82 FR 9572 - Submission for OMB Review; 30-Day Comment Request Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 24 (February 7, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 24 (February 7, 2017)
| Page Range | 9572-9573 | |
| FR Document | 2017-02471 |
[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)] [Notices] [Pages 9572-9573] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-02471] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA) AGENCY: National Institutes of Health. 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 November 2, 2016, Volume 81, No. 212, pages 76371-76372 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 item(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: Ms. Mikia P. Currie, Project Clearance Branch, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number (301) 435-0941, or Email your request, including your address to: [email protected]. SUPPLEMENTARY INFORMATION: The Office of the Director, National Institutes of Health (NIH), 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 (PRA) of 1995, the NIH has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Public Health Service (PHS) Post-award Reporting Requirements. Revision, OMB 0925-0002, Expiration Date 10/31/2018. Form numbers: PHS 2590, PHS 416-7, PHS 2271, PHS 3734, PHS 6031-1, and HHS 568. This collection represents a consolidation of post-award reporting requirements under the PRA, including the Research Performance Progress Report (RPPR). This collection includes the proposed additional reporting requirements for clinical trials. Need and Use of Information Collection: The RPPR is now required to be used by all NIH, Food and Drug Administration, Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality grantees. Interim progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. The phased transition to the RPPR required the maintenance of dual reporting processes for a period of time. Continued use of the PHS Non- competing Continuation Progress Report (PHS 2590) exists for a small group of grantees. This collection also includes other PHS post-award reporting requirements: PHS 416-7 NRSA Termination Notice, PHS 2271 Statement of Appointment, 6031-1 NRSA Annual Payback Activities Certification, HHS 568 Final Invention Statement and Certification, Final Progress Report instructions, iEdison, and PHS 3734 Statement Relinquishing Interests and Rights in a PHS Research Grant. The PHS 416-7, 2271, and 6031-1 are used by NRSA recipients to activate, terminate, and provide for payback of a NRSA. Closeout of an award requires a Final Invention Statement (HHS 568) and Final Progress Report. Using iEdison allows grantees and federal agencies to meet statutory requirements for reporting inventions and patents. The PHS 3734 serves as the official record of grantee relinquishment of a PHS award when an award is transferred from one grantee institution to another. The Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) Life Cycle Certifications are completed by small business grantees once certain milestones are reached during the project period. Pre-award reporting requirements are simultaneously consolidated under 0925-0001 and the changes to the collection here are related. Clinical trials are complex and [[Page 9573]] challenging research activities. Oversight systems and tools are critical for the NIH to ensure participant safety, data integrity, and accountability of the use of public funds. The NIH has been engaged in a multi-year effort to examine how clinical trials are supported and the level of oversight needed. The collection of more structured information in the PHS applications and pre-award reporting requirements as well as continued monitoring and update during the post-award reporting requirements will facilitate the NIH's oversight of clinical trials. In addition, some of the data reported in the RPPR will ultimately be accessible to investigators to update certain sections of forms when registering or reporting their trials with ClinicalTrials.gov. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 519,408. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Information collection forms Number of responses per per response Total annual respondents respondent (in hours) burden hours ---------------------------------------------------------------------------------------------------------------- Reporting: PHS 416-7................................... 12,580 1 30/60 6,290 PHS 6031-1.................................. 1,778 1 20/60 593 PHS 568..................................... 11,180 1 5/60 932 iEdison..................................... 5,697 1 15/60 1,424 PHS 2271.................................... 22,035 1 15/60 5,509 PHS 2590.................................... 243 1 18 4,374 RPPR--Core Data............................. 32,098 1 8 256,784 Biosketch (Part of RPPR).................... 2,544 1 2 5,088 Data Tables (Part of RPPR).................. 758 1 4 3,032 Trainee Diversity Report (Part of RPPR)..... 480 1 15/60 120 PHS Human Subjects and Clinical Trial 6,420 1 4 25,680 Information (Part of RPPR, includes inclusion enrollment report)............... Publication Reporting....................... 97,023 3 5/60 8,085 Final RPPR--Core Data....................... 18,000 1 10 180,000 Data Tables (Part of Final RPPR)............ 758 1 4 3,032 Trainee Diversity Report (Part of Final 480 1 15/60 120 RPPR)...................................... PHS Human Subjects and Clinical Trial 3,600 1 4 14,400 Information (Part of Final RPPR, includes inclusion/enrollment)...................... PHS 3734.................................... 479 1 30/60 240 Final Progress Report....................... 2,000 1 1 2,000 SBIR/STTR Phase II Final Progress Report.... 1,330 1 1 1,330 --------------------------------------------------------------- Reporting Burden Total.................. .............. .............. .............. 499,033 Recordkeeping: SBIR/STTR Life Cycle Certification.......... 1,500 1 15/60 375 --------------------------------------------------------------- Grand Total......................... .............. .............. .............. 519,408 ---------------------------------------------------------------------------------------------------------------- Dated: February 1, 2017. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2017-02471 Filed 2-6-17; 8:45 am] BILLING CODE 4140-01-P
![9572 Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Reduction Act (PRA) of 1995, the NIH
HUMAN SERVICES HUMAN SERVICES has submitted to the Office of
Management and Budget (OMB) a
National Institutes of Health National Institutes of Health request for review and approval of the
information collection listed below.
