View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0925-0768
ICR Reference No:
202003-0925-006
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/NIH
Agency Tracking No:
Title:
Bench to Bedside: Integrating Sex and Gender to Improve Human Health & Sex as a Biological Variable: A Primer (OD/ORWH)
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
11/19/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/16/2020
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2023
36 Months From Approved
Responses
12,600
0
0
Time Burden (Hours)
4,060
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
42 USC 24
Name of Law: public law
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
85 FR 23978
04/30/2020
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 57869
09/16/2020
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
99
IC Title
Form No.
Form Name
Bench to Bedside: Cardiovascular Module-- Attitude survey pre and post test (Federal)
1
Pre-Post test
Bench to Bedside: Cardiovascular Module-- Attitude survey pre and post test (Private)
1
Pre-Post Test
Bench to Bedside: Cardiovascular Module-- Attitude survey pre and post test (individual)
1
Pre-Post test
Bench to Bedside: Cardiovascular Module-- Knowledge check (Federal)
6
Cardiovascular Disease knowledge check
Bench to Bedside: Cardiovascular Module-- Knowledge check (Private)
6
Cardiovascular Disease Knowledge check
Bench to Bedside: Cardiovascular Module-- Knowledge check (individual)
6
Cardiovascular Disease knowledge check
Bench to Bedside: Cardiovascular Module-- Module completion (Federal)
2
Module Completion Course Dashboard
Bench to Bedside: Cardiovascular Module-- Module completion (individual)
2
Module Completion Course Dashboard
Bench to Bedside: Cardiovascular Module-- Module completion (private)
2
Module completion Course Dashboard
Bench to Bedside: Cardiovascular Module-- Module evaluation (Federal)
5
Module Evaluation
Bench to Bedside: Cardiovascular Module-- Module evaluation (Private)
5
Module Evaluation
Bench to Bedside: Cardiovascular Module-- Module evaluation (individual)
5
Module Evaluation
Bench to Bedside: Cardiovascular Module-- Outcomes Evaluation (Federal)
4
Outcomes Evaluation
Bench to Bedside: Cardiovascular Module-- Outcomes Evaluation (Private)
4
Outcomes Evaluation
Bench to Bedside: Cardiovascular Module-- Outcomes Evaluation (individual)
4
Outcomes Evaluation
Bench to Bedside: Neurology Module-- Attitude survey pre and post test (Federal)
1
Pre-Post Test
Bench to Bedside: Neurology Module-- Attitude survey pre and post test (Private)
1
Pre-Post Test
Bench to Bedside: Neurology Module-- Attitude survey pre and post test (individual
1
Pre-Post Test
Bench to Bedside: Neurology Module-- Knowledge check (Federal)
8
neurology Knowledge check
Bench to Bedside: Neurology Module-- Knowledge check (Private)
8
Neurology Knowledge check
Bench to Bedside: Neurology Module-- Knowledge check (individual)
8
Neurology Knowledge chek
Bench to Bedside: Neurology Module-- Module completion (Federal)
2
Module Completion Course Dashboard
Bench to Bedside: Neurology Module-- Module completion (Private)
2
Module Completion Course Dashboard
Bench to Bedside: Neurology Module-- Module completion (individual)
2
Module Completion Course Dashboard
Bench to Bedside: Neurology Module-- Module evaluation (Federal)
5
Module Evaluation
Bench to Bedside: Neurology Module-- Module evaluation (Private)
5
Module Evaluation
Bench to Bedside: Neurology Module-- Module evaluation (individual)
5
Module Evaluation
Bench to Bedside: Neurology Module-- Outcomes Evaluation (Federal)
4
Outcomes Evaluation
Bench to Bedside: Neurology Module-- Outcomes Evaluation (individual)
4
Outcomes Evaluation
Bench to Bedside: Neurology Module--Outcomes Evaluation (Private)
