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
10058 Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices 

Study. The iron status of all of these 

subjects is well characterized, including 

measurement of plasma ferritin and 

soluble transferrin receptor along with 

hemoglobin/hematocrit. These 

laboratory values allow each subject to 

be defined as (1) iron replete, (2) iron 

deficient without anemia or (3) iron 

deficiency anemia. The responses to 

these questions will be correlated with 

the laboratory test values to determine 

the relationship between blood donation 

and the development of RLS and pica 

and will establish its prevalence in 

these populations. 

Frequency of Response: Twice. 

Affected Public: Individuals. Type of 

Respondents: Adult blood donors. The 

annual reporting burden is a follows: 

Estimated Number of Respondents: 

Baseline visit: 2,340. Follow up Visit: 

1,530; Estimated Number of Responses 

per Respondent: 1. Average Burden of 

Hours per Response: Baseline Visit: 

0.37. Follow up Visit: 0.25; and 

Estimated Total Annual Burden Hours 

Requested: Baseline visit: 866. Follow 

up Visit: 383. The annualized cost to 

respondents is estimated at: Baseline 

Visit: $15,588, Follow up Visit: $6,894 

(based on $18 per hour). There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of responses per 

respondent 

Average 

burden hours 

per response 

Estimated total 

annual burden 

hours 

requested 

Blood donors at Baseline Visit ........................................................................ 2,340 1 0.37 866 

Blood donors at Follow-up Visit ....................................................................... 1,530 1 0.25 383 

Total .......................................................................................................... ........................ ........................ ........................ 1,249 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s 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 the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. George Nemo, 

Project Officer, NHLBI, Two Rockledge 

Center, Suite 10042, 6701 Rockledge 

Drive, Bethesda, MD 20892–7950, or 

call 301–435–0075, or e-mail your 

request to nemog@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: February 27, 2009. 

George Nemo, 

NHLBI Project Officer, NHLBI, National 

Institutes of Health. 

[FR Doc. E9–4836 Filed 3–6–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel. Minority Biomedical Research Score 

Applications. 

Date: March 25–26, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, Bethesda, MD 20814. 

Contact Person: John J. Laffan, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 

Natcher Building, Room 3AN18J, Bethesda, 

MD 20892, 301–594–2773, 

laffanjo@mail.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel. Minority Biomedical Research 

Support Score Applications. 

Date: March 26–27, 2009. 

Time: 10 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN18, 45 Center 

Drive, Bethesda, MD 20892. (Virtual 

Meeting). 

Contact Person: Rebecca H. Johnson, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 

Natcher Building, Room 3AN18C, Bethesda, 

MD 20892, 301–594–2771, 

johnsonrh@nigms.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel. Molecular Biology of Hemorrhagic 

Shock. 

Date: March 30, 2009. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN18, 45 Center 

Drive, Bethesda, MD 20892. (Telephone 

Conference Call). 

Contact Person: Brian R. Pike, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN18, Bethesda, MD 

20892, 301–594–3907, pikbr@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: February 27, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–4845 Filed 3–6–09; 8:45 am] 

BILLING CODE 4140–01–P 


dwashington3 on PROD1PC60 with NOTICES