National Institute of Mental Health; Submission for OMB Review; 30-Day Proposed Collection: Public Health
Amended Notice of Meeting Comment Request Post-Award Service (PHS) Post-award Reporting
Reporting Requirements Including Requirements.
Notice is hereby given of a change in Research Performance Progress Revision, OMB 0925–0002, Expiration
the meeting of the National Institute of Report Collection (OD/OPERA) Date 10/31/2018. Form numbers: PHS
Mental Health Special Emphasis Panel, 2590, PHS 416–7, PHS 2271, PHS 3734,
AGENCY: National Institutes of Health.
February 03, 2017, 10:00 a.m. to PHS 6031–1, and HHS 568. This
ACTION: Notice. collection represents a consolidation of
February 03, 2017, 03:00 p.m., National
Institutes of Health, Neuroscience post-award reporting requirements
SUMMARY: In compliance with the
Center, 6001 Executive Boulevard, under the PRA, including the Research
Paperwork Reduction Act of 1995, the
Rockville, MD, 20852 which was Performance Progress Report (RPPR).
National Institutes of Health (NIH) has
This collection includes the proposed
published in the Federal Register on submitted to the Office of Management
additional reporting requirements for
January 18, 2017, 82 FR 5588. and Budget (OMB) a request for review
clinical trials.
This meeting notice is amended to and approval of the information Need and Use of Information
change the meeting time to 10:30 a.m.– collection listed below. This proposed Collection: The RPPR is now required to
1:00 p.m. The meeting is closed to the information collection was previously be used by all NIH, Food and Drug
published in the Federal Register on Administration, Centers for Disease
public.
November 2, 2016, Volume 81, No. 212, Control and Prevention, and Agency for
Dated: February 1, 2017. pages 76371–76372 and allowed 60 days Healthcare Research and Quality
Melanie J. Pantoja, for public comment. No public grantees. Interim progress reports are
Program Analyst, Office of Federal Advisory comments were received. The purpose required to continue support of a PHS
Committee Policy. of this notice is to allow an additional grant for each budget year within a
[FR Doc. 2017–02429 Filed 2–6–17; 8:45 am] 30 days for public comment. competitive segment. The phased
BILLING CODE 4140–01–P DATES: Comments regarding this transition to the RPPR required the
information collection are best assured maintenance of dual reporting processes
of having their full effect if received for a period of time. Continued use of
DEPARTMENT OF HEALTH AND within 30-days of the date of this the PHS Non-competing Continuation
HUMAN SERVICES publication. Progress Report (PHS 2590) exists for a
ADDRESSES: Written comments and/or small group of grantees. This collection
National Institutes of Health suggestions regarding the item(s) also includes other PHS post-award
contained in this notice, especially reporting requirements: PHS 416–7
National Cancer Institute; Amended NRSA Termination Notice, PHS 2271
regarding the estimated public burden
Notice of Meeting and associated response time, should be Statement of Appointment, 6031–1
directed to the: Office of Management NRSA Annual Payback Activities
Notice is hereby given of a change in Certification, HHS 568 Final Invention
