Health Service Act and the sponsor of 
record on such application; or 
‘‘(II) in the case of research de-
scribed in paragraph (2)(B), by iden-
tifying the sponsoring agency and 
supplying the number of the grant, 
contract, cooperative agreement, other 
transaction, or project. 
‘‘(iv) Demonstration that the re-
searcher 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 RESEARCH REGISTRATION.— 
If the practitioner is not currently registered to 
conduct research with a controlled substance in 
schedule I or II— 
‘‘(i) the practitioner may send a no-
tice to the Attorney General containing the 
information listed in subparagraph (A), 
with respect to each substance with which 
the research will be conducted; 
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‘‘(ii) the Attorney General shall treat 
such notice as a sufficient application for 
a research registration; and 
‘‘(iii) within 45 days after receiving 
such a notice that contains all information 
required by subparagraph (A), the Attor-
ney General shall register the applicant, or 
serve an order to show cause upon the ap-
plicant in accordance with section 304(c). 
‘‘(C) VERIFICATION
OF
INFORMATION.— 
On request from the Attorney General, the Sec-
retary of Health and Human Services or the 
Secretary of Veterans Affairs, as appropriate, 
shall verify information submitted by an appli-
cant under subparagraph (A)(iii). 
‘‘(2) RESEARCH SUBJECT TO EXPEDITED PRO-
CEDURE.—Research described in this paragraph is 
research that— 
‘‘(A) is the subject of an application under 
section 505(i) of the Federal Food, Drug, and 
Cosmetic Act or section 351(a)(3) of the Public 
Health Service Act for the investigation of a 
drug which is in effect in accordance with sec-
tion 312.40 of title 21, Code of Federal Regula-
tions; or 
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‘‘(B) is conducted by the Department of 
Health and Human Services, the Department of 
Justice, or the Department of Veterans Affairs 
or is funded partly or entirely by a grant, con-
tract, cooperative agreement, or other trans-
action from the Department of Health and 
Human Services, the Department of Justice, or 
the Department of Veterans Affairs. 
‘‘(3) ELECTRONIC SUBMISSIONS.—The Attorney 
General shall provide a means to allow practitioners 
to submit notifications under paragraph (1) elec-
tronically. 
‘‘(4) LIMITATION ON AMOUNTS.—A practitioner 
conducting research with a controlled substance in 
schedule I pursuant to this subsection shall be al-
lowed to possess only the amounts of the controlled 
substance in schedule I identified in— 
‘‘(A) the notification to the Attorney Gen-
eral under paragraph (1); or 
‘‘(B) if the practitioner needs additional 
amounts for the research, a supplemental notifi-
cation under this subsection that includes the 
practitioner’s name, the additional quantity 
needed of the substance, and an attestation 
that the research to be conducted with the sub-
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stance is consistent with the scope of the re-
search that was the subject of the notification 
under paragraph (1). 
‘‘(5) IMPORTATION
AND
EXPORTATION
RE-
QUIREMENTS NOT AFFECTED.—Nothing in this sec-
tion alters the requirements of part A of title III re-
garding the importation and exportation of con-
trolled substances.’’. 
(b) SEPARATE REGISTRATIONS NOT REQUIRED FOR 
ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sub-
section (c) of section 302 of the Controlled Substances Act 
(21 U.S.C. 822) is amended by adding at the end the fol-
lowing: 
‘‘(4) An agent or employee of a research insti-
tution that is conducting research with a controlled 
substance if— 
‘‘(A) such agent or employee is acting 
within the scope of his or her professional prac-
tice; 
‘‘(B) another agent or employee of such in-
stitution 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 in-
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stitution of the agent or employee who is 
not separately registered; 
‘‘(ii) authorizes such agent or em-
ployee to perform research under the reg-
istered researcher’s registration; and 
‘‘(iii) affirms that all acts taken by 
such agent or employee involving controlled 
substances shall be attributable to the reg-
istered researcher, as if the researcher had 
directly committed such acts, for purposes 
of any proceeding under section 304(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, authoriza-
tion, and affirmation described in subparagraph 
(C), refuse, for a reason listed in section 
304(a), to allow such agent or employee to pos-
sess such substance without a separate registra-
tion.’’. 
