21 CFR § 510.3-510.600 - New Animal Drugs

72 21 CFR Ch. I (4–1–23 Edition) Pt. 510 temporary tolerances for residues of PCB’s are as follows: (1) 0.2 part per million in finished animal feed for food-producing animals (except the following finished animal feeds: feed concentrates, feed supple ments, and feed premixes). (2) 2 parts per million in animal feed components of animal origin, including fishmeal and other by-products of ma rine origin and in finished animal feed concentrates, supplements, and pre mixes intended for food-producing ani mals. (3) 10 parts per million in paper food packaging material intended for or used with finished animal feed and any components intended for animal feeds. The tolerance shall not apply to paper food-packaging material separated from the food therein by a functional barrier which is impermeable to migra tion of PCB’s. (b) A compilation entitled ‘‘Analyt ical Methodology for Polychlorinated Biphenyls, February 1973’’ for deter mining compliance with the tolerances established in this section is available from the Division of Dockets Manage ment, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. [42 FR 52821, Sept. 30, 1977, as amended at 46 FR 8460, Jan. 27, 1981; 59 FR 14365, Mar. 28, 1994; 68 FR 24879, May 9, 2003] Subpart C—Regulatory Limits for Added Poisonous or Delete rious Substances [Reserved] Subpart D—Naturally Occurring Poisonous or Deleterious Sub stances [Reserved] PART 510—NEW ANIMAL DRUGS Subpart A—General Provisions Sec. 510.3 Definitions and interpretations. 510.4 Biologics; products subject to license control. 510.7 Consignees of new animal drugs for use in the manufacture of animal feed. 510.95 [Reserved] Subpart B—Specific Administrative Rulings and Decisions 510.105 Labeling of drugs for use in milk producing animals. 510.106 Labeling of antibiotic and anti biotic-containing drugs intended for use in milk-producing animals. 510.110 Antibiotics used in food-producing animals. 510.112 Antibiotics used in veterinary medi cine and for nonmedical purposes; re quired data. Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food 510.201 Scope. 510.202 Definitions. 510.203 Initiation of a proceeding to estab lish or amend an import tolerance. 510.205 Content and administration of a re quest. 510.206 Review of information supporting actions to establish or amend an import tolerance. 510.207 Disclosure of information submitted in a request. 510.209 Establishment, denial, or amend ment of an import tolerance. 510.210 Revocation of an import tolerance. 510.212 Administrative reconsideration of action. 510.213 Administrative stay of action. Subpart D—Records and Reports 510.301 Records and reports concerning ex perience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect. 510.305 Maintenance of copies of approved medicated feed mill licenses to manufac ture animal feed bearing or containing new animal drugs. Subpart E—Requirements for Specific New Animal Drugs 510.410 Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling requirements. 510.440 Injectable iron preparations. 510.455 Requirements for free-choice medi cated feeds. Subpart F [Reserved] Subpart G—Sponsors of Approved Applications 510.600 Names, addresses, and drug labeler codes of sponsors of approved applica tions. AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00082 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 73 Food and Drug Administration, HHS § 510.3 SOURCE: 40 FR 13807, Mar. 27, 1975, unless otherwise noted. Subpart A—General Provisions § 510.3 Definitions and interpretations. As used in this part: (a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321–392). (b) Department means the Department of Health and Human Services. (c) Secretary means the Secretary of Health and Human Services. (d) Commissioner means the Commis sioner of Food and Drugs. (e) Person means individuals, partner ships, corporations, and associations. (f) The definitions and interpreta tions of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part. (g) The term new animal drug means any drug intended for use for animals other than man, including any drug in tended for use in animal feed but not including such animal feed: (1) The composition of which is such that such drug is not generally recog nized, among experts qualified by sci entific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the la beling thereof; except that such a drug not so recognized shall not be deemed to be a new animal drug if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its la beling contained the same representa tions concerning the conditions of its use; or (2) The composition of which is such that such drug, as a result of investiga tions to determine its safety and effec tiveness for use under such conditions, has become so recognized but which has not, otherwise than in such inves tigations, been used to a material ex tent or for a material time under such conditions. (h) The term animal feed means an ar ticle which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal. (i) The newness of an animal drug, in cluding a new animal drug intended for use in or on animal feed, may arise by reason of: (1) The newness for its in tended drug use of any substance of which the drug is comprised, in whole or in part, whether it be an active sub stance or a menstruum, excipient, car rier, coating, or other component; (2) the newness for its intended drug use of a combination of two or more sub stances, none of which is itself a new animal drug; (3) the newness for its in tended drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new animal drug; (4) the newness for its intended drug use in a different species of animal; (5) the newness of its intended drug use in diagnosing, cur ing, mitigating, treating, or preventing a disease, or to affect a structure or function of the animal body, even though such drug is not a new animal drug when used in another disease or to affect another structure or function of the body; or (6) the newness of a dos age, or method or duration of adminis tration or application, or any other condition of use prescribed, rec ommended, or suggested in the labeling of such drug, even though such drug or animal feed containing such drug when used in another dosage, or another method or duration of administration or application, or different condition, is not a new animal drug. (j) Animals used only for laboratory re search and laboratory research animals mean individual animals or groups of animals intended for use and used sole ly for laboratory research purposes, re gardless of species, and does not in clude animals intended to be used for any food purposes or animals intended to be kept as livestock. (k) Sponsor means the person request ing designation for a minor-use or minor-species drug as defined in part 516 of this chapter, who must be the real party in interest of the develop ment and the intended or actual pro duction and sales of such drug (in this VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00083 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 74 21 CFR Ch. I (4–1–23 Edition) § 510.4 context, the sponsor may be an indi vidual, partnership, organization, or association). Sponsor also means the person responsible for an investigation of a new animal drug. In this context, the sponsor may be an individual, part nership, corporation, or Government agency or may be a manufacturer, sci entific institution, or an investigator regularly and lawfully engaged in the investigation of new animal drugs. Sponsor also means the person submit ting or receiving approval for a new animal drug application (in this con text, the sponsor may be an individual, partnership, organization, or associa tion). In all contexts, the sponsor is re sponsible for compliance with applica ble provisions of the