80 FR 23804 - National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 82 (April 29, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 82 (April 29, 2015)
| Page Range | 23804-23805 | |
| FR Document | 2015-09877 |
[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)] [Notices] [Pages 23804-23805] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09877] ----------------------------------------------------------------------- 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
![23804 Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices
Financial Disclosure by Clinical arrangements with clinical investigators 15 minutes will be required for each
Investigators (Form FDA 3454) or, under § 54.4(a)(3), recordkeeper to add this record to the
disclose to FDA the nature of those clinical investigators’ file.
(OMB Control Number 0910–0396)—
Extension arrangements and the steps taken by the Under § 54.4(b), clinical investigators
applicant or sponsor to minimize the supply to the sponsor of a covered study
Respondents to this collection are potential for bias (Form FDA 3455). financial information sufficient to allow
sponsors of marketing applications that
Under § 54.6, the sponsors of covered the sponsor to submit complete and
contain clinical data from studies
studies must maintain complete records accurate certification or disclosure
covered by the regulations. These
of compensation agreements with any statements. Clinical investigators are
sponsors represent pharmaceutical,
compensation paid to nonemployee accustomed to supplying such
biologic, and medical device firms.
Respondents are also clinical clinical investigators, including information when applying for research
investigators who provide financial information showing any financial grants. Also, most people know the
information to the sponsors of interests held by the clinical financial holdings of their immediate
marketing applications. investigator, for a time period of 2 years family and records of such interests are
Under § 54.4(a) (21 CFR 54.4(a)), after the date of approval of the generally accessible because they are
applicants submitting an application applications. Sponsors of covered needed for preparing tax records. For
that relies on clinical studies must studies maintain many records with these reasons, FDA estimates that it will
submit a complete list of clinical regard to clinical investigators, take clinical investigators 15 minutes to
investigators who participated in a including protocol agreements and submit such records to the sponsor.
covered clinical study, and must either investigator resumes or curriculum FDA estimates the burden of this
certify to the absence of certain financial vitae. FDA estimates than an average of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
respondents responses
respondent response
Certification—54.4(a)(1) and (a)(2)—
Form FDA 3454 .............................. 1,000 1 1,000 1 1,000
Disclosure—54.4(a)(3)—Form FDA
3455 ............................................... 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
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
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
Number of Average
Number of Total annual
21 CFR Section disclosures per burden per Total hours
respondents disclosures
respondent disclosure
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. DEPARTMENT OF HEALTH AND Alexandria, VA, 22314 which was
Peter Lurie, HUMAN SERVICES published in the Federal Register on
Associate Commissioner for Public Health April 3, 2015, 80FRN18241.
Strategy and Analysis. National Institutes of Health
The meeting notice is amended to
[FR Doc. 2015–09908 Filed 4–28–15; 8:45 am]
National Institute of Neurological change the location of the meeting from
BILLING CODE 4164–01–P Disorders and Stroke; Amended Notice the Lorien Hotel & Spa to the Hotel
mstockstill on DSK4VPTVN1PROD with NOTICES
of Meeting Monaco Alexandria. The date and time
remain the same. The meeting is closed
Notice is hereby given of a change in to the public.
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,
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![Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices 23805
Dated: April 23, 2015. Division of Extramural Activities, National Dated: April 23, 2015.
Carolyn Baum, Cancer Institute, NIH, 9609 Medical Center Melanie J. Gray,
Program Analyst, Office of Federal Advisory Drive, Room 7W244, Rockville, MD 20850,
Program Analyst, Office of Federal Advisory
Committee Policy. 240–276–6373, bielatk@mail.nih.gov. Committee Policy.
This notice is being published less than 15
[FR Doc. 2015–09877 Filed 4–28–15; 8:45 am] [FR Doc. 2015–09875 Filed 4–28–15; 8:45 am]
days prior to the meeting due to the timing
BILLING CODE 4140–01–P BILLING CODE 4140–01–P
limitations imposed by the review and
funding cycle.
DEPARTMENT OF HEALTH AND Name of Committee: National Cancer
Institute Special Emphasis Panel; Prevent DEPARTMENT OF HEALTH AND
HUMAN SERVICES HUMAN SERVICES
Bioefficacy/Intermediate Endpoints.
National Institutes of Health Date: May 28, 2015.
Time: 10:30 a.m. to 4:30 p.m. National Institutes of Health
National Cancer Institute; Notice of Agenda: To review and evaluate contract
proposals. National Institute of Neurological
Closed Meetings Disorders and Stroke; Notice of Closed
Place: National Cancer Institute Shady
Pursuant to section 10(d) of the Grove, 9609 Medical Center Drive, Room Meeting
Federal Advisory Committee Act, as 2W914, Rockville, MD 20850 (Telephone
amended (5 U.S.C. App.), notice is Conference Call). Pursuant to section 10(d) of the
hereby given of the following meetings. Contact Person: Thomas M. Vollberg, Federal Advisory Committee Act, as
The meetings will be closed to the Ph.D., Chief, Scientific Review Officer, amended (5 U.S.C. App.), notice is
public in accordance with the Research Technology and Contract Review hereby given of the following meeting.
provisions set forth in sections Branch, Division of Extramural Activities, The meeting will be closed to the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., National Cancer Institute, NIH, 9609 Medical
public in accordance with the
as amended. The grant applications/ Center Drive, Room 7W102, Rockville, MD
20850, 240–276–6341, vollbert@mail.nih.gov.
provisions set forth in sections
contract proposals and the discussions 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
could disclose confidential trade secrets Name of Committee: National Cancer
as amended. The grant applications and
or commercial property such as Institute Special Emphasis Panel; Tumor
Tissue Culture Systems.
the discussions could disclose
patentable material, and personal confidential trade secrets or commercial
information concerning individuals Date: June 23, 2015.
