[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Notices]
[Pages 57869-57872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20232]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-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 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 recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

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. Chyren Hunter, Associate Director, Basic and 
Translational Research, Office of Research on Women's Health, 6707 
Democracy Blvd., Room 437, Bethesda, Maryland 20817 or call non-toll-
free number (301) 496-7849 or email your request to 
[email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on April 30, 2020, pages 
23978-23980 and allowed 60 days for public comment. One comment was 
received. The purpose of this notice is to allow an additional 30 days 
for public comment.
    The Office of Research on Women's Health, 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.

[[Page 57870]]

    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: Bench to Bedside: Integrating Sex and Gender 
to Improve Human Health and Sex as a Biological Variable: A Primer--
0925-New--expiration date, 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, the National Institute 
of General Medical Sciences, 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 4,060.

                                        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)
----------------------------------------------------------------------------------------------------------------
                                       Bench to Bedside: Immunology Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre- and post-  Private sector..             105               2            5/60              18
 test.
                                Federal                      180               2            5/60              30
                                 government.
                                Individual......              15               2            5/60               3
Module completion.............  Private sector..             105               1               1             105
                                Federal                      180               1               1             180
                                 government.
                                Individual......              15               1               1              15
Knowledge check...............  Private sector..             105               1           10/60              18
                                Federal                      180               1           10/60              30
                                 government.
                                Individual......              15               1           10/60               3
Module evaluation.............  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
Outcomes evaluation...........  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
----------------------------------------------------------------------------------------------------------------
                                     Bench to Bedside: Cardiovascular Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre- and post-  Private sector..             105               2            5/60              18
 test.
                                Federal                      180               2            5/60              30
                                 government.
                                Individual......              15               2            5/60               3
Module completion.............  Private sector..             105               1               1             105
                                Federal                      180               1               1             180
                                 government.
                                Individual......              15               1               1              15
Knowledge check...............  Private sector..             105               1           10/60              18
                                Federal                      180               1           10/60              30
                                 government.
                                Individual......              15               1           10/60               3
Module evaluation.............  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
Outcomes evaluation...........  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
----------------------------------------------------------------------------------------------------------------
                                   Bench to Bedside: Pulmonary Disease Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre- and post-  Private sector..             105               2            5/60              18
 test.
                                Federal                      180               2            5/60              30
                                 government.
                                Individual......              15               2            5/60               3
Module completion.............  Private sector..             105               1               1             105
                                Federal                      180               1               1             180
                                 government.
                                Individual......              15               1               1              15
Knowledge check...............  Private sector..             105               1           10/60              18
                                Federal                      180               1           10/60              30
                                 government.
                                Individual......              15               1           10/60               3

[[Page 57871]]

 
Module evaluation.............  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
Outcomes evaluation...........  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
----------------------------------------------------------------------------------------------------------------
                                       Bench to Bedside: Neurology Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre- and post-  Private sector..             105               2            5/60              18
 test.
                                Federal                      180               2            5/60              30
                                 government.
                                Individual......              15               2            5/60               3
Module completion.............  Private sector..             105               1               1             105
                                Federal                      180               1               1             180
                                 government.
                                Individual......              15               1               1              15
Knowledge check...............  Private sector..             105               1           10/60              18
                                Federal                      180               1           10/60              30
                                 government.
                                Individual......              15               1           10/60               3
Module evaluation.............  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
Outcomes evaluation...........  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
----------------------------------------------------------------------------------------------------------------
                                     Bench to Bedside: Endocrinology Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre- and post-  Private sector..             105               2            5/60              18
 test.
                                Federal                      180               2            5/60              30
                                 government.
                                Individual......              15               2            5/60               3
Module completion.............  Private sector..             105               1               1             105
                                Federal                      180               1               1             180
                                 government.
                                Individual......              15               1               1              15
Knowledge check...............  Private sector..             105               1           10/60              18
                                Federal                      180               1           10/60              30
                                 government.
                                Individual......              15               1           10/60               3
Module evaluation.............  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
Outcomes evaluation...........  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
----------------------------------------------------------------------------------------------------------------
                                     Bench to Bedside: Mental Health Module
----------------------------------------------------------------------------------------------------------------
Attitude survey pre- and post-  Private sector..             105               2            5/60              18
 test.
                                Federal                      180               2            5/60              30
                                 government.
                                Individual......              15               2            5/60               3
Module completion.............  Private sector..             105               1               1             105
                                Federal                      180               1               1             180
                                 government.
                                Individual......              15               1               1              15
Knowledge check...............  Private sector..             105               1           10/60              18
                                Federal                      180               1           10/60              30
                                 government.
                                Individual......              15               1           10/60               3
Module evaluation.............  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
Outcomes evaluation...........  Private sector..              17               1            5/60               1
                                Federal                       30               1            5/60               3
                                 government.
                                Individual......               3               1            5/60               0
----------------------------------------------------------------------------------------------------------------
                                                   SABV Primer
----------------------------------------------------------------------------------------------------------------
Attitude survey pre- and post-  Private sector..             105               8            5/60              70
 test.
                                Federal                      180               8            5/60             120
                                 government.
                                Individual......              15               8            5/60              10
Course completion.............  Private sector..             105               4               1             420
                                Federal                      180               4               1             720
                                 government.
                                Individual......              15               4               1              60
Knowledge check...............  Private sector..             105               4           10/60              70

[[Page 57872]]

 
                                Federal                      180               4           10/60             120
                                 government.
                                Individual......              15               4           10/60              10
                                                 ---------------------------------------------------------------
    Total.....................  ................             600          12,570  ..............           4,060
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    Dated: September 6, 2020.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2020-20232 Filed 9-15-20; 8:45 am]
BILLING CODE 4140-01-P