[Federal Register Volume 88, Number 145 (Monday, July 31, 2023)]
[Notices]
[Pages 49472-49473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: [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 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
                                                                                                  ------------------------------------------------------
    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