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 5 Bioethics Fellowship Program Form	New
Form 11 Clinical Research Course Form	Removed
Form 10 Bioethics Form	Removed
Form 4 Resident Elective Program (REP) Form	Modified
Form 1 Clinical Electives Program (CEP Form	Modified
Form 2 Graduate Medical Education (GME) Form	Modified
Form 6 Sabbatical Form	Removed
Form 5 IPPCR Form	Removed
Form 4 PhD Summer Course Form	Removed
Form 3 PCP Form	Removed
Form 2 NIH-Duke Form	Removed
Form 3 Medical Research Scholars Program (MSRP) Form	Modified
pub 30-day FRN2020-14057.pdf Supplementary Document	2020-06-30
Attachment 7_Privacy Act Memo.pdf Supplementary Document	2020-06-30
Attachment 6_PIA.rtf Supplementary Document	2020-06-30
Support Statement A - 0925-0698-6.10.2020.docx Supporting Statement A	2020-06-30

IC Document Collections

IC ID	Document Title	Status
242283	Bioethics Fellowship Program Form	New
226826	Clinical Research Course Form	Removed
226825	Bioethics Form	Removed
226824	Resident Elective Program (REP) Form	Modified
226823	Clinical Electives Program (CEP Form	Modified
226822	Graduate Medical Education (GME) Form	Modified
226821	Sabbatical Form	Removed
226820	IPPCR Form	Removed
226819	PhD Summer Course Form	Removed
226818	PCP Form	Removed
226817	NIH-Duke Form	Removed
226815	Medical Research Scholars Program (MSRP) Form	Modified

ICR Details

OMB Control No: 0925-0698	ICR Reference No: 202006-0925-001
Status: Active	Previous ICR Reference No: 201705-0925-008
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/17/2020
	Date Received in OIRA: 06/30/2020
Terms of Clearance: Approved with the understanding that discontinued activities in this ICR were moved to OMB Control Number 0925-0764.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	1,000	0	12,448
Time Burden (Hours)	333	0	4,148
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 located in the NIH Clinical Center (CC) over a ten year follow-up period.

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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:
	85 FR 21255	04/16/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 39199	06/30/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Graduate Medical Education (GME)	2	Graduated Medical Education
Clinical Electives Program (CEP	1	Clinical Electives Program
Resident Elective Program (REP)	4	Resident Electives Program
PCP	3	PCP
Bioethics	10	Bioethics Fellowship Program
Medical Research Scholars Program (MSRP)	3	Medical Research Scholars Program
IPPCR	5	IPPCR
Bioethics Fellowship Program	5	Bioethics Fellowship Program
NIH-Duke	2	NIH-Duke
PhD Summer Course	4	PhD Summer Course
Sabbatical	6	Sabbatical in Clinical Research Management
Clinical Research Course	11	Clinical Research Training

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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	1,000	12,448	0	-11,448	0	0
Annual Time Burden (Hours)	333	4,148	0	-3,815	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: This is an ongoing project with a request for revision. The request for revision includes the discontinuation of program applications for Introduction to the Principles and Practice of Clinical Research (IPPCR), NIH-Duke Training Program in Clinical Research (NIH-DUKE), Ph.D. Student Summer Course in Clinical and Translational Research, Principles of Clinical Pharmacology Course (PCP), Sabbatical in Clinical Research Management, and Clinical Research Training On-Line Course for Principal Investigators a these training programs initially managed by OCRTME have transitioned to the NIH Office of Clinical Research. With the decrease of training program applications that will be continued under this collection, both the estimated number of survey respondents will decrease from 12,448 to 1,000 respondents and the estimated total burden will decrease from 4148 to 333 hours, respectively.

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Annual Cost to Federal Government: $78,769

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: 06/30/2020

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