Submission for OMB Review; 30-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (Office of the Director), 77872-77874 [2024-21802]

Download as PDF 77872 Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Form name Type of respondent Data Management and Sharing Plan ................... VCOC Certification ............................................... SBIR/STTR Funding Agreement Certification ...... Grant Applicant ............. Grant Applicant ............. Grant Applicant ............. Number of responses per respondent 73,117 6 1,500 Average burden per response (in hours) Total annual burden hours 1 1 1 2 5/60 15/60 146,234 1 375 PHS Fellowship—Electronic PHS Fellowship Supplemental Form (includes F reference letters). Biosketch (Fellowship) .......................................... 416–1 .................................................................... PHS 416–5 ........................................................... PHS 6031 ............................................................. Fellowship cant. Fellowship cant. Fellowship cant. Fellowship cant. Fellowship cant. Grant Appli- 6,707 1 13 87,191 Grant Appli- 6,707 1 2 13,414 Grant Appli- 29 1 10 290 Grant Appli- 6,707 1 5/60 559 Grant Appli- 6,217 1 5/60 518 239 1 11 2,629 486,749 486,749 ........................ 2,175,670 NIH Other Transaction NIH Other Transaction Application Form ............. Total ............................................................... Dated: September 16, 2024. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2024–21801 Filed 9–23–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health lotter on DSK11XQN23PROD with NOTICES1 National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 1009 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 Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Cystic Fibrosis Research and Translation Centers. Date: October 31–November 1, 2024. Time: 9:30 a.m. to 6:00 p.m. VerDate Sep<11>2014 18:07 Sep 23, 2024 Jkt 262001 Other Transaction Applicant. ....................................... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, NIDDK, Democracy II, Suite 7000A, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ryan G. Morris, Ph.D., Scientific Review Officer, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 6707 Democracy Boulevard, Rm 7015, Bethesda, MD 20892–2542, 301–594–4721, ryan.morris@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: September 18, 2024. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–21739 Filed 9–23–24; 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 (Office of the Director) AGENCY: National Institutes of Health, HHS. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 ACTION: Notice. In compliance with the requirement of 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 recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Mikia P. Currie, Program Analyst, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non-toll-free number 301–435–0941 or email your request, including your address to ProjectClearanceBranch@mail.nih.gov. Formal requests for additional plans and SUMMARY: E:\FR\FM\24SEN1.SGM 24SEN1 77873 Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Notices instruments must be requested in writing. This proposed information collection was previously published in the Federal Register on May 22, 2024, pages 45000– 45001 (89 FR 45000) and allowed 60 days for 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 (OD), Office of Extramural Research (OER), 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 Office of Management and Budget (OMB) control number. In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, NIH has submitted to OMB a request for review and approval of the information collection listed below. Proposed Collection Title: Public Health Service (PHS) Post-award Reporting Requirements Revision, OMB 0925–0002, Expiration Date 01/31/2026, Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: Starting in Fiscal Year 2025, NIH will require applicable recipients to address progress in association with their approved Data Management and Sharing (DMS) Plans within the Research Performance Progress Report SUPPLEMENTARY INFORMATION: (RPPR) in accordance with the final NIH Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. The progress report forms will be updated to align with this requirement. The Training Data Tables will also be updated to reduce burden and promote consistent information collection, including limiting the scope of information collection to data only relevant to the training stage(s) of the proposed program in table 1 and removing instructions in table 8 that are reported within the RPPR. Effective for May 2025, NIH will be adopting the Common Forms for Biographical Sketch and Current and Pending (Other) Support as part of the directive from Guidance for Implementing National Security Presidential Memorandum-33. The Common Forms are part of a separate OMB collection, currently approved under 3145–0279 (Expiration Date 10/31/2026). As such, elements that will be collected within the Common Forms will be removed from NIH’s current NIH Biosketch and Other Support formats. NIH will continue to collect additional information not captured on the Common Forms to adhere to the agency’s implementation of the NIH Peer Review Regulations at 42 CFR part 52 as part of the NIH Biosketch form, which will be renamed the NIH Biographical Sketch Supplement to reflect the supplemental information requested. The application and progress report forms and associated instructions will be updated to align with these new requirements. 