[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 5123 Introduced in Senate (IS)]
<DOC>
117th CONGRESS
2d Session
S. 5123
To amend the Controlled Substances Act to modify the registration
requirements relating to research, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
November 17, 2022
Mr. Booker (for himself and Mr. Paul) introduced the following bill;
which was read twice and referred to the Committee on the Judiciary
_______________________________________________________________________
A BILL
To amend the Controlled Substances Act to modify the registration
requirements relating to research, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Breakthrough Therapies Act''.
SEC. 2. REGISTRATION REQUIREMENTS RELATED TO RESEARCH.
(a) Alternative Registration Process for Schedule I Research.--
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended
by adding at the end the following new subsection:
``(l) Special Provisions for Those Conducting Certain Research With
Schedule I Controlled Substances.--
``(1) In general.--Notwithstanding subsection (f), a
practitioner may conduct research that is described by
paragraph (2) and that is with 1 or more schedule I substances
if one of the following conditions is satisfied:
``(A) Researcher with a current schedule i or ii
research registration.--If the practitioner is
registered to conduct research with a controlled
substance in schedule I or II, the practitioner may
conduct research under this paragraph 30 days after the
practitioner has sent a notice to the Attorney General
containing the following information, with respect to
each substance with which the research will be
conducted:
``(i) The chemical name of the substance.
``(ii) The quantity of the substance to be
used in such research.
``(iii) Demonstration that the research is
in the category described by paragraph (2),
which demonstration can be satisfied--
``(I) in the case of a grant,
contract, cooperative agreement, or
other transaction, or intramural
research project, by identifying the
sponsoring agency and supplying
information related to the grant,
contract, cooperative agreement, other
transaction, or project; or
``(II) in the case of an
application under section 505(i) of the
Federal Food, Drug, and Cosmetic Act,
by supplying the application number and
the sponsor of record on such
application.
``(iv) Demonstration that the researcher is
authorized to conduct research with respect to
the substance under the laws of the State in
which the research will take place.
``(B) Researcher without a current schedule i or
ii.--
``(i) Research registration.--If the
practitioner is not currently registered to
conduct research with a controlled substance in
schedule I or II, the practitioner may send a
notice to the Attorney General containing the
information listed in subparagraph (A), with
respect to each substance with which the
research will be conducted, and the Attorney
General will treat such notice as a sufficient
application for a research registration. Not
later than 45 days of receiving such a notice
that contains all information required by
subparagraph (A), the Attorney General shall
register the applicant, or serve an order to
show cause upon the applicant in accordance
with section 824(c) of this title.
``(C) Verification of information.--On request from
the Attorney General, the Secretary of Health and Human
Services or the Secretary of Veterans Affairs, as
appropriate, shall verify information submitted by an
applicant under subparagraph (A)(iii).
``(2) Research subject to expedited procedure.--Research is
described by this paragraph if--
``(A) the research is the subject of an application
under section 505(i) of the Federal Food, Drug, and
Cosmetic Act for the investigation of a drug which is
in effect in accordance with section 312.40 of title
21, Code of Federal Regulations; or
``(B) the research is conducted by the Department
of Health and Human Services or the Department of
Veterans Affairs or is funded partly or entirely by a
grant, contract, cooperative agreement, or other
transaction from the Department of Health and Human
Services, Department of Veterans Affairs, or a State
health department.
``(3) Electronic submissions.--The Attorney General shall
provide a means to permit practitioners to submit notifications
under paragraph (1) electronically.
``(4) Limitation on amounts.--A practitioner conducting
research with a schedule I substance pursuant to this
subsection shall only be permitted to possess the amounts of
schedule I substance identified in--
``(A) the notification to the Attorney General
under paragraph (1); or
``(B) a supplemental notification that the
practitioner may send if the practitioner needs
additional amounts for the research, which supplemental
notification shall include the registrant's name, the
additional quantity needed of the substance, and an
attestation that the research to be conducted with the
substance is consistent with the scope of the research
that was the subject of the notification under
paragraph (1).
``(5) Importation and exportation requirements not
affected.--Nothing in this section alters the requirements of
part A of title III, regarding the importation and exportation
of controlled substances.''.
(b) Separate Registrations Not Required for Additional Researcher
in Same Institution.--Section 302 of the Controlled Substances Act (21
U.S.C. 822) is amended in subsection (c), by adding the following
paragraph:
``(4) An agent or employee of a research institution that
is conducting research with a controlled substance if--
``(A) such agent or employee is acting within the
scope of his or her professional practice;
``(B) another agent or employee of such institution
is registered to conduct research with a controlled
substance in the same schedule;
``(C) the researcher who is so registered--
``(i) informs the Attorney General of the
name, position title, and employing institution
of the agent or employee who is not separately
registered;
``(ii) authorizes such agent or employee to
perform research under the registered
researcher's registration; and
``(iii) affirms that all acts taken by such
agent or employee involving controlled
substances shall be attributable to the
registered researcher, as if the researcher had
directly committed such acts, for purposes of
any proceeding under section 304(a) (21 U.S.C.
