
[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44785-44787]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18109]


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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 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed revision 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 provisions of existing 
FDA regulations concerning FDA-regulated human food, including dietary 
supplements, and cosmetics manufactured from, processed with, or 
otherwise containing material derived from cattle.

DATES: Submit either electronic or written comments on the collection 
of information by September 30, 2014.

ADDRESSES: Submit electronic comments on the collection of 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 revision 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 and 700.27 (OMB Control Number 0910-0623)--
Revision

    FDA's regulations in Sec. Sec.  189.5 and 700.27 (21 CFR 189.5 and 
700.27) set forth bovine spongiform encephalopathy (BSE)-related 
restrictions applicable to FDA-regulated human food and cosmetics. The 
regulations designate certain materials from cattle as ``prohibited 
cattle materials,'' including specified risk materials (SRMs), the 
small intestine of cattle not otherwise excluded from being a 
prohibited cattle material, material from nonambulatory disabled 
cattle, and mechanically separated (MS) beef. Sections 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 manufactured from, processed with, or otherwise containing 
material derived from cattle. The 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 FD&C 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 FD&C 
Act, the FDA is authorized to issue regulations for the FD&C Act's 
efficient enforcement. With regard to records concerning imported human 
food and cosmetics, the FDA relied on its authority under sections 
701(b) and 801(a) of the FD&C Act (21 U.S.C. 371(b) and 381(a)). 
Section 801(a) of the FD&C Act provides requirements with regard to 
imported human food and cosmetics and provides for refusal of admission 
of human food and cosmetics that appear to be adulterated into the 
United States. Section 701(b) of the FD&C Act authorizes the 
Secretaries of Treasury and Health and Human Services to jointly 
prescribe regulations for the efficient enforcement of section 801 of 
the FD&C Act.

[[Page 44786]]

    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 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 MS beef; and (4) whether tallow in human food 
or cosmetics contain less than 0.15 percent insoluble impurities.
    FDA's regulations in Sec. Sec.  189.5(c) and 700.27(c) require 
manufacturers and processors of human food and cosmetics manufactured 
from, processed with, or otherwise containing material from cattle 
establish and maintain records sufficient to demonstrate that the human 
food or cosmetics are not manufactured from, processed with, or 
otherwise containing 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 FDA does 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 human 
food or cosmetics manufactured from, processed with, or otherwise 
containing cattle material must affirm that the human food or cosmetics 
were manufactured from, processed with, or otherwise containing cattle 
material and must affirm that the human food or cosmetics were 
manufactured in accordance with the applicable requirements of 
Sec. Sec.  189.5 or 700.27. In addition, if human food or cosmetics 
were manufactured from, processed with, or otherwise containing cattle 
material, the importer of record must provide within 5 business days 
records sufficient to demonstrate that the human food or cosmetics were 
not manufactured from, processed with, or otherwise containing 
prohibited cattle material, if requested.
    Upon review of the information collection requests supporting these 
BSE-related regulations, FDA found that the burdens associated with the 
requirements for recordkeeping and records access found in Sec. Sec.  
189.5(c) and 700.27(c) are in use without current OMB approval. This 
collection of information was previously approved by OMB under control 
number 0910-0597. FDA submitted a timely information collection request 
to extend the approval of 0910-0597, but the request was denied. To 
most appropriately streamline this information collection and to 
eliminate redundancy in information collection requests, FDA seeks to 
revise the 0910-0623 collection to include the reporting and 
recordkeeping elements of 0910-0597. FDA has included these elements in 
the burden estimates and discussion in this document.
    Under FDA's regulations, FDA may designate a country from which 
cattle materials inspected and passed for human consumption are not 
considered prohibited cattle materials, and their use does not render 
human food or cosmetics adulterated. Sections 189.5(e) and 700.27(e) 
provide that a country seeking to be designated must send a written 
request to the Director of the Center for Food Safety and Applied 
Nutrition (CFSAN Director). The information the country is required to 
submit includes information about a country's BSE case history, risk 
factors, measures to prevent the introduction and transmission of BSE, 
and other information relevant to determining whether SRMs, the small 
intestine of cattle not otherwise excluded from being a prohibited 
cattle material, material from nonambulatory disabled cattle, or MS 
beef from the country seeking designation should be considered 
prohibited cattle materials. FDA uses the information to determine 
whether to grant a request for designation and to impose conditions if 
a request is granted.
    Sections 189.5 and 700.27 further state that countries designated 
under Sec. Sec.  189.5(e) and 700.27(e) will be subject to future 
review by FDA to determine whether their designations remain 
appropriate. As part of this process, FDA may ask designated countries 
to confirm their BSE situation and the information submitted by them, 
in support of their original application, has remained unchanged. FDA 
may revoke a country's designation if FDA determines that it is no 
longer appropriate. Therefore, designated countries may respond to 
periodic FDA requests by submitting information to confirm their 
designations remain appropriate. FDA uses the information to ensure 
their designations remain appropriate.
    Description of Respondents: Respondents to this information 
collection include manufacturers, processors, and importers of FDA-
regulated human food, including dietary supplements, and cosmetics 
manufactured from, processed with, or otherwise containing material 
derived from cattle, as well as, with regard to Sec. Sec.  189.5(e) and 
700.27(e), foreign governments seeking designation under those 
regulations.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
        21 CFR section             Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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189.5(c)(6) and 700.27(c)(6)..          54,825               1          54,825  .033 (2 minutes)           1,809
189.5(e) and 700.27(e);                      1               1               1  80..............              80
 request for designation.
189.5(e) and 700.27(e);                      1               1               1  26..............              26
 response to request for
 review by FDA.
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    Total.....................  ..............  ..............  ..............  ................           1,915
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 44787]]


