60 Day Federal Reigster Notice

Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices
meetings conducted under the BPCA
can be found on the BPCA Web site
listed above.
The ‘‘New’’ BPCA
Title V of Public Law 110–85, the Best
Pharmaceuticals for Children Act of
2007, was enacted on September 27,
2007, as part of the Food and Drug
Administration Amendments Act of
2007.
This legislation, which reauthorizes
the BPCA (Section 409I of the Public
Health Service Act), extends the
provision of additional patent
exclusivity for currently on-patent drugs
that are being tested for pediatric use.
This legislation also extends and
expands the research program at the
NIH established in the earlier law. The
NICHD administers the research
program through its Obstetric and
Pediatric Pharmacology Branch,
working in cooperation with the other
NIH Institutes and Centers with
significant pediatric research portfolios.
Important changes to the 2002 BPCA
legislation for the NIH include the
following:
• Focus on condition-based approach.
• More flexible funding mechanisms.
• Development of Proposed Pediatric
Study Requests (PPSR).
• Feasibility study for the
development of a pediatric formulary.
The NICHD will prioritize all
therapeutic areas over the upcoming
years based on the following
considerations:
• Building upon the current
foundation established by the 2002
BPCA implementation;
• Evaluating all currently listed drugs
and therapeutic areas for feasibility and
identification of additional or new
scientific and therapeutic gaps;
• Changing the listing process from
an individual drug/indication approach
to listing needs in pediatric therapeutic
areas;
• Determining new areas of need
based on consultation with other NIH
Institutes and Centers, as well as experts
in pediatric therapeutics and the
pediatric medical community.
The overall goal of the NIH for
implementing the provisions of the
BPCA is to improve pediatric
therapeutics through scientific
advancements and labeling changes that
will have an impact on the safe and
effective use of drugs in children. This
can be accomplished through the
following:
• Data gathering
—Using the principles of
pharmacoepidemiology research to
quantify adverse drug reactions, drug
efficacy, and patterns of drug use in

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large populations to elucidate health
services utilization.
—Bringing together multidisciplinary
teams to provide input on needs in
pediatric therapeutics through
outreach to experts in pediatric
research in academic institutions;
other NIH Institutes and Centers; and
pediatric organizations, societies,
advocacy groups, and industry.
• Clinical trials
—Phase 1, 2, and 3 clinical trials to
increase the knowledge of PK, safety,
and efficacy of medicines used in
children.
• Basic and translational research
—To inform such areas as
developmental pharmacology,
pharmacogenomics, and pediatric
clinical trial design.
There will be an open scientific
meeting annually, starting in 2008, to
review and discuss the proposed
therapeutic areas, to present progress
from ongoing research, and to provide
an opportunity for the medical
community to provide input into the
future therapeutic areas to be studied
under the BPCA. Stakeholders will
include the NIH, the FDA, and members
of the American Academy of Pediatrics,
and other pediatric organizations and
societies. There will be a report to
Congress at least every 3 years starting
in 2008. Throughout the year, there will
also be smaller group meetings with
expert panels within prioritized
therapeutic areas under the BPCA. The
goals of the working group meetings
will be to evaluate and discuss the gaps
in scientific knowledge (whether
necessary data are available or
unavailable) as well as to determine
gaps in the treatments of these
conditions; for example, to determine
what may be needed to enhance the
treatment of these conditions in
children. These consultations will assist
the NICHD in the development of future
proposed areas of study encompassing
multiple therapeutic categories and/or
addressing multiple questions within a
therapeutic category.
A scientific prioritization meeting was
held in Rockville, Maryland, from June
30 to July 1, 2008, to determine needs
in pediatric therapeutics as mandated
by the BPCA 2007 legislation. The final
BPCA List of Needs in Pediatric
Therapeutics, and information on the
prioritization process, will be posted on
the BPCA Web site http://
bpca.nichd.nih.gov.

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Dated: April 7, 2009.
Raynard S. Kington,
Acting Director, National Institutes of Health.
[FR Doc. E9–8477 Filed 4–13–09; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2009–0008]

The National Infrastructure Advisory
Council
AGENCY: Directorate for National
Protection and Programs, Department of
Homeland Security.
ACTION: Committee Management; Notice
of cancellation for Federal Advisory
Committee Meeting.
SUMMARY: The meeting of the National
Infrastructure Advisory Council (NIAC)
scheduled for Tuesday April 14, 2009 at
the J.W. Marriott, 1331 Pennsylvania
Avenue, Washington, DC announced in
the Federal Register on February 17,
2009 (73 FR 7456), will not be held.
FOR FURTHER INFORMATION CONTACT:
Contact Matthew Sickbert by phone at
703–235–2888 or by e-mail at
[email protected].

Dated: April 9, 2009.
Nancy J. Wong,
Designated Federal Officer for the NIAC.
[FR Doc. E9–8541 Filed 4–10–09; 11:15 am]
BILLING CODE 4410–10–P

DEPARTMENT OF HOMELAND
SECURITY
United States Immigration and
Customs Enforcement
60-Day Notice of New Information
Collection; Form 70–005, ICE Secure
Communities Stakeholder ID
Assessment Questionnaire; Agency
Information Collection Activities: New
Information Collection; Comment
Request
ACTION: 60-Day Notice of New
Information Collection; Form 70–005,
ICE Secure Communities Stakeholder ID
Assessment Questionnaire.

