49 Food and Drug Administration, HHS § 510.600 (1) ALPHABETICAL LISTING OF SPONSORS— Continued Firm name and address Drug label- er code Ayerst Laboratories, Division of American Home Products Corp., 685 Third Ave., New York, NY 10017 ......................................................... 000046 Babineaux’s Veterinary Products, Inc., 6425 Air- line Highway, Metairie, LA 70003 .................... 021188 Balfour Guthrie & Co., Ltd., 315 North H St., Fresno, CA 93701 ............................................ 043728 Bayer Corp., Agriculture Division, Animal Health, P.O. Box 390, Shawnee, Mission, KS 66201 .. 000859 Biocraft Laboratories, Inc., 92 Route 46, Elm- wood Park, NJ 07407 ...................................... 000332 Bioproducts, Inc., 320 Springside Dr., Suite 300, Fairlawn, OH 44333–2435 ............................... 051359 Boehringer Ingelheim Animal Health, Inc., 2621 North Belt Highway, St. Joseph, MO 64502 ... 000010 Bristol Laboratories, Division of Bristol-Myers Co., P.O. Box 4755, Syracuse, NY 13221– 4755 ................................................................. 000015 Carnation Co., 5045 Wilshire Blvd., Los Ange- les, CA 90036 .................................................. 047019 Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland .................. 061651 Chemdex, Inc., 12340 Santa Fe Dr., Lenexa, KS 66215 ......................................................... 017287 Ciba-Geigy Animal Health, Ciba-Geigy Corp., P.O. Box 18300, Greensboro, NC 27419– 8300 ................................................................. 058198 Combe, Inc., 1101 Westchester Ave., White Plains, NY 10604 ............................................. 011509 ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105 .................................... 021091 Cooper U.S.A., Inc., P.O. Box 12338, Research Triangle Park, NC 27709 ................................. 011492 Cooperative Research Farms, Box 69, Charlotteville, NY 12036 .................................. 051267 Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland .............................. 061623 Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501 ............................. 046987 Custom Feed Services Corp., 2100 N. 13th St., Norfolk, NE 68701 ........................................... 017473 Cutter Laboratories, Inc., Fourth and Parker St., Berkeley, CA 94710 ......................................... 000161 Cyanamid Agricultural de Puerto Rico, Inc., P.O. Box 243, Manati, PR 00701 ............................ 043781 Danbury Pharmacal, Inc., 131 West St., Dan- bury, CT 06810 ................................................ 000591 Dawes Laboratories, Inc., 450 State St., Chi- cago Heights, IL 60411 .................................... 024264 Delmarva Laboratories, Inc., 2200 Wadebridge Rd., P.O. Box 525, Midlothian, VA 23113 ....... 059079 Diamond Shamrock Corp., Nutrition & Animal Health Div., 1100 Superior Ave., Cleveland, OH 44114 ......................................................... 025001 DuPont Merck Pharmaceutical Co., DuPont Merck Plaza, MR2117, Wilmington, DE 19805 000056 Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 ............................................................... 000986 Eon Labs Manufacturing, Inc. 227-15 North Conduit Ave., Laurelton, NY 11413 ................. 000185 Evsco Pharmaceuticals, An Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310 ..... 017030 Farmers Feed & Supply Co., Ninth St. at North- western Tracks, Tipton, IA 52772 .................... 043744 Farmland Industries, Inc., Kansas City, MO 64116 ............................................................... 021676 Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928 ................................ 017135 (1) ALPHABETICAL LISTING OF SPONSORS— Continued Firm name and address Drug label- er code Feed Products, Inc., 1000 West 47th Ave., Den- ver, CO 80211 ................................................. 013959 Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, Mankato, MN 56001 ......................... 030841 John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611 ......................................................... 058034 Fermenta Animal Health Co., 10150 North Ex- ecutive Hills Blvd., Kansas City, MO 64153 .... 054273 Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234 ........................................ 015565 Fort Dodge Animal Health, Division of American Home Products Corp., 800 Fifth St. NW., Fort Dodge, IA 50501 .............................................. 000856 Franklin Laboratories, Inc., P.O. Box 717, Fort Dodge, IA 50501 .............................................. 010290 Fujisawa USA, Inc., Deerfield, IL 60015–2548 ... 000469 Furst-McNess Co., Freeport, IL 61032 ............... 010439 Gland-O-Lac Co., 1818 Leavenworth St., Omaha, NE 68102 ........................................... 043735 Global Pharmaceutical Corp., Castor and Ken- sington Aves., Philadelphia, PA 19124 ........... 000115 H. Clay Glover Co., Inc., 1001 Franklin Ave., Garden City, NY 11530 ................................... 010471 Golden Sun Feeds, Inc., 111 South Fifth St., Estherville, IA 51334 ........................................ 021780 Gooch Feed Mill Corp., 540 South St., Lincoln, NE 68501 ......................................................... 021798 Michael Gordon, Inc., P.O. Box 8091, San Fran- cisco, CA 94118 ............................................... 049047 Gossett Nutrition, Inc., 1676 Cascade Dr., Mar- ion, OH 43302 .................................................. 050972 Grain Processing Corp., Muscatine, IA 52761 .... 022591 Growmark, Inc., 1701 Towanda Ave., Blooming- ton, IL 61701 .................................................... 020275 G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201 .............................. 010515 Halocarbon Laboratories, Division of Halocarbon Products Corp., 887 Kinderkamack Rd., P.O. Box 661, River Ridge, NJ 07661 ..................... 012164 Happy Jack, Inc., Snow Hill, NC 28580 .............. 023851 Heinold Feeds, Inc., P.O. Box 377, Kouts, IN 46347 ............................................................... 043727 Henwood Feed Additives, Division of Feed Spe- cialties Co., Inc., 211 Western Rd., Box 577, Lewisburg, OH 45338 ...................................... 026186 Hess & Clark, Inc., Seventh and Orange Sts., Ashland, OH 44805 ......................................... 050749 Dow B. Hickam, Inc., Pharmaceuticals, P.O. Box 35413, Houston, TX 77035 ...................... 000514 Hoechst Roussel Vet, Route 202–206 North, Somerville, NJ 08876 ....................................... 012799 Hoffmann-La Roche, Inc., Nutley, NJ 07110 ...... 000004 Hubbard Milling Co., 424 North Front St., Man- kato, MN 56001 ............................................... 012190 ICI Americas, Inc., Wilmington, DE 19897 .......... 011511 I. D. Russell Co. Laboratories, 1301 Iowa Ave., Longmont, CO 80501 ...................................... 017144 I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137 ............................................................... 050639 Illini Feeds, Box T, Oneida, IL 61467 ................. 037310 Inhalon Pharmaceuticals, Inc., P.O. Box 21170, Lehigh Valley, PA 18002 ................................. 060307 International Nutrition, Inc., 6664 ‘‘L’’ St., Omaha, NE 68117 ........................................... 043733 Intervet, Inc., P.O. Box 318, 405 State St., Millsboro, DE 19966 ........................................ 057926 Ivy Laboratories, Inc., 8857 Bond Street, Over- land Park, KS 66214 ........................................ 021641 J. C. Feed Mills, 1050 Sheffield, P.O. Box 224, Waterloo, IA 50704 .......................................... 039741
Transcript
49
Food and Drug Administration, HHS § 510.600
(1) ALPHABETICAL LISTING OF SPONSORS—Continued
Firm name and address Drug label-er code
Ayerst Laboratories, Division of American HomeProducts Corp., 685 Third Ave., New York,NY 10017 ......................................................... 000046
Elanco Animal Health, A Division of Eli Lilly &Co., Lilly Corporate Center, Indianapolis, IN46285 ............................................................... 000986
Eon Labs Manufacturing, Inc. 227-15 NorthConduit Ave., Laurelton, NY 11413 ................. 000185
Evsco Pharmaceuticals, An Affiliate of IGI, Inc.,Box 209, Harding Hwy., Buena, NJ 08310 ..... 017030
Farmers Feed & Supply Co., Ninth St. at North-western Tracks, Tipton, IA 52772 .................... 043744
Farmland Industries, Inc., Kansas City, MO64116 ............................................................... 021676
Farnam Companies, Inc., 301 West Osborn,Phoenix, AZ 85013–3928 ................................ 017135
(1) ALPHABETICAL LISTING OF SPONSORS—Continued
Firm name and address Drug label-er code
Feed Products, Inc., 1000 West 47th Ave., Den-ver, CO 80211 ................................................. 013959
Fort Dodge Animal Health, Division of AmericanHome Products Corp., 800 Fifth St. NW., FortDodge, IA 50501 .............................................. 000856
Franklin Laboratories, Inc., P.O. Box 717, FortDodge, IA 50501 .............................................. 010290
Fujisawa USA, Inc., Deerfield, IL 60015–2548 ... 000469Furst-McNess Co., Freeport, IL 61032 ............... 010439Gland-O-Lac Co., 1818 Leavenworth St.,
Omaha, NE 68102 ........................................... 043735Global Pharmaceutical Corp., Castor and Ken-
sington Aves., Philadelphia, PA 19124 ........... 000115H. Clay Glover Co., Inc., 1001 Franklin Ave.,
Garden City, NY 11530 ................................... 010471Golden Sun Feeds, Inc., 111 South Fifth St.,
Estherville, IA 51334 ........................................ 021780Gooch Feed Mill Corp., 540 South St., Lincoln,
NE 68501 ......................................................... 021798Michael Gordon, Inc., P.O. Box 8091, San Fran-
Phoenix Scientific, Inc. 3915 South 48th St. Ter-race, P.O. Box 6457, St. Joseph, MO 64506–0457 ................................................................. 059130
Planalquimica Industrial Ltda., Rua das Magno-lias nr. 2405, Jardim das Bandeiras, CEP13053–120, Campinas, Sao Paulo, Brazil ....... 060728
PM Ag Products, Inc., 1055 West 175th St.,Homewood, IL 60430 ....................................... 036904
PM Resources, Inc., 13001 St. Charles RockRd., Bridgeton, MO 63044 ............................... 060594
Premier Malt Products, Inc., Milwaukee, WI53201 ............................................................... 032707
Protein Blenders, Inc., Box 631, Highway 218South, Iowa City, IA 52240 .............................. 033999
Protiva, A Unit of Monsanto Co., 800 NorthLindbergh Blvd., St. Louis, MO 63167 ............ 059945
062925 ............ Veterinary Specialties Inc., 387 North Val-ley Ct., Barrington, Il 60010.
