Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Notices 23873 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission of Childhood 

Vaccines; Request for Nominations for 

Voting Members 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

requesting nominations to fill three 

vacancies on the Advisory Commission 

on Childhood Vaccines (ACCV). The 

ACCV was established by Title XXI of 

the Public Health Service Act (the Act), 

as enacted by Public Law (Pub. L.) 99– 

660 and as subsequently amended, and 

advises the Secretary of Health and 

Human Services (the Secretary) on 

issues related to implementation of the 

National Vaccine Injury Compensation 

Program (VICP). 

DATES: The agency must receive 

nominations on or before June 22, 2009. 

ADDRESSES: All nominations are to be 

submitted to the Director, Division of 

Vaccine Injury Compensation, 

Healthcare Systems Bureau (HSB), 

HRSA, Parklawn Building, Room 11C– 

26, 5600 Fishers Lane, Rockville, 

Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Michelle Herzog, Principal Staff Liaison, 

Policy Analysis Branch, Division of 

Vaccine Injury Compensation, HSB, 

HRSA at (301) 443–0650 or e-mail: 

mherzog@hrsa.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authorities that established the ACCV, 

the Federal Advisory Committee Act of 

October 6, 1972 (Pub. L. 92–463) and 

section 2119 of the Act, 42 U.S.C. 

300aa–19, as added by Public Law 99– 

660 and amended, HRSA is requesting 

nominations for three voting members 

of the ACCV. 

The ACCV advises the Secretary on 

the implementation of the VICP. The 

activities of the ACCV include: 

recommending changes in the Vaccine 

Injury Table at its own initiative or as 

the result of the filing of a petition; 

advising the Secretary in implementing 

section 2127 regarding the need for 

childhood vaccination products that 

result in fewer or no significant adverse 

reactions; surveying Federal, State, and 

local programs and activities related to 

gathering information on injuries 

associated with the administration of 

childhood vaccines, including the 

adverse reaction reporting requirements 

of section 2125(b); advising the 

Secretary on the methods of obtaining, 

compiling, publishing, and using 

credible data related to the frequency 

and severity of adverse reactions 

associated with childhood vaccines; 

consulting on the development or 

revision of the Vaccine Information 

Statements and recommending to the 

Director of the National Vaccine 

Program that vaccine safety research be 

conducted on various vaccine injuries. 

The ACCV consists of nine voting 

members appointed by the Secretary as 

follows: (1) Three health professionals, 

who are not employees of the United 

States Government and have expertise 

in the health care of children, and the 

epidemiology, etiology, and prevention 

of childhood diseases, and the adverse 

reactions associated with vaccines, at 

least two shall be pediatricians; (2) three 

members from the general public, at 

least two shall be legal representatives 

(parents or guardians) of children who 

have suffered a vaccine-related injury or 

death; and (3) three attorneys, at least 

one shall be an attorney whose specialty 

includes representation of persons who 

have suffered a vaccine-related injury or 

death, and one shall be an attorney 

whose specialty includes representation 

of vaccine manufacturers. In addition, 

the Director of the National Institutes of 

Health, the Assistant Secretary for 

Health, the Director of the Centers for 

Disease Control and Prevention, and the 

Commissioner of the Food and Drug 

Administration (or the designees of such 

officials) serve as nonvoting ex officio 

members. 

Specifically, HRSA is requesting 

nominations for three voting members 

of the ACCV representing: (1) A health 

professional, who has expertise in the 

health care of children; and the 

epidemiology, etiology, and prevention 

of childhood diseases; (2) an attorney 

whose specialty includes representation 

of a vaccine manufacturer; and (3) a 

member of the general public. Nominees 

will be invited to serve a 3-year term 

beginning January 1, 2010, and ending 

December 31, 2012. 

Interested persons may nominate one 

or more qualified persons for 

membership on the ACCV. Nominations 

shall state that the nominee is willing to 

serve as a member of the ACCV and 

appears to have no conflict of interest 

that would preclude the ACCV 

membership. Potential candidates will 

be asked to provide detailed information 

concerning consultancies, research 

grants, or contracts to permit evaluation 

of possible sources of conflicts of 

interest. A curriculum vitae or resume 

should be submitted with the 

nomination. 

