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Skip Navigation HomeHelpResourcesContact Us Advanced Search Start of Main Content Veterinary Feed Directive This Proposed Rule document was issued by the Food and Drug Administration (FDA) For related information, Open Docket Folder Show agency attachment(s) DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. FDA-2010-N-0155]
SummaryThe Food and Drug Administration (FDA) is proposing to amend its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This proposed amendment is intended to improve the efficiency of FDA's VFD program.
DatesSubmit either electronic or written comments on the proposed rule by March 12, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by January 13, 2014, (see the “Paperwork Reduction Act of 1995” section).
AddressesYou may submit comments, identified by Docket No. FDA-2010-N-0155, by any of the following methods, except that comments on information collection issues under the PRA must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the “Paperwork Reduction Act of 1995” section).
Electronic SubmissionsSubmit electronic comments in the following way
Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA-2010-N-0155 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the “Comments” heading of theSUPPLEMENTARY INFORMATIONsection.
For Further Information ContactSharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6864, email: Sharon.Benz@fda.hhs.gov. Supplementary InformationTable of ContentsI. Background
IX. CommentsExecutive SummaryPurpose of Proposed RuleThe purpose of this rulemaking is to revise FDA's VFD regulations to improve the efficiency of the VFD program.
As FDA begins to implement the judicious use principles for medically important antimicrobial new animal drugs approved for use in food-producing animals, based on the framework set forth in Guidance for Industry (GFI) #209 (published April 13, 2012), it is critical that the Agency makes the VFD program as efficient as possible for stakeholders while maintaining adequate protection for human and animal health. The provisions included in this proposed rule are based on stakeholder input received in response to multiple opportunities for public comment, including an advance notice ofproposed rulemaking (ANPRM) (75 FR 15387, March 29, 2010) and draft text of proposed amendments to the current VFD regulations (77 FR 22247, April 13, 2012). FDA proposes that if this rule is finalized, it will become effective 60 days after publication of the final rule in theFederal Register.Summary of Major ProvisionsThe proposed rule, if finalized, will make several major changes to the current VFD regulations in 21 CFR part 558: In order to provide increased flexibility for licensed veterinarians issuing VFDs, FDA is proposing to revise the definition of the term “Veterinary Feed Directive” in § 558.3 (21 CFR 558.3) which currently includes a relatively prescriptive, federally defined, code of veterinary professional conduct known as the veterinarian-client-patient relationship (VCPR). Specifically, the Agency proposes to remove the explicit VCPR provision and replace it with the requirement that veterinarians ordering the use of VFD drugs must do so “in compliance with all applicable veterinary licensing and practice requirements.” The purpose of this revision is to provide greater flexibility for veterinarians by deferring to the veterinary profession and individual states for the specific criteria for acceptable veterinary professional conduct, rather than relying on a more rigid, one-size-fits-all, Federal standard. From a practical standpoint, this enables the veterinary profession and individual states to adjust the specific criteria for a VCPR to appropriately align with current veterinary practice standards, technological and medical advances, and other regional considerations. For example, greater flexibility could allow veterinarians to more effectively provide services to food animal producers in remote geographical areas where veterinary professional resources are limited and distances are great.
In order to lower the recordkeeping burden associated with the use of VFD drugs, FDA is proposing to align the recordkeeping requirements for VFD drugs with the current Good Manufacturing Practices (cGMP) recordkeeping requirements for medicated feeds, thus reducing the recordingkeeping burden for VFD drugs from 2 years to 1 year. Under current § 558.6, all involved parties (the veterinarian, the distributor, and the client) must keep their copy of the VFD on file and available for FDA inspection for 2 years. In addition, VFD feed distributors must also keep receipt and distribution records of the VFD feeds they manufacture and make them available for FDA inspection for 2 years. However, the cGMP regulations for medicated feed manufacturing in 21 CFR part 225 require that such records be kept for only 1 year. Feed mill operators have told FDA that this discrepancy is difficult to manage and that they would like to see all feed manufacturing record retention requirements kept the same at 1 year. Based on our experience, FDA does not believe the extra 1 year of recordkeeping for VFD drugs is warranted for any of the involved parties. The value added by the second year of record retention has not been shown to justify the associated paperwork burden. Therefore, FDA is proposing to reduce the recordkeeping requirement for copies of VFDs for all involved parties, and for manufacturing receipt and distribution records for VFD distributors, from 2 years to 1 year.Costs and BenefitsThe estimated one-time costs to industry from this proposed rule, if finalized, are $920,000, most of which are costs to review the rule and prepare a compliance plan. This equates to annualized costs of about $131,000 at a 7 percent discount rate over 10 years. We estimate that the total government costs associated with reviewing the VFD drug labeling supplements that are expected to be submitted by all four VFD drug sponsors to be $1,200.