[40 FR 13807, Mar. 27, 1975]
EDITORIAL NOTE: For FEDERAL REGISTER ci-tations affecting § 510.600, see the List of CFRSections Affected in the Finding Aids sec-tion of this volume.
EFFECTIVE DATE NOTE: At 62 FR 14300, Mar.26, 1997, in § 510.600, paragraph (c)(1) wasamended by removing the entries for ‘‘LandO’Lakes’’ and ‘‘Music City Supplement Co.’’;and paragraph (c)(2) was amended by remov-ing the entries for ‘‘017519’’ and ‘‘034500’’, ef-fective April 7, 1997.
PART 511—NEW ANIMAL DRUGSFOR INVESTIGATIONAL USE
AUTHORITY: Secs. 201, 501, 502, 503, 512, 701of the Federal Food, Drug, and Cosmetic Act(21 U.S.C. 321, 351, 352, 353, 360b, 371).
§ 511.1 New animal drugs for inves-tigational use exempt from section512(a) of the act.
(a) New animal drugs for tests in vitroand in laboratory research animals. (1) Ashipment or other delivery of a newanimal drug or animal feed bearing orcontaining a new animal drug intendedsolely for tests in vitro or in animalsused only for laboratory research pur-poses shall be exempt from section 512(a) and (m) of the act if it is labeled asfollows:
Caution. Contains a new animal drug forinvestigational use only in laboratory re-search animals or for tests in vitro. Not foruse in humans.
(2) The person distributing or causingthe distribution of new animal drugsfor tests in vitro or in animals usedonly for laboratory research purposes
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under this exemption shall use due dili-gence to assure that the consignee isregularly engaged in conducting suchtests and that the shipment of the newanimal drug will actually be used fortests in vitro or in animals used onlyfor laboratory research.
(3) The person who introduced suchshipment or who delivered the new ani-mal drug for introduction into inter-state commerce shall maintain ade-quate records showing the name andpost 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 eachshipment and delivery for a period of 2years after such shipment and delivery.Upon the request of a properly author-ized employee of the Department atreasonable times, he shall make suchrecords available for inspection andcopying.
(4) The exemption allowed in thisparagraph shall not apply to any newanimal drug intended for in vitro use inthe regular course of diagnosing ortreating disease, including anti-bacterial sensitivity discs impregnatedwith 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 otherdelivery of a new animal drug or ananimal feed containing a new animaldrug intended for clinical investiga-tional use in animals shall be exemptfrom section 512(a) and (m) of the act ifall the following conditions are met:
(1) The label shall bear the state-ments:
Caution. Contains a new animal drug foruse only in investigational animals in clini-cal trials. Not for use in humans. Edibleproducts of investigational animals are notto be used for food unless authorization hasbeen granted by the U.S. Food and Drug Ad-ministration or by the U.S. Department ofAgriculture.
In the case of containers too small orotherwise unable to accommodate alabel with sufficient space to bear thecaution statements required by para-graph (a) or (b) of this section, thestatements may be included on the car-ton label and other labeling on or with-
in the package from which the new ani-mal drug is to be dispensed.
(2) The person or firm distributing orcausing the distribution of the new ani-mal drug or animal feed containing anew animal drug shall use due dili-gence to assure that the new animaldrug or animal feed containing a newanimal drug will actually be used fortests in animals and is not used in hu-mans.
(3) The person who introduced suchshipment or who delivered the new ani-mal drug or animal feed containing anew animal drug for introduction intointerstate commerce shall maintainadequate records showing the nameand post office address of the investiga-tor to whom the new animal drug oranimal feed containing a new animaldrug is shipped and the date, quantity,and batch or code mark of each ship-ment and delivery for a period of 2years after such shipment and delivery.Upon the request of a properly author-ized employee of the Department atreasonable times, such records shall bemade available for inspection andcopying.
(4) Prior to shipment of the new ani-mal drug for clinical tests in animals,the sponsor of the investigation shallsubmit in triplicate to the Food andDrug Administration a ‘‘Notice ofClaimed Investigational Exemption fora New Animal Drug’’ including a signedstatement containing the following in-formation:
(i) The identity of the new animaldrug.
(ii) All labeling and other pertinentinformation to be supplied to the inves-tigators. When such pertinent informa-tion includes nonclinical laboratorystudies, the information shall include,with respect to each nonclinical study,either a statement that the study wasconducted in compliance with the re-quirements set forth in part 58 of thischapter, or, if the study was not con-ducted in compliance with such regula-tions, a brief statement of the reasonfor the noncompliance.
(iii) The name and address of eachclinical investigator.
(iv) The approximate number of ani-mals to be treated (or if not available,the amount of new animal drug to beshipped).
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21 CFR Ch. I (4–1–97 Edition)§ 511.1
(v) If the new animal drug is given tofood-producing animals, the statementshall contain the following additionalinformation:
(a) A commitment that the edibleproducts from such animals shall notbe used for food without prior author-ization in accordance with the provi-sions prescribed in this section.
(b) Approximate dates of the begin-ning and end of the experiment or se-ries of experiments.
(c) The maximum daily dose(s) to beadministered to a given species, thesize of animal, maximum duration ofadministration, method(s) of adminis-tration, and proposed withdrawal time,if any.
(vi) If a sponsor has transferred anyobligations for the conduct of any clin-ical study to a contract research orga-nization, a statement containing thename and address of the contract re-search organization, identification ofthe clinical study, and a listing of theobligations transferred. If all obliga-tions governing the conduct of thestudy have been transferred, a generalstatement of this transfer—in lieu of alisting of the specific obligations trans-ferred—may be submitted.
(5) Authorization for use of edibleproducts derived from a treated food-producing animal may be grantedunder the provisions of this section andwhen the following specified conditionsare met, except that in the case of ananimal administered any unlicensedexperimental veterinary biologicalproduct regulated under the viruses,serums, toxins statute (21 U.S.C., chap-ter V, sec. 151 et seq.) the product shallbe exempt from the requirements ofthis section when U.S. Department ofAgriculture approval has been obtainedas provided in 9 CFR 103.2. Conditionalauthorization may be granted in ad-vance of identification of the name(s)and address(es) of the clinical inves-tigator(s) as required by paragraph(b)(4)(iii) of this section. Informationrequired for authorization shall in-clude, in addition to all other require-ments of this section, the following:
(i) Data to show that consumption offood derived from animals treated atthe maximum levels with the mini-mum withdrawal periods, if any, speci-fied in accordance with paragraph
(b)(4)(v)(c) of this section, will not beinconsistent with the public health; or
(ii) Data to show that food derivedfrom animals treated at the maximumlevels and with the minimum with-drawal periods, if any, specified in ac-cordance with paragraph (b)(4)(v)(c) ofthis section, does not contain drug res-idues or metabolites.
(iii) The name and location of thepacking plant where the animals willbe processed, except that this require-ment may be waived, on request, bythe terms of the authorization.
Authorizations granted under thisparagraph do not exempt investiga-tional animals and their products fromcompliance with other applicable in-spection requirements. Any person whocontests a refusal to grant such au-thorization shall have an opportunityfor a regulatory hearing before theFood and Drug Administration pursu-ant to part 16 of this chapter.
(6) On written request of the Foodand Drug Administration, the sponsorshall submit any additional informa-tion reported to or otherwise receivedby him with respect to the investiga-tion deemed necessary to facilitate adetermination whether there aregrounds in the interest of public healthfor terminating the exemption.
(7) The sponsor shall assure himselfthat the new animal drug is shippedonly to investigators who:
(i) Are qualified by scientific trainingand/experience to evaluate the safetyand/or effectiveness of the new animaldrug.
(ii) Shall maintain complete recordsof the investigations, including com-plete records of the receipt and disposi-tion of each shipment or delivery of thenew animal drug under investigation.Copies of all records of the investiga-tion shall be retained by the investiga-tor for 2 years after the termination ofthe investigation or approval of a newanimal drug application.
