10056 Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices 

Dated: February 17, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–4914 Filed 3–6–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Council on Blood Stem Cell 

Transplantation; Request for 

Nominations for Voting Members 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

requesting nominations to fill expected 

vacancies on the Advisory Council on 

Blood Stem Cell Transplantation. 

The Advisory Council on Blood Stem 

Cell Transplantation was established 

pursuant to Public Law 109–129, 42 

U.S.C. 274k (section 379 of the Public 

Health Service Act, as amended). In 

accordance with Public Law 92–463, the 

Council was chartered on December 19, 

2006. 

DATES: The agency must receive 

nominations on or before April 8, 2009. 

ADDRESSES: All nominations should be 

submitted to the Executive Secretary, 

Advisory Council on Blood Stem Cell 

Transplantation, Healthcare Systems 

Bureau, HRSA, Parklawn Building, 

Room 12–105, 5600 Fishers Lane, 

Rockville, Maryland 20857. Federal 

Express, Airborne, or UPS, mail delivery 

should be addressed to Executive 

Secretary, Advisory Council on Blood 

Stem Cell Transplantation, Healthcare 

Systems Bureau, HRSA, at the above 

address. 

FOR FURTHER INFORMATION CONTACT: 

Remy Aronoff, Executive Secretary, 

Advisory Council on Blood Stem Cell 

Transplantation, at (301) 443–3264 or email Remy.Aronoff@hrsa.hhs.gov or 

Robert Baitty, Director, Blood Stem Cell 

Transplantation Program, Division of 

Transplantation, at (301) 443–2612 or email Robert.Baitty@hrsa.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Council was established to implement a 

statutory requirement of the Stem Cell 

Therapeutic and Research Act of 2005 

(Pub. L. 109–129). The Council is 

governed by the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

Appendix 2), which sets forth standards 

for the formation and use of advisory 

committees. 

The Advisory Council advises the 

Secretary and the Administrator, HRSA, 

on matters related to the activities of the 

C.W. Bill Young Cell Transplantation 

Program and the National Cord Blood 

Inventory Program. 

The Council shall, as requested by the 

Secretary, discuss and make 

recommendations regarding the C.W. 

Bill Young Cell Transplantation 

Program (Program). It shall provide a 

consolidated, comprehensive source of 

expert, unbiased analysis and 

recommendations to the Secretary on 

the latest advances in the science of 

blood stem cell transplantation. The 

Council shall advise, assist, consult and 

make recommendations, at the request 

of the Secretary, on broad Program 

policy in areas such as the necessary 

size and composition of the adult donor 

pool available through the Program and 

the composition of the National Cord 

Blood Inventory, requirements regarding 

informed consent for cord blood 

donation, accreditation requirements for 

cord blood banks, the scientific factors 

that define a cord blood unit as high 

quality, public and professional 

education to encourage the ethical 

recruitment of genetically diverse 

donors and ethical donation practices, 

criteria for selecting the appropriate 

blood stem source for transplantation, 

Program priorities, research priorities, 

and the scope and design of the Stem 

Cell Therapeutic Outcomes Database. It 

also shall, at the request of the 

Secretary, review and advise on issues 

relating more broadly to the field of 

blood stem cell transplantation, such as 

regulatory policy including 

compatibility of international 

regulations, and actions that may be 

taken by the State and Federal 

Governments and public and private 

insurers to increase donation and access 

to transplantation. The Advisory 

Council also shall make 

recommendations regarding research on 

emerging therapies using cells from 

bone marrow and cord blood. 

The Council consists of up to 25 

members, including the Chair. Members 

of the Advisory Council shall be chosen 

to ensure objectivity and balance, and 

reduce the potential for conflicts of 

interest. The Secretary shall establish 

bylaws and procedures to prohibit any 

member of the Advisory Council who 

has an employment, governance, or 

financial affiliation with a donor center, 

recruitment organization, transplant 

center, or cord blood bank from 

participating in any decision that 

materially affects the center, recruitment 

organization, transplant center, or cord 

blood bank; and to limit the number of 

members of the Advisory Council with 

any such affiliation. 

