Identification of Institution-based Individual Practitioners, 46396-46399 [E9-21698]
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Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Proposed Rules
estimate the total cost of the proposed
AD to U.S. operators to be $190,840.
PART 39—AIRWORTHINESS
DIRECTIVES
Authority for This Rulemaking
1. The authority citation for part 39
continues to read as follows:
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in subtitle VII,
part A, subpart III, section 44701,
‘‘General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
Regulatory Findings
We have determined that this
proposed AD would not have federalism
implications under Executive Order
13132. This proposed AD would not
have a substantial direct effect 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.
For the reasons discussed above, I
certify that the proposed AD:
1. Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
2. Is not a ‘‘significant rule’’ under the
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979); and
3. Would not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared a regulatory evaluation
of the estimated costs to comply with
this proposed AD. You may get a copy
of this summary at the address listed
under ADDRESSES.
jlentini on DSKJ8SOYB1PROD with PROPOSALS
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Safety.
The Proposed Amendment
Under the authority delegated to me
by the Administrator, the Federal
Aviation Administration proposes to
amend 14 CFR part 39 as follows:
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Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive:
General Electric Company (GE): Docket No.
FAA–2009–0502; Directorate Identifier
2009–NE–02–AD.
Comments Due Date
(a) The Federal Aviation Administration
(FAA) must receive comments on this
airworthiness directive (AD) action by
November 9, 2009.
Affected ADs
(b) None.
Applicability
(c) This AD applies to GE CJ610 series
turbojet and CF700 series turbofan engines
with AFT Technologies combustion liner,
part number (P/N) AFT–5016T30G02,
installed. These engines are installed on, but
not limited to, Learjet Inc. model 24 series
and model 25 series airplanes, Dassault
Aviation Fan Jet Falcon series airplanes, and
Sabreliner Corporation NA–265–70 and NA–
265–80 series airplanes.
Unsafe Condition
(d) This AD results from a report of an AFT
Technologies combustion liner that released
a large section of the inner combustion liner
and reports of six combustion liners with
premature cracks. We are proposing this AD
to prevent premature cracks in the
combustion liner, which could release pieces
of the inner combustion liner. A release of
pieces of the inner combustion liner could
cause an uncontained failure of the engine
turbine and damage to the airplane.
Compliance
(e) You are responsible for having the
actions required by this AD performed within
the compliance times specified unless the
actions have already been done.
Replacement of AFT Technologies
Combustion Liner P/N AFT–5016T30G02
(f) For engines that have an AFT
Technologies combustion liner, P/N AFT–
5016T30G02, with fewer than 200 hourssince-new (HSN) or 300 cycles-since-new
(CSN), remove the AFT Technologies
combustion liner, P/N AFT–5016T30G02,
before exceeding 200 HSN or 300 CSN,
whichever occurs first.
(g) For engines that have an AFT
Technologies combustion liner, P/N AFT–
5016T30G02, with 200 HSN or more or 300
CSN or more, remove the AFT Technologies
combustion liner, P/N AFT–5016T30G02,
within 15 hours-in-service or 10 cycles-inservice, after the effective date of this AD,
whichever occurs first.
(h) After the effective date of this AD, don’t
install any AFT Technologies combustion
liner, P/N AFT–5016T30G02, in any engine.
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Alternative Methods of Compliance
(i) The Manager, New York Aircraft
Certification Office, has the authority to
approve alternative methods of compliance
for this AD if requested using the procedures
found in 14 CFR 39.19.
Related Information
(j) Contact Norman Perenson, Aerospace
Engineer, New York Aircraft Certification
Office, FAA, Engine & Propeller Directorate,
1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; e-mail:
norman.perenson@faa.gov; telephone (516)
228–7337; fax (516) 794–5531, for more
information about this AD.
Issued in Burlington, Massachusetts, on
September 2, 2009.
Peter A. White,
Assistant Manager, Engine and Propeller
Directorate, Aircraft Certification Service.
[FR Doc. E9–21629 Filed 9–8–09; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket no. DEA–321a]
RIN 1117–AB22
Identification of Institution-based
Individual Practitioners
AGENCY: Drug Enforcement
Administration (DEA), Justice.
