Medical Countermeasures.Gov

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
V3.1_20230124_0990-0323_Spt Stmt PRA MCM_FINAL.docx	Supporting Statement A	Uploaded 2023-04-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
182768	Developers of Medical Countermeasures to naturally occuring and intentional public health threats	Other-iNSTRUCTION AND FORM	Modified

ICR Details

OMB Control No: 0990-0323	ICR Reference No: 202304-0990-010
Status: Historical Active	Previous ICR Reference No: 201911-0990-001
Agency/Subagency: HHS/HHSDM	Agency Tracking No: 20518
Title: Medical Countermeasures.Gov
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/24/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/18/2023
Terms of Clearance: Rather than waive the requirement to display the expiration date, we recommend that the agency display on the portal: "Version current as of [insert date of ICR approval; May 2023]" or "Last updated: May 2023" or something similar.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2026	36 Months From Approved
Responses	350	0	0
Time Burden (Hours)	47	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: During the BioShield Stakeholders Workshop, HHS Secretary Michael O. Leavitt announced that HHS would develop a stakeholders' portal, which would be a "web-based system through which those in industry and the research and development community can reach the people they need in the federal government, whether they're looking at a basic level of research or focused on end-stage development." Which led to developing Medical Countermeasures.gov to facilitate communication between federal government agencies and public stakeholders to enhance the Nation's public health emergency preparedness.

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Authorizing Statute(s): US Code: 3 USC 301 Name of Law: General Powers and Duties of Public Health Service, Part A-Research and Investigation
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 6287	01/31/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 23445	04/17/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Developers of Medical Countermeasures to naturally occuring and intentional public health threats

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ICR Summary of Burden

table that charts list 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	350	0	0	350	0	0
Annual Time Burden (Hours)	47	0	0	47	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: This is a continuation of data collection; however, the number of responses has increased due to interest from medical countermeasure developers.

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Annual Cost to Federal Government: $344,572

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.     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

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Common Form ICR:  No

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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: 04/18/2023

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