[Federal Register Volume 64, Number 178 (Wednesday, September 15, 1999)]
[Rules and Regulations]
[Pages 49982-49983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23968]


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DEPARTMENT OF JUSTICE

21 CFR Part 1308

[DEA-182F]


Schedules of Controlled Substances: Placement of Zaleplon Into 
Schedule IV

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, the Deputy Administrator 
of the Drug Enforcement Administration (DEA) places the substance, 
zaleplon, including its salts, into Schedule IV of the Controlled 
Substances Act (CSA). As a result of this rule, the regulatory controls 
and criminal sanctions of Schedule IV will be applicable to the 
manufacture, distribution, importation and exportation of zaleplon and 
products containing zaleplon.

EFFECTIVE DATE: September 15, 1999.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: Zaleplon is a central nervous system (CNS) 
depressant that will be marketed under the trade name 
SONATATM for the short-term treatment of insomnia.
    On March 31, 1999, the Assistant Secretary for Health and Surgeon 
General, Department of Health and Human Services (DHHS), sent the 
Deputy Administrator of DEA letter recommending that zaleplon, and its 
salts, be placed into Schedule IV of the CSA (21 U.S.C. 801 et seq.). 
Enclosed with the March 31, 1999, letter was a document prepared by the 
Food and Drug Administration (FDA) entitled ``Basis for the 
Recommendation for Control of Zaleplon in Schedule IV of the Controlled 
Substances Act (CSA).'' The document contained a review of the factors 
which the CSA requires the Secretary to consider [21 U.S.C. 811 (b)].
    The correspondence from the Assistant Secretary for Health and 
Surgeon General to the DEA dated March 31, 1999, confirmed that FDA had 
determined that the New Drug Application (NDA) for zaleplon was 
``approvable'' and had issued an approvable letter to the NDA sponsor 
on January 6, 1999. According to the March 31, 1999, letter from DHHS, 
``upon full approval of the NDA, zaleplon will have a currently 
accepted medical use in treatment in the United States.''
    After a review of the available data, including the DHHS 
recommendation,

[[Page 49983]]