The Department of Health and Human 

Services has special interest in assuring 

that women, minority groups, and the 

physically disabled are adequately 

represented on advisory committees; 

and therefore, extends particular 

encouragement to nominations for 

appropriately qualified female, 

minority, or disabled candidates. 

Dated: May 15, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–11928 Filed 5–20–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Family Youth and Services Bureau 

AGENCY: Family Youth And Services 

Bureau, ACF, DHHS. 

ACTION: Notice to Award a Single-Source 

Replacement Grant. 

CFDA#: 93.616. 

Legislative Authority: Section 439 of 

the Social Security Act, as amended by 

the Child and Family Services 

Improvement Act of 2006 (Pub. L. 109– 

288) 

Amount of Award: $292,000. 

Project Period: April 1, 2009– 

September 29, 2010. 

SUMMARY: The Family and Youth 

Services Bureau (FYSB) awarded a 

Mentoring Children of Prisoners grant 

(Grant No. 90CV0343) to Prevent Child 

Abuse California of North Highlands, 

CA on September 30, 2007. On October 

31, 2008, Prevent Child Abuse 

California submitted a letter 

relinquishing their grant. Amador 

Tuolumne Community Action Agency 

of Jackson, CA, an eligible non-profit 

organization, submitted their letter 

along with their grant application 

requesting approval as the replacement 

grantee for the Mentoring Children of 

Prisoners grant. FYSB has received and 

reviewed the application from Amador 

Tuolumne Community Action Agency. 

Upon finding that the proposed project 

will be able to carry out objectives 

originally intended to be completed by 

Prevent Child Abuse California, this 

organization has been awarded funds in 

the amount of $292,000 as the 

permanent successor grantee. 

Amador Tuolumne Community 

Action Agency will continue through a 

community-based approach to work 

toward the goal of creating high-quality, 

one-to-one lasting mentoring 


dwashington3 on PROD1PC60 with NOTICES
23874 Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Notices 

relationships that provide young people, 

who have an incarcerated parent with 

caring adult volunteers. 

Additional information about this 

program and its purpose can be located 

on the following Web site: http:// 

www.acf.hhs.gov/programs/fysb. 

Contact for Further Information: 

Gloria Watkins, Family Youth and 

Services Bureau, 1250 Maryland Ave., 

SW., Washington, DC 20047. Telephone: 

(202) 205–9546. E-mail: 

Gloria.Watkins@acf.hhs.gov. 

Dated: May 12, 2009. 

Maiso L. Bryant, 

Acting Commissioner, Administration on 

Children, Youth and Families. 

[FR Doc. E9–11816 Filed 5–20–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0210] 

Temporary Deferment of Activities 

Relating to Medical Device 

Submissions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that the Center for Devices and 

Radiological Health (CDRH) will be 

moving from various Rockville, 

Maryland locations to Building 66 at 

10903 New Hampshire Avenue in Silver 

Spring, Maryland from approximately 

mid May 2009 until the beginning of 

August 2009. Offices will progressively 

move over weekends during this period. 

Specifically, moves will occur on 

Friday, Saturday, and Sunday except on 

holiday weekends. During the period 

required for relocation of files, 

equipment, and agency personnel, the 

Center for Devices and Radiological 

Health will not officially receive 

premarket submissions on the Friday of 

a move weekend and the Monday after 

a move weekend. 