The expected benefit of this proposal is a general improvement in the efficiency of the VFD process. FDA estimates the annualized cost savings associated with the reduced requirements of the VFD process to be $19,000 over 10 years at a 7 percent discount rate (annualized at $16,000 over 10 years at a 3 percent discount rate). Additionally, the reduction in veterinarian labor costs due to this rule is expected to result in a cost savings of about $5.55 million annually.I. BackgroundA. HistoryBefore 1996, FDA had only two options for regulating the distribution of animal drugs: (1) OTC and (2) prescription (Rx). Drugs used in animal feeds were generally approved as OTC drugs. Although the Federal Food, Drug, and Cosmetic Act (the FD&C Act) did not prohibit the approval of prescription drugs for use in animal feed, such approvals have historically been impractical because many states have laws prohibiting feed manufacturers from dispensing prescription drugs. As newer animal drugs were developed, FDA determined that the existing regulatory options—OTC and Rx—did not provide the needed flexibility and safety for these drugs to be prescribed or administered through medicated feed. FDA believed that such drugs should be subject to greater control than provided by OTC status, particularly certain antimicrobial drugs. This control is critical to reducing unnecessary use of such drugs in animals and to slowing or preventing any potential for the development of bacterial resistance to antimicrobial drugs.
After considerable deliberation between FDA and the animal agriculture industry, and with the support of Stateregulatory Agencies, in 1996 Congress enacted the ADAA to facilitate the approval and marketing of new animal drugs and medicated feeds. As part of the ADAA, Congress determined that certain new animal drugs should be approved for use in animal feed but only if these medicated feeds were administered under a veterinarian's order and professional supervision. Therefore, the ADAA created a new category of products called veterinary feed directive drugs (or VFD drugs). 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. For animal feed containing a VFD drug to be used in animals, a licensed veterinarian must first issue an order, called a veterinary feed directive (or VFD), providing for such use. In theFederal Registerof December 8, 2000 (65 FR 76924), FDA issued a final rule amending the new animal drug regulations to implement the VFD-related provisions of the ADAA. In that final rule, FDA stated that because veterinarian oversight is so important for assuring the safe and appropriate use of certain new animal drugs, the Agency should approve such drugs for use in animal feed only if these medicated feeds are administered under a veterinarian's order and professional supervision. As an example, the final rule noted that safety concerns relating to the difficulty of disease diagnosis, drug toxicity, drug residues, antimicrobial resistance, or other reasons may dictate that the use of a medicated feed be limited to use by order and under the supervision of a licensed veterinarian.
In response to these concerns, the Agency began exploring ways to improve the VFD program's efficiency. To that end, FDA initiated the rulemaking process through the publication of an ANPRM in theFederal Registerof March 29, 2010 (75 FR 15387). The ANPRM requested public comment on whether efficiency improvements are needed and, if so, what specific revisions should be made to the VFD regulations. Subsequent to this, FDA published draft text of a proposed VFD regulation (hereinafter, “draft proposed regulation”) in theFederal Registerof April 13, 2012 (77 FR 22247), based on the considerable public input provided to the ANPRM docket, and requested comment on this draft text. The provisions included in this proposed rule reflect the public input FDA received. FDA proposes that if this rule is finalized, it will become effective 60 days after publication of the final rule in theFederal Register.B. Judicious Use Policy for Medically Important AntimicrobialsOn April 13, 2012, FDA finalized a guidance document entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals” (GFI #209). This final guidance represents the Agency's current thinking regarding antimicrobial drugs that are medically important in human medicine and used in food-producing animals. Specifically, GFI #209 discusses FDA's concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when medically important antimicrobial drugs are used in food-producing animals in an injudicious manner. In addition, GFI #209 provides two recommended principles regarding the appropriate or judicious use of medically important antimicrobial drugs: (1) Limit medically important antimicrobial drugs to uses in animals that are considered necessary for assuring animal health and (2) limit medically important antimicrobial drugs to uses in animals that include veterinary oversight or consultation.
