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(c)(1) As used in this subsection the term "enactment date" means the date of enactment of this Act; and the term "basic Act" means the Federal Food, Drug, and Cosmetic Act.
(2) An application filed pursuant to section 505(b) of the basic Act which was "effective" within the meaning of that Act on the day immediately preceding the enactment date shall be deemed, as of the enactment date, to be an application "approved" by the Secretary within the meaning of the basic Act as amended by this Act.
(3) In the case of any drug with respect to which an application filed under section 505(b) of the basic Act is deemed to be an approved application on the enactment date by virtue of paragraph (2) of this subsection—
(A) the amendments made by this Act to section 201(p), and to subsections (b) and (d) of section 505, of the basic Act, insofar as such amendments relate to the effectiveness of drugs, shall not, so long as approval of such application is not withdrawn or suspended pursuant to section 505(e) of that Act, apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling covered by such approved application, but shall apply to any changed use, or conditions of use, prescribed, recommended, or suggested in its labeling, including such conditions of use as are the subject of an amendment or supplement to such application pending on, or filed after, the enactment date; and
(B) clause (3) of the first sentence of section 505(e) of the basic Act, as amended by this Act, shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling covered by such approved application (except with respect to such use, or conditions of use, as are the subject of an amendment or supplement to such approved application, which amendment or supplement has been approved after the enactment date under section 505 of the basic Act as amended by this Act) until whichever of the following first occurs: (i) the expiration of the two-year period beginning with the enactment date; (ii) the effective date of an order under section 505(e) of the basic Act, other than clause (3) of the first sentence of such section 505(e), withdrawing or suspending the approval of such application.
(4) In the case of any drug which, on the day immediately preceding the enactment date, (A) was commercially used or sold inthe United States, (B) was not a new drug as defined by section 201(p) of the basic Act as then in force, and (C) was not covered by an effective application under section 505 of that Act, the amendments to section 201(p) made by this Act shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day.
1. Public Law 87–781, which was enacted October 10, 1962. The amendments made by such Public Law to the Federal Food, Drug, and Cosmetic Act included amendments establishing the requirement that new drugs be effective. Section 107(c) concerned the applicability of the amendments.
TITLE II—DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
FOOD AND DRUG ADMINISTRATION
REVOLVING FUND FOR CERTIFICATION AND OTHER SERVICES 1
For the establishment of a revolving fund for certification and other services, there is hereby appropriated the aggregate of fees (including advance deposits to cover such fees) paid during the fiscal year 1964, and each succeeding fiscal year, for services in connection with the listing, certification, or inspection of certain products and the establishment of tolerances for pesticides, in accordance with sections 406, 408, 507, 702A, and 706 of the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 346a, 356, 357, 372a, and 376), and the unexpended balance of such fees (or advance deposits) heretofore appropriated shall be credited to such revolving fund. This fund shall be available without fiscal year limitation for salaries and expenses necessary to carry out the Secretary’s responsibilities in connection with such listings, certifications, inspections, or establishment of tolerances, including the conduct of scientific research, development of methods of analysis, purchase of chemicals, fixtures, furniture, and scientific equipment and apparatus; expenses of advisory committees; refund of advance deposits for which no services have been rendered: Provided, That any supplies, furniture, fixtures, and equipment on hand or on order on June 30, 1963, and purchased or ordered under appropriations for "Salaries and Expenses, Certification, Inspection, and Other Services," shall be used to capitalize the revolving fund.
1. The revolving fund provision is part of the Departments of Labor, and Health, Education, and Welfare Appropriation Act, 1964.
SEC . 108. (a) Except as otherwise provided in this section, the amendments made by the foregoing sections shall take effect on the first day of the thirteenth calendar month which begins after the date of enactment of this Act.
(b)(1) As used in this subsection, the term "effective date" means the effective date specified in subsection (a) of this section; the term "basic Act" means the Federal Food, Drug, and Cosmetic Act; and other terms used both in this section and the basic Act shall have the same meaning as they have, or had, at the time referred to in the context, under the basic Act.
(2) Any approval, prior to the effective date, of a new animal drug or of an animal feed bearing or containing a new animal drug, whether granted by approval of a new-drug application, master file, antibiotic regulation, or food additive regulation, shall continue in effect, and shall be subject to change in accordance with the provisions of the basic Act as amended by this Act.
(3) In the case of any drug (other than a drug subject to section512(n) of the basic Act as amended by this Act) intended for use n animals other than man which, on October 9, 1962, (A) was commercially used or sold in the United States, (B) was not a new drug as defined by section 201(p) of the basic Act as then in force, and(C) was not covered by an effective application under section 505of that Act, the words "effectiveness" and "effective" contained in section 201(v) to the basic Act shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day.
(4) Regulations providing for fees (and advance deposits to cover fees) which on the day preceding the effective date applicable under subsection (a) of this section were in effect pursuant to section507 of the basic Act shall, except as the Secretary may otherwise prescribe, be deemed to apply also under section 512(n) of the basic Act, and appropriations of fees (and of advance deposits to cover fees) available for the purposes specified in such section 507as in effect prior to the effective date shall also be available for the purposes specified in section 512(n), including preparatory work or proceedings prior to that date
1. Public Law 90–399, which was enacted July 13, 1968 . Such Public Law added section 512to the Federal Food, Drug, and Cosmetic Act, and made related amendments. Section 108 concerned the effective date and applicability of the amendments.
GRANTS AND CONTRACTS FOR DEVELOPMENT OF DRUGS FOR RARE DISEASES AND CONDITIONS
SEC . 5. (a) [21 U.S.C. 360ee ] The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in (1) defraying the costs of qualified testing expenses incurred in connection with the development of drugs for rare diseases and conditions, (2) defraying the costs of developing medical devices for rare diseases or conditions, and (3) defraying the costs of developing medical foods for rare diseases or conditions.
(b) For purposes of subsection (a):
(1) The term "qualified testing" means—
(A) human clinical testing—
(i) which is carried out under an exemption for a drug for a rare disease or condition under section505(i) of the Federal Food, Drug, and Cosmetic Act (or regulations issued under such section); and
(ii) which occurs after the date such drug is designated under section 526 of such Act and before the date on which an application with respect to such drug is submitted under section 505(b) of such Act or under section 351 of the Public Health Service Act; and
(B) preclinical testing involving a drug for a rare disease or condition which occurs after the date such drug is designated under section 526 of such Act and before the date on which an application with respect to such drug is submitted under section 505(b) of such Act or under section351 of the Public Health Service Act.
(2) The term "rare disease or condition" means (1) 2 in the case of a drug, any disease or condition which (A) 2 affects less than 200,000 persons in the United States, or (B) 2 affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drugs, (2) 2 in the case of a medical device, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical device for such disease or condition will be developed without assistance under subsection (a), and (3) 2 in the case of a medical food, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical food for such disease or condition will be developed without assistance under subsection (a). Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under section 526 of the Federal Food, Drug, and Cosmetic Act is made.
(3) The term "medical food" means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
(c) For grants and contracts under subsection (a), there are authorized to be appropriated such sums as already have been appropriated for fiscal year 2002, and $25,000,000 for each of the fiscal years 2003 through 2006.
1. Public Law 97–414.
2. So in law. See section 3 of Public Law 100–290 (102 Stat. 90). In subsection (b)(2) above, the organizational units (1), (2), and (3) probably should be (A), (B), and (C) (and in the unit (1), (A) and (B) probably should be (i) and (ii)).