POLICY BRIEFINGS


NIH Issue Draft Policy on Use of IRBs


The National Institutes of Health (NIH) said it is seeking comments by January 29, 2015 on proposed new policies that would allow for the use of a single institutional review board (IRB) for studies funded by NIH grants. The NIH director said that using single IRBs in multi-site studies would help to reduce duplication of effort, speed the initiation of important research and save time and taxpayer funds. Exceptions would be allowed in cases in which a local IRB review is needed to address the needs of certain participants or in cases where required by specific federal, state or tribal laws or regulations.


Upcoming Health-Related Hearings


House Energy and Commerce Health Subcommittee: hearing to be held titled “Setting Fiscal Priorities;” 10:30 a.m., 2123 Rayburn Bldg.; Dec. 9.

House Oversight and Government Reform Committee: hearing to be held titled “Examining ObamaCare Transparency Failures;” 9:30 a.m., 2154 Rayburn; Dec. 9.

House Energy and Commerce Health Subcommittee: hearing to be held titled “Examining FDA’s Role in the Regulation of Genetically Modified Food Ingredients;” 10:15 a.m., 2123 Rayburn Bldg.; Dec. 10.

Senate Foreign Relations African Affairs Subcommittee: hearing to be held titled “The Ebola Epidemic: The Keys to Success for the International Response;” 10:30 a.m., 419 Dirksen Bldg.; Dec. 10


Health Legislation Recently Introduced


H.R. 5780 (MEDICARE), to amend Title XVIII of the Social Security Act to improve the integrity of Medicare, and for other purposes; BRADY of Texas; jointly, to the committees on Ways and Means and Energy and Commerce, Dec. 2.

H.RES. 769 (SYSTEMS INFRASTRUCTURE SECURITY),expressing the sense of the House of Representatives that the health-care, energy, telecommunications and other sectors of the U.S. economy should continue their sector-specific efforts to protect critical infrastructure, to prevent information security breaches and to prevent cybersecurity breaches; TERRY; to the Committee on Energy and Commerce, Dec. 2.

H.R. 5790 (OUTCOMES), to authorize the director of the National Institutes of Health to design and enter into agreements for the implementation of prize competitions with the goal of improving health outcomes and thereby reducing federal expenditures; YOUNG of Indiana; jointly, to the committees on Energy and Commerce and Ways and Means, Dec. 3.

S. 2975 (MEDICARE), to amend Title XVIII of the Social Security Act to require state licensure and bid surety bonds for entities submitting bids under the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program, and for other purposes; PORTMAN; to the Committee on Finance, Dec. 4.

S. 2977 (INFORMATION TECHNOLOGY), to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of patient records and certain decision support software; BENNET; to the Committee on Health, Education, Labor and Pensions, Dec. 4.

S. 2979 (VETERANS’ HEALTH), to extend eligibility for hospital care, medical services and nursing home and domiciliary care for certain veterans who served in a theater of combat operations; WALSH; to the Committee on Veterans’ Affairs, Dec. 4.

S. 2980 (MEDICARE), to amend Title XVIII of the Social Security Act to modify payment under Medicare for outpatient department procedures that utilize drugs as supplies, and for other purposes; MENENDEZ; to the Committee on Finance, Dec. 4.

H.R. 5797 (APPROPRIATIONS), to make a supplemental appropriation for the Public Health Emergency Fund, and for other purposes; DELAURO; jointly, to the committees on Appropriations and the Budget, Dec. 4.



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