81 FR 83855 - Submission for OMB Review; 30-Day Comment Request; Materials To Support NIH Serving as an IRB of Record or a Single IRB for Outside Institutions (Office of the Director)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 225 (November 22, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 225 (November 22, 2016)
| Page Range | 83855-83856 | |
| FR Document | 2016-28140 |
[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)] [Notices] [Pages 83855-83856] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28140] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Materials To Support NIH Serving as an IRB of Record or a Single IRB for Outside Institutions (Office of the Director) AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2016, page 56667 (81 FR 56667) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. ADDRESSES: Written comments and/or suggestions regarding the items(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Julia Slutsman, Health Science Policy Analyst, Office of Human Subjects Research Protections (OHSRP), IRP, OD, NIH, Building 10, Room 1C154, 10 Center Drive, Bethesda, MD 20892, or call non-toll-free number 301-402-3444 or email your request, including your address to: [email protected]. Formal requests for additional materials must be requested in writing. SUPPLEMENTARY INFORMATION: The Office of Human Subjects Research Protections (OHSRP), Office of the Director (OD), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Materials to Support NIH Serving As an IRB of Record or a Single IRB for Outside Institutions, 0925-New, Office of Human Subjects Research Protections (OHSRP), Office of the Director, National Institutes of Health (NIH). Need and Use of Information Collection: The NIH Human Research Protections Program (HRPP) is preparing to implement the recent ``NIH Policy on the Use of a Single Institutional Review Board (sIRB) of Record for Multi-Site Research,'' which requires the use of a single IRB of record for human subject protections review of certain multisite studies. Additionally, the NIH and HHS have recently established the Public Health Emergency Research Review Board (PHERRB) mechanism, for human subject protections review of certain--typically multisite-- public health emergency research studies. Any of the 12 NIH intramural IRBs can be designated to serve as the PHERRB for review of a public health emergency research protocol. Finally, proposed changes to federal human subject protections regulations, if finalized, will require the use of single IRB review for the majority of HHS funded, multi-site studies. To meet all of these needs, and support efficient single IRB review, researchers at outside institutions will need to provide information to the NIH HRPP, which includes the NIH intramural IRBs, using materials developed by the NIH Office of Human Subject Protections. The required materials include: The Application for PHERRB Review (APR); the Initial Review Local Context Worksheet (IRLCW); and the Continuing Review Local Context Worksheet (CRLCW). This information collection is intended to provide the NIH HRPP and the NIH IRBs with information necessary for NIH to maintain regulatory compliance in its conduct of human subject protections review when an NIH IRB serves an IRB of record for multisite research and to provide high quality and timely human subject protections reviews. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annual burden hours are 790. [[Page 83856]] Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Estimated Estimated number of Average time Estimated Data collection activity Type of respondents number of responses per per response total annual respondents respondent (in hours) burden hours -------------------------------------------------------------------------------------------------------------------------------------------------------- APR............................................ Principal Investigator (MD or PhD)..... 20 1 2 40 IRLCW.......................................... Principal Investigator (MD or PhD 250 1 2 500 degree) or Research Coordinator (RN, BA, MA degree) or Regulatory Staff (BA degree). CRLCW.......................................... Principal Investigator (MD or PhD 250 1 1 250 degree) or Research Coordinator (RN, BA, MA degree) or Regulatory Staff (BA degree). --------------------------------------------------------------- Total...................................... ....................................... 520 520 .............. 790 -------------------------------------------------------------------------------------------------------------------------------------------------------- Dated: November 16, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2016-28140 Filed 11-21-16; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices 83855
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND after October 1, 1995, unless it displays
HUMAN SERVICES HUMAN SERVICES a currently valid OMB control number.
In compliance with Section
National Institutes of Health National Institutes of Health 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
National Heart, Lung, and Blood Submission for OMB Review; 30-Day Institutes of Health has submitted to the
Institute; Notice of Closed Meetings Comment Request; Materials To Office of Management and Budget
Support NIH Serving as an IRB of (OMB) a request for review and
Pursuant to section 10(d) of the
Record or a Single IRB for Outside approval of the information collection
Federal Advisory Committee Act, as
Institutions (Office of the Director) listed below.
amended (5 U.S.C. App.), notice is
hereby given of the following meetings. AGENCY: National Institutes of Health, Proposed Collection: Materials to
The meetings will be closed to the HHS. Support NIH Serving As an IRB of
public in accordance with the ACTION: Notice. Record or a Single IRB for Outside
provisions set forth in section Institutions, 0925-New, Office of Human
552b(c)(6), Title 5 U.S.C., as amended. SUMMARY: In compliance with the Subjects Research Protections (OHSRP),
The grant applications and the Paperwork Reduction Act of 1995, the Office of the Director, National
discussions could disclose confidential National Institutes of Health (NIH) has Institutes of Health (NIH).
