[Federal Register Volume 69, Number 196 (Tuesday, October 12, 2004)]
[Notices]
[Pages 60630-60632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22763]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0442]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Recall Regulations (Guidelines)

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 FDA's recall regulations 
(guidelines) and provides guidance to manufacturers on recall 
responsibilities.

DATES: Submit written or electronic comments on the collection of 
information by December 13, 2004.

ADDRESSES: Submit electronic comments on the collection of to 
information to: http://www.fda.gov/dockets/ecomments. 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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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

[[Page 60631]]

1320.3(c) and includes agency requests 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)

    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 (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); 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).
    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         Hours per
                  21 CFR Section                     No. of Respondents          Response              Responses            Response       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recall Strategy (Sec.   7.42)                                     2,375                      1                  2,375               15           35,625
--------------------------------------------------------------------------------------------------------------------------------------------------------
Firm Initiated Recall & Public Warnings Recall                    2,375                      1                  2,375               20           47,500
 Communications (Sec.  Sec.   7.46 and 7.49)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recall Status Reports and Followup (Sec.   7.53)                  2,375                      4                  9,500               10           95,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Termination of a Recall (Sec.   7.55(b))                          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 voluntarily foods 
and drugs (human or animal), cosmetics, medical devices, and 
biologicals to immediately notify immediately 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 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.
Termination of a Recall
    Provides the firm an opportunity to request in writing that FDA end 
the recall. The agency estimates it will receive 2,375 responses 
annually.


[[Page 60632]]


    Dated: October 4, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22763 Filed 10-8-04; 8:45 am]
BILLING CODE 4160-01-S