FOR FURTHER INFORMATION CONTACT: 

Marjorie Shulman, Center for Devices 

and Radiological Health (HFZ–404), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4186 or 

Marjorie.shulman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH is responsible for activities 

under sections 510, 513, 515, and 520 of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360, 360c, 360e, 

and 360j). These activities include, but 

are not limited to: 

1. Advising the Director, CDRH, and 

other FDA officials on all medical 

device submissions, such as premarket 

notification submissions under section 

510(k) of the act, device classifications 

under section 513 of the act, premarket 

approval applications (PMA’s) and 

product development protocols (PDP’s) 

under section 515 of the act, and 

clinical investigations under section 520 

of the act; 

2. Determining substantial 

equivalence for premarket notification 

submissions; 

3. Planning, conducting, and 

coordinating CDRH actions regarding 

PMA’s, PDP’s, and investigational 

device exemption approvals, denials, or 

withdrawals of approval; 

4. Monitoring sponsors’ compliance 

with regulatory requirements; and 

5. Conducting a continuing review, 

surveillance, and medical evaluation of 

the labeling, clinical experience, and 

required reports submitted by sponsors 

holding approved applications. 

In an effort to consolidate CDRH 

offices, FDA is moving various CDRH 

offices from their present Rockville, 

Maryland locations to Building 66 at 

10903 New Hampshire Avenue in Silver 

Spring, Maryland. Offices will 

progressively move, during weekends, 

during this period. Specifically, moves 

will occur on Friday, Saturday, and 

Sunday except on holiday weekends. 

During the period required for 

relocation of files, equipment, and 

agency personnel, the agency, 

specifically the Center for Devices and 

Radiological Health, will not officially 

receive submissions on the Friday of a 

move weekend and the Monday after a 

move weekend. Although mail will be 

delivered to a CDRH address during the 

move, CDRH will not be able to receive 

it on Fridays and Mondays, and will 

have limited capacity on Tuesday. 

Accordingly, mail delivered on Friday 

or Monday will be logged in on a 

staggered basis to preserve equity in the 

order of receipt and manageability of the 

accumulated workload. Specifically, 

mail delivered on Friday or Monday 

will be received on Tuesday and mail 

delivered on Tuesday will be received 

by Wednesday. Mail delivered on 

Wednesdays and Thursdays will remain 

unaffected. 

The new mailing address for 

submissions and updated telephone 

contact information may be found by 

accessing www.fda.gov/cdrh/ 

whiteoakmove. 

II. Comments 

Persons who may be affected by this 

temporary deferment should contact 

FDA with any questions they may have 

regarding CDRH’s move to the White 

Oak, Maryland. These persons should 

call CDRH’s Division of Small 

Manufacturers, International, and 

Consumer Assistance at 800–638–2041 

(in Maryland, 240–276–3150). 

Dated: May 13, 2009. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E9–11840 Filed 5–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of Intertek 

USA, Inc., as a Commercial Gauger 

and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of accreditation and 

approval of Intertek USA, Inc., as a 

commercial gauger and laboratory. 

SUMMARY: Notice is hereby given that, 

pursuant to 19 CFR 151.12 and 19 CFR 

151.13, Intertek USA, Inc., 101 20th 

Street South, Texas City, TX 77590, has 

been approved to gauge and accredited 

to test petroleum and petroleum 

products, organic chemicals and 

vegetable oils for customs purposes, in 

accordance with the provisions of 19 

CFR 151.12 and 19 CFR 151.13. Anyone 

wishing to employ this entity to conduct 

laboratory analyses and gauger services 

should request and receive written 

assurances from the entity that it is 

accredited or approved by the U.S. 

Customs and Border Protection to 

conduct the specific test or gauger 

service requested. Alternatively, 

inquires regarding the specific test or 

gauger service this entity is accredited 

or approved to perform may be directed 

to the U.S. Customs and Border 

Protection by calling (202) 344–1060. 

The inquiry may also be sent to 

cbp.labhq@dhs.gov. Please reference the 

Web site listed below for a complete 

listing of CBP approved gaugers and 

accredited laboratories.http://cbp.gov/ 

xp/cgov/import/operations_support/ 

labs_scientific_svcs/ 

commercial_gaugers/. 

DATES: The accreditation and approval 

of Intertek USA, Inc., as commercial 

gauger and laboratory became effective 


dwashington3 on PROD1PC60 with NOTICES