[Federal Register Volume 75, Number 71 (Wednesday, April 14, 2010)]
[Notices]
[Pages 19409-19413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8560]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Request for Comment on Minimum Requirements for Criteria in
Fiscal Year 2011 Grant Applications Under the National All Schedules
Prescription Electronic Reporting Act of 2005 (NASPER)
AGENCY: Substance Abuse and Mental Health Services Administration, HHS.
SUMMARY: This notice is to request comments from interested parties
regarding criteria for grants issued under NASPER (42 U.S.C. 280g-3).
NASPER establishes a formula grant program for States to establish or
improve State controlled substance monitoring systems (``prescription
monitoring programs,'' or ``PMPs''). Under NASPER, the Secretary will
award grants to qualifying States, defined in the legislation as the 50
States and the District of Columbia (42 U.S.C. 280g-3(m)(8)). This
notice is required under NASPER and comments received in response to
this notice will be evaluated and as appropriate, included in public
announcements for grants under this law.
SAMHSA will be issuing a Request for Applications (RFA) for formula
grant awards under the NASPER program in Federal fiscal year (FFY)
2010.
Authority: Section 399O, of the Public Health Service Act, as
amended.
DATES: The closing date to submit comments will be May 14, 2010. The
Administrator believes that this limited comment period is necessary
and justified to comply with the timelines necessary to announce,
submit, review and award grants before the end of the fiscal year,
September 30, 2010.
ADDRESSES: To assure proper handling of comments, please reference
``Docket No. CSAT 003'' on all written and electronic correspondence.
Written comments may be submitted to the Division of Pharmacologic
Therapies, Center for Substance Abuse Treatment, 1 Choke Cherry Road,
Room 2-1084, Rockville, MD 20857; Attention: DPT Federal Register
Representative. Alternatively, comments may be submitted directly to
SAMHSA by sending an electronic message to [email protected]. Comments may also be sent electronically
through http://www.regulations.gov using the electronic comment form
provided on that site. An electronic copy of this document is also
available at the http://www.regulation.gov Web site. SAMHSA will accept
attachments to electronic comments in Microsoft Word, WordPerfect,
Adobe PDF, or Excel file formats only. SAMHSA will not accept any file
formats other than those specifically listed here.
Please note that SAMHSA is requesting that electronic comments be
submitted before midnight Eastern time on the day the comment period
closes and http://www.regulations.gov will not accept comments after
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.
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 http://www.regulations.gov and in the SAMHSA
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 SAMHSA'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 CONTACT paragraph.
FOR FURTHER INFORMATION CONTACT: Jennifer Fan, Center for Substance
Abuse Treatment (CSAT), Division of Pharmacologic Therapies, SAMHSA, 1
Choke Cherry Road, Room 2-1084, Rockville, MD 20857, (240) 276-1759, e-
mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The National All Schedules Prescription Electronic Reporting Act of
2005, (``NASPER'' Pub. L. 109-60) enacted August 11, 2005, created a
formula grant program under the authority of the Secretary for Health
and Human Services (``the Secretary'') for State controlled substance
monitoring systems (``prescription monitoring programs,'' hereinafter,
``PMPs''). The intent of this law is to foster the
[[Page 19410]]
establishment or enhancement of State-administered controlled substance
monitoring systems in order to ensure that health care providers and
law enforcement officials and other regulatory bodies have access to
accurate, timely prescription history information as permitted by law.
In addition, the expansion and establishment of prescription monitoring
systems has the potential for assisting in the early identification of
patients at risk for addiction. Although NASPER was authorized in 2005,
an appropriation to fund the Federal grant program was not available
until March 2009. Subsequently, the Consolidated Appropriations Act of
2010 appropriated $2 million to SAMHSA for the NASPER program.