(iii) Shall furnish adequate and time-ly reports of the investigation to thesponsor.
(8) The sponsor:(i) Shall retain all reports received
from investigators for 2 years after thetermination of the investigation or ap-proval of a new animal drug applica-tion and make such reports available
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to a duly authorized employee of theDepartment for inspection at all rea-sonable times.
(ii) Shall provide for current mon-itoring of the investigation by a personqualified by scientific training and ex-perience to evaluate information ob-tained from the investigation, andshall promptly investigate and reportto the Food and Drug Administrationand to all investigators any findingsassociated with use of the new animaldrug that may suggest significant haz-ards pertinent to the safety of the newanimal drug.
(iii) Shall not unduly prolong dis-tribution of the new animal drug forinvestigational use.
(iv) Shall not, nor shall any personacting for or on behalf of the sponsor,represent that the new animal drug issafe or effective for the purposes forwhich it is under investigation. Thisrequirement is not intended to restrictthe full exchange of scientific informa-tion.
(v) Shall not commercially distributenor test-market the new animal druguntil a new animal drug application isapproved pursuant to section 512(c) ofthe act.
(9) If the shipment or other deliveryof the new animal drug is imported oroffered for importation into the UnitedStates for clinical investigational usein animals, it shall also meet the fol-lowing conditions:
(i) The importer of all such ship-ments or deliveries is an agent of theforeign exporter residing in the UnitedStates or the ultimate consignee,which person has, prior to such ship-ments and deliveries, informed theFood and Drug Administration of hisintention to import the new animaldrug as sponsor in compliance with theconditions prescribed in this subdivi-sion; or
(ii) The new animal drug is shippeddirectly to a scientific institution withadequate facilities and qualified per-sonnel to conduct laboratory or clini-cal investigations and is intended sole-ly for use in such institutions andwhich institution has submitted astatement as sponsor of the investiga-tion.
(10) The sponsor shall submit either aclaim for categorical exclusion under
§ 25.24 of this chapter or an environ-mental assessment under § 25.31 of thischapter.
(c) Withdrawal of eligibility to receiveinvestigational-use new animal drugs. (1)Whenever the Food and Drug Adminis-tration has information indicating thatan investigator has repeatedly or delib-erately failed to comply with the con-ditions of these exempting regulationsor has submitted false information ei-ther to the sponsor of the investigationor in any required report, the Centerfor Veterinary Medicine will furnishthe investigator written notice of thematter complained of in general termsand offer him an opportunity to ex-plain the matter in an informal con-ference and/or in writing. If an expla-nation is offered but not accepted bythe Center for Veterinary Medicine,the investigator shall have an oppor-tunity for a regulatory hearing beforethe Food and Drug Administration pur-suant to part 16 of this chapter on thequestion of whether the investigator isentitled to receive investigational newanimal drugs.
(2) If, after evaluating all availableinformation, including any explanationpresented by the investigator, theCommissioner determines that the in-vestigator has repeatedly or delib-erately failed to comply with the con-ditions of the exempting regulations inthis section or has repeatedly or delib-erately submitted false information tothe sponsor of an investigation, theCommissioner will notify the inves-tigator and the sponsor of any inves-tigation in which he has been named asa participant that the investigator isnot entitled to receive investigationaluse new animal drugs with a statementof the basis for such determination.
(3) Each ‘‘Notice of Claimed Inves-tigational Exemption for a New AnimalDrug’’ and each approved new animaldrug application containing data re-ported by an investigator who has beendetermined to be ineligible to receiveinvestigational-use new animal drugswill be examined to determine whetherhe has submitted unreliable data thatare essential to the continuation of theinvestigation or essential to the ap-proval of any new animal drug applica-tion.
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(4) If the Commissioner determines,after the unreliable data submitted bythe investigator are eliminated fromconsideration, that the data remainingare inadequate to support a conclusionthat it is reasonably safe to continuethe investigation, he shall first notifythe sponsor, who shall have an oppor-tunity for a regulatory hearing beforethe Food and Drug Administration pur-suant to part 16 of this chapter onwhether the exemption should be ter-minated. If a danger to the publichealth exists, however, he shall termi-nate the exemption forthwith and no-tify the sponsor of the termination. Insuch event the sponsor shall have anopportunity for a regulatory hearingbefore the Food and Drug Administra-tion pursuant to part 16 (see 42 FR15675, March 22, 1977) of this chapter onthe question of whether the exemptionshould be reinstated.
(5) If the Commissioner determines,after the unreliable data submitted bythe investigator are eliminated fromconsideration, that the data remainingare such that a new animal drug appli-cation would not have been approved,he will proceed to withdraw approval ofthe application in accordance with sec-tion 512(e) of the act.
(6) An investigator who has been de-termined to be ineligible may be rein-stated as eligible to receive investiga-tional-use new animal drugs when theCommissioner determines that he haspresented adequate assurance that hewill employ such new animal drugssolely in compliance with the exempt-ing regulations in this section for in-vestigational-use new animal drugs.
(d) Termination of exemption. If theCommissioner finds that:
(1) The sponsor of the investigationhas failed to comply with any of theconditions for the exemption estab-lished under this section, or
(2) The continuance of the investiga-tion is unsafe or otherwise contrary tothe public interest or the drug is beingor has been used for purposes otherthan bona fide scientific investigation,he shall first notify the sponsor and in-vite his immediate correction. If theconditions of the exemption are notimmediately met, the sponsor shallhave an opportunity for a regulatoryhearing before the Food and Drug Ad-
ministration pursuant of part 16 of thischapter on whether the exemptionshould be terminated. If the exemptionis terminated the sponsor shall recallor have destroyed the unused suppliesof the new animal drug.
(e) Statements and requests. ‘‘Notice(s)of Claimed Investigational Exemptionfor a New Animal Drug’’ and requestsfor authorization to use investigationalanimals and their products for foodshould be addressed to the Departmentof Health and Human Services, Foodand Drug Administration, Center forVeterinary Medicine, 7500 Standish Pl.,Rockville, MD 20855.
(f) Contract research organizations. (1)For purposes of this part and part 514,contract research organization means aperson that assumes, as an independentcontractor with the sponsor, one ormore of the obligations of a sponsor,e.g., design of a protocol, selection ormonitoring of investigations, evalua-tion of reports, and preparation of ma-terials to be submitted to the Food andDrug Administration.
(2) A sponsor may transfer respon-sibility for any or all of the obligationsset forth in this part to a contract re-search organization. Any such transfershall be in writing and, if not all obli-gations are transferred, shall describeeach of the obligations being assumedby the contract research organization.If all obligations are transferred, a gen-eral statement that all obligationshave been transferred is acceptable.Any obligation not covered by thewritten description shall be deemed notto have been transferred.
(3) A contract research organizationthat assumes any obligation of a spon-sor shall comply with the specific regu-lations in this chapter applicable tothis obligation and shall be subject tothe same regulatory action as a spon-sor for failure to comply with any obli-gation assumed under these regula-tions. Thus, all references to sponsor inthis part apply to a contract researchorganization to the extent that it as-sumes one or more obligations of thesponsor.
[40 FR 13823, Mar. 27, 1975, as amended at 41FR 48268, Nov. 2, 1976; 42 FR 15675, Mar. 22,1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668,Apr. 26, 1985; 52 FR 8847, Mar. 19, 1987; 54 FR18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]
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Food and Drug Administration, HHS § 514.1
PART 514—NEW ANIMAL DRUGAPPLICATIONS
Subpart A—General Provisions
Sec.514.1 Applications.514.2 Applications for animal feeds bearing
or containing new animal drugs.514.6 Amended applications.514.7 Withdrawal of applications without
prejudice.514.8 Supplemental new animal drug appli-
cations.514.9 Supplemental applications for animal
feeds bearing or containing new animaldrugs.
514.10 Confidentiality of data and informa-tion in an investigational new animaldrug notice and a new animal drug appli-cation file for an antibiotic drug.
514.11 Confidentiality of data and informa-tion in a new animal drug applicationfile.
514.12 Confidentiality of data and informa-tion in an investigational new animaldrug notice.
514.15 Untrue statements in applications.
Subpart B—Administrative Actions onApplications
514.100 Evaluation and comment on applica-tions.
514.105 Approval of applications.514.106 Approval of supplemental applica-
tions.514.110 Reasons for refusing to file applica-
tions.514.111 Refusal to approve an application.514.112 Return of applications for animal
feeds bearing or containing new animaldrugs.
514.115 Withdrawal of approval of applica-tions.
514.116 Notice of withdrawal of approval ofapplication.
514.120 Revocation of order refusing to ap-prove an application or suspending orwithdrawing approval of an application.
514.121 Service of notices and orders.
Subpart C—Hearing Procedures
514.200 Contents of notice of opportunity fora hearing.
514.201 Procedure for hearings.
Subparts D–E [Reserved]
Subpart F—Judicial Review
514.235 Judicial review.
AUTHORITY: Secs. 501, 502, 512, 701, 721, 801of the Federal Food, Drug, and Cosmetic Act(21 U.S.C. 351, 352, 360b, 371, 379e, 381).
SOURCE: 40 FR 13825, Mar. 27, 1975, unlessotherwise noted.
