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$312.145 Guidelines.

(a) FDA has made available guidelines under $10.90(b) to help persons to comply with certain requirements of this part.

(b) The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research maintain lists of guidelines that apply to the Centers' regulations. The lists state how a person can obtain a copy of each guideline. A request for a copy of the lists should be directed to the CDER Executive

Executive Secretariat Staff (HFD-8), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, for drug products, and the Congressional, Consumer, and International Affairs Staff (HFB-142), Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892, for biological products.

reports, and other correspondence relating to matters covered by the IND should be directed to the appropriate division. The outside wrapper of each submission shall state what is contained in the submission, for example, “IND Application”, “Protocol Amendment”, etc.

(b) Applications for the products listed below should be submitted to the Division of Biological Investigational New Drugs (HFB-230), Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892. (1) Products subject to the licensing provisions of the Public Health Service Act of July 1, 1944 (58 Stat. 682, as amended (42 U.S.C. 201 et seq.)) or subject to part 600; (2) ingredients packaged together with containers intended for the collection, processing, or storage of blood or blood components; (3) urokinase products; (4) plasma volume expanders and hydroxyethyl starch for leukapheresis; and (5) coupled antibodies, i.e., products that consist of an antibody component coupled with a drug or radionuclide component in which both components provide a pharmacological effect but the biological component determines the site of action.

(c) All correspondence relating to biological products for human use which are also radioactive drugs shall be submitted to the Division of Oncology and Radiopharmaceutical Drug Products (HFD-150), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, except that applications for coupled antibodies shall be submitted in accordance with paragraph (b) of this section.

(d) All correspondence relating to export of an investigational drug under 8 312.110(b)(2) shall be submitted to the International Affairs Staff (HFY-50), Office of Health Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

(52 FR 8831, Mar. 19, 1987, as amended at 55 FR 11580, Mar. 29, 1990; 56 FR 3776, Jan. 31, 1991; 57 FR 10814, Mar. 31, 1992)

Subpart G-Drugs for Investiga

tional Use in Laboratory Research Animals or In Vitro Tests

$312.160 Drugs for investigational use

in laboratory research animals or

in vitro tests. (a) Authorization to ship. (1)(i) A person may ship a drug intended solely for tests in vitro or in animals used only for laboratory research purposes if it is labeled as follows:

CAUTION: Contains a new drug for investigational use only in laboratory research animals, or for tests in vitro. Not for use in humans.

(ii) A person may ship a biological product for investigational in vitro diagnostic use that

is listed in $312.2(b)(2)(ii) if it is labeled as follows:

CAUTION: Contains a biological product for investigational in vitro diagnostic tests only.

(Collection of information requirements approved by the Office of Management and Budget under control number 0910-0014)

(52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 55 FR 11580, Mar. 29, 1990]

(2) A person shipping a drug under paragraph (a) of this section shall use due diligence to assure that the consignee is regularly engaged in conducting such tests and that the shipment of animals). The shipper shall maintain records of any alternative disposition.

(Collection of information requirements approved by the Office of Management and Budget under control number 0910-0014)

(52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987. Redesignated at 53 FR 41523, Oct. 21, 1988]

PART 314-APPLICATIONS FOR FDA

APPROVAL TO MARKET A NEW DRUG OR AN ANTIBIOTIC DRUG

Subpart A-General Provisions

Sec. 314.1 Scope of this part. 314.2 Purpose. 314.3 Definitions.

Subpart B-Applications

the new drug will actually be used for tests in vitro or in animals used only for laboratory research.

(3) A person who ships a drug under paragraph (a) of this section shall maintain adequate records showing the name and post office address of the expert to whom the drug is shipped and the date, quantity, and batch or code mark of each shipment and delivery. Records of shipments under paragraph (a)(1)(i) of this section are to be maintained for a period of 2 years after the shipment. Records and reports of data and shipments under paragraph (a)(1)(ii) of this section are to be maintained in accordance with $312.57(b). The person who ships the drug shall upon request from any properly authorized officer or employee of the Food and Drug Administration, at reasonable times, permit such officer or employee to have access to and copy and verify records required to be maintained under this section.

(b) Termination of authorization to ship. FDA may terminate authorization to ship a drug under this section if it finds that:

(1) The sponsor of the investigation has failed to comply with any of the conditions for shipment established under this section; or

(2) The continuance of the investigation is unsafe or otherwise contrary to the public interest or the drug is used for purposes other than bona fide scientific investigation. FDA will notify the person shipping the drug of its finding and invite immediate correction. If correction is not immediately made, the person shall have an opportunity for a regulatory hearing before FDA pursuant to part 16.