According to the Alliance of States with Prescription Monitoring
Programs (Alliance), as of February 2010, 35 States have operational
PMPs. An additional 5 States have enacted legislation and 2 States have
pending legislation to start a PMP. Although there is considerable
variation, the programs essentially require that pharmacies,
physicians, or both, submit information on prescriptions dispensed for
certain controlled substances as mandated by State law. Prescriber and
patient information relating to prescriptions issued for controlled
stimulants, sedatives/depressants, anxiolytics, narcotics, etc., is
transmitted to a central office within each State.
NASPER established the authority for a grant program with the
Secretary, HHS, wherein a State may submit an application to implement
a new controlled substance prescription monitoring system, or to make
improvements upon an existing State controlled substance monitoring
system. In addition, the legislation includes provisions for
standardization that will enable and require the sharing of information
between States with programs.
To be eligible to receive a grant under NASPER, the State must
demonstrate that the State has enacted legislation or regulations to
permit the implementation of the State controlled substance monitoring
program and the imposition of appropriate penalties for the
unauthorized use and disclosure of information maintained in such
program. Additional requirements for applications are set forth under
42 U.S.C. 280g-3(c), and include budget cost estimates,
interoperability standards, uniform electronic formats, access to
information, penalties for unauthorized disclosures and other issues.
SAMHSA will issue a formal request for applications in the next several
weeks that will specify State application requirements for 2010
funding.
The field of electronic patient health records is dynamic. The
Administrator understands that there are several initiatives being
conducted by the Office of the National Coordinator for Health
Information Technology (ONC) under the Health Information Technology
for Economic and Clinical Health Act (HITECH Act) of 2009. ONC supports
the coordination of nationwide efforts to implement and use the most
advanced health information technology and electronic exchange of
health information such as the use of electronic health records (EHR).
The ONC initiative is complemented by a grant program funded by the
American Recovery and Reinvestment Act (ARRA) that accelerates the
development and utilization of standardized EHR systems. In addition,
the Drug Enforcement Administration (DEA) issued a notice of proposed
rulemaking that, if finalized, would permit electronic prescribing of
the controlled substances that are subject to PMPs, 73 FR 36722 (27
June 2008).\1\ The Administrator believes that the future changes in
health information technology and EHRs will have a significant impact
on PMPs.
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\1\ ``Electronic Prescriptions for Controlled Substances,
Proposed Rule.'' Federal Register 73:125 (27 June 2008) p. 36722.
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SAMHSA is currently involved in discussion with the Department of
Health and Human Services (HHS) on Health Information Technology (HIT)
and will monitor the implication for PMPs.
II. Request for Comments
Before awarding grants to States under NASPER, the Secretary is
required, after consulting with States and other interested parties, to
seek public comment on proposed minimum requirements. Under 42 U.S.C.
280g-3(b), the criteria to be used by States relate to the following
four purposes:
1. Criteria for security for information handling and for the
database maintained by the State under subsection (e) generally
including efforts to use appropriate encryption technology or other
appropriate technology to protect the security of such information (42
U.S.C. 280g-3(c)(1)(A)(ii));
2. Criteria for availability of information and limitation on
access to program personnel (42 U.S.C. 280g-3(c)(1)(A)(v));
3. Criteria for access to the database, and procedures to ensure
that information in the database is accurate (42 U.S.C. 280g-
3(c)(1)(A)(vi));
4. Criteria for the use and disclosure of information, including a
description of the certification process to be applied to requests for
information under subsection (f) (42 U.S.C. 280g-3(c)(1)(A)(vii)).
In a Federal Register notice published April 29, 2009, 74 FR 81 (29
April 2009), SAMSHA proposed minimum standards in accordance with
NASPER.\2\ SAMHSA received several comments in response to that notice.
These comments, the 2009 Request for Application (RFA), as well as a
document that summarizes how the comments were addressed can be viewed
by searching ``HHH-OS-2009-0006'' at the http://www.regulations.gov
website. The comments were considered and reflected in the 2009 RFA.
SAMHSA received and funded 13 grants to States in 2009. The minimum
standards contained in the 2009 RFA remain in effect unless
specifically modified as a result of this current process.