The members and Chair shall be 

selected by the Secretary from 

outstanding authorities and 

representatives of marrow donor centers 

and marrow transplant centers; 

representatives of cord blood banks and 

participating birthing hospitals; 

recipients of a bone marrow transplant; 

recipients of a cord blood transplant; 

persons who require such transplants; 

family members of such a recipient or 

family members of a patient who has 

requested the assistance of the Program 

in searching for an unrelated donor of 

bone marrow or cord blood; persons 

with expertise in bone marrow and cord 

blood transplantation; persons with 

expertise in typing, matching, and 

transplant outcome data analysis; 

persons with expertise in the social 

sciences; basic scientists with expertise 

in the biology of adult stem cells; 

ethicists, hematology and transfusion 

medicine researchers with expertise in 

adult blood stem cells; persons with 

expertise in cord blood processing; and 

members of the general public. 

In addition, representatives from the 

Division of Transplantation of the 

Health Resources and Services 

Administration, the Department of 

Defense Marrow Recruitment and 

Research Program operated by the 

Department of the Navy, the Food and 

Drug Administration, the National 

Institutes of Health, the Centers for 

Medicare & Medicaid Services, and the 

Centers for Disease Control and 

Prevention serve as non-voting ex officio 

members. 

Specifically, HRSA is requesting 

nominations for voting members of the 

Advisory Council on Blood Stem Cell 

Transplantation in these categories: 

Marrow donor centers and transplant 

centers representatives; cord blood 

banks and participating hospitals 

representatives; family members of bone 

marrow transplant and cord blood 

transplant recipients or family members 

of a patient who has requested 

assistance by the Program in searching 

for an unrelated donor; persons with 

expertise in bone marrow or cord blood 

transplantation; persons with expertise 

in typing, matching, and transplant 

outcome data analysis; basic scientists 

with expertise in the biology of adult 

stem cells; researchers in hematology 

and transfusion medicine with expertise 

in adult blood stem cells; persons with 

expertise in cord blood processing; and 

members of the general public. 

Nominees will be invited to serve a 2- 

to 6-year term beginning after January 1, 

2010. 


dwashington3 on PROD1PC60 with NOTICES
Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices 10057 

HHS will consider nominations of all 

qualified individuals to ensure that the 

Advisory Council includes the areas of 

subject matter expertise noted above. 

Individuals may nominate themselves 

or other individuals, and professional 

associations and organizations may 

nominate one or more qualified persons 

for membership on the Advisory 

Council. Nominations shall state that 

the nominee is willing to serve as a 

member of the Council. Potential 

candidates will be asked to provide 

detailed information concerning 

financial interests, consultancies, 

research grants, and/or contracts that 

might be affected by recommendations 

of the Council to permit evaluation of 

possible sources of conflicts of interest. 

In addition, nominees will be asked to 

provide detailed information concerning 

any employment, governance, or 

financial affiliation with any donor 

centers, recruitment organizations, 

transplant centers, and/or cord blood 

banks. 

A nomination package should be sent 

in hard copy accompanied by an 

electronic version of the documents on 

compact disc. A nomination package 

should include the following 

information for each nominee: (1) A 

letter of nomination stating the name, 

affiliation, and contact information for 

the nominee, the basis for the 

nomination (i.e., what specific attributes 

recommend him/her for service in this 

capacity), and the nominee’s field(s) of 

expertise; (2) a biographical sketch of 

the nominee and a copy of his/her 

curriculum vitae; and (3) the name, 

return address, e-mail address, and 

daytime telephone number at which the 

nominator can be contacted. 

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: February 27, 2009. 

Elizabeth M. Duke, 

Administrator. 

[FR Doc. E9–4927 Filed 3–6–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; REDS–II Donor Iron Status 

Evaluation (RISE) Study 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

Proposed Collection 

Title: REDS–II Donor Iron Status 

Evaluation (RISE) Study. Type of 

Information Collection Request: 

Revision of a currently approved 

collection. OMB control # 0925–0581. 

