
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27501-27504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12448]


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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 
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 August 14, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2009-N-0505 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 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     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 Division of Dockets Management. 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: http://www.gpo.gov/fdsys/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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726.

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

[[Page 27502]]

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. 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.
    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, 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 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

[[Page 27503]]

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 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  .033 (2 minutes)..........................           1,809
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 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  .25 (15 minutes)..........................           9,061
Foreign facilities..........................             916              52          47,632  .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 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 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 2 entities (i.e., the ingredient supplier 
and the manufacturer of

[[Page 27504]]

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: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12448 Filed 6-14-17; 8:45 am]
 BILLING CODE 4164-01-P


