83 FR 8286 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 38 (February 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 38 (February 26, 2018)
| Page Range | 8286-8287 | |
| FR Document | 2018-03848 |
[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)] [Notices] [Pages 8286-8287] From the Federal Register Online [www.thefederalregister.org] [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
![8286 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices
The estimates in table 2 are Landsdown St., North Bethesda, MD (§ 589.2001(c)(2)(ii)). Renderers that
multiplied across the FDA product 20852, 301–796–7726, PRAStaff@ receive, manufacture, process, blend, or
centers to arrive at a total third party fda.hhs.gov. distribute CMPAF, are required to
disclosure burden estimate of 70,937. SUPPLEMENTARY INFORMATION: In establish and maintain records
FDA regulates many different types of compliance with 44 U.S.C. 3507, FDA sufficient to track the CMPAF to ensure
products including, but not limited to, has submitted the following proposed that they are not introduced into animal
medical products, food and feed, collection of information to OMB for feed (§ 589.2001(c)(2)(vi)).
cosmetics, and tobacco products. FDA review and clearance. Renderers that receive, manufacture,
notes that not all third-party disclosures process, blend, or distribute any cattle
provided by firms to their consignees Substances Prohibited From Use in materials must establish and maintain
are similar in nature and may entail Animal Food or Feed—21 CFR records sufficient to demonstrate that
different methods and mediums of 589.2001 material rendered for use in animal feed
communication. The total burden hours OMB Control Number 0910–0627— was not manufactured from, processed
have decreased since the last Extension with, or does not otherwise contain,
information collection approval based CMPAF (§ 589.2001(c)(3)(i)).
on a reduction in the number of This information collection supports Renderers that receive, manufacture,
respondents. Agency regulations regarding substances process, blend, or distribute any cattle
prohibited from use in animal food or materials must, if these materials were
Dated: February 21, 2018. feed. Bovine spongiform obtained from an establishment that
Leslie Kux, encephalopathy (BSE) is a progressive segregates CMPAF from other materials,
Associate Commissioner for Policy. and fatal neurological disorder of cattle establish and maintain records to
[FR Doc. 2018–03847 Filed 2–23–18; 8:45 am] that results from an unconventional demonstrate that the supplier has
BILLING CODE 4164–01–P transmissible agent. BSE belongs to the adequate procedures in place to
family of diseases known as effectively exclude CMPAF from any
transmissible spongiform materials supplied (§ 589.2001(c)(3)(i)).
DEPARTMENT OF HEALTH AND encephalopathies (TSEs). All TSEs Records will meet this requirement if
HUMAN SERVICES affect the central nervous system of they include either: (1) Certification or
infected animals. Our regulation at other documentation from the supplier
Food and Drug Administration § 589.2001 (21 CFR 589.2001) entitled that materials supplied do not include
[Docket No. FDA–2011–N–0510] ‘‘Cattle materials prohibited in animal CMPAF (§ 589.2001(c)(3)(i)(A)) or (2)
food or feed to prevent the transmission documentation of another method
Agency Information Collection of bovine spongiform encephalopathy’’ acceptable to FDA, such as third-party
Activities; Submission for Office of is designed to further strengthen certification (§ 589.2001(c)(3)(i)(B)).
Management and Budget Review; existing safeguards against the Reporting: Under our regulations, we
Comment Request; Substances establishment and amplification of BSE may designate a country from which
Prohibited From Use in Animal Food or in the United States through animal cattle materials are not considered
Feed feed. The regulation prohibits the use of CMPAF. Section 589.2001(f) provides
certain cattle origin materials in the that a country seeking to be so
AGENCY: Food and Drug Administration, food or feed of all animals. These designated must send a written request
HHS. materials are referred to as ‘‘cattle to the Director of the Center for
ACTION: Notice. materials prohibited in animal feed’’ or Veterinary Medicine. The information
SUMMARY: The Food and Drug CMPAF. Under § 589.2001, no animal the country is required to submit
Administration (FDA) is announcing feed or feed ingredient can contain includes information about that
that a proposed collection of CMPAF. As a result, we impose country’s BSE case history, risk factors,
information has been submitted to the requirements on renderers of measures to prevent the introduction
Office of Management and Budget specifically defined cattle materials, and transmission of BSE, and any other
(OMB) for review and clearance under including reporting and recordkeeping information relevant to determining
the Paperwork Reduction Act of 1995. requirements. For purposes of the whether the cattle materials from the
regulation, we define a renderer as any requesting country do or do not meet
DATES: Fax written comments on the
firm or individual that processes the definitions set forth in
collection of information by March 28,
slaughter byproducts, animals unfit for § 589.2001(b)(1). We use the information
2018.
human consumption, including to determine whether to grant a request
ADDRESSES: To ensure that comments on
carcasses of dead cattle, or meat scraps. for designation and to impose
the information collection are received, Reporting and recordkeeping conditions if a request is granted.