824(a)) to suspend or revoke the registration
of the registered researcher; and
``(D) the Attorney General does not, within 30 days
of receiving the information, authorization, and
affirmation described in subparagraph (C), refuse, for
a reason listed in section 304(a) (21 U.S.C. 824(a)),
to allow such agent or employee to possess such
substance without a separate registration.''.
(c) Single Registration for Related Research Sites.--Such section
302 is further amended in subsection (e) by adding at the end the
following new paragraph:
``(3)(A) Notwithstanding paragraph (1), a person registered
to conduct research with a controlled substance under section
303(f) may conduct such research under a single registration
if--
``(i) such research occurs exclusively on sites all
of which are within the same city or county and are
under the control of the same institution,
organization, or agency; and
``(ii) the researcher notifies the Attorney General
of all sites where the research will be conducted or
where the controlled substance will be stored or
administered prior to commencing such research.
``(B) A site described by subparagraph (A) shall be
included in such registration only if the researcher has
notified the Attorney General of such site--
``(i) in the application for such registration; or
``(ii) before the research is conducted, or before
the controlled substance is stored or administered, at
such site.
``(C) The Attorney General may, in consultation with the
Secretary of Health and Human Services, issue regulations
addressing--
``(i) the manner in which controlled substances may
be delivered to the research sites described in
subparagraph (A);
``(ii) the storage and security of controlled
substances at such research sites;
``(iii) the maintenance of records for such
research sites; and
``(iv) any other matters necessary to ensure
effective controls against diversion at such research
sites.''.
(d) New Inspection Not Required in Certain Situations.--Such
section 302 is further amended in subsection (f)--
(1) by striking ``(f) The'' and inserting ``(f)(1) The'';
and
(2) by adding a new paragraph, as follows:
``(2)(A) If a person is registered to conduct research with
a controlled substance and applies for a registration, or for a
modification of a registration, to conduct research with a
second controlled substance that is in the same schedule as the
first controlled substance, or is in a schedule with a higher
numerical designation than the schedule of the first controlled
substance, a new inspection by the Attorney General of the
registered location is not required.
``(B) Nothing in this paragraph shall prohibit the Attorney
General from conducting any inspection if the Attorney General
deems it necessary to ensure that the registrant maintains
effective controls against diversion.''.
(e) Continuation of Research on Substances Newly Added to Schedule
I.--Such section 302 is further amended by adding at the end the
following new subsection:
``(h) Continuation of Research on Substances Newly Added to
Schedule I.--If a person is conducting research on a substance at the
time the substance is added to schedule I, and such person is already
registered to conduct research with a controlled substance in schedule
I, then--
``(1) the person shall, not later than 90 days of the
scheduling of the newly scheduled substance, submit a completed
application for registration or modification of existing
registration, to conduct research on such substance, in
accordance with the regulations issued by the Attorney General;
``(2) the person may, notwithstanding subsections (a) and
(b), continue to conduct the research on such substance until
the person withdraws such application or until the Attorney
General serves on the person an order to show cause proposing
the denial of the application pursuant to section 304(c);
``(3) if the Attorney General serves such an order to show
cause and the person requests a hearing, such hearing shall be
held on an expedited basis and not later than 45 days after the
request is made, except that the hearing may be held at a later
time if so requested by the person; and
``(4) if the person sends a copy of the application
referred to in that paragraph to a manufacturer or distributor
of such substance, receipt of such copy by such manufacturer or
distributor shall constitute sufficient evidence that the
person is authorized to receive such substance.''.
(f) Treatment of Certain Manufacturing Activities as Coincident to
Research.--Such section 302 (21 U.S.C. 822) is further amended by
adding at the end the following new subsection:
``(j) Treatment of Certain Manufacturing Activities as Coincident
to Research.--
``(1) In general.--Except as specified in paragraph (3), a
person who is registered to perform research on a controlled
substance may perform manufacturing activities with small
quantities of that substance, including activities listed in
paragraph (2), without being required to obtain a manufacturing
registration, if such activities are performed for the purpose
of the research and if the activities and the quantities of the
substance involved in those activities are stated in--
``(A) a notification submitted to the Attorney
General under section 303(l);
``(B) a protocol filed with an application for
registration approval, under section 303(f); or
``(C) a notification to the Attorney General that
includes the registrant's name and an attestation that
the research to be conducted with the small quantities
of manufactured substance is consistent with the scope
of the research that is the basis for the registration.