and Budget, Office of Regulatory Affairs,
the meeting of the National Cancer Statement and Certification, Final
OIRA_submission@omb.eop.gov or by
Institute Special Emphasis Panel, March fax to 202–395–6974, Attention: Desk Progress Report instructions, iEdison,
02, 2017, 12:00 p.m. to March 02, 2017, Officer for NIH. and PHS 3734 Statement Relinquishing
04:00 p.m., National Cancer Institute Interests and Rights in a PHS Research
FOR FURTHER INFORMATION CONTACT: To Grant. The PHS 416–7, 2271, and 6031–
Shady Grove, 9609 Medical Center
request more information on the 1 are used by NRSA recipients to
Drive, 7W538, Rockville, MD, 20850
proposed project or to obtain a copy of activate, terminate, and provide for
which was published in the Federal the data collection plans and
Register on January 27, 2017, 82 FR payback of a NRSA. Closeout of an
instruments, contact: Ms. Mikia P. award requires a Final Invention
8620. Currie, Project Clearance Branch, Office Statement (HHS 568) and Final Progress
The meeting notice is amended to of Policy for Extramural Research Report. Using iEdison allows grantees
change the date of the meeting to March Administration, NIH, Rockledge 1 and federal agencies to meet statutory
8, 2017 from 12:00 p.m. to 4:00 p.m. The Building, Room 3505, 6705 Rockledge requirements for reporting inventions
meeting is closed to the public. Drive, Bethesda, MD 20892–7974, or and patents. The PHS 3734 serves as the
call non-toll-free number (301) 435– official record of grantee relinquishment
Dated: February 1, 2017.
0941, or Email your request, including of a PHS award when an award is
Melanie J. Pantoja, your address to: trialsinfo@od.nih.gov. transferred from one grantee institution
Program Analyst, Office of Federal Advisory SUPPLEMENTARY INFORMATION: The Office to another. The Small Business
Committee Policy.
of the Director, National Institutes of Innovation Research and Small Business
[FR Doc. 2017–02431 Filed 2–6–17; 8:45 am] Health (NIH), may not conduct or Technology Transfer (SBIR/STTR) Life
BILLING CODE 4140–01–P sponsor, and the respondent is not Cycle Certifications are completed by
Lhorne on DSK30JT082PROD with NOTICES
required to respond to, an information small business grantees once certain
collection that has been extended, milestones are reached during the
revised, or implemented on or after project period. Pre-award reporting
October 1, 1995, unless it displays a requirements are simultaneously
currently valid OMB control number. consolidated under 0925–0001 and the
In compliance with Section changes to the collection here are
3507(a)(1)(D) of the Paperwork related. Clinical trials are complex and
VerDate Sep<11>2014 14:31 Feb 06, 2017 Jkt 241001 PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 E:\FR\FM\07FEN1.SGM 07FEN1](https://thefederalregister.org/doc/82_FR_9596/page/1.svg)
![Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices 9573
challenging research activities. structured information in the PHS certain sections of forms when
Oversight systems and tools are critical applications and pre-award reporting registering or reporting their trials with
for the NIH to ensure participant safety, requirements as well as continued ClinicalTrials.gov.
