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H.R. 5238Became Law

Orphan Drug Act

(House agreed to Senate amendment with an amendment)

Orphan Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to allow sponsors of a drug for a rare disease or condition (orphan drug) to request the Secretary of Health and Human Services to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before: (1) it may be approved as a new drug under such Act; or (2) it may be licensed as a biological product under the Public Health Service Act. Authorizes the Secretary to provide such recommendations on the basis of available information on whether such drug is for a disease or condition which is rare in the United States.

Directs the Secretary to designate orphan drugs and notify the public of such designation if the sponsors of such drug conform to provisions of this Act.

Prohibits the Secretary from approving any other applications or issuing any other licenses for an orphan drug until seven years after the initial application or license approval date, unless: (1) the sponsors cannot assure the availability of sufficient quantities of such drug; or (2) the sponsors consent in writing to the approval of other applications or licenses.

Requires the Secretary, if a designated orphan drug is being used solely for research purposes, to encourage its sponsors to design protocols for human clinical investigation for individuals who require its treatment because there is no satisfactory available alternative.

Amends the Public Health Service Act to establish the Orphan Products Board (Board) in the Department of Health and Human Services to promote and coordinate the development of orphan drugs and devices. Requires the Board to submit an annual report to the appropriate congressional committees which identifies the designated orphan drugs, describes the Board's activities, and contains results of its evaluations. Requires the Director of the National Institutes of Health and the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration to include in such report a report on their research activities respecting orphan drugs.

Amends the Internal Revenue Code of 1954 to allow a tax credit equal to 50 percent of the qualified experimental expenses paid or incurred by a taxpayer for certain drugs for rare diseases or conditions. Allows a deduction for the remaining 50 percent of such expenses.

Requires inclusion of a report on the use of such tax credit in the Board's annual report to Congress.

Authorizes appropriations for FY 1983 through FY 1985 for grants or contracts to assist eligible entities to defray costs of qualified experimental expenses.

Amends the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants to public and nonprofit private entities and loans to proprietary entities to meet the initial costs of establishing and operating home health programs. Authorizes such grants and loans to include funds to provide training to professional and paraprofessional personnel to provide home health services.

Directs the Secretary, in making such grants and loans, to: (1) consider the relative need of a State for services; and (2) give preference to areas with a high percentage of elderly, indigent, or disabled individuals.

Requires a proprietary entity to assure that it: (1) is fiscally sound; (2) is unable to obtain the loan from non-Federal lenders at prevailing interest rates; and (3) will remain fiscally sound during the period of the loan.

Authorizes appropriations for FY 1983 and 1984 for such loans and grants.

Authorizes the Secretary to make grants to public and private entities to assist them in developing appropriate training programs for paraprofessional personnel to provide home health services.

Authorizes appropriations for FY 1983 and 1984 for such training grants.

Directs the Secretary to report to specified congressional committees on: (1) the impact of grants and loans made under this Act; (2) the need to continue such grants and loans; and (3) the extent to which standards have been applied to the training of personnel.

Requires the Secretary to report the results of studies currently evaluating home and community based health services, and recommendations for legislative action, prior to January 1, 1985.

Directs the Secretary to compile and analyze the results of significant studies carried out by public or private entities relating to methodologies for home health services. Requires the Secretary to make recommendations to Congress with respect to such methodologies.

Directs the Secretary to investigate and report to Congress on methods to stem fraud abuse.

Directs the Secretary to develop and carry out demonstration projects testing alternative reimbursement methodologies for home health services and methods for identifying patients at risk of institutionalization who could be better treated with home health services. Requires a report to Congress on such projects not later than January 1, 1985.

Directs the Secretary to conduct scientific research and prepare analyses necessary to develop valid assessments of the risks of thyroid cancer associated with thyroid doses of Iodine 131, especially as a product of nuclear fallout. Requires the Secretary to report to Congress within one year of enactment on the results of the study.

Requires the Secretary to develop radioepidemiological tables which will catalog for each radiogenic cancer the probability that a given dose of ionizing radiation caused the cancer of a victim who has received such a dose.

Makes technical and conforming amendments to the Omnibus Budget Reconciliation Act of 1981 and the Public Health Service Act.

Makes funds available under the Energy Security Act for a study of the water quality of the Quabbin Reservoir in Massachusetts.

