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113th Congress Rept. 113-565
HOUSE OF REPRESENTATIVES
2d Session Part 1
IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT
July 29, 2014.--Ordered to be printed
Mr. Upton, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 4299]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 4299) to amend the Controlled Substances Act
with respect to drug scheduling recommendations by the
Secretary of Health and Human Services, and with respect to
registration of manufacturers and distributors seeking to
conduct clinical testing, having considered the same, report
favorably thereon without amendment and recommend that the bill
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 2
Committee Consideration.......................................... 3
Committee Votes.................................................. 3
Committee Oversight Findings..................................... 3
Statement of General Performance Goals and Objectives............ 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 3
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 4
Committee Cost Estimate.......................................... 4
Congressional Budget Office Estimate............................. 4
Federal Mandates Statement....................................... 4
Duplication of Federal Programs.................................. 5
Disclosure of Directed Rule Makings.............................. 5
Advisory Committee Statement..................................... 5
Applicability to Legislative Branch.............................. 5
Section-by-Section Analysis of the Legislation................... 5
Changes in Existing Law Made by the Bill, as Reported............ 5
Purpose and Summary
The bill would amend the Controlled Substances Act (CSA) to
require the Attorney General to issue an interim final rule
placing a drug or substance that has not been marketed
previously in the United States and that has abuse potential in
the CSA schedule recommended by the Secretary of Health and
Human Services (HHS) within 45 days of receiving such
recommendation. If the drug or substance has been approved by
the Food and Drug Administration (FDA), upon issuance of the
interim final rule, marketing of the product is permitted,
subject to the controls included in the schedule.
Under current law, if the Secretary of HHS recommends that
a drug or substance be decontrolled, the Attorney General shall
not control the drug or substance. The bill does not alter the
Attorney General's ministerial obligation to carry out the
The bill also would amend the CSA to require the Attorney
General, within 180 days of receiving an application for
registration to manufacture or distribute a controlled
substance that indicates the substance will be used only in
connection with clinical trials, to make a final decision on
whether to approve the application or provide notice to the
applicant of the outstanding issues that must be resolved and
an estimated date on which a final decision will be made. The
bill does not force the Attorney General to make a decision,
but brings transparency to the process.
Background and Need for Legislation
In addition to requiring approval by the FDA, drugs and
substances that have not been been marketed previously in the
United States and that have abuse potential also must be
scheduled under the CSA by the DEA before a company can begin
marketing its product. In recent years, an increasing number of
companies have had their product launches delayed because of
lengthy and unpredictable review times associated with DEA
During FDA's approval process, the agency examines the
abuse potential of the new drug and makes a scheduling
recommendation through the Secretary of HHS to the DEA. In
formulating its recommendations, the FDA uses an eight part
test outlined in Section 201(c) of the CSA. Currently, the DEA
also utilizes the eight part test, but FDA's decisions related
to scientific and medical matters are binding on the DEA.
Because of the binding nature of FDA's decisionmaking in these
areas and due to the fact that DEA's primary examination
typically involves post-market experience with the drug, over
the past fifteen years, DEA has not made any scheduling
decision for a new drug that was contrary to the FDA
recommendation. H.R. 4299 would remove this duplicative DEA
review process for new drugs and require DEA to take the
ministerial step of issuing an interim final rule within 45
days of receiving FDA's scheduling recommendation so companies
can begin marketing their product if it has been approved by
FDA, and patients can have access to the new therapy. The DEA
would retain its authority to transfer the drug between
schedules under Section 201 of the CSA.
Inconsistency and lengthy review times at DEA are not
limited to scheduling decisions for new drugs, but also apply
to the review of registration applications submitted by
companies in advance of conducting clinical trials. The DEA
registration does not distinguish between the manufacturing of
a controlled substance for marketing and the manufacturing of a
controlled substance for the use in clinical trials. There is
no timetable for the DEA to grant approval of registration
applications, and there is no process for the applicant to
determine the reasons for a delay in the application. H.R. 4299
would bring transparency and predictability to the registration
process so companies can properly plan clinical trial schedules
for new therapies.
The Committee on Energy and Commerce held a hearing on
April 7, 2014.