trade secrets or commercial property submitted to the Office of Management Need and Use of Information
such as patentable material, and and Budget (OMB) a request for review Collection: The NIH Human Research
personal information concerning and approval of the information Protections Program (HRPP) is preparing
individuals associated with the grant collection listed below. This proposed to implement the recent ‘‘NIH Policy on
applications, the disclosure of which information collection was previously the Use of a Single Institutional Review
would constitute a clearly unwarranted published in the Federal Register on Board (sIRB) of Record for Multi-Site
invasion of personal privacy. August 22, 2016, page 56667 (81 FR Research,’’ which requires the use of a
Name of Committee: National Heart, Lung, 56667) and allowed 60 days for public single IRB of record for human subject
and Blood Institute Special Emphasis Panel; comment. No public comments were protections review of certain multisite
Heart, Lung, Blood and Sleep Conference received. The purpose of this notice is studies. Additionally, the NIH and HHS
Support Applications. to allow an additional 30 days for public have recently established the Public
Date: December 12–13, 2016. comment. Health Emergency Research Review
Time: 9:00 a.m. to 6:00 p.m. Board (PHERRB) mechanism, for human
Agenda: To review and evaluate grant DATES: Comments regarding this
information collection are best assured subject protections review of certain—
applications.
Place: National Institutes of Health, 6701 of having their full effect if received typically multisite—public health
Rockledge Drive, Room 7196, Bethesda, MD within 30 days of the date of this emergency research studies. Any of the
20892 (Virtual Meeting). publication. 12 NIH intramural IRBs can be
Contact Person: Stephanie J. Webb, Ph.D., designated to serve as the PHERRB for
Scientific Review Officer, Office of Scientific ADDRESSES: Written comments and/or review of a public health emergency
Review/DERA, National Heart, Lung, and suggestions regarding the items(s) research protocol. Finally, proposed
Blood Institute, 6701 Rockledge Drive, Room contained in this notice, especially changes to federal human subject
7196, Bethesda, MD 20892, 301–435–0291, regarding the estimated public burden protections regulations, if finalized, will
stephanie.webb@nih.gov. and associated response time, should be require the use of single IRB review for
Name of Committee: National Heart, Lung, directed to the: Office of Management the majority of HHS funded, multi-site
and Blood Institute Special Emphasis Panel; and Budget, Office of Regulatory Affairs,
R25 Diversity: Short-Term Research studies.
OIRA_submission@omb.eop.gov or by To meet all of these needs, and
Education to Increase Diversity.
fax to 202–395–6974, Attention: Desk support efficient single IRB review,
Date: December 12, 2016.
Time: 10:00 a.m. to 11:30 a.m. Officer for NIH. researchers at outside institutions will
Agenda: To review and evaluate grant FOR FURTHER INFORMATION CONTACT: To need to provide information to the NIH
applications. request more information on the HRPP, which includes the NIH
Place: National Institutes of Health, 6701 proposed project or to obtain a copy of intramural IRBs, using materials
Rockledge Drive, Room 7189, Bethesda, MD the data collection plans and developed by the NIH Office of Human
20892 (Telephone Conference Call). instruments, contact: Julia Slutsman,
Contact Person: Stephanie L. Constant,
Subject Protections. The required
Health Science Policy Analyst, Office of materials include: The Application for
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart, Human Subjects Research Protections PHERRB Review (APR); the Initial
Lung, and Blood Institute, 6701 Rockledge (OHSRP), IRP, OD, NIH, Building 10, Review Local Context Worksheet
Drive, Room 7189, Bethesda, MD 20892, 301– Room 1C154, 10 Center Drive, Bethesda, (IRLCW); and the Continuing Review
443–8784, constantsl@nhlbi.nih.gov. MD 20892, or call non-toll-free number Local Context Worksheet (CRLCW). This
(Catalogue of Federal Domestic Assistance 301–402–3444 or email your request, information collection is intended to
Program Nos. 93.233, National Center for including your address to: PHERRB@ provide the NIH HRPP and the NIH IRBs
Sleep Disorders Research; 93.837, Heart and mail.nih.gov. Formal requests for with information necessary for NIH to
Vascular Diseases Research; 93.838, Lung additional materials must be requested maintain regulatory compliance in its
Diseases Research; 93.839, Blood Diseases in writing. conduct of human subject protections
and Resources Research, National Institutes
review when an NIH IRB serves an IRB
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION: The Office
of Health, HHS)
of Human Subjects Research Protections of record for multisite research and to
Dated: November 16, 2016. (OHSRP), Office of the Director (OD), provide high quality and timely human
Michelle Trout, National Institutes of Health, may not subject protections reviews.
Program Analyst, Office of Federal Advisory conduct or sponsor, and the respondent OMB approval is requested for 3
Committee Policy. is not required to respond to, an years. There are no costs to respondents
[FR Doc. 2016–27997 Filed 11–21–16; 8:45 am] information collection that has been other than their time. The total
BILLING CODE 4140–01–P extended, revised, or implemented on or estimated annual burden hours are 790.
