[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Notices]
[Pages 54827-54829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25537]
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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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
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 http://www.regulations.gov. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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\
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No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total
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Domestic Facilities 697 52 36,244 0.25 9,061
189.5(c) and 700.27(c)
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Foreign Facilities 916 52 47,632 0.25 11,908
189.5(c) and 700.27(c)
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Total 20,969
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\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\
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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