(E) the sponsor involved is a small business submitting its first animal drug application to the Secretary for review. (2) USE OF STANDARD COSTS.—In making the finding in paragraph (1)(B), the Secretary may use standard costs. (3) RULES FOR SMALL BUSINESSES.— (A) DEFINITION.-In paragraph (1)(E), the term “small business" means an entity that has fewer than 500 employees, including employees of affiliates. (B) WAIVER OF APPLICATION FEE.-The Secretary shall waive under paragraph (1)(E) the application fee for the first animal drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent animal drug applications and supplemental animal drug applications for which safety or effectiveness data are required in the same manner as an entity that does not qualify as a small business. (C) CERTIFICATION.-The Secretary shall require any person who applies for a waiver under paragraph (1)(E) to certify their qualification for the waiver. The Secretary shall periodically publish in the Federal Register a list of persons making such certifications. (e) EFFECT OF FAILURE TO PAY FEES.-An animal drug application or supplemental animal drug application submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. An investigational animal drug submission under section 739(5)(B) that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue review of any animal drug application, supplemental animal drug application or investigational animal drug submission from a person if such person has not submitted for payment all fees owed under this section by 30 days after the date upon which they are due. (f) ASSESSMENT OF FEES. (1) LIMITATION.-Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2003 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved. (2) AUTHORITY.-If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for ani mal drug applications, supplemental animal drug applications, investigational animal drug submissions, animal drug sponsors, animal drug establishments and animal drug products at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid. (g) CREDITING AND AVAILABILITY OF FEES.— (1) IN GENERAL.-Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of animal drug applications. (2) COLLECTIONS AND APPROPRIATION ACTS.— (A) IN GENERAL.-The fees authorized by this section (i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year, and (ii) shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of animal drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2003 multiplied by the adjustment factor. (B) COMPLIANCE.-The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of animal drug applications (i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or (ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in subparagraph (A)ii); and (II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii). (3) AUTHORIZATION OF APPROPRIATIONS.-There are authorized to be appropriated for fees under this section (A) $5,000,000 for fiscal year 2004; (B) $8,000,000 for fiscal year 2005; as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees. (4) OFFSET.—Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriations Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year. (h) COLLECTION OF UNPAID FEES.-In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code. (i) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, AND REFUNDS. To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due. (j) CONSTRUCTION.-This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of animal drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged. (k) ABBREVIATED NEW ANIMAL DRUG APPLICATIONS.-The Secretary shall (1) to the extent practicable, segregate the review of abbreviated new animal drug applications from the process for the review of animal drug applications, and (2) adopt other administrative procedures to ensure that review times of abbreviated new animal drug applications do not increase from their current level due to activities under the user fee program. SUBCHAPTER D-INFORMATION AND EDUCATION SEC. 741. [21 U.S.C. 379k] INFORMATION SYSTEM. The Secretary shall establish and maintain an information system to track the status and progress of each application or submission (including a petition, notification, or other similar form of request) submitted to the Food and Drug Administration requesting agency action. SEC. 742. [21 U.S.C. 3791] EDUCATION. (a) IN GENERAL.-The Secretary shall conduct training and education programs for the employees of the Food and Drug Administration relating to the regulatory responsibilities and policies established by this Act, including programs for (1) scientific training; (2) training to improve the skill of officers and employees authorized to conduct inspections under section 704; (3) training to achieve product specialization in such inspections; and (4) training in administrative process and procedure and integrity issues. (b) INTRAMURAL FELLOWSHIPS AND OTHER TRAINING PROGRAMS. The Secretary, acting through the Commissioner, may, through fellowships and other training programs, conduct and support intramural research training for predoctoral and postdoctoral scientists and physicians. SUBCHAPTER E-ENVIRONMENTAL IMPACT REVIEW SEC. 746. [21 U.S.C. 3790] ENVIRONMENTAL IMPACT. Notwithstanding any other provision of law, an environmental impact statement prepared in accordance with the regulations published in part 25 of title 21, Code of Federal Regulations (as in effect on August 31, 1997) in connection with an action carried out under (or a recommendation or report relating to) this Act, shall be considered to meet the requirements for a detailed statement under section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). SUBCHAPTER F-NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS SEC. 751. [21 U.S.C. 379r] NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS. (a) IN GENERAL.-Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political subdivision of a State may establish or continue in effect any requirement (1) that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1) or 503(f)(1)(A); and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.). (b) EXEMPTION. (1) IN GENERAL.-Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement that (A) protects an important public interest that would otherwise be unprotected, including the health and safety of children; (B) would not cause any drug to be in violation of any applicable requirement or prohibition under Federal law; and (C) would not unduly burden interstate commerce. (2) TIMELY ACTION.-The Secretary shall make a decision on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days after receiving the application of the State or political subdivision under paragraph (1). (c) SCOPE. (1) IN GENERAL.-This section shall not apply to— (A) any State or political subdivision requirement that relates to the practice of pharmacy; or (B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug. (2) SAFETY OR EFFECTIVENESS. For purposes of subsection (a), a requirement that relates to the regulation of a drug shall be deemed to include any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug. (d) EXCEPTIONS.— (1) IN GENERAL.-In the case of a drug described in subsection (a)(1) that is not the subject of an application approved under section 505 or section 507 (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 1997) or a final regulation promulgated by the Secretary establishing conditions under which the drug is generally recognized as safe and effective and not misbranded, subsection (a) shall apply only with respect to a requirement of a State or political subdivision of a State that relates to the same subject as, but is different from or in addition to, or that is otherwise not identical with— (A) a regulation in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or (B) any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after the date of enactment of the Food and Drug Administration Modernization Act of 1997. (2) STATE INITIATIVES.—This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997. (e) NO EFFECT ON PRODUCT LIABILITY LAW.-Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State. (f) STATE ENFORCEMENT AUTHORITY.—Nothing in this section shall prevent a State or political subdivision thereof from enforcing, under any relevant civil or other enforcement authority, a requirement that is identical to a requirement of this Act. SEC. 752. [21 U.S.C. 379s] PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS. (a) IN GENERAL.-Except as provided in subsection (b), (d), or (e), no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this Act, the Poison |