Schedules of Controlled Substances; Placement of Fospropofol Into Schedule IV, 51234-51236 [E9-23971]
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51234
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
will no longer meet or medically equal the
criteria of a listing in this body system.
3. * * * If you have a recurrence or relapse
of your malignancy, your impairment may
meet or medically equal one of the listings
in this body system again.
medulloblastoma or other primitive
neuroectodermal tumors (PNETs) with
documented metastases, grades III and IV
astrocytomas, glioblastoma multiforme,
ependymoblastoma, diffuse intrinsic brain
stem gliomas, or primary sarcomas.
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I. What do we mean by the following
terms?
1. Metastases: The spread of tumor cells by
blood, lymph, or other body fluid. This term
does not include the spread of tumor cells by
direct extension of the tumor to other tissue
or organs.
2. Multimodal therapy: A combination of at
least two types of treatment modalities given
in close proximity as a unified whole and
usually planned before any treatment has
begun. There are three types of treatment
modalities: Surgery, radiation, and systemic
drug therapy (chemotherapy, hormonal
therapy, and immunotherapy). Examples of
multimodal therapy include:
a. Surgery followed by chemotherapy or
radiation.
b. Chemotherapy followed by surgery.
c. Chemotherapy and concurrent radiation.
3. Persistent: Failure to achieve a complete
remission.
4. Progressive: The malignancy becomes
more extensive despite treatment.
5. Recurrent, relapse: A malignancy that
was in complete remission or entirely
removed by surgery has returned.
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K. How do we evaluate specific malignant
neoplastic diseases?
1. Lymphoma.
a. We provide criteria for evaluating
aggressive lymphomas that have not
responded to antineoplastic therapy in
113.05. Indolent (non-aggressive) lymphomas
are rare in children. We will evaluate
indolent lymphomas in children under 13.05
in part A.
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2. Leukemia.
a. Acute leukemia. * * * Recurrent disease
must be documented by peripheral blood,
bone marrow, or cerebrospinal fluid
examination, or by testicular biopsy. * * *
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CPrice-Sewell on DSKGBLS3C1PROD with RULES
4. Brain tumors. We use the criteria in
113.13 to evaluate malignant brain tumors.
We consider a brain tumor to be malignant
if it is classified as grade II or higher under
the World Health Organization (WHO)
classification of tumors of the central nervous
system (WHO Classification of Tumours of
the Central Nervous System, 2007). We
evaluate any complications of malignant
brain tumors, such as resultant neurological
or psychological impairments, under the
criteria for the affected body system. We
evaluate benign brain tumors under 111.05.
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113.09 Thyroid gland.
B. * * *
OR
C. Medullary carcinoma with metastases
beyond the regional lymph nodes.
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113.13 Brain tumors. (See 113.00K4.)
Highly malignant tumors, such as
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[FR Doc. E9–23896 Filed 10–5–09; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–327F]
Schedules of Controlled Substances;
Placement of Fospropofol Into
Schedule IV
AGENCY: Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
SUMMARY: With the issuance of this final
rule, the Deputy Administrator of the
Drug Enforcement Administration
(DEA) places the substance fospropofol,
including its salts, isomers and salts of
isomers whenever the existence of such
salts, isomers, and salts of isomers is
possible, 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, dispensing,
importation, and exportation of
fospropofol and products containing
fospropofol.
DATES:
Effective Date: November 5,
2009.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug
and Chemical Evaluation Section, Office
of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152, Telephone:
(202) 307–7183.
SUPPLEMENTARY INFORMATION:
Background
On December 12, 2008, the Food and
Drug Administration (FDA) approved
fospropofol for marketing under the
trade name Lusedra® in the United
States as a drug product indicated for
monitored anesthesia care (MAC)
sedation in adult patients undergoing
diagnostic or therapeutic procedures.
Fospropofol, 2,6diisopropopylphenoxymethyl
phosphate disodium, is a water soluble,
phosphono-O-methyl prodrug of
propofol. It is metabolized in the body
to propofol, the active metabolite.
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Propofol has been available for medical
use in the United States since 1989 and
is not currently a controlled substance.
The pharmacological effects of
fospropofol are attributed to the
pharmacological actions of propofol.
