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S 845 - 101

Food and Drug Administration Revitalization Act

Became Public Law No: 101-635.

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Healthcare
3 evidence matches
Impact 100% Confidence 90%

Health

Food and Drug Administration Revitalization Act Became Public Law No: 101-635. Health

Food and Drug Administration Revitalization Act Became Public Law No: 101-635. Health

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Summary

35 Passed Senate amended May 29, 2002

Food and Drug Administration Revitalization Act - Title I: Consolidated Administrative and Laboratory Facility - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to direct the Secretary of Health and Human Services to enter into contracts for the design, construction, and operation of a consolidated Food and Drug Administration (FDA) administrative and laboratory facility. Authorizes the Secretary, in carrying out this title, to accept gifts. Authorizes apropriations. Title II: Recovery and Retention of Fees for FOIA Requests - Amends the FDCA to authorize the Secretary, through the Commissioner of Food and Drugs, to charge fees to recover all reasonable costs incurred in processing Freedom of Information Act requests for records obtained or created under the Act. Title III: Scientific Review Groups - Authorizes the Commissioner of Food and Drugs to establish such technical and scientific review groups as necessary to carry out the functions of the FDA. Title IV: Automation of FDA - Directs the Secretary, through the Commissioner, to automate appropriate activities of the FDA to ensure timely review of activities regulated under the FDCA. Authorizes appropriations.

01 Reported to Senate with amendment(s) May 29, 2002

FDA Revitalization Act - Title I: Consolidated Administrative and Laboratory Facility - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to direct the Secretary of Health and Human Services to enter into contracts for the design, construction, and operation of a consolidated Food and Drug Administration (FDA) administrative and laboratory facility. Title II: Senior Scientific Health Service - Amends the Public Health Service Act to authorize the establishment of a Senior Scientific Health Service, outside the competitive civil service, whose members may be appointed based solely on distinction and achievement in the fields of biomedical research or clinical research evaluation. Amends Federal law relating to physicians' comparability allowances to include any physician or dentist who is paid under provisions of this title. Title III: Recovery and Retention of Fees for FOIA Requests - Amends the FDCA to authorize the Secretary, through the Commissioner of Food and Drugs, to charge fees to recover all reasonable costs incurred in processing Freedom of Information Act requests for records obtained or created under the Act. Title IV: Small Business Training and Technical Assistance - Amends the FDCA to authorize the Secretary, through the Commissioner, to establish an office to provide technical and other nonfinancial assistance to small manufacturers of medical devices, drugs, cosmetics, and foods to assist the manufacturers in complying with the Act. Authorizes appropriations for FY 1990 through 1992. Title V: Biotechnology Demonstration Project - Directs the Secretary to establish a demonstration project allowing the use of the facilities of any public or private cooperative with the permission of and in conjunction with the cooperative to promote the development of biotechnology. Authorizes appropriations for FY 1990 through 1992. Title VI: Training and Loan Repayment Programs - Authorizes grants to public or nonprofit academic institutions, including schools of medicine, dentistry, pharmacy, public health, and food science, to enable such institutions to develop core curriculum programs to train individuals in the field of regulatory review. Requires obligated service of grantees as FDA employees. Authorizes appropriations for FY 1990 through 1992 for such grants. Directs the Secretary to establish a loan repayment program under which the Secretary must repay loans incurred by individuals to obtain training in regulatory review in exchange for the individuals serving a period of time as employees of the FDA. Directs the Secretary to: (1) issue regulations to carry out these provisions; and (2) carry out the program, to the extent practicable, in a manner that is consistent with the National Health Service Corps Loan Repayment Program. Authorizes appropriations for FY 1990 through 1992. Title VII: Scientific Review Groups - Authorizes the Commissioner of Food and Drugs to establish such technical and scientific review groups as necessary to carry out the functions of the FDA. Title VIII: Human Food Safety, Technology, and Nutrition Advisory Committee - Directs the Secretary to establish the Human Food Safety, Technology, and Nutrition Advisory Committee to advise the Secretary and the Commissioner of Food and Drugs on issues involving food for human consumption, including: (1) food technology and production; (2) food research and development; (3) biotechnology and food products; (4) food safety; (5) the relationship between diet, nutrition, and health; and (6) health-related claims for food. Title IX: Automation of FDA - Directs the Secretary, through the Commissioner, to automate appropriate activities of the FDA to ensure timely review of activities regulated under the FDCA. Authorizes appropriations. Title X: Compensation and Employment Requirements for FDA and EPA Scientists - Requires the Director of the Office of Personnel Management to ensure, to the extent practicable, that the level of compensation and employment requirements are comparable for scientists employed by the FDA and by the Environmental Protection Agency. Title XI: Funding Floor for FDA - Declares that, notwithstanding any other provisions of law, there shall be appropriated no less than a specified amount each fiscal year for the activities of the FDA. Title XII: Plan of Management Initiatives - Directs the Secretary, through the Commissioner, to contract for a study of the management initiatives undertaken to assess, prioritize, and improve the efficiency and productivity of the FDA. Authorizes appropriations.

