Federal Food, Drug and Cosmetic Act

Contents of this page:
Sec. 901. Separability Clause
Sec. 902. Effective Date and Repeals
Sec. 903. Food and Drug Administration
Sec. 904. Scientific Review Groups
Sec. 905. Loan Repayment Program
Sec. 906. Practice of Medicine
Sec. 907. Contracts for Expert Review
Sec. 908. Notices to States Regarding Imported Food
Sec. 909. Grants to States for Inspections
Sec. 910. Office of the Chief Scientist

Cross-reference of FD&C Act and U.S. Code section numbers

CHAPTER IX--MISCELLANEOUS

SEPARABILITY CLAUSE

SEC. 901. [21 U.S.C. 391] If any provision of this Act is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the Act and the applicability thereof to other persons and circumstances shall not be affected thereby.

EFFECTIVE DATE AND REPEALS

SEC. 902. [21 U.S.C. 392] (a) This Act shall take effect twelve months after the date of its enactment. The Federal Food and Drug Act of June 30, 1906, as amended (U.S.C., 1934 ed., title 21, secs.1–15), shall remain in force until such effective date, and except as otherwise provided in this subsection, is hereby repealed effective upon such date: Provided, That the provisions of section 701 shall become effective on the enactment of this Act, and thereafter the Secretary [of Agriculture] is authorized hereby to (1) conduct hearings and to promulgate regulations which shall become effective on or after the effective date of this Act as the Secretary [of Agriculture] shall direct, and (2) designate prior to the effective date of this Act food having common or usual names and exempt such food from the requirements of clause (2) of section 403(i) for a reasonable time to permit the formulation, promulgation, and effective application of definitions and standards of identity therefor as provided by section 401: Provided further, That sections 502(j), 505, and 601(a), and all other provisions of this Act to the extent that they may relate to the enforcement of such sections, shall take effect on the date of the enactment of this Act, except that in the case of a cosmetic to which the proviso of section 601(a) relates, such cosmetic shall not, prior to the ninetieth day after such date of enactment, be deemed adulterated by reason of the failure of its label to bear the legend prescribed in such proviso: Provided further, That the Act of March 4, 1923 (U.S.C., 1945 ed., title 21, sec. 321a; 32 Stat. 1500, ch. 268), defining butter and providing a standard therefor; the Act of July 24, 1919 (U.S.C., 1946 ed., title 21, sec. 321b; 41 Stat. 271, ch. 26), defining wrapped meats as in package form; and the amendment to the Food and Drug Act, section 10A, approved August 27, 1935 (U.S.C., 1946 ed., title 21, sec. 372a [49 Stat. 871, ch. 739]), shall remain in force and effect and be applicable to the provisions of this Act.

(b) Meats and meat food products shall be exempt from the provisions of this Act to the extent of the application or the extension thereto of the Meat Inspection Act, approved March 4, 1907, as amended (U.S.C., 1946 ed., title 21, secs. 71–96; 34 Stat. 1260 et seq.).

(c) Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of section 351 of Public Health Service Act (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832–833); the Filled Cheese Act of June 6, 1896 (U.S.C., 1946 ed., title 26, ch. 17, secs. 2350–2362); the Filled Milk Act of March 4, 1923 (U.S.C. 1946 ed., title 21, ch. 3, secs. 61–64); or the Import Milk Act of February 15, 1927 (U.S.C., 1946 ed., title 21, ch. 4, secs. 141–149).

SEC. 903. [ 21 U.S.C. 393] FOOD AND DRUG ADMINISTRATION.

(a) IN GENERAL.—There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the ‘‘Administration’’).

(b) MISSION.—The Administration shall—

(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;

(2) with respect to such products, protect the public health by ensuring that—

(A) foods are safe, wholesome, sanitary, and properly labeled;

(B) human and veterinary drugs are safe and effective;

(D) cosmetics are safe and properly labeled; and

(E) public health and safety are protected from electronic product radiation;

(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and

(4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.

(c) INTERAGENCY COLLABORATION.—The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies, including complementary therapies, and advances in nutrition and food science.

(d) COMMISSIONER.—

(1) APPOINTMENT.—There shall be in the Administration a Commissioner of Food and Drugs (hereinafter in this section referred to as the ‘‘Commissioner’’) who shall be appointed by the President by and with the advice and consent of the Senate.

(2) GENERAL POWERS.—The Secretary, through the Commissioner, shall be responsible for executing this Act and for—

(A) providing overall direction to the Food and Drug Administration and establishing and implementing general policies respecting the management and operation of programs and activities of the Food and Drug Administration;

(B) coordinating and overseeing the operation of all administrative entities within the Administration;

(D) conducting educational and public information programs relating to the responsibilities of the Food and Drug Administration; and

(E) performing such other functions as the Secretary may prescribe.

(e) TECHNICAL AND SCIENTIFIC REVIEW GROUPS.—The Secretary through the Commissioner of Food and Drugs may, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific review groups as are needed to carry out the functions of the Administration, including functions under the Federal Food, Drug, and Cosmetic Act, and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

(f) AGENCY PLAN FOR STATUTORY COMPLIANCE.—

(1) IN GENERAL.—Not later than 1 year after the date of enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this Act. The Secretary shall review the plan biannually and shall revise the plan as necessary, in consultation with such persons.

