Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food, 53746-53749 [E9-25100]
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53746
Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
101.14(d)(2)
300,000
1.5
450,000
0.75
337,500
101.22(i)(4)
25
1
25
1
25
1,000
1
1,000
1
1,000
100
1
100
1
100
101.100(d)(2)
101.105(t)
Total
1 There
676,150
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED REPORTING BURDEN1
21 CFR Section/
Form No.
No. of
Respondents
101.9(j)(18) and 101.36(h)(2)/
Form FDA 3570
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1 There
Annual Frequency
per Response
10,000
Total Annual
Responses
1
Hours per
Response
10,000
Total Hours
8
80,000
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual reporting and
recordkeeping burdens are based on
agency communications with industry
and FDA’s knowledge of and experience
with food labeling and the submission
of petitions and requests to the agency.
Where an agency regulation implements
an information collection requirement
in the act or the FPLA, only any
additional burden attributable to the
regulation has been included in FDA’s
burden estimate.
No burden has been estimated for
those requirements where the
information to be disclosed is
information that has been supplied by
FDA. Also, no burden has been
estimated for information that is
disclosed to third parties as a usual and
customary part of a food producer’s
normal business activities. Under 5 CFR
1320.3(c)(2), the public disclosure of
information originally supplied by the
Federal Government to the recipient for
the purpose of disclosure to the public
is not a collection of information. Under
5 CFR 1320.3(b)(2), the time, effort, and
financial resources necessary to comply
with a collection of information are
excluded from the burden estimate if
the reporting, recordkeeping, or
disclosure activities needed to comply
are usual and customary because they
would occur in the normal course of
activities.
In this request for extension of OMB
approval under the PRA, FDA is
combining the burden hours associated
with OMB control numbers 0910–0395
(collection entitled ‘‘Food Labeling:
Nutrition Labeling of Dietary
Supplements on a ‘Per Day’ Basis’’) and
0910–0515 (collection entitled ‘‘Food
Labeling: Trans Fatty Acids in Nutrition
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Labeling’’) with the burden hours
approved under OMB control number
0910–0381 (collection entitled ‘‘Food
Labeling Regulations’’).
Dated: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25102 Filed 10–19–09; 8:45 am]
BILLING CODE 4160–01–S
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.
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
PO 00000
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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 https://
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,
Jonnalynn.Capezzuto@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
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
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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
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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
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53747
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
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Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices
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 BURDEN1
No. of
Respondents
Activity
Annual Frequency
of Disclosure
Total Annual
Disclosures
Hours per
Disclosure
Total Hours
Notifying immediate previous source of the article of food
under section 417(d)(6)(B)(i) of the act ...........................
1,200
1
1,200
0.6
720
Notifying immediate subsequent recipient of the article of
food under section 417(d)(6)(B)(ii) of the act ..................
1,200
1
1,200
0.6
720
Notifying immediate previous source of the article of food
under section 417(d)(7)(C)(i) of the act ...........................
1,200
1
1,200
0.6
720
Notifying immediate subsequent recipient of the article of
food under section 417(d)(7)(C)(ii) of the act ..................
1,200
1
1,200
0.6
720
Total .....................................................................................
1 There
2,880
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.
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Annual Frequency
per Recordkeeping
No. of
Recordkeepers
Activity
Total Annual
Records2
Hours per
Records
Total Hours
Maintenance of reportable food records under section
417(g) of the act—Mandatory reports ..............................
1,200
1
1,200
0.25
300
Maintenance of reportable food records under section
417(g) of the act—Voluntary reports ................................
600
1
600
0.25
150
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Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices
53749
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
No. of
Recordkeepers
Activity
Annual Frequency
per Recordkeeping
Total Annual
Records2
Total .....................................................................................
Hours per
Records
Total Hours
450
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2009–N–0487]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Informed Consent For In Vitro
Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable
Food and Drug Administration,
HHS.
cprice-sewell on DSKGBLS3C1PROD with NOTICES
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
guidance on informed consent for in
vitro diagnostic device studies using
leftover human specimens that are not
individually identifiable.
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 https://
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
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14:46 Oct 19, 2009
Jkt 220001
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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
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.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
docket number found in brackets in the
heading of this document.
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Guidance on Informed Consent For In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable—OMB
Control Number 0910–0582—Extension
FDA’s investigational device
regulations are intended to encourage
the development of new, useful devices
in a manner that is consistent with
public health, safety, and with ethical
standards. Investigators should have
freedom to pursue the least burdensome
means of accomplishing this goal.
However, to ensure that the balance is
maintained between product
development and the protection of
public health, safety, and ethical
standards, FDA has established human
subject protection regulations
addressing requirements for informed
consent and institutional review board
(IRB) review that apply to all FDAregulated clinical investigations
involving human subjects. In particular,
informed consent requirements further
both safety and ethical considerations
by allowing potential subjects to
consider both the physical and privacy
risks they face if they agree to
participate in a trial.
Under FDA regulations, clinical
investigations using human specimens
conducted in support of premarket
submissions to FDA are considered
human subject investigations (see 21
CFR 812.3(p)). Many investigational
device studies are exempt from most
provisions of part 812 (21 CFR part 812),
Investigational Device Exemptions,
under § 812.2(c)(3), but FDA’s
regulations for the protection of human
subjects (21 CFR parts 50 and 56) apply
to all clinical investigations that are
regulated by FDA (see 21 CFR 50.1; 21
CFR 56.101, 21 U.S.C. 360j(g)(3)(A), and
21 U.S.C. 360j(g)(3)(D)).
FDA regulations do not contain
exceptions from the requirements of
informed consent on the grounds that
the specimens are not identifiable or
that they are remnants of human
specimens collected for routine clinical
care or analysis that would otherwise
have been discarded. Nor do FDA
regulations allow IRBs to decide
whether or not to waive informed
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]]>Agencies
[Federal Register Volume 74, Number 201 (Tuesday, October 20, 2009)]
[Notices]
[Pages 53746-53749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25100]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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, Jonnalynn.Capezzuto@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 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
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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\
----------------------------------------------------------------------------------------------------------------
Annual
Activity No. of Frequency of Total Annual Hours per Total Hours
Respondents Disclosure Disclosures Disclosure
----------------------------------------------------------------------------------------------------------------
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.....................
----------------------------------------------------------------------------------------------------------------
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....
----------------------------------------------------------------------------------------------------------------
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.....................
----------------------------------------------------------------------------------------------------------------
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....
----------------------------------------------------------------------------------------------------------------
Total........................... .............. .............. .............. .............. 2,880
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Annual
Activity No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records\2\ Records
----------------------------------------------------------------------------------------------------------------
Maintenance of reportable food 1,200 1 1,200 0.25 300
records under section 417(g) of
the act--Mandatory reports.....
----------------------------------------------------------------------------------------------------------------
Maintenance of reportable food 600 1 600 0.25 150
records under section 417(g) of
the act--Voluntary reports.....
----------------------------------------------------------------------------------------------------------------
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Total........................... .............. .............. .............. .............. 450
----------------------------------------------------------------------------------------------------------------
\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