ACTION: Advance notice of proposed
rulemaking.
SUMMARY: The Drug Enforcement
Administration (DEA) is soliciting
public comments on how best to
standardize the specific internal code
number associated with each individual
practitioner permitted by the hospital or
other institutional practitioner to
administer, dispense, or prescribe
controlled substances using that
institution’s DEA registration. DEA is
taking this action in response to
comments it received to its Notice of
Proposed Rulemaking regarding
electronic prescriptions for controlled
substances.
DATES: Written comments must be
postmarked and electronic comments
must be submitted on or before
November 9, 2009. Commenters should
be aware that the electronic Federal
Docket Management System will not
accept comments after Midnight Eastern
Time on the last day of the comment
period.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–321’’ on all written and
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jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Proposed Rules
electronic correspondence. Written
comments being sent via regular or
express mail should be sent to the Drug
Enforcement Administration, Attention:
DEA Federal Register Representative/
ODL, 8701 Morrissette Drive,
Springfield, VA 22152. Comments may
be sent to DEA by sending an electronic
message to
dea.diversion.policy@usdoj.gov.
Comments may also be sent
electronically through https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document is also available at the
https://www.regulations.gov Web site.
DEA will accept attachments to
electronic comments in Microsoft Word,
WordPerfect, Adobe PDF, or Excel file
formats only. DEA will not accept any
file formats other than those specifically
listed here.
Please note that DEA is requesting
that electronic comments be submitted
before midnight Eastern time on the day
the comment period closes because
https://www.regulations.gov terminates
the public’s ability to submit comments
at midnight Eastern time on the day the
comment period closes. Commenters in
time zones other than Eastern Time may
want to consider this so that their
electronic comments are received. All
comments sent via regular or express
mail will be considered timely if
postmarked on the day the comment
period closes.
FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152; telephone: (202)
307–7297.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments: Please
note that all comments received are
considered part of the public record and
made available for public inspection
online at https://www.regulations.gov
and in the Drug Enforcement
Administration’s public docket. Such
information includes personal
identifying information (such as your
name, address, etc.) voluntarily
submitted by the commenter.
If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all the personal identifying information
you do not want posted online or made
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available in the public docket in the first
paragraph of your comment and identify
what information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment. If a comment has
so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be posted online or made
available in the public docket.
Personal identifying information and
confidential business information
identified and located as set forth above
will be redacted and the comment, in
redacted form, will be posted online and
placed in the Drug Enforcement
Administration’s public docket file.
Please note that the Freedom of
Information Act applies to all comments
received. If you wish to inspect the
agency’s public docket file in person by
appointment, please see the ‘‘For
Further Information’’ paragraph.
DEA’s Legal Authority
DEA implements and enforces the
Comprehensive Drug Abuse Prevention
and Control Act of 1970, often referred
to as the Controlled Substances Act
(CSA) and the Controlled Substances
Import and Export Act (21 U.S.C. 801–
971), (CSA), as amended. DEA publishes
the implementing regulations for these
statutes in Title 21 of the Code of
Federal Regulations (CFR), Parts 1300 to
end. These regulations are designed to
ensure that there is a sufficient supply
of controlled substances for medical,
scientific, and other legitimate purposes
and to deter the diversion of controlled
substances to illegal purposes.
Controlled substances are drugs that
have a potential for abuse and
psychological and physical dependence;
these include substances classified as
opioids, stimulants, depressants,
hallucinogens, anabolic steroids, and
drugs that are immediate precursors of
these classes of substances. DEA lists
controlled substances in 21 CFR part
1308. The substances are divided into
five schedules: Schedule I substances
have a high potential for abuse and have
no accepted medical use in treatment in
the United States. These substances may
only be used for research, chemical
analysis, or manufacture of other drugs.
Schedule II—V substances have an
accepted medical use and also have a
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46397
potential for abuse and psychological
and physical dependence.
The CSA mandates that DEA establish
a closed system of control for
manufacturing, distribution, and
dispensing of controlled substances.