the Deputy Administrator of the DEA, in a May 5, 1999, Federal Register 
Notice (63 FR 24094), proposed placement of zaleplon into Schedule IV 
of the CSA, if and when the zeleplon NDA is approved by the FDA. The 
notice provided an opportunity for all interested persons to submit 
their comments, objections, or requests for hearing in writing to be 
received by the DEA on or before June 4, 1999. The DEA did not receive 
any comments regarding the proposal.
    On August 16, 1999, the FDA notified the DEA that the zaleplon NDA 
was approved by the FDA on August 13, 1999. Relying on the scientific 
and medical evaluation and the recommendation of the DHHS Assistant 
Secretary for Health and Surgeon General received in accordance with 
section 201(b) of the Act [21 U.S.C. 811(b)], and the independent 
review of the DEA, the Deputy Administrator of the DEA, pursuant to 
sections 201(a) and 201(b) of the Act [21 U.S.C. 811(a) and 811(b)], 
finds that:
    (1) Based on information now available, zaleplon has a low 
potential for abuse relative to the drugs or other substances in 
Schedule III;
    (2) Zaleplon has a currently accepted medical use in treatment in 
the United States; and
    (3) Abuse of zaleplon may lead to limited physical dependence and 
psychological dependence relative to the drugs or other substances in 
Schedule III.
    Based on these findings, the Deputy Administrator of the DEA 
concludes that zaleplon, including its salts, warrants control in 
Schedule IV of the CSA.
    In order to make zaleplon pharmaceutical products available for 
medical use as soon as possible, the Schedule IV controls of zaleplon 
will be effective September 15, 1999. In the event that the regulations 
impose special hardships on the registrants, the DEA will entertain any 
justified request for an extension of time to comply with the Schedule 
IV regulations regarding zaleplon. The applicable regulations are as 
follows:
    1. Registration. Any person who manufactures, distributes, 
dispenses, imports or exports zaleplon or who engages in research or 
conducts instructional activities with zaleplon, or who proposes to 
engage in such activities, must be registered to conduct such 
activities in accordance with Part 1301 of Title 21 of the Code of 
Federal Regulations.
    2. Security. Zaleplon must be manufactured, distributed and stored 
in accordance with Secs. 1301.71, 1301.72(b), (c), and (d), 1301.73, 
1301.74, 1301.75(b) and (c) and 1301.76 of Title 21 of the Code of 
Federal Regulations.
    3. Labeling and Packaging. All labels on commercial containers of, 
and all labeling of, zaleplon shall comply with the requirements of 
Secs. 1302.03-1302.07 of Title 21 of the Code of Federal Regulations.
    4. Inventory. Registrants possessing zaleplon are required to take 
inventories pursuant to Secs. 1304.03, 1304.04 and 1304.11 of Title 21 
of the Code of Federal Regulations.
    5. Records. All registrants must keep records pursuant to 
Secs. 1304.03, 1304.04 and 1304.21-1304.23 of Title 21 of the Code of 
Federal Regulations.
    6. Prescriptions. All prescriptions for zaleplon are to be issued 
pursuant to Secs. 1306.03-1306.06 and 1306.21-1306.26 of Title 21 of 
the Code of Federal Regulations.
    7. Importation and Exportation. All importation and exportation of 
zaleplon shall be in compliance with Part 1312 of Title 21 of the Code 
of Federal Regulations.
    8. Criminal Liability. Any activity with zaleplon not authorized 
by, or in violation of, the CSA or the Controlled Substances Import and 
Export Act shall be unlawful.
    In accordance with the provisions of the CSA [21 U.S.C. 811(a)], 
this action is a formal rulemaking on the record after opportunity for 
a hearing. Such proceedings are conducted pursuant to the provisions of 
5 U.S.C. 556 and 557 and, as such, are exempt from review by the Office 
of Management and Budget pursuant to Executive Order (E.O.) 12866, 
Section 3(d)(1).
    The Deputy Administrator, in accordance with the Regulatory 
Flexibility Act [5 U.S.C.. 605(b)], has reviewed this final rule and, 
by approving it, certifies that it will not have a significant economic 
impact on a substantial number of small entities. Zaleplon is a new 
drug in the United States; recent approval of the product and its 
labeling by the FDA will allow it to be marketed once it is placed into 
Schedule IV of the CSA. This final rule will allow these entities to 
have access to a new pharmaceutical product.
    This rule will not result in the expenditure by State, local and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year, and it will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under provisions of the Unfunded Mandates Reform Act of 1995.
    This rule is not a major rule as defined by Sec. 804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996. This rule will 
not result in an annual effect on the economy of $100,000,000 or more; 
a major increase in costs or prices; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or on 
the ability of United States-based companies to compete with foreign-
based companies in domestic and export markets.
    This rule will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with E.O. 12612, it is 
determined that this rule does not have sufficient federalism 
implications to warrant the preparation of a Federalism Assessment.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Narcotics, Prescriptions drugs, Reporting and recordkeeping 
requirements.

    Under the authority vested in the Attorney General by section 
201(a) of the CSA [21 U.S.C. 811(a)], and delegated to the 
Administrator of the DEA by the Department of Justice regulations (28 
CFR 0.100), and redelegated to the Deputy Administrator pursuant to 28 
CFR 0.104, the Deputy Administrator hereby amends 21 CFR part 1308 as 
follows:

PART 1308--[AMENDED]

    1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.

    2. Section 1308.14 is amended by redesignating the existing 
paragraph (c)(48) to (c)(49) and by adding a new paragraph (c)(48) to 
read as follows:


Sec. 1308.14  Schedule IV

* * * * *
    (c) * * *

(48) Zaleplon 2781
* * * * *
    Dated: September 7, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-23968 Filed 9-14-99; 8:45 am]
BILLING CODE 4410-09-M