81 FR 76371 - Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (Office of the Director)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 212 (November 2, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 212 (November 2, 2016)
| Page Range | 76371-76372 | |
| FR Document | 2016-26447 |
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)] [Notices] [Pages 76371-76372] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26447] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-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 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. 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 instruments must be requested in writing. SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: 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 (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 National Research Service Award (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. 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 [[Page 76372]] 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 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. 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 307,116. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total annual Information collection forms respondents responses per response (in burden hours respondent 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 15 3,645 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 PHS Inclusion Enrollment Report (Part of 2,544 1 1 2,544 RPPR)...................................... PHS Clinical Trial Report/Form (Part of 8,264 1 1 8,264 RPPR)...................................... Trainee Diversity Report (Part of RPPR)..... 480 1 15/60 120 Publication Reporting....................... 32,341 3 5/60 8,085 PHS 3734.................................... 479 1 30/60 240 Final Progress Report....................... 11,125 1 1 11,125 SBIR/STTR Phase II Final Progress Report.... 1,330 1 1 1,330 --------------------------------------------------------------- Reporting Burden Total.................. .............. .............. .............. 306,741 Recordkeeping: SBIR/STTR Life Cycle Certification.......... 1,500 1 15/60 375 --------------------------------------------------------------- Grand Total......................... .............. 203,394 .............. 307,116 ---------------------------------------------------------------------------------------------------------------- Dated: October 22, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2016-26447 Filed 11-1-16; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices 76371
agencies of Department of Health and (ICs). To make the application process CoC and to issue the CoC to the
Human Services (HHS), including the consistent across the entire agency, OER requesting organization. It is anticipated
NIH, to authorize researchers launched an electronic application that the NIH ICs will issue
conducting sensitive research to protect system in 2015 that is used by research approximately 1300 new CoCs each year
the privacy of human research subjects organizations that wish to request a CoC for eligible research projects.
by enabling them to refuse to release from any NIH IC. Having one system for
OMB approval is requested for 3
names and identifying characteristics of all CoC applications to the NIH is more
subjects to anyone not connected with efficient for both applicants and NIH years. There are no costs to respondents
the research. At the NIH, the issuance of staff who process these requests. The other than their time. The total
CoCs has been delegated to the NIH uses the information in the annualized burden hours estimate is
individual NIH Institutes and Centers application to determine eligibility for a 1,951.
ESTIMATED ANNUALIZED BURDEN HOURS
Average Total annual
Number of Frequency of time per
Type of respondents burden
respondents response response hours
(in hours)
CoC Applicants—Private ................................................................................. 455 1 90/60 683
CoC Applicants—State/local ............................................................................ 650 1 90/60 975
CoC Applicants—Small business .................................................................... 130 1 90/60 195
CoC Applicants—Federal ................................................................................ 65 1 90/60 98
Dated: October 25, 2016. Rockledge Drive, Suite 350, Bethesda, the proposed additional reporting
Lawrence A. Tabak, Maryland 20892, or call a non-toll-free requirements for clinical trials.
Deputy Director, National Institutes of Health. number 301–435–0941 or Email your Need and Use of Information
[FR Doc. 2016–26445 Filed 11–1–16; 8:45 am] request, including your address to Collection: The RPPR is now required to
BILLING CODE 4140–01–P trialsinfo@od.nih.gov. Formal requests be used by all NIH, Food and Drug
for additional plans and instruments Administration, Centers for Disease
must be requested in writing. Control and Prevention, and Agency for
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: Section Healthcare Research and Quality
HUMAN SERVICES 3506(c)(2)(A) of the Paperwork (AHRQ) grantees. Interim progress
Reduction Act of 1995 requires: written reports are required to continue support
National Institutes of Health comments and/or suggestions from the of a PHS grant for each budget year
Proposed Collection; 60-Day Comment public and affected agencies are invited within a competitive segment. The
Request; Post-Award Reporting to address one or more of the following phased transition to the RPPR required
Requirements Including Research points: (1) Whether the proposed the maintenance of dual reporting
Performance Progress Report collection of information is necessary processes for a period of time.
Collection (Office of the Director) for the proper performance of the Continued use of the PHS Non-
function of the agency, including competing Continuation Progress Report
AGENCY: National Institutes of Health, whether the information will have (PHS 2590), exists for a small group of
HHS. practical utility; (2) The accuracy of the grantees. This collection also includes
ACTION: Notice. agency’s estimate of the burden of the other PHS post-award reporting
proposed collection of information, requirements: PHS 416–7 National
SUMMARY: In compliance with the including the validity of the Research Service Award (NRSA)
requirement of the Paperwork methodology and assumptions used; (3) Termination Notice, PHS 2271
Reduction Act of 1995 to provide Ways to enhance the quality, utility, and Statement of Appointment, 6031–1
opportunity for public comment on clarity of the information to be NRSA Annual Payback Activities
proposed data collection projects, the collected; and (4) Ways to minimizes Certification, HHS 568 Final Invention
National Institutes of Health (NIH) will the burden of the collection of Statement and Certification, Final
publish periodic summaries of proposed information on those who are to Progress Report instructions, iEdison,
projects to be submitted to the Office of respond, including the use of and PHS 3734 Statement Relinquishing
Management and Budget (OMB) for appropriate automated, electronic, Interests and Rights in a PHS Research
review and approval. mechanical, or other technological Grant. The PHS 416–7, 2271, and 6031–
DATES: Comments regarding this collection techniques or other forms of 1 are used by NRSA recipients to
information collection are best assured information technology. activate, terminate, and provide for
of having their full effect if received Proposed Collection Title: Public payback of a NRSA. Closeout of an
within 60 days of the date of this Health Service (PHS) Post-award award requires a Final Invention
publication. Reporting Requirements, Revision, OMB Statement (HHS 568) and Final Progress
FOR FURTHER INFORMATION CONTACT: To 0925–0002, Expiration Date 10/31/2018. Report. iEdison allows grantees and
sradovich on DSK3GMQ082PROD with NOTICES
obtain a copy of the data collection Form numbers: PHS 2590, PHS 416–7, federal agencies to meet statutory
plans and instruments, submit PHS 2271, PHS 3734, PHS 6031–1, and requirements for reporting inventions
comments in writing, or request more HHS 568. This collection represents a and patents. The PHS 3734 serves as the
information on the proposed project, consolidation of post-award reporting official record of grantee relinquishment
contact: Ms. Mikia P. Currie, Program requirements under the PRA, including of a PHS award when an award is
Analyst, Office of Policy for Extramural the Research Performance Progress transferred from one grantee institution
Research Administration, 6705 Report (RPPR). This collection includes to another. Pre-award reporting
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![76372 Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
requirements are simultaneously needed. The collection of more registering or reporting their trials with
consolidated under 0925–0001 and the structured information in the PHS ClinicalTrials.gov.