Propofol binds to g-aminobutyric acid
(GABAA) receptor and acts as a
modulator by potentiating the activity of
GABA at this receptor.
Since propofol is the active metabolite
of fospropofol, the abuse potential of
fospropofol is comparable to that of
propofol. Animal self-administration
studies demonstrated that the
reinforcing effects of propofol are
relatively low and comparable to
midazolam and other schedule IV
benzodiazepines. Fospropofol elicits
behavioral effects similar to
methohexital and midazolam, schedule
IV sedative-hypnotics.
Since fospropofol is a new molecular
entity, there has been no evidence of
diversion, abuse, or law enforcement
encounters involving the drug.
On February 27, 2009, the Acting
Assistant Secretary for Health,
Department of Health and Human
Services (DHHS), sent the Deputy
Administrator of DEA a scientific and
medical evaluation and a letter
recommending that fospropofol be
placed into schedule IV of the CSA.
Enclosed with the February 27, 2009,
letter was a document prepared by the
FDA entitled, ‘‘Basis for the
Recommendation for Control of
Fospropofol and Its Salts 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)).
After a review of the available data,
including the scientific and medical
evaluation and the scheduling
recommendation from DHHS, the
Deputy Administrator of the DEA
published a Notice of Proposed
Rulemaking entitled ‘‘Schedules of
Controlled Substances: Placement of
Fospropofol into Schedule IV’’ on July
23, 2009 (74 FR 36424), which proposed
placement of fospropofol into schedule
IV of the CSA. The proposed rule
provided an opportunity for all
interested persons to submit their
written comments on or before August
24, 2009.
Comments Received
The DEA received two comments in
response to the Notice of Proposed
Rulemaking. One comment received
from a concerned citizen did not relate
to fospropofol, the substance that is
being controlled. Thus DEA did not
consider this comment.
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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
Another comment received from a
professional organization of
anesthesiologists is in agreement with
the findings of scientific and medical
evaluation that formed the basis for the
present rule controlling fospropofol as a
schedule IV substance and it fully
supported this control action.
CPrice-Sewell on DSKGBLS3C1PROD with RULES
Scheduling of Fospropofol
Based on the recommendation of the
Acting Assistant Secretary for Health,
received in accordance with section
201(b) of the Act (21 U.S.C. 811(b)), and
the independent review of the available
data by DEA, the Deputy Administrator
of DEA, pursuant to sections 201(a) and
201(b) of the Act (21 U.S.C. 811(a) and
811(b)), finds that:
(1) Fospropofol has a low potential for
abuse relative to the drugs or substances
in schedule III. Although there is no
direct comparison to a schedule III
substance, this finding is based on the
demonstration of the abuse potential of
propofol, the active metabolite, relative
to the schedule IV substances,
methohexital and midazolam;
(2) Fospropofol has a currently
accepted medical use in treatment in the
United States; and
(3) Abuse of fospropofol may lead to
limited physical dependence or
psychological dependence relative to
the drugs or other substances in
schedule III. This finding is based on
the symptoms exhibited upon
withdrawal from propofol.
Based on these findings, the Deputy
Administrator of DEA concludes that
fospropofol, including its salts, isomers
and salts of isomers whenever the
existence of such salts, isomers, and
salts of isomers is possible warrants
control in schedule IV of the CSA. (21
U.S.C. 812(b)(4))
Requirements for Handling Fospropofol
Registration. Any person who
manufactures, distributes, dispenses,
imports, exports, engages in research or
conducts instructional activities with
fospropofol, or who desires to
manufacture, distribute, dispense,
import, export, engage in instructional
activities or conduct research with
fospropofol, must be registered to
conduct such activities in accordance
with part 1301 of Title 21 of the Code
of Federal Regulations. Any person who
is currently engaged in any of the above
activities and is not registered with DEA
must submit an application for
registration on or before November 5,
2009 and may continue their activities
until DEA has approved or denied that
application.
Security. Fospropofol is subject to
schedules III–V security requirements
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and must be manufactured, distributed,
and stored in accordance with
§§ 1301.71, 1301.72(b), (c), and (d),
1301.73, 1301.74, 1301.75(b) and (c),
1301.76, and 1301.77 of Title 21 of the
Code of Federal Regulations on or after
November 5, 2009.