Subpart A—General Provisions§ 514.1 Applications.
(a) Applications to be filed under sec-tion 512(b) of the act shall be submittedin the form described in paragraph (b)of this section. If any part of the appli-cation is in a foreign language, an ac-curate and complete English trans-lation shall be appended to such part.Translations of literature printed in aforeign language shall be accompaniedby copies of the original publication.The application must be signed by theapplicant or by an authorized attorney,agent, or official. If the applicant orsuch authorized representative doesnot reside or have a place of businesswithin the United States, the applica-tion must also furnish the name andpost office address of, and must becountersigned by, an authorized attor-ney, agent, or official residing or main-taining a place of business within theUnited States. Pertinent informationmay be incorporated in, and will beconsidered as part of, an application onthe basis of specific reference to suchinformation, including informationsubmitted under the provisions of§ 511.1 of this chapter, in the files of theFood and Drug Administration; how-ever, the reference must be specific inidentifying the information. Any ref-erence to information furnished by aperson other than the applicant maynot be considered unless its use is au-thorized in a written statement signedby the person who submitted it.
(b) Applications for new animal drugsshall be submitted in triplicate and as-sembled in the manner prescribed byparagraph (b)(15) of this section, andshall include the following informa-tion:
(1) Identification. Whether the submis-sion is an original or supplemental ap-plication; the name and the address ofthe applicant; the date of the applica-tion; the trade name(s) (if one has beenproposed) and chemical name(s) of thenew animal drug. Upon receipt, the ap-plication will be assigned a numberNADA ———, which shall be used forall correspondence with respect to theapplication.
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(2) Table of contents and summary. Theapplication shall be organized in a co-hesive fashion, shall contain a table ofcontents which identifies the data andother material submitted, and shallcontain a well-organized summary andevaluation of the data in the followingform:
(i) Chemistry:(a) Chemical structural formula or
description for any new animal drugsubstance.
(b) Relationship to other chemicallyor pharmacologically related drugs.
(c) Description of dosage form andquantitative composition.
(ii) Scientific rationale and purposethe new animal drug is to serve:
(a) Clinical purpose.(b) Highlights of laboratory studies:
The reasons why certain types of stud-ies were done or omitted as related tothe proposed conditions of use and toinformation already known about thisclass of compounds. Emphasize any un-usual or particularly significant phar-macological effects or toxicologicalfindings.
(c) Highlights of clinical studies: Therationale of the clinical study planshowing why types of studies weredone, amended, or omitted as relatedto laboratory studies and prior clinicalexperience.
(d) Conclusions: A short statement ofconclusions combining the majorpoints of effectiveness and safety asthey relate to the use of the new ani-mal drug.
(3) Labeling. Three copies of eachpiece of all labeling to be used for thearticle (total of 9).
(i) All labeling should be identified toshow its position on, or the manner inwhich it is to accompany the marketpackage.
(ii) Labeling for nonprescription newanimal drugs should include adequatedirections for use by the layman underall conditions of use for which the newanimal drug is intended, recommended,or suggested in any of the labeling oradvertising sponsored by the applicant.
(iii) Labeling for prescription veteri-nary drugs should bear adequate infor-mation for use under which veterinar-ians can use the new animal drug safe-ly and for the purposes for which it isintended, including those purposes for
which it is to be advertised or rep-resented, in accord with § 201.105 of thischapter.
(iv) All labeling for prescription ornonprescription new animal drugs shallbe submitted with any necessary userestrictions prominently and conspicu-ously displayed.
(v) Labeling for new animal drugs in-tended for use in the manufacture ofmedicated feeds shall include:
(a) Specimens of labeling to be usedfor such new animal drug with ade-quate directions for the manufactureand use of finished feeds for all condi-tions for which the new animal drug isintended, recommended, or suggestedin any of the labeling, including adver-tising, sponsored by the applicant. In-gredient labeling may utilize collectivenames as provided in § 501.110 of thischapter.
(b) Representative labeling proposedto be used for Type B and Type C medi-cated feeds containing the new animaldrug.
(vi) Draft labeling may be submittedfor preliminary consideration of an ap-plication. Final printed labeling willordinarily be required prior to approvalof an application. Proposed advertisingfor veterinary prescription drugs maybe submitted for comment or approval.
(4) Components and composition. Acomplete list of all articles used forproduction of the new animal drug in-cluding a full list of the composition ofeach article:
(i) A full list of the articles used ascomponents of the new animal drug.This list should include all substancesused in the synthesis, extraction, orother method of preparation of anynew animal drug and in the prepara-tion of the finished dosage form, re-gardless of whether they undergochemical change or are removed in theprocess. Each component should beidentified by its established name, ifany, or complete chemical name, usingstructural formulas when necessary forspecific identification. If any propri-etary name is used, it should be fol-lowed by a complete quantitativestatement of composition. Reasonablealternatives for any listed componentmay be specified.
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(ii) A full statement of the composi-tion of the new animal drug. The state-ment shall set forth the name andamount of each ingredient, whether ac-tive or not, contained in a stated quan-tity of the new animal drug in the formin which it is to be distributed (for ex-ample, amount per tablet or milliliter)and a batch formula representative ofthat to be employed for the manufac-ture of the finished dosage form. Allcomponents should be included in thebatch formula regardless of whetherthey appear in the finished product.Any calculated excess of an ingredientover the label declaration should bedesignated as such and percent excessshown. Reasonable variation may bespecified.
(iii) If it is a new animal drug pro-duced by fermentation:
(a) Source and type of microorganismused to produce the new animal drug.
(b) Composition of media used toproduce the new animal drug.
(c) Type of precursor used, if any, toguide or enhance production of the an-tibiotic during fermentation.
(d) Name and composition of preserv-ative, if any, used in the broth.
(e) A complete description of the ex-traction and purification processes in-cluding the names and compositions ofthe solvents, precipitants, ion ex-change resins, emulsifiers, and allother agents used.
(f) If the new animal drug is producedby a catalytic hydrogenation process(such as tetracycline fromchlortetracycline), a complete descrip-tion of each chemical reaction withgraphic formulas used to produce thenew animal drug, including the namesof the catalyst used, how it is removed,and how the new animal drug is ex-tracted and purified.
(5) Manufacturing methods, facilities,and controls. A full description of themethods used in, and the facilities andcontrols used for, the manufacture,processing, and packing of the new ani-mal drug. This description should in-clude full information with respect toany new animal drug in sufficient de-tail to permit evaluation of the ade-quacy of the described methods of man-ufacture, processing, and packing, andthe described facilities and controls todetermine and preserve the identity,
strength, quality, and purity of thenew animal drug, and the following:
(i) If the applicant does not himselfperform all the manufacturing, proc-essing, packaging, labeling, and controloperations for any new animal drug, heshall: Identify each person who willperform any part of such operationsand designate the part; and provide asigned statement from each such per-son fully describing, directly or by ref-erence, the methods, facilities, andcontrols he will use in his part of theoperation. The statement shall includea commitment that no changes will bemade without prior approval by theFood and Drug Administration, unlesspermitted under § 514.8.
(ii) A description of the qualifica-tions, including educational back-ground and experience, of the technicaland professional personnel who are re-sponsible for assuring that the new ani-mal drug has the identity, strength,quality, and purity it purports or isrepresented to possess, and a statementof their responsibilities.
(iii) A description of the physical fa-cilities including building and equip-ment used in manufacturing, process-ing, packaging, labeling, storage, andcontrol operations.
(iv) The methods used in the syn-thesis, extraction, isolation, or purifi-cation of any new animal drug. Whenthe specifications and controls appliedto such new animal drugs are inad-equate in themselves to determine itsidentity, strength, quality, and purity,the methods should be described in suf-ficient detail, including quantitiesused, times, temperature, pH, solvents,etc., to determine these characteris-tics. Alternative methods or variationsin methods within reasonable limitsthat do not affect such characteristicsof the new animal drug may be speci-fied. A flow sheet and indicated equa-tions should be submitted when neededto explain the process.
(v) Precautions to insure proper iden-tity, strength, quality, and purity ofthe raw materials, whether active ornot, including:
(a) The specifications for acceptanceand methods of testing for each lot ofraw material.
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(b) A statement as to whether or noteach lot of raw materials is given a se-rial number to identify it, and the usemade of such numbers in subsequentplant operations.
(vi) The instructions used in themanufacturing, processing, packaging,and labeling of each dosage form of thenew animal drug, including:
(a) The method of preparation of themaster formula records and individualbatch records and the manner in whichthese records are used.
(b) The number of individuals check-ing weight or volume of each individ-ual ingredient entering into each batchof the new animal drug.
(c) A statement as to whether or notthe total weight or volume of eachbatch is determined at any stage of themanufacturing process subsequent tomaking up a batch according to theformula card and, if so, at what stageand by whom it is done.
(d) The precautions used in checkingthe actual package yield produced froma batch of the new animal drug withthe theoretical yield. This should in-clude a description of the accountingfor such items as discards, breakage,etc., and the criteria used in acceptingor rejecting batches of drugs in theevent of an unexplained discrepancy.
(e) The precautions used to assurethat each lot of the new animal drug ispackaged with the proper label and la-beling, including provisions for label-ing storage and inventory control.
