ACAM2000® Myopericarditis Registry

Forms and Documents

Document Name	Status
OMB_SS_ACAM_PART B.doc Supporting Statement B	2012-06-28
OMB_SS_ACAM_PART A.doc Supporting Statement A	2012-06-28

IC Document Collections

IC ID	Document Title	Status
200540	ACAM2000® Myopericarditis Registry Other-Survey	New

ICR Details

OMB Control No: 0720-0054	ICR Reference No: 201112-0720-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: DOD/DODOASHA	Agency Tracking No:
Title: ACAM2000® Myopericarditis Registry
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: 08/27/2012
	Date Received in OIRA: 12/21/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved
Responses	40	0	0
Time Burden (Hours)	20	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The information collected will be used to evaluate factors that may influence myopericarditis disease prognosis. If factors are identified that suggest an elevation in risk, the information collected in this study will guide future studies and can help with the creation of policies to mitigate potential risks as further studies are conducted.

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Authorizing Statute(s): None

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:
	76 FR 13990	03/15/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 13990	03/15/2011
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
ACAM2000® Myopericarditis Registry	DD Form 2870	Authorization for Disclosure of Medical or Dental Information

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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	40	0	0	40	0	0
Annual Time Burden (Hours)	20	0	0	20	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 Collection. Although we would try to use DD Form 2870 to request records from civilian facilities as well, experience tells us that most civilian facilities would require that their own specific facility's HIPAA-compliant Records Request form would need to be used. In such cases we would obtain the specific form from the facility, have it signed by the registry participant, then submit it to the facility. As this process would be on a case-by-case basis, it is impossible to know which facilities would have provided care and therefore which forms would need to be used.

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Annual Cost to Federal Government:

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 12/21/2011

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