Submission for OMB Review; 30-Day Comment Request PHS Applications and Pre-Award Reporting Requirements (OD/OPERA), 9573-9575 [2017-02472]

Download as PDF 9573 Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices 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 postaward reporting requirements will facilitate the NIH’s oversight of clinical trials. In addition, some of the data reported in the RPPR will ultimately be accessible to investigators to update certain sections of forms when registering or reporting their trials with ClinicalTrials.gov. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 519,408. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Information collection forms 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 3734 ................................................................................................. Final Progress Report .............................................................................. SBIR/STTR Phase II Final Progress Report ............................................ Number of responses per respondent Average burden per response (in hours) Total annual burden hours 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 8,085 180,000 3,032 120 3,600 479 2,000 1,330 1 1 1 1 4 30/60 1 1 14,400 240 2,000 1,330 Reporting Burden Total ..................................................................... Recordkeeping: SBIR/STTR Life Cycle Certification .......................................................... ........................ ........................ ........................ 499,033 1,500 1 15/60 375 Grand Total ................................................................................ ........................ ........................ ........................ 519,408 Dated: February 1, 2017. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2017–02471 Filed 2–6–17; 8:45 am] This meeting notice is amended to change the meeting time to 1:00 p.m.– 5:00 p.m. The meeting is closed to the public. Dated: February 1, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2017–02430 Filed 2–6–17; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health Lhorne on DSK30JT082PROD with NOTICES National Institute of Mental Health; Amended Notice of Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice is hereby given of a change in the meeting of the National Institute of Mental Health Special Emphasis Panel, February 03, 2017, 10:00 a.m. to February 03, 2017, 03:00 p.m., National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD, 20852 which was published in the Federal Register on January 18, 2017, 82FR5588. National Institutes of Health VerDate Sep<11>2014 14:31 Feb 06, 2017 Jkt 241001 National Institutes of Health, HHS. ACTION: PO 00000 Notice. Frm 00015 Fmt 4703 Sfmt 4703 Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. DATES: Submission for OMB Review; 30-Day Comment Request PHS Applications and Pre-Award Reporting Requirements (OD/OPERA) 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. This proposed information collection was previously published in the Federal Register on November 2, 2016, Volume 81, No. 212, pages 76368–76370 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. SUMMARY: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden ADDRESSES: E:\FR\FM\07FEN1.SGM 07FEN1 9574 Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices 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. 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, Suite 350, 6705 Rockledge Drive, Bethesda, MD 20892–7974, or call non-toll-free number (301) 435– 0941, or Email your request, including your address to: trialsinfo@od.nih.gov. FOR FURTHER INFORMATION CONTACT: The Office of the Director, NIH, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act (PRA) of 1995, the NIH has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Public Health Service (PHS) Applications and Preaward Reporting Requirements. Revision, OMB 0925–0001, Expiration Date 10/31/2018. Form numbers: PHS 398, PHS416–1, 416–5, and PHS 6031. This collection represents a consolidation of PHS applications and pre-award reporting requirements into a revised data collection under the PRA. This collection includes the proposed SUPPLEMENTARY INFORMATION: instructions is used in combination with the SF424 (R&R) forms/instructions for Fellowships and is used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The PHS 416–5 is used by individuals to indicate the start of their NRSA awards. The PHS 6031 Payback Agreement is used by individuals at the time of activation to certify agreement to fulfill the payback provisions. The Venture Capital Operating Companies (VCOC) Certification and the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) Funding Agreement Certifications are used by small business applicants. 