Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices 17205 

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 

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. 

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 

Matthew.Sickbert@associates.dhs.gov. 

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. 

17206 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. 

(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. 

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: jrogers@.usbr.gov. 

SUPPLEMENTARY INFORMATION: 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. 

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