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 recipients. Interim progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. This collection also includes other PHS postaward reporting requirements: PHS 416–7 National Research Service Award (NRSA) Termination Notice, PHS 2271 Statement of Appointment, 6031–1 NRSA Annual Payback Activities Certification, Department of Health and Human Services (HHS) 568 Final Invention Statement and Certification, and PHS 3734 Statement Relinquishing Interests and Rights in a PHS Research Grant. The PHS 416–7, 2271, and 6031– 1 is 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. The PHS 3734 serves as the official record of recipient relinquishment of a PHS award when an award is transferred from one recipient institution to another. Pre-award reporting requirements are simultaneously consolidated under 0925–0001 and the changes to the collection here are related. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 629,463. ESTIMATED ANNUALIZED BURDEN HOURS Form name Number of respondents Type of respondent Number of responses per respondent Average burden per response (in hours) Total annual burden hours lotter on DSK11XQN23PROD with NOTICES1 Reporting PHS 416–7 ........................................................... PHS 6031–1 ......................................................... PHS 568 ............................................................... 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. 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). PHS 3734 ............................................................. Data Management and Sharing Plan (Part of RPPR). VerDate Sep<11>2014 18:07 Sep 23, 2024 Jkt 262001 Recipient Recipient Recipient Recipient Recipient Recipient Recipient Recipient Recipient Recipient ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... ....................... 12,580 1,778 11,180 22,035 243 32,098 2,544 758 480 6,420 1 1 1 1 1 1 1 1 1 1 30/60 20/60 5/60 15/60 18 9 2 4 15/60 3 6,290 593 932 5,509 4,374 288,882 5,088 3,032 120 25,680 Recipient Recipient Recipient Recipient Recipient ....................... ....................... ....................... ....................... ....................... 97,023 18,000 758 480 3,600 3 1 1 1 1 5/60 11 4 15/60 4 24,256 198,000 3,032 120 14,400 Recipient ....................... Recipient ....................... 479 15,649 1 1 30/60 2 240 31,298 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\24SEN1.SGM 24SEN1 77874 Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of responses per respondent Number of respondents Average burden per response (in hours) Total annual burden hours Form name Type of respondent Data Management and Sharing Plan (Part of Final RPPR). Recipient ....................... 8,621 1 2 17,242 Reporting Burden Total ................................. ....................................... ........................ ........................ ........................ 629,088 Recording Keeping SBIR/STTR Life Cycle Certification ...................... Recipient ....................... 1,500 1 15/60 375 Grand Total .................................................... ....................................... 236,226 430,272 ........................ 629,463 Dated: September 16, 2024. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2024–21802 Filed 9–23–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting lotter on DSK11XQN23PROD with NOTICES1 Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the NIH Clinical Center Research Hospital Board. This will be a hybrid meeting held inperson and virtually and will be open to the public as indicated below. Individuals who plan to attend inperson or view the virtual meeting and need special assistance or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting can be accessed from the NIH Videocast at the following link: https:// videocast.nih.gov/. Name of Committee: NIH Clinical Center Research Hospital Board. Date: October 18, 2024. Time: 9:00 a.m. to 1:00 p.m. Agenda: NIH and Clinical Center (CC) Leadership Announcements, CC CEO Update of Recent Activities and Organizational Priorities, Status Report on Key CC Strategic Plan Initiatives, and Other Business of the Clinical Center Research Hospital Board (CCRHB). Place: National Institutes of Health, Building 31, Conference Room 6C02 A & B, 9000 Rockville Pike, Bethesda, MD 20892 (InPerson and Virtual) Contact Persons: Patricia Piringer, RN, MSN (C), National Institutes of Health Clinical Center, 10 Center Drive, Bethesda, MD 20892 ppiringer@ cc.nih.gov, (301) 402–2435, (202) 460–7542 (direct). VerDate Sep<11>2014 18:07 Sep 23, 2024 Jkt 262001 Natascha Pointer, Management Analyst, Executive Assistant to Dr. Gilman Office of the Chief Executive Officer, National Institutes of Health Clinical Center, 10 Center Drive, Bethesda, MD 20892, npointer@ cc.nih.gov, (301) 496–4114, (301) 402–2434 (direct). Any interested person may file written comments with the committee by forwarding the statement to the Contact Person(s) listed on this notice. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors attending a meeting on campus or at an off-campus federal facility will be asked to show one form of identification (for example, a governmentissued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the CCRHB website: https://www.ccrhb.od.nih.gov/ where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: September 19, 2024. David W. Freeman, Supervisory Program Analyst, Office of Federal Advisory Committee Policy. Dated: September 18, 2024. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–21838 Filed 9–23–24; 8:45 am] [FR Doc. 2024–21738 Filed 9–23–24; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P PO 00000 Frm 00064 Fmt 4703 Sfmt 9990 National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 1009 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 Institute on Aging Special Emphasis Panel; Palliative Care Research Consortium. Date: November 7, 2024. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, 5601 Fishers Lane, Rockville, MD 20892 (Virtual Meeting). Contact Person: Janetta Lun, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institutes of Health, 5601 Fishers Lane, Rm. 213, Rockville, MD 20814, (301) 496–9666, janetta.lun@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 89, Number 185 (Tuesday, September 24, 2024)]
[Notices]
[Pages 77872-77874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21802]