Expiration Date: 05/31/2009. Need and 

Use of Information Collection: Although 

the overall health significance of iron 

depletion in blood donors is uncertain, 

iron depletion leading to iron deficient 

erythropoiesis and lowered hemoglobin 

levels results in donor deferral and, 

occasionally, in mild iron deficiency 

anemia. Hemoglobin deferrals represent 

more than half of all donor deferral, 

deferring 16% of women. The RISE 

Study is a longitudinal study of iron 

status in two cohorts of blood donors: a 

first time/reactivated donor cohort in 

which baseline iron and hemoglobin 

status can be assessed without the 

influence of previous donations, and a 

frequent donor cohort, where the 

cumulative effect of additional frequent 

blood donations can be assessed. Each 

cohort’s donors will donate blood and 

provide evaluation samples during the 

study period. 

The primary goal of the study is to 

evaluate the effects of blood donation 

intensity on iron and hemoglobin status 

and assess how these are modified as a 

function of baseline iron/hemoglobin 

measures, demographic factors, and 

reproductive and behavioral factors. 

Hemoglobin levels, a panel of iron 

protein, red cell and reticulocyte indices 

will be measured at baseline and at a 

final follow-up visit 15–24 months after 

the baseline visit. A DNA sample will be 

obtained once at the baseline visit to 

assess three key iron protein 

polymorphisms. Donors will also 

complete a self-administered survey 

assessing past blood donation, smoking 

history, use of vitamin/mineral 

supplements, iron supplements, aspirin, 

frequency of heme rich food intake, and, 

for females, menstrual status and 

pregnancy history at these two time 

points. This study aims to identify the 

optimal laboratory measures that would 

predict the development of iron 

depletion, hemoglobin deferral, and/or 

iron deficient hemoglobin deferral in 

active whole blood and double red cell 

donors at subsequent blood donations. 

The data collected will help evaluate 

hemoglobin distributions in the blood 

donor population (eligible and deferred 

donors) and compare them with 

NHANES data. Other secondary 

objectives include elucidating key 

genetic influences on hemoglobin levels 

and iron status in a donor population as 

a function of donation history; and 

establishing a serum and DNA archive 

to evaluate the potential utility of future 

iron studies and genetic 

polymorphisms. 

This study will develop better 

predictive models for iron depletion and 

hemoglobin deferral (with or without 

iron deficiency) in blood donors; allow 

for the development of improved donor 

screening strategies and open the 

possibility for customized donation 

frequency guidelines for individuals or 

classes of donors; provide important 

baseline information for the design of 

targeted iron supplementation strategies 

in blood donors, and improved 

counseling messages to blood donors 

regarding diet or supplements; and by 

elucidating the effect of genetic iron 

protein polymorphisms on the 

development of iron depletion, enhance 

the understanding of the role of these 

proteins in states of iron stress, using 

frequent blood donation as a model. 

This request for modification is to add 

eleven questions to the RISE study final 

visit questionnaire that will include 

questions about Restless Leg Syndrome 

(RLS) and pica, two disorders associated 

with iron deficiency. RLS is a 

neurologic movement disorder in which 

patients complain of crawling, aching or 

indescribable feelings in their legs or 

just have the need to move. Pica is an 

eating disorder defined as compulsive 

ingestion of non-food substances. Blood 

donation results in the removal of 200– 

250 mg of iron from the donor. It is well 

established that repeated blood 

donation can produce iron deficiency, 

yet the prevalence of RLS and pica 

among blood donors is unknown. The 

REDS–II RISE study subjects are an 

ideal study population for the 

investigation of RLS and pica in blood 

donors. About 2,400 subjects with 

variable donation intensity (e.g. 

frequency with which a person donates 

blood) are currently enrolled in the RISE 


dwashington3 on PROD1PC60 with NOTICES