Labeling and Packaging. All labels
and labeling for commercial containers
of fospropofol must comply with
requirements of §§ 1302.03–1302.07 of
Title 21 of the Code of Federal
Regulations on or after November 5,
2009.
Inventory. Every registrant required to
keep records and who possesses any
quantity of fospropofol must keep an
inventory of all stocks of fospropofol on
hand pursuant to §§ 1304.03, 1304.04
and 1304.11 of Title 21 of the Code of
Federal Regulations on or after
November 5, 2009. Every registrant who
desires registration in schedule IV for
fospropofol must conduct an inventory
of all stocks of the substance on hand at
the time of registration.
Records. All registrants must keep
records pursuant to §§ 1304.03, 1304.04,
1304.21, 1304.22, and 1304.23 of Title
21 of the Code of Federal Regulations on
or after November 5, 2009.
Prescriptions. All prescriptions for
fospropofol or prescriptions for
products containing fospropofol must be
issued pursuant to §§ 1306.03–1306.06
and 1306.21, 1306.22–1306.27 of Title
21 of the Code of Federal Regulations on
or after November 5, 2009.
Importation and Exportation. All
importation and exportation of
fospropofol must be in compliance with
part 1312 of Title 21 of the Code of
Federal Regulations on or after
November 5, 2009.
Criminal Liability. Any activity with
fospropofol not authorized by, or in
violation of, the Controlled Substances
Act or the Controlled Substances Import
and Export Act shall be unlawful on or
after November 5, 2009.
Regulatory Certifications
Executive Order 12866
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 12866,
section 3(d)(1).
Regulatory Flexibility Act
The Deputy Administrator, in
accordance with the Regulatory
Flexibility Act (5 U.S.C. 601–612), has
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51235
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.
Fospropofol products will be used for
monitored anesthesia care (MAC)
sedation in adult patients undergoing
diagnostic or therapeutic procedures.
Handlers of fospropofol also handle
other controlled substances used for
sedation which are already subject to
the regulatory requirements of the CSA.
Executive Order 12988
This regulation meets the applicable
standards set forth in Sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform.
Executive Order 13132
This rulemaking does not preempt or
modify any provision of state law; nor
does it impose enforcement
responsibilities on any state; nor does it
diminish the power of any state to
enforce its own laws. Accordingly, this
rulemaking does not have federalism
implications warranting the application
of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the
expenditure by state, local and tribal
governments, in the aggregate, or by the
private sector, of $120,000,000 or more
(adjusted for inflation) in any one year,
and will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
provisions of the Unfunded Mandates
Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as
defined by § 804 of the Small Business
Regulatory Enforcement Fairness Act of
1996 (Congressional Review Act). 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.
List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Narcotics, Prescription drugs.
■ 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 DEA
by Department of Justice regulations (28
CFR 0.100), and redelegated to the
Deputy Administrator pursuant to 28
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51236
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
CFR 0.104, the Deputy Administrator
hereby amends 21 CFR part 1308 as
follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
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 in
paragraph (c), by redesignating
paragraphs (c)(23) through (c)(51) as
paragraphs (c)(24) through (c)(52) and
adding a new paragraph (c)(23) as
follows:
■
§ 1308.14
*
Schedule IV.
*
*
(c) * * *
*
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(23) Fospropofol ................................
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*
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2138
*
Dated: September 28, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–23971 Filed 10–5–09; 8:45 am]
BILLING CODE 4410–09–P
22 CFR Part 41
[Public Notice: 6779]
Visas: Documentation of
Nonimmigrants Under the Immigration
and Nationality Act, as Amended;
Requirements for Aliens in Religious
Occupations
State Department.
Final rule.
AGENCY:
CPrice-Sewell on DSKGBLS3C1PROD with RULES
SUMMARY: To comply with the
Department of Homeland Security
regulation requiring sponsoring
employers to file petitions for all aliens
for whom R–1 nonimmigrant status is
sought. This rule establishes the
requirement that consular officers
ensure that R–1 visa applicants have
obtained an approved U.S. Citizenship
and Immigration Services Form I–129
petition from the Department of
Homeland Security before issuance of a
visa.