act and regula tions. [40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 54 FR 22741, May 26, 1989; 64 FR 69190, Dec. 10, 1999; 72 FR 41017, July 26, 2007] § 510.4 Biologics; products subject to license control. An animal drug produced and distrib uted in full conformance with the ani mal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. ) and any regulations issued thereunder shall not be deemed to be subject to section 512 of the Federal Food, Drug, and Cosmetic Act. § 510.7 Consignees of new animal drugs for use in the manufacture of animal feed. (a) A new animal drug intended for use in the manufacture of animal feed shall be deemed to be unsafe unless at the time of its removal from the estab lishment of a manufacturer, packer, or distributor of such drug, such manufac turer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or a notice from the Secretary, to the effect that with respect to the use of such drug in animal feed the consignee: (1) Holds a license issued under § 515.20 of this chapter; or (2) Will, if the consignee is not the user of the drug, ship such drug only to a holder of an approved application under § 515.10 of this chapter. (b) The requirements of paragraph (a) of this section do not apply: (1) Where such drugs are intended for export and/or (2) When the use of such drug in the manufacture of a finished feed has been exempted from the requirements of section 512(m) of the act under the con ditions specified by regulations pub lished in part 558 of this chapter. [40 FR 13807, Mar. 27, 1975, as amended at 64 FR 63203, Nov. 19, 1999] § 510.95 [Reserved] Subpart B—Specific Administrative Rulings and Decisions § 510.105 Labeling of drugs for use in milk-producing animals. (a) Part 526 of this chapter provides for new animal drugs intended for intramammary use in animals and in cludes conditions of use intended to prevent the contamination of milk from the use of such drugs. (b) Preparations containing anti biotics and other potent drugs labeled with directions for use in milk-pro ducing animals will be misbranded under section 502(f)(2) of the act unless their labeling bears appropriate warn ings and directions for use to avoid adulteration of milk under section 402(a)(2)(c)(ii) of the act. (c) It is the position of the Food and Drug Administration that the labeling for such preparations should bear a clear warning that either: (1) The article should not be adminis tered to animals producing milk, since to do so would result in contamination of the milk; or (2) The label should bear the fol lowing statement: ‘‘Warning: Milk that has been taken from animals during treatment and for hours after the latest treatment must not be used for food’’, the blank being filled in with the figure that the manufacturer has determined by appropriate investiga tion is needed to insure that the milk will not carry violative residues result ing from use of the preparation. If the use of the preparation as recommended does not result in contamination of the milk, neither of the above warning statements is required. [40 FR 13807, Mar. 27, 1975, as amended at 63 FR 32980, June 17, 1998; 64 FR 51241, Sept. 22, 1999] VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00084 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 75 Food and Drug Administration, HHS § 510.110 § 510.106 Labeling of antibiotic and an tibiotic-containing drugs intended for use in milk-producing animals. Whenever the labeling of an anti biotic drug included in the regulations in this chapter suggests or recommends its use in milk-producing animals, the label of such drugs shall bear either the statement ‘‘Warning: Not for use in animals producing milk, since this use will result in contamination of the milk’’ or the statement ‘‘Warning: Milk that has been taken from animals during treatment and for hours after the latest treatment must not be used for food’’, the blank being filled in with the figure that the Commissioner has authorized the manufacturer of the drug to use. The Commissioner shall determine what such figures shall be from information submitted by the manufacturer and which the Commis sioner considers is adequate to prove that period of time after the latest treatment that the milk from treated animals will contain no violative resi dues from use of the preparation. If the Commissioner determines from the in formation submitted that the use of the antibiotic drug as recommended does not result in its appearance in the milk, the Commissioner may exempt the drug from bearing either of the above warning statements. [63 FR 32980, June 17, 1998] § 510.110 Antibiotics used in food-pro ducing animals. (a) The Food and Drug Administra tion in the interest of fulfilling its re sponsibilities with regard to protection of the public health has requested an evaluation of the public health aspects of the use of antibiotics in veterinary medical and nonmedical uses. There is particular concern with regard to the potential hazards associated with the extensive use of antibiotics adminis tered to food-producing animals. Ac cordingly, an ad hoc committee on the Veterinary Medical and Nonmedical Uses of Antibiotics was established by the Food and Drug Administration to study and advise the Commissioner of Food and Drugs on the uses of anti biotics in veterinary medicine and for various nonmedical purposes as such uses may affect the enforcement of the Federal Food, Drug, and Cosmetic Act with respect to their safety and effec tiveness. (b) Based upon an evaluation of the conclusions of said Committee and other relevant material, § 510.112 was published in the FEDERAL REGISTER of August 23, 1966 (31 FR 11141), asking sponsors of drugs containing any anti biotic intended for use in food-pro ducing animals to submit data to es tablish whether such antibiotic and its metabolites are present as residues in edible tissues, milk, and eggs from treated animals. The data on the resi dues of antibiotics in milk from intramammary infusion preparations were requested within 60 days and the data on all other products were re quested within 180 days following the date of publication of § 510.112 in the FEDERAL REGISTER. (c) An evaluation of the data now available shows that use of many anti biotic preparations cause residues in edible products of treated animals for varying and, in some cases, for long pe riods of time following the last admin istration. Because of the accumulation of new information with regard to the development of resistance of bacteria to antibiotics, the ability of bacteria to transfer this resistance, and the devel opment of sensitivity to antibiotics in humans, unauthorized and unsafe resi dues of antibiotics cannot be permitted in food obtained from treated animals. (d) Based on evaluation of informa tion available, including the conclu sions of the aforementioned ad hoc Committee, the Commissioner con cludes that antibiotic preparations in tended for use in food-producing ani mals, other than topical and oph thalmic preparations, are not generally recognized among qualified experts as having been shown to be safe for their intended use(s) within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act. (e) Therefore, all exemptions from the provisions of section 409 of the act for use of antibiotics in food-producing animals based on sanctions or approv als granted prior to enactment of the Food Additives Amendment of 1958 (Pub. L. 85–929; 72 Stat. 1784) will be re voked and the uses which are con cluded to be safe will be covered by food additive regulations. On those VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00085 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 76 21 CFR Ch. I (4–1–23 Edition) § 510.112 products for which there are inad equate residue data, actions will be ini tiated to withdraw approval of