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 about proposed clinical trials in the PHS applications and pre-award reporting requirements will facilitate the NIH’s oversight of clinical trials as well as assist in understanding where needs in the NIH research portfolio may exist. In addition, some of the data collected here will ultimately be accessible to investigators to pre-populate certain sections of forms when registering their trials with ClinicalTrials.gov. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,150,389. use of a new PHS Human Subjects and Clinical Trial Information form. Need and Use of Information Collection: This collection includes PHS applications and pre-award reporting requirements: PHS 398 (paper) Public Health Service Grant Application forms and instructions; PHS 398 (electronic) PHS Grant Application component forms and agency specific instructions used in combination with the SF424 (R&R); PHS Fellowship Supplemental Form and agency specific instructions used in combination with the SF424 (R&R) forms/instructions for Fellowships [electronic]; PHS 416–1 Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Application Instructions and Forms used only for a change of sponsoring institution application (paper); Instructions for a Change of Sponsoring Institution for NRSA Fellowships (F30, F31, F32 and F33) and non-NRSA Fellowships; PHS 416– 5 Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice; and PHS 6031 Payback Agreement. The PHS 398 (paper and electronic), PHS 416–1, 416– 5, and PHS 6031 are currently approved under 0925–0001. All forms expire 10/ 31/2018. Post-award reporting requirements are simultaneously consolidated under 0925–0002, and include the Research Performance Progress Report (RPPR). The PHS 398 and SF424 applications are used by applicants to request federal assistance funds for traditional investigatorinitiated research projects and to request access to databases and other PHS resources. The PHS 416–1 is used only for a change of sponsoring institution application. PHS Fellowship Supplemental Form and agency specific ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Lhorne on DSK30JT082PROD with NOTICES Information collection forms PHS 398—Paper ............................................................................................. PHS 398/424—Electronic: PHS Assignment Request Form .............................................................. PHS 398 Cover Page Supplement ........................................................... PHS 398 Modular Budget ........................................................................ PHS 398 Training Budget ........................................................................ PHS 398 Training Subaward Budget Attachment(s) Form ...................... PHS 398 Research Plan .......................................................................... PHS 398 Research Training Program Plan ............................................. Data Tables .............................................................................................. PHS 398 Career Development Award Supplemental Form ..................... PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) .................................................................................. Biosketch (424 Electronic) ........................................................................ PHS Fellowship—Electronic: PHS Fellowship Supplemental Form (includes F reference letters) ........ PHS Assignment Request Form .............................................................. VerDate Sep<11>2014 14:31 Feb 06, 2017 Jkt 241001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden per response (in hours) Total annual burden hours 4,247 1 35 148,645 37,120 74,239 56,693 1,122 561 70,866 1,122 1,515 2,251 1 1 1 1 1 1 1 1 1 30/60 1 1 2 90/60 10 10 4 10 18,560 74,239 56,693 2,244 842 708,660 11,220 6,060 22,510 54,838 80,946 1 1 14 2 767,732 161,892 6,707 3,354 1 1 12.5 30/60 83,838 1,677 E:\FR\FM\07FEN1.SGM 07FEN1 9575 Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Information collection forms Average burden per response (in hours) Number of responses per respondent Total annual burden hours PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) .................................................................................. Biosketch (Fellowship) .............................................................................. 