Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought 42 CFR Part 50 Subpart F and Responsible Prospective Contractors (NIH/OPERA)

Forms and Documents

Document Name	Status
30day FRN 2018-19339.pdf Supplementary Document	2018-09-10
Attachment 2 - OMB No 0925-0417 (Historical information 7-2-2018).docx Supplementary Document	2018-09-10
eRA Privacy Impact Assessment 8-16-16.pdf Supplementary Document	2018-09-10
0925-0417_SUPPORTING_STATEMENT 2018 revised per OMBcomment.doc Supporting Statement A	2018-12-19

IC Document Collections

IC ID	Document Title	Status
7313	Initial Reports- 42 CFR 50.605(b)(1) and (b)(3) or 45 CFR 94.5 (b)(1) and (b) (3) from awardee Institutions (Reporting) Instruction	Modified
232904	Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from awardee Institutions Instruction	New
232903	Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR 94.5(a)(3)(iii) and (b)(2) from awardee Institutions Instruction	New
200605	42 CFR 50.606(c) or 45 CFR 94.6(c) (Disclosure) Instruction	Modified
200604	42 CFR 50.604(e)(3) or 45 CFR 94.4 (e)(3) for - Investigators (Disclosure) Instruction	Modified
200603	42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) for- Investigators (Disclosure) Instruction	Modified
200602	42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) for - Investigators (Disclosure) Instruction	Modified
200601	42 CFR 50.605(b)(4) (Reportimg)	Removed
200600	42 CFR 50.605(a)(4) (Disclosure) Instruction	Modified
200599	42 CFR 50.605(a)(3)(iii) or 45 CFR 94.5 (a)(3)(iii) (Disclosure) Instruction	Modified
200598	42 CFR 50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii) (Disclosure) Instruction	Modified
200597	42 CFR 50.605(a)(3)(i) or 45 CFR (a)(3)(i) (Disclosure) Instruction	Modified
200596	42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) for institutions (Disclosure) Instruction	Modified
200595	42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) for institutions (Disclosure) Instruction	Modified
200594	42 CFR 50.604(f) or 45 CFR 94.4(f) for institutions (Disclosure) Instruction	Modified
200593	42 CFR 50.604(d) or 45 CFR 94.4 for Institutions (Disclosure) Instruction	Modified
200592	42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Institutions (Disclosure) Instruction	Modified
200591	42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for investigators (Disclosure) Instruction	Modified
200590	42 CFR 50.604(a) or 45 CFR 94.4 for investigators (Disclosure) Instruction	Modified
186928	42 CFR - 50.604(c)(1) - from subrecipients (Disclosure) Instruction	Modified
186927	42 CFR 50.605(a)(5) - Institutions (Disclosure) Instruction	Modified
186926	42 CFR 50.604(i)-Institutional files or 45 CFR 94.4(1) from awardee institutions (Recordkeeping) Instruction	Modified
186925	Subsequent Reports under 42 CFR 50.606(a) or 45 CFR 94.6 from awardee Institutions (Reporting) Instruction	Modified
186924	Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR 94.5(a)(3)(iii) and (b)(2) from awardee Institutions (Reportimg) Instruction	Modified

ICR Details

OMB Control No: 0925-0417	ICR Reference No: 201809-0925-001
Status: Active	Previous ICR Reference No: 201112-0925-005
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought 42 CFR Part 50 Subpart F and Responsible Prospective Contractors (NIH/OPERA)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/30/2019
	Date Received in OIRA: 12/21/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2022	36 Months From Approved	02/28/2015
Responses	136,382	0	950
Time Burden (Hours)	677,820	0	950
Cost Burden (Dollars)	0	0	0

---

Abstract: The regulations provided in Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (45 CFR Part 94) are necessary to promote objectivity of the design, conduct, and reporting of research funded by the Public Health Service (PHS). The NIH failed to respond timely to the expiration of this submission and the submission of a reinstatement with change is due to NIH’s focused efforts on the consideration of the analysis of comments received during the Notice of Proposed Rule Making (NPRM) in development of the Final Rule and its implementation to the research community to ensure their understanding and compliance with the different requirements.

---

Authorizing Statute(s): US Code: 42 USC 289b-1 Name of Law: Protection against financial conflicts of interests in certain projects of research
  

Citations for New Statutory Requirements: Statute at Large: 42 Stat. 50 Name of Statute: null

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0925-AA53	Final or interim final rulemaking	76 FR 165	08/25/2011

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 11763	03/16/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 45455	09/07/2018
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 23

IC Title	Form No.	Form Name
Initial Reports- 42 CFR 50.605(b)(1) and (b)(3) or 45 CFR 94.5 (b)(1) and (b) (3) from awardee Institutions (Reporting)
Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR 94.5(a)(3)(iii) and (b)(2) from awardee Institutions (Reportimg)
Subsequent Reports under 42 CFR 50.606(a) or 45 CFR 94.6 from awardee Institutions (Reporting)
42 CFR 50.604(i)-Institutional files or 45 CFR 94.4(1) from awardee institutions (Recordkeeping)
Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR 94.5(a)(3)(iii) and (b)(2) from awardee Institutions
Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from awardee Institutions
42 CFR 50.605(a)(5) - Institutions (Disclosure)
42 CFR - 50.604(c)(1) - from subrecipients (Disclosure)
42 CFR 50.604(a) or 45 CFR 94.4 for investigators (Disclosure)
42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for investigators (Disclosure)
42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Institutions (Disclosure)
42 CFR 50.604(d) or 45 CFR 94.4 for Institutions (Disclosure)
42 CFR 50.604(f) or 45 CFR 94.4(f) for institutions (Disclosure)
42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) for institutions (Disclosure)
42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) for institutions (Disclosure)
42 CFR 50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii) (Disclosure)
42 CFR 50.605(a)(3)(i) or 45 CFR (a)(3)(i) (Disclosure)
42 CFR 50.605(a)(3)(iii) or 45 CFR 94.5 (a)(3)(iii) (Disclosure)
42 CFR 50.605(a)(4) (Disclosure)
42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) for - Investigators (Disclosure)
42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) for- Investigators (Disclosure)
42 CFR 50.604(e)(3) or 45 CFR 94.4 (e)(3) for - Investigators (Disclosure)
42 CFR 50.606(c) or 45 CFR 94.6(c) (Disclosure)
42 CFR 50.605(b)(4) (Reportimg)

---

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	136,382	950	0	1,207	0	134,225
Annual Time Burden (Hours)	677,820	950	0	13,690	0	663,180
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: Miscellaneous Actions

Short Statement: The adjustment of 992 for the initial reports represents an increase in respondents (those reporting an initial FCOI) vs. additional requirements. The initial table published was an estimate and with this reinstatement with change, we had some data on actual numbers. The increase in burden is only an increase in the actual reported initial FCOI reports than was originally estimated.

---

Annual Cost to Federal Government: $14,897

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

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

---

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: 09/11/2018

---