5166 Federal Register / Vol. 74, No. 18 / Thursday, January 29, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Request for Nominations for Voting 

Members on Public Advisory 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the Allergenic Products 

Advisory Committee;Blood Products 

Advisory Committee; Cellular, Tissue, 

and Gene Therapies Advisory 

Committee; Transmissible Spongiform 

Encephalopathies Advisory Committee; 

and the Vaccines and Related Biological 

Products Advisory Committee. 

Nominations will be accepted for 

current vacancies and those that will or 

may occur through September 30, 2009. 

FDA has a special interest in ensuring 

that women, minority groups, and 

individuals with disabilities are 

adequately represented on advisory 

committees and, therefore, encourages 

nominations of qualified candidates 

from these groups. 

DATES: Because scheduled vacancies 

occur on various dates throughout each 

year, no cutoff date is established for the 

receipt of nominations. However, when 

possible, nominations should be 

received at least 6 months before the 

date of scheduled vacancies for each 

year, as indicated in this document. 

ADDRESSES: All nominations for 

membership should be sent 

electronically to CV@OC.FDA.GOV, or 

by mail to Advisory Committee 

Oversight and Management Staff (HF– 

4), Food and Drug Administration, 5600 

Fishers Lane, rm. 15A–12, Rockville, 

MD 20857. Information about becoming 

a member on an FDA advisory 

committee can also be obtained by 

visiting FDA’s Web site athttp:// 

www.fda.gov/oc/advisory/default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Linda Amendt, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration,1401 

Rockville Pike, Rockville, MD 20852– 

1448, 301–827–1370, email:Linda.Amendt@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Vacancies 

FDA is requesting nominations of 

voting members with appropriate 

expertise for vacancies listed as follows: 

TABLE 1. 

Committee and Expertise Needed Current & Upcoming 

Vacancies 

Approximate Date 

Needed 

Allergenics Products Advisory Committee—allergy, immunology, pediatrics, internal medicine, 

biochemistry, statistics, and related specialties 3 Immediately 

2 August 31, 2009 

Blood Products Advisory Committee—clinical and administrative medicine, hematology, immunology, blood banking, tissue banking, surgery, anesthesia, critical care, internal medicine, infectious diseases, biochemistry, engineering, biological and physical sciences, biotechnology, computer technology, statistics, epidemiology, sociology/ethics, clinical trial design, and other related professions 2 Immediately 

4 September 30, 2009 

Cellular, Tissue, and Gene Therapies Advisory Committee—cellular therapies, tissue transplantation, gene transfer therapies and xenotransplantation including biostatistics, bioethics, hematology/oncology, human tissues and transplantation, reproductive medicine, 

general medicine and various medical specialties including surgery and oncology, immunology, virology, molecular biology, cell biology, developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene therapy, infectious diseases, and cellular kinetics 4 Immediately 

3 March 31, 2009 

Transmissible Spongiform Encephalopathies Advisory Committee—clinical and administrative 

medicine, hematology, virology, neurovirology, neurology,infectious diseases, immunology, 

transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, 

biological and physical sciences, sociology/ethics, and other related professions 1 Immediately 

4 January 31, 2009 

Vaccines and Related Biological Products Advisory Committee— immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry 4 Immediately 

1 January 31, 2009 

II. Functions 

A. Allergenic Products Advisory 

Committee 

The committee reviews and evaluates 

available data concerning the safety, 

effectiveness, and adequacy of labeling 

of marketed and investigational 

allergenic biological products or 

materials that are administered to 

humans for the diagnosis, prevention, or 

treatment of allergies and allergic 

diseases. 

B. Blood Products Advisory Committee 

The committee reviews and evaluates 

available data concerning the safety, 

effectiveness, and appropriate use of 

blood, products derived from blood and 

serum or biotechnology which are 

intended for use in the diagnosis, 

prevention, of treatment of human 

diseases. 

C. Cellular, Tissue, and Gene Therapies 

Advisory Committee 

The committee reviews and evaluates 

available data relating to the safety, 

effectiveness, and appropriate use of 

human cells, human tissues, gene 

transfer therapies, and 

xenotransplantation products which are 


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Federal Register / Vol. 74, No. 18 / Thursday, January 29, 2009 / Notices 5167 

intended for transplantation, 

implantation, infusion, and transfer in 

the prevention and treatment of a broad 

spectrum of human diseases and in the 

reconstruction, repair or replacement of 

tissues for various conditions. 

D. Transmissible Spongiform 

Encephalopathies Advisory Committee 

The committee reviews and evaluates 

available scientific data concerning the 

safety of products which may be at risk 

for transmission of spongiform 

encephalopathies having an impact on 

the public health. 

E. Vaccines and Related Biological 

Products Advisory Committee 

The committee reviews and evaluates 

data concerning the safety, 

effectiveness, and appropriate use of 

vaccines and related biological products 

which are intended for use in the 

prevention, treatment, or diagnosis of 

human diseases. 

