[Federal Register Volume 66, Number 160 (Friday, August 17, 2001)]
[Notices]
[Pages 43263-43264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20842]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0174]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; FDA Recall Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written comments on the collection of information by 
September 17, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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--Part 7 (21 CFR Part 7 (Subpart C))--(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 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 
(Sec. 7.42); 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, 
copy of any recall communication(s), and a contact official 
(Sec. 7.46); 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 (Sec. 7.49); and submitting periodic 
status reports so that FDA may assess the progress of the recall. 
Status report information may be determined by, among other things, 
evaluating return reply cards, effectiveness checks, and product 
returns (Sec. 7.53); and providing the opportunity for a firm to 
request in writing that FDA terminate the recall (Sec. 7.55).
    A search of the FDA database was performed to determine the number 
of recalls that took place during fiscal year 2000. The resulting 
number of recalls from this database search (1,933) 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 be 157,675 burden hours.
    In the Federal Register of May 1, 2001 (66 FR 21767), FDA published 
a 60-day notice requesting public comment on the information collection 
provisions. One comment was received on the information collection.
    We agree with the comment that the agency is slow in providing the 
recall classification letter to recalling firms and are taking steps to 
streamline the classification process which, in turn, will improve the 
timeliness of the classification letter. However, we

[[Page 43264]]

believe that recalling firms are usually aware of the significance of 
the defect in a recalled product and know the likely FDA 
classification. This may be based on the firm's own health hazard 
evaluation, by precedent recalls and information published on FDA's Web 
sites, and/or by verbal communication with FDA district office recall 
coordinators. The latter is especially true regarding the 
classification of serious to potentially life-threatening hazard-to-
health recall actions (class I). In such situations, the delivery of a 
classification letter usually follows extensive communications between 
recalling firms and FDA in which classification, recall strategy, and 
press releases are immediately discussed.
    We have accepted the commenter's estimate of the time expended to 
conduct recalls and have used those figures, coupled with revised 
recall numbers, to develop what we believe to be a more realistic 
estimate of the time expended by FDA-regulated industry to develop and 
report recall information requested by FDA.
    FDA agrees with the comment to have a process whereby reports and 
any other necessary information can be submitted by e-mail. In many 
cases, this has become routine for some firms and FDA district offices. 
Certainly there is no reason not to use e-mail or facsimile 
communications in most recall situations; however, FDA would maintain 
the prerogative for investigational visits and other in-person 
communications where the agency considers it appropriate. In fact, FDA 
is currently working toward providing ``industry guidance'' online 
which will provide a format for industry responses to recall 
situations.
    At the present time, the names and telephone numbers of FDA's 
district office recall coordinators may be found on the Internet at 
http://www.fda.gov/ora/inspect--ref/iom/iomoradir--
monitors.html#RECALL. Unfortunately, this provides information from 
FDA's latest published location directory and is not always current. We 
will see that this list is updated if it is possible to do so. 
Additionally, changes to the FDA Web site's recall information and 
reporting systems which are currently under development, will maintain 
an easy to locate, user-friendly recall section that will include a 
current listing of all district coordinators that will include names, 
telephone and facsimile numbers, mail, and e-mail addresses.
    At this time, we will refer to the Center for Food Safety and 
Applied Nutrition your suggestion to allow processing authorities to 
authorize reconditioning/destruction of thermally processed low acid 
and acidified foods in hermetically sealed containers and for the 
recalling firm to then submit a summary of the disposition action to 
FDA.
    As a result of the comment received, the following is a revised 
summary of the estimated annual burden hours for 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 the burden of this collection of 
information as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                   Annual Frequency         Total Annual
             21 CFR Section                No. of Respondents        perResponse             Responses         Hours per Response        Total Hours
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7.42                                           1,855                      1                  1,855                    15                27,825
7.26 and 7.49                                  1,855                      1                  1,855                    20                37,100
7.53                                           1,855                      4                  7,420                    10                74,200
7.55(b)                                        1,855                      1                  1,855                    10                18,550
  Total                                                                                                                                157,675
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: August 13, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-20842 Filed 8-16-01; 8:45 am]
BILLING CODE 4160-01-S