Jul 27

Federal Affairs Activity Report: July 27 – July 31, 2015

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Below is an overview of federal activity in the U.S. House of Representatives, the U.S. Senate, and federal agencies this week related to health care and/or other areas of interest for our clients.

House of Representatives

The House will convene Monday, July 27 at 12:00 p.m.

Education and the Workforce Committee
The Education and Workforce full committee will hold a hearing entitled “Reviewing the Policies and Priorities of the U.S. Department of Health and Human Services (HHS).”
Witnesses: Sylvia Mathews Burwell, HHS Secretary
Date and time: Tuesday, July 28; 10:00 a.m. EDT
Location: 2175 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Ways and Means Committee
The House Ways and Means Health Subcommittee will hold a hearing on rural health care disparities created by Medicare regulations.
Witnesses: TBA
Date and time: Tuesday, July 28; 10:00 a.m. EDT
Location: 1100 Longworth House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Energy and Commerce Committee
The House Energy and Commerce full committee will hold a markup of the following legislation: H.R.985, the “Concrete Masonry Products Research, Education, and Promotion Act of 2015”; H.R.1344, the “Early Hearing Detection and Intervention Act of 2015”; H.R.1462, the “Protecting Our Infants Act of 2015”; H.R.1725, the “National All Schedules Prescription Electronic Reporting Authorization Act of 2015”; H.R.2820, the “Stem Cell Therapeutic and Research Reauthorization Act of 2015”; and H.R.3154, the “E-Warranty Act of 2015.”
Date and time: Tuesday, July 28; 5:00 p.m. EDT
Location: 2123 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.


 

Senate

The Senate will convene Monday, July 27. No healthcare related votes are expected in the Senate this week.


 

Federal Agencies

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 10124) – Workshop
The Food and Drug Administration (FDA) will host a public, two day workshop on “Robotically-Assisted Surgical (RAS) Devices: Challenges and Opportunities,” to obtain information on the current challenges and opportunities related to robotically-assisted surgical Class II medical devices. Feedback and comments received throughout the workshop will be taken into consideration for future RAS regulatory controls.
Date and Time: Monday – Tuesday, July 27-28 at 8:00 AM
Location: FDA’s White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room, Room 1503A, Silver Spring, Md.
To register for the event and view the agenda, click HERE.

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 40070) – Meeting
The Food and Drug Administration (FDA) will hold a meeting of the Science Board to the Food and Drug Administration to accept a report from the Commissioner’s Fellowship Program Evaluation subcommittee and a progress report from the Science Looking Forward subcommittee. The meeting is meant to provide platform to address urgent and serious drug-resistant threats that affect society. During the meeting there will also be an overview of two scientific activities from the Center for Veterinary Medicine and strategies to implement targeted directives contained in the National Strategy for Combating Antibiotic-Resistant Bacteria.
Date and Time: Wednesday, July 29 at 8:30 am
Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room, Room 1503 B and C, Silver Spring, Md.
The agenda can be found HERE.

Defense Department (DOD); Office of the Secretary of Defense (F.R. Page 7844) – Meeting
The Food and Drug Administration (FDA) will host a public meeting on the reauthorization of the Medical Device User Fee Amendments (MDUFA) for FY2018 through FY2022. The meeting objectives include reviewing actuarial assumptions and methods needed for calculation of various user fees. In September 2017, the current legislative authority for the medical device user fee program will terminate and new legislation will be necessary for the FDA to continue gathering user fees for the medical device program.
Date and Time: Friday, July 31 at 10:00 AM
Location: 4800 Mark Center Drive, Conference Room 18, Level B1, Alexandria, Va.
The agenda is available HERE.