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Poison Act, the ammonia content is to be calculated as NH3.

Subpart G-Provisions Applicable

to Specific Products Subject to the Federal Food, Drug, and Cosmetic Act

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storage and shipment of articles containing or bearing disease organisms or poisonous or deleterious substances.

(b) The Commissioner concludes that such dangerous or potentially dangerous practices include, but are not limited to, the following:

(1) Some vegetable growers and packers employ used poultry crates for shipment of fresh vegetables, including cabbage and celery. Salmonella organisms are commonly present on dressed poultry and in excreta and fluid exudates from dressed birds. Thus wooden crates in which dressed poultry has been iced and packed are potential sources of Salmonella or other enteropathogenic microorganisms that may contaminate fresh vegetables which are frequently consumed without heat treatment.

(2) Some potato growers and producers of animal feeds use secondhand bags for shipment of these articles. Such bags may have originally been used for shipping or storing pesticidetreated seed or other articles bearing or containing poisonous substances. Thus these secondhand bags are potential sources of contamination of the food or animal feed stored or shipped therein.

(c) In a policy statement issued April 11, 1968, the Food and Drug Administration declared adulterated within the meaning of section 402(a) of the Federal Food, Drug, and Cosmetic Act shipments of vegetables or other edible food in used crates or containers that may render the contents injurious to health. This policy statement is extended so that the Food and Drug Administration will regard as adulterated within the meaning of section 402(a) of the act shipments of vegetables, other edible food, or animal feed in used crates, bags, or other containers that may render the contents injurious to health.

$ 2.125 Use of chlorofluorocarbon pro

pellants in self-pressurized

tainers.
(a) As used in this section:

(1) Chlorofluorocarbon means any fully halogenated chlorofluoroalkane.

(2) Propellant means a liquefied or compressed gas that is used in whole or in part to expel from the same selfpressurized container or from a separate container a liquid or solid material different from the propellant, but the term does not include the use of a chlorofluorocarbon

aerating agent for foamed or sprayed food products.

(b) Chlorofluorocarbons are widely used in products subject to the Federal Food, Drug, and Cosmetic Act, with the principal use being as propellants in self-pressurized containers. Information recently developed indicates that chlorofluorocarbons may reduce the amount of ozone in the stratosphere and thus increase the amount of ultraviolet radiation reaching the earth. An increase in ultraviolet radiation may increase the incidence of skin cancer, change the climate, and produce other effects of unknown magnitude on humans,

animals, and plants. Chlorofluorocarbons may also affect the climate by increasing infrared absorption in the atmosphere.

(c) Except as provided in paragraph (e) of this section, any food, drug, device, or cosmetic in a self-pressurized container that contains a chlorofluorocarbon propellant is adulterated and/or misbranded in violation of the act, and any drug product in a self-pressurized container that contains a chlorofluorocarbon propellant is a new drug or a new animal drug.

(d) The use of a chlorofluorocarbon as a propellant in a self-pressurized container of a drug product will not result in the drug product being adulterated and/or misbranded provided a new drug

Subparts C-E [Reserved]

Subpart F-Caustic Poisons

$ 2.110 Definition of ammonia under

Federal Caustic Poison Act. For the purpose of determining whether an article containing ammonia is subject to the Federal Caustic

application, a new animal drug application, or in the case of a certifiable antibiotic an antibiotic application for the drug product has been approved, a petition has been filed as provided by paragraph (f) of this section, and paragraph (e) of this section has been amended to specify the use as essential.

(e) The adulteration and misbranding provisions of paragraph (c) of this section shall not apply to the following essential uses of chlorofluorocarbons:

(1) Metered-dose steriod human drugs for nasal inhalation,

(2) Metered-dose steriod human drugs for oral inhalation,

(3) Metered-dose adrenergic bronchodilator human drugs for oral inhalation,

(4) Contraceptive vaginal foams for human use, and

(5) Metered-dose ergotamine tartrate drug products administered by oral inhalation for use in humans.