DATES: This rule is effective October 6,
2009.
FOR FURTHER INFORMATION CONTACT:
Lauren A. Prosnik, Legislation and
Regulations Division, Visa Services,
Department of State, 2401 E Street, NW.,
Room L–603D, Washington, DC 20520–
0106, (202) 663–2951.
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
13:16 Oct 05, 2009
Regulatory Findings
Administrative Procedure Act
This regulation involves a foreign
affairs function of the United States and,
therefore, in accordance with 5 U.S.C.
553(a)(1), is not subject to the rule
making procedures set forth at 5 U.S.C.
553.
DEPARTMENT OF STATE
ACTION:
Why is the Department promulgating
this rule?
On November 26, 2008, the
Department of Homeland Security
(DHS) promulgated regulations
requiring sponsoring employers to file
petitions for all aliens for whom R–1
nonimmigrant status is sought. 73 FR
72276. As a result, the requirements for
an R–1 nonimmigrant visa now include
establishing that the applicant is the
beneficiary of an approved petition. U.S.
Citizenship and Immigration Services
(USCIS) has implemented the petition
requirement for nonimmigrant religious
workers as a way to determine the bona
fides of a petitioning religious
organization located in the United
States and to determine that a religious
worker will be admitted to the United
States to work for a specific religious
organization at the request of that
religious organization. This rule amends
the Department regulations to ensure
consistency with the regulations set
forth by DHS.
Jkt 220001
Regulatory Flexibility Act/Executive
Order 13272: Small Business
Because this final rule is exempt from
notice and comment rulemaking under
5 U.S.C. 553, it is exempt from the
regulatory flexibility analysis
requirements set forth at sections 603
and 604 of the Regulatory Flexibility
Act (5 U.S.C. 603 and 604). Nonetheless,
consistent with section 605(b) of the
Regulatory Flexibility Act (5 U.S.C.
605(b)), the Department certifies that
this rule will not have a significant
economic impact on a substantial
number of small entities. This regulates
individual aliens who seek
consideration for R–1 nonimmigrant
visas and does not affect any small
entities, as defined in 5 U.S.C. 601(6).
The Unfunded Mandates Reform Act of
1995
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UFMA),
Public Law 104–4, 109 Stat. 48, 2 U.S.C.
1532, generally requires agencies to
prepare a statement before proposing
any rule that may result in an annual
expenditure of $100 million or more by
State, local, or tribal governments, or by
the private sector. This rule will not
result in any such expenditure, nor will
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it significantly or uniquely affect small
governments.
The Small Business Regulatory
Enforcement Fairness Act of 1996
This rule is not a major rule as
defined by 5 U.S.C. 804, for purposes of
congressional review of agency
rulemaking under the Small Business
Regulatory Enforcement Fairness Act of
1996, Public Law 104–121. This rule
will not result in an annual effect on the
economy of $100 million or more; a
major increase in costs or prices; or
adverse effects on competition,
employment, investment, productivity,
innovation, or the ability of United
States-based companies to compete with
foreign based companies in domestic
and import markets.
Executive Order 12866
The Department of State has reviewed
this proposed rule to ensure its
consistency with the regulatory
philosophy and principles set forth in
Executive Order 12866 and has
determined that the benefits of this final
regulation justify its costs. The
Department does not consider this final
rule to be an economically significant
action within the scope of section 3(f)(1)
of the Executive Order since it is not
likely to have an annual effect on the
economy of $100 million or more or to
adversely affect in a material way the
economy, a sector of the economy,
competition, jobs, the environment,
public health or safety, or State, local or
tribal governments or communities.
Executive Orders 12372 and 13132:
Federalism
This regulation will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or the
distribution of power and
responsibilities among the various
levels of government. Nor will the rule
have federalism implications warranting
the application of Executive Orders No.
12372 and No. 13132.
Executive Order 12988: Civil Justice
Reform
The Department has reviewed the
regulations in light of sections 3(a) and
3(b)(2) of Executive Order No. 12988 to
eliminate ambiguity, minimize
litigation, establish clear legal
standards, and reduce burden.
