2024-06438. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cattle Materials 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:

Submit written comments (including recommendations) on the collection of information by April 26, 2024.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910–0627. The title of this information collection is “Cattle Materials Prohibited From Use in Animal Food or Feed.” Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 240–994–7399, [e-mail].

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.

Cattle Materials Prohibited From Use in Animal Food or Feed

OMB Control Number 0910–0627—Extension

This information collection helps to support implementation of section 402 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 342(a)(5)), which governs 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. Our regulation at § 589.2001 (21 CFR 589.2001) is designed to safeguard 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 to maintain adequate written procedures and recordkeeping on renderers that receive, manufacture, process, blend, or distribute raw material from cattle and to make these records available for inspection and copying by FDA to demonstrate they are taking measures to ensure that CMPAF is not introduced into animal feed.

Under § 589.2001(f), we may designate a country from which cattle materials are not considered CMPAF. A country seeking to be so designated must send a written request to the Director of the Center for Veterinary Medicine, including certain required information. We use the information provided to determine whether to grant a request for designation and to impose conditions if a request is granted. Additionally, designated countries will be subject to our future review to determine whether their designations remain appropriate. As part of this process, we may ask designated countries at any 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 submitting information to confirm their designations remain appropriate.

The 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.

Description of Respondents: Respondents to this information collection are foreign governments seeking designation under § 589.2001(f) and private sector rendering facilities that process cattle materials under § 589.2001(c).

In the Federal Register of October 12, 2023 (88 FR 70676), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although three comments were received, the comments were not responsive to the four collection of information topics solicited.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

21 CFR part; activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
589.2001(f); Request for designation by FDA for exemption from requirements of this regulation and response to request for review by FDA	1	2	2	33	66
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Since the last renewal, we reduced the request for designation average burden per response by 40 hours (from 80 hours to 40 hours). We take this reduction because foreign governments are required to provide this information to other entities in order to comply with international standards and therefore will have already compiled the necessary information. The average burden per response to a request for review by FDA remains the same (26 hours). The burden we attribute to reporting activities is assumed to be distributed among the individual elements of the information collection activities.

Since the effective date of the regulations in 2009, only two requests for designation have been received; however, we retain our current estimate of one respondent to permit such requests for designation by respondents and also to permit related responses to FDA.

Table 2—Estimated Annual Recordkeeping Burden ¹

21 CFR part; activity	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
589.2001(c)(2)(ii), 589.2001(c)(2)(vi), and (c)(3)(i), and 589.2001(c)(3)(i)(A) and (B); Rendering facilities maintain written procedures and records, and certification or documentation from the supplier	145	1	145	45	6,525
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2 reflects an adjustment decrease in our recordkeeping burden estimate, based primarily on consolidation within the industry and the related decrease in the estimated number of respondents subject to recordkeeping requirements. The burden we attribute to recordkeeping activities is assumed to be distributed among the individual elements and averaged among respondents. The total number of recordkeepers contains a subset of 50 recordkeepers who maintain written procedures and records specifically required by § 589.2001(c).

Based on our review since the last OMB approval, there is an overall adjustment decrease of 2,565 burden hours. The adjustment is attributable to decreases in the average reporting burden time and in respondents subject to recordkeeping requirements.

Dated: March 21, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.