[Education Assistance Programs] Title VI - Education of the Handicapped Act; P.L. 91-230 476 Employee Retirement Income Security Act of 1974; P.L. 93-406 Federal Employees' Retirement System Act of 1986; P.L. 99-335 625 207 Financial Institutions Regulatory and Interest Rate Control Act of 1978; 560 Floyd D. Spence National Defense Authorization Act For Fiscal Year 2001; 811 Food Stamp Act of 1977; P.L. 88-525 427 Foreign Relations Authorization Act, Fiscal Years 1988 and 1989; P.L. 100204 654 Foreign Service Act of 1980; P.L. 96-465 576 Foster Care Independence Act of 1999; P.L. 106-169 794 [Further Continuing Appropriations for Fiscal Year 1983] P.L. 97-377 GI Bill Improvement Act of 1977; P.L. 95-202 592 547 Health Care Quality Improvement Act of 1986, Title IV; P.L. 99-660 636 847 Health Insurance Portability and Accountability Act of 1996; P.L. 104-191 Housing and Community Development Amendments of 1978; P.L. 95-557 551 Housing and Urban Development Act of 1965; P.L. 89-117 [Indian Claims Commission-Confederated Tribes and Bands of the Yakima Indian National]P.L. 95-433 550 [Indian Claims Distribution of Funds to Seminole Indians] P.L. 101-277 Indian Health Care Amendments of 1988; P.L. 100-713 Indian Self-Determination and Education Assistance Act; P.L. 93-638 International Child Abduction Remedies Act; P.L. 100-300 656 257 659 Maternal and Child Health Services Block Grant Act, Title XXI; P.L. 97-35. 585 [Mdewakanton and Wahpekute Eastern or Mississippi Sioux] P.L. 99-130 Medicare Catastrophic Coverage Act of 1988; P.L. 100-360 610 657 Medicare-Medicaid Anti-Fraud and Abuse Amendments; P.L. 95-142 Old Age Assistance Claims Settlement Act; P.L. 98-500 Older Americans Amendments of 1975; P.L. 94-135 609 534 585 590 629 645 669 Omnibus Budget Reconciliation Act of 1990; P.L. 101-508 675 Omnibus Budget Reconciliation Act of 1993; P.L. 103-66 707 Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999; P.L. 105-277 770 Omnibus Reconciliation Act of 1980; P.L. 96-499 584 Peace Corps Act; P.L. 87-293 420 Peer Review Improvement Act of 1982, Title I, Subtitle C; P.L. 97-248 [Per Capita Payments to Indians] P.L. 98-64 587 599 Perishable Agricultural Commodities Act, 1930; P.L. 71-325 178 Personal Responsibility and Work Opportunity Reconciliation Act of 1996; 740 Privacy Act of 1974; P.L. 93-579 516 Promoting Safe and Stable Families Amendments of 2001; P.L. 107-133 845 744 Protection and Advocacy for Mentally Ill Individuals Act of 1986; P.L. 99319 [Pueblo of Santa Ana Indians, New Mexico] P.L. 95-498 550 [Pueblo of Zia, New Mexico Indians] P.L. 95-499 550 Puyallup Tribe of Indians Settlement Act of 1989; P.L. 101-41 Revenue Act of 1951 [Jenner Amendment] P.L. 82-183 264 176 Richard B. Russell National School Lunch Act; P.L. 79-396 Saginaw Chippewa Indian Tribe of Michigan Distribution of Judgment 627 Shoalwater Bay Indian Tribe-Dexter-by-the-Sea Claim Settlement Act; 609 [Small Business Export Expansion Act of 1980] P.L. 96-481 Social Security Domestic Employment Reform Act of 1994; P.L. 103-387 731 [Social Security-Hearings and Review Procedures] P.L. 94-202 536 Social Security Independence and Program Improvements Act of 1994; P.L. 103-296 718 [Social Security- Rural Health Clinic Services] P.L. 95-210 548 418 1 Stewart B. McKinney Homeless Assistance Amendments Act of 1988; P.L. 100-628 661 Strengthening Abuse and Neglect Courts Act of 2000; P.L. 106-314 805 587 766 The Robert T. Stafford Disaster Relief and Emergency Assistance Act; P.L. 93-288 Technical and Miscellaneous Revenue Act of 1988; P.L. 100-647 [Temporary Payment of Disability Benefits] P.L. 97-455 Ticket to Work and Work Incentives Improvement Act of 1999; P.L. 106-170 Title 10 U.S. Code Title 11 U.S. Code Title 14 U.S. Code Government Organization and Employees Coast Guard Crimes and Criminal Procedure Foreign Relations and Intercourse 664 659 594 511 795 9 10 79 89 89 90 115 116 122 122 135 [Tread Rubber Excise Tax Refunds] P.L. 96-598 Unemployment Compensation Amendments of 1976; P.L. 94-566 Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970; P.L. 91-646 585 546 483 United States Housing Act of 1937; P.L. 75-412 203 Veterans' and Survivors' Pension Improvement Act of 1978; P.L. 95-588 552 Veterans Health Care Act of 1992; P.L. 102-585 706 Victims of Terrorism Tax Relief Act of 2001; P.L. 107-134 846 Wagner-Peyзer Act; P.L. 73-30 179 White Earth Reservation Land Settlement Act of 1985; P.L. 99-264 [Wyandotte Tribe of Oklahoma] P.L. 98-602 617 610 $310.6. Applicability of "new drug" or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products. (a) The Food and Drug Administration's conclusions on the effectiveness of drugs are currently being published in the FEDERAL REGISTER as Drug Efficacy Study Implementation (DESI) Notices and as Notices of Opportunity for Hearing. The specific products listed in these notices include only those that were introduced into the market through the new drug procedures from 1938-62 and were submitted for review by the National Academy of Sciences-National Research Council (NAS-NRC), Drug Efficacy Study Group. Many products which are identical to, related to, or similar to the products listed in these notices have been marketed under different names or by different firms during this same period or since 1962 without going through the new drug procedures or the Academy review. Even though these products are not listed in the notices, they are covered by the new drug applications reviewed and thus are subject to these notices. All persons with an interest in a product that is identical, related, or similar to a drug listed in a drug efficacy notice or a notice of