National Institute of General Medical Sciences; Notice of Closed Meeting, 55053 [E9-25513]

Download as PDF mstockstill on DSKH9S0YB1PROD with NOTICES Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator’s care; and for the control of drugs, biological products, and devices under investigation (§§ 312.60 and 812.100). This guidance clarifies the responsibilities of investigators in the conduct of clinical investigations conducted under parts 312 and 812, particularly the responsibilities to supervise the conduct of the clinical investigation, and to protect the rights, safety, and welfare of study participants in drug, biologic, and medical device clinical trials. The guidance also provides recommendations on how investigators should supervise the study-related actions of persons not in the direct employ of the investigator, including certain study staff and parties conducting associated testing and assessments. On May 10, 2007 (72 FR 26639), FDA issued a draft of this guidance with the goal of received input from the public. During the finalization of this guidance, FDA carefully considered all substantive comments concerning the content of the guidance. During finalization, FDA’s major emphasis was on clarifying issues that were identified as confusing and correcting apparent errors. These efforts resulted in relatively minor changes throughout the guidance. FDA also removed a significant amount of content from the background section because it was duplicative of content in the guidance appendices. FDA also reordered section III.A.3 of the guidance concerning adequate supervision of the conduct of a clinical trial to make the sequence more logical. We reversed the order of presentation so that the section begins with the factors that may predispose to inadequate supervision, and ends with the steps that could be taken to mitigate the potential for inadequate supervision. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on investigator responsibilities. 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. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and VerDate Nov<24>2008 15:19 Oct 23, 2009 Jkt 220001 Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in part 312 have been approved under OMB control number 0910–0014; and the collections of information in part 812 have been approved under OMB control number 0910–0078. The information requested for general investigator responsibilities is covered by the collection of information in FDA’s regulations for investigational new drug applications (part 312) and investigational device exemptions (part 812) and FDA Form 1572. The guidance also refers to FDA’s requirements in 21 CFR parts 11, 50, 54, and 56 for the conduct of clinical trials of drugs, biologics, and medical devices. The collections of information in 21 CFR part 11 have been approved under OMB control number 0910–0303; the collections of information in 21 CFR part 54 have been approved under OMB control number 0910–0396; and the collections of information in 21 CFR part 56 (including information required under 21 CFR part 50) have been approved under OMB control number 0910–0130. The collection of information for form FDA 3674 has been approved under OMB control number 0910–0616. III. 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. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. Dated: October 20, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–25629 Filed 10–23–09; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 55053 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; 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 General Medical Sciences; Special Emphasis Panel Trauma and Burn. Date: November 19, 2009. Time: 1 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, Room 3AN34, 45 Center Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Brian R. Pike, PhD, Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3AN18, Bethesda, MD 20892, 301–594–3907, pikbr@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives, National Institutes of Health, HHS) Dated: October 16, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–25513 Filed 10–23–09; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 74, Number 205 (Monday, October 26, 2009)]
[Notices]
[Page 55053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25513]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of General Medical Sciences; 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 General Medical 
Sciences; Special Emphasis Panel Trauma and Burn.
    Date: November 19, 2009.
    Time: 1 p.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Natcher Building, Room 
3AN34, 45 Center Drive, Bethesda, MD 20892 (Telephone Conference 
Call).
    Contact Person: Brian R. Pike, PhD, Scientific Review Officer, 
Office of Scientific Review, National Institute of General Medical 
Sciences, National Institutes of Health, 45 Center Drive, Room 
3AN18, Bethesda, MD 20892, 301-594-3907,
    pikbr@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.375, 
Minority Biomedical Research Support; 93.821, Cell Biology and 
Biophysics Research; 93.859, Pharmacology, Physiology, and 
Biological Chemistry Research; 93.862, Genetics and Developmental 
Biology Research; 93.88, Minority Access to Research Careers; 93.96, 
Special Minority Initiatives, National Institutes of Health, HHS)

    Dated: October 16, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-25513 Filed 10-23-09; 8:45 am]
BILLING CODE 4140-01-M

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