Notice2023-22351

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)

Primary source

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Published
October 6, 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 the 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.

Full Text

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<title>Federal Register, Volume 88 Issue 193 (Friday, October 6, 2023)</title>
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[Federal Register Volume 88, Number 193 (Friday, October 6, 2023)]
[Notices]
[Pages 69643-69646]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22351]


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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 the 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. 
Elizabeth Barr, 6707 Democracy Blvd., Suite 438, Bethesda, Maryland, 
20817 or call non-toll-free number (301) 402-7895 or email your request 
to <a href="/cdn-cgi/l/email-protection#d09f828798b3bfa5a2a3b5a390bfb4febeb9b8feb7bfa6"><span class="__cf_email__" data-cfemail="541b06031c373b2126273127143b307a3a3d3c7a333b22">[email&#160;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 minimize 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 
[Extension], 0925-0768, expiration date

[[Page 69644]]

11/30/2023, 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 Food and Drug Administration, 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 differences on illness, 
guidance on incorporating NIH policy on sex as a biological variable 
into studies, and an exploration of sex- and gender-related differences 
in key disease areas. The Bench to Bedside course offers 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 the 
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
                   Form name                               Type of respondents               Number of     responses per   per response    Total annual
                                                                                            respondents     respondent      (in hours)     burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Bench to Bedside: Immunology Module
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attitude survey pre-test.......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module completion..............................  Private sector.........................              25               1               1              25
                                                 Federal Government.....................              60               1               1              60
                                                 Individual.............................              15               1               1              15
Knowledge check................................  Private sector.........................              25               1           10/60               4
                                                 Federal Government.....................              60               1           10/60              10
                                                 Individual.............................              15               1           10/60               3
Attitude survey post-test......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module evaluation..............................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Bench to Bedside: Cardiovascular Module
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attitude survey pre-test.......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module completion..............................  Private sector.........................              25               1               1              25
                                                 Federal Government.....................              60               1               1              60
                                                 Individual.............................              15               1               1              15
Knowledge check................................  Private sector.........................              25               1           10/60               4
                                                 Federal Government.....................              60               1           10/60              10
                                                 Individual.............................              15               1           10/60               3
Attitude survey post-test......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module evaluation..............................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Bench to Bedside: Pulmonary Module
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attitude survey pre-test.......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module completion..............................  Private sector.........................              25               1               1              25
                                                 Federal Government.....................              60               1               1              60
                                                 Individual.............................              15               1               1              15
Knowledge check................................  Private sector.........................              25               1           10/60               4
                                                 Federal Government.....................              60               1           10/60              10
                                                 Individual.............................              15               1           10/60               3
Attitude survey post-test......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module evaluation..............................  Private sector.........................              25               1            5/60               2

[[Page 69645]]

 
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Bench to Bedside: Neurology Module
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attitude survey pre-test.......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module completion..............................  Private sector.........................              25               1               1              25
                                                 Federal Government.....................              60               1               1              60
                                                 Individual.............................              15               1               1              15
Knowledge check................................  Private sector.........................              25               1           10/60               4
                                                 Federal Government.....................              60               1           10/60              10
                                                 Individual.............................              15               1           10/60               3
Attitude survey post-test......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module evaluation..............................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Bench to Bedside: Endocrinology Module
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attitude survey pre-test.......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module completion..............................  Private sector.........................              25               1               1              25
                                                 Federal Government.....................              60               1               1              60
                                                 Individual.............................              15               1               1              15
Knowledge check................................  Private sector.........................              25               1           10/60               4
                                                 Federal Government.....................              60               1           10/60              10
                                                 Individual.............................              15               1           10/60               3
Attitude survey post-test......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module evaluation..............................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Bench to Bedside: Mental Health Module
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attitude survey pre-test.......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module completion..............................  Private sector.........................              25               1               1              25
                                                 Federal Government.....................              60               1               1              60
                                                 Individual.............................              15               1               1              15
Knowledge check................................  Private sector.........................              25               1           10/60               4
                                                 Federal Government.....................              60               1           10/60              10
                                                 Individual.............................              15               1           10/60               3
Attitude survey post-test......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Module evaluation..............................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 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 Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Course completion..............................  Private sector.........................              25               1               1              25
                                                 Federal Government.....................              60               1               1              60
                                                 Individual.............................              15               1               1              15
Attitude survey post-test......................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5
                                                 Individual.............................              15               1            5/60               1
Course evaluation..............................  Private sector.........................              25               1            5/60               2
                                                 Federal Government.....................              60               1            5/60               5

[[Page 69646]]

 
                                                 Individual.............................              15               1            5/60               1
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             100           3,400  ..............             970
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    Dated: October 2, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2023-22351 Filed 10-5-23; 8:45 am]
BILLING CODE 4140-01-P


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