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\2\ ``Request for Comment on Minimum Requirements for Criteria
in Grant Applications Under the National All Schedules Prescription
Electronic Reporting Act of 2005 (NASPER).'' Federal Register 74:81
(29 April 2009) p. 19566.
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A. Consultation With States and Other Interested Parties
Prescription monitoring programs (``PMPs'') have been in place for
decades. In addition, the Federal Government has supported the
development, enhancement, and expansion of these State programs for
several years under the ``Harold Rogers Prescription Drug Monitoring
Grant Program,'' which is administered by the Department of Justice,
Bureau of Justice Assistance (DOJ/BJA). Since FY 2003, BJA has provided
training and technical assistance to grantees and to States which are
planning to implement a program. BJA training and technical assistance
partners have included the National Alliance for Model State Drug Laws,
the IJIS Institute, the National Conference of State Legislatures, the
Addiction Technology Transfer Center, Brandeis University, and the
Alliance of States with Prescription Drug Monitoring Programs.
In developing these revisions to the minimum standards, SAMHSA has
consulted with DOJ/BJA and the Alliance of States with Prescription
Drug Monitoring Programs to obtain information about their experience
with PMP operating requirements. In addition, SAMHSA has discussed
NASPER provisions with individual States with PMPs, and entities such
as
[[Page 19411]]
the Institute of Justice Information Systems, which have provided
technical assistance to State PMPs on interstate information sharing.
SAMHSA has also reviewed the Model State PMP law, the Harold Rogers
Grant Program grant solicitations as well as numerous reports, survey
results, and published articles. SAMHSA believes that taken together,
the approach outlined above provides a sufficient level of consultation
for the minimum requirements proposed for comment in this notice.
In addition from these consultations, SAMHSA understands that
standards are not uniform from State to State. However, while some
States have, or will adopt the minimum standards proposed in the
notice, other States will consider the need to modify their systems
substantially in order to conform with the new standards.
B. Proposed Minimum Requirements
Overall, the Administrator's intent in proposing the minimum
standards below is to facilitate the stated goals of NASPER--to foster
establishment of PMPs that provide timely information to health care
providers and others, and, over time, to guide the improvement of PMPs
with best practices.
1. Criteria for security for information handling and for the
database maintained by the State under subsection (e) generally
including efforts to use appropriate encryption technology or other
appropriate technology to protect the security of such information (42
U.S.C. 280g-3(c)(1)(A)(ii)).
State PMPs include personal patient health information on
individuals who receive and fill controlled substance prescriptions as
well as those who have had a controlled substance dispensed to them
beyond a 48-hour supply. In addition, PMPs need to collect
identification information on prescribers and dispensers. Finally, the
systems need to collect information that identifies the types and
quantities of the prescribed/dispensed substances. The information
collection requirements under NASPER are set forth under 42 U.S.C.
280g-3(d)(3)(A)-(J).
The Administrator is not proposing any new minimum standards for
security under this system. The standards have not changed from those
incorporated into the Fiscal Year 2009 RFA. To summarize, information
from PMPs must be stored and protected in an electronic manner that, at
a minimum, is at least equivalent to the standards set forth in
regulations promulgated under section 262 of the Health Insurance
Portability and Accountability Act of 1996 (Pub. L. 104-191; 110 Stat.
2033). This would include the technical safeguards standards of the
HIPAA Security Rule under 45 CFR 164.312. ``Technical safeguards'' is
defined at 45 CFR 164.304 as, ``the technology and the policy and
procedures for its use that protect electronic protected health
information and control access to it.'' These HIPAA security
regulations include technical safeguards for access control, audit
controls, integrity, person or entity authentication, and transmission
security. The access control standards require, at a minimum, unique
user identification, and an emergency access procedure, with automatic
logoff and encryption/decryption as addressable implementation
specifications.
In addition, NASPER does not supersede the requirements of the
Federal substance abuse confidentiality law (42 U.S.C. 290dd-2) and
regulations under 42 CFR part 2.
2. Criteria for availability of information and limitation on
access to program personnel (42 U.S.C. 280g-3(c)(1)(A)(v)).
