Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting, 25246 [E9-12195]

Download as PDF 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 The draft guidance describes factors FDA considers when evaluating the risk information in promotional materials for these products.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 In this draft guidance, FDA discusses both the content and format factors that are relevant to its determination of whether promotional materials adequately present risk information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 This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on risk information in prescription drug and medical device promotion.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. erowe on PROD1PC63 with NOTICES 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. VerDate Nov<24>2008 15:23 May 26, 2009 Jkt 217001 III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm or https:// 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) PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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 E:\FR\FM\27MYN1.SGM 27MYN1

Agencies

[Federal Register Volume 74, Number 100 (Wednesday, May 27, 2009)]
[Notices]
[Page 25246]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12195]


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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. Hindi-Alexander, 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
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