00 Introduced in Senate May 29, 2002

FDA Revitalization Act - Title I: Power of FDA Over Real Property, Buildings, and Facilities - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to grant the Secretary of Health and Human Services specified powers in connection with real property, buildings, and facilities (such as acquiring and disposing of property, leasing buildings, and accepting gifts) to facilitate the transaction of the business of the Food and Drug Administration (FDA). Title II: Senior Scientific Health Service - Amends the Public Health Service Act to authorize the establishment of a Senior Scientific Health Service, outside the competitive civil service, whose members may be appointed based solely on distinction and achievement in the fields of biomedical research or clinical research evaluation. Amends Federal law relating to physicians' comparability allowances to include any physician or dentist who is paid under provisions of this title. Title III: Recovery and Retention of Fees for FOIA Requests - Amends the FDCA to authorize the Secretary, through the Commissioner of Food and Drugs, to charge fees to recover direct and indirect costs incurred in processing Freedom of Information Act requests for records obtained or created under the Act. Title IV: Small Business Training and Technical Assistance - Amends the FDCA to authorize the Secretary, through the Commissioner, to establish an office to provide technical and other nonfinancial assistance to small manufacturers of medical devices, drugs, cosmetics, and foods to assist the manufacturers in complying with the Act. Authorizes appropriations for FY 1990 through 1992. Title V: Biotechnology Demonstration Project - Directs the Secretary to establish a demonstration project allowing the use of the facilities of any public or private cooperative with the permission of and in conjunction with the cooperative to promote the development of biotechnology. Authorizes appropriations for FY 1990 through 1992. Title VI: Training and Loan Repayment Programs - Authorizes grants to public or nonprofit academic institutions, including schools of medicine, dentistry, pharmacy, and food science, to enable such institutions to develop core curriculum programs to train individuals in the field of regulatory review. Requires obligated service of grantees as FDA employees. Authorizes appropriations for FY 1990 through 1992 for such grants. Directs the Secretary to establish a loan repayment program under which the Secretary must repay loans incurred by individuals to obtain training in regulatory review in exchange for the individuals serving a period of time as employees of the FDA. Directs the Secretary to: (1) issue regulations to carry out these provisions; and (2) carry out the program, to the extent practicable, in a manner that is consistent with the National Health Service Corps Loan Repayment Program. Authorizes appropriations for FY 1990 through 1992. Title VII: Scientific Review Groups - Authorizes the Commissioner of Food and Drugs to establish such technical and scientific review groups as necessary to carry out the functions of the FDA. Title VIII: Human Food Safety, Technology, and Nutrition Advisory Committee - Directs the Secretary to establish the Human Food Safety, Technology, and Nutrition Advisory Committee to advise the Secretary and the Commissioner of Food and Drugs on issues involving food for human consumption, including: (1) food technology and production; (2) food research and development; (3) biotechnology and food products; (4) food safety; (5) the relationship between diet, nutrition, and health; and (6) health-related claims for food. Title IX: Automation of FDA - Directs the Secretary, through the Commissioner, to automate appropriate activities of the FDA to ensure timely review of activities regulated under the FDCA. Authorizes appropriations. Title X: Compensation and Employment Requirements for FDA and EPA Scientists - Requires the Director of the Office of Personnel Management to ensure, to the extent practicable, that the level of compensation and employment requirements are comparable for scientists employed by the FDA and by the Environmental Protection Agency. Title XI: Funding Floor for FDA - Declares that, notwithstanding any other provision of law, there shall be appropriated no less than a specified amount each fiscal year for the activities of the FDA.

Sponsors

Timeline

Nov 28, 1990

Signed by President.

Nov 28, 1990

Signed by President.

Nov 28, 1990

Became Public Law No: 101-635.

Nov 28, 1990

Became Public Law No: 101-635.

Nov 19, 1990

Presented to President.

Nov 19, 1990

Presented to President.

Nov 13, 1990

Measure Signed in Senate.

Oct 27, 1990

Mr. Sharp moved to suspend the rules and pass the bill.

Oct 27, 1990

Mr. Whittaker demanded a second on the motion to suspend the rules.

Oct 27, 1990

Considered under suspension of the rules.

Oct 27, 1990

On ordering a second Agreed to without objection.

Oct 27, 1990

DEBATE - The House proceeded with forty minutes of debate.

Oct 27, 1990

At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 5, rule I, the chair announced that further proceedings on the motion would be postponed until Oct. 27.

Oct 27, 1990

Considered as unfinished business.

Oct 27, 1990

Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.

Oct 27, 1990

On motion to suspend the rules and pass the bill Agreed to by voice vote.

Oct 27, 1990

Motion to reconsider laid on the table Agreed to without objection.

Oct 25, 1990

Measure laid before Senate by unanimous consent.

Oct 25, 1990

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

Oct 25, 1990

Passed Senate with an amendment by Voice Vote.

Oct 25, 1990

Message on Senate action sent to the House.

Oct 25, 1990

Received in the House.

Oct 25, 1990

Referred to the House Committee on Energy and Commerce.

Feb 1, 1990

Committee on Labor and Human Resources. Reported to Senate by Senator Kennedy with an amendment in the nature of a substitute. With written report No. 101-242.

Feb 1, 1990

Committee on Labor and Human Resources. Reported to Senate by Senator Kennedy with an amendment in the nature of a substitute. With written report No. 101-242.

Feb 1, 1990

Placed on Senate Legislative Calendar under General Orders. Calendar No. 440.

Nov 1, 1989

Committee on Labor and Human Resources. Ordered to be reported with an amendment in the nature of a substitute favorably.

May 17, 1989

Committee on Labor and Human Resources requested executive comment from Department of Health and Human Services.

Apr 19, 1989

Introduced in Senate

Apr 19, 1989

Read twice and referred to the Committee on Labor and Human Resources.

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