III. Qualifications 

Persons nominated for membership 

on the committees shall have adequately 

diversified experience appropriate to 

the work of the committee in such fields 

as clinical and administrative medicine, 

engineering, biological and physical 

sciences, statistics, and other related 

professions. The nature of specialized 

training and experience necessary to 

qualify the nominee as an expert 

suitable for appointment may include 

experience in medical practice, 

teaching, and/or research relevant to the 

field of activity of the committee. The 

particular need for vacancies on each 

committee for the calendar years 2008 

and 2009 is shown in table 1 of this 

document. The term of office is up to 4 

years depending on the appointment 

date. Committees meet one to five times 

a year. Most meetings are for 2 days. 

IV. Nomination Procedures 

Any interested person may nominate 

one or more qualified persons for 

membership on one or more of the 

advisory committees. Self-nominations 

are also accepted. Nominations shall 

include the name of the committee, a 

complete curriculum vitae of each 

nominee, current business address and 

telephone number, and shall state that 

the nominee is aware of the nomination. 

Potential candidates will be required to 

provide detailed information concerning 

such matters as financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflict of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14 

relating to advisory committees. 

Dated: January 21, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–1821 Filed 1–28–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Loan Repayment Program for 

Repayment of Health Professions 

Educational Loans 

Announcement Type: Initial. 

CFDA Number: 93.164. 

Key Dates: January 16, 2009 first 

award cycle deadline date, September 

30, 2009 entry on duty deadline date. 

I. Funding Opportunity Description 

The Indian Health Service (IHS) 

estimated budget request for Fiscal Year 

(FY) 2009 includes $17,488,854 for the 

IHS Loan Repayment Program (LRP) for 

health professional educational loans 

(undergraduate and graduate) in return 

for full-time clinical service in Indian 

health programs. 

This program announcement is 

subject to the appropriation of funds. 

This notice is being published early to 

coincide with the recruitment activity of 

the IHS, which competes with other 

Government and private health 

management organizations to employ 

qualified health professionals. 

This program is authorized by Section 

108 of the Indian Health Care 

Improvement Act (IHCIA) as amended, 

25 U.S.C. 1601 et seq. The IHS invites 

potential applicants to request an 

application for participation in the LRP. 

II. Award Information 

The estimated funds available is 

approximately $17,488,854 to support 

approximately 391 competing awards 

averaging $44,740 per award for a two 

year contract. One year contract 

continuations will receive priority 

consideration in any award cycle. 

Applicants selected for participation in 

the FY 2009 program cycle will be 

expected to begin their service period 

no later than September 30, 2009. 

III. Eligibility Information 

1. Eligible Applicants 

Pursuant to Section 108(b), to be 

eligible to participate in the LRP, an 

individual must: 

(1) (A) Be enrolled— 

(i) In a course of study or program in 

an accredited institution, as determined 

by the Secretary, within any State and 

be scheduled to complete such course of 

study in the same year such individual 

applies to participate in such program; 

or 

(ii) In an approved graduate training 

program in a health profession; or 

(B) Have a degree in a health 

profession and a license to practice in 

a state; and 

(2) (A) Be eligible for, or hold an 

appointment as a Commissioned Officer 

in the Regular or Reserve Corps of the 

Public Health Service (PHS); or 

(B) Be eligible for selection for service 

in the Regular or Reserve Corps of the 

PHS; or 

(C) Meet the professional standards 

for civil service employment in the IHS; 

or 

(D) Be employed in an Indian health 

program without service obligation; and 

(E) Submit to the Secretary an 

application for a contract to the LRP. 

The Secretary must approve the contract 

before the disbursement of loan 

repayments can be made to the 

participant. Participants will be 

required to fulfill their contract service 

agreements through full-time clinical 

practice at an Indian health program site 

determined by the Secretary. Loan 

repayment sites are characterized by 

physical, cultural, and professional 

isolation, and have histories of frequent 

staff turnover. All Indian health 

program sites are annually prioritized 

within the Agency by discipline, based 

on need or vacancy. 

Any individual who owes an 

obligation for health professional 

service to the Federal Government, a 

State, or other entity is not eligible for 

the LRP unless the obligation will be 

completely satisfied before they begin 

service under this program. 

Section 108 of the IHCIA, as amended 

by Public Laws 100–713 and 102–573, 

authorizes the IHS LRP and provides in 

pertinent part as follows: 

‘‘(a)(1) The Secretary, acting through the 

Service, shall establish a program to be 

known as the Indian Health Service Loan 

Repayment Program (hereinafter referred to 

as the ‘‘Loan Repayment Program’’) in order 

to assure an adequate supply of trained 

health professionals necessary to maintain 

accreditation of, and provide health care 

services to Indians through, Indian health 

programs.’’ 

Section 4(n) of the IHCIA, as amended 

by the Indian Health Care Improvement 

Technical Corrections Act of 1996, 

Public Law 104–313, provides that: 

‘‘Health Profession’’ means allopathic 

medicine, family medicine, internal 

medicine, pediatrics, geriatric medicine, 

obstetrics and gynecology, podiatric 

medicine, nursing, public health 


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