Submission for OMB Review; 30-Day Comment Request Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA), 71965-71966 [2019-28130]

Download as PDF Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices Dated: December 23, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–28151 Filed 12–27–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings khammond on DSKJM1Z7X2PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 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 on Aging Special Emphasis Panel; Exploratory Alzheimer’s Disease Research Centers Evaluation. Date: January 31, 2020. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Maurizio Grimaldi, MD, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue, Gateway Building, Suite 2W200, Bethesda, MD 20892, 301–496–9374, grimaldim2@mail.nih.gov. Name of Committee: National Institute on Aging Special Emphasis Panel; Marmoset Model U34 Review. Date: February 18, 2020. Time: 12:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Birgit Neuhuber, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue, Gateway Building, Suite 2W200, Bethesda, MD 20892, 301–480–1266, neuhuber@ ninds.nih.gov. Name of Committee: National Institute on Aging Special Emphasis Panel; Microbiome and Aging Meeting. VerDate Sep<11>2014 20:00 Dec 27, 2019 Jkt 250001 Date: February 28, 2020. Time: 8:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: Admiral Fell Inn, Conference Room, Admiral Ballroom, 888 South Broadway, Baltimore, MD 21231. Contact Person: Greg Bissonette, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue, Gateway Building, Suite 2W200, Bethesda, MD 20892, 301–402–1622, bissonettegb@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: December 20, 2019. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–28155 Filed 12–27–19; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health National Eye Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 Eye Institute Special Emphasis Panel—BRAIN Initiative: New Concepts and Early-Stage Research for Large-Scale Recording and Modulation in the Nervous System (R21). Date: January 23, 2020. Time: 12:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Eye Institute 6700B Rockledge Drive Bethesda, MD 20818 (Virtual Meeting). Contact Person: Brian Hoshaw, Ph.D., Acting Review Chief, National Eye Institute, National Institutes of Health, Division of Extramural Research, 6700 B Rockledge Dr., Ste. 3400, Rockville, MD 20892, (301) 451– 2020, hoshawb@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) PO 00000 Frm 00076 Fmt 4703 Dated: December 20, 2019. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–28152 Filed 12–27–19; 8:45 am] BILLING CODE 4140–01–P 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, HHS. ACTION: Notice. 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. 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, OIRA_submission@omb.eop.gov 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 803–C, 6705 Rockledge Drive, Bethesda, MD 20892–7974, or call non-toll-free number (301) 435– 0941, or email your request, including your address to: projectclearancebranch@mail.nih.gov. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on April 12, 2019, Volume 84, No. 71 pages 14958–14959 and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The Office of the Director, NIH, may not conduct or SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Sfmt 4703 71965 E:\FR\FM\30DEN1.SGM 30DEN1 71966 Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices 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 3/31/2020, Office of the Director (OD), National Institutes of Health (NIH). This collection represents eliminating the Final Progress Report form as the form has been incorporated into the Final RPPR. Competing applications in the future may be updated to reflect related Human Fetal Tissue (HFT) information. Need and Use of Information Collection: The RPPR is required to be used by all NIH, Food and Drug Administration, Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality (AHRQ) 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 Noncompeting 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, 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. 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. Pre-award reporting requirements are simultaneously consolidated under 0925–0001 and the changes to the collection here are related. Clinical trials are complex and challenging research activities. Oversight systems and tools are critical for NIH to ensure participant safety, data integrity, and accountability of the use of public funds. 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 postaward reporting requirements will facilitate 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. Frequency of response: Applicants may submit applications for published receipt dates. For NRSA awards, fellowships are activated, and trainees appointed. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 517,408. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Information collection forms Number of responses per respondent Average burden per response (in hours) Total annual burden hours khammond on DSKJM1Z7X2PROD with NOTICES Reporting PHS 416–7 ................................................................................................................................................................................................ PHS 6031–1 .............................................................................................................................................................................................. PHS 568 .................................................................................................................................................................................................... iEdison ....................................................................................................................................................................................................... PHS 2271 .................................................................................................................................................................................................. PHS 2590 .................................................................................................................................................................................................. RPPR—Core Data ..................................................................................................................................................................................... Biosketch (Part of RPPR) .......................................................................................................................................................................... Data Tables (Part of RPPR) ...................................................................................................................................................................... Trainee Diversity Report (Part of RPPR) .................................................................................................................................................. PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report) ........................................... Publication Reporting ................................................................................................................................................................................ Final RPPR—Core Data ............................................................................................................................................................................ Data Tables (Part of Final RPPR) ............................................................................................................................................................. Trainee Diversity Report (Part of Final RPPR) ......................................................................................................................................... PHS Human Subjects and Clinical Trial Information (Part of Final RPPR, includes inclusion/enrollment) ............................................. PHS 374 .................................................................................................................................................................................................... SBIR/STTR Phase II Final Progress Report ............................................................................................................................................. SBIR/STTR Life Cycle Certification ........................................................................................................................................................... 12,580 1,778 11,180 5,697 22,035 243 32,098 2,544 758 480 6,420 97,023 18,000 758 480 3,600 479 1,330 1,500 1 1 1 1 1 1 1 1 1 1 1 3 1 1 1 1 1 1 1 30/60 20/60 5/60 15/60 15/60 18 8 2 4 15/60 4 5/60 10 4 15/60 4 30/60 1 15/60 6,290 593 932 1,424 5,509 4,374 256,784 5,088 3,032 120 25,680 8,085 180,000 3,032 120 14,400 240 1,330 375 Total .................................................................................................................................................................................................... ........................ 218,983 .................... 517,408 Dated: December 20, 2019. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2019–28130 Filed 12–27–19; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 20:00 Dec 27, 2019 Jkt 250001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71965-71966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28130]


