Submission for OMB Review; 30-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (Office of the Director), 43258-43260 [2021-16849]

Download as PDF 43258 Federal Register / Vol. 86, No. 149 / Friday, August 6, 2021 / Notices through the use of appropriate automated collection techniques of other forms of information technology, e.g., permitting electronic submission of responses. Title: 0917–0014, ‘‘Indian Health Service Loan Repayment Program.’’ Type of Information Collection Request: Three year extension approval of this information collection. OMB Control Number: 0917–0014. Forms: Educational and Professional Background, Financial Information, and General Applicant Information (i.e., all forms are part of the LRP application). The LRP application is available in an electronically fillable and fileable format. Need and Use of Information Collection: The IHS LRP identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract through which the IHS agrees to repay part or all of their indebtedness in exchange for an initial two-year service commitment to practice fulltime at an eligible Indian health program. This program is necessary to augment the critically low health professional staff at IHS health care facilities. Eligible health professionals wishing to have their health education loans repaid may apply to the IHS LRP. A two-year contract obligation is signed by both parties, and the individual agrees to work at an eligible Indian health program location and provide health services to American Indian and Alaska Native individuals. The information collected via the online application from individuals is analyzed and a score is given to each applicant. This score will determine which applicants will be awarded each fiscal year. The administrative scoring system assigns a score to the geographic location according to vacancy rates for that fiscal year and also considers whether the location is in an isolated area. When an applicant accepts employment at a location, the applicant in turn ‘‘picks-up’’ the score of that location. Status of the Proposed Information Collection: Renewal of a current collection. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, estimated number of respondents, Number of responses per respondent, annual number of responses, Average burden hour per response, and Total annual burden hour(s). ESTIMATED BURDEN HOURS Data collection instrument(s) Number of respondents Number of responses per respondent Average burden per response (in hours) Total annual responses (in hours) LRP Application ............................................................................................... LRP Application (3 forms in total) 1,999 1 1.5 2,998.5 There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. Elizabeth A. Fowler, Acting Director, Indian Health Service. [FR Doc. 2021–16837 Filed 8–5–21; 8:45 am] BILLING CODE 4165–16–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) National Institutes of Health, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:29 Aug 05, 2021 Jkt 253001 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 request more information on the proposed project or to obtain a copy of the data collection plans and instruments, 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 instruments must be requested in writing. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on April 12, 2021, pages PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 18994–18995 (86 FR 18994) 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. The Office of the Director (OD) Office of Policy and Extramural Research Administration (OPERA), 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 (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 Including Research Performance Progress Report Collection, Revision, OMB 0925–0002, Expiration Date 2/28/2023, Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: This collection is being revised to omit the Inclusion Enrollment E:\FR\FM\06AUN1.SGM 06AUN1 43259 Federal Register / Vol. 86, No. 149 / Friday, August 6, 2021 / Notices Report form, which is being converted to a Common form to include the Department of Defense (DoD). The Inclusion Enrollment Report is used for all applications involving NIH-defined clinical research. This form is used to report both planned and cumulative (or actual) enrollment, and describes the sex/gender, race, and ethnicity of the study participants. Starting in January 2022, NIH will require will applicants and recipients to provide their Unique Entity Identifier (UEI) instead of the Data Universal Number System (DUNS) number. Also, the application forms will be updated to align with the Grants.gov updated Country and State lists. NIH also anticipates adding an optional field to the end of our forms and applications to get a more accurate assessment of the time it takes our applicants to complete the various forms and applications. 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 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 multiyear 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 532,249. 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 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. 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 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 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 RPPR, includes inclusion enrollment report)) ........................................................................ PHS 374 .......................................................................................................... 12,580 1,778 11,180 5,697 22,035 243 32,098 2,544 758 480 1 1 1 1 1 1 1 1 1 1 30/60 20/60 5/60 15/60 15/60 18 8 2 4 15/60 6,290 593 932 1,424 5,509 4,374 256,784 5,088 3,032 120 6,420 97,023 18,000 758 480 1 3 1 1 1 4 5/60 10 4 15/60 25,680 24,256 180,000 3,032 120 3,600 479 1 1 4 30/60 14,400 240 Reporting Burden Total ............................................................................ ........................ ........................ ........................ 531,874 jbell on DSKJLSW7X2PROD with NOTICES Recordkeeping SBIR/STTR Life Cycle Certification ................................................................. 1,500 1 15/60 375 Grand Total ............................................................................................... 217,653 411,699 ........................ 532,249 VerDate Sep<11>2014 19:29 Aug 05, 2021 Jkt 253001 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 E:\FR\FM\06AUN1.SGM 06AUN1 43260 Federal Register / Vol. 86, No. 149 / Friday, August 6, 2021 / Notices Dated: July 30, 2021. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2021–16849 Filed 8–5–21; 8:45 am] National Center for Advancing Translational Sciences; Notice of Closed Meeting BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 Institute on Aging Special Emphasis Panel; Insulin Resistance and Alzheimer’s Disease pathology. Date: September 3, 2021. Time: 1:30 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 (Video Meeting). 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. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: August 2, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. jbell on DSKJLSW7X2PROD with NOTICES [FR Doc. 2021–16803 Filed 8–5–21; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health 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 Center for Advancing Translational Sciences Special Emphasis Panel; Rare Diseases. Date: September 14, 2021. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Room 1037, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Alumit Ishai, Ph.D., Scientific Review Officer, Office of Grants Management and Scientific Review, National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Room 1037, Bethesda, MD 20817, 301–827–5819, alumit.ishai@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–16866 Filed 8–5–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 19:29 Aug 05, 2021 Jkt 253001 PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 Name of Committee: National Eye Institute Special Emphasis Panel; Request for Proposals 75N98021R00006: Development, Statistical Design, Monitoring and Coordination of Vision Clinical Trials and Epidemiology Research. Date: August 30, 2021. Time: 1:00 p.m. to 3:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Eye Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 3400, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Brian Hoshaw, Ph.D., Designated Federal Official, Division of Extramural Research, National Eye Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 3400, Bethesda, 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) Dated: August 3, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–16863 Filed 8–5–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR 6277–N–01] Fair Market Rents for the Housing Choice Voucher Program, Moderate Rehabilitation Single Room Occupancy Program, and Other Programs Fiscal Year 2022 Office of the Assistant Secretary for Policy Development and Research, Housing and Urban Development (HUD). ACTION: Notice of Fiscal Year (FY) 2022 Fair Market Rents (FMRs). AGENCY: Section 8(c)(1) of the United States Housing Act of 1937 (USHA), as amended by the Housing Opportunities Through Modernization Act of 2016 (HOTMA), requires the Secretary to publish FMRs not less than annually, adjusted to be effective on October 1 of each year. This notice describes the SUMMARY: 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. VerDate Sep<11>2014 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. E:\FR\FM\06AUN1.SGM 06AUN1

