Medicated feed mill license (21 CFR 515.10-515.40)

122 21 CFR Ch. I (4–1–16 Edition) § 514.201 not be public, unless the respondent so specifies in his appearance. [40 FR 13825, Mar. 27, 1975, as amended at 43 FR 1941, Jan. 13, 1978] § 514.201 Procedures for hearings. Hearings relating to new animal drugs under section 512(d) and (e) of the act shall be governed by part 12 of this chapter. [64 FR 63204, Nov. 19, 1999] Subparts D–E [Reserved] Subpart F—Judicial Review § 514.235 Judicial review. (a) The transcript and record shall be certified by the Commissioner. In any case in which the Commissioner enters an order without a hearing pursuant to § 314.200(g) of this chapter, the re quest(s) for hearing together with the data and information submitted and the Commissioner’s findings and con clusions shall be included in the record certified by the Commissioner. (b) Judicial review of an order with drawing approval of a new drug appli cation, whether or not a hearing has been held, may be sought by a manu facturer or distributor of an identical, related, or similar drug product, as de fined in § 310.6 of this chapter, in a United States court of appeals pursu ant to section 505(h) of the act. [42 FR 4717, Jan. 25, 1977] PART 515—MEDICATED FEED MILL LICENSE Subpart A—Applications Sec. 515.10 Medicated feed mill license applica tions. 515.11 Supplemental medicated feed mill li cense applications. Subpart B—Administrative Actions on Licenses 515.20 Approval of medicated feed mill li cense applications. 515.21 Refusal to approve a medicated feed mill license application. 515.22 Suspension and/or revocation of ap proval of a medicated feed mill license. 515.23 Voluntary revocation of medicated feed mill license. 515.24 Notice of revocation of a medicated feed mill license. 515.25 Revocation of order refusing to ap prove a medicated feed mill license appli cation or suspending or revoking a li cense. 515.26 Services of notices and orders. Subpart C—Hearing Procedures 515.30 Contents of notice of opportunity for a hearing. 515.31 Procedures for hearings. Subpart D—Judicial Review 515.40 Judicial review. AUTHORITY: 21 U.S.C. 360b, 371. SOURCE: 64 FR 63204, Nov. 19, 1999, unless otherwise noted. Subpart A—Applications § 515.10 Medicated feed mill license applications. (a) Medicated feed mill license appli cations (Forms FDA 3448) may be ob tained from the Public Health Service, Consolidated Forms and Publications Distribution Center, Washington Com merce Center, 3222 Hubbard Rd., Land over, MD 20785, or electronically from the Center for Veterinary Medicine home page at http://www.fda.gov/cvm. (b) A completed medicated feed mill license must contain the following in formation: (1) The full business name and ad dress of the facility at which the manu facturing is to take place. (2) The facility’s FDA registration number as required by section 510 of the Federal Food, Drug, and Cosmetic Act (the act). (3) The name, title, and signature of the responsible individual or individ uals for that facility. (4) A certification that the animal feeds bearing or containing new animal drugs are manufactured and labeled in accordance with the applicable regula tions published under section 512(i) of the act or in accordance with the index listing published under section 572(e)(2) of the act. (5) A certification that the methods used in, and the facilities and controls used for, manufacturing, processing, packaging, and holding such animal VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00132 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 123 Food and Drug Administration, HHS § 515.21 feeds conform to current good manu facturing practice as described in sec tion 501(a)(2)(B) of the act and in part 225 of this chapter. (6) A certification that the facility will establish and maintain all records required by regulation or order issued under sections 512(m)(5)(A) or 504(a)(3)(A) of the act, and will permit access to, or copying or verification of such records. (7) A commitment that current ap proved or index listed Type B and/or Type C medicated feed labeling for each Type B and/or Type C medicated feed to be manufactured will be in the possession of the feed manufacturing facility prior to receiving the Type A medicated article containing such drug. (8) A commitment to renew registra tion every year with FDA as required in §§ 207.20 and 207.21 of this chapter. (c) Applications must be completed, signed, and submitted to the Division of Animal Feeds (HFV–220), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. (d) Applications that are facially de ficient will be returned to the appli cant. All reasons for the return of the application will be made known to the applicant. (e) Upon approval, the original copy of the application will be signed by an authorized employee of FDA des ignated by the Commissioner of Food and Drugs, and a copy will be returned to