(6) Intrarectal hydrocortisone acetate for human use.

(7) Polymyxin B sulfate-bacitracin zinc-neomycin sulfate soluble antibiotic powder without excipients, for topical use on humans.

(8) Anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application.

(9) Metered-dose nitroglycerin human drugs administered to the oral cavity.

(10) Metered-dose cromolyn sodium human drugs administered by oral inhalation.

(11) Metered-dose ipratropium bromide for oral inhalation.

(12) Metered-dose atropine sulfate aerosol human drugs administered by oral inhalation.

(13) Metered-dose nedocromil sodium human drugs administered by oral inhalation.

(14) Metered-dosed ipratropium bromide and albuterol sulfate, in combination, administered by oral inhalation for human use.

(15) Sterile aerosol talc administered intrapleurally by thoracoscopy for human use.

(f) Any person may file a petition in accordance with part 10 of this chapter to amend paragraph (e) of this section to specify a use of chlorofluorocarbons in a product as not being subject to the

adulteration and misbranding provisions in paragraph (c) of this section. The petition must be supported by an adequate showing that:

(1) There are no technically feasible alternatives to the use of a chlorofluorocarbon in the product,

(2) The product provides a substantial health benefit, environmental benefit, or other public benefit that would not be obtainable without the use of the chlorofluorocarbon, and

(3) The use does not involve a significant release of chlorofluorocarbons into the atmosphere or that the release is warranted in view of the consequence if the use were not permitted.

(g) Any holder of an approved new drug application or new animal drug application for a drug product containing a chlorofluorocarbon in a selfpressurized container, except those drug products listed in paragraph (e) of this section, shall submit to the Food and Drug Administration on or before October 1, 1978, either a supplemental application providing for a revised formulation complying with the requirements of $314.70 or $514.8 of this chapter or a letter requesting that a new drug application or a new animal drug application for the drug product containing chlorofluorocarbon be withdrawn and that the right to a hearing on the withdrawal of the application is waived.

(h)(1) Each manufacturer of a drug product listed in paragraph (e) of this section that is not covered by an approved new drug application shall submit a new drug application in accord with $314.50 of this chapter on or before June 15, 1978.

(2) An abbreviated new drug application conforming to $314.94 of this chapter is acceptable in lieu of a full new drug application for any product included in the classes of products in paragraph (e) of this section if the product is one that is described under $314.92 of this chapter. A finding has been made that an abbreviated new drug application may be submitted for the following products included in the classes of products listed in paragraph (e) of this section:

(i) Ergotamine tartrate supplied in a metered-dose aerosol form suitable for oral inhalation for the treatment of

an

migraine headaches. Each measured dose must deliver a dose of the active ingredient equivalent to that contained in the product that has been the subject of a separate finding that an abbreviated new drug application is suitable.

(ii) Isoproterenol hydrochloride supplied in a metered-dose aerosol form suitable for oral inhalation for use as

adrenergic bronchodilator. Each measured dose must deliver a dose of the active ingredient equivalent to that contained in the products that have been the subject of a separate finding that an abbreviated new drug application is suitable.

(iii) Epinephrine, epinephrine bitartrate, or epinephrine hydrochloride (racemic) in a metered-dose aerosol form suitable for oral inhalation for use as an adrenergic bronchodilator. Each measured dose must deliver a dose of the active ingredient equivalent to that specified in an OTC proposed or final monograph issued under the provisions of 21 CFR part 330.

(iv) Nonoxynol 9 in an aerosol foam suitable for vaginal administration as a contraceptive foam. The aerosol foam must contain 8 to 12.5 percent of nonoxynol 9.

(i) Any sponsor of an “Investigational New Drug Application" (IND) or “Notice of Claimed Exemption for a New Animal Drug” (INAD) for a drug product containing chlorofluorocarbon shall:

(1) Amend the IND or INAD on or before December 15, 1978, to revise the formulation removing the chlorofluorocarbon.