Implementation of these judicious use principles, particularly the second principle, reinforces the need for FDA to reconsider the current VFD program and how best to make the program more efficient and less burdensome for stakeholders while maintaining adequate protection for human and animal health. Currently, the vast majority of the antimicrobial animal drug products that are the focus of GFI #209 are feed-use drugs—that is, they are products approved for use in or on animal feed. All but a few of these products are currently available OTC without veterinary oversight or consultation and would be affected by the recommendation to switch to VFD status. It is critical, therefore, that the VFD process be as efficient as possible when FDA's judicious use policy is fully implemented because an overly burdensome VFD process could lead to unanticipated disruptions in the current channels of commercial feed distribution.II. Highlights of the Proposed RuleThe primary purpose of this rulemaking is to improve the efficiency of the VFD program, while still ensuring that VFD drugs are used in a manner that affords adequate protection for human and animal health. The key changes in this proposal include: User-friendly reorganization of the VFD regulation;
lower recordkeeping burden for all involved parties.A.The proposed rule, if finalized, will revise and reorganize the existing VFD regulation at § 558.6 to make it more user-friendly. Proposed § 558.6 includes only three subsections, (a), (b), and (c), in contrast to the existing regulation, which has six subsections. In addition, for ease in identifying what is expected from each party involved in the VFD process, the proposed rule organizes the provisions by affected party or stakeholder group. Subsection (a) contains general provisions that are common to all affected parties, including veterinarians, distributors, and clients (including clients that are on-farm mixers handling VFD drugs and feeds for use in their own animals). Subsection (b) contains specific provisions for veterinarians and subsection (c) contains specific provisions for animal feed distributers. Consistent with public comments we received on the ANPRM and draft regulation, these revisions are intended to make it clearer what is expected from each of these parties. Important aspects of subsection (b) include that the veterinarian issuing the VFD must be licensed and must assure that the VFD is complete and accurate before it is issued. The veterinarian must also assure that the terms of the VFD are in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug. Important aspects of subsection (c) include that the VFD feed distributor is responsible for assuring that the VFD is complete before filling the order. The VFD feed distributor must also assure that the medicated feed is manufactured and labeled in accordance with the VFD and in conformity with the approved,conditionally approved, or indexed conditions of use. See section III for a more detailed description of these provisions.B.FDA proposes to modify provisions in the existing regulation at 21 CFR part 558 relating to professional conduct by veterinarians issuing orders for VFD drugs in several important ways. First, in order to provide greater flexibility for veterinarians, FDA is proposing to revise the definition of the term “Veterinary Feed Directive” in § 558.3(b)(7) which currently includes a relatively prescriptive, federally-defined, code of veterinary professional conduct known as the VCPR. Specifically, the Agency proposes to remove the explicit VCPR provision and replace it with the requirement that veterinarians ordering the use of VFD drugs must be “in compliance with all applicable veterinary licensing and practice requirements.” The purpose of this revision is to provide greater flexibility for veterinarians by deferring to the veterinary profession and individual states for the specific criteria for acceptable veterinary professional conduct, rather than relying on a more rigid, one-size-fits-all, Federal standard. As discussed further below, the veterinary profession and individual state veterinary medical licensing boards already embrace the concept of a VCPR as an element of veterinary licensing and practice requirements. From a practical standpoint, this proposal would enable the veterinary profession and individual states to adjust the specific criteria for a VCPR to appropriately align with current practice standards, technological and medical advances, and other regional considerations. For example, providing for this greater degree of flexibility is of particular importance for those veterinarians providing services to producers in remote geographical areas where veterinary professional resources are limited and distances are great. Further, this proposal provides greater flexibility for veterinarians working in consultation with other animal health professionals, such as poultry pathologists and fish health biologists. The need for greater flexibility in a veterinarian's professional relationship with his or her clients and patients will become increasingly important as FDA's judicious use policy for medically important antimicrobial dugs is implemented.
Second, FDA is proposing to further revise the definition of the term “Veterinary Feed Directive” in § 558.3(b)(7) to explicitly incorporate the concept of veterinary “supervision or oversight.” Section 504(a)(1) of the FD&C Act (21 U.S.C. 354(a)(1)) states that a veterinary feed directive drug is a drug intended for use in or on animal feed which is limited to use under the professional “supervision” of a licensed veterinarian. In addition, the second judicious use principle of GFI #209 recommends veterinary “oversight” when using medically important antimicrobial drugs in food-producing animals. Therefore, to better align the VFD regulations with the statute and with the judicious use principles outlined in GFI #209, we propose to incorporate the phrase “supervision or oversight” in the revised definition of VFD. Thus, the proposed revised definition for VFD would require that a veterinarian may only issue a VFD for the use of VFD drugs in animals that are under his or her “supervision or oversight.”