-----------------------------------------------------------------------

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, 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.

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 803-C, 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: This proposed information collection was 
previously published in the Federal Register on April 12, 2019, Volume 
84, No. 71 pages 14958-14959 and allowed 60 days for public comment. 
One public comment was received. The purpose of this notice is to allow 
an additional 30 days for public comment. The Office of the Director, 
NIH, may not conduct or

[[Page 71966]]

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 3/31/
2020, Office of the Director (OD), National Institutes of Health (NIH). 
This collection represents eliminating the Final Progress Report form 
as the form has been incorporated into the Final RPPR. Competing 
applications in the future may be updated to reflect related Human 
Fetal Tissue (HFT) information.
    Need and Use of Information Collection: The RPPR is required to be 
used by all NIH, Food and Drug Administration, Centers for Disease 
Control and Prevention, and Agency for Healthcare Research and Quality 
(AHRQ) 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, 
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. 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. Pre-award reporting requirements are simultaneously 
consolidated under 0925-0001 and the changes to the collection here are 
related. Clinical trials are complex and challenging research 
activities. Oversight systems and tools are critical for NIH to ensure 
participant safety, data integrity, and accountability of the use of 
public funds. 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 
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.
    Frequency of response: Applicants may submit applications for 
published receipt dates. For NRSA awards, fellowships are activated, 
and trainees appointed.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 517,408.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                            Number of     Average       Total
                                                              Number of     responses    burden per     annual
               Information collection forms                  respondents       per        response      burden
                                                                            respondent   (in hours)     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             6,420            1            4       25,680
 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 RPPR)............             480            1        15/60          120
PHS Human Subjects and Clinical Trial Information (Part             3,600            1            4       14,400
 of Final RPPR, includes inclusion/enrollment)...........
PHS 374..................................................             479            1        30/60          240
SBIR/STTR Phase II Final Progress Report.................           1,330            1            1        1,330
SBIR/STTR Life Cycle Certification.......................           1,500            1        15/60          375
                                                          ------------------------------------------------------
    Total................................................  ..............      218,983  ...........      517,408
----------------------------------------------------------------------------------------------------------------


    Dated: December 20, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-28130 Filed 12-27-19; 8:45 am]
BILLING CODE 4140-01-P