Requires extension of the patent on any composition of matter or a process for using such composition which was reviewed by the Federal Food and Drug Administration but for which a stay of regulation of approval was imposed and in effect on January 1, 1981.

Became Public Law No: 97-414.

Rep. Waxman, Henry A. [D-CA-24](D-CA)Sponsor
171 cosponsors118 D52 R1 I
171cosponsors3committees32actions2amendments1related bills38subjects
  • Public LawJan 5, 1983
  1. PresidentE40000

    Became Public Law No: 97-414.

  2. BecameLaw36000

    Became Public Law No: 97-414.

  3. PresidentE30000

    Signed by President.

  4. BecameLaw36000

    Signed by President.

  5. FloorE20000

    Presented to President.

  6. President28000

    Presented to President.

  7. Floor

    Measure Signed in Senate.

  8. ResolvingDifferences

    Senate agreed to the House amendment to the Senate amendment by Voice Vote.

  9. NotUsed20500

    Resolving differences -- Senate actions: Senate agreed to the House amendment to the Senate amendment by Voice Vote.

  10. ResolvingDifferencesH41610

    House Concurred, in Senate Amendments , with Amendments by Voice Vote.

  11. NotUsed19500

    Resolving differences -- House actions: House Concurred, in Senate Amendments , with Amendments by Voice Vote.

  12. ResolvingDifferences

    Senate insists on its amendments, asks for a conference, appoints conferees Hatch; Quayle; Hawkins; Kennedy; Metzenbaum.

  13. Floor

    Passed Senate with amendments by Voice Vote.

  14. Floor17000

    Passed/agreed to in Senate: Passed Senate with amendments by Voice Vote.

  15. Floor

    Considered by Senate.

  16. Discharge

    Senate Committee on Labor and Human Resources discharged by Unanimous Consent.

    Health, Education, Labor, and Pensions Committee
  17. Committee14500

    Senate Committee on Labor and Human Resources discharged by Unanimous Consent.

    Health, Education, Labor, and Pensions Committee
  18. IntroReferral

    Received in the Senate and read twice and referred to the Committee on Labor and Human Resources.

    Health, Education, Labor, and Pensions Committee
  19. FloorH37100

    Passed House (Amended) by Voice Vote.

  20. Floor8000

    Passed/agreed to in House: Passed House (Amended) by Voice Vote.

  21. FloorH30000

    Called up by House Under Suspension of Rules.

  22. CommitteeH12200

    Reported to House (Amended) by House Committee on Energy and Commerce. Report No: 97-840 (Part I).

    Energy and Commerce Committee
  23. Committee5000

    Reported to House (Amended) by House Committee on Energy and Commerce. Report No: 97-840 (Part I).

    Energy and Commerce Committee
  24. CommitteeH19000

    Ordered to be Reported (Amended).

    Energy and Commerce Committee
  25. CommitteeH15000-B

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  26. CommitteeH25000

    Subcommittee on Health and the Environment Discharged.

    Health and Environment Subcommittee
  27. CommitteeH21000

    Subcommittee Hearings Held.

    Health and Environment Subcommittee
  28. CommitteeH11000

    Referred to Subcommittee on Health and the Environment.

    Health and Environment Subcommittee
  29. IntroReferralH11100

    Referred to House Committee on Ways and Means.

    Ways and Means Committee
  30. IntroReferralH11100

    Referred to House Committee on Energy and Commerce.

    Energy and Commerce Committee
  31. IntroReferralIntro-H

    Introduced in House

  32. IntroReferral1000

    Introduced in House

Dec 14, 198240
(House agreed to Senate amendment with an amendment)

Orphan Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to allow sponsors of a drug for a rare disease or condition (orphan drug) to request the Secretary of Health and Human Services to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before: (1) it may be approved as a new drug under such Act; or (2) it may be licensed as a biological product under the Public Health Service Act. Authorizes the Secretary to provide such recommendations on the basis of available information on whether such drug is for a disease or condition which is rare in the United States.

Directs the Secretary to designate orphan drugs and notify the public of such designation if the sponsors of such drug conform to provisions of this Act.

Prohibits the Secretary from approving any other applications or issuing any other licenses for an orphan drug until seven years after the initial application or license approval date, unless: (1) the sponsors cannot assure the availability of sufficient quantities of such drug; or (2) the sponsors consent in writing to the approval of other applications or licenses.

