National Cancer Institute; Notice of Closed Meetings, 26103-26104 [06-4145]

Download as PDF jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 71, No. 85 / Wednesday, May 3, 2006 / Notices use of innovative technologies to disseminate safety information, particularly when doing so can provide a public health benefit. We are making clear in the guidance that manufacturers and distributors may disseminate the communications discussed in §§ 7.49 and 200.5 (21 CFR 7.49 and 200.5) by various electronic methods, including email. The guidance also applies to those instances, not addressed in any regulation, where we recommend that manufacturers and distributors voluntarily convey certain safety information about their products to members of the public. The use of e-mail and other electronic communications has dramatically changed how we and the public convey information. Electronic communications have a number of advantages over paper-based communications. They can significantly shorten the time between an event and the public’s knowledge of the event. When the event involves product safety, it is even more important that accurate safety information be transmitted rapidly. Email and other electronic communications can be more efficient and timelier than traditional mail. These communications involve considerably less cost to the sender than older, more traditional delivery services. Verification of receipt or delivery is less expensive and can be automatically accomplished through various means such as delivery or read receipt confirmation, or other electronic receipt acknowledgement mechanisms. Any necessary followup (such as when receipt of the e-mail is not acknowledged in some fashion) also can be accomplished electronically. If receipt of the electronic communication is not acknowledged appropriately by the recipient (as determined by the sender) or the electronic communication is undeliverable, the sender can resort to more traditional notification methods to ensure the communication is received. We interpret the provisions of §§ 7.49 and 200.5 to allow the use of e-mail and other electronic communication methods, such as fax or text messaging, to accomplish any recall notification or distribution of important safety information. Section 7.49(b) provides that, ‘‘A recall communication can be accomplished by telegrams, mailgrams, or first class letters* * *’’ Given the use of the term ‘‘can,’’ we read the three examples as being illustrative rather than the sole means of accomplishing recall communications. Electronic notification, with appropriate safeguards and the use of acknowledgement mechanisms, is a VerDate Aug<31>2005 17:19 May 02, 2006 Jkt 208001 viable alternative to more traditional methods. II. Comments/Responses We received a number of comments on the guidance and have modified the guidance to address some of the comments. Other comments are outside the scope of the guidance and thus are not addressed in the guidance. We have made changes on our own initiative to provide clarity to certain statements and recommendations. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this guidance. 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. 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 Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C 3501–3520). The collection of information in this guidance has been approved under OMB control number 0910–0249 which expires October 18, 2008. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/oc/guidance/ electronic.html or https://www.fda.gov/ ohrms/dockets/default.htm. Dated: April 26, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–6705 Filed 5–2–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings 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 meetings. PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 26103 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: National Cancer Institute Special Emphasis Panel, Information Resources for Radiation Science. Date: June 8, 2006. Time: 12 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6130 Executive Blvd., Conference Room C, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Kenneth L. Bielat, PhD, Scientific Review Administrator, Division Of Extramural Activities, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, Room 7147, Bethesda, MD 20892, (301) 496–7576, bielatk@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, Innovations in Cancer Sample Preparation. Date: June 13, 2006. Time: 12 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6130 Executive Blvd, Conference Room F, Rockville, MD 20852, (Telephone Conference Call). Contact Person: C. Michael Kerwin, PhD, MPH, Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd., Rm. 8057, Bethesda, MD 20892–8329, (301)– 496–7421. kerwinm@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, Discover and Development. Date: June 19–21, 2006. Time: 6 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878. Contact Person: Peter J. Wirth, PhD, Scientific Review Administrator, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 8131, Bethesda, MD 20892–8328, 301–496– 7565, pw2q@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, RFA CA– 06–014, ‘‘Tumor Microenvironment Network’’. Date: August 2–4, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\03MYN1.SGM 03MYN1 26104 Federal Register / Vol. 71, No. 85 / Wednesday, May 3, 2006 / Notices Place: Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD 20877. Contact Person: Lalita D. Palekar, PhD, Scientific Review Administrator, Special Review and Resources Branch, Division of Extramural Activities, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, Room 8105, Bethesda, MD 20892–7405, (301) 496–7575. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: April 26, 2006. David Clary, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–4145 Filed 5–2–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research Resources; Notice of Closed Meetings jlentini on PROD1PC65 with NOTICES 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 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: National Center for Research Resources Special Emphasis Panel, Loan Repayment Program SEP. Date: May 25, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Mohan Viswanathan, PhD, Deputy Director, Office of Review, NCRR, National Institutes of Health, 6701 Democracy Blvd., Room 1084, MSC 4874, 1 Democracy Plaza, Bethesda, MD 20892–4874, 301–435–0829, mv10f@nih.gov. Name of Committee: National Center for Research Resources Special Emphasis Panel, GCRC K23 SEP. Date: June 1, 2006. VerDate Aug<31>2005 17:19 May 02, 2006 Jkt 208001 Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Guo Zhang, PhD, Scientific Review Administrator, National Center for Research Resources/OR, National Institutes of Health, 6701 Democracy Boulevard, 1 Democracy Plaza, Rm. 1064, Bethesda, MD 20892–4874, 301–435–0812. zhanggu@mail.nih.gov. Name of Committee: National Center for Research Resources Initial Review Group, Comparative Medicine Review Committee. Date: June 6–7, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Double Tree Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: John R. Glowa, PhD, Scientific Review Administrator, Office of Review, National Center for Research Resources, 6701 Democracy Boulevard, Room 1078—MSC 4874, Bethesda, MD 20892–4874, 301–435–0807, glowaj@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333, National Institutes of Health, HHS) Dated: April 25, 2006. David Clary, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–4146 Filed 5–2–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings 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 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 clearly unwarranted invasion of personal privacy. Name of Committee: Training Grant and Career Development Review Committee. Date: May 11–12, 2006. Time: 8 a.m. to 5 p.m. PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 Agenda: To review and evaluate grant applications. Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. Contact Person: Raul A. Saavedra, PhD, Scientific Review Administrator, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS, NSC; 6001 Executive Blvd., Ste. 3208, Bethesda, MD 20892–9529, 301–496–9223, saavedrrninds.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Initial Review Group Neurological Sciences and Disorders C. Date: June 22–23, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Latham Hotel, 3000 M Street, NW., Washington, DC 20007. Contact Person: Andrea Sawczuk, DDS, PhD, Scientific Review Administrator, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS, 6001 Executive Boulevard, Room #3208, Bethesda. MD 20892, 301–496–0660, sawczukzninds.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Initial Review Group, Neurological Sciences and Disorder K. Date: June 22–23, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Grand Hyatt-Washington Center, 1000 H St., NW., Washington, DC 20001. Contact Person: Katherine M. Woodbury, PhD, Scientific Review Administrator, Scientific Review Branch, NINDS/NIH/ DHHS, Neuroscience Center, 6001 Executive Blvd, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–496–9223. Name of Committee: National Institutes of Neurological Disorders and Stroke Initial Review Group, Neurological Sciences and Disorders A. Date: June 22–23, 2006. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC., 2401 M Street, NW., Washington, DC 20037. Contact Person: Richard D. Crosland, PhD, Scientific Review Administrator, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301– 496–9223. Name of Committee: National Institute of Neurological Disorders and Stroke Initial Review Group Neurological Sciences and Disorders B. Date: June 22–23, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Savoy Suites Hotel, 2505 Wisconsin Avenue, NW., Washington, DC 20007. Contact Person: W. Ernest Lyons, PhD, Scientific Review Administrator, Scientific Review Branch, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 71, Number 85 (Wednesday, May 3, 2006)]
[Notices]
[Pages 26103-26104]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Notice of Closed Meetings