new drug applications under the provisions of section 505 of the act. Antibiotic preparations, other than those for top ical and ophthalmic application in food-producing animals, which are not covered by food additive regulations will be subject to regulatory action within 180 days after publication of the forthcoming revocation order. (f) Because of the variation in the pe riod of time that antibiotic residues may remain in edible products from treated animals, all injectable, intramammary infusion, intrauterine, and oral preparations, including medi cated premixes intended for use in food-producing animals, are deemed to be new drugs as well as food additives. [40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 64 FR 403, Jan. 5, 1999] § 510.112 Antibiotics used in veteri nary medicine and for nonmedical purposes; required data. (a) An ad hoc committee, Committee on the Veterinary Medical and Non medical Uses of Antibiotics, was formed by the Food and Drug Adminis tration to study, and advise the Com missioner on, the use of antibiotics in veterinary medicine and for various nonmedical purposes as such uses may affect the enforcement of the Federal Food, Drug, and Cosmetic Act with re spect to the safety and effectiveness of such substances. A copy of the report may be obtained from the Food and Drug Administration, Office of Public Affairs, Room 15–05, Parklawn Build ing, 5600 Fishers Lane, Rockville, MD 20857. (b) On the basis of the report of the Committee and other information, sponsors of drugs containing any anti biotic intended for use in food-pro ducing animals shall submit data for determining whether or not such anti biotics and their metabolites are present as residues in edible tissues, milk, and eggs from treated animals; however, in the case of a drug for which such data have already been sub mitted and for which a regulation has been promulgated under section 409 of the act, only such data as has been ac cumulated since the issuance of the regulation need be submitted. (c) The required data shall be sub mitted within 180 days of the date of publication of this section in the FED ERAL REGISTER; except that in the case of data on intramammary infusion preparations the data shall be sub mitted within 60 days of such publica tion. Data demonstrating the absence in milk of residues of intramammary infusion preparations when used as di rected in their labeling are needed within the 60-day period because of the importance of milk in the human diet. (d) Regulatory proceedings including revocation of prior sanctions, or ac tions to suspend or amend new drug or antibiotic approvals granted prior to passage of the Food Additives Amend ment of 1958 (72 Stat. 1784), may be ini tiated with regard to the continued marketing of any antibiotic prepara tion on which the required information is not submitted within the period of time prescribed by paragraph (c) of this section. (e) Questions relating to the accept ability of proposed research protocols and assay methods for determining the amount of antibiotic residues in food should be directed to the Director, Cen ter for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. [40 FR 13807, Mar. 27, 1975, as amended at 46 FR 8460, Jan. 27, 1981; 54 FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992] Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food SOURCE: 86 FR 52410, Sept. 21, 2021, unless otherwise noted. § 510.201 Scope. This subpart applies to tolerances for residues of new animal drugs not ap proved or conditionally approved for use in the United States, but lawfully used in another country and present in imported, animal-derived food and food products. § 510.202 Definitions. The following definitions of terms apply when used in this subpart: VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00086 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 77 Food and Drug Administration, HHS § 510.205 CNADA means an application for con ditional approval of a new animal drug submitted under section 571 of the Fed eral Food, Drug, and Cosmetic Act, and includes all amendments and permis sible supplements. Import tolerance means a tolerance for a residue of a new animal drug not ap proved or conditionally approved for use in the United States, but present in any imported edible portion of any ani mal. NADA means a new animal drug ap plication submitted under section 512 of the Federal Food, Drug, and Cos metic Act, including all amendments and permissible supplements, for ap proval of a new animal drug. Request means a request to establish or amend an import tolerance. § 510.203 Initiation of a proceeding to establish or amend an import toler ance. (a) Any interested person may re quest that the Commissioner establish or amend an import tolerance. Such a request must be in the form specified in § 510.205 of this chapter. (b) The Commissioner may initiate a proceeding to establish or amend an import tolerance on his or her own ini tiative pursuant to § 10.25(b) of this chapter. § 510.205 Content and administration of a request. (a) Pertinent information previously submitted to and currently retained in the files of the Food and Drug Adminis tration (FDA) may be incorporated in, and will be considered as part of, a re quest on the basis of specific reference to such information. If the requester refers to any nonpublic information other than its own, the requester shall obtain a written right of reference to that nonpublic information and submit the right of reference with the request. Any reference to published information offered in support of a request should be accompanied by reprints or copies of such references. (b) Requests shall be submitted and addressed to the Document Control Unit (HFV–199), Center for Veterinary Medicine, Food and Drug Administra tion, 7500 Standish Pl., Rockville, MD 20855. Requests may be submitted in an electronic format as authorized by FDA. See FDA′s Electronic Submis sions Gateway website: https:// www.fda.gov/industry/electronic-submis sions-gateway. (c) Any material submitted in a for eign language shall be accompanied by a complete and accurate English trans lation. Translations of literature print ed in a language other than English shall be accompanied by copies of the original publication. (d) The request must be dated and must be signed by the requester or by his or her authorized attorney, agent, or official and shall state the request er’s correspondence address. If the re quester or such authorized representa tive does not reside or have a place of business within the United States, the requester must also furnish the name and post office address of, and the re quest must be countersigned by, an au thorized attorney, agent, or official re siding or maintaining a place of busi ness within the United States. (e) The request must include the fol lowing information: (1) The established name and all per tinent information concerning the new animal drug, including chemical iden tity and composition of the new animal drug, and its physical, chemical, and biological properties; (2) The conditions of use for the new animal drug, including the route of ad ministration and dosage, together with all labeling, directions, and rec ommendations regarding the uses in countries in which the new animal drug is lawfully used; (3) The proposed import tolerance(s) for residues of the new animal drug; (4) Human food safety information to support the proposed import toler ance(s) in either of the following forms: (i) If a permanent maximum residue limit (MRL) has been established by the Codex Alimentarius Committee (Codex MRL), the requester shall pro vide the permanent Codex MRL and monographs and reports from the Joint Expert Committee on Food Additives (JECFA) of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) of the United