``(2) Activities included.--Activities permitted under
paragraph (1) include--
``(A) processing the substance to create extracts,
tinctures, oils, solutions, derivatives, or other forms
of the substance consistent the information provided as
part of a notification submitted to the Attorney
General under section 303(l) (21 U.S.C. 823(l)) or a
research protocol filed with the application for
registration approval; and
``(B) dosage form development studies performed for
the purpose of satisfying FDA regulatory requirements
for submitting an investigational new drug application.
``(3) Exception regarding marihuana.--The authority under
paragraph (1) to manufacture substances does not include
authority to grow marihuana.''.
(g) Transparency Regarding Special Procedures.--Section 303 of such
Act (21 U.S.C. 823) is further amended by adding at the end the
following new subsection:
``(m) Transparency Regarding Special Procedures.--
``(1) In general.--If the Attorney General determines, with
respect to a controlled substance, that an application by a
practitioner to conduct research with such substance should be
considered under a process, or subject to criteria, different
from the process or criteria applicable to applications to
conduct research with other controlled substances in the same
schedule, the Attorney General shall make public, including by
posting on the website of the Drug Enforcement Administration--
``(A) the identities of all substances for which
such determinations have been made;
``(B) the process and criteria that shall be
applied to applications to conduct research with such
substances; and
``(C) how such process and criteria differ from
those applicable to applications to conduct research
with other controlled substances in the same schedule.
``(2) Timing of posting.--The Attorney General shall make
such information public upon making such determination,
regardless of whether a practitioner has submitted such an
application at that time.''.
SEC. 3. CURRENTLY ACCEPTED MEDICAL USE WITH SEVERE RESTRICTIONS.
(a) Definitions.--Section 102 of the Controlled Substances Act (21
U.S.C. 802) is amended by inserting after paragraph (7) the following:
``(7)(A) Subject to subparagraph (B), the term `currently
accepted medical use with severe restrictions', with respect to
a drug or other substance, includes a drug or other substance
that is an active moiety or active ingredient (whether in
natural or synthetic form) of an investigational new drug for
which a waiver is in effect under section 505(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or section
351(a)(3) of the Public Health Service Act (42 U.S.C.
262(a)(3)) and that the Secretary--
``(i) designates as a breakthrough therapy under
section 506(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356(a)); or
``(ii) authorizes for expanded access under
subsection (b) or (c) of section 561 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb), either
alone or as part of a therapeutic protocol, to treat
patients with serious or life-threatening diseases for
which no comparable or satisfactory therapies are
available.
``(B) A drug or other substance shall not meet the criteria
under subparagraph (A) for having a currently accepted medical
use with severe restrictions if--
``(i) in the case of a drug or other substance
described in subparagraph (A)(ii)--
``(I) the Secretary places the expanded
access or protocol for such drug on clinical
hold as described in section 312.42 of title
21, Code of Federal Regulations (or any
successor regulations);
``(II) there is no other investigational
new drug containing the drug or other substance
for which expanded access has been authorized
under section 561(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb(a)); and
``(III) the drug or other substance does
not meet the requirements of subparagraph
(A)(i); or
``(ii) the drug or other substance is an active
moiety or active ingredient (whether natural or
synthetic) of an application approved under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) or section 351 of the Public Health Service Act
(42 U.S.C. 262).''.
(b) Authority and Criteria for Classification of Substances.--
Section 201(j) of the Controlled Substances Act (21 U.S.C. 811(j)) is
amended--
(1) in paragraph (1), by inserting ``a drug designated as a
breakthrough therapy under section 506(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356(a)), or a drug authorized
for expanded access under subsection (b) or (c) of section 561
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb)'' after ``subsection (f),''; and
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``; or'' and
inserting a semicolon;
(B) in subparagraph (B), by striking the period at
the end and inserting a semicolon; and
(C) by adding at the end the following:
``(C) the date on which the Attorney General
receives notification from the Secretary of Health and
Human Services that the Secretary has designated a drug
as a breakthrough therapy under section 506(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a))
or authorized a drug for expanded access under
subsection (b) or (c) of section 561 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb); or
``(D) the date on which the Attorney General
receives any written notification demonstrating that
the Secretary, before the date of enactment of this
subparagraph, designated a drug as a breakthrough
therapy under section 506(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356(a)) or authorized a
drug for expanded access under subsection (b) or (c) of
section 561 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb).''.
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