Source: https://www.federalregister.gov/documents/2018/01/17/2018-00676/agency-information-collection-activities-proposed-collection-comment-request-veterinary-feed
Timestamp: 2019-09-22 02:39:43
Document Index: 657005914

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A Notice by the Food and Drug Administration on 01/17/2018
Submit either electronic or written comments on the collection of information by March 19, 2018.
Veterinary Feed Directive—21 CFR 558.6
https://www.federalregister.gov/d/2018-00676 https://www.federalregister.gov/d/2018-00676
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 response to the notice. This notice solicits comments on the information collection provisions of our veterinary feed directive (VFD) regulation.
Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to Start Printed Page 2457the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
Instructions: All submissions received must include the Docket No. FDA-2010-N-0155 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 office between 9 a.m. and 4 p.m., Monday through Friday.
Section 504 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 354) establishes a regulatory category for certain new animal drugs called 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 practice (§ 558.3 (21 CFR 558.3(b)(6))). 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 (§ 558.6(a)(1)).
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 (§§ 558.6(a)(4) and 558.6(b)(8)-(9)). The VFD includes information about the number and species of animals to receive feed containing one or more of the VFD drugs (§ 558.6(b)(3)), along with other information required under § 558.6. All distributors of medicated feed containing VFD drugs must notify us of their intent to distribute such feed and must maintain records of the receipt and distribution of all medicated feeds containing VFD drugs.
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. The VFD regulation is tailored to the unique circumstances relating to the distribution and use of animal feeds containing a VFD drug.
We will use the information collected to assess compliance with the VFD regulation. The required 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 Start Printed Page 2458products from treated animals will be free of unsafe drug residues.
We estimate the burden of this collection of information as follows. We base our estimates on our analysis of the information collection provisions of the final rule entitled “Veterinary Feed Directive,” published in the Federal Register of June 3, 2015 (80 FR 31708 at 31728) (the June 3, 2015, final rule).
Description of Respondents: VFD Feed Distributors, VFD Drug Sponsors.
A distributor of animal feed containing a VFD drug must notify us prior to the first time it distributes the VFD feed (§ 558.6(c)(5)). This notification is required one time per distributor and must include the information set forth in § 558.6(c)(5). In addition, a distributor must notify us within 30 days of any change in ownership, business name, or business address (§ 558.6(c)(6)). Additional reporting burdens for current VFD drug sponsors are approved under OMB control numbers 0910-0032 (New Animal Drug Applications) and 0910-0669 (Abbreviated New Animal Drug Applications).
21 CFR section, activity
558.6(c)(5); requires a distributor to notify us prior to the first time it distributes a VFD feed 300 1 300 .125 (7 minutes) 37.5
558.6(c)(6); requires a distributor to notify us within 30 days of any change in ownership, business name, or business address 20 1 20 .125 (7 minutes) 2.5
As stated previously, 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. All involved parties (the veterinarian, the distributor, and the client) must retain a copy of the VFD for 2 years (§ 558.6(a)(4)). In addition, VFD feed distributors must also keep receipt and distribution records of VFD feeds they manufacture and make them available for inspection by us for 2 years (§ 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 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.” Distributors may distribute VFD to another distributor only if the originating distributor first obtains a written acknowledgement letter. Such letters, like VFDs, are also subject to a 2-year record retention requirement (§ 558.6(c)(8)).
558.6(a)(4); required recordkeeping by veterinarians and producers 13,050 114.9 1,500,000 .0167 (1 minute) 25,050
558.6(a)(4), (c)(3)-(4), and (c)(8); required recordkeeping by distributors 1,376 545.1 750,000 .0167 (1 minute) 12,525
Our regulation requires that veterinarians include the information specified at § 558.6(b)(3) through (5) on the VFD. Additional requirements relating to the VFD are specified at § 558.6(b)(7) through (9). A distributor may only distribute a VFD feed to another distributor for further distribution if the originating distributor (consignor) first obtains a written acknowledgement letter from the receiving distributor (consignee) before the feed is shipped (§ 558.6(c)(8)).Start Printed Page 2459
558.6(b)(3)-(5) and (b)(7)-(9); required disclosures when a veterinarian issues a VFD 3,050 246 750,000 .125 (7 minutes) 93,750
558.6(c)(8); required disclosure (acknowledgement letter) from one distributor to another 1,000 5 5,000 .125 (7 minutes) 625
2. “This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” (List specific approved, conditionally approved, or indexed combination medicated feeds following this statement. § 558.6(b)(6)(ii).)
These labeling statements are not subject to review by OMB because, as stated previously, they 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.). Our estimate of the annual burden for this information collection has not changed since the last OMB approval, which was associated with the June 3, 2015, final rule. However, the one-time burdens that we included in our analysis of the June 3, 2015, final rule (80 FR 31708 at 31729 to 31732) are not included in our current estimate.
[FR Doc. 2018-00676 Filed 1-16-18; 8:45 am]