Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle, 54827-54829 [E9-25537]
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54827
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices
• Provide the dates during which the
reported receipts or sales were
collected; and
• Bear the official seal of the national
taxing authority.
Both FDA Forms 3602 and 3602A are
available in the guidance document,
‘‘Guidance for Industry, FDA and
Foreign Governments: FY 2010
MDUFMA Small Business Qualification
and Certification’’ , available on the
Internet at https://www.fda.gov/
downloads/MedicalDevices/Device
RegulationandGuidance/Overview/
MedicalDeviceUserFeeand
ModernizationActMDUFMA/
UCM179257.pdf. This guidance
describes the criteria FDA will use to
decide whether an entity qualifies as a
MDUFMA small business and will help
prospective applicants understand what
they need to do to meet the small
business criteria for FY 2010.
FDA estimates the burden of this
collection of information as follows:
prevented those businesses from
qualifying for the small business fee
rates. Thus, foreign governments,
including the European Union, have
objected.
In lieu of a Federal income tax return,
the 2007 Amendments will allow a
foreign business to qualify as a small
business by submitting a certification
from its national taxing authority, the
foreign equivalent of our Internal
Revenue Service. This certification,
referred to as a ‘‘National Taxing
Authority Certification,’’ must:
• Be in English;
• Be from the national taxing
authority of the country in which the
business is headquartered;
• Provide the business’ gross receipts
or sales for the most recent year, in both
the local currency and in U.S. dollars,
and the exchange rate used in
converting local currency to U.S.
dollars;
materials and decide whether an
applicant is a ‘‘small business’’ within
the meaning of MDUFMA.
FDA Form 3602A— For Foreign Small
Business Applicants
The 2007 Amendments provide an
alternative way for a foreign business to
qualify as a small business eligible to
pay a significantly-lower fee when a
medical device user fee must be paid.
Before passage of the 2007
Amendments, the only way a business
could qualify as a small business was to
submit a Federal (U.S.) income tax
return showing its gross receipts or sales
that did not exceed a statutory
threshold, currently, $100 million. If a
business could not provide a Federal
income tax return, it did not qualify as
a small business and had to pay the
standard (full) fee. Because many
foreign businesses have not, and cannot,
file a Federal (U.S.) income tax return,
this requirement has effectively
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
FDA
Form No.
Number of
Respondents
3602
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
Hours
3,000
1
3,000
1
340
1
340
33
3602A
Section III
3,000
340
3602A
Sections I and II
1
7
231
1
231
TOTALS
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
1There
3,571
are no capital costs or operating and maintenance costs associated with this collection of information.
The FDA Form 3602 burden is based
on the number of applications received
in the last 3 years. FDA believes most
entities that submit FDA Form 3602A
will not have any affiliates, and very
few will have more than three or four
affiliates. Based on our experience with
FDA Form 3602A, FDA believes each
business will require 1 hour to complete
Sections I and II. FDA does not have any
data on the time that will be required to
complete Section III, the National
Taxing Authority Certification, since
there is a different tax verification
process by each country’s National
Taxing Authority.
The information collection for FDA
Form 3602 is currently approved under
OMB control number 0910–0508. The
information collection for FDA Form
3602A is currently approved under
OMB control number 0910–0613. With
this request for approval, FDA is
requesting to consolidate OMB
approvals 0910–0508 and 0910–0613
into one information collection using
the OMB control number 0910–0508.
VerDate Nov<24>2008
15:24 Oct 22, 2009
Jkt 220001
Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25538 Filed 10–22–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0505]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recordkeeping
and Reporting Requirements for
Human Food and Cosmetics
Manufactured From, Processed With,
or Otherwise Containing, Material
From Cattle
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Fmt 4703
DATES: Submit written or electronic
comments on the collection of
information by December 22, 2009.
ADDRESSES: Submit electronic
comments on the collection of
Notice.
Frm 00052
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 requirements
of FDA’s regulations that require records
on FDA-regulated human food,
including dietary supplements, and
cosmetics that are manufactured from,
processed with, or otherwise contain,
material derived from cattle.
