[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23978-23980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09137]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Bench to Bedside:
Integrating Sex and Gender To Improve Human Health & Sex as a
Biological Variable: A Primer (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 National Institutes of Health Office of
Research on Women's Health (ORWH) 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. Chyren
Hunter, Associate Director, Basic and Translational Research, 6707
Democracy Blvd., Room 437, Bethesda, Maryland 20817 or call non-toll-
free number (301) 402-1770 or email your request 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 minimize's 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: Bench to Bedside: Integrating Sex and
Gender to Improve Human Health & Sex as a Biological Variable: A
Primer, 0925-NEW, expiration date XX/XX/XXXX, Office of Research on
Women's Health (ORWH), Office of the Director (OD), National Institutes
of Health (NIH).
Need and Use of Information Collection: Bench to Bedside:
Integrating Sex and Gender to Improve Human Health'' is an online
course developed by ORWH, the FDA Office of Women's Health, and other
non-federal subject matter experts. ``Sex as a Biological Variable: A
Primer'' is an online course developed by ORWH, NIGMS, and other non-
federal subject matter experts. Together, these two courses will
provide learners a rationale for the study of biological differences
between the sexes, the impact of sex and gender difference on illness,
guidance on incorporating the NIH policy on sex as a biological
variable (SABV) into studies, and an exploration of sex- and gender-
related differences in key disease areas. The Bench to Bedside course
will also offer free continuing medical education credits.
In conjunction with these two courses, ORWH will collect
information through registration information and surveys (knowledge
checks, attitude assessments, and course evaluations). The information
collected will be used in the following ways: 1. To assess uptake and
learning of concepts in each lesson; 2. To identify demographic trends
across learners in order to inform targeted outreach 3. To assess
effectiveness of course materials; and 4. To identify areas of focus
for future course improvement, modifications, and expansion.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 970.
Estimated Annualized Burden Hours
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Average
Type of Number of Number of burden per Total annual
Form name respondents respondents responses per response (in burden hours
respondent hours)
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Bench to Bedside: Immunology Module
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Attitude survey pre-test...... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module completion............. Private sector.. 25 1 1 25
Federal 60 1 1 60
government.
Individual...... 15 1 1 15
Knowledge check............... Private sector.. 25 1 10/60 4
Federal 60 1 10/60 10
government.
Individual...... 15 1 10/60 3
Attitude survey post-test..... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module evaluation............. Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
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[[Page 23979]]
Bench to Bedside: Cardiovascular Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre-test...... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module completion............. Private sector.. 25 1 1 25
Federal 60 1 1 60
government.
Individual...... 15 1 1 15
Knowledge check............... Private sector.. 25 1 10/60 4
Federal 60 1 10/60 10
government.
Individual...... 15 1 10/60 3
Attitude survey post-test..... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module evaluation............. Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
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Bench to Bedside: Pulmonary Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre-test...... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module completion............. Private sector.. 25 1 1 25
Federal 60 1 1 60
government.
Individual...... 15 1 1 15
Knowledge check............... Private sector.. 25 1 10/60 4
Federal 60 1 10/60 10
government.
Individual...... 15 1 10/60 3
Attitude survey post-test..... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module evaluation............. Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
----------------------------------------------------------------------------------------------------------------
Bench to Bedside: Neurology Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre-test...... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module completion............. Private sector.. 25 1 1 25
Federal 60 1 1 60
government.
Individual...... 15 1 1 15
Knowledge check............... Private sector.. 25 1 10/60 4
Federal 60 1 10/60 10
government.
Individual...... 15 1 10/60 3
Attitude survey post-test..... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module evaluation............. Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
----------------------------------------------------------------------------------------------------------------
Bench to Bedside: Endocrinology Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre-test...... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module completion............. Private sector.. 25 1 1 25
Federal 60 1 1 60
government.
Individual...... 15 1 1 15
Knowledge check............... Private sector.. 25 1 10/60 4
Federal 60 1 10/60 10
government.
Individual...... 15 1 10/60 3
Attitude survey post-test..... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module evaluation............. Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
[[Page 23980]]
Individual...... 15 1 5/60 1
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Bench to Bedside: Mental Health Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre-test...... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module completion............. Private sector.. 25 1 1 25
Federal 60 1 1 60
government.
Individual...... 15 1 1 15
Knowledge check............... Private sector.. 25 1 10/60 4
Federal 60 1 10/60 10
government.
Individual...... 15 1 10/60 3
Attitude survey post-test..... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Module evaluation............. Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
----------------------------------------------------------------------------------------------------------------
Sex as a Biological Variable: A Primer
----------------------------------------------------------------------------------------------------------------
Attitude survey pre-test...... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Course completion............. Private sector.. 25 1 1 25
Federal 60 1 1 60
government.
Individual...... 15 1 1 15
Attitude survey post-test..... Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
Course evaluation............. Private sector.. 25 1 5/60 2
Federal 60 1 5/60 5
government.
Individual...... 15 1 5/60 1
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Total..................... ................ 100 3400 .............. 970
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Dated: April 22, 2020.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2020-09137 Filed 4-29-20; 8:45 am]
BILLING CODE 4140-01-P