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![83856 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated Average
Estimated Estimated
number of time per
Data collection activity Type of respondents number of total annual
responses per response
respondents burden hours
respondent (in hours)
APR ............................... Principal Investigator (MD or PhD) ..................... 20 1 2 40
IRLCW ........................... Principal Investigator (MD or PhD degree) or 250 1 2 500
Research Coordinator (RN, BA, MA degree)
or Regulatory Staff (BA degree).
CRLCW .......................... Principal Investigator (MD or PhD degree) or 250 1 1 250
Research Coordinator (RN, BA, MA degree)
or Regulatory Staff (BA degree).
Total ........................ .............................................................................. 520 520 ........................ 790
Dated: November 16, 2016. Cancer Therapy Evaluation Program Need and Use of Information
Lawrence A. Tabak, (CTEP), 9609 Medical Center Drive, Collection: The Cancer Therapy
Deputy Director, National Institutes of Health. MSC 9742, Rockville, MD 20850 or call Evaluation Program (CTEP) establishes
[FR Doc. 2016–28140 Filed 11–21–16; 8:45 am] non-toll-free number 240–276–6080 or and supports programs to facilitate the
BILLING CODE 4140–01–P
Email your request, including your participation of qualified investigators
address to: montellom@mail.nih.gov. on CTEP-supported studies, and to
Formal requests for additional plans and institute programs that minimize
DEPARTMENT OF HEALTH AND instruments must be requested in redundancy among grant and contract
HUMAN SERVICES writing. holders, thereby reducing overall cost of
maintaining a robust treatment trials
National Institutes of Health SUPPLEMENTARY INFORMATION: Section program. Currently guided by the efforts
3506(c)(2)(A) of the Paperwork of the Clinical Trials Working Group
Proposed Collection; 60-Day Comment Reduction Act of 1995 requires: Written (CTWG) and the Institute of Medicine
Request; Cancer Trials Support Unit comments and/or suggestions from the (IOM) recommendations to revitalize the
(National Cancer Institute) public and affected agencies are invited Cooperative Group program, CTEP has
to address one or more of the following funded the Cancer Trials Support Unit
AGENCY: National Institutes of Health. points: (1) Whether the proposed (CTSU). The CTSU collects
ACTION: Notice. collection of information is necessary standardized forms to process site
for the proper performance of the regulatory information, changes to
SUMMARY: In compliance with the function of the agency, including
requirement of the Paperwork membership, patient enrollment data,
whether the information will have and routing information for case report
Reduction Act of 1995 to provide practical utility; (2) The accuracy of the
opportunity for public comment on forms. In addition, CTSU collects
agency’s estimate of the burden of the annual surveys of customer satisfaction
proposed data collection projects, the proposed collection of information,
National Cancer Institute (NCI) will for clinical site staff using the CTSU
including the validity of the Help Desk, the CTSU Web site, and the
publish periodic summaries of propose methodology and assumptions used; (3)
projects to be submitted to the Office of Protocol and Information Office (PIO).
Ways to enhance the quality, utility, and An ongoing user satisfaction survey is in
Management and Budget (OMB) for clarity of the information to be
review and approval. place for the Oncology Patient
collected; and (4) Ways to minimize the Enrollment Network (OPEN). User
DATES: Comments regarding this burden of the collection of information satisfaction surveys are compiled as part
information collection are best assured on those who are to respond, including of the project quality assurance
of having their full effect if received the use of appropriate automated, activities and are used to direct
within 60 days of the date of this electronic, mechanical, or other improvements to processes and
publication. technological collection techniques or technology.
FOR FURTHER INFORMATION CONTACT: To other forms of information technology. OMB approval for an extension to the
obtain a copy of the data collection Proposed Collection Title: Cancer existing approval is requested for one
plans and instruments, submit Trials Support Unit (CTSU) (NCI), year. There are no costs to respondents
comments in writing, or request more 0925–0624, EXTENSION, National other than their time. The total
information on the proposed project, Cancer Institute (NCI), National estimated annualized burden hours are
contact: Michael Montello, Pharm. D., Institutes of Health (NIH). 25,204.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total annual
sradovich on DSK3GMQ082PROD with NOTICES
Form name Type of respondent responses per
respondents response burden hour
respondent (in hours)
CTSU IRB/Regulatory Approval Transmittal Health Care Practitioner ..... 9,000 12 2/60 3,600
Form.
CTSU IRB Certification Form ......................... Health Care Practitioner ..... 8,500 12 10/60 17,000
CTSU Acknowledgement Form ...................... Health Care Practitioner ..... 500 12 5/60 500
Withdrawal from Protocol Participation Form Health Care Practitioner ..... 50 12 5/60 50
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Document Created: 2018-02-14 08:29:10
Document Modified: 2018-02-14 08:29:10
| 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 | |
| Action | Notice. | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Julia Slutsman, Health Science Policy Analyst, Office of Human Subjects Research Protections (OHSRP), IRP, OD, NIH, Building 10, Room 1C154, 10 Center Drive, Bethesda, MD 20892, or call non-toll-free number 301-402-3444 or email your request, including your | |
| FR Citation | 81 FR 83855 |
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