Nations and/or monographs and reports from the Joint FAO/WHO Meet ing on Pesticide Residues (JMPR) that VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00087 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 78 21 CFR Ch. I (4–1–23 Edition) § 510.206 support the development of the perma nent Codex MRL. FDA may request ad ditional information as needed. (ii) If no permanent Codex MRL has been established, or upon notification by FDA, the requester must provide full reports of investigations made with respect to the human food safety of the new animal drug. A request may be regarded as incomplete unless it in cludes full reports of adequate tests by all methods reasonably applicable to show whether or not any imported edi ble portion of any animal receiving the new animal drug will be safe for human consumption. The reports must include detailed data derived from appropriate animal and other biological experi ments in which the methods used and the results obtained are clearly set forth, including data submitted to the appropriate regulatory authority in any country where the new animal drug is lawfully used. The request must also include a statement that all such reports have been submitted or contain an explanation of why such reports were not submitted. With respect to each nonclinical laboratory study con tained in the request, the requestor must submit either a statement that the study was conducted in compliance with the good laboratory practice regu lations set forth in part 58 of this chap ter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance, and how this may have impacted the study; (5) Other human food safety informa tion as deemed necessary by the Com missioner; (6) A description of practicable meth ods for determining the quantity, if any, of the new animal drug in or on food, and any substance formed in or on food because of its use; (7) An environmental assessment under § 25.40 of this chapter; and (8) Any information required under §§ 500.80 through 500.92 of this chapter (Subpart E, Regulation of Carcinogenic Compounds Used in Food-Producing Animals), where applicable. (f) A request to amend an established import tolerance must contain infor mation to support each proposed change. The request may omit state ments made in the original request for which no change is proposed. (g) The requester may withdraw the request at any time before the notifica tion provided for in § 510.207(a) of this chapter has been made publicly avail able. § 510.206 Review of information sup porting actions to establish or amend an import tolerance. In establishing or amending an im port tolerance, the Commissioner shall rely on data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria used by the Commissioner to establish toler ances for applications for new animal drugs filed under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act. In establishing or amending an import tolerance, the Commissioner will give appropriate consideration to the an ticipated residue concentrations and conditions of use of the new animal drug specified. § 510.207 Disclosure of information submitted in a request. (a) When a request is determined to be complete for FDA’s consideration, the Commissioner will provide public notification of the request containing the name of the requester and a brief description of the request in general terms. A copy of the notification will be sent to the requester at the time the information is made available to the public. (b) Any notification establishing, amending, or revoking an import toler ance will be made publicly available. A summary of the basis for the decision will be publicly released in accordance with the provisions of part 20 of this chapter. If FDA determines that the new animal drug referred to in the re quest is a new animal drug that in duces cancer when ingested by people or animals, and the requester complies with the requirements of §§ 500.80 through 500.92 of this chapter (Subpart E, Regulation of Carcinogenic Com pounds Used in Food-Producing Ani mals), the regulatory method for ascertaining the marker residue in the target tissue will be made publicly available. All information and safety data submitted with the request, or VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00088 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 79 Food and Drug Administration, HHS § 510.213 previously submitted information in corporated in, and considered as part of, a request on the basis of specific ref erence to such information, shall be available for public disclosure, also in accordance with the provisions of part 20 of this chapter. Trade secrets and confidential commercial or financial information are exempted from release under § 20.61 of this chapter. § 510.209 Establishment, denial, or amendment of an import tolerance. (a) If an import tolerance is estab lished or amended, the Commissioner will provide public notification of the action, which will be effective from the date of public notification. A copy of the notification will be sent to any re questor at the time the information is made available to the public. (b) If a request to establish or amend an import tolerance is denied, a notifi cation of the denial will be made pub licly available, and a copy of the denial letter, including the reasons for such action, will be sent to the requester. (c) A tolerance established in an ap proved NADA or conditionally ap proved CNADA will supersede an exist ing import tolerance. In the event the conditionally approved CNADA is not renewed or is withdrawn, or such drug does not achieve approval under sec tion 512 of the Federal Food, Drug, and Cosmetic Act within 5 years following the date of the conditional approval, the Agency will reinstate the import tolerance unless § 510.210(a)(1) or (a)(2) is applicable at that time. § 510.210 Revocation of an import tol erance. (a) The Commissioner, on his or her own initiative or on the petition of an interested person, under § 10.25 of this chapter, may revoke an import toler ance if: (1) Scientific evidence shows an im port tolerance to be unsafe; or (2) Information demonstrates that the use of a new animal drug under ac tual use conditions results in food being imported into the United States with residues exceeding the import tol erance. (b) The Commissioner will provide public notification under § 510.207(b) that will specify the basis for the deci sion and will be effective at the time the information is made available to the public. (c) A petition for revocation must be submitted in the form specified in § 10.30 of this chapter. § 510.212 Administrative reconsider ation of action. (a) The Commissioner may at any time, on his or her own initiative or on the petition of an interested person under part 10 of this chapter, recon sider part or all of a decision to estab lish, not establish, amend, or revoke an import tolerance. (b) A petition for reconsideration must be submitted in accordance with § 10.20 of this chapter and in the form specified in § 10.33 of this chapter no later than 30 days after the date of pub lic notification of the decision in volved. The Commissioner may, for good cause, permit a petition to be filed more than 30 days after public no tification of the decision. The petition for reconsideration must demonstrate that relevant information contained in the administrative record was not pre viously or not adequately considered by the Commissioner. No new informa tion may be included in a petition for reconsideration. (c) An interested person who wishes to rely on information not included in the administrative record shall submit either a petition to amend an import tolerance under § 510.205 or to revoke an import tolerance under § 510.210 and § 10.25 of this chapter. § 510.213 Administrative stay of action. (a) The Commissioner may at any time, on his or her own initiative or on the request of an interested person under part 10 of this chapter, stay or extend the effective date of a decision to establish, not establish, amend, or revoke an import tolerance. (b) A request for stay must be sub mitted in accordance with § 10.20 of this chapter and in the form specified in § 10.35 of this chapter no later than 30 days after public notification of the de cision involved. The Commissioner may, for good cause, permit a petition to be filed more than 30 days after pub lic notification of the decision. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00089 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 80 21 CFR Ch. I (4–1–23 Edition) § 510.301 Subpart D—Records and Reports § 510.301 Records and reports con cerning experience with animal feeds bearing or containing new animal drugs for which an ap proved medicated feed mill license application is in effect. Records and reports of clinical and other experience with the new animal drug will be maintained and reported, appropriately identified with the new animal drug application(s) or index listing(s) to which they relate, to the Center for Veterinary Medicine in du plicate in accordance with the fol lowing: (a) Immediately upon receipt by the applicant, complete records or reports covering information of the following kinds: (1) Information concerning any mixup in the new animal drug or its la beling with another article. (2) Information concerning any bac teriological or any significant chem ical, physical, or other change or dete rioration in the drug, or any failure of one or more distributed batches of the drug to meet the specifications estab lished for it in the new animal drug ap plication or request for determination of eligibility for indexing. (b) As soon as possible, and in any event within 15 working days of its re ceipt by the applicant, complete records or reports concerning any in formation of the following kinds: (1) Information concerning any unex pected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidence or severity thereof associ ated with clinical uses, studies, inves tigations, or tests, whether or not de termined to be attributable to the new animal drug, except that this require ment shall not apply to the submission of information described in a written communication to the applicant from the Food and Drug Administration as types of information that may be sub mitted at other designated intervals. Unexpected as used in this paragraph refers to conditions or developments not previously submitted as part of the new animal drug application or in sup port of the index listing or not encoun tered during clinical trials of the drug, or conditions or developments occur ring at a rate higher than shown by in formation previously submitted as part of the new animal drug application or in support of the index listing or at a rate higher than encountered during such clinical trials. (2) Information concerning any un usual failure of the new animal drug to exhibit its expected pharmacological activity. [40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 72 FR 69121, Dec. 6, 2007] § 510.305 Maintenance of copies of ap proved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs. Each applicant shall maintain in a single accessible location: (a) A copy of the approved medicated feed mill license (Form FDA 3448) on the premises of the manufacturing es tablishment; and (b) Approved or index listed labeling for each Type B and/or Type C feed being manufactured on the premises of the manufacturing establishment or the facility where the feed labels are generated. [64 FR 63203, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007] Subpart E—Requirements for Specific New Animal Drugs § 510.410 Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling re quirements. (a) The Food and Drug Administra tion has received reports of side effects associated with the oral, injectable, and ophthalmic use of corticosteroid animal drugs. The use of these drugs administered orally or by injection has resulted in premature parturition when administered during the last trimester of pregnancy. Premature parturition may be followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids used in dogs, rabbits, and rodents during preg nancy have produced cleft palate in off spring. Use in dogs has resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca. Drugs subject to this section are required to carry the veterinary VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00090 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 81 Food and Drug Administration, HHS § 510.455 prescription legend and are subject to the labeling requirements of § 201.105 of this chapter. (b) In view of these potentially seri ous side effects, the Food and Drug Ad ministration has concluded that the la beling on or within packaged corticosteroid-containing preparations intended for animal use shall bear con spicuously the following warning state ment: Warning: Clinical and experimental data have demonstrated that corticosteroids ad ministered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits, and rodents during preg nancy have resulted in cleft palate in off spring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca. [49 FR 48535, Dec. 13, 1984] § 510.440 Injectable iron preparations. There has been an increasing interest in the use of injectable iron compounds for the prevention or treatment of iron-deficiency anemia in animals. Al though some such preparations have been shown to be safe, such articles are regarded as new animal drugs within the meaning of the Federal Food, Drug, and Cosmetic Act. Accordingly, an ap proved new animal drug application is required prior to the marketing of such preparations within the jurisdiction of the act. In addition to the need for demonstrating the safety of such arti cles, the labeling of such preparations should not only recommend appro priate dosages of iron but also declare the amount (in milligrams) of available iron (Fe) per milliliter of the subject product. § 510.455 Requirements for free-choice medicated feeds. (a) What is free-choice medicated feed? For the purpose of this part, free choice medicated feed is medicated feed that is placed in feeding or grazing areas and is not intended to be con sumed fully at a single feeding or to constitute the entire diet of the ani mal. Free-choice feeds include, but are not limited to, medicated blocks (ag glomerated feed compressed or ren dered into a solid mass and cohesive enough to hold its form), mineral mixes, and liquid feed tank supple ments (‘‘lick tank’’ supplements) con taining one or more new animal drugs. The manufacture of medicated free choice feeds is subject to the current good manufacturing practice regula tions in part 225 of this chapter for medicated feeds. (b) What is required for new animal drugs intended for use in free-choice feed? Any new animal drug intended for use in free-choice feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)) or listed in the index under section 572 of the act (21 U.S.C. 360ccc–1). Such approvals under section 512 of the act must be: (1) An original new animal drug ap plication (NADA), (2) A supplemental NADA, or (3) An abbreviated NADA. (c) What are the approval requirements under section 512 of the act for new ani mal drugs intended for use in free-choice feed? An approval under section 512 of the act for a Type A medicated article intended for use in free-choice feed must contain the following informa tion: (1) Data, or reference to data in a master file (MF), showing that the tar get animal consumes the new animal drug in the Type C free-choice feed in an amount that is safe and effective (consumption/effectiveness data); and (2) Data, or