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                   Number of
 21 CFR 189.5(c) and 700.27(c)     Number of      records per    Total annual    Average burden     Total hours
                                 recordkeepers   recordkeeper       records     per recordkeeper
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Domestic facilities...........             697              52          36,244  0.25 (15                   9,061
                                                                                 minutes).
Foreign facilities............             916              52          47,632  0.25 (15                  11,908
                                                                                 minutes).
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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.

    Except where otherwise noted, this estimate is based on FDA's 
estimate of the number of facilities affected by the final rule 
entitled, ``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).

Reporting

    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 
manufactured from, processed with, or otherwise containing cattle 
material. Importers of these products must affirm that the human food 
or cosmetics are not manufactured from, processed with, or otherwise 
contain prohibited cattle materials and must affirm that the human food 
or cosmetics were 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 the FDA through FDA's Operational and 
Administrative System for Import Support. Affirmation by importers is 
expected to take approximately 2 minutes per entry line. Table 2 shows 
54,825 lines of human food and cosmetics likely to contain cattle 
materials are imported annually. The reporting burden of affirming 
whether import entry lines contain cattle-derived materials is 
estimated to take 1,809 hours annually (54,825 lines multiplied by 2 
minutes per line).
    FDA's estimate of the reporting burden for designation under 
Sec. Sec.  189.5 and 700.27 is based on its experience and the average 
number of requests for designation received in the past 3 years. In the 
last 3 years, FDA has not received any requests for designation. Thus, 
FDA estimates that one or fewer will be received annually in the 
future. Based on this experience, FDA estimates the annual number of 
new requests for designation will be one. FDA estimates that preparing 
the information required by Sec. Sec.  189.5 and 700.27 and submitting 
it to FDA in the form of a written request to the CFSAN Director will 
require a burden of approximately 80 hours per request. Thus, the 
burden for new requests for designation is estimated to be 80 hours 
annually, as shown in Table 1, row 1.
    Under Sec. Sec.  189.5(e) and 700.27(e), designated countries are 
subject to future review by FDA and may respond to periodic FDA 
requests by submitting information to confirm their designations remain 
appropriate. In the last 3 years, FDA has not requested any reviews. 
Thus, FDA estimates that one or fewer will occur annually in the 
future. FDA estimates that the designated country undergoing a review 
in the future will need one-third of the time it took preparing its 
request for designation to respond to FDA's request for review, or 26 
hours (80 hours x 0.33 = 26.4 hours, rounded to 26). The annual burden 
for reviews is estimated to be 26 hours, as shown in Table 1, row 2. 
The total reporting burden for this information collection is estimated 
to be 1,915 hours annually.

Recordkeeping

    FDA estimates that there are 697 domestic facility relationships 
and 916 foreign facility relationships 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 
cosmetics 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, FDA treats 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, FDA estimates the time burden of developing 
these records as a joint task between the two facilities. Thus, FDA 
estimates that this recordkeeping burden will be about 15 minutes per 
week, or 13 hours per year, and FDA assumes 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 9,061 
hours (13 hours multiplied by 697), and the total recordkeeping burden 
for foreign facilities is estimated to be 11,908 hours (13 hours 
multiplied by 916), as shown in Table 1.

    Dated: July 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18109 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P


