§379g. Definitions

For purposes of this part:

(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,

(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

(ii) an indication for a use,

that had not been approved under an application submitted under section 355(b) of this title,

(C) initial certification or initial approval of an antibiotic drug under section 357 of this title, or

(D) licensure of a biological product under 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, an allergenic extract product, or an in vitro diagnostic biologic product licensed under section 262 of title 42, and does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992.

(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-

(A) for which a human drug application has been approved, and

(B) which may be dispensed only under prescription pursuant to section 353(b) of this title.

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, or an in vitro diagnostic biologic product licensed under section 262 of title 42, and does not include a large volume parenteral drug product approved before September 1, 1992.

(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 further manufacturing.

(5) The term "prescription drug establishment" means a foreign or domestic place of business which is-

(A) at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more prescription drug products are manufactured in final dosage form, and

(B) under the management of a person that is listed as the applicant in a human drug application for a prescription drug product with respect to at least one such product.

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.

(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, employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees,

(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 lower of-

(A) the Consumer Price Index for all urban consumers (all items; United States city average) for August of the preceding fiscal year divided by such Index for August 1992, 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(d) of the Balanced Budget and Emergency Deficit Control Act of 1985 [2 U.S.C. 904(d)]) divided by such budget authority for fiscal year 1992 (as reported in the Office of Management and Budget final sequestration report submitted after the end of the 102d Congress, 2d 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.

(June 25, 1938, ch. 675, §735, as added Oct. 29, 1992, Pub. L. 102–571, title I, §103, 106 Stat. 4491 .)

Termination of Section

For termination of section by section 105 of Pub. L. 102–571, see Termination Date note below.

References in Text

The Balanced Budget and Emergency Deficit Control Act of 1985, referred to in par. (8), is title II of Pub. L. 99–177, Dec. 12, 1985, 99 Stat. 1038 , as amended, which enacted chapter 20 (§900 et seq.) and sections 654 to 656 of Title 2, The Congress, amended sections 602, 622, 631 to 642, and 651 to 653 of Title 2, sections 1104 to 1106, and 1109 of Title 31, Money and Finance, and section 911 of Title 42, The Public Health and Welfare, repealed section 661 of Title 2, enacted provisions set out as notes under section 900 of Title 2 and section 911 of Title 42, and amended provisions set out as a note under section 621 of Title 2. For complete classification of this Act to the Code, see Short Title note set out under section 900 of Title 2 and Tables.

Termination Date

Section 105 of Pub. L. 102–571 provided that: "The amendments made by section 103 [enacting this subpart] shall not be in effect after October 1, 1997 and section 104 [enacting provisions set out as a note below] shall not be in effect after 120 days after such date."

Congressional Findings Concerning Prescription Drug User Fees

Section 102 of title I of Pub. L. 102–571 provided that: "The Congress finds that-

"(1) prompt approval of safe and effective new drugs is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;

"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for review of human drug applications; and

"(3) the fees authorized by this title [see Short Title of 1992 Amendment note, set out under section 301 of this title] will be dedicated toward expediting the review of human drug applications as set forth in the goals identified in the letters of September 14, 1992, and September 21, 1992, from the Commissioner of Food and Drugs to the Chairman of the Energy and Commerce Committee of the House of Representatives and the Chairman of the Labor and Human Resources Committee of the Senate, as set forth at 138 Cong. Rec. H9099–H9100 (daily ed. September 22, 1992)."

Annual Reports

Section 104 of Pub. L. 102–571 provided that:

"(a) First Report.-Within 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], the Secretary of Health and Human Services shall submit a report stating the Food and Drug Administration's progress in achieving the goals identified in section 102(3) of this Act [set out as a note above] during such fiscal year and that agency's future plans for meeting such goals.

"(b) Second Report.-Within 120 days after the end of each fiscal year during which such fees are collected, the Secretary of Health and Human Services shall submit a report on the implementation of the authority for such fees during such fiscal year and on the use the Food and Drug Administration made of the fees collected during such fiscal year for which the report is made.

"(c) Committees.-The reports described in subsections (a) and (b) shall be submitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate."

Animal Drug User Fee Study

Section 108 of Pub. L. 102–571 provided that:

"(a) Study.-The Secretary, in consultation with manufacturers of animal drug products and other interested persons, shall undertake a study to evaluate whether, and under what conditions, to impose user fees to supplement appropriated funds in order to improve the process of reviewing applications (including abbreviated and supplemental applications) for new animal drugs under section 512 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b]. The study shall include-

"(1) an assessment of the overall review process for animal drugs at the Center for Veterinary Medicine, including the number of applications received, and the average times for interim and final decisions on each type of application,

"(2) the current allocation of funds to the animal drug review process,

"(3) recommendations for goals for decision making times on applications submitted to the Center for Veterinary Medicine and for additional resources required to meet the goals, and

"(4) recommendations for supplementing the resources for the animal drug review process through user fees.

"(b) Completion.-The results of the study required by subsection (a) shall be presented no later than January 4, 1994, to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate."

Section Referred to in Other Sections

This section is referred to in section 379h of this title.