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Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 ( printed page 70677) response to the notice. This notice solicits comments on the reporting and recordkeeping requirements for cattle materials prohibited from use in animal food or feed.
Either electronic or written comments on the collection of information must be submitted by December 11, 2023.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 11, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2023-N-4181 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Cattle Materials Prohibited From Use in Animal Food or Feed.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
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, PRAStaff@fda.hhs.gov.
Under the PRA (44 U.S.C. 3501-3521), 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 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.
This information collection supports implementation of Agency statutory and regulatory requirements 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. 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 ( printed page 70678) 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 that process cattle materials, including reporting and recordkeeping requirements. 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.
Under our regulations, 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. We use the information to ensure their designations remain appropriate.
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.
Description of Respondents: Respondents to this information collection are foreign governments seeking designation under § 589.2001(f) and rendering facilities that process cattle materials.
FDA estimates the burden of this collection of information as follows:
| 21 CFR part; activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| 589.2001(f); Process for designating countries to request exemption from the requirements of this regulation | 1 | 1 | 1 | 40 | 40 |
| 589.2001(f); response to request for review by FDA | 1 | 1 | 1 | 26 | 26 |
| Total | 66 | ||||
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
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).
Since the last renewal, we have reduced the request for designation burden from 80 hours to 40 hours. This reduction is because respondents 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.
Our estimate of the reporting burden for designation under § 589.2001(f) is based on estimates found in our final rule. Since the rule's effective date in 2009, only two requests for designation have been received; however, we retain our current estimate of one to permit such requests for designation by respondents and to permit related responses to FDA.
| 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. | |||||
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 21 CFR 589.2001(c).
We have adjusted our recordkeeping burden estimate in Table 2, which results in a decrease of 2,525 hours. This is based primarily on consolidation within the industry and a decrease in the estimated number of respondents subject to recordkeeping requirements.
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 respondent subject to recordkeeping requirements.
Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22495 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P
3 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.