(2) OBJECTIVES OF AGENCY PLAN.—The plan required by paragraph (1) shall establish objectives and mechanisms to achieve such objectives, including objectives related to—

(A) maximizing the availability and clarity of information about the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this Act;

(B) maximizing the availability and clarity of information for consumers and patients concerning new products;

(D) ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1);

(E) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in this Act for the review of all applications and submissions described in subparagraph (A) and submitted after the date of enactment of the Food and Drug Administration Modernization Act of 1997; and

(F) eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1, 2000.

(g) ANNUAL REPORT.—The Secretary shall annually prepare and publish in the Federal Register and solicit public comment on a report that—

(1) provides detailed statistical information on the performance of the Secretary under the plan described in subsection (f);

(2) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; and

(3) identifies any regulatory policy that has a significant negative impact on compliance with any objective of the plan or any statutory obligation and sets forth any proposed revision to any such regulatory policy.

Sec. 904. [21 U.S.C.394] SCIENTIFIC REVIEW GROUPS.

Without regard to the provisions of title 5, United States Code, governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may—

(1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this Act); and

(2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

SEC. 905. [ 21 U.S.C. 395] LOAN REPAYMENT PROGRAM.

(a) IN GENERAL.—

(1) AUTHORITY FOR PROGRAM.—Subject to paragraph (2), the Secretary shall carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct research, as employees of the Food and Drug Administration, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $20,000 of the principal and interest of the educational loans of such health professionals.

(2) LIMITATION.—The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—

(A) has a substantial amount of educational loans relative to income; and

(B) agrees to serve as an employee of the Food and Drug Administration for purposes of paragraph (1) for a period of not less than 3 years.

(b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III of the Public Health Service Act, the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply to the program established in such subsection in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.

(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996.

SEC. 906. [ 21 U.S.C. 396] PRACTICE OF MEDICINE.

Nothing in this Act shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.

SEC. 907. [ 21 U.S.C. 397] CONTRACTS FOR EXPERT REVIEW.

(a) IN GENERAL.—

(1) AUTHORITY.—The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with relevant expertise, to review and evaluate, for the purpose of making recommendations to the Secretary on, part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this Act for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 708 relating to the confidentiality of information.

(2) INCREASED EFFICIENCY AND EXPERTISE THROUGH CONTRACTS.—The Secretary may use the authority granted in paragraph (1) whenever the Secretary determines that use of a contract described in paragraph (1) will improve the timeliness of the review of an application or submission described in paragraph (1), unless using such authority would reduce the quality, or unduly increase the cost, of such review. The Secretary may use such authority whenever the Secretary determines that use of such a contract will improve the quality of the review of an application or submission described in paragraph (1), unless using such authority would unduly increase the cost of such review. Such improvement in timeliness or quality may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies.

(b) REVIEW OF EXPERT REVIEW.—

(1) IN GENERAL.—Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter in a timely manner.

(2) LIMITATION.—A final decision by the Secretary on any such application or submission shall be made within the applicable prescribed time period for review of the matter as set forth in this Act or in the Public Health Service Act (42 U.S.C. 201 et seq.).

SEC. 908. [21 USC 398] NOTICES TO STATES REGARDING IMPORTED FOOD.

(a) IN GENERAL..--If the Secretary has credible evidence or information indicating that a shipment of imported food or portion thereof presents a threat of serious adverse health consequences or death to humans or animals, the Secretary shall provide notice regarding such threat to the States in which the food is held or will be held, and to the States in which the manufacturer, packer, or distributor of the food is located, to the extent that the Secretary has knowledge of which States are so involved. In providing notice to a State, the Secretary shall request the State to take such action as the State considers appropriate, if any, to protect the public health regarding the food involved.

(b) RULE OF CONSTRUCTION.--Subsection (a) may not be construed as limiting the authority of the Secretary with respect to food under any other provision of this Act.

SEC. 909. [21 USC 399] GRANTS TO STATES FOR INSPECTIONS.

(a) IN GENERAL.--The Secretary is authorized to make grants to States, territories, and Indian tribes (as defined in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(e))) that undertake examinations, inspections, and investigations, and related activities under section 702. The funds provided under such grants shall only be available for the costs of conducting such examinations, inspections, investigations, and related activities.

(b) NOTICES REGARDING ADULTERATED IMPORTED FOOD.--The Secretary may make grants to the States for the purpose of assisting the States with the costs of taking appropriate action to protect the public health in response to notification under section 908, including planning and otherwise preparing to take such action.

(c) AUTHORIZATION OF APPROPRIATIONS.--For the purpose of carrying out this section, there are authorized to be appropriated $10,000,000 for fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2003 through 2006.

Section 910 [21 USC § 399a] Office of the Chief Scientist

(a) Establishment; appointment. The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.

(b) Duties of the Office. The Office of the Chief Scientist shall--

(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;

(2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;

(3) develop and advocate for a budget to support intramural research;

(4) develop a peer review process by which intramural research can be evaluated;

(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include--

(A) representatives of each of the centers and the science-based offices within the Office of the Commissioner; and

(B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and

(6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.

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