reference to data in an MF, showing the relevant ranges of conditions under which the drug will be chemically and physically stable in the Type C free-choice feed under field con ditions. (d) How are consumption/effectiveness and/or stability data to be submitted? The data must be submitted as follows: (1) Directly in the NADA, by a spon sor; and/or (2) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder. (e) What will be stated in the published approval for a new animal drug intended for use in free-choice feed? The approval of a new animal drug intended for use VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00091 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 82 21 CFR Ch. I (4–1–23 Edition) § 510.600 in free-choice feed, as published in this subchapter, will include: (1) The formula and/or specifications of the free-choice medicated feed, where the owner of this information re quests such publication, or (2) A statement that the approval has been granted for a proprietary formula and/or specifications. (f) When is a medicated feed mill license required for the manufacture of a free choice medicated feed? An approved medicated feed mill license is required for the manufacture of the following types of feeds: (1) All free-choice medicated feeds that contain a Category II drug, and (2) Free-choice medicated feeds that contain a Category I drug and use a proprietary formula and/or specifica tions. [69 FR 30197, May 27, 2004, as amended at 72 FR 69121, Dec. 6, 2007] Subpart F [Reserved] Subpart G—Sponsors of Approved Applications § 510.600 Names, addresses, and drug labeler codes of sponsors of ap proved applications. (a) Section 512(i) of the act requires publication of names and addresses of sponsors of approved applications for new animal drugs. (b) In this section each name and ad dress is identified by a numerical drug labeler code. The labeler codes identify the sponsors of the new animal drug applications associated with the regu lations published pursuant to section 512(i) of the act. The codes appear in the appropriate regulations and serve as a reference to the names and ad dresses listed in this section. The drug labeler code is established pursuant to section 510 of the act. (c) The names, addresses, and drug labeler codes of sponsors of approved new animal drug applications are as follows: (1) ALPHABETICAL LISTING OF SPONSORS Firm name and address Drug labeler code A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527 .................................................. 057699 Accord Healthcare, Inc., 1009 Slater Rd., suite 210–B, Durham, NC 27703 .......................................................... 016729 ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115 .............................................................. 012286 Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 .............................................................................. 057561 Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112 ....................................................................................... 017762 Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788 ............................................................ 011788 Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031 ......................................................... 059399 Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210 .................................................................... 069334 American Regent, Inc., Animal Health Division, Shirley, NY 11967 ........................................................................ 010797 Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801 .............................................................. 060865 Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808 ............................................................... 086121 Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043 ............................................. 086073 AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754 ........................................... 086053 Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057–3009 ................................................ 051072 Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France ...................................... 086009 B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756 ............................................................................................ 067188 Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807 .................................................. 099207 Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777 ................................................................ 062250 Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland ....................... 061133 Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 ....................................... 000010 Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767 ................................................................... 068330 Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France .......................................................... 013744 Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland ................................................ 061651 Cronus Pharma Specialities India Private Ltd., Sy No–99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India ..................... 069043 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom .... 043264 Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 ................................ 017033 ECO LLC, 344 Nassau St., Princeton, NJ 08540 ..................................................................................................... 066916 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 .................................................................................. 058198 Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928 ................................................................. 017135 Felix Pharmaceuticals Pvt. Ltd., 25–28 North Wall Quay, Dublin 1, Ireland ............................................................ 086101 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 ......................................................................................... 058829 Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747 ............................................... 025463 GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702 ............................................................... 042976 Happy Jack, Inc., Snow Hill, NC 28580 .................................................................................................................... 023851 Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964 .................................................. 063075 Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525 ................................................................................... 063604 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00092 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 83 Food and Drug Administration, HHS § 510.600 (1) ALPHABETICAL LISTING OF SPONSORS—Continued Firm name and address Drug labeler code HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652 ................................................... 042791 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria ........................................................ 016592 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 ................................................................. 000115 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ................................................................................................. 000061 Ishihara Sangyo Kaisha, Ltd., 3–15, Edobori 1-chome, Nishi-ku, Osaka 550–0002, Japan ................................... 