Paperwork Reduction Act
This rule does not impose information
collection requirements under the
provisions of the Paperwork Reduction
Act, 44 U.S.C., Chapter 35.
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Agencies
[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Rules and Regulations]
[Pages 51234-51236]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23971]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-327F]
Schedules of Controlled Substances; Placement of Fospropofol Into
Schedule IV
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: With the issuance of this final rule, the Deputy Administrator
of the Drug Enforcement Administration (DEA) places the substance
fospropofol, including its salts, isomers and salts of isomers whenever
the existence of such salts, isomers, and salts of isomers is possible,
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, dispensing,
importation, and exportation of fospropofol and products containing
fospropofol.
DATES: Effective Date: November 5, 2009.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield,
Virginia 22152, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Background
On December 12, 2008, the Food and Drug Administration (FDA)
approved fospropofol for marketing under the trade name Lusedra[reg] in
the United States as a drug product indicated for monitored anesthesia
care (MAC) sedation in adult patients undergoing diagnostic or
therapeutic procedures.
Fospropofol, 2,6-diisopropopylphenoxymethyl phosphate disodium, is
a water soluble, phosphono-O-methyl prodrug of propofol. It is
metabolized in the body to propofol, the active metabolite. Propofol
has been available for medical use in the United States since 1989 and
is not currently a controlled substance. The pharmacological effects of
fospropofol are attributed to the pharmacological actions of propofol.
Propofol binds to [gamma]-aminobutyric acid (GABAA) receptor
and acts as a modulator by potentiating the activity of GABA at this
receptor.
Since propofol is the active metabolite of fospropofol, the abuse
potential of fospropofol is comparable to that of propofol. Animal
self-administration studies demonstrated that the reinforcing effects
of propofol are relatively low and comparable to midazolam and other
schedule IV benzodiazepines. Fospropofol elicits behavioral effects
similar to methohexital and midazolam, schedule IV sedative-hypnotics.
Since fospropofol is a new molecular entity, there has been no
evidence of diversion, abuse, or law enforcement encounters involving
the drug.
On February 27, 2009, the Acting Assistant Secretary for Health,
Department of Health and Human Services (DHHS), sent the Deputy
Administrator of DEA a scientific and medical evaluation and a letter
recommending that fospropofol be placed into schedule IV of the CSA.
Enclosed with the February 27, 2009, letter was a document prepared by
the FDA entitled, ``Basis for the Recommendation for Control of
Fospropofol and Its Salts 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)).
After a review of the available data, including the scientific and
medical evaluation and the scheduling recommendation from DHHS, the
Deputy Administrator of the DEA published a Notice of Proposed
Rulemaking entitled ``Schedules of Controlled Substances: Placement of
Fospropofol into Schedule IV'' on July 23, 2009 (74 FR 36424), which
proposed placement of fospropofol into schedule IV of the CSA. The
proposed rule provided an opportunity for all interested persons to
submit their written comments on or before August 24, 2009.
Comments Received
The DEA received two comments in response to the Notice of Proposed
Rulemaking. One comment received from a concerned citizen did not
relate to fospropofol, the substance that is being controlled. Thus DEA
did not consider this comment.
[[Page 51235]]
Another comment received from a professional organization of
anesthesiologists is in agreement with the findings of scientific and
medical evaluation that formed the basis for the present rule
controlling fospropofol as a schedule IV substance and it fully
supported this control action.
Scheduling of Fospropofol
Based on the recommendation of the Acting Assistant Secretary for
Health, received in accordance with section 201(b) of the Act (21
U.S.C. 811(b)), and the independent review of the available data by
DEA, the Deputy Administrator of DEA, pursuant to sections 201(a) and
201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:
(1) Fospropofol has a low potential for abuse relative to the drugs
or substances in schedule III. Although there is no direct comparison
to a schedule III substance, this finding is based on the demonstration
of the abuse potential of propofol, the active metabolite, relative to
the schedule IV substances, methohexital and midazolam;
(2) Fospropofol has a currently accepted medical use in treatment
in the United States; and
(3) Abuse of fospropofol may lead to limited physical dependence or
psychological dependence relative to the drugs or other substances in
schedule III. This finding is based on the symptoms exhibited upon
withdrawal from propofol.
