
[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38184-38186]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16252]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0439]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; FDA Recall Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements on 
FDA recalls.

DATES: Submit either electronic or written comments on the collection 
of information by August 29, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr. 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests

[[Page 38185]]

or requirements that members of the public submit reports, keep 
records, or provide information to a third party. Section 3506(c)(2)(A) 
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to 
provide a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
of an existing collection of information, before submitting the 
collection to OMB for approval. To comply with this requirement, FDA is 
publishing notice of the proposed collection of information set forth 
in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (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; biological products intended for human use; and tobacco). 
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, a 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, evaluation 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(b)).
    A search of the FDA database was performed to determine the number 
of recalls, and terminations that took place during fiscal years 2008 
to 2010. The resulting number of total recalls (9,303) and terminations 
(2,858) from this database search were then averaged over the 3 years, 
and the resulting per year average of recalls (3,101) and terminations 
(953) are used in estimating the current annual reporting burden for 
this report. FDA estimates the total annual industry burden to collect 
and provide the previous information to be 443,820 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 the burden of this collection of 
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
                                     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Recall strategy (Sec.   7.42)...           3,101               1           3,101              20          62,020
Firm initiated recall and recall           3,101               1           3,101              30          93,030
 communications (Sec.  Sec.
 7.46 and 7.49).................
Recall status reports and                  2,148              13          27,924              10         279,240
 followup (Sec.   7.53).........
Termination of a recall (Sec.                953               1             953              10           9,530
 7.55(b)).......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         443,820
----------------------------------------------------------------------------------------------------------------
\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:

I. Total Annual 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 3,101 
responses annually based on the average number of recalls over the last 
3 fiscal years.

B. Firm Initiated Recall and Recall Communications

    Request firms voluntarily remove or correct foods and drugs (human 
or animal), cosmetics, medical devices, biologics, and tobacco 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 
3,101 responses annually based on the average number of recalls over 
the last 3 fiscal years.

C. Recall Status Reports

    Request that recalling firms provide periodic status reports so FDA 
can ascertain the progress of the recall. This request only applies to 
firms with active recalls, and is estimated to be reported every 2 to 4 
weeks. This collection of information will generate approximately 
27,924 responses annually, based on the average number of recalls over 
the last 3 fiscal years (3,101), less the average number of 
terminations over the last 3

[[Page 38186]]

fiscal years (953), multiplied by the conservative frequency of 
reporting per year (13).

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 953 responses annually 
based on the average number of terminations over the past 3 fiscal 
years.

II. Hours per Response Estimates

    FDA has no information which would allow it to make a calculated 
estimate on the hours per response burden to FDA regulated firms to 
conduct recalls. Variables in the type of products, the quantity and 
level of distribution and the various circumstances of recall 
notifications could cause the hours per response to vary significantly. 
The best guesstimate of average burden hours per response from previous 
information collection request reports are utilized again for the 
current estimates on burden hours per response.

    Dated: June 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16252 Filed 6-28-11; 8:45 am]
BILLING CODE 4160-01-P