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

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 (Office of the Director)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement of 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 recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Ms. Mikia P. 
Currie, Program Analyst, Office of Policy for Extramural Research 
Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 
20892, or call a non-toll-free number 301-435-0941 or email your 
request, including your address to [email protected]. 
Formal requests for additional plans and

[[Page 77873]]

instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on May 22, 2024, pages 
45000-45001 (89 FR 45000) and allowed 60 days for 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 (OD), Office of Extramural Research 
(OER), 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 Office of 
Management and Budget (OMB) control number.
    In compliance with section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, NIH has submitted to OMB a request for review and approval 
of the information collection listed below.
    Proposed Collection Title: Public Health Service (PHS) Post-award 
Reporting Requirements Revision, OMB 0925-0002, Expiration Date 01/31/
2026, Office of the Director (OD), National Institutes of Health (NIH).
    Need and Use of Information Collection: Starting in Fiscal Year 
2025, NIH will require applicable recipients to address progress in 
association with their approved Data Management and Sharing (DMS) Plans 
within the Research Performance Progress Report (RPPR) in accordance 
with the final NIH Policy for Data Management and Sharing (DMS Policy) 
to promote the management and sharing of scientific data generated from 
NIH-funded or conducted research. The progress report forms will be 
updated to align with this requirement. The Training Data Tables will 
also be updated to reduce burden and promote consistent information 
collection, including limiting the scope of information collection to 
data only relevant to the training stage(s) of the proposed program in 
table 1 and removing instructions in table 8 that are reported within 
the RPPR. Effective for May 2025, NIH will be adopting the Common Forms 
for Biographical Sketch and Current and Pending (Other) Support as part 
of the directive from Guidance for Implementing National Security 
Presidential Memorandum-33. The Common Forms are part of a separate OMB 
collection, currently approved under 3145-0279 (Expiration Date 10/31/
2026). As such, elements that will be collected within the Common Forms 
will be removed from NIH's current NIH Biosketch and Other Support 
formats. NIH will continue to collect additional information not 
captured on the Common Forms to adhere to the agency's implementation 
of the NIH Peer Review Regulations at 42 CFR part 52 as part of the NIH 
Biosketch form, which will be renamed the NIH Biographical Sketch 
Supplement to reflect the supplemental information requested. The 
application and progress report forms and associated instructions will 
be updated to align with these new requirements. 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 recipients. Interim progress reports are required to continue 
support of a PHS grant for each budget year within a competitive 
segment. This collection also includes other PHS post-award reporting 
requirements: PHS 416-7 National Research Service Award (NRSA) 
Termination Notice, PHS 2271 Statement of Appointment, 6031-1 NRSA 
Annual Payback Activities Certification, Department of Health and Human 
Services (HHS) 568 Final Invention Statement and Certification, and PHS 
3734 Statement Relinquishing Interests and Rights in a PHS Research 
Grant. The PHS 416-7, 2271, and 6031-1 is 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. The PHS 3734 serves as the official record of recipient 
relinquishment of a PHS award when an award is transferred from one 
recipient institution to another. Pre-award reporting requirements are 
simultaneously consolidated under 0925-0001 and the changes to the 
collection here are related.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 629,463.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
                                                    Reporting
----------------------------------------------------------------------------------------------------------------
PHS 416-7.....................  Recipient.......          12,580               1           30/60           6,290
PHS 6031-1....................  Recipient.......           1,778               1           20/60             593
PHS 568.......................  Recipient.......          11,180               1            5/60             932
PHS 2271......................  Recipient.......          22,035               1           15/60           5,509
PHS 2590......................  Recipient.......             243               1              18           4,374
RPPR--Core Data...............  Recipient.......          32,098               1               9         288,882
Biosketch (Part of RPPR)......  Recipient.......           2,544               1               2           5,088
Data Tables (Part of RPPR)....  Recipient.......             758               1               4           3,032
Trainee Diversity Report (Part  Recipient.......             480               1           15/60             120
 of RPPR).
PHS Human Subjects and          Recipient.......           6,420               1               3          25,680
 Clinical Trial Information.
Publication Reporting.........  Recipient.......          97,023               3            5/60          24,256
Final RPPR--Core Data.........  Recipient.......          18,000               1              11         198,000
Data Tables (Part of Final      Recipient.......             758               1               4           3,032
 RPPR).
Trainee Diversity Report (Part  Recipient.......             480               1           15/60             120
 of Final RPPR).
PHS Human Subjects and          Recipient.......           3,600               1               4          14,400
 Clinical Trial Information
 (Part of Final RPPR).
PHS 3734......................  Recipient.......             479               1           30/60             240
Data Management and Sharing     Recipient.......          15,649               1               2          31,298
 Plan (Part of RPPR).

[[Page 77874]]

 
Data Management and Sharing     Recipient.......           8,621               1               2          17,242
 Plan (Part of Final RPPR).
                                                 ---------------------------------------------------------------
    Reporting Burden Total....  ................  ..............  ..............  ..............         629,088
----------------------------------------------------------------------------------------------------------------
                                                Recording Keeping
----------------------------------------------------------------------------------------------------------------
SBIR/STTR Life Cycle            Recipient.......           1,500               1           15/60             375
 Certification.
                               ---------------------------------------------------------------------------------
    Grand Total...............  ................         236,226         430,272  ..............         629,463
----------------------------------------------------------------------------------------------------------------


    Dated: September 16, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-21802 Filed 9-23-24; 8:45 am]
BILLING CODE 4140-01-P


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