Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed, 8286-8287 [2018-03848]

Download as PDF 8286 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices The estimates in table 2 are multiplied across the FDA product centers to arrive at a total third party disclosure burden estimate of 70,937. FDA regulates many different types of products including, but not limited to, medical products, food and feed, cosmetics, and tobacco products. FDA notes that not all third-party disclosures provided by firms to their consignees are similar in nature and may entail different methods and mediums of communication. The total burden hours have decreased since the last information collection approval based on a reduction in the number of respondents. Dated: February 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–03847 Filed 2–23–18; 8:45 am] BILLING CODE 4164–01–P 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. 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 oira_ submission@omb.eop.gov. 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 daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:58 Feb 23, 2018 Jkt 244001 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. 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 § 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 § 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 (§ 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 (§ 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 (§ 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 (§ 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 (§ 589.2001(c)(3)(i)(A)) or (2) documentation of another method acceptable to FDA, such as third-party certification (§ 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 § 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 E:\FR\FM\26FEN1.SGM 26FEN1 8287 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices 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 § 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 recordkeepers 21 CFR section Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours 589.2001(c)(2)(ii), maintain written procedures ................. 589.2001(c)(2)(vi) and (c)(3)(i), maintain records ............. 589.2001(c)(3)(i)(A) and (B), certification or documentation from the supplier ..................................................... 50 175 1 1 50 175 20 20 1,000 3,500 175 1 175 26 4,550 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 (§ 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 § 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 § 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 § 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 1 589.2001(f); request for designation .................................. 589.2001(f); response to request for review by FDA ........ daltland on DSKBBV9HB2PROD with NOTICES 1 There Number of responses per respondent Number of respondents 21 CFR section 1 1 Average burden per response Total annual responses 1 1 1 1 Total hours 80 26 80 26 are no capital costs or operating and maintenance costs associated with this collection of information. Our estimate of the reporting burden for designation under § 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 § 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 VerDate Sep<11>2014 17:58 Feb 23, 2018 Jkt 244001 a foreign government to request designation under § 589.2001(f). Table 2, row 1, presents the expected burden of requests for designation. Countries designated under § 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Request for Nominations Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Request for Nominations to the Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. AGENCY: HRSA is seeking nominations of four qualified candidates to be considered for appointment as members of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (Committee). The Committee consists of 18 public SUMMARY: E:\FR\FM\26FEN1.SGM 26FEN1

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[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

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