Sfmt 4703
E:\FR\FM\23OCN1.SGM
23OCN1
54828
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices
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.
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.
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
15:24 Oct 22, 2009
Jkt 220001
Recordkeeping and Reporting
Requirements for Human Food and
Cosmetics Manufactured From,
Processed With, or Otherwise
Containing, Material From Cattle—21
CFR 189.5(c) and 700.27(c) (OMB
Control Number 0910–0597—Extension)
Sections 189.5(c) and 700.27(c) (21
CFR 189.5(c) and 700.27(c)) of FDA’s
regulations set forth the requirements
for recordkeeping and records access for
FDA-regulated human food, including
dietary supplements, and cosmetics that
are manufactured from, processed with,
or otherwise contain, material derived
from cattle. FDA issued these
recordkeeping regulations under the
adulteration provisions in sections
402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c),
and 701(a) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c),
and 371(a)). Under section 701(a) of the
act, FDA is authorized to issue
regulations for the act’s efficient
enforcement. With regard to records
concerning imported human food and
cosmetics, FDA relied on its authority
under sections 801(a) and 701(b) of the
act (21 U.S.C. 381(a)). Section 801(a) of
the act provides requirements with
regard to imported food and cosmetics
and provides for refusal of admission
into the United States of human food
and cosmetics that appear to be
adulterated. Section 701(b) of the act
authorizes the Secretaries of Treasury
and Health and Human Services to
jointly prescribe regulations for the
efficient enforcement of section 801 of
the act.
These requirements are necessary
because, once materials are separated
from an animal, it may not be possible
without records to know the following:
(1) Whether cattle material may contain
specified risk materials (SRMs). SRMs
include brain, skull, eyes, trigeminal
ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the
transverse processes of the thoracic and
lumbar vertebrae and the wings of the
sacrum), and dorsal root ganglia from
animals less than 30 months old and
tonsils and distal ileum of the small
intestine from all animals of all ages; (2)
whether the source animal for cattle
material was inspected and passed; (3)
whether the source animal for cattle
material was nonambulatory disabled or
mechanically separated beef; and (4)
whether tallow in a human food or
cosmetic contains less than 0.15 percent
insoluble impurities.
These regulations implement
recordkeeping for the provisions of
FDA’s interim final rule entitled ‘‘Use of
Materials Derived From Cattle in
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Human Food and Cosmetics’’ (the IFR)
(69 FR 42256, July 14, 2004). FDA’s
regulations in §§ 189.5(c) and 700.27(c)
require that manufacturers and
processors of human food and cosmetics
that are manufactured from, processed
with, or otherwise contain, material
from cattle establish and maintain
records sufficient to demonstrate that
the human food or cosmetic is not
manufactured from, processed with, or
does not otherwise contain, prohibited
cattle materials. These records must be
retained for 2 years at the manufacturing
or processing establishment or at a
reasonably accessible location.
Maintenance of electronic records is
acceptable and electronic records are
considered to be reasonably accessible if
they are accessible from an onsite
location. Records required by these
sections and existing records relevant to
compliance with these sections must be
available to FDA for inspection and
copying. Existing records may be used
if they contain all of the required
information and are retained for the
required time period.
Because we do not easily have access
to records maintained at foreign
establishments, FDA regulations in
§§ 189.5(c)(6) and 700.27(c)(6),
respectively, require that when filing for
entry with U.S. Customs and Border
Protection, the importer of record of a
human food or cosmetic manufactured
from, processed with, or otherwise
containing, cattle material must affirm
that the human food or cosmetic was
manufactured from, processed with, or
otherwise contains, cattle material and
must affirm that the human food or
cosmetic was manufactured in
accordance with the applicable
requirements of §§ 189.5 or 700.27. In
addition, if a human food or cosmetic is
manufactured from, processed with, or
otherwise contains, cattle material, then
the importer of record must, if
requested, provide within 5 business
days records sufficient to demonstrate
that the human food or cosmetic is not
manufactured from, processed with, or
does not otherwise contain, prohibited
cattle material.