064642 Ivaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155 ............................................................... 086064 Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104 ............................................................ 086149 Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia ......................................................................... 049480 Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509 ........................................................ 051031 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601 ...................................................................................... 061690 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861 .......................................................... 054925 Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432 ................................................. 086039 Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186 ................................................... 015914 Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478 ............................................................ 051079 Mylan Institutional LLC, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505 .............................. 063286 Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120 ............................................................ 049968 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511 ........................................................................................ 059051 Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom ...... 055529 Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden .................................................................... 052818 Orion Corp., Orionintie 1, 02200 Espoo, Finland ..................................................................................................... 052483 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia .......... 068504 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 ............................................................................ 055246 Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970 ................................................................... 050057 Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069 ............................................................................ 042552 Pharmaq AS, Skogmo Industriomrade, N–7863 Overhalla, Norway ........................................................................ 015331 Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405 .................................................................................... 069254 Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 ..................................................................................................................................................................... 066104 Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 ............................................................... 066794 Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India ....................................................................................................................................................................... 065085 Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053–120, Campinas, Sao Paulo, Brazil ................................................................................................................................. 060728 Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126–2910 ....................................... 017800 QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia ............................ 086132 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 ............................................................... 076475 Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060 ........................................................................................................................................... 086134 Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001 ..................................................................... 067949 Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138 ......................................................... 021091 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 ........................................................... 058005 Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151 ...................................................................................... 017153 Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752 ................................................................................ 037990 Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062 ....................................................................... 027053 Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248 .......................................................................................... 050378 Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532 ............................................................... 051672 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503 ........................................................................................ 052923 Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901 ...................................................................................... 086106 United-AH II LLC, 322 S Main St., Sheridan, IN 46069 ........................................................................................... 051233 VetDC, Inc., 320 E. Vine Dr., suite 218, Fort Collins, CO 80524 ............................................................................ 086072 Vétoquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5 .................................................. 059320 Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, TX 76137 ...................................................................... 017030 Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161 ......................................................................................... 051311 Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616 ........................................................................................... 086113 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550 ............................................................. 053923 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 ................................................................................................. 054771 ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534 .......................................................................... 086117 (2) NUMERICAL LISTING OF SPONSORS Drug labeler code Firm name and address 000010 Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096. 000061 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. 000115 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. 010797 American Regent, Inc., Animal Health Division, Shirley, NY 11967. 011788 Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788. 012286 ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115. 012578 Janssen Pharmaceutica NV, Turnhoutseweg 30, B–2340 Beerse, Belgium. 013744 Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00093 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 84 21 CFR Ch. I (4–1–23 Edition) § 510.600 (2) NUMERICAL LISTING OF SPONSORS—Continued Drug labeler code Firm name and address 015331 Pharmaq AS, Skogmo Industriomrade, N–7863 Overhalla, Norway. 015914 Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186. 016592 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria. 016729 Accord Healthcare, Inc., 1009 Slater Rd., suite 210–B, Durham, NC 27703. 017030 Vetoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137. 