[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