Agencies

[Federal Register Volume 86, Number 149 (Friday, August 6, 2021)]
[Notices]
[Pages 43258-43260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16849]


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

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, Health and Human Services (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 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 request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, 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 instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on April 12, 2021, pages 
18994-18995 (86 FR 18994) 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. The Office of the Director 
(OD) Office of Policy and Extramural Research Administration (OPERA), 
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 (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 Including Research Performance Progress Report 
Collection, Revision, OMB 0925-0002, Expiration Date 2/28/2023, Office 
of the Director (OD), National Institutes of Health (NIH).
    Need and Use of Information Collection: This collection is being 
revised to omit the Inclusion Enrollment

[[Page 43259]]

Report form, which is being converted to a Common form to include the 
Department of Defense (DoD). The Inclusion Enrollment Report is used 
for all applications involving NIH-defined clinical research. This form 
is used to report both planned and cumulative (or actual) enrollment, 
and describes the sex/gender, race, and ethnicity of the study 
participants. Starting in January 2022, NIH will require will 
applicants and recipients to provide their Unique Entity Identifier 
(UEI) instead of the Data Universal Number System (DUNS) number. Also, 
the application forms will be updated to align with the Grants.gov 
updated Country and State lists. NIH also anticipates adding an 
optional field to the end of our forms and applications to get a more 
accurate assessment of the time it takes our applicants to complete the 
various forms and applications. 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 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. 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 532,249.

                                        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          24,256
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                      3,600               1               4          14,400
 Information (Part of RPPR, includes inclusion
 enrollment report))............................
PHS 374.........................................             479               1           30/60             240
                                                 ---------------------------------------------------------------
    Reporting Burden Total......................  ..............  ..............  ..............         531,874
----------------------------------------------------------------------------------------------------------------
                                                  Recordkeeping
----------------------------------------------------------------------------------------------------------------
SBIR/STTR Life Cycle Certification..............           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
    Grand Total.................................         217,653         411,699  ..............         532,249
----------------------------------------------------------------------------------------------------------------



[[Page 43260]]

    Dated: July 30, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-16849 Filed 8-5-21; 8:45 am]
BILLING CODE 4140-01-P