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Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) 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 ( printed page 20219) existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting, recordkeeping, and third-party disclosure burden associated with the veterinary feed directive regulations.
Either electronic or written comments on the collection of information must be submitted by May 20, 2024.
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 May 20, 2024. 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-2024-N-0802 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive.” 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 helps support implementation of FDA statutory and regulatory requirements. Section 504 of the Federal Food, Drug, and Cosmetic Act (FD&C) (21 U.S.C. 354) establishes a regulatory category for certain new animal drugs called veterinary feed directive (VFD) drugs. Our VFD regulation is set forth at § 558.6 (21 CFR 558.6). VFD drugs are new animal drugs, intended for use in or on animal feed, which are limited to use under the professional supervision of a licensed veterinarian in the course of the veterinarian's professional ( printed page 20220) practice. An animal feed containing a VFD drug or a combination VFD drug may be fed to animals only by or upon a lawful VFD issued by a licensed veterinarian.
Distributors of medicated feed containing VFD drugs notify FDA of their intent to distribute such feed via U.S. Postal mail, email, or fax and must maintain records of the receipt and distribution of all medicated feeds containing VFD drugs. Veterinarians issue three copies of the VFD: one for their own records, one for their client, and one to the client's VFD feed distributor. For third-party disclosures, FDA regulation requires that veterinarians include specific information on the VFD. A distributor may only distribute a VFD feed to another distributor for further distribution if the originating distributor (consignor) first obtains a written acknowledgment letter from the receiving distributor (consignee) before the feed is shipped.
We developed the guidance document “Guidance for Industry (GFI) #233 Veterinary Feed Directive Common Format Questions and Answers” (September 2016) ( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-233-veterinary-feed-directive-common-format-questions-and-answers) to provide guidance concerning the elements that must be included on the VFD and the elements that may be included on the VFD as described in § 558.6. The guidance also provides examples that illustrate how a common VFD format might appear. We plan to revise the information collection to incorporate this guidance document as an instrument. Agency guidance documents are issued in accordance with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time.
The VFD regulation ensures the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and cost effectively as possible. We will use the information collected to assess compliance with the VFD regulation. The required reporting, recordkeeping, and third-party disclosures provide assurance that the medicated feeds will be safe and effective for their labeled conditions of use and that edible products from treated animals will be free of unsafe drug residues.
Description of Respondents: VFD Feed Distributors.
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 |
|---|---|---|---|---|---|
| 558.6(c)(5) requires a distributor to notify FDA prior to the first time it distributes a VFD feed | 112 | 1 | 112 | 0.12 (7 minutes) | 13 |
| 558.6(c)(6) requires a distributor to notify FDA within 30 days of any change in ownership, business name, or business address | 239 | 1 | 239 | 0.12 (7 minutes) | 29 |
| Total | 351 | 42 | |||
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
The number of respondents is based on the average number of notifications we have received over the past 3 years.
Description of Respondents: VFD Feed Distributors, Food Animal Veterinarians, and Clients (Food Animal Producers).
| 21 CFR part/activity | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| 558.6(a)(4) and (c)(3), (4), and (8); requires recordkeeping by veterinarians, producers, and distributors to maintain their copy of the VFD Order, their receipt and distribution records, and their manufacturing records and acknowledgement letters, if applicable, for 2 years | 30,800 | 219.03 | 6,746,096 | 0.02 (1 minute) | 134,922 |
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
FDA's guidance document, “GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” (December 2013) ( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-213-new-animal-drugs-and-new-animal-drug-combination-products-administered-or-medicated-feed) describes a voluntary process wherein sponsors of new animal drugs used in and on animal feed and in water changed the marketing status of these drugs from over-the-counter to VFD. As a result of this voluntary process, which occurred in January 2017, the number of establishments distributing feeds containing VFD drugs increased, as well as the number of veterinarians issuing VFDs, and the number of food animal producers using VFD medicated feed. Thus, based on the current number of mixed practice veterinarians and the number of food animal veterinarians listed on the American Veterinary Medical Association's website, we have increased the number of recordkeepers for veterinarians and producers.
Additionally, based on our program experience, we have decreased the number of records per recordkeeper, as we believe the previous numbers were too high. The burden we attribute to recordkeeping activities is assumed to be distributed among the individual elements and averaged among respondents.
In addition to the recordkeeping requirement under § 558.6(c)(3), if a distributor manufactures the VFD feed, the distributor must also keep VFD manufacturing records for 1 year in accordance with 21 CFR part 225 and ( printed page 20221) such records must be made available for inspection and copying by FDA upon request (§ 558.6(c)(4)). These record requirements are currently approved under OMB control number 0910-0152, “Current Good Manufacturing Practice Regulations for Medicated Feed.”
Description of Respondents: Food Animal Veterinarians, VFD Feed Distributors, and Clients.
| 21 CFR part/activity | Number of respondents | Number of disclosures per respondent | Total annual disclosures | Average burden per disclosure | Total hours |
|---|---|---|---|---|---|
| 558.6(b)(3)(v) and (b)(7)(ix); requires veterinarians to disclose information on a VFD | 5,278 | 40 | 211,120 | 0.12 (7 minutes) | 25,334 |
| 558.6(c)(8); requires acknowledgment letter from one distributor to another | 2,422 | 5 | 12,110 | 0.12 (7 minutes) | 1,453 |
| Total | 7,700 | 26,787 | |||
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Based on program experience, we believe the original number of third-party disclosures estimate was too high and have decreased the number of disclosures per respondent. The VFD regulation also contains several labeling provisions. These labeling statements are a “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)) and therefore do not constitute a “collection of information” under the PRA (44 U.S.C. 3501, et seq.).
After a review of the information collection since our last request for OMB approval, we have adjusted our estimates based on our experience with the VFD regulations and updated data. As a result, the total burden for the information collection has decreased 39,387 hours since the last OMB approval.
Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05986 Filed 3-20-24; 8:45 am]
BILLING CODE 4164-01-P