Medical Countermeasures.Gov

Forms and Documents

Document Name	Status
DRAFT V2.1 - 10.26.2016 _0990-0323_Spt Stmt PRA MCM (2).doc Supporting Statement A	2016-11-04

IC Document Collections

IC ID	Document Title	Status
182768	Developers of Medical Countermeasures to naturally occuring and intentional public health threats Other-form	Modified

ICR Details

OMB Control No: 0990-0323	ICR Reference No: 201608-0990-001
Status: Historical Active	Previous ICR Reference No: 201312-0990-002
Agency/Subagency: HHS/HHSDM	Agency Tracking No: 20518
Title: Medical Countermeasures.Gov
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/21/2016
	Date Received in OIRA: 11/07/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2019	36 Months From Approved	01/31/2017
Responses	225	0	225
Time Burden (Hours)	30	0	30
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:
	81 FR 57924	08/24/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 75831	11/01/2016
Did the Agency receive public comments on this ICR? No

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

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

	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	225	225	0	0	0	0
Annual Time Burden (Hours)	30	30	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	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:

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Annual Cost to Federal Government: $344,572

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 11/07/2016

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