Center for Scientific Review; Notice of Closed Meetings, 45131-45132 [2010-18880]

Download as PDF Federal Register / Vol. 75, No. 147 / Monday, August 2, 2010 / Notices erowe on DSK5CLS3C1PROD with NOTICES whether research studies must be conducted under an investigational new drug application (IND). It also offers answers to frequently asked questions on conducting research with radioactive drugs, and provides information on the membership, functions, and reporting requirements of a radioactive drug research committee approved by FDA. DATES: Submit either electronic or written comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Orhan Suleiman, Center for Drug Evaluation and Research, Food and Drug Administration, 10901 New Hampshire Ave., Bldg. 22, rm. 2202, Silver Spring, MD 20993–0002, 301– 796–1471. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry and researchers entitled ‘‘The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application.’’ In a document published in the Federal Register on July 25, 1975 (40 FR 31298), FDA changed the conditions under which new radioactive drug and biological products could be used. First, the Agency terminated a 1963 order from the Commissioner of Food and Drugs (28 FR 183, January 8, 1963) that had exempted radioactive new drug and biological products for investigational use in humans from new drug requirements (21 CFR part 312), as long as they were shipped consistent with regulations issued by the then Atomic Energy Commission (AEC). FDA and AEC had agreed that all radioactive drugs and biological products should now become subject to the same requirements for investigational use as other new drugs under section 505 of the Federal Food, Drug, and Cosmetic VerDate Mar<15>2010 15:04 Jul 30, 2010 Jkt 220001 Act (21 U.S.C. 355) and section 351 of the Public Health Service Act (42 U.S.C. 262). Simultaneously, the Agency issued regulations (§ 361.1 (21 CFR 361.1)) explaining when radioactive drugs for basic science and medical research would not be subject to the same requirements for investigational use as other new drugs. Today, research studies with a radioactive drug or biological product may be conducted in a number of ways: (1) Under an IND (part 312), (2) exempt from IND requirements (§ 312.2), or (3) under certain conditions, with the supervision and approval of an FDAapproved Radioactive Drugs Research Committee (RDRC) (§ 361.1). This guidance discusses the conditions under which research with a radioactive drug may be conducted under § 361.1. Appendices to the guidance answer frequently asked questions about those conditions and provide additional information on RDRCs. Appendix A of the guidance answers questions on basic science research with radioactive drugs. Appendix B addresses approval by the RDRC and the information that must be submitted by investigators to the RDRC. Appendix C discusses the limits on the pharmacological dose, and Appendix D discusses the limits on the radiation dose. Each of these appendices also includes a summary of the regulations. Appendix E provides information on the membership, functions, and reports of an RDRC. The final appendix, Appendix F, is an RDRC review criteria checklist, indicating the areas on which the RDRC will focus when considering a proposed research study. In the Federal Register of June 3, 2009 (74 FR 26703), FDA announced the availability of a draft guidance for industry and researchers entitled ‘‘The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application.’’ The notice gave interested persons an opportunity to comment by September 1, 2009. We received comments from seven institutions, organizations, and individuals. We have carefully considered the comments and, where appropriate, have made corrections, added information, or clarified the information in the guidance in response to the comments or on our own initiative. 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 determining whether human research with a radioactive drug can be conducted under a radioactive drug research PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 45131 committee. 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) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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 https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: July 27, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–18853 Filed 7–30–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings 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 meetings. The meetings 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 Member Conflict: AIDS Molecular Biology and Opportunistic Infections. Date: August 12–13, 2010. Time: 8 a.m.to 5 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\02AUN1.SGM 02AUN1 45132 Federal Register / Vol. 75, No. 147 / Monday, August 2, 2010 / Notices Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Robert Freund, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3200, MSC 7848, Bethesda, MD 20892, 301–435– 1050, freundr@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. Name of Committee: Center for Scientific Review Special Emphasis Panel PAR10–074: Crystallography Partnership. Date: August 27–28, 2010. Time: 8 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Nuria E. Assa-Munt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4164, MSC 7806, Bethesda, MD 20892, (301) 451– 1323, assamunu@csr.nih.gov. (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: July 23, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–18880 Filed 7–30–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Notice of Meeting; National Commission on Children and Disasters Administration for Children and Families, Department of Health and Human Services. ACTION: Notice of Meeting. AGENCY: The meeting will be held on Monday, August 23, 2010, from 9:30 a.m. to 3:30 p.m. ADDRESSES: The meeting will be held at the Administration for Children and Families, 901 D Street SW., Washington, DC 20024. To attend either in person or via teleconference, please