View all text of Subpart 2 [§ 379g - § 379h-2]
§ 379g. DefinitionsFor purposes of this subpart:
(1) The term “human drug application” means an application for—
(A) approval of a new drug submitted under section 355(b) of this title, or
(B) licensure of a biological product under subsection (a) of section 262 of title 42.
Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under section 262 of title 42, does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (B), of a large volume biological product intended for single dose injection for intravenous use or infusion.
(2) The term “supplement” means a request to the Secretary to approve a change in a human drug application which has been approved.
(3)
(A) The term “prescription drug product” means a specific strength or potency of a drug in final dosage form—
(i) for which a human drug application has been approved,
(ii) which may be dispensed only under prescription pursuant to section 353(b) of this title, and
(iii) which is on the list of products described in section 355(j)(7)(A) of this title (not including the discontinued section of such list) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 262 of title 42 (not including the discontinued section of such list).
(B) Such term does not include whole blood or a blood component for transfusion, does not include a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, or an in vitro diagnostic biologic product licensed under section 262 of title 42. Such term does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.
(C)
(i) If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the prescription drug program fee under section 379h(a)(2) of this title, the Secretary shall consider such product to have been included in the discontinued section on the later of—(I) the date such request was received; or(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.
(ii) For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.
(4) The term “final dosage form” means, with respect to a prescription drug product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).
(5) The term “prescription drug establishment” means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form. For purposes of this paragraph, the term “manufactured” does not include packaging.
(6) The term “process for the review of human drug applications” means the following activities of the Secretary with respect to the review of human drug applications and supplements:
(A) The activities necessary for the review of human drug applications and supplements.
(B) The issuance of action letters which approve human drug applications or which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.
(C) The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary’s review of pending human drug applications and supplements.
(D) Activities necessary for the review of applications for licensure of establishments subject to section 262 of title 42 and for the release of lots of biologics under such section.
(E) Monitoring of research conducted in connection with the review of human drug applications.
(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities:
(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.
(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.
(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
(iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies).
(v) Carrying out section 355(k)(5) of this title (relating to adverse event reports and postmarket safety activities).
(7) The term “costs of resources allocated for the process for the review of human drug applications” means the expenses in connection with the process for the review of human drug applications for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors,
(B) management of information, and the acquisition, maintenance, and repair of computer resources,
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies, and
(D) collecting fees under section 379h of this title and accounting for resources allocated for the review of human drug applications and supplements.
(8) The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 1996.
(9) The term “person” includes an affiliate thereof.
(10) The term “active”, with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.
(11) The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
(A) one business entity controls, or has the power to control, the other business entity; or
(B) a third party controls, or has power to control, both of the business entities.
(12) The term “skin-test diagnostic product”—
(A) means a product—
(i) for prick, scratch, intradermal, or subcutaneous administration;
(ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect;
(iii) not intended to be a preventive or therapeutic intervention; and
(iv) intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of—(I) an allergy to an antimicrobial agent;(II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or(III) infection with fungal or mycobacterial pathogens; and
(B) includes positive and negative controls required to interpret the results of a product described in subparagraph (A).
(June 25, 1938, ch. 675, § 735, as added Pub. L. 102–571, title I, § 103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L. 105–115, title I, §§ 102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat. 2298, 2326; Pub. L. 107–188, title V, § 503, June 12, 2002, 116 Stat. 688; Pub. L. 110–85, title I, § 102, Sept. 27, 2007, 121 Stat. 825; Pub. L. 111–148, title VII, § 7002(f)(3)(A), Mar. 23, 2010, 124 Stat. 818; Pub. L. 112–144, title I, § 102, title IV, § 407, July 9, 2012, 126 Stat. 996, 1039; Pub. L. 117–180, div. F, title I, § 1002, Sept. 30, 2022, 136 Stat. 2140.)