the applicant. [64 FR 63204, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007] § 515.11 Supplemental medicated feed mill license applications. (a) After approval of a medicated feed mill license application to manufac ture animal feed, a supplemental appli cation shall be submitted for a change in ownership and/or a change in mail ing address of the facility site. (b) Each supplemental application should be accompanied by a fully com pleted Form FDA 3448 and include an explanation of the change. (c) Within 30 working days after a supplemental application has been filed, if the Commissioner of Food and Drugs determines that the application provides adequate information respect ing the change in ownership and/or postal address of the facility site, then an authorized employee of the Food and Drug Administration designated by the Commissioner shall notify the ap plicant that it is approved by signing and mailing to the applicant a copy of the Form FDA 3448. Supplemental ap plications that do not provide adequate information shall be returned to the applicant and all reasons for the return of the application shall be made known to the applicant. Subpart B—Administrative Actions on Licenses § 515.20 Approval of medicated feed mill license applications. Within 90 days after an application has been filed under § 515.10, if the Com missioner of Food and Drugs (the Com missioner) determines that none of the grounds for denying approval specified in section 512(m)(3) of the Federal Food, Drug, and Cosmetic Act (the act) applies, an authorized employee of the Food and Drug Administration des ignated by the Commissioner shall no tify the applicant that it is approved by signing and mailing to the applicant a copy of the Form FDA 3448. § 515.21 Refusal to approve a medi cated feed mill license application. (a) The Commissioner of Food and Drugs (the Commissioner) shall within 90 days, or such additional period as may be agreed upon by the Commis sioner and the applicant, after the fil ing of an application under § 515.10, in form the applicant in writing of his/her intention to issue a notice of oppor tunity for a hearing on a proposal to refuse to approve the application, if the Commissioner determines upon the basis of the application, on the basis of a preapproval inspection, or upon the basis of any other information before him that: (1) The application is incomplete, false, or misleading in any particular; or (2) The methods used in and the fa cilities and controls used for the manu facturing, processing, and packaging of such animal feed are not adequate to VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00133 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 124 21 CFR Ch. I (4–1–16 Edition) § 515.22 preserve the identity, strength, qual ity, and purity of the new animal drug therein; or (3) The facility manufactures animal feeds bearing or containing new animal drugs in a manner that does not accord with the specifications for manufac ture or labels animal feeds bearing or containing new animal drugs in a man ner that does not accord with the con ditions or indications of use that are published under section 512(i) or 572(e)(2) of the act. (b) The Commissioner, as provided in § 515.30, shall expeditiously notify the applicant of an opportunity for a hear ing on the question of whether such ap plication is approvable, unless by the 30th day following the date of issuance of the letter informing the applicant of the intention to issue a notice of op portunity for a hearing the applicant: (1) Withdraws the application; or (2) Waives the opportunity for a hear ing; or (3) Agrees with the Commissioner on an additional period to precede issuance of such notice of hearing. [64 FR 63204, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007] § 515.22 Suspension and/or revocation of approval of a medicated feed mill license. (a) The Secretary of Health and Human Services may suspend a medi cated feed mill license approved under section 512(m)(2) of the Federal Food, Drug, and Cosmetic Act (the act) and give the person holding the medicated feed mill license application prompt notice of this action and afford the ap plicant the opportunity for an expe dited hearing on a finding that there is an imminent hazard to the health of man or of the animals for which such animal feed is intended. (b) The Commissioner of Food and Drugs (the Commissioner) shall notify in writing the person holding an appli cation approved under section 512(m)(2) of the act and afford an opportunity for a hearing on a proposal to revoke ap proval of such application if the Com missioner finds: (1) That the application contains any untrue statement of a material fact; or (2) That the applicant has made any changes that would cause the applica tion to contain any untrue statements of material fact or that would affect the safety or effectiveness of the ani mal feeds