416–1 ........................................................................................................ PHS 416–5 ............................................................................................... PHS 6031 ................................................................................................. VCOC Certification ................................................................................... SBIR/STTR Funding Agreement Certification .......................................... 5,030 6,707 29 6,707 6,217 6 1,500 1 1 1 1 1 1 1 14 2 10 5/60 5/60 5/60 15/60 70,420 13,414 290 559 518 1 375 Total Annual Burden Hours ............................................................... ........................ ........................ ........................ 2,150,389 Dated: February 1, 2017. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2017–02472 Filed 2–6–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES (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) Dated: February 1, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. National Institutes of Health [FR Doc. 2017–02433 Filed 2–6–17; 8:45 am] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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. Lhorne on DSK30JT082PROD with NOTICES National Center for Advancing Translational Sciences; Notice of Closed Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–P Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel, NTU—Bench Testing Therapeutic/Indication Pairing Strategies (UH2/UH3). Date: March 1–2, 2017. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 1066, 6701 Democracy Blvd., Bethesda, MD 20817 (Virtual Meeting). Contact Person: Barbara J. Nelson, Ph.D., Scientific Review Officer, Office of Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1080, Bethesda, MD 20892–4874, 301–435–0806, nelsonbj@ mail.nih.gov. VerDate Sep<11>2014 14:31 Feb 06, 2017 Jkt 241001 National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, February 27, 2017, 08:00 a.m. to February 28, 2017, 12:00 p.m., RitzCarlton Hotel, 1700 Tysons Boulevard, McLean, VA, 22102 which was published in the Federal Register on January 27, 2017, 82 FR 8619. The meeting notice is amended to change the name of the meeting to NCI R03/R21 SEP–4. The meeting is closed to the public. Dated: February 1, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–02432 Filed 2–6–17; 8:45 am] BILLING CODE 4140–01–P Frm 00017 Fmt 4703 Coast Guard [Docket No. USCG–2017–0020] Merchant Marine Personnel Advisory Committee Coast Guard, Department of Homeland Security. ACTION: Notice of Federal Advisory Committee Meeting. AGENCY: The Merchant Marine Personnel Advisory Committee and its working groups will meet to discuss various issues related to the training and fitness of merchant marine personnel. The meetings will be open to the public. DATES: The Merchant Marine Personnel Advisory Committee and its working groups are scheduled to meet on Wednesday, March 22, 2017, from 8 a.m. until 5:30 p.m., and the full Committee is scheduled to meet on Thursday, March 23, 2017, from 8 a.m. until 5:30 p.m. Please note that these meetings may adjourn early if the Committee has completed its business. ADDRESSES: The meetings will be held at The U.S. Coast Guard Headquarters, Room 6I10–01–C, 2703 Martin Luther King Jr. Ave. SE., Stop 7509, Washington, DC 20593–7509 (https:// www.uscg.mil/baseNCR/pages/visitor_ trans.asp). Attendees at the U.S. Coast Guard Headquarters who are U.S. citizens will be required to pre-register no later than 5 p.m. on March 14, 2017, to be admitted to the meeting. This preregistration should include your name, telephone number, and company or group with which you are affiliated. Non-US citizens will be required to preregister no later than 5 p.m. on March 01, 2017, to be admitted to the meeting. This pre-registration should include name, country of citizenship, passport and expiration date, or diplomatic SUMMARY: National Institutes of Health PO 00000 DEPARTMENT OF HOMELAND SECURITY Sfmt 4703 E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Notices]
[Pages 9573-9575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02472]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request PHS 
Applications and Pre-Award Reporting Requirements (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. This proposed information 
collection was previously published in the Federal Register on November 
2, 2016, Volume 81, No. 212, pages 76368-76370 and allowed 60 days for 
public comment. No public comments were received. The purpose of this 
notice is to allow an additional 30 days for public comment.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: Written comments and/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden

[[Page 9574]]

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, Suite 350, 6705 Rockledge Drive, Bethesda, MD 20892-7974, 
or call non-toll-free number (301) 435-0941, or Email your request, 
including your address to: trialsinfo@od.nih.gov.

SUPPLEMENTARY INFORMATION: The Office of the Director, NIH, may not 
conduct or sponsor, and the respondent is not required to respond to, 
an information collection that has been extended, revised, or 
implemented on or after October 1, 1995, unless it displays a currently 
valid OMB control number.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act (PRA) of 1995, the NIH has submitted to the Office of Management 
and Budget (OMB) a request for review and approval of the information 
collection listed below.
    Proposed Collection: Public Health Service (PHS) Applications and 
Pre-award Reporting Requirements. Revision, OMB 0925-0001, Expiration 
Date 10/31/2018. Form numbers: PHS 398, PHS416-1, 416-5, and PHS 6031. 
This collection represents a consolidation of PHS applications and pre-
award reporting requirements into a revised data collection under the 
PRA. This collection includes the proposed use of a new PHS Human 
Subjects and Clinical Trial Information form.
    Need and Use of Information Collection: This collection includes 
PHS applications and pre-award reporting requirements: PHS 398 (paper) 
Public Health Service Grant Application forms and instructions; PHS 398 
(electronic) PHS Grant Application component forms and agency specific 
instructions used in combination with the SF424 (R&R); PHS Fellowship 
Supplemental Form and agency specific instructions used in combination 
with the SF424 (R&R) forms/instructions for Fellowships [electronic]; 
PHS 416-1 Ruth L. Kirschstein National Research Service Award (NRSA) 
Individual Fellowship Application Instructions and Forms used only for 
a change of sponsoring institution application (paper); Instructions 
for a Change of Sponsoring Institution for NRSA Fellowships (F30, F31, 
F32 and F33) and non-NRSA Fellowships; PHS 416-5 Ruth L. Kirschstein 
National Research Service Award Individual Fellowship Activation 
Notice; and PHS 6031 Payback Agreement. The PHS 398 (paper and 
electronic), PHS 416-1, 416-5, and PHS 6031 are currently approved 
under 0925-0001. All forms expire 10/31/2018. Post-award reporting 
requirements are simultaneously consolidated under 0925-0002, and 
include the Research Performance Progress Report (RPPR). The PHS 398 
and SF424 applications are used by applicants to request federal 
assistance funds for traditional investigator-initiated research 
projects and to request access to databases and other PHS resources. 
The PHS 416-1 is used only for a change of sponsoring institution 
application. PHS Fellowship Supplemental Form and agency specific 
instructions is used in combination with the SF424 (R&R) forms/
instructions for Fellowships and is used by individuals to apply for 
direct research training support. Awards are made to individual 
applicants for specified training proposals in biomedical and 
behavioral research, selected as a result of a national competition. 
The PHS 416-5 is used by individuals to indicate the start of their 
NRSA awards. The PHS 6031 Payback Agreement is used by individuals at 
the time of activation to certify agreement to fulfill the payback 
provisions. The Venture Capital Operating Companies (VCOC) 
Certification and the Small Business Innovation Research and Small 
Business Technology Transfer (SBIR/STTR) Funding Agreement 
Certifications are used by small business applicants. 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 about proposed clinical trials in the PHS 
applications and pre-award reporting requirements will facilitate the 
NIH's oversight of clinical trials as well as assist in understanding 
where needs in the NIH research portfolio may exist. In addition, some 
of the data collected here will ultimately be accessible to 
investigators to pre-populate certain sections of forms when 
registering their trials with ClinicalTrials.gov.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 2,150,389.

                                        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
----------------------------------------------------------------------------------------------------------------
PHS 398--Paper..................................           4,247               1              35         148,645
PHS 398/424--Electronic:
    PHS Assignment Request Form.................          37,120               1           30/60          18,560
    PHS 398 Cover Page Supplement...............          74,239               1               1          74,239
    PHS 398 Modular Budget......................          56,693               1               1          56,693
    PHS 398 Training Budget.....................           1,122               1               2           2,244
    PHS 398 Training Subaward Budget                         561               1           90/60             842
     Attachment(s) Form.........................
    PHS 398 Research Plan.......................          70,866               1              10         708,660
    PHS 398 Research Training Program Plan......           1,122               1              10          11,220
    Data Tables.................................           1,515               1               4           6,060
    PHS 398 Career Development Award                       2,251               1              10          22,510
     Supplemental Form..........................
    PHS Human Subjects and Clinical Trial                 54,838               1              14         767,732
     Information (includes inclusion enrollment
     report)....................................
    Biosketch (424 Electronic)..................          80,946               1               2         161,892
PHS Fellowship--Electronic:
    PHS Fellowship Supplemental Form (includes F           6,707               1            12.5          83,838
     reference letters).........................
    PHS Assignment Request Form.................           3,354               1           30/60           1,677

[[Page 9575]]

 
    PHS Human Subjects and Clinical Trial                  5,030               1              14          70,420
     Information (includes inclusion enrollment
     report)....................................
    Biosketch (Fellowship)......................           6,707               1               2          13,414
    416-1.......................................              29               1              10             290
    PHS 416-5...................................           6,707               1            5/60             559
    PHS 6031....................................           6,217               1            5/60             518
    VCOC Certification..........................               6               1            5/60               1
    SBIR/STTR Funding Agreement Certification...           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
        Total Annual Burden Hours...............  ..............  ..............  ..............       2,150,389
----------------------------------------------------------------------------------------------------------------


    Dated: February 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017-02472 Filed 2-6-17; 8:45 am]
 BILLING CODE 4140-01-P