It is important to remember that this provision would only apply to on-label animal drug use. The statutory provision for an explicit, federally defined VCPR, which was introduced with the Animal Medicinal Use Clarification Act of 1994 (AMDUCA) (Pub. L. 103-396) (see section 512(a)(4)(A)(i) of the FD&C Act (U.S.C. 360b(a)(4)(A)(i))) and defined by regulation (see § 530.3(i)), continues to apply in circumstances involving extralabel animal drug use. However, because AMDUCA specifically prohibits extralabel use of animal drugs in or on animal feed, including VFD drugs, FDA does not believe that the explicit VCPR requirement as defined in § 530.3(i) is necessary in the context of VFD drug use.
This proposed revision is not intended to lower the standard for professional conduct by veterinarians. Instead of continuing to impose explicit, federally defined VCPR requirements on veterinarians using VFD drugs in their professional practice, these proposed revisions would, consistent with the approach to regulating veterinary professional conduct in the context of prescription animal drug use, recognize and appropriately defer to existing regulatory oversight standards for veterinary professional conduct. This includes VCPR standards that have been established by the veterinary profession and individual state veterinary medical licensing boards. The Agency believes that state veterinary medical licensing boards are well suited for this role because of their unique perspective on factors such as the local availability of professional veterinary medical resources and the needs of their individual agricultural communities. However, while each state's veterinary medical practice code may be somewhat different, the practice of veterinary medicine in the United States is, to a great extent, guided by the AmericanVeterinary Medical Association (AVMA) and its Principles of Veterinary Medical Ethics, (1)
As noted earlier, the Agency intends to provide for greater flexibility by deferring to the veterinary profession and individual states for the specific criteria for complying with the concept of a VCPR as an element of veterinary licensing and practice requirements. This would allow the specific criteria for a VCPR to be adjusted as appropriate to align with the most recent practice standards, technological and medical advances, and practical considerations in particular regions of the country.C. Continued Access to Category I Type AUnder the current VFD regulations, all medicated feed distributors, licensed or unlicensed, are able to manufacture and sell medicated feeds containing VFD drugs. The only difference is that licensed facilities are able to start the manufacturing process with a VFD Type A medicated article and unlicensed facilities must start with a VFD Type B (3)
or Type C (4)
Furthermore, FDA has reconsidered its previous position that all VFD drugs should be classified as Category II drugs (see final rule of December 8, 2000 (65 FR 76924 at 76926)). Based on our experience with VFD drugs (e.g., investigating animal drug residue violations, cGMP inspections), the Agency no longer believes that the enhanced inspection requirements for licensed feed mills are necessary to assure the safe and effective use of VFD drugs that would otherwise be classified as Category I drugs. This is because (as noted in section II.E) feed-use drugs, in general, have a very safe record of use and Category I feed-use drugs, because of their extremely safe pharmacological and toxicological profile, have the lowest potential of creating unsafe drug residues at their approved dose levels.D.A number of stakeholders responding to the ANPRM and draft proposed regulation requested that FDA remove the requirement for veterinarians to include the amount of medicated feed to be dispensed on the VFD, as is currently required in § 558.6(a)(4)(vi). Although this request was voiced by respondents from several different food animal production industries, each of them based their request on the difficulty of predicting, prior to feeding, exactly how much medicated feed a particular flock, herd, pen, house, or tank of animals will actually consume during a specific period of drug administration. Feed consumption rates can vary significantly depending on several factors, including environmental conditions. However, the most important sources of variability liein the animals' health status at the beginning of drug administration and how quickly these animals respond to treatment. Regardless of species, healthy animals generally eat more than sick animals. It is difficult to predict how quickly animals will respond to treatment and how quickly they will return to their normal feed consumption rate. In an effort to purchase or manufacture the right amount of medicated feed, food animal producers often monitor feed consumption rates during the treatment period and later make adjustments in feed orders accordingly.