Time: 11:00 a.m. to 5:00 p.m. property such as patentable material,
associated with the grant applications/ and personal information concerning
Agenda: To review and evaluate contract
contract proposals, the disclosure of proposal. individuals associated with the grant
which would constitute a clearly Place: National Cancer Institute, Shady applications, the disclosure of which
unwarranted invasion of personal Grove, 9609 Medical Center Drive, Room would constitute a clearly unwarranted
privacy. 6W030, Rockville, MD 20850 (Telephone invasion of personal privacy.
Name of Committee: National Cancer Conference Call). Name of Committee: National Institute of
Institute Special Emphasis Panel; Prevent Contact Person: Nicholas J. Kenney, Ph.D., Neurological Disorders and Stroke Special
ToxPharm. Scientific Review Officer, Research
Emphasis Panel; Contract Grant Review.
Date: May 19, 2015. Technology and Contract Review Branch,
Time: 10:30 a.m. to 4:30 p.m. Date: May 5, 2015.
Division of Extramural Activities, National
Agenda: To review and evaluate contract Time: 1:00 p.m. to 2:00 p.m.
Cancer Institute, NIH, 9609 Medical Center
proposals. Agenda: To review and evaluate grant
Drive, Room 7W246, Rockville, MD 20850,
Place: National Cancer Institute Shady applications.
240–276–6374, nicholas.kenney@nih.gov.
Grove, 9609 Medical Center Drive, Room Place: National Institutes of Health,
2W914, Rockville, MD 20850 (Telephone Name of Committee: National Cancer Neuroscience Center, 6001 Executive
Conference Call). Institute Special Emphasis Panel; Omnibus Boulevard, Rockville, MD 20852 (Telephone
Contact Person: Thomas M. Vollberg, SEP–16. Conference Call).
Ph.D., Chief, Scientific Review Officer, Date: July 15, 2015. Contact Person: Ernest Lyons, Ph.D.,
Research Technology and Contract Review Time: 8:00 a.m. to 5:00 p.m. Scientific Review Administrator, Scientific
Branch, Division of Extramural Activities, Agenda: To review and evaluate grant Review Branch, Division of Extramural
National Cancer Institute, NIH, 9609 Medical applications. Research, NINDS/NIH/DHHS/Neuroscience
Center Drive, Room 7W102, Rockville, MD Place: National Cancer Institute Shady Center, 6001 Executive Boulevard, Suite
20850, 240–276–6341, vollbert@mail.nih.gov. Grove, 9609 Medical Center Drive, Room
This notice is being published less than 15 3208, MSC 9529, Bethesda, MD 20892–9529,
6W032, Rockville, MD 20850 (Telephone 301–496–4056,lyonse@ninds.nih.gov.
days prior to the meeting due to the timing Conference Call).
limitations imposed by the review and Contact Person: Majed M. Hamawy, Ph.D., This notice is being published less than 15
funding cycle. MBA, Scientific Review Officer, Research days prior to the meeting due to the timing
Name of Committee: National Cancer Program Review Branch, Division of limitations imposed by the review and
Institute Special Emphasis Panel; Novel Extramural Activities, National Cancer funding cycle.
Imaging Agents to Expand the Clinical Institute, NIH, 9609 Medical Center Drive, (Catalogue of Federal Domestic Assistance
Toolkit for Cancer Diagnosis, Staging and Room 7W120, Rockville, MD 20850, 240– Program Nos. 93.853, Clinical Research
Treatment. 276–6457, mh101v@nih.gov. Related to Neurological Disorders; 93.854,
Date: May 20, 2015. Biological Basis Research in the
Time: 11:00 a.m. to 2:00 p.m. (Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction; Neurosciences, National Institutes of Health,
mstockstill on DSK4VPTVN1PROD with NOTICES
Agenda: To review and evaluate contract HHS)
proposals. 93.393, Cancer Cause and Prevention
Place: National Cancer Institute Shady Research; 93.394, Cancer Detection and Dated: April 23, 2015.
Grove, 9609 Medical Center Drive, Room Diagnosis Research; 93.395, Cancer Carolyn Baum,
1E030, Rockville, MD 20850 (Telephone Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support; Program Analyst, Office of Federal Advisory
Conference Call).
93.398, Cancer Research Manpower; 93.399, Committee Policy.
Contact Person: Kenneth L. Bielat, Ph.D.,
Scientific Review Officer, Research Cancer Control, National Institutes of Health, [FR Doc. 2015–09876 Filed 4–28–15; 8:45 am]
Technology and Contract Review Branch, HHS) BILLING CODE 4140–01–P
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Document Created: 2015-12-16 08:25:47
Document Modified: 2015-12-16 08:25:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 23804 |
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