(f) Any special precautions used inthe operations.
(vii) The analytical controls usedduring the various stages of the manu-facturing, processing, packaging, andlabeling of the new animal drug, in-cluding a detailed description of thecollection of samples and the analyt-ical procedures to which they are sub-jected. The analytical proceduresshould be capable of determining theactive components within a reasonabledegree of accuracy and of assuring theidentity of such components.
(a) A description of practicable meth-ods of analysis of adequate sensitivityto determine the amount of the newanimal drug in the final dosage formshould be included. The dosage formmay be a finished pharmaceutical prod-uct, a Type A medicated article, a Type
B or a Type C medicated feed, or aproduct for use in animal drinkingwater. Where two or more active ingre-dients are included, methods should bequantitative and specific for each ac-tive ingredient.
(b) If the article is one that is rep-resented to be sterile, the same infor-mation with regard to the manufactur-ing, processing, packaging, and the col-lection of samples of the drug should begiven for sterility controls. Include thestandards used for acceptance of eachlot of the finished drug.
(viii) An explanation of the exact sig-nificance of any batch control numbersused in the manufacturing, processing,packaging, and labeling of the new ani-mal drug, including such control num-bers that may appear on the label ofthe finished article. State whetherthese numbers enable determination ofthe complete manufacturing history ofthe product. Describe any methodsused to permit determination of thedistribution of any batch if its recall isrequired.
(ix) Adequate information with re-spect to the characteristics of and thetest methods employed for the con-tainer, closure, or other componentparts of the drug package to assuretheir suitability for the intended use.
(x) A complete description of, anddata derived from, studies of the stabil-ity of the new animal drug in the finaldosage form, including informationshowing the suitability of the analyt-ical methods used. A description of anyadditional stability studies underwayor planned. Stability data for the fin-ished dosage form of the new animaldrug in the container in which it is tobe marketed, including any proposedmultiple dose container, and, if it is tobe put into solution at the time of dis-pensing, for the solution prepared asdirected. If the new animal drug is in-tended for use in the manufacture ofType C medicated feed as defined in§ 558.3 of this chapter, stability data de-rived from studies in which representa-tive formulations of the medicated feedarticles are used. Similar data may berequired for Type B medicated feeds asdetermined by the Food and Drug Ad-ministration on a case-by-case basis.Expiration dates shall be proposed forfinished pharmaceutical dosage forms
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and Type A medicated articles. If thedata indicate that an expiration date isneeded for Type B or Type C medicatedfeeds, the applicant shall propose suchexpiration date. If no expiration date isproposed for Type B or Type C medi-cated feeds, the applicant shall justifyits absence with data.
(xi) Additional procedures employedwhich are designed to prevent contami-nation and otherwise assure propercontrol of the product. An applicationmay be refused unless it includes ade-quate information showing that themethods used in, and the facilities andcontrols used for, the manufacturing,processing, and packaging of the newanimal drug are adequate to preserveits identity, strength, quality, and pu-rity in conformity with good manufac-turing practice and identifies each es-tablishment, showing the location ofthe plant conducting these operations.
(6) Samples. Samples of the new ani-mal drug and articles used as compo-nents and information concerningthem may be requested by the Centerfor Veterinary Medicine as follows:
(i) Each sample shall consist of fouridentical, separately packaged subdivi-sions, each containing at least threetimes the amount required to performthe laboratory test procedures de-scribed in the application to determinecompliance with its control specifica-tions for identity and assays. Each ofthe samples submitted shall be appro-priately packaged and labeled to pre-serve its characteristics, to identifythe material and the quantity in eachsubdivision of the sample, and to iden-tify each subdivision with the name ofthe applicant and the new animal drugapplication to which it relates. In-cluded are:
(a) A sample or samples of any ref-erence standard and blank used in theprocedures described in the applicationfor assaying each new animal drug andother assayed components of the fin-ished new animal drug.
(b) A representative sample or sam-ples of each strength of the finisheddosage form proposed in the applica-tion and employed in the clinical in-vestigations and a representative sam-ple or samples of each new animal drugfrom the batch(es) employed in theproduction of such dosage form.
(c) A representative sample or sam-ples of finished market packages ofeach strength of the dosage form of thenew animal drug prepared for initialmarketing and, if any such sample isnot from a representative commercial-scale production batch, such a samplefrom a representative commercial-scale production batch, and a rep-resentative sample or samples of eachnew animal drug from the batch(es)employed in the production of suchdosage form, provided that in the caseof new animal drugs marketed in largepackages the sample should containonly three times a sufficient quantityof the new animal drug to allow forperforming the control tests for drugidentity and assays.
(ii) The following information shallbe included for the samples when re-quested:
(a) For each sample submitted, fullinformation regarding its identity andthe origin of any new animal drug con-tained therein (including a statementwhether it was produced on a labora-tory, pilot-plant, or full-productionscale) and detailed results of all labora-tory tests made to determine the iden-tity, strength, quality, and purity ofthe batch represented by the sample,including assays.
(b) For any reference standard sub-mitted, a complete description of itspreparation and the results of all lab-oratory tests on it. If the test methodsused differed from those described inthe application, full details of themethods employed in obtaining the re-porting results.
(7) Analytical methods for residues. Ap-plications shall include a description ofpracticable methods for determiningthe quantity, if any, of the new animaldrug in or on food, and any substanceformed in or on food because of its use,and the proposed tolerance or with-drawal period or other use restrictionsto ensure that the proposed use of thisdrug will be safe. When data or otheradequate information establish that itis not reasonable to expect the newanimal drug to become a component offood at concentrations considered un-safe, a regulatory method is not re-quired.
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(i) The kind of information requiredby this subdivision may include: Com-plete experimental protocols for deter-mining drug residue levels in the edibleproducts, and the length of time re-quired for residues to be eliminatedfrom such products following thedrug’s use; residue studies conductedunder appropriate (consistent with theproposed usage) conditions of dosage,time, and route of administration toshow levels, if any, of the drug and/orits metabolites in test animals duringand upon cessation of treatment and atintervals thereafter in order to estab-lish a disappearance curve; if the drugis to be used in combination with otherdrugs, possible effects of interactiondemonstrated by the appropriate dis-appearance curve or depletion patternsafter drug withdrawal under appro-priate (consistent with the proposedusage) conditions of dosage, time, androute of administration; if the drug isgiven in the feed or water, appropriateconsumption records of the medicatedfeed or water and appropriate perform-ance data in the treated animal; if thedrug is to be used in more than onespecies, drug residue studies or appro-priate metabolic studies conducted foreach species that is food-producing. Toprovide these data, a sufficient numberof birds or animals should be used ateach sample interval. Appropriate useof labeled compounds (e.g. radioactivetracers), may be utilized to establishmetabolism and depletion curves. Drugresidue levels ordinarily should be de-termined in muscle, liver, kidney, andfat and where applicable, in skin, milk,and eggs (yolk and egg white). As apart of the metabolic studies, levels ofthe drug or metabolite should be deter-mined in blood where feasible. Samplesmay be combined where necessary.Where residues are suspected or knownto be present in litter from treated ani-mals, it may be necessary to includedata with respect to such residues be-coming components of other agricul-tural commodities because of use of lit-ter from treated animals.
(ii) A new animal drug that has thepotential to contaminate human foodwith residues whose consumption couldpresent a risk of cancer to people mustsatisfy the requirements of subpart Eof part 500 of this chapter.
(8) Evidence to establish safety and ef-fectiveness. (i) An application may berefused unless it contains full reportsof adequate tests by all methods rea-sonably applicable to show whether ornot the new animal drug is safe and ef-fective for use as suggested in the pro-posed labeling.
(ii) An application may be refusedunless it includes substantial evidence,consisting of adequate and well-con-trolled investigations, including fieldinvestigation, by experts qualified byscientific training and experience toevaluate the effectiveness of the newanimal drug involved, on the basis ofwhich it could fairly and reasonably beconcluded by such experts that the newanimal drug will have the effect itpurports or is represented to haveunder the conditions of use prescribed,recommended, or suggested in the pro-posed labeling.
(iii) An application may be refusedunless it contains detailed reports ofthe investigations, including studiesmade on laboratory animals, in whichthe purpose, methods, and results ob-tained are clearly set forth of acute,subacute, and chronic toxicity, and un-less it contains appropriate clinicallaboratory results related to safety andefficacy. Such information should in-clude identification of the person whoconducted each investigation, a state-ment of where the investigations wereconducted, and where the raw data areavailable in the application.
(iv) All information pertinent to anevaluation of the safety and effective-ness of the new animal drug received orotherwise obtained by the applicantfrom any source, including informationderived from other investigations orcommercial marketing (for example,outside the United States), or reportsin the scientific literature, both favor-able and unfavorable, involving thenew animal drug that is the subject ofthe application and related new animaldrugs shall be submitted. An adequatesummary may be acceptable in lieu ofa reprint of a published report thatonly supports other data submitted. In-clude any evaluation of the safety oreffectiveness of the new animal drugthat has been made by the applicant’sveterinary or medical department, ex-pert committee, or consultants.
