[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Notices]
[Pages 8286-8287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03848]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0510]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Substances Prohibited 
From Use in Animal Food or Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 March 
28, 2018.

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 0910-0627. 
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, 10 a.m.-12 p.m., 
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.

Substances Prohibited From Use in Animal Food or Feed--21 CFR 589.2001

OMB Control Number 0910-0627--Extension

    This information collection supports Agency regulations regarding 
substances prohibited from use in animal food or feed. Bovine 
spongiform encephalopathy (BSE) is a progressive and fatal neurological 
disorder of cattle that results from an unconventional transmissible 
agent. BSE belongs to the family of diseases known as transmissible 
spongiform encephalopathies (TSEs). All TSEs affect the central nervous 
system of infected animals. Our regulation at Sec.  589.2001 (21 CFR 
589.2001) entitled ``Cattle materials prohibited in animal food or feed 
to prevent the transmission of bovine spongiform encephalopathy'' is 
designed to further strengthen existing safeguards against the 
establishment and amplification of BSE in the United States through 
animal feed. The regulation prohibits the use of certain cattle origin 
materials in the food or feed of all animals. These materials are 
referred to as ``cattle materials prohibited in animal feed'' or CMPAF. 
Under Sec.  589.2001, no animal feed or feed ingredient can contain 
CMPAF. As a result, we impose requirements on renderers of specifically 
defined cattle materials, including reporting and recordkeeping 
requirements. For purposes of the regulation, we define a renderer as 
any firm or individual that processes slaughter byproducts, animals 
unfit for human consumption, including carcasses of dead cattle, or 
meat scraps. Reporting and recordkeeping requirements are necessary 
because once materials are separated from an animal it may not be 
possible, without records, to know whether the cattle material meets 
the requirements of our regulation.
    Recordkeeping: Renderers that receive, manufacture, process, blend, 
or distribute CMPAF, or products that contain or may contain CMPAF, 
must take measures to ensure that the materials are not introduced into 
animal feed, including maintaining adequate written procedures 
specifying how such processes are to be carried out (Sec.  
589.2001(c)(2)(ii)). Renderers that receive, manufacture, process, 
blend, or distribute CMPAF, are required to establish and maintain 
records sufficient to track the CMPAF to ensure that they are not 
introduced into animal feed (Sec.  589.2001(c)(2)(vi)).
    Renderers that receive, manufacture, process, blend, or distribute 
any cattle materials must establish and maintain records sufficient to 
demonstrate that material rendered for use in animal feed was not 
manufactured from, processed with, or does not otherwise contain, CMPAF 
(Sec.  589.2001(c)(3)(i)).
    Renderers that receive, manufacture, process, blend, or distribute 
any cattle materials must, if these materials were obtained from an 
establishment that segregates CMPAF from other materials, establish and 
maintain records to demonstrate that the supplier has adequate 
procedures in place to effectively exclude CMPAF from any materials 
supplied (Sec.  589.2001(c)(3)(i)). Records will meet this requirement 
if they include either: (1) Certification or other documentation from 
the supplier that materials supplied do not include CMPAF (Sec.  
589.2001(c)(3)(i)(A)) or (2) documentation of another method acceptable 
to FDA, such as third-party certification (Sec.  589.2001(c)(3)(i)(B)).
    Reporting: Under our regulations, we may designate a country from 
which cattle materials are not considered CMPAF. Section 589.2001(f) 
provides that a country seeking to be so designated must send a written 
request to the Director of the Center for Veterinary Medicine. The 
information the country is required to submit includes information 
about that country's BSE case history, risk factors, measures to 
prevent the introduction and transmission of BSE, and any other 
information relevant to determining whether the cattle materials from 
the requesting country do or do not meet the definitions set forth in 
Sec.  589.2001(b)(1). We use the information to determine whether to 
grant a request for designation and to impose conditions if a request 
is granted. Section 589.2001(f) further states that countries 
designated under that section will be subject to our future review to 
determine whether their designations remain appropriate. As part of 
this process, we may ask designated countries from time to time to 
confirm that their BSE situation and the information submitted by them 
in support of their original application remains unchanged. We may 
revoke a country's designation if we determine that it is no longer 
appropriate. Therefore, designated countries may respond to our 
periodic requests by

