[Federal Register: August 17, 2001 (Volume 66, Number 160)]
[Notices]
[Page 43263-43264]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au01-104]
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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