81 FR 91183 - Extension of Effective Date of NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 242 (December 16, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 242 (December 16, 2016)
| Page Range | 91183-91183 | |
| FR Document | 2016-30398 |
[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)] [Notices] [Page 91183] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30398] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Extension of Effective Date of NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research The National Institutes of Health (NIH) is extending the effective date of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research from May 25, 2017, to September 25, 2017. A copy of the NIH Policy was published in the Federal Register on June 21, 2016 (81 FR 40325). See https://www.thefederalregister.org/fdsys/pkg/FR-2016-06-21/pdf/2016-14513.pdf. Guidance and Frequently Asked Questions to assist in the implementation of the policy will soon be available at http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/models-irb-review. For further information contact the NIH Office of Science Policy, Telephone: 301-496-9838, Email: [email protected]. Dated: December 12, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2016-30398 Filed 12-15-16; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices 91183
each year, 5 of which FDA expects to be information required by section 515A(a) Furthermore, because supplements may
HDEs. This estimate is based on the of the FD&C Act and part 814 (21 CFR include readily available information on
average of FDA’s receipt of new PMA part 814). pediatric populations by referencing a
applications. The Agency estimates that All that is required is to gather, previous submission, FDA estimates the
10 of the estimated 40 original PMA organize, and submit information that is average time to obtain and submit the
submissions will fail to provide the readily available, using any approach required information in a supplement to
required pediatric use information and that meets the requirements of section be 2 hours. FDA estimates that the total
their sponsors will therefore be required 515A(a) of the FD&C Act and part 814. estimated burden is 1,760 hours.
to submit PMA amendments. The We believe that because the applicant is
Agency also expects to receive required to organize and submit only FDA estimates the burden of this
approximately 700 supplements that readily available information, no more collection of information as follows:
will include the pediatric use than 8 hours will be required to comply.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response
Pediatric information in an original PMA or PDP—814.20(b)(13) 30 1 30 8 240
Pediatric information in a PMA amendment—814.37(b)(2) .......... 10 1 10 8 80
Pediatric information in a PMA supplement—814.39(c)(2) ........... 700 1 700 2 1,400
Pediatric information in an HDE—814.104(b)(6) ........................... 5 1 5 8 40
Total ........................................................................................ ...................... ........................ ...................... ...................... 1,760
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 12, 2016. Dated: December 12, 2016. constitute a clearly unwarranted
Leslie Kux, Lawrence A. Tabak, invasion of personal privacy.
Associate Commissioner for Policy. Deputy Director, National Institutes of Health. Name of Committee: National Advisory
[FR Doc. 2016–30243 Filed 12–15–16; 8:45 am] [FR Doc. 2016–30398 Filed 12–15–16; 8:45 am] Council on Alcohol Abuse and Alcoholism.
BILLING CODE 4140–01–P Date: February 9, 2017.
BILLING CODE 4164–01–P
Closed: 9:00 a.m. to 9:30 a.m.
Agenda: BSC Report: Evaluation of the
DEPARTMENT OF HEALTH AND NIAAA Intramural Program.
DEPARTMENT OF HEALTH AND Place: National Institutes of Health,
HUMAN SERVICES HUMAN SERVICES
National Institute on Alcohol Abuse and
National Institutes of Health Alcoholism, 5635 Fishers Lane, Terrace
National Institutes of Health Conference Rooms, Bethesda, MD 20892.
National Institute on Alcohol Abuse Closed: 9:40 a.m. to 10:50 a.m.
Extension of Effective Date of NIH Agenda: To review and evaluate grant
and Alcoholism; Notice of Meeting
Policy on the Use of a Single applications.
Institutional Review Board for Multi- Pursuant to section 10(d) of the Place: National Institutes of Health,
Site Research Federal Advisory Committee Act, as National Institute on Alcohol Abuse and
Alcoholism, 5635 Fishers Lane, Terrace
amended (5 U.S.C. App.), notice is Conference Rooms, Bethesda, MD 20892.
The National Institutes of Health hereby given of a meeting of the Open: 11:00 a.m. to 3:15 p.m.
(NIH) is extending the effective date of National Advisory Council on Alcohol Agenda: Presentations and other business
the NIH Policy on the Use of a Single Abuse and Alcoholism. of the Council.
Institutional Review Board for Multi- The meeting will be open to the Place: National Institutes of Health,
Site Research from May 25, 2017, to public as indicated below, with National Institute on Alcohol Abuse and
September 25, 2017. A copy of the NIH attendance limited to space available. Alcoholism, 5635 Fishers Lane, Terrace
Policy was published in the Federal Individuals who plan to attend and Conference Rooms, Bethesda, MD 20892.
need special assistance, such as sign Contact Person: Abraham P. Bautista,
Register on June 21, 2016 (81 FR 40325).
Ph.D., Executive Secretary, National Institute
See https://www.gpo.gov/fdsys/pkg/FR- language interpretation or other on Alcohol Abuse and Alcoholism, National
2016-06-21/pdf/2016-14513.pdf. reasonable accommodations, should Institutes of Health, 5635 Fishers Lane, Room
Guidance and Frequently Asked notify the Contact Person listed below 2085, Rockville, MD 20852, 301–443–9737
Questions to assist in the in advance of the meeting. bautista@mail.nih.gov.
implementation of the policy will soon The meeting will be closed to the Any interested person may file written
be available at http://osp.od.nih.gov/ public in accordance with the comments with the committee by forwarding
office-clinical-research-and-bioethics- provisions set forth in sections the statement to the Contact Person listed on
policy/clinical-research-policy/models- 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., this notice. The statement should include the
as amended. The grant applications and name, address, telephone number and when
mstockstill on DSK3G9T082PROD with NOTICES
irb-review. applicable, the business or professional
the discussions could disclose
For further information contact the confidential trade secrets or commercial affiliation of the interested person.
NIH Office of Science Policy, Information is also available on the
property such as patentable material, Institute’s/Center’s home page: http://
Telephone: 301–496–9838, Email: and personal information concerning www.niaaa.nih.gov/AboutNIAAA/
SingleIRBPolicy@mail.nih.gov. individuals associated with the grant AdvisoryCouncil/Pages/default.aspx, where
applications and/or contract proposals, an agenda and any additional information for
the disclosure of which would the meeting will be posted when available.
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Document Created: 2018-02-14 09:07:23
Document Modified: 2018-02-14 09:07:23
| 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 | 81 FR 91183 |
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