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

Forms and Documents

Document Name	Status
Form 11 Clinical Research Course Form	New
Form 10 Bioethics Form	New
Form 9 REP Form	New
Form 8 CEP Form	New
Form 7 GME Form	New
Form 6 Sabbatical Form	New
Form 5 IPPCR Form	New
Form 4 PhD Summer Course Form	New
Form 3 PCP Form	New
Form 2 NIH-Duke Form	New
Form 1 Medical Research Scholars Program (MSRP) Form	New
Form 1 OCRTME Appilications for the NIH Clinical Center Form and Instruction	Removed
30-day FRN2017-10205.pdf Supplementary Document	2017-05-23
Support Statement A - 0925-0698-Final-5-9-17.docx Supporting Statement A	2017-05-12
Attachment 12 CRS-PrivacyImpactAssessment.PDF Supplementary Document	2017-05-12

IC Document Collections

IC ID	Document Title	Status
226826	Clinical Research Course Form	New
226825	Bioethics Form	New
226824	REP Form	New
226823	CEP Form	New
226822	GME Form	New
226821	Sabbatical Form	New
226820	IPPCR Form	New
226819	PhD Summer Course Form	New
226818	PCP Form	New
226817	NIH-Duke Form	New
226815	Medical Research Scholars Program (MSRP) Form	New
210634	OCRTME Appilications for the NIH Clinical Center Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0698	ICR Reference No: 201705-0925-008
Status: Historical Active	Previous ICR Reference No: 201403-0925-001
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
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: 07/25/2017
	Date Received in OIRA: 05/24/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	36 Months From Approved	07/31/2017
Responses	12,448	0	6,629
Time Burden (Hours)	4,148	0	2,210
Cost Burden (Dollars)	0	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 (OCRTME) 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 in accordance 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:
	82 FR 13127	03/09/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 23010	05/19/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Clinical Research Course	11	Clinical Research Training
PhD Summer Course	4	PhD Summer Course
Bioethics	10	Bioethics Fellowship Program
NIH-Duke	2	NIH-Duke
IPPCR	5	IPPCR
OCRTME Appilications for the NIH Clinical Center	1	All OCRTME Application forms
Medical Research Scholars Program (MSRP)	1	Medical Research Scholars Program
PCP	3	PCP
Sabbatical	6	Sabbatical in Clinical Research Management
GME	7	Graduated Medical Education
CEP	8	Clinical Electives Program
REP	9	Resident Electives Program

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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	12,448	6,629	0	5,819	0	0
Annual Time Burden (Hours)	4,148	2,210	0	1,938	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: Miscellaneous Actions

Short Statement: Accordingly, this revision, combined with an increase in the applicant pool for all OCRTME programs since the original submission in 2014, will result in an increase in both the annual total number of survey respondents and the estimated annual total burden hours

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Annual Cost to Federal Government: $64,448

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

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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: 05/24/2017

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