21 U.S.C. § 379G
Section 379g · Definitions
Version as of June 12, 2002, with additions and removals from the November 21, 1997 version.
For purposes of this part:
For purposes of this part:
(1) The term “human drug application” means an application for—
(1) The term “human drug application” means an application for—
(A) approval of a new drug submitted under section 355(b)(1) of this title,
(A) approval of a new drug submitted under section 355(b)(1) of this title,
(B) approval of a new drug submitted under section 355(b)(2) of this title after September 30, 1992, which requests approval of—
(B) approval of a new drug submitted under section 355(b)(2) of this title after September 30, 1992, which requests approval of—
(i) a molecular entity which is an active ingredient (including any salt or ester of an active ingredient), or
(i) a molecular entity which is an active ingredient (including any salt or ester of an active ingredient), or
(ii) an indication for a use,
(ii) an indication for a use,
that had not been approved under an application submitted under section 355(b) of this title, or
that had not been approved under an application submitted under section 355(b) of this title, or
(C) licensure of a biological product under section 262 of title 42.
(C) licensure of a biological product under section 262 of title 42.
(2) The term “supplement” means a request to the Secretary to approve a change in a human drug application which has been approved.
(2) The term “supplement” means a request to the Secretary to approve a change in a human drug application which has been approved.
(3) The term “prescription drug product” means a specific strength or potency of a drug in final dosage form—
(3) The term “prescription drug product” means a specific strength or potency of a drug in final dosage form—
(C) which is on the list of products described in section 355(j)(7)(A) of this title or is on a list created and maintained by the Secretary of products approved under human drug applications under section 262 of title 42.
(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.
(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.
(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.
(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:
(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.
(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.
(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.
(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.
(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.
(E) Monitoring of research conducted in connection with the review of human drug applications.
(F) In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years.
(7) The term “costs of resources allocated for the process for the review of human drug applications” means the expenses incurred in connection with the process for the review of human drug applications for—
(7) The term “costs of resources allocated for the process for the review of human drug applications” means the expenses incurred 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,
(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,
(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
(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.
(D) collecting fees under section 379h of this title and accounting for resources allocated for the review of human drug applications and supplements.
(A) the Consumer Price Index for all urban consumers (all items; United States city average) for April of the preceding fiscal year divided by such Index for April 1997, or
(B) the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year (as reported in the Office of Management and Budget sequestration preview report, if available, required under section 254(c) of the Balanced Budget and Emergency Deficit Control Act of 1985 [2 U.S.C. 904(c)]) divided by such budget authority for fiscal year 1997 (as reported in the Office of Management and Budget final sequestration report submitted after the end of the 105th Congress, 1st Session).
The terms “budget authority” and “category” in subparagraph (B) are as defined in the Balanced Budget and Emergency Deficit Control Act of 1985 [2 U.S.C. 900 et seq.], as in effect as of September 1, 1992.
(9) The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
(9) 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
(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.
(B) a third party controls, or has power to control, both of the business entities.