Requires the Secretary, if a designated orphan drug is being used solely for research purposes, to encourage its sponsors to design protocols for human clinical investigation for individuals who require its treatment because there is no satisfactory available alternative.

Amends the Public Health Service Act to establish the Orphan Products Board (Board) in the Department of Health and Human Services to promote and coordinate the development of orphan drugs and devices. Requires the Board to submit an annual report to the appropriate congressional committees which identifies the designated orphan drugs, describes the Board's activities, and contains results of its evaluations. Requires the Director of the National Institutes of Health and the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration to include in such report a report on their research activities respecting orphan drugs.

Amends the Internal Revenue Code of 1954 to allow a tax credit equal to 50 percent of the qualified experimental expenses paid or incurred by a taxpayer for certain drugs for rare diseases or conditions. Allows a deduction for the remaining 50 percent of such expenses.

Requires inclusion of a report on the use of such tax credit in the Board's annual report to Congress.

Authorizes appropriations for FY 1983 through FY 1985 for grants or contracts to assist eligible entities to defray costs of qualified experimental expenses.

Amends the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants to public and nonprofit private entities and loans to proprietary entities to meet the initial costs of establishing and operating home health programs. Authorizes such grants and loans to include funds to provide training to professional and paraprofessional personnel to provide home health services.

Directs the Secretary, in making such grants and loans, to: (1) consider the relative need of a State for services; and (2) give preference to areas with a high percentage of elderly, indigent, or disabled individuals.

Requires a proprietary entity to assure that it: (1) is fiscally sound; (2) is unable to obtain the loan from non-Federal lenders at prevailing interest rates; and (3) will remain fiscally sound during the period of the loan.

Authorizes appropriations for FY 1983 and 1984 for such loans and grants.

Authorizes the Secretary to make grants to public and private entities to assist them in developing appropriate training programs for paraprofessional personnel to provide home health services.

Authorizes appropriations for FY 1983 and 1984 for such training grants.

Directs the Secretary to report to specified congressional committees on: (1) the impact of grants and loans made under this Act; (2) the need to continue such grants and loans; and (3) the extent to which standards have been applied to the training of personnel.

Requires the Secretary to report the results of studies currently evaluating home and community based health services, and recommendations for legislative action, prior to January 1, 1985.

Directs the Secretary to compile and analyze the results of significant studies carried out by public or private entities relating to methodologies for home health services. Requires the Secretary to make recommendations to Congress with respect to such methodologies.

Directs the Secretary to investigate and report to Congress on methods to stem fraud abuse.

Directs the Secretary to develop and carry out demonstration projects testing alternative reimbursement methodologies for home health services and methods for identifying patients at risk of institutionalization who could be better treated with home health services. Requires a report to Congress on such projects not later than January 1, 1985.

Directs the Secretary to conduct scientific research and prepare analyses necessary to develop valid assessments of the risks of thyroid cancer associated with thyroid doses of Iodine 131, especially as a product of nuclear fallout. Requires the Secretary to report to Congress within one year of enactment on the results of the study.

Requires the Secretary to develop radioepidemiological tables which will catalog for each radiogenic cancer the probability that a given dose of ionizing radiation caused the cancer of a victim who has received such a dose.

Makes technical and conforming amendments to the Omnibus Budget Reconciliation Act of 1981 and the Public Health Service Act.

Makes funds available under the Energy Security Act for a study of the water quality of the Quabbin Reservoir in Massachusetts.

Requires extension of the patent on any composition of matter or a process for using such composition which was reviewed by the Federal Food and Drug Administration but for which a stay of regulation of approval was imposed and in effect on January 1, 1981.

Oct 1, 198235
(Measure passed Senate, amended)

Orphan Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to allow sponsors of a drug for a rare disease or condition (orphan drug) to request the Secretary of Health and Human Services to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before: (1) it may be approved as a new drug under such Act; or (2) it may be licensed as a biological product under the Public Health Service Act. Authorizes the Secretary to provide such recommendations on the basis of available information on whether such drug is for a disease or condition which is rare in the United States.

Directs the Secretary to designate orphan drugs and notify the public of such designation if the sponsors of such drug conform to provisions of this Act.

Prohibits the Secretary from approving any other applications or issuing any other licenses for an orphan drug until seven years after the initial application or license approval date, unless: (1) the sponsors cannot assure the availability of sufficient quantities of such drug; or (2) the sponsors consent in writing to the approval of other applications or licenses.

