[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1308.43]

[Page 107-108]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1308_SCHEDULES OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1308.43  Initiation of proceedings for rulemaking.

    (a) Any interested person may submit a petition to initiate 
proceedings for the issuance, amendment, or repeal of any rule or 
regulation issuable pursuant to the provisions of section 201 of the 
Act.
    (b) Petitions shall be submitted in quintuplicate to the 
Administrator in the following form:

________________________________________________________________________
(Date)
Administrator, Drug Enforcement
Administration
Department of Justice,
Washington, DC 20537.
    Dear Sir: The undersigned ------------ hereby petitions the 
Administrator to initiate proceedings for the issuance (amendment or 
repeal) of a rule or regulation pursuant to section 201 of the 
Controlled Substances Act.
    Attached hereto and constituting a part of this petition are the 
following:
    (A) The proposed rule in the form proposed by the petitioner. (If 
the petitioner seeks the amendment or repeal of an existing rule, the 
existing rule, together with a reference to the section in the Code of 
Federal Regulations where it appears, should be included.)

[[Page 108]]

    (B) A statement of the grounds which the petitioner relies for the 
issuance (amendment or repeal) of the rule. (Such grounds shall include 
a reasonably concise statement of the facts relied upon by the 
petitioner, including a summary of any relevant medical or scientific 
evidence known to the petitioner.)
    All notices to be sent regarding this petition should be addressed 
to:

________________________________________________________________________

                                 (Name)

________________________________________________________________________

                            (Street Address)

________________________________________________________________________

                            (City and State)

    Respectfully yours,

________________________________________________________________________

                        (Signature of petitioner)

    (c) Within a reasonable period of time after the receipt of a 
petition, the Administrator shall notify the petitioner of his 
acceptance or nonacceptance of the petition, and if not accepted, the 
reason therefor. The Administrator need not accept a petition for filing 
if any of the requirements prescribed in paragraph (b) of this section 
is lacking or is not set forth so as to be readily understood. If the 
petitioner desires, he may amend the petition to meet the requirements 
of paragraph (b) of this section. If accepted for filing, a petition may 
be denied by the Administrator within a reasonable period of time 
thereafter if he finds the grounds upon which the petitioner relies are 
not sufficient to justify the initiation of proceedings.
    (d) The Administrator shall, before initiating proceedings for the 
issuance, amendment, or repeal of any rule either to control a drug or 
other substance, or to transfer a drug or other substance from one 
schedule to another, or to remove a drug or other substance entirely 
from the schedules, and after gathering the necessary data, request from 
the Secretary a scientific and medical evaluation and the Secretary's 
recommendations as to whether such drug or other substance should be so 
controlled, transferred, or removed as a controlled substance. The 
recommendations of the Secretary to the Administrator shall be binding 
on the Administrator as to such scientific and medical matters, and if 
the Secretary recommends that a drug or other substance not be 
controlled, the Administrator shall not control that drug or other 
substance.
    (e) If the Administrator determines that the scientific and medical 
evaluation and recommendations of the Secretary and all other relevant 
data constitute substantial evidence of potential for abuse such as to 
warrant control or additional control over the drug or other substance, 
or substantial evidence that the drug or other substances should be 
subjected to lesser control or removed entirely from the schedules, he 
shall initiate proceedings for control, transfer, or removal as the case 
may be.
    (f) If and when the Administrator determines to initiate 
proceedings, he shall publish in the Federal Register general notice of 
any proposed rule making to issue, amend, or repeal any rule pursuant to 
section 201 of the Act. Such published notice shall include a statement 
of the time, place, and nature of any hearings on the proposal in the 
event a hearing is requested pursuant to Sec. 1308.44. Such hearings 
may not be commenced until after the expiration of at least 30 days from 
the date the general notice is published in the Federal Register. Such 
published notice shall also include a reference to the legal authority 
under which the rule is proposed, a statement of the proposed rule, and, 
in the discretion of the Administrator, a summary of the subjects and 
issues involved.
    (g) The Administrator may permit any interested persons to file 
written comments on or objections to the proposal and shall designate in 
the notice of proposed rule making the time during which such filings 
may be made.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated and amended at 62 FR 13968, Mar. 24, 1997]