National Cancer Institute; Notice of Meeting, 50064-50065 [2013-19902]

Download as PDF 50064 Federal Register / Vol. 78, No. 159 / Friday, August 16, 2013 / Notices Attn: Desk Officer for the Administration for Children and Families. Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0523. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301–796–3794, Jonnalynn.capezzuto@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Robert Sargis, ACF Reports Clearance Officer. [FR Doc. 2013–19929 Filed 8–15–13; 8:45 am] BILLING CODE 4184–09–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0380] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by September 16, 2013. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of SUMMARY: Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications—(OMB Control Number 0910–0523)—Extension This regulation relates to Agency management and organization and has two purposes. The first is to implement section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by the Safe Medical Devices Act of 1990 (Pub. L. 101–629), and amended by the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107– 250), by specifying how FDA will determine the organizational component within FDA assigned to have primary jurisdiction for the premarket review and regulation of products that are comprised of any combination of: (1) A drug and a device; (2) a device and a biological product; (3) a biological product and a drug; or (4) a drug, a device, and a biological product. The second purpose of this regulation is to enhance the efficiency of Agency management and operations by providing procedures for classifying and determining which Agency component is designated to have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. The regulation establishes a procedure by which an applicant may obtain an assignment or designation determination. The regulation requires that the request include the identity of the applicant, a comprehensive description of the product and its proposed use, and the applicant’s recommendation as to which Agency component should have primary jurisdiction, with an accompanying statement of reasons. The information submitted would be used by FDA as the basis for making the assignment or designation decision. Most information required by the regulation is already required for premarket applications affecting drugs, devices, biological products, and combination products. The respondents will be businesses or other for-profit organizations. In the Federal Register of May 2, 2013 (78 FR 25746), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR Part Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Part 3 ................................................................................... 59 1 59 24 1,416 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These burden estimates are based on the number of applications FDA received over the past 2 fiscal years. Dated: August 12, 2013. Leslie Kux, Assistant Commissioner for Policy. emcdonald on DSK67QTVN1PROD with NOTICES [FR Doc. 2013–19916 Filed 8–15–13; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 19:06 Aug 15, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the President’s Cancer Panel. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: President’s Cancer Panel. Date: October 11, 2013. Time: 8:30 a.m. to 3:30 p.m. Agenda: Cancer Communication for Prevention: In the Digital Commons, Opportunities Amongst the Challenges. Place: National Institutes of Health, 9000 Rockville Pike, Building 31, C–Wing, 6th Floor, Conference Room 10, Bethesda, MD 20892. Contact Person: Abby B. Sandler, Ph.D., Executive Secretary, President’s Cancer Panel, Special Assistant to the Director, NCI E:\FR\FM\16AUN1.SGM 16AUN1 Federal Register / Vol. 78, No. 159 / Friday, August 16, 2013 / Notices Center for Cancer Research, 9000 Rockville Pike, Building 31, Room B2B37, MSC 2590, Bethesda, MD 20892–8349, (301) 451–9399, sandlera@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// deainfo.nci.nih.gov/advisory/pcp/index.htm, where an agenda and any additional information for the meeting will be posted when available. (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: August 8, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–19902 Filed 8–15–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings emcdonald on DSK67QTVN1PROD with NOTICES 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: National Cancer Institute Special Emphasis Panel; NCI SPORE REVIEW. Date: October 1–2, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Hotel, 5151 Pooks Hill Road, Bethesda, MD 20812. Contact Person: Wlodek Lopaczynski, MD, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of VerDate Mar<15>2010 19:06 Aug 15, 2013 Jkt 229001 Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, 7W608, Bethesda, MD 20892, 240–276–6458, lopacw@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Omnibus Cancer Biology 3. Date: October 3–4, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Shakeel Ahmad, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W122, Bethesda, MD 20892–8328, 240–276–6349, ahmads@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Drug Development and Discovery. Date: October 16–17, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Majed M. Hamawy, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Dr. Room 7W120, Bethesda, MD 20892, 240–276–6457, mh101v @nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection. Date: October 16, 2013. Time: 10:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, West Tower, 9609 Medical Center Drive, Room 1W030, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Gerald G. Lovinger, Ph.D., Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W266, Bethesda, MD 20892–9750, 240–276–6385, lovingeg@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Research Answers to NCI’s Provocative Questions— Group A. Date: October 17–18, 2013. Time: 4:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Sonya Roberson, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W116, Bethesda, MD 20892, 240– 276–6347, robersos@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Awards for PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 50065 Research on Imaging and Biomarkers for Early Cancer Detection (U01). Date: October 21, 2013. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, West Tower, 9609 Medical Center Drive, Room 3W034, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Kenneth L. Bielat, Ph.D., Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W244, Bethesda, MD 20892–8329, 240–276–6373, bielatk@mail.nih.gov. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee J—Career Development. Date: October 24–25, 2013. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, West Tower, 9609 Medical Center Drive, Room 7W032—24th & 7W30–25th, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Ilda F.S. Melo, Ph.D., Scientific Review Officer, Research Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, 7W640, Bethesda, MD 20892, 240–276–6468, mckennai@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts. Date: October 25, 2013. Time: 10:30 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, West Tower, 9609 Medical Center Drive, Room 2W904, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Kenneth L. Bielat, Ph.D., Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W244, Bethesda, MD 20892–8329, 240–276–6373, bielatk@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Omnibus R03/R21: Tumor Immunology. Date: November 6–7, 2013. Time: 6:30 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Robert Bird, Ph.D., Chief, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W110, Bethesda, MD 20892– 8328, 240–276–6344, birdr@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Small Grants Program (Omnibus). Date: November 7, 2013. Time: 12:00 p.m. to 5:00 p.m. E:\FR\FM\16AUN1.SGM 16AUN1

Agencies

[Federal Register Volume 78, Number 159 (Friday, August 16, 2013)]
[Notices]
[Pages 50064-50065]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19902]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of a meeting of the 
President's Cancer Panel.
    The meeting will be open to the public, with attendance limited to 
space available. Individuals who plan to attend and need special 
assistance, such as sign language interpretation or other reasonable 
accommodations, should notify the Contact Person listed below in 
advance of the meeting.

    Name of Committee: President's Cancer Panel.
    Date: October 11, 2013.
    Time: 8:30 a.m. to 3:30 p.m.
    Agenda: Cancer Communication for Prevention: In the Digital 
Commons, Opportunities Amongst the Challenges.
    Place: National Institutes of Health, 9000 Rockville Pike, 
Building 31, C-Wing, 6th Floor, Conference Room 10, Bethesda, MD 
20892.
    Contact Person: Abby B. Sandler, Ph.D., Executive Secretary, 
President's Cancer Panel, Special Assistant to the Director, NCI

[[Page 50065]]

Center for Cancer Research, 9000 Rockville Pike, Building 31, Room 
B2B37, MSC 2590, Bethesda, MD 20892-8349, (301) 451-9399, 
sandlera@mail.nih.gov.
    Any interested person may file written comments with the 
committee by forwarding the statement to the Contact Person listed 
on this notice. The statement should include the name, address, 
telephone number and when applicable, the business or professional 
affiliation of the interested person.
    Information is also available on the Institute's/Center's home 
page: https://deainfo.nci.nih.gov/advisory/pcp/index.htm, where an 
agenda and any additional information for the meeting will be posted 
when available.

(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: August 8, 2013.
Melanie J. Gray,
 Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-19902 Filed 8-15-13; 8:45 am]
BILLING CODE 4140-01-P
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