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), 23978-23980 [2020-09137]
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23978
Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
Dated: April 22, 2020.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2020–09138 Filed 4–29–20; 8:45 am]
BILLING CODE 4140–01–P
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.
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.
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
FOR FURTHER INFORMATION CONTACT:
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 ORWHinfo@
mail.nih.gov. 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
Form name
Number of
respondents
Type of respondents
Number of
responses per
respondent
Average
burden
per response
(in hours)
Total annual
burden hours
Bench to Bedside: Immunology Module
Attitude survey pre-test .....................
Module completion ............................
jbell on DSKJLSW7X2PROD with NOTICES
Knowledge check ..............................
Attitude survey post-test ...................
Module evaluation .............................
VerDate Sep<11>2014
18:56 Apr 29, 2020
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Jkt 250001
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
25
60
15
25
60
15
25
60
15
25
60
15
25
60
15
E:\FR\FM\30APN1.SGM
1
1
1
1
1
1
1
1
1
1
1
1
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30APN1
5/60
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5/60
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5/60
5/60
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2
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15
4
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3
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1
23979
Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Number of
respondents
Type of respondents
Number of
responses per
respondent
Average
burden
per response
(in hours)
Total annual
burden hours
Bench to Bedside: Cardiovascular Module
Attitude survey pre-test .....................
Module completion ............................
Knowledge check ..............................
Attitude survey post-test ...................
Module evaluation .............................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
25
60
15
25
60
15
25
60
15
25
60
15
25
60
15
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
5/60
5/60
5/60
1
1
1
10/60
10/60
10/60
5/60
5/60
5/60
5/60
5/60
5/60
2
5
1
25
60
15
4
10
3
2
5
1
2
5
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
5/60
5/60
5/60
1
1
1
10/60
10/60
10/60
5/60
5/60
5/60
5/60
5/60
5/60
2
5
1
25
60
15
4
10
3
2
5
1
2
5
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
5/60
5/60
5/60
1
1
1
10/60
10/60
10/60
5/60
5/60
5/60
5/60
5/60
5/60
2
5
1
25
60
15
4
10
3
2
5
1
2
5
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
5/60
5/60
5/60
1
1
1
10/60
10/60
10/60
5/60
5/60
5/60
5/60
5/60
2
5
1
25
60
15
4
10
3
2
5
1
2
5
Bench to Bedside: Pulmonary Module
Attitude survey pre-test .....................
Module completion ............................
Knowledge check ..............................
Attitude survey post-test ...................
Module evaluation .............................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
25
60
15
25
60
15
25
60
15
25
60
15
25
60
15
Bench to Bedside: Neurology Module
Attitude survey pre-test .....................
Module completion ............................
Knowledge check ..............................
Attitude survey post-test ...................
Module evaluation .............................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
25
60
15
25
60
15
25
60
15
25
60
15
25
60
15
Bench to Bedside: Endocrinology Module
Attitude survey pre-test .....................
jbell on DSKJLSW7X2PROD with NOTICES
Module completion ............................
Knowledge check ..............................
Attitude survey post-test ...................
Module evaluation .............................
VerDate Sep<11>2014
18:56 Apr 29, 2020
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Jkt 250001
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
25
60
15
25
60
15
25
60
15
25
60
15
25
60
E:\FR\FM\30APN1.SGM
30APN1
23980
Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Number of
respondents
Type of respondents
Individual ..........................................
Number of
responses per
respondent
15
Average
burden
per response
(in hours)
Total annual
burden hours
1
5/60
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
5/60
5/60
5/60
1
1
1
10/60
10/60
10/60
5/60
5/60
5/60
5/60
5/60
5/60
2
5
1
25
60
15
4
10
3
2
5
1
2
5
1
Bench to Bedside: Mental Health Module
Attitude survey pre-test .....................
Module completion ............................
Knowledge check ..............................
Attitude survey post-test ...................
Module evaluation .............................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
25
60
15
25
60
15
25
60
15
25
60
15
25
60
15
Sex as a Biological Variable: A Primer
Attitude survey pre-test .....................
Course completion ............................
Attitude survey post-test ...................
Course evaluation .............................
Total ...........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
25
60
15
25
60
15
25
60
15
25
60
15
1
1
1
1
1
1
1
1
1
1
1
1
5/60
5/60
5/60
1
1
1
5/60
5/60
5/60
5/60
5/60
5/60
2
5
1
25
60
15
2
5
1
2
5
1
...........................................................
100
3400
........................
970
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
VerDate Sep<11>2014
18:56 Apr 29, 2020
Jkt 250001
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: NIDCR Special Grants
Review Committee.
Date: June 18–19, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental and
Craniofacial Research, National Institutes of
Health, 6701 Democracy Boulevard, Room
672, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Latarsha J. Carithers,
Scientific Review Officer, Scientific Review
Branch, National Institute of Dental and
Craniofacial Research, National Institutes of
Health, 6701 Democracy Boulevard, Room
672, Bethesda, MD 20892, 301–594–4859,
latarsha.carithers@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Dated: April 27, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–09245 Filed 4–29–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
E:\FR\FM\30APN1.SGM
30APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
