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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0925-0001
ICR Reference No:
201701-0925-003
Status:
Historical Active
Previous ICR Reference No:
201611-0925-001
Agency/Subagency:
HHS/NIH
Agency Tracking No:
19797
Title:
PHS Applications and Pre-award Related Reporting (OD)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
03/15/2017
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/08/2017
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2020
36 Months From Approved
10/31/2018
Responses
421,777
0
420,101
Time Burden (Hours)
2,150,389
0
850,756
Cost Burden (Dollars)
0
0
0
Abstract:
This 0925-0001 revision submission consolidates application and other related pre-award reporting requirements previously collected under 0925-0001. 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.
Authorizing Statute(s):
US Code:
42 USC 286
Name of Law: Public Health Service Act
US Code:
42 USC 300
Name of Law: Public Health Service Act
US Code:
42 USC 288
Name of Law: Public Health Serive Act
US Code:
42 USC 216
Name of Law: Public health Service Act
US Code:
42 USC 285
Name of Law: public Health Serice Act
US Code:
42 USC 241
Name of Law: Public Health Service
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
81 FR 76368
11/02/2016
30-day Notice:
Federal Register Citation:
Citation Date:
82 FR 9573
02/07/2017
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
21
IC Title
Form No.
Form Name
398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)
16, 17, 18
PHS Human Subjects and Clinical Trial Information - Landing Page
,
PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report
,
PHS Human Subjects and Clinical Trial Information - Sections 1-5
416-1
21, 22, 24, 23, 19, 20
Attachment 7B PHS 416-1 Face Page 1
,
Attachment 7C PHS 416-1 Face Page 2
,
Attachment 7D PHS 416-1 Face Page 3
,
Attachment 7E PHS 416-1 Face Page 4
,
Attachment 7F PHS 416-1 Checklist Form Page
,
Attachment 7G PHS 416-1 Continuation Page
Biosketch (424 Electronic)
12
General Biographical Sketch Format Page
Biosketch (Fellowship)
15
Fellowship Applicant Biographical Sketch Format Page
Data Tables
10
Introduction to the Data Tables
Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)
16, 17, 18
PHS Human Subjects and Clinical Trial Information - Landing Page
,
PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report
,
PHS Human Subjects and Clinical Trial Information - Sections 1-5
PHS 398 Career Development Award Supplemental Form
11
PHS 398 Career Development Award Supplemental Form
PHS 398 Cover Page Supplement
4
PHS 398 Cover Page Supplement Form
PHS 398 Modular Budget
5
PHS 398 Modular Budget Instructions
PHS 398 Paper
2, 1
PHS 398 Paper Application Forms
,
PHS 398 Paper Application Instructions
PHS 398 Research Plan
8
PHS 398 Research Plan form
PHS 398 Research Training Program Plan
9
PHS 398 Research Training Program Plan Form
PHS 398 Training Budget
6
PHS 398 Training Budget Form
PHS 398 Training Subaward Budget Attachment(s) Form
7
Attachment 5M PHS 398 Training Subaward Budget Form
PHS 416-5
29
PHS 416.5
PHS 6031
25
PHS 6031
PHS Assignment Request Form
14
PHS Assignment Reqest Form
PHS Assignment Request Form
3
PHS Assignment Reqest Form
PHS Fellowship Supplemental Form (includes F reference letters)
13
PHS Fellowship Supplement Form
PHS Inclusion Enrollment Report
1
Attachment 5G PHS Inclusion Enrollment Report
PHS Inclusion Enrollment Report
1, 2
Attachment 5G PHS Inclusion Enrollment Report
,
Attachment 5F PHS Inclusion Enrollment Report Instructions
SBIR/STTR Funding Agreement Certification
27, 28
SBIR Funding Agreement Certification
,
STTR Funding Agreement Certification
VCOC Certification
26
VCOC Certification
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
421,777
420,101
0
1,676
0
0
Annual Time Burden (Hours)
2,150,389
850,756
0
1,299,633
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Changing Forms
Short Statement:
This submission represents program changes; previous estimated total burden hours for 0925-0001 were 850,756; current estimated total burden hours for 0925-0001 is 2,150,389. This represents an increase of 1,299,632 hours since the last approval. This increase is largely due to the addition of a new PHS Human Subjects and Clinical Trial Information form, as well as a recalculation of burden hour estimates on the following forms: PHS 398 Research Plan, PHS 398 Research Training Program Plan, and PHS 398 Career Development Award Supplemental Form.
Annual Cost to Federal Government:
$222,054
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
02/08/2017
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