The Department of Homeland
Security, U.S. Immigration and Customs
Enforcement (USICE), has submitted the
following information collection request
for review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection is
published to obtain comments from the
public and affected agencies. Comments
are encouraged and will be accepted for
sixty days until June 15, 2009.

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Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices

Written comments and suggestions
regarding items contained in this notice,
and especially with regard to the
estimated public burden and associated
response time should be directed to the
Department of Homeland Security
(DHS), Joseph M. Gerhart, Chief,
Records Management Branch, U.S.
Immigration and Customs Enforcement,
500 12th Street, SW., Room 3138,
Washington, DC 20536; (202) 732–6337.
Comments are encouraged and will be
accepted for sixty days until June 15,
2009. Written comments and
suggestions from the public and affected
agencies concerning the proposed
collection of information should address
one or more of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of this information
collection:
(1) Type of Information Collection:
New information collection.
(2) Title of the Form/Collection: ICE
Secure Communities Stakeholder ID
Assessment Questionnaire.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form 70–005,
U.S. Immigration and Customs
Enforcement.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individual or
Households, Business or other nonprofit. The information collected on the
Form 70–005 is necessary for U.S.
Immigration and Customs Enforcement
(ICE) to provide immigration bond
obligors a standardized method to notify
ICE of address updates. Upon receipt of
the formatted information records will
then be updated to ensure accurate
service of correspondence between ICE
and the obligor.

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(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 1,000 responses at 10 minutes
(0.1667 hours) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 166.7 annual burden hours.
Comments and/or questions; requests
for a copy of the proposed information
collection instrument, with instructions;
or inquiries for additional information
should be directed to: Joseph M.
Gerhart, Chief, Records Management
Branch, U.S. Immigration and Customs
Enforcement, 500 12th Street, SW.,
Room 3138, Washington, DC 20536;
(202) 732–6337.
Dated: April 8, 2009.
Joseph M. Gerhart,
Chief, Records Management Branch, U.S.
Immigration and Customs Enforcement,
Department of Homeland Security.
[FR Doc. E9–8391 Filed 4–13–09; 8:45 am]
BILLING CODE 9111–28–P

DEPARTMENT OF THE INTERIOR
Bureau of Reclamation
Change of Use for the Oak Shores
Recreation Area at Lake Berryessa,
Napa County, CA
AGENCY: Bureau of Reclamation,
Interior.
ACTION: Notice of change in use of
public access.
SUMMARY: The Bureau of Reclamation’s
Central California Area Office (CCAO) at
Lake Berryessa will temporarily change
public use at Oak Shores Day Use Area.
After 50 years, concession contracts
have expired and recreational
opportunities provided at four closed
resorts are no longer available. Until
such time as new contracts can be
awarded, Reclamation will provide a
change from day use to overnight
camping at this area. The North End of
Oak Shores will be converted from day
use only to overnight camping with up
to 100 sites. Camping will be considered
semi-primitive and will provide potable
water spigots, restroom facilities, fire
rings, picnic tables and some shade
shelters. This change in use will serve
to enhance public safety, provide
additional public recreational services
while providing for and protection of
cultural and natural resources.
DATES: Effective Dates: The change of
use will become effective May 22, 2009
and continue indefinitely until new
contracts can be awarded and the new
concessioner can begin to provide
recreational services.

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ADDRESSES: A map is available for
review at Reclamation’s Lake Berryessa
Visitor Center, located at 5520 Knoxville
Rd, Napa, California 94558. The map
may be viewed between the hours of 10
a.m. and 4 p.m. daily. A copy of the
map may be requested from above
address, attention: Lake Berryessa
Change of Use Map Request.
FOR FURTHER INFORMATION CONTACT:
Reclamation, Mid-Pacific Region Public
Affairs Office, at 916–978–5100 or
Reclamation, Lake Berryessa Recreation
Resources Branch, 707–966–2111.
Written comments will be accepted
regarding this change of use through
May 14, 2009. Please send written
comments to: Bureau of Reclamation,
Attn: Janet Rogers, 5520 Knoxville Rd.,
Napa, California; Fax: 707–966–0409, Email: [email protected].

This
action is being taken under 43 CFR part
423 to provide recreational services to
the public, provide public safety and
prevent additional resource degradation.
Reclamation will change public use of
Oak Shores. Presently Oak Shores is
being used for day use; picnics, fishing,
wildlife viewing, and swimming. By not
providing designated camping,
additional resource degradation at nondesignated sites would occur.
The south side of Oak Shores will
remain open for day use and the north
side will be sectioned off to provide for
the campsites. Camping at Oak Shores
will be available for up to fourteen days
only during any period of 30
consecutive days, as required by 43 CFR
part 423.33.
Reclamation will develop the
campgrounds and offer an interim
contract to a concessioner for operation
of the campgrounds. Security will be
provided by the concessioner. A
reservation system will be required and
fees will be charged based on
comparable fees to other areas in a 100
mile radius of Lake Berryessa. The
public will be notified of the changes
through signage, newspaper press
releases and Web site postings.
This order is posted in accordance
with 43 CFR part 423.60. Violation of
this prohibition or any prohibition
listed in 43 CFR part 423 is punishable
by fine or imprisonment for not more
than six months or both.

SUPPLEMENTARY INFORMATION:

Dated: April 7, 2009.
Michael R. Finnegan,
Area Manager, Central California Area Office.
[FR Doc. E9–8468 Filed 4–13–09; 8:45 am]
BILLING CODE 4310–MN–P

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