data integrity, and accountability of the monitoring and update during the post- OMB approval is requested for 3
use of public funds. The NIH has been award reporting requirements will
years. There are no costs to respondents
engaged in a multi-year effort to facilitate the NIH’s oversight of clinical
other than their time. The total
examine how clinical trials are trials. In addition, some of the data
supported and the level of oversight reported in the RPPR will ultimately be estimated annualized burden hours are
needed. The collection of more accessible to investigators to update 519,408.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total annual
Information collection forms responses per
respondents response burden hours
respondent (in hours)
Reporting:
PHS 416–7 ............................................................................................... 12,580 1 30/60 6,290
PHS 6031–1 ............................................................................................. 1,778 1 20/60 593
PHS 568 ................................................................................................... 11,180 1 5/60 932
iEdison ...................................................................................................... 5,697 1 15/60 1,424
PHS 2271 ................................................................................................. 22,035 1 15/60 5,509
PHS 2590 ................................................................................................. 243 1 18 4,374
RPPR—Core Data .................................................................................... 32,098 1 8 256,784
Biosketch (Part of RPPR) ......................................................................... 2,544 1 2 5,088
Data Tables (Part of RPPR) ..................................................................... 758 1 4 3,032
Trainee Diversity Report (Part of RPPR) ................................................. 480 1 15/60 120
PHS Human Subjects and Clinical Trial Information (Part of RPPR, in-
cludes inclusion enrollment report) ....................................................... 6,420 1 4 25,680
Publication Reporting ............................................................................... 97,023 3 5/60 8,085
Final RPPR—Core Data ........................................................................... 18,000 1 10 180,000
Data Tables (Part of Final RPPR) ............................................................ 758 1 4 3,032
Trainee Diversity Report (Part of Final RPPR) ........................................ 480 1 15/60 120
PHS Human Subjects and Clinical Trial Information (Part of Final
RPPR, includes inclusion/enrollment) ................................................... 3,600 1 4 14,400
PHS 3734 ................................................................................................. 479 1 30/60 240
Final Progress Report .............................................................................. 2,000 1 1 2,000
SBIR/STTR Phase II Final Progress Report ............................................ 1,330 1 1 1,330
Reporting Burden Total ..................................................................... ........................ ........................ ........................ 499,033
Recordkeeping:
SBIR/STTR Life Cycle Certification .......................................................... 1,500 1 15/60 375
Grand Total ................................................................................ ........................ ........................ ........................ 519,408
Dated: February 1, 2017. This meeting notice is amended to SUMMARY: In compliance with the
Lawrence A. Tabak, change the meeting time to 1:00 p.m.– Paperwork Reduction Act of 1995, the
Deputy Director, National Institutes of Health. 5:00 p.m. The meeting is closed to the National Institutes of Health (NIH) has
[FR Doc. 2017–02471 Filed 2–6–17; 8:45 am]
public. submitted to the Office of Management
Dated: February 1, 2017. and Budget (OMB) a request for review
BILLING CODE 4140–01–P
Melanie J. Pantoja, and approval of the information
Program Analyst, Office of Federal Advisory
collection listed below. This proposed
DEPARTMENT OF HEALTH AND Committee Policy. information collection was previously
HUMAN SERVICES [FR Doc. 2017–02430 Filed 2–6–17; 8:45 am]
published in the Federal Register on
November 2, 2016, Volume 81, No. 212,
BILLING CODE 4140–01–P
National Institutes of Health pages 76368–76370 and allowed 60 days
for public comment. No public
National Institute of Mental Health; DEPARTMENT OF HEALTH AND comments were received. The purpose
Amended Notice of Meeting HUMAN SERVICES of this notice is to allow an additional
30 days for public comment.
Notice is hereby given of a change in National Institutes of Health DATES: Comments regarding this
the meeting of the National Institute of information collection are best assured
Mental Health Special Emphasis Panel, Submission for OMB Review; 30-Day
Comment Request PHS Applications of having their full effect if received
Lhorne on DSK30JT082PROD with NOTICES
February 03, 2017, 10:00 a.m. to within 30-days of the date of this
February 03, 2017, 03:00 p.m., National and Pre-Award Reporting
Requirements (OD/OPERA) publication.
Institutes of Health, Neuroscience
Center, 6001 Executive Boulevard, AGENCY: National Institutes of Health, ADDRESSES: Written comments and/or
Rockville, MD, 20852 which was HHS. suggestions regarding the item(s)
published in the Federal Register on contained in this notice, especially
ACTION: Notice.
January 18, 2017, 82FR5588. regarding the estimated public burden
VerDate Sep<11>2014 14:31 Feb 06, 2017 Jkt 241001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\FR\FM\07FEN1.SGM 07FEN1](https://thefederalregister.org/doc/82_FR_9596/page/2.svg)
Document Created: 2017-02-07 00:27:09
Document Modified: 2017-02-07 00:27:09
| 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: Ms. Mikia P. Currie, Project Clearance Branch, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number (301) 435-0941, or Email your request, | |
| FR Citation | 82 FR 9572 |
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