(c) SINGLE REGISTRATION FOR RELATED RESEARCH 
SITES.—Such section 302(e) of the Controlled Substances 
Act (21 U.S.C. 822(e)) is amended by adding at the end 
the following: 
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‘‘(4)(A) Notwithstanding paragraph (1), a person 
registered to conduct research with a controlled substance 
under section 303(f) may conduct such research at mul-
tiple sites under a single registration if— 
‘‘(i) such research occurs exclusively at sites 
which are all within the same city or county and are 
all under the control of the same institution, organi-
zation, or agency; and 
‘‘(ii) the researcher notifies the Attorney Gen-
eral, prior to commencing such research, of all sites 
where— 
‘‘(I) the research will be conducted; or 
‘‘(II) the controlled substance will be 
stored or administered. 
‘‘(B) A site described by subparagraph (A) shall be 
included in such registration only if the researcher has no-
tified 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 regu-
lations addressing— 
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‘‘(i) the manner in which controlled substances 
may be delivered to research sites described in sub-
paragraph (A); 
‘‘(ii) the storage and security of controlled sub-
stances at such research sites; 
‘‘(iii) the maintenance of records for such re-
search sites; and 
‘‘(iv) any other matters necessary to ensure ef-
fective controls against diversion at such research 
sites.’’. 
(d) NEW INSPECTION NOT REQUIRED IN CERTAIN 
SITUATIONS.—Subsection (f) of section 302 of the Con-
trolled Substances Act (21 U.S.C. 822) is amended— 
(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 
The’’; and 
(2) by adding at the end the following: 
‘‘(2)(A) A new inspection by the Attorney General of 
a registered location is not required if a person is reg-
istered under this title to conduct research with a con-
trolled substance and applies for a registration, or for a 
modification of a registration, to conduct research with a 
second controlled substance that is— 
‘‘(i) in the same schedule as the first controlled 
substance; or 
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‘‘(ii) is in a schedule with a higher numerical 
designation than the schedule of the first controlled 
substance. 
‘‘(B) Nothing in this paragraph shall prohibit the At-
torney General from conducting any inspection if the At-
torney General deems it necessary to ensure that the reg-
istrant maintains effective controls against diversion.’’. 
(e) CONTINUATION OF RESEARCH ON SUBSTANCES 
NEWLY ADDED TO SCHEDULE I.—Section 302 of the 
Controlled Substances Act (21 U.S.C. 822) is amended 
by adding at the end the following: 
‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES 
NEWLY ADDED TO SCHEDULE I.—If a person is con-
ducting research on a substance at the time the substance 
is added to schedule I, and such person is already reg-
istered under this title to conduct research with a con-
trolled substance in schedule I, then— 
‘‘(1) the person shall, within 90 days of the 
scheduling in schedule I, submit a completed appli-
cation for registration under this title or modifica-
tion of an existing registration under this title, to 
conduct research on such substance, in accordance 
with regulations issued by the Attorney General; 
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‘‘(2) the person may, notwithstanding sub-
sections (a) and (b), continue to conduct the re-
search on such substance until— 
‘‘(A) the person withdraws such applica-
tion; or 
‘‘(B) 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 hear-
ing, 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 applica-
tion required by paragraph (1) 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 AC-
TIVITIES AS COINCIDENT TO RESEARCH.—Section 302 of 
the Controlled Substances Act (21 U.S.C. 822), as amend-
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ed by subsection (e), is further amended by adding at the 
end the following: 
‘‘(i) TREATMENT OF CERTAIN MANUFACTURING AC-
TIVITIES 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 para-
graph (2), without being required to obtain a manu-
facturing registration, if such activities are per-
formed for the purpose of the research and if the ac-
tivities and the quantities of the substance involved 
in those activities are stated in— 
‘‘(A) a notification submitted to the Attor-
ney General under section 303(m); 
‘‘(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 at-
testation 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. 
