[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Notices]
[Pages 49657-49660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17876]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 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 
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 October 13, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 13, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

[[Page 49658]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2020-N-1677 for ``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.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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

[[Page 49659]]

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 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 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.
    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 designation               1               1               1  80.....................................              80
189.5(e) and 700.27(e); response to request for               1               1               1  26.....................................              26
 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 49660]]


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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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: August 10, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17876 Filed 8-13-20; 8:45 am]
BILLING CODE 4164-01-P


