MedWatch: FDA's Medical Product Reporting Program

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
5854	MedWatch: FDA's Medical Product Reporting Program Form	Migrated

ICR Details

OMB Control No: 0910-0291	ICR Reference No: 199806-0910-001
Status: Historical Active	Previous ICR Reference No: 199509-0910-018
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: MedWatch: FDA's Medical Product Reporting Program
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/29/1998
	Date Received in OIRA: 06/03/1998
Terms of Clearance: This collection is approved through 1/99 on the following conditions: (1) FDA work actively over the next 6 months to redesign the data collected 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 by 10/98 (3) make appropriate revisions and subject the redesigned forms to public comment prior to the OMB submission. 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 in the resubmission any comments received. This collection has been in violation of the Paperwork Reduction Act and will be reported to Congress as part of OMB's annual reporting of such violations.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/1999	01/31/1999
Responses	298,570	0	0
Time Burden (Hours)	289,005	0	0
Cost Burden (Dollars)	6,427,000	0	0

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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 safety information is communicated rapidly to the medical 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

IC Title	Form No.	Form Name
MedWatch: FDA's Medical Product Reporting Program	3500, 3500A

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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	298,570	0	0	298,570	0	0
Annual Time Burden (Hours)	289,005	0	0	289,005	0	0
Annual Cost Burden (Dollars)	6,427,000	0	0	6,427,000	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: 06/03/1998

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