[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71967-71968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28129]


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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.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below.

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

ADDRESSES: Written comments and/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
[email protected] or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Ms. Mikia P. Currie, Project Clearance Branch, 
Office of Policy for Extramural Research Administration, NIH, Rockledge 
1 Building, Room 803-C, 6705 Rockledge Drive, Bethesda, MD 20892-7974, 
or call non-toll-free number (301) 435-0941, or email your request, 
including your address to: [email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on April 12, 2019, Volume 
84, No.212 pages 14956-14957 and allowed 60 days for public comment. 
One public comment was received. The purpose of this notice is to allow 
an additional 30 days for public comment. The Office of the Director, 
NIH, may not conduct or 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 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 3/31/2020. 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: NIH has received approval 
to require applicants and recipients to address Human Fetal Tissue 
requirements within the SF-424 R&R and the Research Performance 
Progress Report due to Congressional ((Sections 498A and 498B of the 
PHS Act (42 U.S.C. 289g-1 and 289g-2)) and Department of Health and 
Human Services (45 CFR 46.204 and 46.206) mandates regarding human 
fetal tissue research. Applicants and recipients will be required to 
comply with Federal and state laws concerning the acquisition of human 
fetal tissue (including cell lines) obtained from elective abortions as 
well as include a description of the proposed characteristics of the 
human fetal cells/tissue outlining the procurement budget details, and 
how the applicants/recipients will document the processes for how they 
will use the human fetal tissues and cells. Additionally, this revision 
will clarify information regarding an institutional commitment to 
ensuring that proper policies, procedures, and oversight are in place 
to

[[Page 71968]]

prevent discriminatory harassment and other discriminatory practices.
    This collection also continues to include 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
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                                                                            Number of     Average       Total
                                                              Number of     responses    burden per     annual
               Information collection forms                  respondents       per        response      burden
                                                                            respondent   (in hours)     hours
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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 Attachment(s) Form..             561            1        90/60          842
    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 Supplemental Form...           2,251            1           10       22,510
    PHS Human Subjects and Clinical Trial Information              54,838            1           14      767,732
     (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
    PHS Human Subjects and Clinical Trial Information               5,030            1           14       70,420
     (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............................................  ..............      421,777  ...........    2,150,389
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    Dated: December 19, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-28129 Filed 12-27-19; 8:45 am]
BILLING CODE 4140-01-P