Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle, 4077-4079 [2010-1436]
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Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Notices
fees due, and to fulfill any applicable
unsatisfied data requirements.
V. Provisions for Disposition of Existing
Stocks
Existing stocks are those stocks of
registered pesticide products which are
currently in the United States and
which were packaged, labeled, and
released for shipment prior to the
effective date of the cancellation action.
EPA’s existing stocks policy (56 FR
29362, June 26, 1991) provides that: ‘‘If
a registrant requests to voluntarily
cancel a registration where the Agency
has identified no particular risk
concerns, the registrant has complied
with all applicable conditions of
reregistration, conditional registration,
and data call ins, and the registration is
not subject to a Registration Standard,
Label Improvement Program, or
reregistration decision, the Agency will
generally permit a registrant to sell or
distribute existing stocks for 1 year after
the cancellation request was received.
Persons other than registrants will
generally be allowed to sell, distribute,
or use existing stocks until such stocks
are exhausted.’’
Upon cancellation of the pesticides
identified in Table 1, EPA anticipates
allowing sale, distribution and use as
described above. Exception to this
general policy will be made in specific
cases when more stringent restrictions
on sale, distribution, or use of the
products or their ingredients have
already been imposed, as in a special
review action, or where the Agency has
identified significant potential risk
concerns associated with a particular
chemical.
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: January 14, 2010
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division,
Office of Pesticide Programs.
[FR Doc. 2010–1476 Filed 1–25–10; 8:45 am]
BILLING CODE 6560–50–S
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
FEDERAL COMMUNICATIONS
COMMISSION
Notice of Public Information Collection
Being Reviewed by the Federal
Communications Commission,
Comments Requested
January 21, 2010.
SUMMARY: The Federal Communications
Commission, as part of its continuing
effort to reduce paperwork burden
invites the general public and other
VerDate Nov<24>2008
14:10 Jan 25, 2010
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Federal agencies to take this
opportunity to comment on the
following information collection(s), as
required by the Paperwork Reduction
Act of 1995, 44 U.S.C. 3501–3520.
Comments are requested concerning (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the
information shall have practical utility;
(b) the accuracy of the Commission’s
burden estimate; (c) ways to enhance
the quality, utility, and clarity of the
information collected; (d) ways to
minimize the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology, and (e) ways to
further reduce the information
collection burden for small business
concerns with fewer than 25 employees.
The FCC may not conduct or sponsor
a collection of information unless it
displays a currently valid control
number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
Paperwork Reduction Act (PRA) that
does not display a valid control number.
DATES: Persons wishing to comments on
this information collection should
submit comments on or before March
29, 2010. If you anticipate that you will
be submitting comments, but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contact listed below as soon
as possible.
ADDRESSES: Direct all PRA comments to
Nicholas A. Fraser, Office of
Management and Budget (OMB), via fax
at (202) 395–5167, or via the Internet at
Nicholas_A._Fraser@omb.eop.gov and
to Judith B. Herman, Federal
Communications Commission (FCC). To
submit your PRA comments by e–mail
send them to: PRA@fcc.gov.
FOR FURTHER INFORMATION CONTACT:
Judith B. Herman, OMD, 202–418–0214.
For additional information about the
information collection(s) send an e–mail
to PRA@fcc.gov or contact Judith B.
Herman, 202–418–0214.
SUPPLEMENTARY INFORMATION:
OMB Control No: 3060–0295.
Title: Section 90.607(a)(1) and (b)(1),
Supplemental Information To Be
Furnished By Applicants For Facilities
Under Subpart S.
Form No.: N/A.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other for–
profit; not–for–profit institutions, and
state, local or tribal government.
PO 00000
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4077
Number of Respondents: 3,788
respondents; 3,788 responses.
Estimated Time Per Response: .25
hours.
Frequency of Response: One time
reporting requirement.
Obligation to Respond: Required to
obtain or retain benefits.
