Bench to Bedside: Integrating Sex and Gender to Improve Human Health & Sex as a Biological Variable: A Primer (OD/ORWH)

ICR 202003-0925-006

OMB: 0925-0768

Federal Form Document

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Supplementary Document
2020-09-16
Supplementary Document
2020-08-31
Supplementary Document
2020-08-31
Supplementary Document
2020-08-31
Supporting Statement A
2020-11-17
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ICR Details
0925-0768 202003-0925-006
Active
HHS/NIH
Bench to Bedside: Integrating Sex and Gender to Improve Human Health & Sex as a Biological Variable: A Primer (OD/ORWH)
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 11/19/2020
Retrieve Notice of Action (NOA) 09/16/2020
  Inventory as of this Action Requested Previously Approved
11/30/2023 36 Months From Approved
12,600 0 0
4,060 0 0
0 0 0

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.

US Code: 42 USC 24 Name of Law: public law
  
None

Not associated with rulemaking

  85 FR 23978 04/30/2020
85 FR 57869 09/16/2020
Yes

99
IC Title Form No. Form Name
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-- Module evaluation (Private) 5 Module Evaluation
Bench to Bedside: Pulmonary Module-- Module evaluaion (Federal) 5 Module Evaluation
Bench to Bedside: Pulmonary Module-- Module evaluation (individual) 5 Module Evaluation
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 (Federal) 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-- Module completion (Private) 2 Module Completion Course Dashboard
Bench to Bedside: Neurology Module-- Module completion (Federal) 2 Module Completion Course Dashboard
Bench to Bedside: Neurology Module-- Knowledge check (Private) 8 Neurology Knowledge check
Bench to Bedside: Neurology Module-- Knowledge check (Federal) 8 neurology Knowledge check
Bench to Bedside: Neurology Module-- Knowledge check (individual) 8 Neurology Knowledge chek
Bench to Bedside: Neurology Module--Outcomes Evaluation (Private) 4 Outcomes 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-- Module evaluation (Private) 5 Module Evaluation
Bench to Bedside: Neurology Module-- Module evaluation (Federal) 5 Module Evaluation
Bench to Bedside: Neurology Module-- Module evaluation (individual) 5 Module Evaluation
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 (Federal) 1 Pre-Post Test
Bench to Bedside Immunology Module -- Outcomes Evaluation (individual) 4 Outcomes Evaluation
Bench to Bedside Immunology Module -- Module evaluation (Private) 5 Module Evaluation
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: Cardiovascular Module-- Attitude survey pre and post test (Federal) 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-- Module completion (private) 2 Module completion Course Dashboard
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-- Knowledge check (Private) 6 Cardiovascular Disease Knowledge check
Bench to Bedside: Cardiovascular Module-- Knowledge check (Federal) 6 Cardiovascular Disease knowledge check
Bench to Bedside: Cardiovascular Module-- Knowledge check (individual) 6 Cardiovascular Disease knowledge check
Bench to Bedside: Endocrinology Module-- Module completion (Private) 2 Module Completion Course Dashboard
Bench to Bedside: Endocrinology Module-- Module completion (Federal) 2 Module Completion Course Dashboard
Bench to Bedside: Endocrinology Module-- Module completion (individual) 2 Module Completion Course Dashboard
Bench to Bedside: Endocrinology Module-- Knowledge check (Private) 9 Endocrinology knowledge check
Bench to Bedside: Endocrinology Module-- Knowledge check (Federal) 9 Endocrinology knowledge check
Bench to Bedside: Endocrinology Module-- Knowledge check (individual) 9 Endocrinology knowledge check
Bench to Bedside: Endocrinology Module-- Outcomes Evaluation (Federal) 4 Outcomes Evaluation
Bench to Bedside: Endocrinology Module-- Outcomes Evaluation (individual) 4 Outcomes Evaluation
Bench to Bedside: Endocrinology Module-- Module evaluation (Private) 5 Module Evaluation
Bench to Bedside: Endocrinology Module-- Module evaluation (Federal) 5 Module Evaluation
Bench to Bedside: Endocrinology Module-- Module evaluation (individual) 5 Module Evaluation
