MedWatch: The FDA Medical Products Reporting Program

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

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

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5855	MedWatch: The FDA Medical Products Reporting Program	Form	Migrated

ICR Details

OMB Control No: 0910-0291	ICR Reference No: 199909-0910-001
Status: Historical Active	Previous ICR Reference No: 199806-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: MedWatch: The FDA Medical Products Reporting Program
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: 11/15/1999
	Date Received in OIRA: 09/07/1999
Terms of Clearance: This collection is approved through 8/00 consistent with the previous terms of clearance. Specifically, FDA will (1) continue to redesign the data ocllected under the current Medical Device Reporting (MDR) program including the 3500A, the Baseline Report, and the Medical Device Registration and Listing Process; (2) present the redesign to OMB and the regulated community prior to the resubmission to OMB; (3) make appropriate revisions and subject the redesigned forms to public comment prior to the OMB submission. As agreed to previously, FDA shall take particular care to work closely with interested parties who will be affected by any changes to the form and will address in detail any changes in the resubmission any comments received. This collection has been previously extended numerous times for this purpose. It will not be extended in the future until these conditions are met in full.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2000	08/31/2000	11/30/1999
Responses	328,361	0	298,570
Time Burden (Hours)	320,081	0	289,005
Cost Burden (Dollars)	0	0	6,427,000

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Abstract: Reporting of adverse events and product problems by health professionals to the FDA either directly or via the manufacturer is critical to an effective national postmarketing surveillance system. The overall MedWatch program is a national educational/ promotional initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems to FDA and/or the manufacturer and to ensure that new medical products' safety information is communicated rapidly to the health professional community, thereby improving patient care.

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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

table that charts list of burden

IC Title	Form No.	Form Name
MedWatch: The FDA Medical Products Reporting Program	FDA-3500, FDA-3500A

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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	328,361	298,570	0	29,791	0	0
Annual Time Burden (Hours)	320,081	289,005	0	31,076	0	0
Annual Cost Burden (Dollars)	0	6,427,000	0	0	-6,427,000	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: 09/07/1999

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