[Federal Register: August 24, 2005 (Volume 70, Number 163)]
[Page 49654-49655]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0442]

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: 202-395-6974.

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 Burden\1\
                                                                      Annual Frequency per       Total Annual
             21 CFR Section                  No. of Respondents             Response               Responses      Hours per Response      Total Hours
Recall Strategy                                             2,375                         1               2,375                  15              35,625
Firm Initiated Recall & Public Warnings                     2,375                         1               2,375                  20              47,500
 Recall Communications
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

[[Page 49655]]

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.
[FR Doc. 05-16846 Filed 8-23-05; 8:45 am]