As noted by several stakeholders, if the veterinarian is required to specify on the VFD the amount of medicated feed to be dispensed, he or she may overestimate that amount in order to make sure the food animal producer does not run out of feed before the end of the treatment period. Unfortunately, this will often times result in leftover medicated feed on the farm. Alternatively, if the amount of medicated feed listed on the VFD is too little, the food animal producer may need to get another VFD to complete the course of treatment. FDA acknowledges stakeholders' concerns about the variability of feed consumption rates and therefore, in response to these concerns, proposes to eliminate the requirement for veterinarians to specify the amount of medicated feed to be dispensed on the VFD. FDA believes that the proposed new requirements for veterinarians to specify on the VFD the duration of use and the approximate number of animals to be fed the medicated feed, along with the current requirement to include the level of VFD drug in the feed, should provide adequate control over the total amount of medicated feed authorized by the VFD.E.Another commonly heard suggestion from stakeholders responding to the ANPRM and draft proposed regulation is the need to reduce the VFD recordkeeping burden from 2 years to 1 year. Under the current VFD regulation, all involved parties (the veterinarian, the distributor, and the client) must keep their copy of the VFD on file and available for FDA inspection for 2 years (see current § 558.6(c)). In addition, VFD feed distributors must also keep receipt and distribution records of the VFD feeds they manufacture and make them available for FDA inspection for 2 years (see current § 558.6(e)).
As noted in FDA's proposed VFD rule that was published in theFederal Registeron July 2, 1999 (64 FR 35966), the usual and customary manufacturing records kept by distributors to comply with the cGMP regulations in 21 CFR part 225 satisfies the VFD receipt and distribution recordkeeping requirement as well (see 21 CFR part 225, subpart E (licensed feed mill distributors) and subpart I (unlicensed feed mill distributors)). However, the cGMP regulations in part 225 only require that such records be kept for 1 year, in contrast to the 2-year requirement for VFD feeds in § 558.6(e). Feed mill operators have told us that this discrepancy is difficult to manage and that they would like to see all feed manufacturing record retention requirements kept the same at 1 year, thus eliminating the need for two separate filing systems: One for non-VFD feed records (1-year record retention) and one for VFD feed records (2-year record retention).
Based on our experience, FDA does not believe the extra 1 year of recordkeeping for VFD drugs is warranted for any of the involved parties. The value added by the second year of record retention has not been shown to justify the associated paperwork burden. FDA compliance investigations regarding violative drug residues in edible animal tissues are normally completed within the first year of their detection and nearly all of these are associated with dosage form drugs (i.e., non-feed use drugs). Therefore, FDA is proposing to reduce the recordkeeping requirement for copies of VFDs for all involved parties, and for manufacturing receipt and distribution records for VFD distributors, from 2 years to 1 year. Because the usual and customary records of purchase and sales kept by distributors to comply with the cGMP regulations in part 225 adequately support the VFD inspection program, we have not included the VFD receipt and distribution recordkeeping requirement found in current § 558.6(e) in this proposed rule.III. Proposed RegulationsA.The CFR citation noted in the new animal drug application regulations at 21 CFR 514.1(b)(9) would be revised to reflect the new VFD format provision found in proposed § 558.6(b)(3).B.The definitions of terms used in the medicated feed regulations of part 558, including the VFD drug regulations in § 558.6, can be found in § 558.3(b). FDA proposes to amend § 558.3(b) as follows:
Proposed § 558.3(b)(12) includes the new term “combination veterinary feed directive (VFD) drug” to account for combination animal drugs used in or on animal feed that include one or more VFD drugs.C. General Requirements Related to VFD Drugs (Proposed § 558.6(a))As noted in section II.A, proposed § 558.6(a) contains general provisions that are common to all involved parties (the veterinarian, the distributor, and the client). This includes clients that are also on-farm mixers that only manufacture VFD feeds for use in their own animals.
Proposed § 558.6(a)(3) reminds stakeholders that the extralabel use (ELU) of any medicated feed, including medicated feeds containing VFD drugs, is not permitted under Federal law. (See section 512(a)(4)(A) of the FD&C Act.) Several stakeholders responding to the ANPRM and draft regulation requested that FDA allow ELU for VFD feeds. AMDUCA legalized, for the first time, ELU of approved drugs in animals. However, AMDUCA specifically prohibits ELU of such drugs in or on animal feed. (See Pub. L. 103-396.)
Proposed § 558.6(a)(6) revises the required cautionary labeling statement for all VFD drugs and feeds.D. Responsibilities of the Veterinarian Issuing the VFD (Proposed § 558.6(b))Proposed § 558.6(b)(1) reiterates that a VFD may only be issued by a licensed veterinarian for the use of VFD drugs in animals under his or her supervision or oversight in the course of his or her professional practice, and in compliance with all applicable veterinary licensing and practice requirements. This would replace the current federally defined VCPR provision that cites § 530.3(i), as discussed in section II.B.