Description of Respondents:
Respondents to this information
collection include manufacturers,
processors, and importers of FDAregulated human food, including dietary
supplements, and cosmetics that are
manufactured from, processed with, or
otherwise contain, material derived
from cattle.
FDA estimates the burden of this
collection of information as follows:
This estimate is based on FDA’s
estimate of the number of facilities
affected by the final rule entitled,
E:\FR\FM\23OCN1.SGM
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54829
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices
‘‘Recordkeeping Requirements for
Human Food and Cosmetics
Manufactured From, Processed With, or
Otherwise Containing, Material From
Cattle,’’ published in the Federal
Register of October 11, 2006 (71 FR
59653 at 59667).
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total
Domestic Facilities
189.5(c) and 700.27(c)
697
52
36,244
0.25
9,061
Foreign Facilities
189.5(c) and 700.27(c)
916
52
47,632
0.25
11,908
Total
1 There
20,969
are no capital or operating and maintenance costs associated with this collection of information.
FDA estimates that there are 697
domestic facility relationships (71 FR
59653 at 59667), and 916 foreign facility
relationships (71 FR 59653 at 59663),
consisting of the following facilities: An
input supplier of cattle-derived
materials that requires records (the
upstream facility) and a purchaser of
cattle-derived materials requiring
documentation—this may be a human
food or cosmetic manufacturer or
processor. The recordkeeping burden of
FDA’s regulations in §§ 189.5(c) and
700.27(c) is the burden of sending,
verifying, and storing documents
regarding shipments of cattle material
that is to be used in human food and
cosmetics. In this estimate of the
recordkeeping burden, we treat these
recordkeeping activities as shared
activities between the upstream and
downstream facilities. It is in the best
interests of both facilities in the
relationship to share the burden
necessary to comply with the
regulations; therefore, we estimate the
time burden of developing these records
as a joint task between the two facilities.
Thus, we estimate that this
recordkeeping burden will be about 15
minutes per week, or 13 hours per year
(71 FR 59653 at 59667), and we assume
that the recordkeeping burden will be
shared between 2 entities (i.e. the
ingredient supplier and the
manufacturer of finished products).
Therefore, the total recordkeeping
burden for domestic facilities is
estimated to be 13 hours x 697 = 9,061
hours, and the total recordkeeping
burden for foreign facilities is estimated
to be 13 hours x 916 = 11,908 hours, as
shown in table 1 of this document.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
189.5(c)(6) and 700.27(c)(6)
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
1 There
Annual Frequency
per Response
54,825
Total Annual
Responses
1
Hours per
Response
54,825
Total Hours
0.033
1,809
are no capital or operating and maintenance costs associated with this collection of information.
FDA’s regulations in §§ 189.5(c)(6)
and 700.27(c)(6) impose a reporting
burden on importers of human food and
cosmetics that are manufactured from,
processed with, or otherwise contain,
cattle material. Importers of these
products must affirm that the food or
cosmetic is manufactured from,
processed with, or does not otherwise
contain, prohibited cattle materials and
must affirm that the human food or
cosmetic was manufactured in
accordance with the applicable
requirements of §§ 189.5 or 700.27. The
affirmation is made by the importer of
record to FDA through the agency’s
Operational and Administrative System
for Import Support. Affirmation by
importers is expected to take
approximately 2 minutes per entry line.
Table 2 of this document shows that
54,825 lines of food and cosmetics that
likely contain cattle materials are
imported annually (71 FR 59653 at
59667). The annual reporting burden of
affirming whether import entry lines
VerDate Nov<24>2008
15:24 Oct 22, 2009
Jkt 220001
contain cattle-derived materials is
estimated to take 1,809 hours annually
(54,825 lines x 2 minutes per line).
Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25537 Filed 10–22–09; 8:45 am]
BILLING CODE 4160–01–S
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–10–0789]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Program Effectiveness Evaluation of
Workplace Intervention for Intimate
Partner Violence (IPV)—[OMB# 0920–
0789] [exp. 12/31/09]—Extension—
National Center for Injury Prevention
and Control (NCIPC), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Intimate partner violence (IPV) affects
a substantial number of Americans, and
there has recently been increasing
recognition of the impact it has on the
workplace. In addition to direct impacts
(batterers often stalk or even attack IPV
E:\FR\FM\23OCN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Notices]
[Pages 54827-54829]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25537]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0505]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Recordkeeping and Reporting Requirements for Human
Food and Cosmetics Manufactured From, Processed With, or Otherwise
Containing, Material From Cattle
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
requirements of FDA's regulations that require records on FDA-regulated
human food, including dietary supplements, and cosmetics that are
manufactured from, processed with, or otherwise contain, material
derived from cattle.
DATES: Submit written or electronic comments on the collection of
information by December 22, 2009.
ADDRESSES: Submit electronic comments on the collection of
[[Page 54828]]
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.
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 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.
Recordkeeping and Reporting Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing, Material
From Cattle--21 CFR 189.5(c) and 700.27(c) (OMB Control Number 0910-
0597--Extension)
Sections 189.5(c) and 700.27(c) (21 CFR 189.5(c) and 700.27(c)) of
FDA's regulations set forth the requirements for recordkeeping and
records access for FDA-regulated human food, including dietary
supplements, and cosmetics that are manufactured from, processed with,
or otherwise contain, material derived from cattle. FDA issued these
recordkeeping regulations under the adulteration provisions in sections
402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c), and 701(a) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342(a)(2)(C), (a)(3),
(a)(4), (a)(5), 361(c), and 371(a)). Under section 701(a) of the act,
FDA is authorized to issue regulations for the act's efficient
enforcement. With regard to records concerning imported human food and
cosmetics, FDA relied on its authority under sections 801(a) and 701(b)
of the act (21 U.S.C. 381(a)). Section 801(a) of the act provides
requirements with regard to imported food and cosmetics and provides
for refusal of admission into the United States of human food and
cosmetics that appear to be adulterated. Section 701(b) of the act
authorizes the Secretaries of Treasury and Health and Human Services to
jointly prescribe regulations for the efficient enforcement of section
801 of the act.
These requirements are necessary because, once materials are
separated from an animal, it may not be possible without records to
know the following: (1) Whether cattle material may contain specified
risk materials (SRMs). SRMs include brain, skull, eyes, trigeminal
ganglia, spinal cord, vertebral column (excluding the vertebrae of the
tail, the transverse processes of the thoracic and lumbar vertebrae and
the wings of the sacrum), and dorsal root ganglia from animals less
than 30 months old and tonsils and distal ileum of the small intestine
from all animals of all ages; (2) whether the source animal for cattle
material was inspected and passed; (3) whether the source animal for
cattle material was nonambulatory disabled or mechanically separated
beef; and (4) whether tallow in a human food or cosmetic contains less
than 0.15 percent insoluble impurities.
These regulations implement recordkeeping for the provisions of
FDA's interim final rule entitled ``Use of Materials Derived From
Cattle in Human Food and Cosmetics'' (the IFR) (69 FR 42256, July 14,
2004). FDA's regulations in Sec. Sec. 189.5(c) and 700.27(c) require
that manufacturers and processors of human food and cosmetics that are
manufactured from, processed with, or otherwise contain, material from
cattle establish and maintain records sufficient to demonstrate that
the human food or cosmetic is not manufactured from, processed with, or
does not otherwise contain, prohibited cattle materials. These records
must be retained for 2 years at the manufacturing or processing
establishment or at a reasonably accessible location. Maintenance of
electronic records is acceptable and electronic records are considered
to be reasonably accessible if they are accessible from an onsite
location. Records required by these sections and existing records
relevant to compliance with these sections must be available to FDA for
inspection and copying. Existing records may be used if they contain
all of the required information and are retained for the required time
period.