manufactured at the facility unless the applicant has supplemented the application by filing a supple mental application under § 515.11. (c) The Commissioner may notify in writing the person holding an applica tion approved under section 512(m)(2) of the act and afford an opportunity for a hearing on a proposal to revoke ap proval of such application if the Com missioner finds: (1) That the applicant has failed to establish a system for maintaining re quired records, or has repeatedly or de liberately failed to maintain such records or to make required reports in accordance with a regulation or order under sections 512(m)(5)(A) or 504(a)(3)(A) of the act, or the applicant has refused to permit access to, or copying, or verification of, such records as required by sections 512(m)(5)(B) or 504(a)(3)(B) of the act; or (2) That on the basis of new informa tion before him, evaluated together with the evidence before him when such license was issued, the methods used in, or the facilities and controls used for, the manufacture, processing, packing, and holding of such animal feed are inadequate to assure and pre serve the identity, strength, quality, and purity of the new animal drug therein, and were not made adequate within a reasonable time after receipt of written notice from the Commis sioner specifying the matter com plained of; or (3) That on the basis of new informa tion before him, evaluated together with the evidence before him when such license was issued, the labeling of any animal feeds, based on a fair eval uation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Commissioner specifying the matter complained of; or (4) That on the basis of new informa tion before him, evaluated together with the evidence before him when such license was issued, the facility has manufactured, processed, packed, or held animal feed bearing or containing a new animal drug adulterated under VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00134 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 125 Food and Drug Administration, HHS § 515.30 section 501(a)(6) of the act, and the fa cility did not discontinue the manufac ture, processing, packing, or holding of such animal feed within a reasonable time after receipt of written notice from the Commissioner specifying the matter complained of. § 515.23 Voluntary revocation of medi cated feed mill license. A license issued under section 512(m)(2) of the Federal Food, Drug, and Cosmetic Act (the act) will be re voked on the basis of a request for its revocation submitted in writing by a responsible individual holding such li cense on the grounds that the facility no longer manufactures any animal feed covered under § 558.4(b) of this chapter. A written request for such revocation shall be construed as a waiver of the opportunity for a hearing as otherwise provided for in this sec tion. Revocation of approval of a medi cated feed mill license under the provi sions of this paragraph shall be with out prejudice. § 515.24 Notice of revocation of a medi cated feed mill license. When a license approved under sec tion 512 of the Federal Food, Drug, and Cosmetic Act (the act) is revoked by the Commissioner of Food and Drugs (the Commissioner), the Commissioner will give appropriate public notice of such action by publication in the FED ERAL REGISTER. § 515.25 Revocation of order refusing to approve a medicated feed mill li cense application or suspending or revoking a license. The Commissioner of Food and Drugs (the Commissioner), upon his/her own initiative or upon request of an appli cant stating reasonable grounds there for and if the Commissioner finds that the facts so require, may issue an order approving a medicated feed mill license application that previously has had its approval refused, suspended, or re voked. § 515.26 Services of notices and orders. All notices and orders under this part 515 and section 512 of the Federal Food, Drug, and Cosmetic Act (the act) per taining to medicated feed mill licenses shall be served: (a) In person by any officer or em ployee of the Department of Health and Human Services designated by the Commissioner of Food and Drugs; or (b) By mailing the order by certified mail addressed to the applicant or re spondent at the applicant or respond ent’s last known address in the records of the Food and Drug Administration. Subpart C—Hearing Procedures § 515.30 Contents of notice of oppor tunity for a hearing. (a) The notice to the applicant of op portunity for a hearing on a proposal by the Commissioner of Food and Drugs (the Commissioner) to refuse to approve a medicated feed mill license application or to revoke the approval of a medicated feed mill license will specify the grounds upon which the Commissioner proposes to issue this order. On request of the applicant, the Commissioner will explain the reasons for the action. The notice of oppor tunity for a hearing will