register by 5 p.m., Eastern Time, August 18, 2010. To register, please e-mail jacqueline.haye@acf.hhs.gov with ‘‘Meeting Registration’’ in the subject line, or call (202) 205–9560. Registration must include your name, affiliation, and phone number. If you require a sign erowe on DSK5CLS3C1PROD with NOTICES DATES: VerDate Mar<15>2010 15:04 Jul 30, 2010 Jkt 220001 language interpreter or other special assistance, please call Jacqueline Haye at (202) 205–9560 or e-mail jacqueline.haye@acf.hhs.gov as soon as possible and no later than 5 p.m. Eastern Time, August 9, 2010. AGENDA: The Commission will: (1) Review and vote on the Final Report to the President and Congress; (2) Host panel discussion on the progress of children’s working group activities and collaborations between Federal Emergency Management Agency, Assistant Secretary for Preparedness and Response and the Administration for Children and Families. Written comments may be submitted electronically to Juliana.Sadovich@ACF.hhs.gov with ‘‘Public Comment’’ in the subject line. The Commission recommends that you include your name, mailing address and an e-mail address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment, and it allows the Commission to contact you if further information on the substance of the comment is needed or if your comment cannot be read due to technical difficulties. The Commission’s policy is that the Commission will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment placed in the official record. The Commission will provide an opportunity for public comments during the public meeting on August 23, 2010. Those wishing to speak will be limited to three minutes each; speakers are encouraged to submit their remarks in writing in advance to ensure their comment is received in case there is inadequate time for all comments to be heard on August 23, 2010. Additional Information: Contact CAPT Juliana Sadovich, RN, Ph.D. Director, Office of Human Services Emergency Preparedness and Response, e-mail Juliana.Sadovich@ACF.hhs.gov or call (202) 401–9306. SUPPLEMENTARY INFORMATION: The National Commission on Children and Disasters is an independent Commission that shall conduct a comprehensive study to examine and assess the needs of children as they relate to preparation for, response to, and recovery from all hazards, building upon the evaluations of other entities and avoiding unnecessary duplication by reviewing the findings, conclusions, and recommendations of these entities. The Commission shall then submit a report to the President and the Congress on the Commission’s independent and specific PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 findings, conclusions, and recommendations to address the needs of children as they relate to preparation for, response to, and recovery from all hazards, including major disasters and emergencies. Dated: July 20, 2010. David A. Hansell, Acting Assistant Secretary for Children and Families. [FR Doc. 2010–18905 Filed 7–30–10; 8:45 am] BILLING CODE 4184–06–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given that the Substance Abuse and Mental Health Services Administration (SAMHSA) National Advisory Council will meet on August 17–18 at the Omni Hotel at CNN Center, Atlanta, Georgia. The meeting is open to the public. The SAMHSA National Advisory Council was established to advise the Secretary, Department of Health and Human Services (HHS), and the Administrator, SAMHSA, to reduce the impact of substance abuse and mental illnesses in American communities. The Agenda will include a report from the SAMHSA Administrator, updates on SAMHSA’s strategic initiatives, and a panel discussion on health reform and the role of peers and families in behavioral health. In addition, Council members will participate in a listening session on September 18 at the Centers for Disease Control and Prevention’s Fourth National Conference on Health Communication, Marketing, and Media. Attendance by the public will be limited to space available. Public comments are welcome. The meeting can also be accessed via webstream. To obtain the call-in numbers and access codes, to submit written or brief oral comments, or to request special accommodations for persons with disabilities, please register on-line at https://nac.samhsa.gov/Registration/ meetingsRegistration.aspx. You may also communicate with the SAMHSA National Advisory Council Designated Federal Officer, Ms. Toian Vaughn (see contact information below). Substantive program information and a roster of Council members may be obtained either by accessing the SAMHSA Committee Web site, https:// nac.samhsa.gov/NACcouncil/ index.aspx or by contacting Ms. E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 75, Number 147 (Monday, August 2, 2010)]
[Notices]
[Pages 45131-45132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18880]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    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 
meetings.
    The meetings 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 Member Conflict: AIDS Molecular Biology and Opportunistic 
Infections.
    Date: August 12-13, 2010.
    Time: 8 a.m.to 5 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 45132]]

    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Robert Freund, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3200, MSC 7848, Bethesda, MD 20892, 301-435-
1050, freundr@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.
    Name of Committee: Center for Scientific Review Special Emphasis 
Panel PAR10-074: Crystallography Partnership.
    Date: August 27-28, 2010.
    Time: 8 a.m. to 12 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Nuria E. Assa-Munt, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4164, MSC 7806, Bethesda, MD 
20892, (301) 451-1323, assamunu@csr.nih.gov.

(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: July 23, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-18880 Filed 7-30-10; 8:45 am]
BILLING CODE 4140-01-P

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