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‘‘(2) ACTIVITIES
INCLUDED.—Activities per-
mitted under paragraph (1) include— 
‘‘(A) processing the substance to create ex-
tracts, tinctures, oils, solutions, derivatives, or 
other forms of the substance consistent with the 
information provided as part of a notification 
submitted to the Attorney General under sec-
tion 303(m) or a research protocol filed with 
the application for registration approval; and 
‘‘(B) dosage form development studies per-
formed for the purpose of satisfying regulatory 
requirements of the Food and Drug Adminis-
tration 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 mari-
huana.’’. 
(g) TRANSPARENCY REGARDING SPECIAL PROCE-
DURES.—Section 303 of such Act (21 U.S.C. 823), as 
amended by subsection (a), is further amended by adding 
at the end the following: 
‘‘(n) TRANSPARENCY REGARDING SPECIAL PROCE-
DURES.— 
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‘‘(1) IN GENERAL.—If the Attorney General de-
termines, 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 con-
duct 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 will 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 Gen-
eral shall make such information public upon mak-
ing such determination, regardless of whether a 
practitioner has submitted such an application at 
that time.’’. 
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SEC. 8. RULEMAKING. 
(a) INTERIM FINAL RULES.—The Attorney Gen-
eral— 
(1) not later than 1 year of the date of enact-
ment of this Act, shall issue rules to implement this 
Act and the amendments made by this Act; and 
(2) may issue such rules as interim final rules. 
(b) PROCEDURE FOR FINAL RULE.—A rule issued by 
the Attorney General as an interim final rule under sub-
section (a) shall become immediately effective as an in-
terim final rule without requiring the Attorney General to 
demonstrate good cause therefor. The interim final rule 
shall give interested persons the opportunity to comment 
and to request a hearing. After the conclusion of such pro-
ceedings, the Attorney General shall issue a final rule in 
accordance with section 553 of title 5, United States Code. 
SEC. 9. GAO REPORT. 
(a) IN GENERAL.—Not more than 4 years after the 
date of enactment of this Act, the Comptroller General 
of the United States shall submit to the Committees on 
Energy and Commerce and the Judiciary of the House 
of Representatives and the Committee on the Judiciary 
of the Senate a report analyzing the implementation and 
impact, to the extent information is available, of perma-
nent class scheduling pursuant to schedule I(e) of section 
202(c) of the Controlled Substances Act, as added by sec-
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tion 2 of this Act, of fentanyl-related substances (as de-
fined in such schedule I(e)), which report shall include— 
(1) an analysis of the impact on research of 
fentanyl-related substances; 
(2) an analysis of any actions taken to remove 
or reschedule in a different class any fentanyl-re-
lated substance; 
(3) an analysis of the impact of permanent 
scheduling on the unlawful importation, manufac-
ture, trafficking, and use of fentanyl-related sub-
stances, taking into consideration data collected con-
cerning the proliferation of fentanyl-related sub-
stances since class scheduling was instituted; 
(4) an analysis of sentences attributable to 
criminal charges involving fentanyl-related sub-
stances, comparing those sentences to sentences at-
tributable to criminal charges involving fentanyl and 
individually scheduled fentanyl analogues; and 
(5) an analysis of the efficacy of class sched-
uling generally, in terms of reducing the prolifera-
tion of new controlled substance analogues. 
(b) CONSULTATIONS.—In developing the report re-
quired by subsection (a), the Comptroller General— 
(1) shall consider the views of the Secretary of 
Health and Human Services, the Attorney General, 
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the Secretary of Homeland Security, the Secretary 
of State, the Director of the Office of National Drug 
Control Policy, the scientific and medical research 
community, the State and local law enforcement 
community, and the civil rights and criminal justice 
reform communities; and 
(2) to the greatest extent possible, should base 
such report on reliable data and empirical informa-
tion. 
Æ 
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