Any person who manufactures,
distributes, dispenses, imports, exports,
or conducts research or chemical
analysis with controlled substances
must register with DEA (unless exempt),
keep track of all stocks of controlled
substances, and maintain records to
account for all controlled substances
received, distributed, dispensed, or
otherwise disposed of.
Background
The CSA requires that every person
who dispenses controlled substances
shall obtain from the Attorney General
a registration (21 U.S.C. 822(a)(2)).
Authority to issue such registrations has
been delegated by the Attorney General
to the Administrator of the Drug
Enforcement Administration (28 CFR
0.100).
An individual practitioner who is an
agent or employee of a hospital or other
institution registered with DEA may use
the DEA registration of that hospital or
other institution to administer,
dispense, or prescribe controlled
substances in accordance with the
regulations (21 CFR 1301.22(c)).
Specifically:
An individual practitioner who is an agent
or employee of a hospital or other institution
may, when acting in the normal course of
business or employment, administer,
dispense, or prescribe controlled substances
under the registration of the hospital or other
institution which is registered in lieu of
being registered him/herself, provided that:
(1) Such dispensing, administering or
prescribing is done in the usual course of his/
her professional practice;
(2) Such individual practitioner is
authorized or permitted to do so by the
jurisdiction in which he/she is practicing;
(3) The hospital or other institution by
whom he/she is employed has verified that
the individual practitioner is so permitted to
dispense, administer, or prescribe drugs
within the jurisdiction;
(4) Such individual practitioner is acting
only within the scope of his/her employment
in the hospital or institution;
(5) The hospital or other institution
authorizes the individual practitioner to
administer, dispense or prescribe under the
hospital registration and designates a specific
internal code number for each individual
practitioner so authorized. The code number
shall consist of numbers, letters, or a
combination thereof and shall be a suffix to
the institution’s DEA registration number,
preceded by a hyphen (e.g., APO123456–10
or APO123456–A12); and
(6) A current list of internal codes and the
corresponding individual practitioners is
kept by the hospital or other institution and
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Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Proposed Rules
jlentini on DSKJ8SOYB1PROD with PROPOSALS
is made available at all times to other
registrants and law enforcement agencies
upon request for the purpose of verifying the
authority of the prescribing individual
practitioner. (21 CFR 1301.22(c))
Notice of Proposed Rulemaking
Regarding Electronic Prescriptions for
Controlled Substances
On June 27, 2008, DEA published a
Notice of Proposed Rulemaking
‘‘Electronic Prescriptions for Controlled
Substances’’ [Docket No. DEA–218, RIN
1117–AA61] (73 FR 36722). In that rule,
DEA proposed that pharmacy
applications receiving electronic
prescriptions for controlled substances
be capable of reading and retaining the
full DEA registration number, including
any extensions, or other identification
numbers used under 21 CFR 1306.05(c).
DEA further proposed that the full
number including extensions must be
retained in the prescription record. DEA
further proposed that the pharmacy
application must verify that the
practitioner’s DEA registration was valid
at the time the prescription was signed.
DEA indicated the pharmacy
application may do this by checking the
DEA CSA database or by having another
entity check the DEA CSA database
during transmission and indicate on the
record that the check has occurred and
the registration is valid. Finally, DEA
proposed that the pharmacy application
must reject prescriptions that were
signed by practitioners without valid
DEA registrations.
Comments received. DEA received
numerous comments to its Notice of
Proposed Rulemaking regarding this
issue. Approximately twenty
commenters representing State licensing
boards, pharmacy and pharmacist
organizations, chain drug stores, and
electronic prescription and electronic
pharmacy application vendors
commented regarding this issue. One
commenter, an organization
representing health system pharmacists,
believed that whatever system is used
for extensions, the system must allow
pharmacies to validate the original DEA
number and determine whether the DEA
number belongs to a facility for which
extensions are permissible. A standards
development organization for electronic
prescription applications asked DEA to
propose an industry solution to
extensions, such as a standard length. It
noted that the same problem exists for
paper prescriptions.