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(v) If the new animal drug is a com-bination of previously investigated ormarketed new animal drugs, an ade-quate summary of preexisting informa-tion from preclinical and clinical in-vestigation and experience with itscomponents, including all reports re-ceived or otherwise obtained by the ap-plicant suggesting side effects, contra-indications, and ineffectiveness in useof such components, shall be submit-ted. Such summary should include anadequate bibliography of publicationsabout the components and may incor-porate by reference information con-cerning such components previouslysubmitted to the Food and Drug Ad-ministration by the applicant; withwritten authorization, informationmay also be incorporated from the ma-terial that another applicant has onfile with the Food and Drug Adminis-tration. Each ingredient designated asactive in any new animal drug com-bination must make a contribution tothe effect in the manner claimed orsuggested in the labeling, and, if in theabsence of express labeling claims ofadvantages for the combination such aproduct purports to be better than ei-ther component alone, it must be es-tablished that the new animal drug hasthat purported effectiveness.
(vi) An application shall include acomplete list of the names and post of-fice addresses of all investigators whoreceived the new animal drug. Thismay be incorporated in whole or inpart by reference to information sub-mitted under the provisions of § 511.1 ofthis chapter.
(vii) Explain any omission of reportsfrom any investigator to whom the in-vestigational new animal drug has beenmade available. The unexplained omis-sion of any reports of investigationsmade with the new animal drug by theapplicant or submitted to him by an in-vestigator or the unexplained omissionof any pertinent reports of investiga-tions or clinical experience received orotherwise obtained by the applicantfrom published literature or othersources that would bias an evaluationof the safety of the new animal drug orits effectiveness in use, constitutesgrounds for the refusal or withdrawalof the approval of an application.
(viii) If a sponsor has transferred anyobligations for the conduct of any clin-ical study to a contract research orga-nization, the application is required toinclude a statement containing thename and address of the contract re-search organization, identifying theclinical study, and listing the obliga-tions transferred. If all obligations gov-erning the conduct of the study havebeen transferred, a general statementof this transfer—in lieu of a listing ofthe specific obligations transferred—may be submitted.
(ix) If original subject records wereaudited or reviewed by the sponsor inthe course of monitoring any clinicalstudy to verify the accuracy of the casereports submitted to the sponsor, a listidentifying each clinical study so au-dited or reviewed.
(9) [Reserved](10) Supplemental applications. If it is
a supplemental application, full infor-mation shall be submitted on each pro-posed change concerning any state-ment made in the approved applica-tion.
(11) Applicant’s commitment. It is un-derstood that the labeling and adver-tising for the new animal drug will pre-scribe, recommend, or suggest its useonly under the conditions stated in thelabeling which is part of this applica-tion and if the article is a prescriptionnew animal drug, it is understood thatany labeling which furnishes orpurports to furnish information for useor which prescribes, recommends, orsuggests a dosage for use of the newanimal drug will also contain, in thesame language and emphasis, informa-tion for its use including indications,effects, dosages, routes, methods, andfrequency and duration of administra-tion, any relevant hazards, contra-indications, side effects, and pre-cautions contained in the labelingwhich is part of this application. It isunderstood that all representations inthis application apply to the drug pro-duced until changes are made in con-formity with § 514.8.
(12) Additional commitments. (i) Newanimal drugs as defined in § 510.3 of thischapter, intended for use in the manu-facture of animal feeds in any Statewill be shipped only to persons who
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may receive such drugs in accordancewith § 510.7 of this chapter.
(ii) The methods, facilities, and con-trols described under item 5 of this ap-plication conform to the current goodmanufacturing practice regulations insubchapter C of this chapter.
(iii) With respect to each nonclinicallaboratory study contained in the ap-plication, either a statement that thestudy was conducted in compliancewith the good laboratory practice regu-lations set forth in part 58 of this chap-ter, or, if the study was not conductedin compliance with such regulations, abrief statement of the reason for thenoncompliance.
(13) [Reserved](14) Environmental assessment. The ap-
plicant is required to submit either aclaim for categorical exclusion under§ 25.24 of this chapter or an environ-mental assessment under § 25.31 of thischapter.
(15) Assembling and binding the appli-cation. Assemble and bind an originaland two copies of the application asfollows:
(i) Bind the original or ribbon copy ofthe application as copy No. 1.
(ii) Bind two identical copies as copyNo. 2 and copy No. 3.
(iii) Identify each front cover withthe name of the applicant, new animaldrug, and the copy number.
(iv) Number each page of the applica-tion sequentially in the upper righthand corner or in another location sothat the page numbers remain legibleafter the application has been bound,and organize the application consistentwith paragraphs (b) (1) through (14) ofthis section. Each copy should bear thesame page numbering, whether sequen-tial in each volume or continuous andsequential throughout the application.
(v) Include complete labeling in eachof the copies. It is suggested that label-ing be identified by date of printing ordate of preparation.
(vi) Submit separate applications foreach different dosage form of the drugproposed. Repeating basic informationpertinent to all dosage forms in eachapplication is unnecessary if referenceis made to the application containingsuch information. Include in each ap-plication information applicable to thespecific dosage form, such as labeling,
composition, stability data, and meth-od of manufacture.
(vii) Submit in folders amendments,supplements, and other correspondencesent after submission of an original ap-plication. The front cover of these sub-missions should be identified with thename of the applicant, new animaldrug, copy number, and the new animaldrug application number, if known.
(c) When a new animal drug applica-tion is submitted for a new animaldrug which has a stimulant, depres-sant, or hallucinogenic effect on thecentral nervous system, if it appearsthat the drug has a potential for abuse,the Commissioner shall forward thatinformation to the Attorney General ofthe United States.
(d) Minor use applications. Applica-tions for minor use new animal drugs:
(1) Definitions. For the purpose of thissection:
(i) Minor use means the use of: (a)New animal drugs in minor animal spe-cies, or (b) new animal drugs in anyanimal species for the control of a dis-ease that (1) occurs infrequently or (2)occurs in limited geographic areas.
(ii) Minor species means animals otherthan cattle, horses, swine, chickens,turkeys, dogs, and cats. Sheep are aminor species with respect to effective-ness and animal safety data collectionrequirements; sheep are a major spe-cies with respect to human safety datacollection requirements arising fromthe possible presence of drug residuesin food.
(2) Animal safety, effectiveness, humanfood safety, and environmental consider-ations. Guidelines for the preparationand submission of data to satisfy therequirements of section 512 of the actregarding animal safety, effectiveness,human food safety, and environmentalconsiderations for new animal drugs in-tended for a minor use (as defined inparagraph (d)(1)(i) of this section) areavailable from the Industry Informa-tion Staff (HFV–11), Center for Veteri-nary Medicine, Food and Drug Admin-istration, 7500 Standish Pl., Rockville,MD 20855.
(i) Animal safety and effectiveness.Where the guidelines do not specifi-cally provide for a particular minor use,the Center for Veterinary Medicine,upon request, will advise interested
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persons on the effectiveness and animalsafety data regarding the minor usethat will be needed to satisfy the re-quirements of section 512 of the act.Where scientifically appropriate, theCenter for Veterinary Medicine willallow the use of animal models and theextrapolation of data from a major spe-cies to a minor species to satisfy therequirements of the act.
(ii) Human food safety and environ-mental considerations. These guidelinesdo not specifically provide for a par-ticular minor use. Therefore, the Centerfor Veterinary Medicine will, upon re-quest, advise interested persons of thedata that will be needed. Where sci-entifically appropriate, the Center forVeterinary Medicine will allow the ex-trapolation of data from a major spe-cies to a minor species to satisfy therequirements of the act.
(Approved by the Office of Management andBudget under control number 0910–0032)
[40 FR 13825, Mar. 27, 1975]
EDITORIAL NOTE: For Federal Register cita-tions affecting § 514.1, see the List of CFRSections Affected in the Finding Aids sec-tion of this volume.
§ 514.2 Applications for animal feedsbearing or containing new animaldrugs.
(a) Applications (Form FDA 1900) tobe filed under section 512(m) of the actshall be completed, signed, and submit-ted in triplicate in the form describedin paragraphs (b) and (c) of this sec-tion.
(b) Each application for a Type B orType C medicated feed, as defined in§ 558.3 of this chapter, shall include thefollowing information:
(1) The name and address of the ap-plicant.
(2) The registration number assignedpursuant to section 510 of the act andlast date of registration of each mill.
(3) Whether the submission is anoriginal or supplemental application.
(4) Identification of the Type A medi-cated article, as defined in § 558.3 ofthis chapter, used by generic name, po-tency, and manufacturer.
(5) The species of animal(s) for whichthe feed is intended.
(6) The form of feed to be produced,i.e., mash, meal crumbles, pellets, liq-uid, or other specified form.
(7) Whether the feed is a Type B orType C medicated feed.
(8) Whether the feed is for sale or forown use (not for sale).
(9) Level of the drug(s) in the finishedfeed, and the amount of Type A medi-cated article per ton contained therein.
(10) Identification of the regula-tion(s) in subchapter E of this chapteron which approval relies.
(11) Labeling representative of eachintended use as stated in the claim.Each generic label shall include theclaim, drug level, mixing directions,feeding directions, caution and/orwarning statements, and any other spe-cial directions required by the pub-lished regulation. This shall consist ofbag labels, invoice copy, bulk labels,and placards when applicable.
