H.R.2430 – FDA Reauthorization Act of 2017

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Week ending September 8, 2017

H.R.2430 – FDA Reauthorization Act of 2017

Brief

The Congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

The Secretary shall establish a pilot program under which–

“(A) testing laboratories may be accredited, by accreditation bodies meeting criteria specified by the  Secretary, to assess the conformance of a device with certain standards recognized under this section; and

`(B) subject to paragraph (2), determinations by testing laboratories so accredited that a device conforms with such standard or standards shall be accepted by the Secretary for purposes of demonstrating such conformity under this section unless the Secretary finds that a particular such determination shall not be so accepted.

Finding.–The Congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

 (Full text of H.R. 2430 congress.gov)

Sponsor:  Rep. Walden, Greg [R-OR-2] (Introduced 05/16/2017)

VOTES and FLOOR ACTION

HOUSE

On Passage: Passed House by voice vote

House Amendments:

Motion to recommit:

Text of the motion:

SENATE

On Passage: Passed Senate by unanimous consent

Procedural Actions:

Senate Amendments:

COST AND IMPACT

Cost to the taxpayers:  Data not available

Pay-as-you-go requirements:  Data not available

Regulatory and Other Impact:

H.R. 2430 would impose intergovernmental and private‐sector man
dates, as defined in the Unfunded Mandates Reform Act (UMRA), o
n
public and private manufacturers of prescription drugs and medi
cal devices. In addition, the bill would preempt state and loca
l laws that
interfere with the distribution of over‐the‐counter hearing aid
s. CBO estimates that the cost of the mandates on public entiti
es would be
small and fall well below the annual threshold established in U
MRA for intergovernmental mandates ($78 million in 2017, adjust
ed annually
for inflation). However, in aggregate, CBO estimates that the c
ost of the mandates on private entities would well exceed the a
nnual
threshold established in UMRA for private‐sector mandates ($156
million in 2017, adjusted annually for inflation) in each of t
he first five
years the mandates are in effect, primarily because of the requ
irement to pay fees

Dynamic Scoring:   Data not available

Tax Complexity:  Not applicable to this bill.

Earmark Certification:  Data not available

Duplication of programs: Data not available

Direct Rule-Making:  Data not available

Advisory Committee Statement: Data not available

Budget Authority: Data not available

Constitutional Authority:   Assumed.

 

More Bill Information:

 

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