[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
----------------------------------------------------------------------------------------------------------------
                                                                                      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-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
----------------------------------------------------------------------------------------------------------------

[[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
----------------------------------------------------------------------------------------------------------------
                                       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
----------------------------------------------------------------------------------------------------------------
                                     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
                                                 ---------------------------------------------------------------
    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