(12) A commitment to establish andmaintain a program of sampling andanalysis consisting of an assay of thefirst batch manufactured, followedthereafter by two samples at periodicintervals during the calendar year. If amedicated feed contains a combinationof drugs, only one of the drugs need besubject to analysis each time, providedthe one tested is different from theone(s) previously tested. Reports of as-says shall be kept on the premises fornot less than 1 year after the date ofmanufacture of the medicated feed.
(13) A statement of the minimum andmaximum assay value permitted fromthe labeled amount of the drug.
(14) Identification of the agent au-thorized to act on behalf of the appli-cant.
(15) The applicant’s name, respon-sible individual’s title and original sig-nature, and date.
(c) Upon approval, one copy of the ap-plication will be signed by an author-ized employee of the Food and DrugAdministration designated by the Com-missioner, and it will be returned tothe applicant.
(d) Applications (Form FDA 1900)may be obtained from the PublicHealth Service, Consolidated Formsand Publications Distribution Center,Washington Commerce Center, 3222Hubbard Rd., Landover, MD 20785.
(Approved by the Office of Management andBudget under control number 0910–0011)
[51 FR 7391, Mar. 3, 1986, as amended at 55 FR14831, Apr. 19, 1990]
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21 CFR Ch. I (4–1–97 Edition)§ 514.6
§ 514.6 Amended applications.The applicant may submit an amend-
ment to an application that is pending,including changes that may alter theconditions of use, the labeling, safety,effectiveness, identity, strength, qual-ity, or purity of the drug or the ade-quacy of the manufacturing methods,facilities, and controls to preservethem, in which case the unamended ap-plication may be considered as with-drawn and the amended applicationmay be considered resubmitted on thedate on which the amendment is re-ceived by the Food and Drug Adminis-tration. The applicant will be notifiedof such date.
§ 514.7 Withdrawal of applicationswithout prejudice.
The sponsor may withdraw his pend-ing application from consideration as anew animal drug application upon writ-ten notification to the Food and DrugAdministration. Such withdrawal maybe made without prejudice to a futurefiling. Upon resubmission, the timelimitation will begin to run from thedate the resubmission is received bythe Food and Drug Administration.The original application will be re-tained by the Food and Drug Adminis-tration although it is considered with-drawn. The applicant shall be furnisheda copy at cost on request.
§ 514.8 Supplemental new animal drugapplications.
(a)(1) After a new animal drug appli-cation is approved, a supplemental newanimal drug application may proposechanges. A supplemental applicationmay omit statements made in the ap-proved application concerning whichno change is proposed. Each supple-mental application shall include up-to-date reports of any of the kinds of in-formation required by § 510.300(a) ofthis chapter that has not previouslybeen submitted. A supplemental appli-cation shall be accompanied by eithera claim for categorical exclusion under§ 25.24 of this chapter or an environ-mental assessment under § 25.31 of thischapter.
(2) A supplemental new animal drugapplication shall be submitted for anychange beyond the variations providedfor in the application, including
changes in the scale of production suchas from pilot-plant to productionbatch, that may alter the conditions ofuse, the labeling, safety, effectiveness,identity, strength, quality, or purity ofthe new animal drug, or the adequacyof the manufacturing methods, facili-ties, or controls to preserve them.
(3) If it is a prescription drug, anymailing or promotional piece usedafter the drug is placed on the marketis labeling requiring a supplementalapplication, unless:
(i) The parts of the labeling furnish-ing directions, warnings, and informa-tion for use of the drug are the same inlanguage and emphasis as labeling ap-proved or permitted; and
(ii) Any other parts of the labelingare consistent with and not contrary tosuch approved or permitted labeling.
(4) The supplemental applicationshall be submitted as follows. A com-munication proposing a change in anew animal drug application shouldprovide for any one of the followingkinds of changes:
(i) Revision in labeling, such as up-dating information pertaining to ef-fects, dosages, and side effects and con-traindications, which includes informa-tion headed ‘‘side effects,’’ ‘‘warnings,’’‘‘precautions,’’ and ‘‘contraindica-tions.’’
(ii) Addition of claim.(iii) Revision in manufacturing or
control procedures; for example,changes in components, composition,method of manufacture, analyticalcontrol procedures, package or tabletsize, etc.
(iv) Change in manufacturing facili-ties.
(v) Provision for outside firm to par-ticipate in the preparation, distribu-tion, or packaging of a new animaldrug (new distributor, packer, supplier,manufacturer, etc.); one firm per sub-mission.
Any number of changes may be submit-ted at any one time; but if they fallinto different categories as listed inparagraphs (a)(4) (i) through (v) of thissection, the proposed changes should becovered by separate communications.Where, however, a change necessitatesan overlap in categories, it should besubmitted in a single communication.
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Food and Drug Administration, HHS § 514.8
For example, a change in tablet po-tency would require other changes suchas in components, composition, and la-beling and should be submitted in asingle communication.
(5) The following kinds of changesmay be placed into effect without theapproval of a supplemental application,if such change is fully described in thenext periodic report required under§ 510.300(b)(4) of this chapter or, whensuch a report is not required, in a writ-ten communication to the Food andDrug Administration within 60 days ofthe effective date of the change (thisdoes not apply to a change proposed be-cause of any mixup or any bacterio-logical or significant chemical, phys-ical, or other change or deteriorationin the drug or any failure of one ormore distributed batches of the drug tomeet its specifications):
(i) A different container size for solidoral dosage forms where container andclosure are of the same materials asthose provided for in the approved ap-plication.
(ii) Change in personnel not involvingnew facilities.
(iii) Change in equipment that doesnot alter the method of manufacture ofa new animal drug.
(iv) Change from one commercialbatch size to another without anychange in manufacturing procedure.
(v) Change to more stringent speci-fication without altering the methoddescribed in the approved application.
(vi) Inclusion of additional specifica-tions and methods without deletion ofthose described in the approved appli-cation.
(vii) Alteration of specifications ormethods for inactive ingredients tobring them into compliance with newor revised specifications or methods inan official compendium.
(viii) Initiation of a product identi-fication coding system.
(ix) Addition to labeling of a reason-able expiration date where none waspreviously used, with related condi-tions of drug storage when appropriate,except when evidence shows that a sig-nificant deterioration of the drugunder marketing conditions has oc-curred which necessitates the imme-diate submission of a report under§ 510.300(b)(1) of this chapter. The re-
port or written communication de-scribing such change in labeling shouldinclude stability data justifying the ex-piration date and recommended condi-tions of storage.
(x) Change from paper labels to di-rect printing on glass or other kinds ofimmediate containers without achange in text.
(6) Approval of a supplemental newanimal drug application will not be re-quired to provide for an additional dis-tributor to distribute a drug which isthe subject of an approved new animaldrug application if the conditions de-scribed below are met prior to puttingsuch a change into effect. An ordermay issue refusing approval if any con-dition is not met or if any of the rea-sons for refusing or withdrawing ap-proval, as stated in section 512(d) and(e) of the act or § 514.110 applies. Forthe purposes of maintaining recordsand making reports under the require-ments of § 510.300 of this chapter, a dis-tributor provided for under this sectionshall be considered an applicant withinthe meaning of § 510.300(b) of this chap-ter. Said conditions are:
(i) A supplemental application is fur-nished to the Food and Drug Adminis-tration to provide for a designated dis-tributor.
(ii) There are no changes from theconditions of the approved applicationexcept for a different and suitable pro-prietary name of the new animal drug(if one is used) and the name and ad-dress of the distributor as used on thelabel and labeling. The name of the dis-tributor shall be accompanied by anappropriate qualifying phrase such as‘‘manufactured for’’ or ‘‘distributedby.’’
(iii) A distributor’s statement is fur-nished to the Food and Drug Adminis-tration identifying the category of hisoperations (for example, wholesaler, re-tailer) and stating: That he will dis-tribute the new animal drug only underthe labeling provided for in the newanimal drug application; that anyother labeling or advertising for thedrug will prescribe, recommend, or sug-gest its use only under the conditionsstated in the labeling provided for inthe application; and, if the drug is a
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21 CFR Ch. I (4–1–97 Edition)§ 514.8
prescription article, that he is regu-larly and lawfully engaged in the dis-tribution or dispensing of prescriptiondrugs.
(iv) Nine copies of the printed labelsand other labeling to be used by thedistributor are submitted, identifiedwith the new animal drug applicationnumber.
(b) When necessary for the safety oreffectiveness of the drug, a supple-mental new animal drug applicationshall specify a period of time withinwhich the proposed change will bemade.
(c) If a material change is made inthe components’ composition, manu-facturing methods, facilities, or con-trols, or in the labeling or advertising,from the representations in an ap-proved application for a new animaldrug (except changes conforming to theconditions set forth in paragraph (a)(5)and (6) and/or paragraphs (d), (e), (f),and (g) of this section), and the drug ismarketed before a supplement is ap-proved for such change, approval of theapplication may be suspended or with-drawn as provided in section 512(e) ofthe act.
(d) Changes of the following kindsproposed in supplemental new animaldrug applications should be placed intoeffect at the earliest possible time:
(1) The addition to package labeling,promotional labeling, and prescriptiondrug advertising of additional warning,contraindication, side effect, and pre-caution information.