Proposed § 558.6(b)(9) would clarify that veterinarians may not issue a VFD verbally, including verbal transmission by telephone. However, transmission of a written (nonverbal) VFD by telephones that are capable of this function (i.e. smartphones) is allowed.E. Responsibilities of the Medicated Feed Distributor (Proposed § 558.6(c))Proposed § 558.6(c)(1) would require medicated feed distributors who handle VFD drugs to make sure all VFDs are completely filled out before manufacturing the specified VFD feed. VFDs that do not include all the information required by proposed § 558.6(b)(3) are incomplete and considered invalid.
Proposed § 558.6(c)(2) reminds medicated feed distributors that they may only distribute an animal feed containing a VFD drug or combination VFD drug that is in compliance with the terms of a valid VFD and is manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug. This dual responsibility is not new but is a very important concept that all VFD distributors mustunderstand. VFDs that are not in compliance with the conditions of use approved, conditionally approved, or indexed for the VFD drug are invalid and may not be used to authorize the distribution of a medicated feed containing a VFD drug.
Proposed § 558.6(c)(7) retains the statutory requirement for medicated feed distributors that consign VFD drug-containing feeds to another distributor to receive an acknowledgement letter from that person. This section references a revised definition of “acknowledgement letter” found in proposed § 558.3(b)(11). Proposed § 558.6(c)(7) also includes an explicit 1-year recordkeeping requirement for acknowledgment letters.IV. Legal AuthorityFDA's authority for issuing this proposed rule is provided by section 504 of the FD&C Act. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.V. Preliminary Regulatory Impact AnalysisFDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this proposed rule is not a significant regulatory action as defined by Executive Order 12866. We have developed a preliminary regulatory impact analysis (PRIA) that presents the benefits and costs of this proposed rule to stakeholders and the government.
The summary analysis of benefits and costs included in the Executive Summary of this document is drawn from the detailed PRIA, which is available at http://www.regulations.gov (enter Docket No. FDA-2010-N-0155), and is also available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. VI. Paperwork Reduction Act of 1995This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given in the Description section that follows with estimates of the annual reporting, recordkeeping, and third-party disclosure burden. Included in each burden estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
Currently, there are few approved VFD drugs. However, FDA has received feedback from stakeholders characterizing the current VFD process as being overly burdensome. In response to these concerns, FDA began exploring ways to improve the VFD program's efficiency. To this end, FDA published an ANPRM inviting public comment on possible VFD program efficiency improvements in March 2010. Based on the considerable public input received in response to the ANPRM, in April 2012 FDA issued for public comment draft text for proposed revisions to the current VFD regulation.Current and Proposed Information Collection RequirementsThe current veterinary feed directive regulation, § 558.6, has information collection provisions contained at OMB control number 0910-0363 (expiration date December, 31, 2014). Many of these provisions will be unaffected by the proposed rule, if finalized; therefore, this Paperwork Reduction Act section will concentrate on the changes being proposed in this rulemaking and will describe how the paperwork reduction implications will be affected.Proposed Reporting Requirements Description of Respondents: VFD Feed Distributors.
Because the reporting requirements for distributors under proposed § 558.6(c)(4) are the same as the current requirements under § 558.6(d)(1), there is no new reporting burden. FDA understands that VFD feed distributors must review the rule in order to determine what actions are necessary to comply with the new regulation. For VFD feed distributors we estimate administrative review of the rule will take 4 hours to complete.
Table 1—Estimated One-Time Reporting Burden 1 21 CFR 558.6/activityNumber ofrespondentsNumber ofresponsesperrespondentTotalresponsesAverageburden perrespondentin hoursTotal hoursTotal costs
Administrative Review of the Rule (VFD Feed Distributors)1,36611,36645,464 2$387,000
Number of Respondents multiplied by Number of Responses per Respondent equals Total Responses. Total Responses multiplied by Average Burden per Response equals Total Hours.Proposed Recordkeeping Requirements Description of Respondents: VFD Feed Distributors, Food Animal Veterinarians, and Clients (Food Animal Producers).
Recordkeeping costs are calculated as follows: 750,000 VFDs (an average of 375,000 VFDs issued per VFD drug) issued in triplicate equals 2,250,000 VFDs issued and stored in files per year. (5)
We anticipate that computer storage will eliminate the need for large amounts of physical space devoted to file cabinets. If, as we expect, one-half of the VFD recordkeepers (veterinarians, distributors, and clients) use electronic recordkeeping, this would result in a cost savings of $19,575 annually ($21.75 per square foot per year rental cost of space times 6 square feet per file cabinet times 150 filing cabinets equals $19,575 annual savings for switching to computer storage) (Thorpe, K., Edwards, J., and Bondarenko, E. Cassidy Turley Commercial Real Estate Services. “U.S. Office Trends Report—2nd Quarter 2013.” Page 10. http://www.cassidyturley.com/Research/MarketReports/Report.aspx?topic=U_S_Office_Trends_Report&action=download, 2nd Quarter 2013).