(c) Disposition of unused drug. The person who ships the drug under paragraph (a) of this section shall assure the return of all unused supplies of the drug from individual investigators whenever the investigation discontinues or the investigation is terminated. The person who ships the drug may authorize in writing alternative disposition of unused supplies of the drug provided this alternative disposition does not expose humans to risks from the drug, either directly or indirectly (e.g., through food-producing

314.50 Content and format of an application. 314.52 Notice of certification of invalidity

or noninfringement of a patent. 314.53 Submission of patent information. 314.54 Procedure for submission of an appli

cation requiring investigations for approval of a new indication for, or other

change from, a listed drug. 314.60 Amendments to an unapproved appli

cation. 314.65 Withdrawal by the applicant of an un

approved application. 314.70 Supplements and other changes to an

approved application. 314.71 Procedures for submission of a sup

plement to an approved application. 314.72 Change in ownership of an applica

tion. 314.80 Postmarketing reporting of adverse

drug experiences. 314.81 Other postmarketing reports. 314.90 Waivers.

Subpart C-Abbreviated Applications

314.92 Drug products for which abbreviated

applications may be submitted. 314.93 Petition to request a change from a

listed drug. 314.94 Content and format of an abbreviated

application. 314.95 Notice of certification of invalidity

or noninfringement of a patent. 314.96 Amendments to an unapproved abbre

viated application. 314.97 Supplements and other changes to an

approved abbreviated application. 314.98 Postmarketing reports. 314.99 Other responsibilities of an applicant

of an abbreviated application.

ment, or repeal of regulations.

Subpart D-FDA Action on Applications

and Abbreviated Applications

Subpart G-Miscellaneous Provisions

314.410 Imports and exports of new drugs

and antibiotics. 314.420 Drug master files. 314.430 Availability for public disclosure of

data and information in an application

or abbreviated application. 314.440 Addresses for applications and ab

breviated applications. 314.445 Guidelines.

a

Subpart H-Accelerated Approval of New

Drugs for Serious or Life-Threatening Illnesses

314.100 Timeframes for reviewing applica

tions and abbreviated applications. 314.101 Filing an application and an abbre

viated antibiotic application and receiv

ing an abbreviated new drug application. 314.102 Communications between FDA and

applicants. 314.103 Dispute resolution. 314.104 Drugs with potential for abuse. 314.105 Approval of an application and an

abbreviated application. 314.106 Foreign data. 314.107 Effective date of approval of

505(b)(2) application or abbreviated new drug application under section 505(j) of

the act. 314.108 New drug product exclusivity. 314.110 Approvable letter to the applicant. 314.120 Not approvable letter to the appli

cant. 314.122 Submitting an abbreviated applica

tion for, or a 505(1)(2)(C) petition that relies on, a listed drug that is no longer

marketed. 314.125 Refusal to approve an application or

abbreviated antibiotic application. 314.126 Adequate and well-controlled stud

ies. 314.127 Refusal to approve an abbreviated

new drug application. 314.150 Withdrawal of approval of an appli

cation or abbreviated application. 314.151 withdrawal of approval of an abbre

viated new drug application under sec

tion 505(1)(5) of the act. 314.152 Notice of withdrawal of approval of

an application or abbreviated application

for a new drug. 314.153 Suspension of approval of an abbre

viated new drug application. 314.160 Approval of an application or abbre

viated application for which approval was previously refused, suspended, or

withdrawn. 314.161 Determination of reasons for vol

untary withdrawal of a listed drug. 314.162 Removal of a drug product from the

list. 314.170 Adulteration and misbranding of an

approved drug.

314.500 Scope. 314.510 Approval based on a surrogate end

point or on an effect on a clinical endpoint other than survival or irreversible

morbidity. 314.520 Approval with restrictions to assure

safe use. 314.530 Withdrawal procedures. 314.540 Postmarketing safety reporting. 314.550 Promotional materials. 314.560 Termination of requirements.

AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 371, 374, 379e.

SOURCE: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

Subpart A-General Provisions

$314.1 Scope of this part.

(a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications, as well as amendments, supplements, and postmarketing reports to them, by persons seeking or holding approval from FDA of the following:

(1) An application or abbreviated application under section 505 of the Federal Food, Drug, and Cosmetic Act to market a new drug.

(2) An application or abbreviated application under section 507 of the Federal Food, Drug, and Cosmetic Act to market an antibiotic drug.

(b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended (42 U.S.C. 201 et seq.)) and subchapter F of chapter I of title 21 of the Code of Federal Regulations.

Subpart E-Hearing Procedures for New

Drugs

314.200 Notice of opportunity for hearing;

notice of participation and request for

hearing; grant or denial of hearing. 314.201 Procedure for hearings. 314.235 Judicial review.

Subpart F-Administrative Procedures for

Antibiotics

314.300 Procedure for the issuance, amend

(c) References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

(50 FR 7493, Feb. 22, 1985, as amended at 57 FR 17981, Apr. 28, 1992]

$314.2 Purpose.

