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Notice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recall Regulations

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Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by November 10, 2008.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910-0249. Also include the FDA docket number found in brackets in the heading of this document.

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FOR FURTHER INFORMATION CONTACT:

Elizabeth Berbakos, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3792.

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SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

FDA Recall Regulations—21 CFR Part 7—(OMB Control Number 0910-0249—Extension)

Section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371) and part 7, subpart C (21 CFR part 7, subpart C), set forth the recall regulations (guidelines) and provide guidance to manufacturers on recall responsibilities. The guidelines apply to all FDA regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; and biological products intended for human use). These responsibilities include: (1) developing a recall strategy that requires time by the firm to determine the actions or procedures required to manage the recall (§ 7.42); (2) providing FDA with complete details of the recall including reason(s) for the removal or correction, risk evaluation, quantity produced, distribution information, firm's recall strategy, a copy of any recall communication(s), and a contact official (§ 7.46); (3) notifying direct accounts of the recall, providing guidance regarding further distribution, giving instructions as to what to do with the product, providing recipients with a ready means of reporting to the recalling firm (§ 7.49); (4) submitting periodic status reports so that FDA may assess the progress of the recall (status report information may be determined by, among other things, evaluation return reply cards, effectiveness checks, and product returns) (§ 7.53); and (5) providing the opportunity for a firm to request in writing that FDA terminate the recall (§ 7.55).

A search of the FDA database was performed to determine the number of recalls that took place during fiscal year 2007. The resulting number of recalls from this database search (2,166) is used in estimating the current annual reporting burden for this report. FDA Start Printed Page 59634estimates the total annual industry burden to collect and provide the previous information to 216,600 burden hours.

Table 1 of this document is a summary of the estimated annual burden hours for recalling firms (manufacturers, processors, and distributors) to comply with the voluntary reporting requirements of FDA's recall regulations.

In the Federal Register of June 3, 2008 (73 FR 31696), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

Recognizing that there may be a vast difference in the information collection and reporting time involved in different recalls of FDA's regulated products, FDA estimates on average the burden of collection for recall information to be as follows:

Table 1.—Estimated Annual Reporting Burden1

21 CFR SectionNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
Recall strategy 7.422,16612,1662043,320
Firm initiated recall and recall communications 7.46 and 7.492,16612,1663064,980
Recall status reports and followup 7.532,16648,6641086,640
Termination of a recall 7.55(b)2,16612,1661021,660
Total216,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The annual reporting burdens are explained as follows:

Reporting

A. Recall Strategy

Request firms develop a recall strategy including provision for public warnings and effectiveness checks. Under this portion of the collection of information, the agency estimates it will receive 2,166 responses annually.

B. Firm Initiated Recall and Recall Communications

Request firms voluntarily remove or correct foods and drugs (human or animal), cosmetics, medical devices, and biologicals to immediately notify the appropriate FDA district office of such actions. The firm is to provide complete details of the recall reason, risk evaluation, quantity produced, distribution information, firms' recall strategy and a contact official as well as requires firms to notify their direct accounts of the recall and to provide recipients with a ready means of reporting to the recalling firm. Under these portions of the collection of information, the agency estimates it will receive 2,166 responses annually for each.

C. Recall Status Reports

Request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. This collection of information will generate approximately 8,664 responses annually.

D. Termination of a Recall

Provide the firms an opportunity to request in writing that FDA end the recall. The agency estimates it will receive 2,166 responses annually.

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Dated: October 1, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E8-23910 Filed 10-8-08; 8:45 am]

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