05-16846. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations (Guidelines)

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 September 23, 2005.

ADDRESSES:

The Office of Management and Budget (OMB) is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: [phone].

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

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.

Food and Drug Administration Recall Regulations (Guidelines)—(OMB Control Number 0910-0249)—Extension

Section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371) and part 7 (21 CFR part 7), subpart C sets forth the recall regulations (guidelines) and provides 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 development of a recall strategy that requires time by the firm to determine the actions or procedures required to manage the recall; 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; 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; 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; and providing the opportunity for a firm to request in writing that FDA terminate the recall.

A search of the FDA database was performed to determine the number of recalls that took place during fiscal year 2003. The resulting number of recalls from this database search (2,375) is used in estimating the current annual reporting burden for this report. FDA estimates the total annual industry burden to collect and provide the above information to 201,875 burden hours.

The following 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.

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 Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Recall Strategy	2,375	1	2,375	15	35,625
Firm Initiated Recall & Public Warnings Recall Communications	2,375	1	2,375	20	47,500
Recall Status Reports & Followup	2,375	4	9,500	10	95,000
Termination of a Recall	2,375	1	2,375	10	23,750
Total					201,875
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:

Recall Strategy

Requests firms to 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 2,375 responses annually.

Firm Initiated Recall and Recall Communications

Requests firms that 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, firm's 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 2,375 responses annually for each.

Recall Status Reports

Requests that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. This collection of information will generate approximately 9,500 responses annually.

In the Federal Register of October 12, 2004 (69 FR 60630), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

Dated: August 17, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.