As stated previously, both the current and proposed requirements state that the veterinarian, the distributor, and the client must keep a copy of the VFD. Whether a paper copy is filed or whether the VFD is filed electronically, we calculate that the time spent to file the VFD is the same at 0.167 hours. Therefore, no revision to the paperwork burden for filing the VFD is needed.
Table 2—Estimated One-Time Recordkeeping Burden 1 21 CFR 558.6/activityNumber ofrecordkeepersNumber of records perrecordkeeperTotal recordsAverageburden perrecordkeeperin hoursTotal hoursTotal costs
Administrative Review of the Rule (Food Animal Veterinarians)3,05013,05013,050 2$180,000
Administrative Review of the Rule (Clients)10,000110,0000.55,000 3 154,000
Recordkeeping by Electronic Storage for 1 Year 4 45,000
Total8,050379,000
Number of Recordkeepers multiplied by Number of Records per Recordkeeper equals Total Records. Total Records multiplied by Average Burden per Recordkeeper equals Total Hours.Proposed Third-Party Disclosure Requirements Description of Respondents: VFD Drug Sponsors, Food Animal Veterinarians, VFD Feed Distributors, and Clients (Food Animal Producers)
Proposed § 558.6(b)(3) includes various changes to the information that would need to be included on the VFD form that is filled out by the veterinarian in order for the VFD to be valid, including but not limited to, deleting the requirement that the veterinarian must include the amount of feed needed to treat the animals. Proposed § 558.6(b)(7) would allow veterinarians to send VFDs to the client or distributor via fax or other electronic means (as is currently permitted under § 558.6(b)(4)). However, if a VFD is transmitted electronically, the veterinarian would no longer be required to assure that the original, signed VFD is given to the distributor within 5 days. FDA estimates that a veterinarian currently requires about 0.25 hours to issue a VFD (i.e., research, fill out, and deliver all copies, including the original, signed VFD to the distributor). At a compensation rate of about $59 (veterinarian wage rate, see PRIA), the labor cost of currently issuing VFDs is estimated at $11.09 million (the estimated average of 750,000 VFDs issued annually times 0.25 hours to issue each VFD times $59 per hour equals approximately $11.09 million (rounded to be in accordance with the PRIA)). FDA estimates that the effect of this rule would be to reduce the average time to issue a VFD by 50 percent, or about 0.125 hours per VFD. This would result in a cost of about $5.55 million annually (the estimated average of 750,000 VFDs issued annually times 0.125 hours to issue each VFD times $59 per hour equals approximately $5.55 million (rounded to be in accordance with the PRIA)), a cost savings of about $5.55 million ($11.09 million − $5.55 million = approximately $5.55 million.
Currently, a distributor may only consign a VFD feed to another distributor if the originating distributor (consignor) first obtains a written acknowledgement letter from the receiving distributor (consignee) before the feed is shipped (§ 558.6(d)(2)). Because this current requirement is the same as that being proposed in § 558.6(c)(7), there is no new reporting burden.
Proposed § 558.6(c)(7), also includes an explicit recordkeeping requirement for acknowledgment letters. While the VFD final rule issued in December 2000 did not explicitly require distributors to retain acknowledgment letters for any specified period of time, a 2-year recordkeeping burden was accounted for in the PRA section of the final rule for this function as part of the VFD recordkeeping burden in Table 2, noted as § 558.6(d)(2) (65 FR 76928). (6)
Table 3—Estimated Annual Third-Party Disclosure Burden 1 21 U.S.C. 343m 21 CFR Section(Labeling Activity)Number ofrespondentsNumber ofdisclosures perrespondentTotal annualdisclosuresAverageburden perdisclosure in hoursTotal hoursTotal costs
Administrative Review of the Rule, Current VFD Drug Sponsors (General and Operations Managers) 2 212612 2$1,200
558.6(b)(3) Changes to VFD Form by Drug Sponsors 3 2241664 3 5,308
Veterinarian issues VFD 4 3,050245.9750,0000.12593,7505,550,000
Total93,8265,556,508
In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in theFederal Register.VII. Environmental ImpactThe Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.VIII. FederalismFDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule, if finalized, would not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently,a federalism summary impact statement is not required.IX. CommentsInterested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (seeADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. List of Subjects21 CFR Part 514
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 514 and 558 be amended as follows:Part 514 New Animal Drug Applications
Authority21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 371, 379e, 381.
