[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75330-75331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1677]


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: Submit written comments (including recommendations) on the 
collection of information by December 28, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0623. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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 from cattle. 
We 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 (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, we are authorized to issue regulations 
for the FD&C Act's efficient enforcement. With regard to records 
concerning imported human food and cosmetics, we relied on our 
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 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 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 
contains, 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 
contains 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, we may designate a country from which 
cattle materials inspected and passed for

[[Page 75331]]

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. 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. We use 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, we may ask designated countries 
to confirm that their BSE situation and the information submitted by 
them, in support of their original application, has remained unchanged. 
We may revoke a country's designation if we determine that it is no 
longer appropriate. Therefore, designated countries may respond to 
periodic FDA requests by submitting information to confirm their 
designations remain appropriate. We use 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 August 14, 2020 (85 FR 49657), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although some comments were received, only 
one pertained to the information collection. The comment suggested 
requiring greater than a 2-year retention period for records; however, 
we believe that additional retention requirements may impose undue 
burden on respondents to the information collection without providing 
greater utility to the Agency.
    We estimate 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; activity               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); affirmation of          54,825               1          54,825  0.033 (2 minutes).........................           1,809
 compliance.
189.5(e) and 700.27(e); request for                        1               1               1  80........................................              80
 designation.
189.5(e) and 700.27(e); response to request                1               1               1  26........................................              26
 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.


                                                     Table 2--Estimated Annual Recordkeeping Burden1
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                                                                 Number of
             Type of respondent                  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
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    Total...................................  ..............  ..............  ..............  ..........................................          20,969
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: November 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26059 Filed 11-24-20; 8:45 am]
BILLING CODE 4164-01-P