For the purposes of organization, the Administrator will address
``criteria for availability of information'' under section four, below.
``Limitation on access to program personnel'' will be interpreted for
the purposes of this notice to mean limiting access to individuals
within the State PMP program to the PMP database and the PMP data
itself.
The Administrator is not proposing any new minimum standards under
this section.
3. Criteria for access to the database, and procedures to ensure
that information in the database is accurate (42 U.S.C. 280g-
3(c)(1)(A)(vi)).
For the purposes of organization, the Administrator will address
``criteria for access to the database'' under section four, and the
revised minimum standards here (section 3) relating to procedures to
ensure that information in the database is accurate.
Based upon consultations with States and other entities, the
Administrator believes that the procedures applied by PMPs to ensure
accuracy have evolved over the years. Indeed, electronic PMPs rely on
much of the same technology for transmission of prescription drug data
as that used by the private and public insurance systems. As such,
these electronic data transmission switches have evolved procedures and
safeguards to help assure that the information is accurate for
reimbursement purposes.
From the 2009 RFA, existing PMPs must adopt the 1995 or higher
version of the American Society for Automation in Pharmacy (ASAP)
standard for electronic prescription formatting to ensure the accuracy
of the information in the PMP database, while PMPs that are being
established and implemented must adopt the most current ASAP version
(i.e., ASAP 2007). However, the Administrator proposes for comment the
following new minimum requirements for accuracy. Existing PMPs must
adopt the 2007 version of the ASAP standard for electronic prescription
formatting by September 30, 2011. The Administrator believes the
adoption of the minimum will help ensure that gross formatting errors
in identification numbers, NDC codes, etc., are minimized. In addition,
using the most recent version of the ASAP standard may enhance the
potential for increased State-to-State interoperability, the potential
to collect information on cash purchases, and the potential for ``real
time'' reporting.
4. Criteria for the use and disclosure of information, including a
description of the certification process to be applied to requests for
information under subsection (f) (42 U.S.C. 280g-3(c)(1)(A)(vii)).
The intent of this provision is to limit the disclosure of
information from a State PMP to that necessary for public health and
law enforcement purposes. NASPER envisions two types of disclosures
from PMPs--solicited disclosures and unsolicited disclosures.
Solicited Disclosure of Information from PMP. Under 42 U.S.C. 280g-
3(f)(1), a State may disclose information from the PMP only in response
to a request (``a solicited request'') from any of five entities: (a) A
practitioner (or the agent thereof), (b) any local, State, or Federal
law enforcement, narcotics control, licensure, disciplinary, or program
authority, (c) the controlled substance monitoring program of another
State or group of States with whom the State has established an
interoperability agreement, (d) any agent of the Department of Health
and Human Services, a State Medicaid program, a State health
department, or the Drug Enforcement Administration, and (e) an agent of
the State agency or entity of another State that is responsible for the
establishment and maintenance of that State's controlled substance
monitoring program. The Administrator views solicited requests for
information as a two component process. First, the individual or entity
requesting information from the PMP must be authorized
(``authentication'') to receive the information. Next, the authorized
individual or entity must provide a need (``certification'') for the
requested information.
[[Page 19412]]
The Administrator is proposing minimum authentication and
certification requirements for solicited disclosures from PMPs for the
five entities listed in NASPER. These authentication requirements are
proposed to bring PMPs into compliance with National Institute of
Standards and Technology (NIST) 800-63.