    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 
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: National Cancer Institute Special Emphasis 
Panel, Information Resources for Radiation Science.
    Date: June 8, 2006.
    Time: 12 p.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6130 Executive Blvd., 
Conference Room C, Rockville, MD 20852, (Telephone Conference Call).
    Contact Person: Kenneth L. Bielat, PhD, Scientific Review 
Administrator, Division Of Extramural Activities, National Cancer 
Institute, National Institutes of Health, 6116 Executive Boulevard, 
Room 7147, Bethesda, MD 20892, (301) 496-7576, bielatk@mail.nih.gov.

    Name of Committee: National Cancer Institute Special Emphasis 
Panel, Innovations in Cancer Sample Preparation.
    Date: June 13, 2006.
    Time: 12 p.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6130 Executive Blvd, 
Conference Room F, Rockville, MD 20852, (Telephone Conference Call).
    Contact Person: C. Michael Kerwin, PhD, MPH, Scientific Review 
Administrator, Special Review and Logistics Branch, Division of 
Extramural Activities, National Cancer Institute, NIH, 6116 
Executive Blvd., Rm. 8057, Bethesda, MD 20892-8329, (301)-496-7421. 
kerwinm@mail.nih.gov.

    Name of Committee: National Cancer Institute Special Emphasis 
Panel, Discover and Development.
    Date: June 19-21, 2006.
    Time: 6 p.m. to 6 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Gaithersburg Marriott Washingtonian Center, 9751 
Washingtonian Boulevard, Gaithersburg, MD 20878.
    Contact Person: Peter J. Wirth, PhD, Scientific Review 
Administrator, Research Programs Review Branch, Division of 
Extramural Activities, National Cancer Institute, 6116 Executive 
Boulevard, Room 8131, Bethesda, MD 20892-8328, 301-496-7565, 
pw2q@nih.gov.

    Name of Committee: National Cancer Institute Special Emphasis 
Panel, RFA CA-06-014, ``Tumor Microenvironment Network''.
    Date: August 2-4, 2006.
    Time: 8 a.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 26104]]

    Place: Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD 
20877.
    Contact Person: Lalita D. Palekar, PhD, Scientific Review 
Administrator, Special Review and Resources Branch, Division of 
Extramural Activities, National Cancer Institute, National 
Institutes of Health, 6116 Executive Boulevard, Room 8105, Bethesda, 
MD 20892-7405, (301) 496-7575.

(Catalogue of Federal Domestic Assistance Program Nos. 93.392, 
Cancer Construction; 93.393, Cancer Cause and Prevention Research; 
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer 
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer 
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer 
Control, National Institutes of Health, HHS)

    Dated: April 26, 2006.
David Clary,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 06-4145 Filed 5-2-06; 8:45 am]
BILLING CODE 4140-01-M

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