Center for Scientific Review; Notice of Closed Meeting, 34941 [E8-13509]

Download as PDF 34941 Federal Register / Vol. 73, No. 119 / Thursday, June 19, 2008 / Notices ingredient will reasonably be expected to be safe. Part 190 (21 CFR part 190) implements these statutory provisions. Section 190.6(a) requires each manufacturer or distributor of a dietary supplement containing a new dietary ingredient, or of a new dietary ingredient, to submit to the Office of Nutrition, Labeling, and Dietary Supplements notification of the basis for their conclusion that said supplement or ingredient will reasonably be expected to be safe. Section 190.6(b) requires that the notification include the following: (1) The complete name and address of the manufacturer or distributor, (2) the name of the new dietary ingredient, (3) a description of the dietary supplements that contain the new dietary ingredient, and (4) the history of use or other evidence of safety establishing that the dietary ingredient will reasonably be expected to be safe. The notification requirements described previously are designed to enable FDA to monitor the introduction into the food supply of new dietary ingredients and dietary supplements that contain new dietary ingredients, in order to protect consumers from unsafe dietary supplements. FDA uses the information collected under these regulations to help ensure that a manufacturer or distributor of a dietary supplement containing a new dietary ingredient is in full compliance with the act. In the Federal Register of March 26, 2008 (73 FR 16020), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 190.6 1There 71 Total Annual Responses 1 Hours per Response 71 Total Hours 20 1,420 are no capital costs or operating and maintenance costs associated with this collection of information. The agency believes that there will be minimal burden on the industry to generate data to meet the requirements of the premarket notification program because the agency is requesting only that information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in full compliance with the act. However, the agency estimates that extracting and summarizing the relevant information from the company’s files and presenting it in a format that will meet the requirements of section 413 of the act will require a burden of approximately 20 hours of work per submission. The estimated number of premarket notifications and hours per response is an average based on the agency’s experience with notifications received during the last 3 years (i.e., 2005, 2006, and 2007), and information from firms that have submitted recent premarket notifications. Dated: June 13, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–13818 Filed 6–18–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health mstockstill on PROD1PC66 with NOTICES Annual Frequency per Response Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice VerDate Aug<31>2005 19:00 Jun 18, 2008 Jkt 214001 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. Dated: June 10, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–13509 Filed 6–18–08; 8:45 am] Name of Committee: Center for Scientific Review Special Emphasis Panel, The Biochemistry and Molecular Biology of Pathogens. Date: June 20, 2008. Time: 11 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call) Contact Person: Rolf Menzel, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3196, MSC 7808, Bethesda, MD 20892, 301–435– 0952, menzelro@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, July 21, 2008, 12 p.m. to July 21, 2008, 1:30 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on June 9, 2008, 73 FR 32589– 32590. The meeting will be held July 29, 2008, 2 p.m. to 3:30 p.m. The meeting location remains the same. The meeting is closed to the public. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Dated: June 10, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–13510 Filed 6–18–08; 8:45 am] BILLING CODE 4140–01–M E:\FR\FM\19JNN1.SGM 19JNN1

Agencies

[Federal Register Volume 73, Number 119 (Thursday, June 19, 2008)]
[Notices]
[Page 34941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meeting

    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 
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: Center for Scientific Review Special Emphasis 
Panel, The Biochemistry and Molecular Biology of Pathogens.
    Date: June 20, 2008.
    Time: 11 a.m. to 2 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892. (Telephone Conference Call)
    Contact Person: Rolf Menzel, PhD, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3196, MSC 7808, Bethesda, MD 20892, 301-435-
0952, menzelro@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

    Dated: June 10, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-13509 Filed 6-18-08; 8:45 am]
BILLING CODE 4140-01-M
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