(a) A practitioner or dispenser (pharmacist) must submit a hard
copy written, signed, and notarized request every three years to the
designated State agency, which in turn, verifies the information before
providing a username and password to the practitioner. The request must
include the practitioner's name and date of birth, a corresponding DEA
registration number, and State medical license number. In soliciting
information from the State PMP database, the practitioner must certify
that the requested information is for the purpose of providing medical
or pharmaceutical treatment or evaluating the need for such treatment
to a bona fide current patient. Such requests/certifications can be
conducted by web-based procedures. In the 2009 RFA, States have until
September 30, 2010 to apply this minimum requirement. This minimum
requirement procedure must now be utilized by States at the time of
funding. States, or their agents, must comply with level 2 authority
verification and authorization mechanism level 2 as set forth in the
NIST Electronic Authentication Guideline of April 2006.\3\
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\3\ ``National Institute of Standards and Technology. Electronic
Authentication Guideline. [Online] April 2006. Gaithersburg, MD:
NIST Special Publication 800-63 Version 1.0.2. http://csrc.nist.gov/publications/nistpubs/800-63/SP800-63V1_0_2.pdf (accessed February
18, 2010).
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In addition, the Administrator recognizes that a number of States
allow prescribers to enlist the assistance of agents who can retrieve
patient information on behalf of the prescriber. The Administrator
proposes the authorization of one PMP subaccount per prescriber, if
permitted by State law. The dispenser would not be permitted to obtain
subaccounts.
(b) The Administrator is not proposing any new minimum standards
under this section with respect to local, State, or Federal law
enforcement, narcotics control, licensure, disciplinary, or program
authorities.
(c) The Administrator is not proposing any new minimum standards
under this section with respect to the controlled substance monitoring
program of another State or a group of States.
(d) The Administrator is not proposing any new minimum standards
under this section with respect to any agent of the Department of
Health and Human Services, a State Medicaid program, a State health
department, or the Drug Enforcement Administration.
(e) The Administrator is not proposing any new minimum standards
under this section with respect to an agent of the State agency or
entity of another State that is responsible for the establishment and
maintenance of the State's controlled substance monitoring program.
Patients: The Administrator is not proposing any new minimum
standards under this section.
Unsolicited Disclosures of Information from PMPs. Practitioners and
Dispensers. Under 42 U.S.C. 280g-3(f)(2)(A), NASPER requires that
``[I]n consultation with practitioners, dispensers, and other relevant
and interested stakeholders, a State receiving a grant under subsection
(a) * * * shall establish a program to notify practitioners and
dispensers of information that will help identify and prevent the
unlawful diversion or misuse of controlled substances * * *.''
The Administrator understands that notifying prescribers and
dispensers when PMP activity identifies individuals who may need
substance abuse treatment, or suggests drug diversion, is important to
reducing substance abuse and reducing illicit distribution of
controlled prescription substances.
Prescription drug abuse and prescription drug mortality continue to
present a significant public health problem. A recent Centers for
Disease Control and Prevention Information Brief indicates that from
1999 through 2006, the number of fatal poisonings involving opioid
analgesics more than tripled from 4,000 to 13,800 deaths. That same
report indicates that opioid analgesics were involved in almost 40% of
all poisoning deaths in 2006.
According to SAMHSA's 2008 National Survey on Drug Use and Health
(NSDUH 2008), individuals age 12 and over initiate abuse of
prescription controlled substance pain relievers at approximately the
same rate as marijuana. That same report indicates that 55.9% of those
individuals obtain the abused prescription drug free from a friend or
relative. In turn, those friends or relatives obtained the prescription
controlled substance from one doctor almost 80% of the time, and from
one or more doctors 3.4% of the time. Clearly, there is a need to
better inform prescribing physicians on how their patients are
obtaining prescription controlled substances for potentially non-
medical uses.
The inappropriate use of controlled prescription drugs is also
taxing public insurance. According to the September 2009 U.S.
Government Accountability Office (GAO) Report titled ``Medicaid: Fraud
and Abuse Related to Controlled Substances Identified in Selected
States,'' which looked at potential Medicaid fraud in California,
Illinois, New York, North Carolina, and Texas, indicated that during
fiscal years 2006 and 2007, ``doctor shopping'' activities involving
controlled substances resulted in $63 million in Medicaid payments, not
including medical costs related to getting prescriptions.\4\
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\4\ U.S. Government Accountability Office. Medicaid: Fraud and
Abuse Related to Controlled Substances Identified in Selected
States, GAO-09-957. Washington, DC: Government Accountability
Office, September 2009. http://www.gao.gov/new.items/d09957.pdf
(accessed February 23, 2010).
