection:
Revision of a currently approved
information collection.
OMB Number: OMB No. 1660–0054.
FEMA Forms: FEMA Form 080–2,
AFG Application (General Questions
and Narrative); FEMA Form 080–2a,
Activity Specific Questions for AFG
Vehicle Applicants; F FEMA Form 080–
2b, Activity Specific Questions for AFG
Operations and Safety Applications;
FEMA Form 080–3, Activity Specific
Questions for Fire Prevention and Safety
Applicants; FEMA Form 080–3a, Fire
Prevention and Safety; and FEMA Form
080–3b, Research and Development
Abstract: The FEMA forms for this
collection are used to objectively
evaluate each of the anticipated
applicants to determine which
applicants’ submission in each of the
AFG activities are close to the
established program priorities. FEMA
also uses the information to determine
eligibility and whether the proposed use

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Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Notices
of funds meets the requirements and
intent of AFG legislation.
Affected Public: State, Local or Tribal
Government, and Not-for-profit
institutions.
Estimated Number of Respondents:
28,010.
Estimated Total Annual Burden
Hours: 201,130 hours.
Frequency of Response: One Time.
Dated: November 21, 2012.
Charlene D. Myrthil,
Director, Records Management Division,
Mission Support Bureau, Federal Emergency
Management Agency, Department of
Homeland Security.
[FR Doc. 2012–28841 Filed 11–27–12; 8:45 am]
BILLING CODE 9111–78–P

DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–R1–R–2012–N114; 1265–0000–10137–
S3]

Dungeness National Wildlife Refuge,
Clallam County, WA; Comprehensive
Conservation Plan and Environmental
Assessment
Fish and Wildlife Service,
Interior.
ACTION: Notice of availability; request
for comments.
AGENCY:

We, the U.S. Fish and
Wildlife Service (Service), announce the
availability of a draft comprehensive
conservation plan and environmental
assessment (Draft CCP/EA) for
Dungeness National Wildlife Refuge
(refuge or NWR) for public review and
comment. The Draft CCP/EA describes
our proposal for managing the refuge for
the 15 years following approval of the
final CCP. Implementing the CCP is
subject to the availability of funding and
any other compliance regulations.
DATES: To ensure consideration, please
send your written comments by
December 28, 2012.
ADDRESSES: You may submit comments
or requests for copies or more
information by any of the following
methods. You may request hard copies
or a CD–ROM of the documents.
Email:
[email protected].
Include ‘‘Dungeness NWR draft CCP’’ in
the subject line of the message.
Fax: Attn: Project Leader, (360) 457–
9778.
U.S. Mail: Washington Maritime
National Wildlife Refuge Complex, 715
Holgerson Road, Sequim, WA 98382.
Web site: http://www.fws.gov/pacific/
planning/main/docs/wa/
docsdungeness.htm.

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In-Person Drop-off, Viewing, or
Pickup: Call (360) 457–8451 to make an
appointment (necessary for viewing/
pickup only) during regular business
hours at the above address. For more
information on locations for viewing or
obtaining documents, see ‘‘Public
Availability of Documents’’ under
SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT:
Kevin Ryan, Project Leader, Washington
Maritime National Wildlife Refuge
Complex, 715 Holgerson Road, Sequim,
WA 98382; phone (360) 457–8451 and
fax (360) 457–9778.
SUPPLEMENTARY INFORMATION:
Introduction
With this notice, we continue the CCP
process for Dungeness NWR in Clallam
County, Washington. We started this
process through a notice in the Federal
Register (76 FR 61378; October 4, 2011).
For more information about the history
of the refuge, see that notice.
Background
The CCP Process
The National Wildlife Refuge System
Administration Act of 1966, 16 U.S.C.
668dd–668ee (Refuge Administration
Act), as amended by the National
Wildlife Refuge System Improvement
Act of 1997, 111 Stat. 1254, requires us
to develop a CCP for each national
wildlife refuge. The purpose for
developing a CCP is to provide refuge
managers with a 15-year plan for
achieving refuge purposes and
contributing toward the mission of the
National Wildlife Refuge System
(NWRS), consistent with sound
principles of fish and wildlife
management, conservation, legal
mandates, the National Environmental
Policy Act (NEPA), and our policies. In
addition to outlining broad management
direction on conserving wildlife and
their habitats, CCPs identify compatible
wildlife-dependent recreational
opportunities available to the public,
including opportunities for hunting,
fishing, wildlife observation and
photography, and environmental
education and interpretation. We will
review and update the CCP at least
every 15 years in accordance with the
Refuge Administration Act.
Public Outreach
We began public outreach by
publishing a notice of intent in the
Federal Register (76 FR 61378; October
4, 2011) announcing our intent to
complete a CCP and EA for the refuge
and inviting public comments. In
October 2011, we distributed Planning
Update 1, which included background

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information on the refuge; refuge
purposes; preliminary issues, vision,
and goals; and a request for public
comments. Some scoping comments we
received were about broad or long-range
issues, while others suggested very
specific or detailed strategies that could
be used to achieve biological or public
use objectives. The comments were
categorized into eight general categories:
Threats to refuge resources; wildlife and
habitat management; wildlife-dependent
public use; non-wildlife-dependent
public use; law enforcement; cultural
resources; land acquisition; and refuge
administration.
We reviewed and evaluated the
potential issues, management concerns,
and opportunities that we, our partners,
and the public identified during
scoping. We used this information to
define the major issues to be addressed
in the CCP/EA. Preliminary draft
alternatives were then developed to
address these issues and meet the goals
and objectives of the refuge. In January
2012, we distributed Planning Update 2,
which included a summary of the
scoping comments we received, a
summary of our preliminary draft
alternatives, notice of public open house
meetings, and information on how and
where to comment. On January 19 and
February 2, 2012, we held a total of four
public open house meetings in Sequim,
Washington, to meet the public, present
our preliminary draft alternatives, and
solicit comments. The meetings were
announced through local media outlets,
on the refuge’s Web site, and in
Planning Update 2. Comments we
received have been considered and
evaluated, with many incorporated into
the various alternatives addressed in the
draft CCP/EA.
Draft CCP/EA Alternatives We Are
Considering
During the public scoping process
with which we started work on this
draft CCP, we, other governmental
partners, Tribes, and the public raised
several issues, which the draft CCP
addresses. A full description of each
alternative is in the EA. To address
these issues, we developed and
evaluated the following alternatives,
briefly summarized below.
Common to All Alternatives
The New Dungeness Light Station,
within the approved refuge boundary, is
due to be excessed by the U.S. Coast
Guard (USCG). Under all alternatives,
the Service would work with the USCG
to bring the light station property into
the NWRS either through interagency
cooperative management agreement or
property transfer. Subsequently, the

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