2017-10205. Submission for OMB Review; 30-Day Comment Request: Application Process for Clinical Research Training and Medical Education at the NIH Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness (Clinical ...

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 9, 2017, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

DATES:

Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

ADDRESSES:

Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [e-mail] or by fax to 202-395-6974, Attention: Desk Officer for NIH.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Robert M. Lembo, Deputy Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center, Building 10, Room 1N252, MSC-1158, Bethesda, Maryland, 20892 or call non-toll-free number [phone] or Email your request, including your address to: [e-mail].

SUPPLEMENTARY INFORMATION:

The NIH Clinical Center (CC), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Proposed Collection: Application Process for Clinical Research Training and Medical Education at the NIH Clinical Center, Revision OMB #0925-0698, Expiration date May 31, 2017, National Institutes of Health Clinical Center (CC), National Institutes of Health (NIH).

Need and Use of Information Collection: The primary objective of the application process is to allow the Office of Clinical Research Training and Medical Education (OCRTME) at the NIH Clinical Center to evaluate applicants' qualifications to determine applicants' eligibility for courses and training programs managed by the Office. Applicants must provide the required information requested in the respective applications to be considered a candidate for participation. Information submitted by candidates for training programs is reviewed initially by OCRTME administrative staff to establish eligibility for participation. Eligible candidates are then referred to the designated training program director/administrator or training program selection committee for review and decisions regarding acceptance for participation. A secondary objective of the application process is to track enrollment in courses and training programs over time.

OMB approval is requested for 3 years. There is no cost to respondents other than their time. There are capital, operating, and/or maintenance costs of $64,448. The total estimated annualized burden hours are 4,148.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents per year	Number of responses per respondent	Average burden per response (in hours)	Total annual burden hours
Pre-Doctoral (MD, DDS, DVM, PhD) Students, Post-Doctoral Students, Physicians/Surgeons, Other Health Care Practitioners/Technicians	MRSP	140	1	20/60	47
	IPPCR	6700	1	20/60	2233
	NIH-Duke	16	1	20/60	5
	PCP	800	1	20/60	267
	PhD Summer Course	70	1	20/60	23
	Sabbatical	10	1	20/60	3
Pre-Doctoral (MD, DDS, DVM, PhD) Students, Post-Doctoral Students, Physicians/Surgeons, Other Health Care Practitioners/Technicians	GME	2500	1	20/60	833
	CEP	300	1	20/60	100
	REP	90	1	20/60	30
	Bioethics	262	1	20/60	87
	Clinical Research Course	1560	1	20/60	520
Totals		12,448			4148

Dated: May 9, 2017.

Laura M. Lee,

Project Clearance Liaison, NIH Clinical Center, National Institutes of Health.