2. Amend § 514.1 by revising paragraph (b)(9) to read as follows:
§ 514.1
* * * * *Part 558 New Animal Drugs for Use in Animal Feeds
3. The authority citation for 21 CFR part 558 is revised to read as follows:
Authority21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
4. Amend § 558.3 by revising paragraphs (b)(1)(ii), (b)(6), (b)(7), (b)(9), and (b)(11) and by adding new paragraph (b)(12) to read as follows:
5. Revise § 558.6 to read as follows:
(6) All labeling and advertising for VFD drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs must prominently and conspicuously display the following cautionary statement: “Caution: Federal law restricts medicated feed containing this VFD drug to use by or on the order of a licensed veterinarian.”
[FR Doc. 2013-29696 Filed 12-11-13; 8:45 am]BILLING CODE 4160-01-PFootnotes
https://www.avma.org/KB/Policies/Pages/Principles-of-Veterinary-Medical-Ethics-of-the-AVMA.aspx. (2)
A “Type A medicated article” is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. It consists of a new animal drug(s), with or without carrier (e.g., calcium carbonate, rice hull, corn, gluten) with or without inactive ingredients.
A “Type B medicated feed” is intended solely for the manufacture of other medicated feeds (Type B or Type C). It contains a substantial quantity of nutrients including vitamins and/or minerals and/or other nutritional ingredients in an amount not less than 25 percent of the weight. It is manufactured by diluting a Type A medicated article or another Type B medicated feed.
A “Type C medicated feed” is intended as the complete feed for the animal or may be fed “top dressed” on (added on top of usual ration) or offered “free-choice” (e.g., supplement) in conjunction with other animal feed. It contains a substantial quantity of nutrients including vitamins, minerals, and/or other nutritional ingredients. It is manufactured by diluting a Type A medicated article or a Type B medicated feed. A Type C medicated feed may be further diluted to produce another Type C medicated feed.
Distributors may receive an acknowledgment letter in lieu of a VFD when consigning VFD feed to another distributor. Such letters, like VFDs, would also be subject to a 1-year record retention requirement (see proposed § 558.6(c)(7)). Thus, the recordkeeping burden for acknowledgment letters is included as a subset of the VFD recordkeeping burden.
The recordkeeping burdens for VFDs and acknowledgement letters were combined because distributors may receive an acknowledgement letter in lieu of a VFD before distributing a medicated feed containing a VFD drug. This combined recordkeeping burden, estimated at 18,788 hours in the 2000 final rule, is still cited in Table 2 of the currently approved Information Collection Request (ICR) for § 558.6 (0910-0363). As noted in the PRA section of the December 2000 final rule, “[a]ny person who distributes medicated feed containing VFD drugs must file with [FDA] a one-time notification letter of intent to distribute, and retain a copy of each VFD serviced or each consignee's acknowledgment letter for 2 years.” (65 FR 76928).
Attachments View All (0) View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed Mar 12 2014, at 11:59 PM ET ID: FDA-2010-N-0155-0139 Tracking Number: View original printed format: Document Information Date Posted: Dec 12, 2013CFR: 21 CFR Parts 514 and 558Federal Register Number: 2013-29696 Show More Details Submitter Information Comments125,460 Comments Received* See Attached View Comment See Attached View Comment The Honorable Margaret A. Hamburg, M.D.
C/o Division of Dockets Management (HFA–305) U.S. Food and Drug Administration
Room 1061... View Comment Docket Information This document is contained in FDA-2010-N-0155 Related Dockets: FDA-1999-N-3551Related RINs: NoneRelated Documents: Guidance for Industry Veterinary Feed Directive Common...Veterinary Feed Directive Common Format Questions and...Veterinary Feed Directive Regulation Questions and Answers... Related Comments: View all * This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document. Document text and images courtesy of the Federal Register Home Search Advanced Search Browse By Category Learn About Us eRulemaking Program Media Toolkit Agencies Awards & Recognition Enhancements & Fixes Resources Site Data Regulatory Agenda Agency Reports Required by Statute API Overview Developers Help How to use Regulations.gov FAQs Glossary Connect With Contact Us Privacy and Security Notice User Notice Accessibility Statement Partner Sites We the People Federal Register Reginfo Congress.gov USA.gov E-Gov Opengov Participate Today!