4
Outcomes Evaluation
Sex as a Biological Variable: A Primer-- Attitude survey pre and post test (Federal)
1
Pre-Post Test
Sex as a Biological Variable: A Primer-- Attitude survey pre and post test (Private)
1
Pre-Post Test
Sex as a Biological Variable: A Primer-- Attitude survey pre-test (individual)
1
Pre-Post Test
Sex as a Biological Variable: A Primer-- Course completion (individual)
2
Course completion Course Dashboard
Sex as a Biological Variable: A Primer-- Course completion (Federal)
2
Course completion Course Dashboard
Sex as a Biological Variable: A Primer-- Course completion (Private)
2
Course completion Course Dashboard
Bench to Bedside Immunology Module -- Knowledge check (Federal)
3
Immunology knowledge check
Bench to Bedside Immunology Module -- Knowledge check (Individual)
3
Immunology knowledge check
Bench to Bedside Immunology Module -- Module Evaluation (Federal)
5
Module Evaluation
Bench to Bedside Immunology Module -- Module Evaluation (individual)
5
Module Evaluation
Bench to Bedside Immunology Module -- Module evaluation (Private)
5
Module Evaluation
Bench to Bedside Immunology Module -- Outcomes Evaluation (Private)
4
Outcomes Evaluation
Bench to Bedside Immunology Module -- Outcomes Evaluation (individual)
4
Outcomes Evaluation
Bench to Bedside Immunology Module Attitude survey pre and post test (Federal)
1
Pre-Post test
Bench to Bedside Immunology Module Attitude survey pre and post test (individual)
1
Pre-Post test
Bench to Bedside Immunology Module Attitude survey pre and post test (private sector)
1
Pre-Post Test
Bench to Bedside Immunology Module Completion (Federal)
2
Module Completion Course Dashboard
Bench to Bedside Immunology Module Completion (Individual)
2
Module Completion Course Dashboard
Bench to Bedside Immunology Module Completion (Private)
2
Module Completion Course Dashboard
Bench to Bedside Immunology Module-- Knowledge check (Private)
3
Immunology knowledge check
Bench to Bedside Immunology Module-- Outcomes Evaluation (Federal)
4
Outcomes Evaluation
Bench to Bedside: Endocrinology Module-- Attitude survey pre and post test (Federal)
1
Pre-Post Test
Bench to Bedside: Endocrinology Module-- Attitude survey pre and post test (Private)
1
Pre-Post Test
Bench to Bedside: Endocrinology Module-- Attitude survey pre and post test (individual)
1
Pre-Post Test
Bench to Bedside: Endocrinology Module-- Knowledge check (Federal)
9
Endocrinology knowledge check
Bench to Bedside: Endocrinology Module-- Knowledge check (Private)
9
Endocrinology knowledge check
Bench to Bedside: Endocrinology Module-- Knowledge check (individual)
9
Endocrinology knowledge check
Bench to Bedside: Endocrinology Module-- Module completion (Federal)
2
Module Completion Course Dashboard
Bench to Bedside: Endocrinology Module-- Module completion (Private)
2
Module Completion Course Dashboard
Bench to Bedside: Endocrinology Module-- Module completion (individual)
2
Module Completion Course Dashboard
Bench to Bedside: Endocrinology Module-- Module evaluation (Federal)
5
Module Evaluation
Bench to Bedside: Endocrinology Module-- Module evaluation (Private)
5
Module Evaluation
Bench to Bedside: Endocrinology Module-- Module evaluation (individual)
5
Module Evaluation
Bench to Bedside: Endocrinology Module-- Outcomes Evaluation (Federal)
4
Outcomes Evaluation
Bench to Bedside: Endocrinology Module-- Outcomes Evaluation (Private)
4
Outcomes Evaluation
Bench to Bedside: Endocrinology Module-- Outcomes Evaluation (individual)
4
Outcomes Evaluation
Bench to Bedside: Mental Health Module-- Attitude survey pre and post test (Federal)
1
Pre-Post Test
Bench to Bedside: Mental Health Module-- Attitude survey pre and post test (Private)
1
Pre-Post Test
Bench to Bedside: Mental Health Module-- Attitude survey pre and post test (individual)