opportunity for a hearing will be given the same opportunity as the applicant to submit data and information, to request a hearing, and to participate in any hearing. It is not feasible for the Food and Drug Administration to list all products which are covered by an NDA and thus subject to each notice. However, it is essential that the findings and conclusions that a drug product is a "new drug" or that there is a lack of evidence to show that a drug product is safe or effective be applied to all identical, related, and similar drug products to which they are reasonably applicable. Any product not in compliance with an applicable drug efficacy notice is in violation of section 505 (new drugs) and/or section 502 (misbranding) of the act. (b)(1) An identical, related, or similar drug includes other brands, potencies, dosage forms, salts, and esters of the same drug moiety as well as of any drug moiety related in chemical structure or known pharmacological properties. (2) Where experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs would conclude that the findings and conclusions, stated in a drug efficacy notice or notice of opportunity for hearing, that a drug product is a “new drug" or that there is a lack of evidence to show that a drug product is safe or effective are applicable to an identical, related, or similar drug product, such product is affected by the notice. A combination drug product containing a drug that is identical, related, or similar to a drug named in a notice may also be subject to the findings and conclusions in a notice that a drug product is a "new drug" or that there is a lack of evidence to show that a drug product is safe or effective. (3) Any person may request an opinion on the applicability of such a notice to a specific product by writing to the Food and Drug Administration at the address shown in paragraph (e) of this section. (c) Manufacturers and distributors of drugs should review their products as drug efficacy notices are published and assure that identical, related, or similar products comply with all applicable provisions of the notices. (d) The published notices and summary lists of the conclusions are of particular interest to drug purchasing agents. These agents should take particular care to assure that the same purchasing policy applies to drug products that are identical, related, or similar to those named in the drug efficacy notices. The Food and Drug Administration applies the same regulatory policy to all such products. In many instances a determination can readily be made as to the applicability of a drug efficacy notice by an individual who is knowledgeable about drugs and their indications for use. Where the relationships are more subtle and not readily recognized, the §310.6. purchasing agent may request an opinion by writing to the Food and Drug Administration at the address shown in paragraph (e) of this section. (e) Interested parties may submit to the Food and Drug Administration, Center for Drugs and Biologics, Office of Compliance, HFN-300, 5600 Fishers Lane, Rockville, MD 20857, the names of drug products, and of their manufacturers or distributors, that should be the subject of the same purchasing and regulatory policies as those reviewed by the Drug Efficacy Study Group. Appropriate action, including referral to purchasing officials of various government agencies, will be taken. (f) This regulation does not apply to OTC drugs identical, similar, or related to a drug in the Drug Efficacy Study unless there has been or is notification in the FEDERAL REGISTER that a drug will not be subject to an OTC panel review pursuant to §§330.10, 330.11, and 330.5 of this chapter. * [Internal References.-Social Security Act §§1862(c) and 1927(k) cite §310.6 of title 21 of the Code of Federal Regulations.] Code of Federal Regulations Title 42 §405.454. Payments to providers. 1 * * (j) Periodic interim payment method of reimbursement. (1Xi) Covered services furnished before July 1, 1987. In addition to the regular methods of interim payment on individual provider billings for covered services, the periodic interim payment (PIP) method is available for Part A hospital and SNF inpatient services and for both Part A and Part B HHA services. (ii) Covered services furnished on or after July 1, 1987. Effective with covered services furnished to beneficiaries on or after July 1, 1987, the PIP method, in addition to the other methods of interim payment on individual provider billings for covered services, is available only for the following: (A) Part A SNF services. (B) Part A and Part B HHA services. (C) Part A services furnished in hospitals receiving payment in accordance with a demonstration project authorized under section 402(a) of Pub. L. 90-248 (42 U.S.C. 1395b-1) or section 222(a) of Pub. L. 92-603 (42 U.S.C. 1395b-1 (note)), or a State reimbursement control system approved under section 1886(c) of the Act and Subpart C of Part 403 of this chapter, if that type of payment is specifically approved by HCFA as a part of the demonstration or control system. (D) Part A services furnished in hospitals located in a rural area as defined in §412.62(f) of this chapter that have fewer than 100 beds available for use excluding beds assigned to newborns. (2) Any participating provider furnishing the services described in paragraph (j)(1) of this section that establishes to the satisfaction of the intermediary that it meets the following requirements may elect to be reimbursed under the PIP method, beginning with the first month after its request that the intermediary finds administratively feasible: 1 As in effect October 1, 1986. |