Because we do not easily have access to records maintained at
foreign establishments, FDA regulations in Sec. Sec. 189.5(c)(6) and
700.27(c)(6), respectively, require that when filing for entry with
U.S. Customs and Border Protection, the importer of record of a human
food or cosmetic manufactured from, processed with, or otherwise
containing, cattle material must affirm that the human food or cosmetic
was manufactured from, processed with, or otherwise contains, cattle
material and must affirm that the human food or cosmetic was
manufactured in accordance with the applicable requirements of
Sec. Sec. 189.5 or 700.27. In addition, if a human food or cosmetic is
manufactured from, processed with, or otherwise contains, cattle
material, then the importer of record must, if requested, provide
within 5 business days records sufficient to demonstrate that the human
food or cosmetic is not manufactured from, processed with, or does not
otherwise contain, prohibited cattle material.
Description of Respondents: Respondents to this information
collection include manufacturers, processors, and importers of FDA-
regulated human food, including dietary supplements, and cosmetics that
are manufactured from, processed with, or otherwise contain, material
derived from cattle.
FDA estimates the burden of this collection of information as
follows:
This estimate is based on FDA's estimate of the number of
facilities affected by the final rule entitled,
[[Page 54829]]
``Recordkeeping Requirements for Human Food and Cosmetics Manufactured
From, Processed With, or Otherwise Containing, Material From Cattle,''
published in the Federal Register of October 11, 2006 (71 FR 59653 at
59667).
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic Facilities 697 52 36,244 0.25 9,061
189.5(c) and 700.27(c)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign Facilities 916 52 47,632 0.25 11,908
189.5(c) and 700.27(c)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 20,969
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.
FDA estimates that there are 697 domestic facility relationships
(71 FR 59653 at 59667), and 916 foreign facility relationships (71 FR
59653 at 59663), consisting of the following facilities: An input
supplier of cattle-derived materials that requires records (the
upstream facility) and a purchaser of cattle-derived materials
requiring documentation--this may be a human food or cosmetic
manufacturer or processor. The recordkeeping burden of FDA's
regulations in Sec. Sec. 189.5(c) and 700.27(c) is the burden of
sending, verifying, and storing documents regarding shipments of cattle
material that is to be used in human food and cosmetics. In this
estimate of the recordkeeping burden, we treat these recordkeeping
activities as shared activities between the upstream and downstream
facilities. It is in the best interests of both facilities in the
relationship to share the burden necessary to comply with the
regulations; therefore, we estimate the time burden of developing these
records as a joint task between the two facilities. Thus, we estimate
that this recordkeeping burden will be about 15 minutes per week, or 13
hours per year (71 FR 59653 at 59667), and we assume that the
recordkeeping burden will be shared between 2 entities (i.e. the
ingredient supplier and the manufacturer of finished products).
Therefore, the total recordkeeping burden for domestic facilities is
estimated to be 13 hours x 697 = 9,061 hours, and the total
recordkeeping burden for foreign facilities is estimated to be 13 hours
x 916 = 11,908 hours, as shown in table 1 of this document.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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189.5(c)(6) and 54,825 1 54,825 0.033 1,809
700.27(c)(6)
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.
FDA's regulations in Sec. Sec. 189.5(c)(6) and 700.27(c)(6) impose
a reporting burden on importers of human food and cosmetics that are
manufactured from, processed with, or otherwise contain, cattle
material. Importers of these products must affirm that the food or
cosmetic is manufactured from, processed with, or does not otherwise
contain, prohibited cattle materials and must affirm that the human
food or cosmetic was manufactured in accordance with the applicable
requirements of Sec. Sec. 189.5 or 700.27. The affirmation is made by
the importer of record to FDA through the agency's Operational and
Administrative System for Import Support. Affirmation by importers is
expected to take approximately 2 minutes per entry line. Table 2 of
this document shows that 54,825 lines of food and cosmetics that likely
contain cattle materials are imported annually (71 FR 59653 at 59667).
The annual reporting burden of affirming whether import entry lines
contain cattle-derived materials is estimated to take 1,809 hours
annually (54,825 lines x 2 minutes per line).
Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25537 Filed 10-22-09; 8:45 am]
BILLING CODE 4160-01-S
