25244 Federal Register / Vol. 74, No. 100 / Wednesday, May 27, 2009 / Notices 

Specifically, the BSC advises the NTP 

on matters of scientific program content, 

both present and future, and conducts 

periodic review of the program for the 

purpose of determining and advising on 

the scientific merit of its activities and 

their overall scientific quality. Its 

members are selected from recognized 

authorities knowledgeable in fields such 

as toxicology, pharmacology, pathology, 

biochemistry, epidemiology, risk 

assessment, carcinogenesis, 

mutagenesis, molecular biology, 

behavioral toxicology, neurotoxicology, 

immunotoxicology, reproductive 

toxicology or teratology, and 

biostatistics. Members serve overlapping 

terms of up to four years. BSC meetings 

are held annually or biannually. 

Dated: May 15, 2009. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. E9–12204 Filed 5–26–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; REDS–II Donor Iron Status 

Evaluation (RISE) Study 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request to review and approve the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on March 9, 2009, pages 

10057–10058 and allowed 60-days for 

public comment. No comments were 

received in response to this notice. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a current valid OMB control 

number. 

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 

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 as 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 


erowe on PROD1PC63 with NOTICES
Federal Register / Vol. 74, No. 100 / Wednesday, May 27, 2009 / Notices 25245 

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) 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) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and the assumptions used; 

(3) Ways to enhance the quality, utility, 

and clarity of the information collected; 

and (4) Ways to 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. 

Direct Comments to OMB 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the: 

Office of Management and Budget, 

Office of Regulatory Affairs, New 

Executive Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIH. 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 361, 6700 

Rockledge Drive, Bethesda, MD 20892, 

or call non-toll free number 301–435– 

0075, or e-mail your request, including 

your address to nemog@nih.gov. 

Comments Due Date 

Comments regarding this information 

collection are best assured of having 

their full effect if received within 30 

days of the date of this publication. 

Dated: May 15, 2009. 

George Nemo, 

Project Officer, NHLBI. 

[FR Doc. E9–12210 Filed 5–26–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0253] 

Draft Guidance for Industry on 

Presenting Risk Information in 

Prescription Drug and Medical Device 

Promotion; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Presenting Risk 

Information in Prescription Drug and 

Medical Device Promotion.’’ This 

guidance responds to stakeholder 

requests for specific guidance on how 

FDA evaluates prescription drug and 

device promotional pieces to determine 

whether they adequately present risk 

information. The guidance describes 

and discusses the factors FDA considers 

when evaluating prescription drug 

advertisements (ads), restricted device 

ads, and prescription drug and device 

promotional labeling for their 

compliance with the Federal Food, 

Drug, and Cosmetic Act (the act) and 

relevant regulations. The guidance gives 

examples to illustrate FDA’s thinking on 

these factors and is intended to help 

regulated industry gain a better 

understanding of what they should 

consider as they develop the content 

and format of their promotional 

communications. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by August 25, 2009. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding human prescription drugs: 

Kristin Davis, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 Hampshire 

Ave., Bldg. 22, Silver Spring, MD 20993, 

301–796–1200. 

Regarding prescription human 

biological products: Ele Ibarra-Pratt, 

Center for Biologics Evaluation and 

Research (HFM–602), Food and Drug 

Administration, 5515 Security Lane, 

Rockville, MD 20852–1448, 301–827– 

3028. 

Regarding medical device products: 

Ann Simoneau, Center for Devices and 

Radiological Health (HFZ–302), 2094 

Gaither Rd., Rockville, MD 20850, 240– 

276–0100. 

Regarding prescription animal drug 

products: Martine Hartogensis, Center 

for Veterinary Medicine (HFV–216), 

7519 Standish Pl., Rockville, MD 20855, 

240–453–6833. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Presenting Risk Information in 


erowe on PROD1PC63 with NOTICES