017033 Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. 017135 Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928. 017153 Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151. 017762 Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112. 017800 Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126–2910. 021091 Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. 023851 Happy Jack, Inc., Snow Hill, NC 28580. 025463 Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747. 027053 Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062. 037990 Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752. 042552 Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069. 042791 HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652. 042976 GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702. 043264 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom. 049480 Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia. 049968 Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120. 050057 Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970. 050378 Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248. 051031 Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509. 051072 Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057–3009. 051079 Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478. 051233 United-AH II LLC, 322 S Main St., Sheridan, IN 46069. 051311 Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161. 051672 Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532. 052483 Orion Corp., Orionintie 1, 02200 Espoo, Finland. 052818 Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden. 052923 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503. 053923 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550. 054771 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. 054925 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861. 055246 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514. 055529 Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom. 057561 Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503. 057699 A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527. 058005 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215. 058198 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. 058829 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123. 059051 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511. 059320 Vétoquinol N.–A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5. 059399 Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031. 060728 Planalquimica Industrial Ltda., Rua das Magnolias nr. Jardim das Bandeiras, CEP 13053–120, Campinas, Sao Alto, Brazil. 060865 Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801. 061133 Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland. 061651 Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland. 061690 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601. 062250 Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777. 062794 Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478. 063075 Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964. 063286 Mylan Institutional LLC, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505. 063604 Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525. 064642 Ishihara Sangyo Kaisha, Ltd., 3–15, Edobori 1-chome, Nishi-ku, Osaka 550–0002, Japan. 065085 Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India. 066104 Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666. 066794 Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017. 066916 ECO LLC, 344 Nassau St., Princeton, NJ 08540. 067188 B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756. 067949 Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001. 068330 Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767. 068504 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia. 069043 Cronus Pharma Specialities India Private Ltd., Sy No–99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India. 069254 Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405. 069334 Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00094 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 85 Food and Drug Administration, HHS § 511.1 (2) NUMERICAL LISTING OF SPONSORS—Continued Drug labeler code Firm name and address 076475 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349. 086009 Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France. 086039 Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432. 086053 AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754. 086064 Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155. 086072 VetDC, Inc., 320 E Vine Dr., suite 218, Fort Collins, CO 80524. 086073 Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043. 086101 Felix Pharmaceuticals Pvt. Ltd., 25–28 North Wall Quay, Dublin 1, Ireland. 086106 Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901. 086113 Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616. 086117 ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534. 086121 Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808. 086132 QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia. 086134 Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060. 086149 Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104. 099207 Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. [40 FR 13807, Mar. 27, 1975] EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 510.600, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. PART 511—NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE Sec. 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act. 511.3 Definitions. AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 360b, 371. § 511.1 New animal drugs for inves tigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act. (a) New animal drugs for tests in vitro and in laboratory research animals. (1) A shipment or other delivery of a new animal drug or animal feed bearing or containing a new animal drug intended solely for tests in vitro or in animals used only for laboratory research pur poses shall be exempt from section 512 (a) and (m) of the act if it is labeled as follows: Caution. Contains a new animal drug for investigational use only in laboratory re search animals or for tests in vitro. Not for use in humans. (2) The person distributing or causing the distribution of new animal drugs for tests in vitro or in animals used only for laboratory research purposes under this exemption shall use due dili gence to assure that the consignee is regularly engaged in conducting such tests and that the shipment of the new animal drug will actually be used for tests in vitro or in animals used only for laboratory research. (3) The person who introduced such shipment or who delivered the new ani mal drug for introduction into inter state commerce shall maintain ade quate records showing the name and post office address of the expert or ex pert organization to whom the new ani mal drug is shipped and the date, quan tity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment and delivery. Upon the request of a properly author ized employee of the Department at reasonable times, he shall make such records available for inspection and copying. (4) The exemption allowed in this paragraph shall not apply to any new animal drug intended for in vitro use in the regular course of diagnosing or treating disease, including anti bacterial sensitivity discs impregnated with any new animal drug or drugs, which discs are intended for use in de termining susceptibility of microorga nisms to the new animal drug or drugs. (b) New animal drugs for clinical inves tigation in animals. A shipment or other VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00095 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B