(2) The deletion from package label-ing, promotional labeling, and drug ad-vertising of false, misleading, or unsup-ported indications for use or claims foreffectiveness.
(3) Changes in the methods, facilities,or controls used for the manufacture,processing, packing, or holding of thenew animal drug (other than utiliza-tion of establishments not covered bythe approval that is in effect) that giveincreased assurance that the drug willhave the characteristics of identity,strength, quality, and purity which itpurports or is represented to possess.
(e) The Food and Drug Administra-tion will take no action against a newanimal drug or applicant solely be-cause changes of the kinds described inparagraph (d) of this section are placed
into effect by the applicant prior to hisreceipt of a written notice of approvalof the supplemental new animal drugapplication if all the following condi-tions are met:
(1) The supplemental new animaldrug application providing a full expla-nation of the basis for the changes hasbeen submitted, plainly marked on themailing cover and on the supplement,‘‘Special new animal drug applicationSupplement—changes being effected.’’
(2) The applicant specifically informsthe Food and Drug Administration ofthe date on which such changes arebeing effected and submits to the Ad-ministration nine printed copies of anyrevised labeling to be placed in use,identified with the new animal drug ap-plication number.
(3) All promotional labeling and alldrug advertising are promptly revisedconsistent with the changes made inthe labeling on or within the new ani-mal drug package.
(f) When a supplemental new animaldrug application proposes changes onlyof the kinds described in paragraph (d)of this section, and the applicant in-forms the Food and Drug Administra-tion that the changes are being putinto effect, such notification will be re-garded as an agreement by the appli-cant to an extension of the time forformal action on the application.
(g) In addition to changes as per-mitted by paragraphs (d) and (e) of thissection, an applicant may place into ef-fect changes proposed in a supplementto a new animal drug application thatbecame effective prior to October 10,1962, upon written notification fromthe Food and Drug Administrationthat such action is permitted, withoutapproval of the supplemental applica-tion, pending the completion of the re-view of the effectiveness of such drugby the National Academy of Sciences-National Research Council and a deter-mination as to whether there aregrounds for refusing approval undersection 512(d) of the act or for invokingsection 512(e) of the act. The Food andDrug Administration will take no ac-tion against a new animal drug or anapplicant solely because changes thathave been permitted in a written com-munication are placed into effect bythe applicant prior to his receipt of a
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Food and Drug Administration, HHS § 514.9
written notice of approval of the sup-plemental new animal drug applica-tion.
(h) Except as provided in paragraphs(e) and (g) of this section, no provisionof this section shall limit the authorityof the Secretary or of the Commis-sioner to suspend or withdraw approvalof a new animal drug application in ac-cord with the provisions of section512(e) of the act or to initiate any otherregulatory proceedings with respect toa drug or applicant under provisions ofthe act.
(i) Changes from the conditions of anapproved new animal drug applicationin accord with the provisions of para-graphs (d), (e), and (g) of this sectionare permitted on the basis of a tem-porary deferral of final action on thesupplemental application under theprovisions of section 512 (c), (d), or (e)of the act.
(j) When an applicant receives writ-ten notification from the Food andDrug Administration, under the provi-sions of paragraph (g) of this section,that he may place into effect changesproposed in a supplemental applicationwithout approval of the supplementalapplication, he may within 30 days sub-mit a written request that the Foodand Drug Administration process thesupplemental application. In such case,the change shall not be put into effectuntil approved. Within 180 days of thereceipt of such written request, theFood and Drug Administration will ap-prove the supplemental application orfurnish notice of an opportunity for ahearing under the provisions of section512 (d) or (e), or both, of the act on aproposal to refuse approval of the sup-plemental application or to withdrawapproval of the application and supple-ments thereto.
(k) A supplement to an applicationthat became effective prior to October10, 1962, may include a written state-ment to the effect that a temporary de-ferral of final action under the provi-sions of paragraph (d), (e), or (g) of thissection is unacceptable to the appli-cant and that the applicant requestsaction as provided in section 512(c) ofthe act. Final action on such supple-mental applications will be expeditedin accord with applicable provisions of
section 512 of the act and regulationsin this subchapter E. In such cases, ifthe applicant places into effect any ofthe proposed changes prior to his re-ceipt of a written notice of approval ofthe supplemental new animal drug ap-plication, such action may be regardedby the Food and Drug Administrationas a basis for invoking the provisionsof section 512(e)(1)(D) of the act; thatis, the applicant may be furnished no-tice of an opportunity for a hearing ona proposal to withdraw approval of theapplication on the ground that the ap-plication contains an untrue statementof a material fact related to thechanges from the conditions approvedin the application.
(l) A supplemental application thatcontains nonclinical laboratory studiesshall include, with respect to each non-clinical study, either a statement thatthe study was conducted in compliancewith the requirements set forth in part58 of this chapter, or, if the study wasnot conducted in compliance with suchregulations, a brief statement of thereason for the noncompliance.
[40 FR 13825, Mar. 27, 1975, as amended at 50FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 26,1985]
(a) After an application for an animalfeed bearing or containing a new ani-mal drug has been approved, a supple-mental application may proposechanges.
(b) A supplemental application shallbe submitted for any change which de-viates from the conditions under whichthe application was originally ap-proved.
(c) Each supplemental applicationshall be accompanied by a fully com-pleted Form FDA 1900 in triplicate in-cluding an explanation of the changesproposed.
[40 FR 13825, Nov. 27, 1975, as amended at 42FR 15675, Mar. 22, 1977; 50 FR 16668, Apr. 26,1985; 51 FR 7391, Mar. 3, 1986]
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21 CFR Ch. I (4–1–97 Edition)§ 514.10
§ 514.10 Confidentiality of data and in-formation in an investigational newanimal drug notice and a new ani-mal drug application file for an an-tibiotic drug.
(a) The rules established in §§ 514.11and 514.12 of this chapter with regardto the confidentiality of an investiga-tional new animal drug notice and anew animal drug application file shallapply to such notices and files for anti-biotic drugs for new animal drug use.
(b) All records showing the Food andDrug Administration’s testing of andaction on a particular lot of a certifi-able antibiotic drug for veterinary useare immediately available for publicdisclosure.
§ 514.11 Confidentiality of data and in-formation in a new animal drug ap-plication file.
(a) For purposes of this section theNADA file includes all data and infor-mation submitted with or incorporatedby reference in the NADA, INAD’s in-corporated into the NADA, supple-mental NADA’s, reports under §§ 510.300and 510.301 of this chapter, master files,and other related submissions. Theavailability for public disclosure of anyrecord in the NADA file shall be han-dled in accordance with the provisionsof this section.
(b) The existence of an NADA filewill not be disclosed by the Food andDrug Administration before an ap-proval has been published in the FED-ERAL REGISTER, unless it has pre-viously been publicly disclosed or ac-knowledged.
(c) If the existence of an NADA filehas not been publicly disclosed or ac-knowledged, no data or information inthe NADA file is available for publicdisclosure.
(d) If the existence of an NADA filehas been publicly disclosed or acknowl-edged before an approval has been pub-lished in the FEDERAL REGISTER, nodata or information contained in thefile is available for public disclosurebefore such approval is published, butthe Commissioner may, in his discre-tion, disclose a summary of such se-lected portions of the safety and effec-tiveness data as are appropriate forpublic consideration of a specific pend-ing issue, e.g., at an open session of a
Food and Drug Administration advi-sory committee or pursuant to an ex-change of important regulatory infor-mation with a foreign government.
(e) After an approval has been pub-lished in the FEDERAL REGISTER, thefollowing data and information in theNADA file are immediately availablefor public disclosure unless extraor-dinary circumstances are shown:
(1) All safety and effectiveness dataand information previously disclosed tothe public, as defined in § 20.81 of thischapter.
(2) A summary or summaries of thesafety and effectiveness data and infor-mation submitted with or incorporatedby reference in the NADA file. Suchsummaries do not constitute the fullreports of investigations under section512(b)(1) of the act (21 U.S.C. 360b(b)(1))on which the safety or effectiveness ofthe drug may be approved. Such sum-maries shall consist of the following:
(i) For an NADA approved prior toJuly 1, 1975, internal agency recordsthat describe such data and informa-tion, e.g., a summary of basis for ap-proval or internal reviews of the dataand information, after deletion of:
(a) Names and any information thatwould identify the investigators.
(b) Any inappropriate gratuitouscomments unnecessary to an objectiveanalysis of the data and information.
(ii) For an NADA approved on orafter July 1, 1975, a summary of suchdata and information prepared in oneof the following two alternative waysshall be publicly released when the ap-proval is published in the FEDERALREGISTER.
(a) The Center for Veterinary Medi-cine may at an appropriate time priorto approval of the NADA require theapplicant to prepare a summary ofsuch data and information, which willbe reviewed and, where appropriate, re-vised by the Center.
(b) The Center for Veterinary Medi-cine may prepare its own summary ofsuch data and information.
(3) A protocol for a test or study, un-less it is shown to fall within the ex-emption established for trade secretsand confidential commercial informa-tion in § 20.61 of this chapter.
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