(2) Submit the information required under paragraph (f) of this section to amend paragraph (e) of this section to show that the use of chlorofluorocarbon is essential, or

(3) Submit the information required under paragraph (j) of this section requesting that studies with the drug product containing a chlorofluorocarbon propellant be allowed to be performed.

(j) Any sponsor of an IND or INAD who wishes to initiate or continue a study beyond December 15, 1978 on a drug product containing chlorofluorocarbon shall submit a petition in accordance with part 10 of this chapter

requesting that studies be permitted to collect the data to show that the use of the chlorofluorocarbon is an essential use. The petitions must be supported by the following:

(1) A description of the drug product,

(2) An explanation why a chlorofluorocarbon propellant is used in the product rather than another propellant or another dosage form of the product, and

(3) The benefit that the investigational product is believed to have and that the sponsor hopes to demonstrate by the studies.

(k) The Commissioner will initiate action to withdraw approval of an application or terminate an IND or INAD notice in accordance with the applicable provisions of section 505 of the act and parts 312 and 314 of this chapter, or section 512 of the act and parts 511 and 514 of this chapter upon failure of a holder of an approved new drug application or approved new animal drug application or sponsor of an IND or INAD notice to comply with the applicable provisions of this section.

(1) Food, drug, device, or cosmetic products manufactured or packaged on or after December 15, 1978, and finished products initially introduced into interstate commerce on or after April 15, 1979, shall comply with this regulation.

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[43 FR 11316, Mar. 17, 1978, as amended at 44 FR 3961, Jan. 19, 1979; 44 FR 30334, May 26, 1979; 45 FR 22902, April 4, 1980; 51 FR 4591, Feb. 6, 1986; 52 FR 15717, Apr. 30, 1987; 54 FR 9034, Mar. 3, 1989; 55 FR 39267, Sept. 26, 1990; 57 FR 17980, Apr. 28, 1992; 58 FR 6088, Jan. 26, 1993; 61 FR 15700, Apr. 9, 1996; 61 FR 25392, May 21, 1996)

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3.10 Stay of review time.

(c) Applicant means any person who

submits or plans to submit an applicaSubpart B [Reserved]

tion to the Food and Drug Administra

tion for premarket review. For purAUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, poses of this section, the terms “spon360, 360c-360f, 360h-360j, 360gg-360ss, 371(a),

sor” and “applicant” have the same 379e, 381, 394; 42 U.S.C. 216, 262.

meaning. SOURCE: 56 FR 58756, Nov. 21, 1991, unless (d) Biological product has the meaning otherwise noted.

given the term in section 351(a) of the

Public Health Service Act (42 U.S.C. Subpart A-Assignment of Agen- 262(a)).

cy Component for Review of (e) Combination product includes:
Premarket Applications

(1) A product comprised of two or

more regulated components, i.e., drug/ $3.1 Purpose.

device, biologic/device, drug/biologic,

or drug/device/biologic, that are physThis regulation relates to agency

ically, chemically, or otherwise commanagement and organization and has

bined or mixed and produced as a single two purposes. The first is to implement

entity; section 503(g) of the act, as added by

(2) Two or more separate products section 16 of the Safe Medical Devices

packaged together in a single package Act of 1990 (Pub. L. 101-629), by speci

or as a unit and comprised of drug and fying how FDA will determine the or

device products, device and biological ganizational component within FDA

products, or biological and drug proddesignated to have primary jurisdic

ucts; tion for the premarket review and reg

(3) A drug, device, or biological produlation of products that are comprised

uct packaged separately that according of any combination of a drug and a de

to its investigational plan or proposed vice; a device and a biological; a bio

labeling is intended for use only with logical and a drug; or a drug, a device

an approved individually specified and a biological. This determination

drug, device, biological product will eliminate, in most cases, the need

where both are required to achieve the to receive approvals from more than

intended use, indication, or effect and one FDA component for such combina

where upon approval of the proposed tion products. The second purpose of

product the labeling of the approved this regulation is to enhance the effi

product would need to be changed, e.g., ciency of agency management and op

to reflect a change in intended use, erations by providing procedures for

dosage form, strength, route of admindetermining which agency component

istration, or significant change in dose; will have primary jurisdiction for any drug, device, or biological product