On May 28, 2014, the Subcommittee on Health met in open
markup session and approved H.R. 4299, Improving Regulatory
Transparency for New Medical Therapies Act, for full Committee
consideration by a voice vote. On June 10, 2014, the full
Committee met in open markup session and approved H.R. 4299 by
a voice vote.
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 4299. A motion by Mr. Upton to order H.R. 4299 reported to
the House, without amendment, was agreed to by a voice vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee held a hearing and made
findings that are reflected in this report.
Statement of General Performance Goals and Objectives
The objective of this legislation is to facilitate patient
access to new therapies in an efficient and transparent manner,
while ensuring appropriate controls are in place under the CSA.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
4299 would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the Rules of the House of Representatives, the Committee
finds that H.R. 4299 contains no earmarks, limited tax
benefits, or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
June 26, 2014.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 4299, the
Improving Regulatory Transparency for New Medical Therapies
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Mark
Douglas W. Elmendorf.
H.R. 4299--Improving Regulatory Transparency for New Medical Therapies
H.R. 4299 would modify the administrative procedures
followed by the Department of Justice in regulating new drugs
that are already approved by the Food and Drug Administration
and in authorizing drugs to be used in clinical trials. The
legislation would aim to streamline the current review and
approval process. CBO estimates that implementing the bill
would have no significant costs to the federal government.
Enacting the legislation would not affect direct spending or
revenues; therefore, pay-as-you-go procedures do not apply.
H.R. 4299 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act and
would impose no costs on state, local, or tribal governments.
The CBO staff contact for this estimate is Mark Grabowicz.
The estimate was approved by Theresa Gullo, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Duplication of Federal Programs
No provision of H.R. 4299 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that enacting H.R. 4299
specifically directs to be completed zero specific rule makings
within the meaning of 5 U.S.C. 551.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1: Short title
Section 1 provides the short title of ``Improving
Regulatory Transparency for New Medical Therapies Act.''
Section 2: Scheduling of substances included in new FDA-approved drugs
Section 2 amends Section 201 of the CSA (21 U.S.C. 811) by
requiring DEA to issue an interim final rule within 45 days of
receiving FDA's recommendation and place the drug or substance
on the recommended schedule.
Section 3: Enhancing new drug development
Section 3 amends Section 302 of the CSA by requiring DEA,
within 180 days of receiving such an application, to make a
determination on a registration application that includes an
indication that the controlled substance will be used only in
connection with clinical trials, or to provide notice to the
applicant of the outstanding issues that must be resolved along
with an estimated date on which a final decision on the
application will be made.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
CONTROLLED SUBSTANCES ACT
TITLE II--CONTROL AND ENFORCEMENT
* * * * * * *
Part B--Authority To Control; Standards and Schedules
authority and criteria for classification of substances
Sec. 201. (a) * * *
* * * * * * *
(i) Within 45 days of receiving a recommendation from the
Secretary to add a drug or substance that has never been
marketed in the United States to a schedule under this title,
the Attorney General shall, without regard to the findings
required by subsection (a) of this section or section 202(b),
issue an interim final rule, under the exception for good cause
described in subparagraph (B) of section 553(b) of title 5,
United States Code, placing the drug or substance into the
schedule recommended by the Secretary. The interim final rule
shall be made immediately effective under section 553(d)(3) of
title 5, United States Code.
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
persons required to register
Sec. 302. (a) * * *
* * * * * * *
(h)(1) A person who submits an application for registration
to manufacture or distribute a controlled substance in
accordance with this section may indicate on the registration
application that the substance will be used only in connection
with clinical trials of a drug in accordance with section
505(i) of the Federal Food, Drug, and Cosmetic Act.
(2) When an application for registration to manufacture or
distribute a controlled substance includes an indication that
the controlled substance will be used only in connection with
clinical trials of a drug in accordance with section 505(i) of
the Federal Food, Drug, and Cosmetic Act, the Attorney General
(A) make a final decision on the application for
registration within 180 days; or
(B) provide notice to the applicant in writing of--
(i) the outstanding issues that must be
resolved in order to reach a final decision on
the application; and
(ii) the estimated date on which a final
decision on the application will be made.
* * * * * * *