Requires the Secretary, if a designated orphan drug is being used solely for research purposes, to encourage its sponsors to design protocols for human clinical investigation for individuals who require its treatment because there is no satisfactory available alternative.

Amends the Public Health Service Act to establish the Orphan Products Board (Board) in the Department of Health and Human Services to promote and coordinate the development of orphan drugs and devices. Requires the Board to submit an annual report to the appropriate congressional committees which identifies the designated orphan drugs, describes the Board's activities, and contains results of its evaluations. Requires the Director of the National Institutes of Health and the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration to include in such report a report on their research activities respecting orphan drugs.

Authorizes appropriations for FY 1983 through FY 1985 for grants or contracts to assist eligible entities to defray costs of qualified experimental expenses.

Amends the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants to public and nonprofit private entities and loans to proprietary entities to meet the initial costs of establishing and operating home health programs. Authorizes such grants and loans to include funds to provide training to professional and paraprofessional personnel to provide home health services. Directs the Secretary to make such grants and loans only in areas without adequate home health services.

Directs the Secretary, in making such grants and loans, to: (1) consider the relative need of a State for services; and (2) give preference to areas with a high percentage of elderly, indigent, or disabled individuals.

Requires a proprietary entity to assure that it: (1) is fiscally sound; (2) is unable to obtain the loan from non-Federal lenders at prevailing interest rates; and (3) will remain fiscally sound during the period of the loan.

Authorizes appropriations for FY 1983 and 1984 for such loans and grants.

Authorizes the Secretary to make grants to public and private entities to assist them in developing appropriate training programs for professional and paraprofessional personnel to provide home health services.

Authorizes appropriations for FY 1983 and 1984 for such training grants.

Directs the Secretary to report to specified congressional committees on: (1) grants and loans made under this Act; (2) home health personnel training standards; and (3) efforts to stem home health services fraud and abuse.

Directs the Secretary to: (1) study and make recommendations to Congress with respect to current and alternative reimbursement methodologies for home health services; and (2) implement cost effective reimbursement methodologies.

Directs the Secretary to develop and carry out demonstration projects testing alternative reimbursement methodologies for home health services and report the findings to Congress.

Directs the Secretary to conduct scientific research and prepare analyses necessary to develop valid assessments of the risks of thyroid cancer associated with thyroid doses of Iodine 131, especially as a product of nuclear fallout. Requires the Secretary to report to Congress within one year of enactment on the results of the study.

Requires the Secretary to develop radioepidemiological tables which will catalog for each radiogenic cancer the probability that a given dose of ionizing radiation caused the cancer of a victim who has received such a dose.

Makes technical and conforming amendments to the Ominibus Budget Reconciliation Act of 1981 and the Public Health Service Act.

Amends the Public Health Service Act, effective as of October 1, 1982, to revise the alcohol, drug abuse, and mental health block grant formula to include specified mental health demonstration funds in State allotment determinations.

Authorizes appropriations through FY 1984 for nurse anesthetist training.

Requires a baccalaureate degree (currently a postbaccalaureate degree is required) for specified nonpublic health school graduate health traineeships.

Eliminates a requirement that graduate health administration programs maintain the number of first year students enrolled in the program.

Provides that funds appropriated under title VIII (Nurse Training) of such Act may be used to provide technical assistance for any authority under such title.

Permits the Secretary of Health and Human Services to sell real property pledged as security on specified medical facility loans.

Eliminates the requirement that the National Center for Health Statistics serve as a clearinghouse for guideline information on the health effects of working conditions and the environment.

Permits grants to community health centers serving underserved populations for the purpose of repaying certain Farmers Home Administration loans.

Permits Public Health Service appointments in the field of psychology.

Amends the Federal Security Agency Appropriations Act to authorize cash advances within NIH for supply purchases.

Renames the Office of Health Information, Health Promotion and Physical Fitness and Sports Medicine as the Office of Health Promotion.

Increases the period during which the Secretary may provide State and local health emergency assistance from 45 days to six months.

Shifts the 1982 authorization of appropriations for primary care research and demonstration projects from urban to rural projects.

Directs the Secretary to provide for not less than ten comprehensive centers for sickle cell disease.

Requires the Interagency Task Force on Acid Deposition to study the effects of acid deposition on the Quabbin Reservoir, in Massachusetts.

