I 
114TH CONGRESS 
1ST SESSION H. R. 2424 
To amend the Federal Food, Drug, and Cosmetic Act with respect to training 
and oversight in least burdensome appropriate means concept. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 19, 2015 
Mr. SHIMKUS introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to training and oversight in least burdensome 
appropriate means concept. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. TRAINING AND OVERSIGHT IN LEAST BURDEN-
SOME APPROPRIATE MEANS CONCEPT. 
(a) IN GENERAL.—Section 513 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 
inserting after subsection (i) the following: 
‘‘(j) TRAINING AND OVERSIGHT IN LEAST BURDEN-
SOME APPROPRIATE MEANS CONCEPT.— 
VerDate Sep 11 2014 
02:18 May 27, 2015
Jkt 049200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H2424.IH
H2424
SSpencer on DSK4SPTVN1PROD with BILLS
‘‘(1) TRAINING.—Each employee of the Food 
and Drug Administration who is involved in the re-
view of premarket submissions under section 515 or 
section 510(k), including supervisors, shall receive 
training regarding the meaning and implementation 
of the least burdensome appropriate means concept 
in the context of the use of that term in subsections 
(a)(3)(D) and (i)(1)(D) of this section and in section 
515(c)(5). 
‘‘(2) GUIDANCE DOCUMENTS.— 
‘‘(A) DRAFT
UPDATED
GUIDANCE.—Not 
later than 12 months after the date of enact-
ment of the 21st Century Cures Act, the Sec-
retary shall issue a draft guidance document 
updating the October 4, 2002, guidance docu-
ment entitled ‘The Least Burdensome Provision 
of the FDA Modernization Act of 1997: Con-
cept and Principles; Final Guidance for FDA 
and Industry’. 
‘‘(B) MEETING
OF
STAKEHOLDERS.—In 
developing such draft guidance document, the 
Secretary shall convene a meeting of stake-
holders to ensure a full record to support the 
publication of such document. 
VerDate Sep 11 2014 
02:18 May 27, 2015
Jkt 049200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2424.IH
H2424
SSpencer on DSK4SPTVN1PROD with BILLS
‘‘(3) OMBUDSMAN AUDIT.—Not later than 18 
months after the date of issuance of final version of 
the draft guidance under paragraph (2), the om-
budsman for the organizational unit of the Food and 
Drug Administration responsible for the premarket 
review of devices shall— 
‘‘(A) conduct, or have conducted, an audit 
of the training described in paragraph (1); and 
‘‘(B) include in such audit interviews with 
a representative sample of persons from indus-
try regarding their experience in the device pre-
market review process.’’. 
(b) ADDITIONAL INFORMATION REGARDING PRE-
MARKET APPLICATIONS.—Subsection (c) of section 515 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360e) is amended by adding at the end the follows: 
‘‘(5)(A) Whenever the Secretary requests additional 
information from an applicant regarding an application 
under paragraph (1), the Secretary shall consider the least 
burdensome appropriate means necessary to demonstrate 
device safety and effectiveness, and request information 
accordingly. 
‘‘(B) For purposes of subparagraph (A), the term 
‘necessary’ means the minimum required information that 
would support a determination by the Secretary that an 
VerDate Sep 11 2014 
21:31 May 28, 2015
Jkt 049200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2424.IH
H2424
SSpencer on DSK4SPTVN1PROD with BILLS