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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 Generic ICR - OIRA Conclusion
OMB Control No:
0990-0488
ICR Reference No:
202211-0990-001
Status:
Active
Previous ICR Reference No:
Agency/Subagency:
HHS/HHSDM
Agency Tracking No:
Title:
Administration for Strategic Preparedness and Response—Office of Strategy, Policy, Planning, and Requirements Generic Clearance for the National Strategy for a Resilient Public Health Supply Chain
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 without change
Conclusion Date:
03/29/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/16/2022
Terms of Clearance:
The agency will submit individual collections (GenICs) under this generic clearance to OMB. These submissions will include the actual study instruments along with a memo describing the specific study goal, the study design, any incentives to be used, coordination with relevant federal offices and agencies (including those outside of HHS) for specific GenICs, and the sampling and analysis plans (as applicable).
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2026
36 Months From Approved
Responses
32,800
0
0
Time Burden (Hours)
358,934
0
0
Cost Burden (Dollars)
23,226,620
0
0
Abstract:
As directed by Executive Order 14001, The National Strategy for a Resilient Public Health Supply Chain (The National Strategy) provides a strategic approach to design, build, and sustain a long-term capability in the United States to manufacture supplies for future pandemics and biological threats. The Administration for Strategic Preparedness and Response at the Department of Health and Human Services is leading an interagency team in implementing the National Strategy and is requesting a generic clearance for purposes of implementation to: gain a better understanding of the public health supply chain; develop future strategic goals and recommendations for building immediate and long-term resilience through increased visibility, agility, and robustness in the public health supply chain to prepare for and mitigate future public health emergencies; and to ensure ASPR, HHS, and the broader U.S. government have current data and information to inform program and policy decision-making. Formative research and assessment are the main objectives of the activities included in this clearance. The participants will include, but not be limited to, SLTTs, trade groups and associations, mixed cross-sector audiences, non-governmental organizations, manufacturers, academia, healthcare providers and facilities, and local communities, labor unions, workforce training providers, organizations, and state and local workforce boards.
Authorizing Statute(s):
EO: EO 14001 Name/Subject of EO: A Sustainable Public Health Supply Chain
Citations for New Statutory Requirements:
EO: EO 14001 Name/Subject of EO: A Sustainable Public Health Supply Chain
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:
87 FR 30230
05/18/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 77127
12/16/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
0
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
32,800
0
32,800
0
0
0
Annual Time Burden (Hours)
358,934
0
358,934
0
0
0
Annual Cost Burden (Dollars)
23,226,620
0
23,226,620
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new generic information collection request.
Annual Cost to Federal Government:
$2,023,077
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
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.
No
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.
No
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?
Yes
Agency Contact:
Shante Edwards 202 578-4154 shante.edwards@hhs.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:
12/16/2022
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