Based on these findings, the Deputy Administrator of DEA concludes
that fospropofol, including its salts, isomers and salts of isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible warrants control in schedule IV of the CSA. (21 U.S.C.
812(b)(4))
Requirements for Handling Fospropofol
Registration. Any person who manufactures, distributes, dispenses,
imports, exports, engages in research or conducts instructional
activities with fospropofol, or who desires to manufacture, distribute,
dispense, import, export, engage in instructional activities or conduct
research with fospropofol, must be registered to conduct such
activities in accordance with part 1301 of Title 21 of the Code of
Federal Regulations. Any person who is currently engaged in any of the
above activities and is not registered with DEA must submit an
application for registration on or before November 5, 2009 and may
continue their activities until DEA has approved or denied that
application.
Security. Fospropofol is subject to schedules III-V security
requirements and must be manufactured, distributed, and stored in
accordance with Sec. Sec. 1301.71, 1301.72(b), (c), and (d), 1301.73,
1301.74, 1301.75(b) and (c), 1301.76, and 1301.77 of Title 21 of the
Code of Federal Regulations on or after November 5, 2009.
Labeling and Packaging. All labels and labeling for commercial
containers of fospropofol must comply with requirements of Sec. Sec.
1302.03-1302.07 of Title 21 of the Code of Federal Regulations on or
after November 5, 2009.
Inventory. Every registrant required to keep records and who
possesses any quantity of fospropofol must keep an inventory of all
stocks of fospropofol on hand pursuant to Sec. Sec. 1304.03, 1304.04
and 1304.11 of Title 21 of the Code of Federal Regulations on or after
November 5, 2009. Every registrant who desires registration in schedule
IV for fospropofol must conduct an inventory of all stocks of the
substance on hand at the time of registration.
Records. All registrants must keep records pursuant to Sec. Sec.
1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of Title 21 of the Code
of Federal Regulations on or after November 5, 2009.
Prescriptions. All prescriptions for fospropofol or prescriptions
for products containing fospropofol must be issued pursuant to
Sec. Sec. 1306.03-1306.06 and 1306.21, 1306.22-1306.27 of Title 21 of
the Code of Federal Regulations on or after November 5, 2009.
Importation and Exportation. All importation and exportation of
fospropofol must be in compliance with part 1312 of Title 21 of the
Code of Federal Regulations on or after November 5, 2009.
Criminal Liability. Any activity with fospropofol not authorized
by, or in violation of, the Controlled Substances Act or the Controlled
Substances Import and Export Act shall be unlawful on or after November
5, 2009.
Regulatory Certifications
Executive Order 12866
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
12866, section 3(d)(1).
Regulatory Flexibility Act
The Deputy Administrator, in accordance with the Regulatory
Flexibility Act (5 U.S.C. 601-612), 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. Fospropofol products
will be used for monitored anesthesia care (MAC) sedation in adult
patients undergoing diagnostic or therapeutic procedures. Handlers of
fospropofol also handle other controlled substances used for sedation
which are already subject to the regulatory requirements of the CSA.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local and
tribal governments, in the aggregate, or by the private sector, of
$120,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under provisions of the Unfunded Mandates
Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by Sec. 804 of the Small
Business Regulatory Enforcement Fairness Act of 1996 (Congressional
Review Act). 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.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Narcotics, Prescription drugs.
0
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 DEA
by Department of Justice regulations (28 CFR 0.100), and redelegated to
the Deputy Administrator pursuant to 28
[[Page 51236]]
CFR 0.104, the Deputy Administrator hereby amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
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.
0
2. Section 1308.14 is amended in paragraph (c), by redesignating
paragraphs (c)(23) through (c)(51) as paragraphs (c)(24) through
(c)(52) and adding a new paragraph (c)(23) as follows:
Sec. 1308.14 Schedule IV.
* * * * *
(c) * * *
(23) Fospropofol................................................ 2138
* * * * *
Dated: September 28, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-23971 Filed 10-5-09; 8:45 am]
BILLING CODE 4410-09-P