OMB recommends that written requirements are necessary because Section 589.2001(f) further states that
comments be faxed to the Office of once materials are separated from an countries designated under that section
Information and Regulatory Affairs, animal it may not be possible, without will be subject to our future review to
OMB, Attn: FDA Desk Officer, Fax: 202– records, to know whether the cattle determine whether their designations
395–7285, or emailed to oira_ material meets the requirements of our remain appropriate. As part of this
submission@omb.eop.gov. All regulation. process, we may ask designated
comments should be identified with the Recordkeeping: Renderers that countries from time to time to confirm
OMB control number 0910–0627. Also receive, manufacture, process, blend, or that their BSE situation and the
daltland on DSKBBV9HB2PROD with NOTICES
include the FDA docket number found distribute CMPAF, or products that information submitted by them in
in brackets in the heading of this contain or may contain CMPAF, must support of their original application
document. take measures to ensure that the remains unchanged. We may revoke a
FOR FURTHER INFORMATION CONTACT: Ila materials are not introduced into animal country’s designation if we determine
S. Mizrachi, Office of Operations, Food feed, including maintaining adequate that it is no longer appropriate.
and Drug Administration, Three White written procedures specifying how such Therefore, designated countries may
Flint North, 10 a.m.–12 p.m., 11601 processes are to be carried out respond to our periodic requests by
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![Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices 8287
submitting information to confirm their feed manufacturers, livestock feeders, information. We received four
designations remain appropriate. We and foreign governments seeking comments, which were not responsive
use the information to ensure their designation under § 589.2001(f). to the four collection of information
designations remain appropriate. In the Federal Register of November topics solicited, and therefore will not
Description of Respondents: 3, 2017 (82 FR 51279), FDA published be discussed in this document.
Respondents to this information a 60-day notice requesting public FDA estimates the burden of this
collection include rendering facilities, comment on the proposed collection of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
589.2001(c)(2)(ii), maintain written procedures ................. 50 1 50 20 1,000
589.2001(c)(2)(vi) and (c)(3)(i), maintain records ............. 175 1 175 20 3,500
589.2001(c)(3)(i)(A) and (B), certification or documenta-
tion from the supplier ..................................................... 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 inspected and passed for human handle CMPAF. We estimate that the
estimate is based on our estimate of the consumption are to be rendered for use recordkeeping burden associated with
number of facilities affected by the final in animal feed. The recordkeeping § 589.2001(c)(3)(i) would apply to the
rule entitled ‘‘Substances Prohibited burden associated with the requirement balance of the rendering firms not
From Use in Animal Food or Feed’’ to maintain written procedures handling CMPAF. Table 1 also reflects
published in the Federal Register of (§ 589.2001(c)(2)(ii)) will apply to only the estimated 26 hours each renderer
April 25, 2008 (73 FR 22720 at 22753). those renderers that choose to render for will need to satisfy the requirement in
The estimated recordkeeping burden is use in animal feed cattle not inspected § 589.2001(c)(3)(i)(A) and (B) under
derived from Agency resources and and passed for human consumption. which renderers must maintain records
discussions with affected industry. Our The recordkeeping requirement in from their supplier, certifying that
regulations require the maintenance of § 589.2001(c)(2)(vi) will apply to the
materials provided were free of CMPAF.
certain written procedures if cattle not limited number of renderers that will
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
589.2001(f); request for designation .................................. 1 1 1 80 80
589.2001(f); response to request for review by FDA ........ 1 1 1 26 26
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate of the reporting burden a foreign government to request DEPARTMENT OF HEALTH AND
for designation under § 589.2001(f) is designation under § 589.2001(f). Table HUMAN SERVICES
based on estimates in the final rule 2, row 1, presents the expected burden
entitled ‘‘Substances Prohibited From of requests for designation. Countries Health Resources and Services
Use in Animal Food or Feed’’ published designated under § 589.2001(f) are Administration
in the Federal Register of April 25, subject to review by FDA to ensure that
2008, our experience, and the average Request for Nominations
their designation remains appropriate.
number of requests for designation We assume a country’s response to a AGENCY: Health Resources and Services
received in the past 3 years. The request for review will take about one Administration (HRSA), Department of
reporting burden for § 589.2001(f) is third the time and effort of a request for Health and Human Services (HHS).
minimal because requests for designation. Table 2, row 2, presents the ACTION: Request for Nominations to the
designation are seldom submitted. Since expected burden of a request for review. Centers for Disease Control and
2009, we have received two requests for The burden for this information Prevention (CDC)/HRSA Advisory
designation. In the last 3 years, we have collection has not changed since the last Committee on HIV, Viral Hepatitis and
not received any new requests for OMB approval. STD Prevention and Treatment.
designation; therefore, we estimate that
daltland on DSKBBV9HB2PROD with NOTICES
one or fewer requests for designation Dated: February 21, 2018.
SUMMARY: HRSA is seeking nominations
will be submitted annually. Although Leslie Kux, of four qualified candidates to be
we have not received any new requests Associate Commissioner for Policy. considered for appointment as members
for designation in the last 3 years, we [FR Doc. 2018–03848 Filed 2–23–18; 8:45 am] of the CDC/HRSA Advisory Committee
believe these information collection BILLING CODE 4164–01–P on HIV, Viral Hepatitis and STD
provisions should be extended to Prevention and Treatment (Committee).
provide for the potential future need of The Committee consists of 18 public
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Document Created: 2018-02-24 01:00:28
Document Modified: 2018-02-24 01:00:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by March 28, 2018. | |
| 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] | |
| FR Citation | 83 FR 8286 |
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