changes to the collection here are applications and pre-award reporting Frequency of response: Applicants
related. Clinical trials are complex and requirements as well as continued may submit applications for published
challenging research activities. monitoring and update during the post- receipt dates. For NRSA awards,
Oversight systems and tools are critical award reporting requirements will fellowships are activated and trainees
for the NIH to ensure participant safety, facilitate the NIH’s oversight of clinical appointed.
data integrity, and accountability of the trials. In addition, some of the data OMB approval is requested for 3
use of public funds. The NIH has been reported in the RPPR will ultimately be years. There are no costs to respondents
engaged in a multi-year effort to accessible to investigators to update other than their time. The total
examine how clinical trials are certain sections of forms when estimated annualized burden hours are
supported and the level of oversight 307,116.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total annual
Number of burden per
Information collection forms responses per burden
respondents response
respondent hours
(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 15 3,645
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
PHS Inclusion Enrollment Report (Part of RPPR) ................................... 2,544 1 1 2,544
PHS Clinical Trial Report/Form (Part of RPPR) ....................................... 8,264 1 1 8,264
Trainee Diversity Report (Part of RPPR) ................................................. 480 1 15/60 120
Publication Reporting ............................................................................... 32,341 3 5/60 8,085
PHS 3734 ................................................................................................. 479 1 30/60 240
Final Progress Report .............................................................................. 11,125 1 1 11,125
SBIR/STTR Phase II Final Progress Report ............................................ 1,330 1 1 1,330
Reporting Burden Total ..................................................................... ........................ ........................ ........................ 306,741
Recordkeeping:
SBIR/STTR Life Cycle Certification .......................................................... 1,500 1 15/60 375
Grand Total ................................................................................ ........................ 203,394 ........................ 307,116
Dated: October 22, 2016. applications are filed on selected human and veterinary uses is a method
Lawrence A. Tabak, inventions to extend market coverage of activating mammalian oocytes. These
Deputy Director, National Institutes of Health. for companies and may also be available methods include contacting a
[FR Doc. 2016–26447 Filed 11–1–16; 8:45 am] for licensing. mammalian oocyte of interest arrested at
BILLING CODE 4140–01–P FOR FURTHER INFORMATION CONTACT: metaphase II with an effective amount
Licensing information and copies of the of a Regulator of G-Protein Signaling
U.S. patent applications listed below (RGS)2 inhibitor; and contacting the
DEPARTMENT OF HEALTH AND may be obtained by writing to the mammalian oocyte of interest with an
HUMAN SERVICES indicated licensing contact at the effective amount of a G protein coupled
National Heart, Lung and Blood receptor activator. In general, RGS
National Institutes of Health Institute, Office of Technology Transfer proteins stimulate the hydrolysis of GTP
and Development, National Institutes of bound to activated Ga subunits, leading
Government-Owned Inventions; Health, 31 Center Drive Room 4A29, to signal termination. RGS2, which
Availability for Licensing MSC2479, Bethesda, MD 20892–2479; inhibits both G-aq and G-as signaling
AGENCY: National Institutes of Health, telephone: 301–402–5579. A signed suppresses Ca2+ release in mature
HHS. Confidential Disclosure Agreement may mammalian eggs. Regulators of G-
be required to receive copies of the Protein Signaling (RGS)2 inhibitor and a
ACTION: Notice. patent applications. G protein coupled receptor activator can
SUMMARY: The inventions listed below SUPPLEMENTARY INFORMATION: be used to artificially activate a
sradovich on DSK3GMQ082PROD with NOTICES
are owned by an agency of the U.S. Technology descriptions follow. mammalian oocyte such that it re-enters
Government and are available for Methods for Artificial Oocyte the cell cycle. Examples of RGS2
licensing in the U.S. in accordance with Activation inhibitors can be nucleic acids like
35 U.S.C. 209 and 37 CFR part 404 to siRNAs or dsRNAs. G-protein coupled
achieve expeditious commercialization Description of Technology receptor activators can be acetylcholine,
of federally-funded research and Available for licensing and a neurotransmitter such as serotonin,
development. Foreign patent commercial development for both hormones, natural or synthetic G
VerDate Sep<11>2014 17:18 Nov 01, 2016 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\02NON1.SGM 02NON1](https://thefederalregister.org/doc/81_FR_76583/page/2.svg)
Document Created: 2016-11-02 01:40:36
Document Modified: 2016-11-02 01:40:36
| 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 60 days of the date of this publication. | |
| 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 | |
| FR Citation | 81 FR 76371 |
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