§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, or

(C) 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, 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 (D), 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) 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, does not include a large volume parenteral drug product approved before September 1, 1992, 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.

(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.

(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, 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 lower of-

(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-

(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.

(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.)

Amendment of Section

For termination of amendment by section 107 of Pub. L. 105–115, see Effective and Termination Dates of 1997 Amendment note below.

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.

Amendments

1997-Par. (1). Pub. L. 105–115, §§102(1), 107, in closing provisions, temporarily struck out "and" before "does not include an application" and substituted "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 (D), of a large volume biological product intended for single dose injection for intravenous use or infusion" for "September 1, 1992" before period at end. See Effective and Termination Dates of 1997 Amendment note below.

Par. (1)(B) to (D). Pub. L. 105–115, §125(b)(2)(M), inserted "or" at end of subpar. (B), redesignated subpar. (D) as (C), and struck out former subpar. (C) which read as follows: "initial certification or initial approval of an antibiotic drug under section 357 of this title, or".

Par. (3). Pub. L. 105–115, §§102(2), 107, in closing provisions, temporarily struck out "and" before "does not include a large volume parenteral drug" and substituted "September 1, 1992, 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" for "September 1, 1992" before period at end. See Effective and Termination Dates of 1997 Amendment note below.

Par. (4). Pub. L. 105–115, §§102(3), 107, temporarily substituted "without substantial further manufacturing" for "without further manufacturing". See Effective and Termination Dates of 1997 Amendment note below.

Par. (5). Pub. L. 105–115, §§102(4), 107, temporarily amended first sentence generally. Prior to amendment, first sentence read as follows: "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."

See Effective and Termination Dates of 1997 Amendment note below.

Par. (7)(A). Pub. L. 105–115, §§102(5), 107, temporarily substituted "contractors of the Food and Drug Administration," for "employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration," and "and committees and to contracts with such contractors," for "and committees,". See Effective and Termination Dates of 1997 Amendment note below.

Par. (8)(A). Pub. L. 105–115, §§102(6)(A), 107, temporarily substituted "April of the preceding fiscal year" for "August of the preceding fiscal year" and "April 1997" for "August 1992". See Effective and Termination Dates of 1997 Amendment note below.

Par. (8)(B). Pub. L. 105–115, §§102(6)(B), 107, temporarily substituted "section 254(c)" for "section 254(d)", "fiscal year 1997" for "fiscal year 1992", and "105th Congress, 1st Session" for "102d Congress, 2d Session". See Effective and Termination Dates of 1997 Amendment note below.

Par. (9). Pub. L. 105–115, §§102(7), 107, temporarily added par. (9). See Effective and Termination Dates of 1997 Amendment note below.

Effective and Termination Dates of 1997 Amendment

Section 106 of title I of Pub. L. 105–115 provided that: "The amendments made by this subtitle [subtitle A (§§101–107) of title I of Pub. L. 105–115, amending this section and section 379h of this title] shall take effect October 1, 1997."

Section 107 of Pub. L. 105–115 provided that: "The amendments made by sections 102 and 103 [amending this section and section 379h of this title] cease to be effective October 1, 2002, and section 104 [enacting provisions set out as a note below] ceases to be effective 120 days after such date."

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."

Savings Provision

Section 105 of Pub. L. 105–115 provided that: "Notwithstanding section 105 of the Prescription Drug User Fee Act of 1992 [section 105 of Pub. L. 102–571, set out above], the Secretary shall retain the authority to assess and collect any fee required by part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] for a human drug application or supplement accepted for filing prior to October 1, 1997, and to assess and collect any product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998."

Congressional Findings Concerning Fees Relating to Drugs

Section 101 of title I of Pub. L. 105–115 provided that: "Congress finds that-

"(1) prompt approval of safe and effective new drugs and other therapies 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;

"(3) the provisions added by the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under section 301 of this title] have been successful in substantially reducing review times for human drug applications and should be-

"(A) reauthorized for an additional 5 years, with certain technical improvements; and

"(B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration; and

"(4) the fees authorized by amendments made in this subtitle [subtitle A (§§101–107) of title I of Pub. L. 105–115, amending this section and section 379h of this title] will be dedicated toward expediting the drug development process and the review of human drug applications as set forth in the goals identified, for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Commerce of the House of Representatives and the chairman of the Committee on Labor and Human Resources of the Senate, as set forth in the Congressional Record."

Annual Reports

Pub. L. 102–571, title I, §104, Oct. 29, 1992, 106 Stat. 4498 , which provided that the Secretary of Health and Human Services submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, within 60 days after the end of each fiscal year during which fees were collected under this subpart, a report stating the Food and Drug Administration's progress in achieving the goals identified in section 102(3) of Pub. L. 102–571, set out as a note above, during such fiscal year and that agency's future plans for meeting such goals, and within 120 days after the end of each fiscal year during which such fees were collected, 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, ceased to be in effect 120 days after Oct. 1, 1997. See Termination Date note above.

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 directed Secretary, in consultation with manufacturers of animal drug products and other interested persons, to undertake study to evaluate whether, and under what conditions, to impose user fees to supplement appropriated funds in order to improve process of reviewing applications (including abbreviated and supplemental applications) for new animal drugs under section 360b of this title, and further provided for submission of study to Congress no later than Jan. 4, 1994.