MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations - Survey

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
6314	MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations - Survey	Migrated

ICR Details

OMB Control No: 0910-0593	ICR Reference No: 200606-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations - Survey
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 06/20/2006
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/27/2006
	Date Received in OIRA: 06/08/2006
Terms of Clearance: This request has been cleared for 180 days as specified by the em ergency clearance process. HHS/FDA is required to make changes t o the burden calculations as discussed as part of OMB review. Ad ditionally, HHS/FDA has indicated that this is a one-time collect ion, and therefore OMB assumes that HHS/FDA will submit another p aperwork request if they want to re-administer the survey.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2006	12/31/2006
Responses	96	0	0
Time Burden (Hours)	48	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The FDA MedWatch Partners program is an outreach effort directed at health care provider organizations. The effort facilitates the timely dissemination of clinically important new information on drugs, devices and other human medical care products regulated by the FDA and prescribed, dispensed or used by the membership of these professional societies. In voluntarily agreeing to work with FDA MedWatch, these partner organizations disseminate this information to their members and their members' patients so medical products necessary to efforts to improve a patients health may be used more safely and reduce risk of harm. The....

Emergency Justfication:

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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:

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Federal Register Notices & Comments

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
MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations - Survey

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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	96	0	0	96	0	0
Annual Time Burden (Hours)	48	0	0	48	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:

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: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 06/08/2006

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