1
Pre-Post Test
Bench to Bedside: Mental Health Module-- Knowledge check (Federal)
10
Mental Health knowledge check
Bench to Bedside: Mental Health Module-- Knowledge check (Private)
10
Mental Health knowledge check
Bench to Bedside: Mental Health Module-- Knowledge check (individual)
10
Mental Health knowledge check
Bench to Bedside: Mental Health Module-- Module completion (Federal)
2
Module Completion Course Dashboard
Bench to Bedside: Mental Health Module-- Module completion (Private)
2
Module Completion Course Dashboard
Bench to Bedside: Mental Health Module-- Module completion (individual)
2
Module Completion Course Dashboard
Bench to Bedside: Mental Health Module-- Module evaluation (Federal)
5
Module Evaluation
Bench to Bedside: Mental Health Module-- Module evaluation (Private)
5
Module Evaluation
Bench to Bedside: Mental Health Module-- Module evaluation (individual)
5
Module Evaluation
Bench to Bedside: Mental Health Module-- Outcomes Evaluation (Federal)
4
Outcomes Evaluation
Bench to Bedside: Mental Health Module-- Outcomes Evaluation (Private)
4
Outomes Evaluation
Bench to Bedside: Mental Health Module-- Outcomes Evaluation (individual)
4
Outcomes Evaluation
Bench to Bedside: Pulmonary Module-- Attitude survey pre and post test (individual)
1
Pre-Post Test
Bench to Bedside: Pulmonary Module-- Attitude survey pre and post-test (Federal)
1
Pre-Post Test
Bench to Bedside: Pulmonary Module-- Attitude survey pre and post-test (Private)
1
Pre-Post Test
Bench to Bedside: Pulmonary Module-- Knowledge check (Federal)
7
Pulmonary Disease knowledge check
Bench to Bedside: Pulmonary Module-- Knowledge check (Private)
7
Pulmonary Disease knowledge check
Bench to Bedside: Pulmonary Module-- Knowledge check (individual)
7
Pulmonary Disease Knowledge check
Bench to Bedside: Pulmonary Module-- Module completion (Federal)
2
Module Completion Course Dashboard
Bench to Bedside: Pulmonary Module-- Module completion (Private)
2
Module Completion Course Dashboard
Bench to Bedside: Pulmonary Module-- Module completion (individual)
2
Module Completion Course Dashboard
Bench to Bedside: Pulmonary Module-- Module evaluaion (Federal)
5
Module Evaluation
Bench to Bedside: Pulmonary Module-- Module evaluation (Private)
5
Module Evaluation
Bench to Bedside: Pulmonary Module-- Module evaluation (individual)
5
Module Evaluation
Bench to Bedside: Pulmonary Module-- Outcomes Evaluation (Federal)
4
outcomes Evaluation
Bench to Bedside: Pulmonary Module-- Outcomes Evaluation (individual)
4
Outcomes Evaluation
Bench to Bedside: Pulmonary Module--Outcomes Evaluation (Private)
4
Outcomes Evaluation
Sex as a Biological Variable: A Primer-- Course evaluation (individual)
12, 11, 13, 14
SABV and the Health of Women and Men knowledge check
,
SABV and Experimental Design Knowledge check
,
SABV and Analyses knowledge check
,
SABV and Reporting knowledge check
Sex as a Biological Variable: A Primer-- Knowledge check (Federal)
11, 12, 13, 14
SABV and Health and Women and Men Knowledge check
,
SABV and Experimental Design Knowledge check
,
SABV and Analyses knowledge check
,
SABV and Reporting knowledge check
Sex as a Biological Variable: A Primer-- Knowledge check (Private)
11, 13, 14, 12
SABV and the Health of Women and Men Knowledge check
,
SABV and Experimental Design knowledge check
,
SABV and Analyses knowledge check
,
SABV and Reporting knowledge check
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
12,600
0
0
12,600
0
0
Annual Time Burden (Hours)
4,060
0
0
4,060
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
New submission
Annual Cost to Federal Government:
$193,172
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
09/16/2020
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