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draft guidance, FDA discusses both the 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This draft guidance is being issued 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The draft guidance, when finalized, will 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