A commenter representing grocery
stores with pharmacies stated that DEA
is placing the pharmacy in an untenable
situation. The pharmacy would be
expected to check and store a number
on DEA’s behalf for which there is no
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standard and over which DEA exerts no
jurisdiction, as DEA does not specify
criteria regarding the format or content
of the suffix data for each individual
practitioner using the institutional
practitioner’s registration. The
commenter noted that the health-system
or hospital choosing to employ a suffix
system is tasked with the
implementation and tracking of that
process. The commenter recommended
that DEA require the validity of the
health-system DEA number be verified
and that a health-system’s use of a suffix
system be guided by DEA directly at
that user’s facility.
Various State and national pharmacy
organizations, an association
representing chain drug stores, several
State boards of pharmacy, several chain
drug stores, and several pharmacy
system providers all stated that DEA
should standardize extensions and make
it clear that pharmacies are not
responsible for checking the validity of
the extensions.
In response to the comments received,
DEA is considering how best to
standardize the internal code numbers
assigned by institutional practitioners to
the individual practitioners they permit
to use their registration to administer,
dispense, and prescribe controlled
substances. DEA believes such
standardization would benefit the
overall dispensing of controlled
substances by bringing a level of
uniformity to such extensions. As
commenters noted, this standardization
is essential for DEA to require pharmacy
systems to retain this information.
DEA recognizes, however, that there
are many institutional practitioners
employing internal code number
systems. There has never been
standardization regarding this number,
and DEA believes it extremely likely
that institutional practitioner registrants
have established a variety of internal
code number systems. Therefore, to
address this issue, DEA is soliciting
information from the regulated industry
and other interested members of the
public regarding current methods being
used and how best to implement
industry standardization in this area.
Specifically, DEA seeks the following
information:
• Information regarding formats used
by institutional practitioners when
establishing internal code numbers for
individual practitioners permitted to
use the institution’s registration
number;
• Estimates of the number of
individual practitioners using internal
code numbers for identification
purposes;
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• Estimates of the number of
individual practitioners using internal
code numbers for identification
purposes in a particular institutional
practitioner;
• Estimates of costs to institutional
practitioners if code numbers for
individual practitioners were to be
standardized and what changes would
be associated with those costs;
• Formats pharmacy applications
could accommodate or would prefer,
recognizing that pharmacy applications
may need to be reprogrammed to accept
this information;
• Estimates of the costs to pharmacies
and/or pharmacy application providers
for such reprogramming;
• Comments regarding whether
pharmacies have had difficulty
obtaining information from institutional
practitioners regarding individual
practitioners’ internal code numbers
and, if so, any proposed solutions.
Commenters wishing to address the
above topics or provide other
information should see the ‘‘Dates,’’
‘‘Addresses,’’ and ‘‘Posting of public
comments’’ sections above for
information regarding public comment
procedures.
Regulatory Certifications
This action is an Advance Notice of
Proposed Rulemaking (ANPRM).
Accordingly, the requirement of
Executive Order 12866 to assess the
costs and benefits of this action does not
apply. Rather, among the purposes DEA
has in publishing this ANPRM is to seek
information from the public regarding
the standardization of internal code
numbers used by institutional
practitioners to identify individual
practitioners who use the institution’s
DEA registration to administer,
dispense, or prescribe controlled
substances. Similarly, the requirements
of section 603 of the Regulatory
Flexibility Act do not apply to this
action since, at this stage, it is an
ANPRM and not a ‘‘rule’’ as defined in
section 601 of the Regulatory Flexibility
Act. Following review of the comments
received to this ANPRM, if DEA
promulgates a Notice or Notices of
Proposed Rulemaking regarding this
issue, DEA will conduct all analyses
required by the Regulatory Flexibility
Act, Executive Order 12866, and any
other statutes or Executive Orders
relevant to those rules and in effect at
the time of promulgation.
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Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Proposed Rules
Dated: August 28, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control.
[FR Doc. E9–21698 Filed 9–8–09; 8:45 am]
Note: For general information about the
negotiated rulemaking process, see The
Negotiated Rulemaking Process for Title IV
Regulations, Frequently Asked Questions at
https://www.ed.gov/policy/highered/reg/
hearulemaking/hea08/neg-reg-faq.html.