be published in the FEDERAL REGISTER and will specify that the applicant has 30 days after issuance of the notice within which the Commissioner is required to file a written appearance electing whether: (1) To avail himself of the oppor tunity for a hearing; or (2) Not to avail himself of the oppor tunity for a hearing. (b) If the applicant fails to file a written appearance in answer to the notice of opportunity for hearing, this failure will be construed as an election not to avail himself of the opportunity for the hearing, and the Commissioner without further notice may enter a final order. (c) If the applicant elects to avail himself of the opportunity for a hear ing, the applicant is required to file a written appearance requesting the hearing within 30 days after the publi cation of the notice, giving the reason why the application should not be re fused or the medicated feed mill license should not be revoked, together with a well-organized and full-factual analysis VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00135 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 126 21 CFR Ch. I (4–1–16 Edition) § 515.31 of the information the applicant is pre pared to prove in support of his opposi tion to the Commissioner’s proposal. A request for a hearing may not rest upon mere allegations or denials, but must set forth specific facts showing there is a genuine and substantial issue of fact that requires a hearing. When it clearly appears from the information in the application and from the reasons and factual analysis in the request for the hearing that no genuine and sub stantial issue of fact precludes the re fusal to approve the application or the revocation of approval of the applica tion, the Commissioner will enter an order on this information, stating his/ her findings and conclusions. If a hear ing is requested and is justified by the applicant’s response to the notice of opportunity for a hearing, the issues will be defined, an Administrative Law Judge will be named, and the Judge shall issue a written notice of the time and place at which the hearing will commence. In the case of denial of ap proval, such time shall be not more than 90 days after the expiration of such 30 days unless the Administrative Law Judge and the applicant otherwise agree; and, in the case of withdrawal of approval, such time shall be as soon as practicable. (d) The hearing will be open to the public; however, if the Commissioner finds that portions of the application which serve as a basis for the hearing contain information concerning a method or process entitled to protec tion as a trade secret, the part of the hearing involving such portions will not be public, unless the respondent so specifies in the appearance. § 515.31 Procedures for hearings. Hearings relating to new animal drugs under section 512(m)(3) and (m)(4) of the Federal Food, Drug, and Cos metic Act (the act) shall be governed by part 12 of this chapter. Subpart D—Judicial Review § 515.40 Judicial review. The transcript and record shall be certified by the Commissioner of Food and Drugs (the Commissioner). In any case in which the Commissioner enters an order without a hearing under § 314.200(g) of this chapter, the re quest(s) for hearing together with the data and information submitted and the Commissioner’s findings and con clusions shall be included in the record certified by the Commissioner. PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Subpart A—General Provisions Sec. 516.1 Scope. 516.2 Purpose. 516.3 Definitions. Subpart B—Designation of a Minor Use or Minor Species New Animal Drug 516.11 Scope of this subpart. 516.12 Purpose. 516.13 Definitions. 516.14 Submission of requests for designa tion. 516.16 Eligibility to request designation. 516.20 Content and format of a request for MUMS-drug designation. 516.21 Documentation of minor use status. 516.22 Permanent-resident U.S. agent for foreign sponsor. 516.23 Timing of requests for MUMS-drug designation. 516.24 Granting MUMS-drug designation. 516.25 Refusal to grant MUMS-drug designa tion. 516.26 Amendment to MUMS-drug designa tion. 516.27 Change in sponsorship. 516.28 Publication of MUMS-drug designa tions. 516.29 Termination of MUMS-drug designa tion. 516.30 Annual reports for a MUMS-des ignated drug. 516.31 Scope of MUMS-drug exclusive mar keting rights. 516.34 FDA recognition of exclusive mar keting rights. 516.36 Insufficient quantities of MUMS-des ignated drugs. 516.52 Availability for public disclosure of data and information in requests. Subpart C—Index of Legally Marketed Un approved New Animal Drugs for Minor Species 516.111 Scope of this subpart. 516.115 Definitions. 516.117 Submission of correspondence under this subpart. 516.119 Permanent-resident U.S. agent for foreign requestors and holders. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00136 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B