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The GAO Report also examined the use of PMPs in reducing fraud,
abuse, and diversion of controlled substances. The GAO concluded that:
For PDMPs to be useful, health care providers and pharmacies
must use the data. Officials from the five selected states said that
physician participation in the PDMP is not widespread and not
required. In fact, one state did not have a Web-based PDMP; a health
care provider has to put in a manual request to the agency to have a
controlled substance report generated.
SAMHSA agrees that PMPs are most effective when prescribers have
information on patients; however, prescribers do not request or receive
information from PMPs with acceptable frequency.\5\
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\5\ Tribble SJ. (2010, January 20). Ohio lawmakers want to
mandate prescription monitoring by doctors. Cleveland.com [Online]
January 20, 2010. http://www.cleveland.com/healthfit/index.ssf/2010/01/lawmakers_want_to_mandate_pres.html (accessed February 23,
2010).
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Some States have enacted laws that require prescribers to solicit
information on patients before prescribing. The Administrator is aware
that many States have established ``thresholds'' that trigger
unsolicited notifications to prescribers and in some cases
dispensers.\6\
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\6\ Katz N et al. Usefulness of prescription monitoring programs
for surveillance--analysis of Schedule II opioid prescription data
in Massachusetts, 1996-2006. Pharmacoepidemiology and Drug Safety
2010; 19: 115-123.
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In the 2009 RFA, the unsolicited notification minimum requirement
was met by the State if the State established a plan and articulated a
threshold for notifying practitioners and dispensers of information
that will help identify and prevent unlawful diversion or misuse of
controlled drugs. A threshold example
[[Page 19413]]
was provided of an individual who has filled five or more controlled
substance prescriptions from five different prescribers or five
different dispensers in the State within a six month period. After
proposing this a minimum requirement in 2009, SAMHSA did receive a
comment that this threshold would create a resource burden on States.
Due to this, SAMHSA considered alternative notification plans.
SAMHSA realizes that in the September 2009 GAO report, a threshold
of patients using six or more physicians in a year to obtain controlled
substances was used while a threshold of four or more physicians and
four or more pharmacies in the span of one year was used by Katz et al
in examining the data in Massachusetts.4 6 In addition, CDC
recommended PMPs provide ``reports to providers on patients less than
65 years old if they are being treated with opioids for more than 6
weeks by two or more providers or if there are signs of inappropriate
use of controlled substances.'' \7\ These thresholds have not been
validated; however the GAO report found that approximately 65,000
Medicaid beneficiaries in the five states investigated visited six or
more doctors to acquire prescriptions for the same type of controlled
substances in the selected states during fiscal years 2006 and 2007. In
light of the above regarding the effectiveness of PMPs when prescribers
and dispensers have access to PMP data as well as the burden on States
with such disclosures, the Administrator is proposing as a minimum
standard the following threshold: Any individual that has filled six or
more controlled substance prescriptions from six different prescribers,
or six different dispensers in the State, within a six month period
shall be the subject of a report from the prescription drug monitoring
program to each prescriber. This higher threshold for unsolicited
reporting will reduce the burden to States from what was proposed in
2009. To further mitigate the burden to States for unsolicited
reporting to prescribers, the Administrator also proposes that reports
must be sent to at least ten percent of the registered prescribers in
the State in one calendar year.
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\7\ Centers for Disease Control and Prevention. CDC's Issue
Brief: Unintentional Drug Poisoning in the United States. [Online]
March 2010. Atlanta, GA: http://www.cdc.gov/HomeandRecreationalSafety/pdf/poision-issue-brief.pdf (accessed
April 5, 2010).
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Drug Diversion Investigators: The Administrator is not proposing
any new minimum standards under this section.
Pamela S. Hyde,
Administrator, Substance Abuse and Mental Health Services
Administration.
[FR Doc. 2010-8560 Filed 4-13-10; 8:45 am]
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