National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting, 23804-23805 [2015-09877]

Download as PDF 23804 Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices Financial Disclosure by Clinical Investigators (OMB Control Number 0910–0396)— Extension Respondents to this collection are sponsors of marketing applications that contain clinical data from studies covered by the regulations. These sponsors represent pharmaceutical, biologic, and medical device firms. Respondents are also clinical investigators who provide financial information to the sponsors of marketing applications. Under § 54.4(a) (21 CFR 54.4(a)), applicants submitting an application that relies on clinical studies must submit a complete list of clinical investigators who participated in a covered clinical study, and must either certify to the absence of certain financial 15 minutes will be required for each recordkeeper to add this record to the clinical investigators’ file. Under § 54.4(b), clinical investigators supply to the sponsor of a covered study financial information sufficient to allow the sponsor to submit complete and accurate certification or disclosure statements. Clinical investigators are accustomed to supplying such information when applying for research grants. Also, most people know the financial holdings of their immediate family and records of such interests are generally accessible because they are needed for preparing tax records. For these reasons, FDA estimates that it will take clinical investigators 15 minutes to submit such records to the sponsor. FDA estimates the burden of this collection of information as follows: arrangements with clinical investigators (Form FDA 3454) or, under § 54.4(a)(3), disclose to FDA the nature of those arrangements and the steps taken by the applicant or sponsor to minimize the potential for bias (Form FDA 3455). Under § 54.6, the sponsors of covered studies must maintain complete records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for a time period of 2 years after the date of approval of the applications. Sponsors of covered studies maintain many records with regard to clinical investigators, including protocol agreements and investigator resumes or curriculum vitae. FDA estimates than an average of TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR Section Average burden per response Total annual responses Total hours Certification—54.4(a)(1) and (a)(2)— Form FDA 3454 .............................. Disclosure—54.4(a)(3)—Form FDA 3455 ............................................... 1,000 1 1,000 1 1,000 100 1 100 5 500 Total ............................................ .............................. .............................. .............................. .................................. 1,500 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 21 CFR Section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Recordkeeping—54.6 ........................ 1,000 1 1,000 0.25 (15 minutes) 250 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 21 CFR Section Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours 54.4(b)—Clinical Investigators ........... 7,106 1 7,106 0.17 (10 minutes) 1,208 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 23, 2015. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–09908 Filed 4–28–15; 8:45 am] National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting mstockstill on DSK4VPTVN1PROD with NOTICES BILLING CODE 4164–01–P National Institutes of Health Notice is hereby given of a change in the meeting of the National Institute of Neurological Disorders and Stroke Special Emphasis Panel, April 22, 2015, 08:00 a.m. to April 23, 2015, 06:00 p.m., Lorien Hotel & Spa, 1600 King Street, VerDate Sep<11>2014 17:18 Apr 28, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Alexandria, VA, 22314 which was published in the Federal Register on April 3, 2015, 80FRN18241. The meeting notice is amended to change the location of the meeting from the Lorien Hotel & Spa to the Hotel Monaco Alexandria. The date and time remain the same. The meeting is closed to the public. E:\FR\FM\29APN1.SGM 29APN1 Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices Dated: April 23, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–09877 Filed 4–28–15; 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 mstockstill on DSK4VPTVN1PROD 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/ contract proposals 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/ contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Prevent ToxPharm. Date: May 19, 2015. Time: 10:30 a.m. to 4:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 2W914, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Thomas M. Vollberg, Ph.D., Chief, Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W102, Rockville, MD 20850, 240–276–6341, vollbert@mail.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: National Cancer Institute Special Emphasis Panel; Novel Imaging Agents to Expand the Clinical Toolkit for Cancer Diagnosis, Staging and Treatment. Date: May 20, 2015. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 1E030, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Kenneth L. Bielat, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, VerDate Sep<11>2014 17:18 Apr 28, 2015 Jkt 235001 Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W244, Rockville, MD 20850, 240–276–6373, bielatk@mail.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: National Cancer Institute Special Emphasis Panel; Prevent Bioefficacy/Intermediate Endpoints. Date: May 28, 2015. Time: 10:30 a.m. to 4:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 2W914, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Thomas M. Vollberg, Ph.D., Chief, Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W102, Rockville, MD 20850, 240–276–6341, vollbert@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Tumor Tissue Culture Systems. Date: June 23, 2015. Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate contract proposal. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 6W030, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Nicholas J. Kenney, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W246, Rockville, MD 20850, 240–276–6374, nicholas.kenney@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Omnibus SEP–16. Date: July 15, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 6W032, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Majed M. Hamawy, Ph.D., MBA, Scientific Review Officer, Research Program Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W120, Rockville, MD 20850, 240– 276–6457, mh101v@nih.gov. (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) PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 23805 Dated: April 23, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–09875 Filed 4–28–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; 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 Neurological Disorders and Stroke Special Emphasis Panel; Contract Grant Review. Date: May 5, 2015. Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Ernest Lyons, Ph.D., Scientific Review Administrator, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–496–4056,lyonse@ninds.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. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: April 23, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–09876 Filed 4–28–15; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23804-23805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Neurological Disorders and Stroke; Amended 
Notice of Meeting

    Notice is hereby given of a change in the meeting of the National 
Institute of Neurological Disorders and Stroke Special Emphasis Panel, 
April 22, 2015, 08:00 a.m. to April 23, 2015, 06:00 p.m., Lorien Hotel 
& Spa, 1600 King Street, Alexandria, VA, 22314 which was published in 
the Federal Register on April 3, 2015, 80FRN18241.
    The meeting notice is amended to change the location of the meeting 
from the Lorien Hotel & Spa to the Hotel Monaco Alexandria. The date 
and time remain the same. The meeting is closed to the public.


[[Page 23805]]


    Dated: April 23, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-09877 Filed 4-28-15; 8:45 am]
 BILLING CODE 4140-01-P
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