[Federal Register Volume 74, Number 201 (Tuesday, October 20, 2009)]
[Notices]
[Pages 53746-53749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25100]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0501]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Third Party Disclosure and Recordkeeping Requirements 
for Reportable Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 information collection 
provisions of FDA's third party disclosure and recordkeeping 
requirements for reportable food.

DATES: Submit written or electronic comments on the collection of 
information by December 21, 2009.

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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794, [email protected].

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 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

[[Page 53747]]

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.

Third Party Disclosure and Recordkeeping Requirements for Reportable 
Food--21 U.S.C. 350f (OMB Control Number 0910-0643)--Extension

    On September 27, 2007, the President signed into law the Food and 
Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85). 
Section 1005 of FDAAA amends the Federal Food, Drug, and Cosmetic Act 
(the act) by creating a new section 417 (21 U.S.C. 350f), among other 
things. Section 417 of the act requires the Secretary of Health and 
Human Services (the Secretary) to establish within the FDA a Reportable 
Food Registry (the Registry). The Secretary has delegated to the 
Commissioner of FDA the responsibility for administering the act, 
including section 417.
    Section 417 of the act defines ``reportable food'' as an ``article 
of food (other than infant formula) for which there is a reasonable 
probability that the use of, or exposure to, such article of food will 
cause serious adverse health consequences or death to humans or 
animals.'' (see section 417(a)(2) of the act). Section 417 of the act 
requires FDA to establish an electronic portal (the Reportable Food 
electronic portal) by which instances of reportable food must be 
submitted to FDA by responsible parties and may be submitted by public 
health officials. FDA made the decision that the most efficient and 
cost effective means to implement the requirements of section 417 of 
the act relating to the Registry was to utilize the business enterprise 
system currently under development within the agency: the MedWatchPlus 
Portal. The electronic portal became operational on September 8, 2009. 
The collection of information associated with the submission of 
reportable food reports to FDA using the MedWatchPlus electronic portal 
has been approved under OMB Control No. 0910-0645.
    In addition, section 1005(f) of FDAAA required FDA to issue 
guidance to industry about submitting reports through the electronic 
portal of instances of reportable food and providing notifications to 
other persons in the supply chain of such article of food. FDA issued 
guidance containing questions and answers relating to the requirements 
under section 417 of the act, including: (1) How, when, and where to 
submit reports to FDA; (2) who is required to submit reports to FDA; 
(3) what is required to be submitted to FDA; and (4) what may be 
required when providing notifications to other persons in the supply 
chain of an article of food. The agency announced the availability of 
the guidance document entitled ``Questions and Answers Regarding the 
Reportable Food Registry as Established by the Food and Drug 
Administration Amendments Act of 2007,'' on September 9, 2009 (74 FR 
46434). The guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
question 28 of the guidance have been approved under OMB Control No. 
0910-0249.
    Section 417 of the act established third party disclosure and 
recordkeeping burdens associated with the Reportable Food Registry. 
Specifically, FDA may require the responsible party to notify the 
immediate previous source(s) and/or immediate subsequent recipient(s) 
of the reportable food (see section 417(d)(6)(B)(i) and (d)(6)(B)(ii) 
of the act). Similarly, FDA may also require the responsible party that 
is notified (i.e., the immediate previous source and/or immediate 
subsequent recipient) to notify their own immediate previous source(s) 
and/or immediate subsequent recipient(s) of the reportable food 
(section 417(d)(7)(C)(i) and (d)(7)(C)(ii) of the act).
    Notification to the immediate previous source(s) and immediate 
subsequent recipient(s) of the article of food may be accomplished by 
electronic communication methods such as e-mail, fax or text messaging 
or by telegrams, mailgrams, or first class letters. Notification may 
also be accomplished by telephone call or other personal contacts but 
FDA recommends that such notifications also be confirmed by one of the 
previous methods and/or documented in an appropriate manner. FDA may 
require that the notification include any or all of the following data 
elements: (1) The date on which the article of food was determined to 
be a reportable food; (2) a description of the article of food 
including the quantity or amount; (3) the extent and nature of the 
adulteration; (4) the results of any investigation of the cause of the 
adulteration if it may have originated with the responsible party, if 
known; (5) the disposition of the article of food, when known; (6) 
product information typically found on packaging including product 
codes, use-by dates, and the names of manufacturers, packers, or 
distributors sufficient to identify the article of food; (7) contact 
information for the responsible party; (8) contact information for 
parties directly linked in the supply chain and notified under sections 
417(d)(6)(B) or 417(d)(7)(C) of the act, as applicable; (9) the 
information required by FDA to be included in the notification provided 
by the responsible party involved under sections 417(d)(6)(B) or 
417(d)(7)(C) of the act or required to report under section 
417(d)(7)(A) of the act; and (10) the unique number described in 
section 417(d)(4) of the act (section 417(d)(6)(B)(iii)(I), 
(d)(7)(C)(iii)(I), and (e) of the act). FDA may also require that the 
notification provide information about the actions that the recipient 
of the notification shall perform and/or any other information FDA may 
require (section 417(d)(6)(B)(iii)(II), (d)(6)(B)(iii)(III), 
(d)(7)(C)(iii)(II), and (d)(7)(C)(iii)(III) of the act).
    Section 417(g) of the act requires that responsible persons 
maintain records related to reportable foods reports and notifications 
under section 417 of the act for a period of 2 years.
    The congressionally-identified purpose of the Registry is to 
provide ``a reliable mechanism to track patterns of adulteration in 
food [which] would support efforts by the Food and Drug Administration 
to target limited inspection resources to protect the public health'' 
(Public Law 110-085, section 1005(a)(4)). The third party disclosure 
and recordkeeping requirements described previously are designed to 
enable FDA to quickly identify and track an article of food (other than 
infant formula) for which there is a reasonable probability that the 
use of, or exposure to, such article of food will cause serious adverse 
health consequences or death to humans or animals. FDA uses the 
information collected to help ensure that such products are quickly and 
efficiently removed from the market.
    Description of Respondents: Mandatory respondents to this 
collection of information are the