[[Page 8287]]

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 rendering facilities, feed manufacturers, livestock 
feeders, and foreign governments seeking designation under Sec.  
589.2001(f).
    In the Federal Register of November 3, 2017 (82 FR 51279), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received four comments, which were not 
responsive to the four collection of information topics solicited, and 
therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                Table 1--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section             Number of       records per    Total annual         per         Total hours
                                  recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
589.2001(c)(2)(ii), maintain                  50               1              50              20           1,000
 written procedures............
589.2001(c)(2)(vi) and                       175               1             175              20           3,500
 (c)(3)(i), maintain records...
589.2001(c)(3)(i)(A) and (B),                175               1             175              26           4,550
 certification or documentation
 from the supplier.............
                                --------------------------------------------------------------------------------
    Total......................  ...............  ..............  ..............  ..............           9,050
----------------------------------------------------------------------------------------------------------------
\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 our 
estimate of the number of facilities affected by the final rule 
entitled ``Substances Prohibited From Use in Animal Food or Feed'' 
published in the Federal Register of April 25, 2008 (73 FR 22720 at 
22753). The estimated recordkeeping burden is derived from Agency 
resources and discussions with affected industry. Our regulations 
require the maintenance of certain written procedures if cattle not 
inspected and passed for human consumption are to be rendered for use 
in animal feed. The recordkeeping burden associated with the 
requirement to maintain written procedures (Sec.  589.2001(c)(2)(ii)) 
will apply to only those renderers that choose to render for use in 
animal feed cattle not inspected and passed for human consumption. The 
recordkeeping requirement in Sec.  589.2001(c)(2)(vi) will apply to the 
limited number of renderers that will handle CMPAF. We estimate that 
the recordkeeping burden associated with Sec.  589.2001(c)(3)(i) would 
apply to the balance of the rendering firms not handling CMPAF. Table 1 
also reflects the estimated 26 hours each renderer will need to satisfy 
the requirement in Sec.  589.2001(c)(3)(i)(A) and (B) under which 
renderers must maintain records from their supplier, certifying that 
materials provided were free of CMPAF.

                                  Table 2--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                    Number of
         21 CFR section             Number of     responses per    Total annual   Average burden    Total hours
                                   respondents      respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
589.2001(f); request for                      1                1               1              80              80
 designation...................
589.2001(f); response to                      1                1               1              26              26
 request for review by FDA.....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate of the reporting burden for designation under Sec.  
589.2001(f) is based on estimates in the final rule entitled 
``Substances Prohibited From Use in Animal Food or Feed'' published in 
the Federal Register of April 25, 2008, our experience, and the average 
number of requests for designation received in the past 3 years. The 
reporting burden for Sec.  589.2001(f) is minimal because requests for 
designation are seldom submitted. Since 2009, we have received two 
requests for designation. In the last 3 years, we have not received any 
new requests for designation; therefore, we estimate that one or fewer 
requests for designation will be submitted annually. Although we have 
not received any new requests for designation in the last 3 years, we 
believe these information collection provisions should be extended to 
provide for the potential future need of a foreign government to 
request designation under Sec.  589.2001(f). Table 2, row 1, presents 
the expected burden of requests for designation. Countries designated 
under Sec.  589.2001(f) are subject to review by FDA to ensure that 
their designation remains appropriate. We assume a country's response 
to a request for review will take about one third the time and effort 
of a request for designation. Table 2, row 2, presents the expected 
burden of a request for review. The burden for this information 
collection has not changed since the last OMB approval.

    Dated: February 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03848 Filed 2-23-18; 8:45 am]
 BILLING CODE 4164-01-P