(4) Any investigational drug, device, where such jurisdiction is unclear or in

or biological product packaged sepadispute. Nothing in this section pre

rately that according to its proposed vents FDA from using any agency re- labeling is for use only with another sources it deems necessary to ensure

individually specified investigational adequate review of the safety and effec

drug, device, or biological product tiveness of any product, or the substan

where both are required to achieve the tial equivalence of any device to a

intended use, indication, or effect. predicate device.

(f) Device has the meaning given the

term in section 201(h) of the act. $ 3.2 Definitions.

(g) Drug has the meaning given the For the purpose of this part:

term in section 201(g)(1) of the act. (a) Act means the Federal Food, (h) FDA means Food and Drug AdDrug, and Cosmetic Act.

ministration. (b) Agency component means the Cen- (i) Letter of designation means the ter for Biologics Evaluation and Re- written notice issued by the product search, the Center for Devices and Ra- jurisdiction officer specifying the agendiological Health, or the Center for cy component with primary jurisdicDrug Evaluation and Research.

tion for a combination product.

or

or

(2) A device, the agency component charged with premarket review of devices shall have primary jurisdiction;

(3) A biological product, the agency component charged with premarket review of biological products shall have primary jurisdiction.

(b) The designation of one agency component as having primary jurisdiction for the premarket review and regulation of a combination product does not preclude consultations by that component with other agency components or, in appropriate cases, the requirement by FDA of separate applications.

(j) Letter of request means an applicant's written submission to the product jurisdiction officer seeking the designation of the agency component with primary jurisdiction.

(k) Premarket review includes the examination of data and information in an application for premarket review described in sections 505, 510(k), 513(f), 515, or 520(g) or 520(1) of the act or section 351 of the Public Health Service Act of data and information contained in any investigational new drug (IND) application, investigational device exemption (IDE), new drug application (NDA), biologics license application, device premarket notification, device reclassification petition, and premarket approval application (PMA).

(1) Product means any article that contains any drug as defined in section 201(g)(1) of the act; any device as defined in section 201(h) of the act; or any biologic as defined in section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)).

(m) Product jurisdiction officer is the person or persons responsible for designating the component of FDA with primary jurisdiction for the premarket review and regulation of a combination product or any product requiring a jurisdictional designation under this part.

(n) Sponsor means "applicant” (see 83.2(c)).

[56 FR 58756, Nov. 21, 1991 as amended at 64 FR 398, Jan. 5, 1999; 64 FR 56447, Oct. 20, 1999)

$3.5 Procedures for identifying the

designated agency component. (a)(1) The Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Drug Evaluation and Research have entered into agreements clarifying product jurisdictional issues. These guidance documents are on display in

the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and are entitled “Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health;' "Intercenter Agreement Between the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research;” "Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.” The availability of any amendments to these intercenter agreements will be announced by FEDERAL REGISTER notice.

(2) These guidance documents describe the allocation of responsibility for categories of products or specific products. These intercenter agreements, and any amendments thereto, are nonbinding determinations designed to provide useful guidance to the public.

(3) The sponsor of a premarket application or required investigational filing for a combination or other product covered by these guidance documents may contact the designated agency

$ 3.3 Scope.

This section applies to:
(a) Any combination product, or

(b) Any product where the agency component with primary jurisdiction is unclear or in dispute.

83.4 Designated agency component.

(a) To designate the agency component with primary jurisdiction for the premarket review and regulation of a combination product, the agency shall determine the primary mode of action of the product. Where the primary mode of action is that of:

(1) A drug (other than a biological product), the agency component charged with premarket review of drugs shall have primary jurisdiction;

197-062 D-2

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