Requires extension of the patent on any composition of matter or a process for using such composition which was reviewed by the Federal Food and Drug Administration but for which a stay of regulation of approval was imposed and in effect on January 1, 1981.

Sep 28, 198236
(Measure passed House, amended)

Orphan Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to allow sponsors of a drug for a rare disease or condition (orphan drug) to request the Secretary of Health and Human Services to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before: (1) it may be approved as a new drug under such Act; or (2) it may be licensed as a biological product under the Public Health Service Act. Authorizes the Secretary to provide such recommendations on the basis of available information on whether such drug is for a disease or condition which is rare in the United States.

Directs the Secretary to designate orphan drugs and notify the public of such designation if the sponsors of such drug conform to provisions of this Act.

Prohibits the Secretary from approving any other applications or issuing any other licenses for an orphan drug until seven years after the initial application or license approval date, unless: (1) the sponsors cannot assure the availability of sufficient quantities of such drug; or (2) the sponsors consent in writing to the approval of other applications or licenses.

Requires the Secretary, if a designated orphan drug is being used solely for research purposes, to encourage its sponsors to design protocols for human clinical investigation for individuals who require its treatment because there is no satisfactory available alternative.

Amends the Public Health Service Act to establish the Orphan Products Board (Board) in the Department of Health and Human Services to promote and coordinate the development of orphan drugs and devices. Requires the Board to submit an annual report to the appropriate congressional committees which identifies the designated orphan drugs, describes the Board's activities, and contains results of its evaluations. Requires the Director of the National Institutes of Health and the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration to include in such report a report on their research activities respecting orphan drugs.

Amends the Internal Revenue Code of 1954 to allow a tax credit equal to 90 percent of the qualified experimental expenses paid or incurred by a taxpayer for certain drugs for rare diseases or conditions.

Requires inclusion of a report on the use of such tax credit in the Board's annual report to Congress.

Sep 17, 198218
(Reported to House from the Committee on Energy and Commerce with amendment, H. Rept. 97-840 (Part I))

Orphan Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to allow sponsors of a drug for a rare disease or condition (orphan drug) to request the Secretary of Health and Human Services to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before: (1) it may be approved as a new drug under such Act; or (2) it may be licensed as a biological product under the Public Health Service Act. Authorizes the Secretary to provide such recommendations on the basis of available information on whether such drug is for a disease or condition which is rare in the United States.

Directs the Secretary to designate orphan drugs and notify the public of such designation if the sponsors of such drug conform to provisions of this Act.

Prohibits the Secretary from approving any other applications or issuing any other licenses for an orphan drug until seven years after the initial application or license approval date, unless: (1) the sponsors cannot assure the availability of sufficient quantities of such drug; or (2) the sponsors consent in writing to the approval of other applications or licenses.

Requires the Secretary, if a designated orphan drug is being used solely for research purposes, to encourage its sponsors to design protocols for human clinical investigation for individuals who require its treatment because there is no satisfactory available alternative.

Amends the Public Health Service Act to establish the Orphan Products Board (Board) in the Department of Health and Human Services to promote and coordinate the development of orphan drugs and devices. Requires the Board to submit an annual report to the appropriate congressional committees which identifies the designated orphan drugs, describes the Board's activities, and contains results of its evaluations. Requires the Director of the National Institutes of Health and the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration to include in such report a report on their research activities respecting orphan drugs.

Amends the Internal Revenue Code of 1954 to allow a tax credit equal to 90 percent of the qualified experimental expenses paid or incurred by a taxpayer for certain drugs for rare diseases or conditions.

Requires inclusion of a report on the use of such tax credit in the Board's annual report to Congress.

Dec 15, 198100

Orphan Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations to exempt from such Act drugs intended solely for drug treatment investigations. Defines "drug treatment investigation" as an investigation of a drug which involves human participants with a rare disease or condition.

Establishes in the Department of Health and Human Services an interagency committee known as the Committee on Orphan Drug Development. Makes it the function of such committee to promote the development of drugs for rare diseases or conditions (orphan drugs). Requires the Director of the National Institutes of Health (NIH) to submit to the Committee an annual report on the rare disease and condition research activities of NIH. Requires the Committee to report by June 1 of each year to the appropriate congressional committees on its activities and the results of its evaluations, including the report submitted by NIH.

Amends the Internal Revenue Code to allow a tax credit for qualified experimental expenses incurred while researching orphan drugs.