BILLING CODE 4410–09–P
If you use a telecommunications
device for the deaf (TDD), call the
Federal Relay Service (FRS), toll free at
1–800–877–8339.
Individuals with disabilities can
obtain this document in an accessible
format (e.g., braille, large print,
audiotape, or computer diskette) by
contacting the contact person under FOR
FURTHER INFORMATION CONTACT.
SUPPLEMENTARY INFORMATION: On May
26, 2009, we published a notice in the
Federal Register (74 FR 24728)
announcing our intent to establish
negotiated rulemaking committees to
develop proposed regulations (1)
governing foreign schools, including the
implementation of the changes made to
the HEA by the Higher Education
Opportunity Act of 2008 (HEOA), Public
Law 110–315, that affect foreign
schools; and (2) to maintain or improve
program integrity in the Title IV, HEA
programs. We announced our intent to
develop these proposed regulations by
following the negotiated rulemaking
procedures in section 492 of the HEA.
The notice also announced a series of
three regional hearings at which
interested parties could comment on the
topics suggested by the Department, and
suggest additional topics for
consideration for action by the
negotiating committees. We invited
parties to comment and submit topics
for consideration in writing, as well. We
heard testimony and received written
comments from approximately 290
individuals. Transcripts from the
hearings and copies of the written
comments can be found at https://
www.ed.gov/policy/highered/reg/
hearulemaking/2009/negregsummerfall.html.
Regulatory Issues: After consideration
of the information received at the
regional hearings and in writing, we
have decided to establish the following
two negotiating committees:
• Team I—Program Integrity Issues
• Team II—Foreign School Issues
We received many comments
suggesting that we negotiate issues
related to the student loan programs
authorized under Title IV of the HEA.
As we anticipate the need to convene a
negotiated rulemaking committee
following the completion of pending
legislative action related to student
loans, we will not be including student
loan issues on the agenda at this time.
Many of those who testified and those
who provided written comments made
DEPARTMENT OF EDUCATION
34 CFR Chapter VI
Office of Postsecondary Education;
Notice of Negotiated Rulemaking for
Programs Authorized Under Title IV of
the Higher Education Act of 1965, as
Amended
Department of Education.
Notice of establishment of
negotiated rulemaking committees.
AGENCY:
ACTION:
SUMMARY: We announce our intention to
establish two negotiated rulemaking
committees to prepare proposed
regulations under Title IV of the Higher
Education Act of 1965, as amended
(HEA). Each committee will include
representatives of organizations or
groups with interests that are
significantly affected by the subject
matter of the proposed regulations. We
request nominations for individual
negotiators who represent key
stakeholder constituencies that are
involved in the student financial
assistance programs authorized under
Title IV of the HEA to serve on these
committees.
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DATES: We must receive your
nominations for negotiators to serve on
the committees on or before September
25, 2009.
ADDRESSES: Please send your
nominations for negotiators to Patty
Chase, U.S. Department of Education,
1990 K Street, NW., room 8034,
Washington, DC 20006, or by fax at
(202) 502–7874. You may also e-mail
your nominations to
Patty.Chase@ed.gov. Nominees will be
notified whether or not they have been
selected as negotiators, as soon as the
Department’s review process is
completed.
FOR FURTHER INFORMATION CONTACT: For
information about the content of this
notice, including information about the
negotiated rulemaking process or the
nomination submission process contact:
Wendy Macias, U.S. Department of
Education, 1990 K Street, NW., room
8017, Washington, DC 20006.
Telephone: (202) 502–7526. You may
also e-mail your questions about the
nomination submission process to:
Wendy.Macias@ed.gov.
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the case for changes to bankruptcy rules
as they relate to student loans; some
also called for changes in statutes of
limitations and loan refinancing rules.
While those issues are important,
addressing them would require action
by Congress.
We also received comments
suggesting revisions to the institutional
financial responsibility regulations for
Title IV, HEA institutional eligibility.
We agree that this is an area where
changes may be beneficial. However,
significant analysis must be done by the
Department before we can bring this
issue to a committee for negotiation. We
will be beginning this process in the
near future. More information about the
public aspects of this process will be
forthcoming on the Department’s Web
site.
