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
25246 Federal Register / Vol. 74, No. 100 / Wednesday, May 27, 2009 / Notices 

Prescription Drug and Medical Device 

Promotion.’’ FDA has responsibility 

under the act for regulating promotional 

labeling for prescription drugs and 

devices and advertising for prescription 

drugs and restricted devices. As 

required by the act and regulations, FDA 

evaluates the promotional materials for 

these products to determine whether the 

promotional materials for the product 

convey an accurate and nonmisleading 

net impression about the risks and 

benefits of the product. The draft 

guidance describes factors FDA 

considers when evaluating the risk 

information in promotional materials for 

these products. 

FDA relies on an extensive body of 

knowledge regarding human cognition 

in assessing which factors to consider in 

evaluating promotional materials and 

making regulatory decisions about the 

presentation of risk information. In this 

draft guidance, FDA discusses both the 

content and format factors that are 

relevant to its determination of whether 

promotional materials adequately 

present risk information and provides 

numerous examples to illustrate FDA’s 

thinking on these factors. The agency 

also makes recommendations about how 

manufacturers can develop the content 

and format of their promotional 

materials to comply with the 

requirements. The recommendations in 

the guidance apply to both consumerand professional-directed promotional 

materials. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on risk information in prescription drug 

and medical device promotion. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: May 13, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–12255 Filed 5–26–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting 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 

Child Health and Human Development Initial 

Review Group; Health, Behavior, and Context 

Subcommittee. 

Date: June 15–16, 2009. 

Time: 8 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Michele C. HindiAlexander, PhD, Division Of Scientific 

Review, National Institutes Of Health, Eunice 

Kennedy Shriver National Institute of Child 

Health and Human Development, 6100 

Executive Boulevard, Room, 5B01, Bethesda, 

MD 20812–7510, (301) 435–8382, 

hindialm@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: May 15, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–12195 Filed 5–26–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting 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 

Child Health and Human Development Initial 

Review Group; Obstetrics and Maternal-Fetal 

Biology Subcommittee. 

Date: June 15, 2009. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Gaithersburg Marriott 

Washingtonian Center, 9751 Washingtonian 

Boulevard, Gaithersburg, MD 20878. 

Contact Person: Gopal M. Bhatnagar, PhD, 

Scientific Review Administrator, National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6100 Executive Boulevard, Rm 5B01, 

Rockville, MD 20852, (301) 435–6889, 

bhatnagg@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: May 15, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–12197 Filed 5–26–09; 8:45 am] 

BILLING CODE 4140–01–P 


erowe on PROD1PC63 with NOTICES