Adding Middle East Respiratory Syndrome to the FDA Priority Review Voucher Program Act

Bill: 114-hr-6033
Sponsor: full_name: Rep. Peters, Scott H. [D-CA-52]
Introduced: 2016-09-14
Policy area: Health
Subjects: Cardiovascular and respiratory health

Drug safety, medical device, and laboratory regulation

Drug therapy

Infectious and parasitic diseases
Latest action: action_date: 2016-09-14
text: Referred to the House Committee on Energy and Commerce.

Summaries:
action_date: 2016-09-14
action_desc: Introduced in House
text: <p><b>Adding Middle East Respiratory Syndrome to the FDA Priority Review Voucher Program Act</b></p> This bill amends the Federal Food, Drug, and Cosmetic Act to add Middle East respiratory syndrome to the list of tropical diseases under the priority review voucher program, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a tropical disease. (A voucher entitles the holder to have a future new drug or biological product application acted upon by the Food and Drug Administration within six months.)

tv_txt: I 114th CONGRESS 2d Session H. R. 6033 IN THE HOUSE OF REPRESENTATIVES September 14, 2016 Mr. Peters (for himself, Mr. Rothfus , and Mr. Brendan F. Boyle of Pennsylvania ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To expand the tropical disease product priority review voucher program to encourage treatments for the Middle East respiratory syndrome.

1. Short title This Act may be cited as the Adding Middle East Respiratory Syndrome to the FDA Priority Review Voucher Program Act . 2. Expanding tropical disease product priority review voucher program to encourage treatments for Middle East respiratory syndrome Section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n(a)(3) ) is amended— (1) by redesignating subparagraph (S) as subparagraph (T); and (2) by inserting after subparagraph (R) the following: (S) Middle East respiratory syndrome. .