We list the topics each committee is
likely to address during this round of
negotiations elsewhere in this notice
under Committee Topics.
We intend to select negotiators for the
committees that represent the interests
significantly affected by the topics
proposed for negotiations. In so doing,
we will follow the requirement in
section 492(b)(1) of the HEA that the
individuals selected must have
demonstrated expertise or experience in
the relevant subjects under negotiation.
We will also select individual
negotiators who reflect the diversity
among program participants, in
accordance with section 492(b)(1) of the
HEA. Our goal is to establish
committees that will allow significantly
affected parties to be represented while
keeping the committee size manageable.
The committees may create subgroups
on particular topics that would involve
additional individuals who are not
members of the committees. Individuals
who are not selected as members of the
committees will be able to attend the
meetings, have access to the individuals
representing their constituencies, and
participate in informal working groups
on various issues between the meetings.
The committee meetings will be open to
the public.
The Department has identified the
following constituencies as having
interests that are significantly affected
by the topics proposed for negotiations.
The Department plans to seat as
negotiators individuals from
organizations or groups representing
each of these constituencies. The
Department anticipates that individuals
from organizations or groups
representing each of these
constituencies will participate as
members of one or more committees as
appropriate. These constituencies are:
• Students.
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]]>Agencies
[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Proposed Rules]
[Pages 46396-46399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21698]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket no. DEA-321a]
RIN 1117-AB22
Identification of Institution-based Individual Practitioners
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Advance notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is soliciting public
comments on how best to standardize the specific internal code number
associated with each individual practitioner permitted by the hospital
or other institutional practitioner to administer, dispense, or
prescribe controlled substances using that institution's DEA
registration. DEA is taking this action in response to comments it
received to its Notice of Proposed Rulemaking regarding electronic
prescriptions for controlled substances.
DATES: Written comments must be postmarked and electronic comments must
be submitted on or before November 9, 2009. Commenters should be aware
that the electronic Federal Docket Management System will not accept
comments after Midnight Eastern Time on the last day of the comment
period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-321'' on all written and
[[Page 46397]]
electronic correspondence. Written comments being sent via regular or
express mail should be sent to the Drug Enforcement Administration,
Attention: DEA Federal Register Representative/ODL, 8701 Morrissette
Drive, Springfield, VA 22152. Comments may be sent to DEA by sending an
electronic message to dea.diversion.policy@usdoj.gov. Comments may also
be sent electronically through https://www.regulations.gov using the
electronic comment form provided on that site. An electronic copy of
this document is also available at the https://www.regulations.gov Web
site. DEA will accept attachments to electronic comments in Microsoft
Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not
accept any file formats other than those specifically listed here.
Please note that DEA is requesting that electronic comments be
submitted before midnight Eastern time on the day the comment period
closes because https://www.regulations.gov terminates the public's
ability to submit comments at midnight Eastern time on the day the
comment period closes. Commenters in time zones other than Eastern Time
may want to consider this so that their electronic comments are
received. All comments sent via regular or express mail will be
considered timely if postmarked on the day the comment period closes.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152;
telephone: (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at https://www.regulations.gov and in the Drug
Enforcement Administration's public docket. Such information includes
personal identifying information (such as your name, address, etc.)
voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase ``CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted
and the comment, in redacted form, will be posted online and placed in
the Drug Enforcement Administration's public docket file. Please note
that the Freedom of Information Act applies to all comments received.
If you wish to inspect the agency's public docket file in person by
appointment, please see the ``For Further Information'' paragraph.
DEA's Legal Authority
DEA implements and enforces the Comprehensive Drug Abuse Prevention
and Control Act of 1970, often referred to as the Controlled Substances
Act (CSA) and the Controlled Substances Import and Export Act (21
U.S.C. 801-971), (CSA), as amended. DEA publishes the implementing
regulations for these statutes in Title 21 of the Code of Federal
Regulations (CFR), Parts 1300 to end. These regulations are designed to
ensure that there is a sufficient supply of controlled substances for
medical, scientific, and other legitimate purposes and to deter the
diversion of controlled substances to illegal purposes.
