[Federal Register Volume 76, Number 226 (Wednesday, November 23, 2011)]
[Notices]
[Pages 72420-72422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30146]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Drug 
Administration Recall Regulations

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 
December 23, 2011.

ADDRESSES: 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: FDA Desk Officer, 
Fax: (202) 395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0249. 
Also include the FDA 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, 
[email protected].

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--(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 (FYs) 
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.
    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 FYs.

B. Firm Initiated Recall and Recall Communications

    Request firms voluntarily remove or correct foods and drugs (human 
or animal), cosmetics, medical devices,

[[Page 72421]]

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 FYs.

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 FYs (3,101), less the average number of terminations over 
the last 3 FYs (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 FYs.

II. Hours per Response Estimates

    FDA has no information that 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.
    In the Federal Register of June 29, 2011 (76 FR 38184), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received and was PRA 
related.
    (Comment) One comment noted that the FDA Average Burden per 
Response (ABPR) are low. The commenter's estimates are double the 
estimates provided by FDA.
    (Response) FDA regulates many different types of products 
including, but not limited to, medical products, food and feed, 
cosmetics, and tobacco products. From FYs 2008 to 2010, FDA classified 
approximately 9,303 recalls of FDA-regulated products. Further, FDA 
notes that not all recall events reported to the Agency are similar in 
nature and may entail different information and volume of information 
on a case-by-case basis. Therefore, FDA could not calculate or 
determine an estimate for the average burden per response for a 
particular or specific product type or area and has based its estimates 
for all industries that it regulates.
    (Comment) One comment questioned the validity of the methodology 
and assumption used by FDA, citing that data ranges are not given. The 
comment encouraged FDA to provide data ranges for industry to assess 
better the accuracy of the Agency's estimates.
    (Response) As stated in the prior response, FDA regulates many 
different types of products including, but not limited to, medical 
products, food and feed, cosmetics, and tobacco products. From FY 2008 
to 2010, FDA classified approximately 9,303 recalls of FDA-regulated 
products. Further, FDA notes that not all recall events reported to the 
Agency are similar in nature where complexity and size of the recall 
can dictate the amount of recall information and data to be submitted. 
Therefore, FDA could not provide ranges of the burden for data 
collection for industry and based its estimates across the entire scope 
of recalls of FDA-regulated products.
    (Comment) One comment suggests that the Agency develop an 
electronic tool for recall reporting or ``eRecall'' tool, and ask, that 
industry be able to provide input to any developer of user requirements 
for such a tool before implementations.
    (Response) FDA will consider the suggestion of an electronic recall 
tool for reporting. However, because of the many types of industries 
that FDA regulates, such a tool may not be able to accommodate the 
variety of information specific to many of these industries.
    (Comment) One comment suggests that recall requirements should 
apply only to finished goods that are consumable and that FDA's entire 
recall program, not just information collection, be reviewed to 
determine if the program serves the purpose originally intended to 
protect consumers.
    (Response) FDA disagrees with the comment. FDA believes that 
violative products in the marketplace should be recalled from 
consignees and customers who received them even if they are not 
finished goods that are consumables. For example, a recall of a 
violative product which is used for further manufacture and that poses 
a health risk would also serve as notification to consignees and 
customers to remove the recalled product from further use or 
distribution, including providing instructions for additional recall of 
products that may have been manufactured using the recalled products.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              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 & 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.



[[Page 72422]]

    Dated: November 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30146 Filed 11-22-11; 8:45 am]
BILLING CODE 4160-01-P