Total Annual Burden: 947 hours.
Privacy Act Impact Assessment: N/A.
Nature and Extent of Confidentiality:
No questions of a confidential nature are
asked.
Need and Uses: The Commission is
submitting this information collection to
the Office of Management and Budget
(OMB) after this comment period in
order to obtain the full three year
clearance. There is a reduction in the
number of respondents/responses and
therefore, the total annual burden hours
have been reduced.
This rule section requires the affected
applicants to submit a list of any radio
facilities they hold within 40 miles of
the base station transmitter site being
applied for. This information is used to
determine if an applicant’s proposed
system is necessary in light of
communications facilities it already
owns. Such a determination helps the
Commission to equitably distribute
limited spectrum and prevents spectrum
warehousing. The information is
collected only once – upon initial
license application.
Federal Communications Commission.
Marlene H. Dortch,
Secretary, Office of the Secretary, Office of
Managing Director.
[FR Doc. 2010–1459 Filed 1–25–10; 8:45 am]
BILLING CODE 6712–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0505]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
that a proposed collection of
information has been submitted to the
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Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Notices
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
25, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0597. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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) of
FDA’s regulations (21 CFR 189.5(c) and
700.27(c)) 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 under section 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) and 371(b)).
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 §§ 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
§§ 189.5(c) and 700.27(c) 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.
In the Federal Register of October 23,
2009 (74 FR 54827), FDA published a
60-day notice requesting public
comment. No comments were received.
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 published in
the Federal Register of October 11, 2006
(71 FR 59653 at 59667), entitled
‘‘Recordkeeping Requirements for
Human Food and Cosmetics
Manufactured From, Processed With, or
Otherwise Containing, Material From
Cattle.’’
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
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
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Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
Total
1 There
20,969
are no capital costs 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 two 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 2.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
189.5(c)(6) and 700.27(c)(6)
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
1 There
Annual Frequency
per Response
54,825
Total Annual
Responses
1
Hours per
Response
54,825
0.033
Total Hours
1,809
are no capital costs 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 (OASIS). 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).
VerDate Nov<24>2008
14:10 Jan 25, 2010
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Dated: January 20, 2010.
David Dorsey
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–1436 Filed 1–25–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0221]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Labeling;
Notification Procedures for Statements
on Dietary Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
25, 2010.
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0331. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Food Labeling; Notification Procedures
for Statements on Dietary
Supplements—21 CFR 101.93 (OMB
Control Number 0910–0331—Extension)
Section 403(r)(6) of the act (21 U.S.C.
343(r)(6)) requires that the agency be
notified by manufacturers, packers, and
distributors of dietary supplements that
they are marketing a dietary supplement
product that bears on its label or in its
labeling a statement provided for in
E:\FR\FM\26JAN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 16 (Tuesday, January 26, 2010)]
[Notices]
[Pages 4077-4079]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1436]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0505]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the
[[Page 4078]]
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 25, 2010.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0597.
Also include the FDA docket number found in brackets in the heading of
this document.
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.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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) of FDA's regulations (21 CFR
189.5(c) and 700.27(c)) 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 under section 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) and 371(b)).
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 Sec. Sec. 189.5(c) and 700.27(c) 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.
In the Federal Register of October 23, 2009 (74 FR 54827), FDA
published a 60-day notice requesting public comment. No comments were
received.
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 published in the Federal Register
of October 11, 2006 (71 FR 59653 at 59667), entitled ``Recordkeeping
Requirements for Human Food and Cosmetics Manufactured From, Processed
With, or Otherwise Containing, Material From Cattle.''
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 4079]]
Total 20,969
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs 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 two 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 2.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
189.5(c)(6) and 54,825 1 54,825 0.033 1,809
700.27(c)(6)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs 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 (OASIS). 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: January 20, 2010.
David Dorsey
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1436 Filed 1-25-10; 8:45 am]
BILLING CODE 4160-01-S