Controlled substances are drugs that have a potential for abuse and
psychological and physical dependence; these include substances
classified as opioids, stimulants, depressants, hallucinogens, anabolic
steroids, and drugs that are immediate precursors of these classes of
substances. DEA lists controlled substances in 21 CFR part 1308. The
substances are divided into five schedules: Schedule I substances have
a high potential for abuse and have no accepted medical use in
treatment in the United States. These substances may only be used for
research, chemical analysis, or manufacture of other drugs. Schedule
II--V substances have an accepted medical use and also have a potential
for abuse and psychological and physical dependence.
The CSA mandates that DEA establish a closed system of control for
manufacturing, distribution, and dispensing of controlled substances.
Any person who manufactures, distributes, dispenses, imports, exports,
or conducts research or chemical analysis with controlled substances
must register with DEA (unless exempt), keep track of all stocks of
controlled substances, and maintain records to account for all
controlled substances received, distributed, dispensed, or otherwise
disposed of.
Background
The CSA requires that every person who dispenses controlled
substances shall obtain from the Attorney General a registration (21
U.S.C. 822(a)(2)). Authority to issue such registrations has been
delegated by the Attorney General to the Administrator of the Drug
Enforcement Administration (28 CFR 0.100).
An individual practitioner who is an agent or employee of a
hospital or other institution registered with DEA may use the DEA
registration of that hospital or other institution to administer,
dispense, or prescribe controlled substances in accordance with the
regulations (21 CFR 1301.22(c)). Specifically:
An individual practitioner who is an agent or employee of a
hospital or other institution may, when acting in the normal course
of business or employment, administer, dispense, or prescribe
controlled substances under the registration of the hospital or
other institution which is registered in lieu of being registered
him/herself, provided that:
(1) Such dispensing, administering or prescribing is done in the
usual course of his/her professional practice;
(2) Such individual practitioner is authorized or permitted to
do so by the jurisdiction in which he/she is practicing;
(3) The hospital or other institution by whom he/she is employed
has verified that the individual practitioner is so permitted to
dispense, administer, or prescribe drugs within the jurisdiction;
(4) Such individual practitioner is acting only within the scope
of his/her employment in the hospital or institution;
(5) The hospital or other institution authorizes the individual
practitioner to administer, dispense or prescribe under the hospital
registration and designates a specific internal code number for each
individual practitioner so authorized. The code number shall consist
of numbers, letters, or a combination thereof and shall be a suffix
to the institution's DEA registration number, preceded by a hyphen
(e.g., APO123456-10 or APO123456-A12); and
(6) A current list of internal codes and the corresponding
individual practitioners is kept by the hospital or other
institution and
[[Page 46398]]
is made available at all times to other registrants and law
enforcement agencies upon request for the purpose of verifying the
authority of the prescribing individual practitioner. (21 CFR
1301.22(c))
Notice of Proposed Rulemaking Regarding Electronic Prescriptions for
Controlled Substances
On June 27, 2008, DEA published a Notice of Proposed Rulemaking
``Electronic Prescriptions for Controlled Substances'' [Docket No. DEA-
218, RIN 1117-AA61] (73 FR 36722). In that rule, DEA proposed that
pharmacy applications receiving electronic prescriptions for controlled
substances be capable of reading and retaining the full DEA
registration number, including any extensions, or other identification
numbers used under 21 CFR 1306.05(c). DEA further proposed that the
full number including extensions must be retained in the prescription
record. DEA further proposed that the pharmacy application must verify
that the practitioner's DEA registration was valid at the time the
prescription was signed. DEA indicated the pharmacy application may do
this by checking the DEA CSA database or by having another entity check
the DEA CSA database during transmission and indicate on the record
that the check has occurred and the registration is valid. Finally, DEA
proposed that the pharmacy application must reject prescriptions that
were signed by practitioners without valid DEA registrations.
Comments received. DEA received numerous comments to its Notice of
Proposed Rulemaking regarding this issue. Approximately twenty
commenters representing State licensing boards, pharmacy and pharmacist
organizations, chain drug stores, and electronic prescription and
electronic pharmacy application vendors commented regarding this issue.
