Notice2023-16184
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)
Primary source
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Published
July 31, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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, Collaboration, and Outreach (OCRECO), Office of the Director (OD), 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.
Full Text
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<title>Federal Register, Volume 88 Issue 145 (Monday, July 31, 2023)</title>
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[Federal Register Volume 88, Number 145 (Monday, July 31, 2023)]
[Notices]
[Pages 49472-49473]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16184]
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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,
Collaboration, and Outreach (OCRECO), Office of the Director (OD),
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 comments in writing, or
request more information on the proposed project, contact: Dr. Anne
Zajicek, M.D., Pharm.D., Program Director, Office of Clinical Research
Education, Collaboration, and Outreach, NIH Office of the Director,
Building 1, Room 201, MSC-0155, Bethesda, Maryland 20892 or call non-
toll-free number (301) 480-9913 or email your request, including your
address to: <a href="/cdn-cgi/l/email-protection#dea4bfb4b7bdbbb5bf9eb3bfb7b2f0b0b7b6f0b9b1a8"><span class="__cf_email__" data-cfemail="6f150e05060c0a040e2f020e06034101060741080019">[email protected]</span></a>. 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 02/28/2026, Revision Office of Clinical
Research Education and Collaboration Outreach (OCRECO), National
Institutes of Health (NIH), Office of the Director (OD).
Need and Use of Information Collection: The purpose of this
revision is to: update the name of the office responsible for these on-
line training programs (from Office of Clinical Research to Office of
Clinical Research Education and Collaboration Outreach); revise the
course evaluation survey questions; add an additional on-line course,
``Ethical and Regulatory Aspects of Clinical Research''; change the
course opening and close dates from Oct-June to Sept-July. The survey
will continue to assess the long-term impact and outcomes of clinical
research training programs provided by the newly formed Office of
Clinical Research Education, Collaboration, and Outreach (previously
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 820.
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 Healthcare Professionals......................... 2000 1 5/60 167
(Attachment 1).
Students......................................... 1000 1 5/60 83
General Public................................... 500 1 5/60 42
IPPCR Lecture Evaluation (Attachment 2)....... Healthcare Professionals......................... 750 1 5/60 63
Students......................................... 500 1 5/60 42
General Public................................... 250 1 5/60 21
IPPCR Final Course Evaluation(Attachment 4)... Healthcare Professionals......................... 750 1 5/60 63
Students......................................... 500 1 5/60 42
[[Page 49473]]
General Public................................... 250 1 5/60 21
PCP Lecture Evaluation (Attachment 3)......... Healthcare Professionals......................... 750 1 5/60 63
Students......................................... 500 1 5/60 42
General Public................................... 250 1 5/60 21
PCP Final Course Evaluation (Attachment 5).... Healthcare Professionals......................... 750 1 5/60 63
Students......................................... 500 1 5/60 42
General Public................................... 250 1 5/60 21
NIH Summer Course in Clinical and Healthcare Professionals......................... 20 1 5/60 2
Translational 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......................... 100 1 5/60 8
Research (Asynchronous/Online) Course Students......................................... 50 1 5/60 4
(Attachment 8). General Public................................... 100 1 5/60 8
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Total..................................... ................................................. .............. 9,790 ........... 820
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Dated: July 25, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2023-16184 Filed 7-28-23; 8:45 am]
BILLING CODE 4140-01-P
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