[Federal Register Volume 90, Number 231 (Thursday, December 4, 2025)]
[Notices]
[Pages 55871-55873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-21913]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-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.
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SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the Office of Clinical Research Education and
Collaboration Outreach (OCRECO), Office of Intramural Research (OIR),
National Institutes of Health, will publish periodic summaries of
proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit
[[Page 55872]]
comments in writing, or request more information on the proposed
project, contact: Dr. Ahmed M. Gharib, Program Director, Office of
Clinical Research Education and Collaboration Outreach, NIH Office of
the Director, Building 1, Room 201, MSC-0155, Bethesda, Maryland 20892
or email your request, including your address to: [email protected]. Formal requests for additional plans and
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimizes the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Application and Impact of Clinical
Research Training on Healthcare Professionals in Academia and Clinical
Research, 0925-0764, exp., date 07/31/2027, Revision, Office of
Clinical Research Education and Collaboration Outreach (OCRECO), Office
of Intramural Research (OIR), National Institutes of Health (NIH),
Office of the Director (OD).
Need and Use of Information Collection: The purpose of these
revised surveys is to continue to assess the long-term impact and
outcomes of clinical research training programs provided by the Office
of Clinical Research Education and Collaboration Outreach, located in
the Office of Intramural Research, over a ten-year follow-up period.
The information received from respondents will continue to 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 continue to 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.
This revision request is comprised of the addition of 4 new
surveys: two application surveys for two new certificate programs and
two generic/template surveys for additional courses as part of the
clinical research education programs of the office. The clinical
research education programs include: the Introduction to the Principles
and Practice of Clinical Research and Principles of Clinical
Pharmacology, Sabbatical in Clinical Research Management, the NIH
Summer Course in Clinical and Translational Research, the Ethical and
Regulatory Aspects of Clinical Research Course (Asynchronous/Online),
the Clinical Research Curriculum Certificate Program, the Radiology
Research Certificate Program, and additional future courses.
OMB revision request approval is requested for 3 years. There are
no costs to respondents other than their time. The total estimated
annualized burden hours are 2,723.
Estimated Annualized Burden Hours
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Average Total
Estimated Number of burden per annual
Form name Type of respondents number of responses per response burden
respondents respondent (in hours) hours
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OCRECO Learning Portal Registration (Attachment Healthcare Professionals........................ 5,000 1 5/60 417
1). General Public.................................. 15,000 1 5/60 1,250
IPPCR Lecture Evaluation (Attachment 2)........ Healthcare Professionals........................ 2,000 1 5/60 167
General Public.................................. 5,000 1 5/60 417
IPPCR Final Course Evaluation (Attachment 4)... Healthcare Professionals........................ 300 1 5/60 25
General Public.................................. 500 1 5/60 42
PCP Lecture Evaluation (Attachment 3).......... Healthcare Professionals........................ 1,000 1 3/60 50
General Public.................................. 3,000 1 3/60 150
PCP Final Course Evaluation (Attachment 5)..... Healthcare Professionals........................ 200 1 3/60 10
General Public.................................. 400 1 3/60 20
NIH Summer Course in Clinical and Translational Healthcare Professionals........................ 20 1 5/60 2
Research Course Evaluation (Attachment 6).
Sabbatical in Clinical Research Management Healthcare Professionals........................ 20 1 5/60 2
Course Evaluation (Attachment 7).
Ethical and Regulatory Aspects of Clinical Healthcare Professionals........................ 500 1 5/60 25
Research (Asynchronous/Online) Final Course General Public.................................. 1,000 1 3/60 50
Evaluation (Attachment 8).
Clinical Research Curriculum Certificate Healthcare Professionals........................ 100 1 5/60 8
Program Application (Attachment 10).
Radiology Research Certificate Program Healthcare Professionals........................ 20 1 5/60 2
Application (Attachment 10).
Generic Lecture Evaluation (Attachment 11)..... Healthcare Professionals........................ 500 1 3/60 25
General Public.................................. 1,000 1 3/60 50
Generic Final Course Evaluation (Attachment 12) Healthcare Professionals........................ 100 1 3/60 5
General Public.................................. 150 1 3/60 8
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Total...................................... ................................................ ............ 35,810 ........... 2,723
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[[Page 55873]]
Ahmed M. Gharib,
Project Clearance Liaison, Office of the Director, National Institutes
of Health.
[FR Doc. 2025-21913 Filed 12-3-25; 8:45 am]
BILLING CODE 4140-01-P