One commenter, an organization representing health system pharmacists,
believed that whatever system is used for extensions, the system must
allow pharmacies to validate the original DEA number and determine
whether the DEA number belongs to a facility for which extensions are
permissible. A standards development organization for electronic
prescription applications asked DEA to propose an industry solution to
extensions, such as a standard length. It noted that the same problem
exists for paper prescriptions.
A commenter representing grocery stores with pharmacies stated that
DEA is placing the pharmacy in an untenable situation. The pharmacy
would be expected to check and store a number on DEA's behalf for which
there is no standard and over which DEA exerts no jurisdiction, as DEA
does not specify criteria regarding the format or content of the suffix
data for each individual practitioner using the institutional
practitioner's registration. The commenter noted that the health-system
or hospital choosing to employ a suffix system is tasked with the
implementation and tracking of that process. The commenter recommended
that DEA require the validity of the health-system DEA number be
verified and that a health-system's use of a suffix system be guided by
DEA directly at that user's facility.
Various State and national pharmacy organizations, an association
representing chain drug stores, several State boards of pharmacy,
several chain drug stores, and several pharmacy system providers all
stated that DEA should standardize extensions and make it clear that
pharmacies are not responsible for checking the validity of the
extensions.
In response to the comments received, DEA is considering how best
to standardize the internal code numbers assigned by institutional
practitioners to the individual practitioners they permit to use their
registration to administer, dispense, and prescribe controlled
substances. DEA believes such standardization would benefit the overall
dispensing of controlled substances by bringing a level of uniformity
to such extensions. As commenters noted, this standardization is
essential for DEA to require pharmacy systems to retain this
information.
DEA recognizes, however, that there are many institutional
practitioners employing internal code number systems. There has never
been standardization regarding this number, and DEA believes it
extremely likely that institutional practitioner registrants have
established a variety of internal code number systems. Therefore, to
address this issue, DEA is soliciting information from the regulated
industry and other interested members of the public regarding current
methods being used and how best to implement industry standardization
in this area. Specifically, DEA seeks the following information:
Information regarding formats used by institutional
practitioners when establishing internal code numbers for individual
practitioners permitted to use the institution's registration number;
Estimates of the number of individual practitioners using
internal code numbers for identification purposes;
Estimates of the number of individual practitioners using
internal code numbers for identification purposes in a particular
institutional practitioner;
Estimates of costs to institutional practitioners if code
numbers for individual practitioners were to be standardized and what
changes would be associated with those costs;
Formats pharmacy applications could accommodate or would
prefer, recognizing that pharmacy applications may need to be
reprogrammed to accept this information;
Estimates of the costs to pharmacies and/or pharmacy
application providers for such reprogramming;
Comments regarding whether pharmacies have had difficulty
obtaining information from institutional practitioners regarding
individual practitioners' internal code numbers and, if so, any
proposed solutions.
Commenters wishing to address the above topics or provide other
information should see the ``Dates,'' ``Addresses,'' and ``Posting of
public comments'' sections above for information regarding public
comment procedures.
Regulatory Certifications
This action is an Advance Notice of Proposed Rulemaking (ANPRM).
Accordingly, the requirement of Executive Order 12866 to assess the
costs and benefits of this action does not apply. Rather, among the
purposes DEA has in publishing this ANPRM is to seek information from
the public regarding the standardization of internal code numbers used
by institutional practitioners to identify individual practitioners who
use the institution's DEA registration to administer, dispense, or
prescribe controlled substances. Similarly, the requirements of section
603 of the Regulatory Flexibility Act do not apply to this action
since, at this stage, it is an ANPRM and not a ``rule'' as defined in
section 601 of the Regulatory Flexibility Act. Following review of the
comments received to this ANPRM, if DEA promulgates a Notice or Notices
of Proposed Rulemaking regarding this issue, DEA will conduct all
analyses required by the Regulatory Flexibility Act, Executive Order
12866, and any other statutes or Executive Orders relevant to those
rules and in effect at the time of promulgation.
[[Page 46399]]
Dated: August 28, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E9-21698 Filed 9-8-09; 8:45 am]
BILLING CODE 4410-09-P