[[Page 53748]]

owners, operators, or agents in charge of a domestic or foreign 
facility engaged in manufacturing, processing, packing, or holding food 
for consumption in the United States (``responsible parties'') who have 
information on a reportable food. Voluntary respondents to this 
collection of information are Federal, State, and local public health 
officials who have information on a reportable food.
    FDA estimates the burden of this collection of information as 
follows:
Third Party Disclosure
    FDA estimates that approximately 1,200 reportable food events with 
mandatory reporters will occur annually. FDA received 625 voluntary 
food complaints leading to adverse events from January 1, 2008, to June 
30, 2008, and there were 206 and 182 class 1 recalls for human food in 
fiscal years 2006 and 2007, respectively. Based on these experiences, 
FDA estimates that FDA could receive 200 to 1,200 ``reportable'' food 
reports annually from 200 to 1,200 mandatory and voluntary users of the 
electronic reporting system. FDA will utilize the upper-bound estimate 
of 1,200 for these calculations (73 FR 63153 at 63157, October 23, 
2008; 74 FR 23721 at 23727, May 20, 2009).
    FDA estimates that notifying the immediate previous source(s) will 
take 0.6 hours per reportable food and notifying the immediate 
subsequent recipient(s) will take 0.6 hours per reportable food. FDA 
also estimates that it will take 0.6 hours for the immediate previous 
source and/or the immediate subsequent recipient to also notify their 
immediate previous source(s) and/or immediate subsequent recipient(s). 
The agency bases its estimate on its experience with mandatory and 
voluntary reports recently submitted to FDA that would be considered 
reportable food reports in the future (73 FR 63153 at 63157).
    Although it is not mandatory under FDAAA section 1005 that 
responsible persons notify the sources and recipients of instances of 
reportable food, for purposes of the burden estimate we are assuming 
FDA would exercise its authority and require such notifications in all 
such instances for mandatory reporters. This notification burden will 
not affect voluntary reporters of reportable food events. Therefore, 
FDA estimates that the total burden of notifying the immediate previous 
source(s) and immediate subsequent recipient(s) under section 
417(d)(6)(B)(i), (d)(6)(B)(ii), (d)(7)(C)(i), and (d)(7)(C)(ii) of the 
act for 1,200 reportable foods will be 2,880 hours annually (1,200 x 
0.6 hours) + (1,200 x 0.6 hours) + (1,200 x 0.6 hours) + (1,200 x 0.6 
hours).

                           Table 1--Estimated Annual Third Party Disclosure Burden\1\
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                                                      Annual
            Activity                  No. of       Frequency  of   Total Annual      Hours per      Total Hours
                                    Respondents     Disclosure      Disclosures     Disclosure
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Notifying immediate previous               1,200               1           1,200             0.6             720
 source of the article of food
 under section 417(d)(6)(B)(i)
 of the act.....................
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Notifying immediate subsequent             1,200               1           1,200             0.6             720
 recipient of the article of
 food under section
 417(d)(6)(B)(ii) of the act....
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Notifying immediate previous               1,200               1           1,200             0.6             720
 source of the article of food
 under section 417(d)(7)(C)(i)
 of the act.....................
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Notifying immediate subsequent             1,200               1           1,200             0.6             720
 recipient of the article of
 food under section
 417(d)(7)(C)(ii) of the act....
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Total...........................  ..............  ..............  ..............  ..............           2,880
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Recordkeeping
    As noted previously, section 417(g) of the act requires that 
responsible persons maintain records related to reportable foods 
reports and notifications under section 417 of the act for a period of 
2 years. We estimate that each mandatory report and its associated 
notifications will require 30 minutes of recordkeeping for the 2-year 
period, or 15 minutes per record per year. FDA bases its estimate on 
its experience with recordkeeping for food and cosmetics derived from 
cattle materials (71 FR 59653 at 59667, October 11, 2006). The annual 
recordkeeping burden for mandatory reportable food reports and their 
associated notifications is thus estimated to be 300 hours (1,200 x 
0.25 hours).
    We do not expect that records will always be kept in relation to 
voluntary reportable food reports. Therefore, FDA estimates that 
records will be kept for 600 of the 1,200 voluntary reports we expect 
to receive annually. The recordkeeping burden associated with voluntary 
reports is thus estimated to be 150 hours annually (600 x 0.25 hours). 
The estimated total annual recordkeeping burden is shown in Table 2.

                                Table 2--Estimated Annual Recordkeeping Burden\1\
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                                                      Annual
            Activity                  No. of      Frequency  per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping    Records\2\        Records
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Maintenance of reportable food             1,200               1           1,200            0.25             300
 records under section 417(g) of
 the act--Mandatory reports.....
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Maintenance of reportable food               600               1             600            0.25             150
 records under section 417(g) of
 the act--Voluntary reports.....
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[[Page 53749]]

 
Total...........................  ..............  ..............  ..............  ..............             450
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ For purposes of estimating number of records and hours per record, a ``record'' means all records kept for
  an individual reportable food by the responsible party or a voluntary reporter.


    Dated: October 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25100 Filed 10-19-09; 8:45 am]
BILLING CODE 4160-01-S