[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56615-56617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25767]


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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 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 
December 29, 2017.

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 emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0623. 
Also, include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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 and 700.27

OMB Control Number 0910-0623--Extension

    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

[[Page 56616]]

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 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, FDA is authorized to 
issue regulations for the FD&C Act's efficient enforcement. With regard 
to records concerning imported human food and cosmetics, 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.
    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 
(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 30 months and older 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 contains 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 (CBP), 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 contains prohibited 
cattle material, if requested.
    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 any 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 that 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.
    In the Federal Register of June 15, 2017 (82 FR 27501), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received three comments. One comment was 
unrelated to the information collection; one comment noted that the 
length of time to keep records was insufficient but offered no 
suggested timeframe; and one comment supported the information 
collection. After evaluating these comments FDA will not revise the 
information collection.
    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  per response           Total hours
                                                respondents     respondent       responses
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189.5(c)(6) and 700.27(c)(6)................          54,825               1          54,825  0.033 (2 minutes).........................           1,809
189.5(e) and 700.27(e); request for                        1               1               1  80........................................              80
 designation.

[[Page 56617]]

 
189.5(e) and 700.27(e); response to request                1               1               1  26........................................              26
 for review by FDA.
                                             ------------------------------------------------                                            ---------------
    Total...................................  ..............  ..............  ..............  ..........................................           1,915
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                 Number of
                  Activity                       Number of      records per    Total annual        Average burden  per recordkeeper         Total hours
                                               recordkeepers   recordkeeper       records
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Domestic facilities.........................             697              52          36,244  0.25 (15 minutes).........................           9,061
Foreign facilities..........................             916              52          47,632  0.25 (15 minutes).........................          11,908
                                             ------------------------------------------------                                            ---------------
    Total...................................  ..............  ..............  ..............  ..........................................          20,969
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\1\ There are no capital costs 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 at CBP entry. Affirmation by 
importers is expected to take approximately 2 minutes per entry line. 
Table 1 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 x 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 2.
    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 3. 
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 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 
9,061 hours (13 hours x 697), and the total recordkeeping burden for 
foreign facilities is estimated to be 11,908 hours (13 hours x 916), as 
shown in table 2.

    Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25767 Filed 11-28-17; 8:45 am]
 BILLING CODE 4164-01-P


