Application Process for Clinical Research Training and Medical Education at the Clinical Center and its impact on Course and Training Program Enrollment and Effectiveness (CC)

Forms and Documents

Document Name	Status
Form 1 OCRTME Onboarding Application Form and Instruction	New
Form 1 Bioethics Fellowship Program Form and Instruction	Modified
Form 1 Resident Elective Program (REP) Form and Instruction	Modified
Form 1 Clinical Electives Program (CEP Form and Instruction	Modified
Form 1 Graduate Medical Education (GME) Form and Instruction	Modified
Form 1 Medical Research Scholars Program (MSRP) Form and Instruction	Modified
Attachment 8_Privacy Act Memo.pdf Supplementary Document	2023-08-29
Supporting Statement A - 0925-0698 August 2023.docx Supporting Statement A	2023-08-28
Attachment 7 CC CRSS OCRTME Training Program PIA.docx Supplementary Document	2023-08-28
30day FRN 0698.pdf Supplementary Document	2023-08-28

IC Document Collections

IC ID	Document Title	Status
261394	OCRTME Onboarding Application Form and Instruction	New
242283	Bioethics Fellowship Program Form and Instruction	Modified
226824	Resident Elective Program (REP) Form and Instruction	Modified
226823	Clinical Electives Program (CEP Form and Instruction	Modified
226822	Graduate Medical Education (GME) Form and Instruction	Modified
226815	Medical Research Scholars Program (MSRP) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0698	ICR Reference No: 202308-0925-002
Status: Received in OIRA	Previous ICR Reference No: 202006-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 21541
Title: Application Process for Clinical Research Training and Medical Education at the Clinical Center and its impact on Course and Training Program Enrollment and Effectiveness (CC)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/29/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2023
Responses	1,300	1,000
Time Burden (Hours)	433	333
Cost Burden (Dollars)	0	0

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Abstract: The existing information collection proposed for revision allows on-going assessment of the eligibility and qualifications of candidates applying for participation in clinical research training programs provided by the Office of Clinical Research Training and Medical Education located in the NIH Clinical Center (CC) over a ten-year follow-up period. The information received from respondents is evaluated by training program directors for the purpose of selecting qualified and competent participants in these resource-limited training programs operating within the Intramural Research Program (IRP) of the National Institutes of Health, and the NIH Clinical Center, located in Bethesda, Maryland. The information collected is also required to validate the compliance of graduate medical education training programs sponsored by the CC with the requirements of external accrediting organizations, specifically the Accreditation Council for Graduate Medical Education located in Chicago, IL. Applicant data are also used to assess the effectiveness of efforts to inform the applicant pool and the public about clinical research training within the IRP.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 19158	03/30/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 58286	08/25/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Bioethics Fellowship Program	1	Application
Clinical Electives Program (CEP	1	Application
Graduate Medical Education (GME)	1	Application
Medical Research Scholars Program (MSRP)	1	Application
OCRTME Onboarding Application	1	Application
Resident Elective Program (REP)	1	Application

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ICR Summary of Burden

	Total Request	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	1,300	1,000	0	300	0	0
Annual Time Burden (Hours)	433	333	0	100	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: No

Burden Reduction Due to:

Short Statement: The request for revision includes the addition of an onboarding eligibility documents collection application to collect required eligibility materials from applicants selected to participate in the Clinical Electives Program, Medical Research Scholars Program, Clinical Center Summer Internship Program and Clinical Center Postbaccalaureate Program. With the addition of the onboarding eligibility documents collection application, the estimated number of survey respondents will increase from 1,000 respondents to 1,300 respondents and the estimated total burden will increase from 333 hours to 633.

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Annual Cost to Federal Government: $84,733

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? No

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Common Form ICR:  No

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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: 08/29/2023

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