[Federal Register Volume 75, Number 16 (Tuesday, January 26, 2010)]
[Notices]
[Pages 4077-4079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1436]


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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.

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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 [email protected]. 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\
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                                                           No. of         Annual Frequency       Total Annual
                   21 CFR Section                      Recordkeepers      per Recordkeeping        Records         Hours per  Record      Total Hours
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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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[[Page 4079]]

 
Total                                                                                                                                             20,969
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\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\
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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 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