2019-20747. Submission for OMB Review; 30-Day Comment Request; Application and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research (Office of the Director)

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.

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. Anne Zajicek, Deputy Director, Office of Clinical Research, OD, NIH, Building 1, Room 208A, 1 Center Drive, Bethesda, MD 20892, or call non-toll-free number [phone] or Email your request, including your address to: [e-mail].

SUPPLEMENTARY INFORMATION:

This proposed information collection was previously published in the Federal Register on Friday, July 12, 2019, Volume 84, pages 33270-33272 (64 FR 15367) 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.

The Office of Clinical Research, Office of the Director, 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 and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research, Office of Clinical Research (OCR), National Institutes of Health (NIH), Office of the Director (OD).

Need and Use of Information Collection: The purpose of this survey is to assess the long-term impact and outcomes of clinical research training programs provided by the Office of Clinical Research located in the NIH Office of the Director (OD) over a ten-year follow-up period. The information received from respondents will provide insight on the following: Impact of the courses on (a) promotion of professional competence, (b) research productivity and independence, and (c) future career development within clinical, translational and academic research settings. These surveys will provide preliminary data and guidance in (1) developing recommendations for collecting outcomes to assess the effectiveness of the training courses, and (2) tracking the impact of the curriculum on participants' ability to perform successfully in academic, non-academic, research, and non-research settings.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,589.

Estimated Annualized Burden Hours

Form name	Type of respondents	Estimated number of respondents	Number of responses per respondent	Average time per response (in hours)	Total annual burden hours
OCR Learning Portal Registration (Attachment 1)	Healthcare Professionals	2000	1	10/60	333
	Students	1000	1	10/60	167
	General Public	500	1	10/60	83
IPPCR Lecture Evaluation (Attachment 2)	Healthcare Professionals	750	1	10/60	125
	Students	500	1	10/60	83
	General Public	250	1	10/60	42
IPPCR Final Course Evaluation (Attachment 4)	Healthcare Professionals	750	1	10/60	125
	Students	500	1	10/60	83
	General Public	250	1	10/60	42
PCP Lecture Evaluation (Attachment 3)	Healthcare Professionals	750	1	10/60	125
	Students	500	1	10/60	83
	General Public	250	1	10/60	42
PCP Final Course Evaluation (Attachment 5)	Healthcare Professionals	750	1	10/60	125
	Students	500	1	10/60	83
	General Public	250	1	10/60	42
NIH Summer Course in Clinical and Translational Research Course Evaluation (Attachment 6)	Healthcare Professionals	20	1	10/60	3
Sabbatical in Clinical Research Management Course Evaluation (Attachment 7)	Healthcare Professionals	20	1	10/60	3
Total			9,540		1,589

Dated: September 18, 2019.

Lawrence A. Tabak,

Principal Deputy Director, National Institutes of Health.