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 (Federal) 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-- Module completion (Private) 2 Module Completion Course Dashboard
Bench to Bedside: Mental Health Module-- Module completion (Federal) 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-- Knowledge check (Private) 10 Mental Health knowledge check
Bench to Bedside: Mental Health Module-- Knowledge check (Federal) 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-- Outcomes Evaluation (Private) 4 Outomes Evaluation
Bench to Bedside: Mental Health Module-- Outcomes Evaluation (Federal) 4 Outcomes Evaluation
Bench to Bedside: Mental Health Module-- Outcomes Evaluation (individual) 4 Outcomes 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
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 and post test (Federal) 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 (Private) 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-- 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
Sex as a Biological Variable: A Primer-- Course evaluation (individual) 11, 12, 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
Bench to Bedside Immunology Module Attitude survey pre and post test (private sector) 1 Pre-Post Test
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 Completion (Private) 2 Module Completion Course Dashboard
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-- Knowledge check (Private) 3 Immunology knowledge check
Bench to Bedside Immunology Module -- Knowledge check (Federal) 3 Immunology knowledge check
Bench to Bedside: Neurology Module-- Module completion (individual) 2 Module Completion Course Dashboard
Bench to Bedside: Endocrinology Module-- Attitude survey pre and post test (individual) 1 Pre-Post Test
Bench to Bedside: Endocrinology Module-- Outcomes Evaluation (Private) 4 Outcomes Evaluation
Bench to Bedside: Mental Health Module-- Module evaluation (Federal) 5 Module Evaluation
Sex as a Biological Variable: A Primer-- Course completion (individual) 2 Course completion Course Dashboard
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
Bench to Bedside: Pulmonary Module-- Module completion (individual) 2 Module Completion Course Dashboard
Bench to Bedside: Cardiovascular Module-- Attitude survey pre and post test (Private) 1 Pre-Post Test
Bench to Bedside: Cardiovascular Module-- Outcomes Evaluation (Private) 4 Outcomes Evaluation
Bench to Bedside: Cardiovascular Module-- Outcomes Evaluation (Federal) 4 Outcomes Evaluation
Bench to Bedside: Cardiovascular Module-- Outcomes Evaluation (individual) 4 Outcomes Evaluation
Bench to Bedside: Cardiovascular Module-- Module evaluation (Private) 5 Module Evaluation
Bench to Bedside: Pulmonary Module-- Module completion (Federal) 2 Module Completion Course Dashboard
Bench to Bedside: Cardiovascular Module-- Module evaluation (Federal) 5 Module Evaluation
Bench to Bedside: Cardiovascular Module-- Module evaluation (individual) 5 Module Evaluation
Bench to Bedside: Pulmonary Module-- Attitude survey pre and post-test (Private) 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 (individual) 1 Pre-Post Test
Bench to Bedside: Pulmonary Module-- Module completion (Private) 2 Module Completion Course Dashboard
Bench to Bedside: Pulmonary Module-- Knowledge check (Private) 7 Pulmonary Disease knowledge check
Bench to Bedside: Pulmonary Module-- Knowledge check (Federal) 7 Pulmonary Disease knowledge check
Bench to Bedside: Pulmonary Module-- Knowledge check (individual) 7 Pulmonary Disease Knowledge check
Bench to Bedside: Pulmonary Module--Outcomes Evaluation (Private) 4 Outcomes Evaluation
Bench to Bedside Immunology Module -- Outcomes Evaluation (Private) 4 Outcomes Evaluation
Bench to Bedside Immunology Module-- Outcomes Evaluation (Federal) 4 Outcomes Evaluation
Bench to Bedside Immunology Module -- Knowledge check (Individual) 3 Immunology knowledge check

  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
Yes
Miscellaneous Actions
No
New submission

$193,172
No
    Yes
    Yes
No
No
No
No
Tawanda Abdelmouti 240 276-5530 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
09/16/2020


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