
[Federal Register: October 23, 2009 (Volume 74, Number 204)]
[
Notices]               
[Page 54827-54829]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc09-50]                         

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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\

--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                              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

----------------------------------------------------------------------------------------------------------------

189.5(c)(6) and               54,825                  1             54,825              0.033              1,809

 700.27(c)(6)

----------------------------------------------------------------------------------------------------------------

\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