The purpose of this part is to establish an efficient and thorough drug review process in order to: (a) Facilitate the approval of drugs shown to be safe and effective; and (b) ensure the disapproval of drugs not shown to be safe and effective. These regulations are also intended to establish an effective system for FDA's surveillance of marketed drugs. These regulations shall be construed in light of these objectives.

a

8314.3 Definitions.

(a) The definitions and interpretations contained in section 201 of the act apply to those terms when used in this part.

(b) The following definitions of terms apply to this part:

Abbreviated application means the application described under $314.94, including all amendments and supplements to the application. “Abbreviated application” applies to both an abbreviated new drug application and an abbreviated antibiotic application.

Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901 (21 U.S.C. 301-392)).

Applicant means any person who submits an application or abbreviated application or an amendment or supplement to them under this part to obtain FDA approval of a new drug or an antibiotic drug and any person who owns an approved application or abbreviated application.

Application means the application described under $314.50, including all amendements and supplements to the application.

505(b)(2) Application means an application submitted under section 505(b)(1) of the act for a drug for which the investigations described in section 505(b)(1)(A) of the act and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for

whom the investigations were conducted.

Approvable letter means a written communication to an applicant from FDA stating that the agency will approve the application or abbreviated application if specific additional information or material is submitted or specific conditions are met. An approvable letter does not constitute approval of any part of an application or abbreviated application and does not permit marketing of the drug that is the subject of the application or abbreviated application.

Approval letter means a written communication to an applicant from FDA approving an application or an abbreviated application.

Drug product means a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.

Drug substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates use in the synthesis of such ingredient.

FDA means the Food and Drug Administration.

Listed drug means a new drug product that has an effective approval under section 505(c) of the act for safety and effectiveness or under section 505(j) of the act, which has not been withdrawn or suspended under section 505(e)(1) through (e)(5) or (j)(5) of the act, and which has not been withdrawn from sale for what FDA has determined are reasons of safety or effectiveness. Listed drug status is evidenced by the drug product's identification as a drug with an effective approval in the current edition of FDA's “Approved Drug Products with Therapeutic Equivalence Evaluations" (the list) or any current supplement thereto, as a drug with an effective approval. A drug product is deemed to be a listed drug on the date of effective approval of the application or abbreviated application for that drug product.

Not approvable letter means a written communication to an applicant from FDA stating that the agency does not consider the application or abbreviated application approvable because one or more deficiencies in the application or abbreviated application preclude the agency from approving it.

Reference listed drug means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application.

Right of reference or use means the authority to rely upon, and otherwise use, an investigation for the purpose of obtaining approval of an application, including the ability to make available the underlying raw data from the investigation for FDA audit, if necessary.

The list means the list of drug products with effective approvals published in the current edition of FDA's publication “Approved Drug Products with Therapeutic Equivalence Evaluations' and any current supplement to the publication.

(50 FR 7493, Feb. 22, 1985, as amended at 57 FR 17981, Apr. 28, 1992]

nent to an evaluation of the application that is received or otherwise obtained by the applicant from any source. FDA will maintain guidelines on the format and content of applications to assist applicants in their preparation.

(a) Application form. The applicant shall submit a completed and signed application form that contains the following:

(1) The name and address of the applicant; the date of the application; the application number if previously issued (for example, if the application is a resubmission, an amendment, or a supplement); the name of the drug product, including its established, proprietary, code, and chemical names; the dosage form and strength; the route of administration; the identification numbers of all investigational new drug applications that are referenced in the application; the identification numbers of all drug master files and other applications under this part that are referenced in the application; and the drug product's proposed indications for use.

(2) A statement whether the submission is an original submission, 505(b)(2) application, a resubmission, or a supplement to an application under $314.70.

(3) A statement whether the applicant proposes to market the drug product as a prescription or an over-thecounter product.

(4) A check-list identifying what enclosures required under this section the applicant is submitting.

(5) The applicant, or the applicant's attorney, agent, or other authorized official shall sign the application. If the person signing the application does not reside or have a place of business within the United States, the application is required to contain the name and address of, and be countersigned by, an attorney, agent, or other authorized official who resides or maintains a place of business within the United States.

(b) Index. The archival copy of the application is required to contain a comprehensive index by volume number and page number to the summary under paragraph (c) of this section, the technical sections under paragraph (d)

Subpart B-Applications

а.

$314.50 Content and format of an ap

piication. Applications and supplements to approved applications are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the application are required: An archival copy, a review copy, and a field copy. An application for a new chemical entity will generally contain an application form, an index, a summary, five or six technical sections, case report tabulations of patient data, case report forms, drug samples, and labeling. Other applications will generally contain only some of those items, and information will be limited to that needed to support the particular submission. These include an application of the type described in section 505(b)(2) of the act, an amendment, and a supplement. The application is required to contain reports of all investigations of the drug product sponsored by the applicant, and all other information about the drug perti

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