[House Report 111-616]
[From the U.S. Government Publishing Office]
111th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 111-616
======================================================================
NATIONAL ALL SCHEDULES PRESCRIPTION ELECTRONIC REPORTING
REAUTHORIZATION ACT OF 2010
_______
September 22, 2010.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Waxman, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 5710]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 5710) to amend and reauthorize the controlled
substance monitoring program under section 399O of the Public
Health Service Act, having considered the same, report
favorably thereon with an amendment and recommend that the bill
as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Committee Consideration.......................................... 4
Committee Votes.................................................. 5
Committee Oversight Findings and Recommendations................. 5
New Budget Authority, Entitlement Authority, and Tax Expenditures 5
Statement of General Performance Goals and Objectives............ 5
Constitutional Authority Statement............................... 5
Earmarks and Tax and Tariff Benefits............................. 5
Federal Advisory Committee Statement............................. 6
Applicability of Law to Legislative Branch....................... 6
Federal Mandates Statement....................................... 6
Committee Cost Estimate.......................................... 6
Congressional Budget Office Cost Estimate........................ 6
Section-by-Section Analysis of the Legislation................... 7
Explanation of Amendments........................................ 8
Changes in Existing Law Made by the Bill, as Reported............ 8
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National All Schedules Prescription
Electronic Reporting Reauthorization Act of 2010''.
SEC. 2. AMENDMENT TO PURPOSE.
Paragraph (1) of section 2 of the National All Schedules Prescription
Electronic Reporting Act of 2005 (Public Law 109-60) is amended to read
as follows:
``(1) foster the establishment of State-administered
controlled substance monitoring systems in order to ensure
that--
``(A) health care providers have access to the
accurate, timely prescription history information that
they may use as a tool for the early identification of
patients at risk for addiction in order to initiate
appropriate medical interventions and avert the tragic
personal, family, and community consequences of
untreated addiction; and
``(B) appropriate law enforcement, regulatory, and
State professional licensing authorities have access to
prescription history information for the purposes of
investigating drug diversion and prescribing and
dispensing practices of errant prescribers or
pharmacists; and''.
SEC. 3. AMENDMENTS TO CONTROLLED SUBSTANCE MONITORING PROGRAM.
Section 399O of the Public Health Service Act (42 U.S.C. 280g-3) is
amended--
(1) in subsection (a)(1)--
(A) in subparagraph (A), by striking ``or'';
(B) in subparagraph (B), by striking the period at
the end and inserting ``; or''; and
(C) by adding at the end the following:
``(C) to maintain and operate an existing State-
controlled substance monitoring program.'';
(2) by amending subsection (b) to read as follows:
``(b) Minimum Requirements.--The Secretary shall maintain and, as
appropriate, supplement or revise (after publishing proposed additions
and revisions in the Federal Register and receiving public comments
thereon) minimum requirements for criteria to be used by States for
purposes of clauses (ii), (v), (vi), and (vii) of subsection
(c)(1)(A).'';
(3) in subsection (c)--
(A) in paragraph (1)(B)--
(i) in the matter preceding clause (i), by
striking ``(a)(1)(B)'' and inserting
``(a)(1)(B) or (a)(1)(C)'';
(ii) in clause (i), by striking ``program to
be improved'' and inserting ``program to be
improved or maintained''; and
(iii) in clause (iv), by striking ``public
health'' and inserting ``public health or
public safety'';
(B) in paragraph (3)--
(i) by striking ``If a State that submits''
and inserting the following:
``(A) In general.--If a State that submits'';
(ii) by inserting before the period at the
end ``and include timelines for full
implementation of such interoperability''; and
(iii) by adding at the end the following:
``(B) Monitoring of efforts.--The Secretary shall
monitor State efforts to achieve interoperability, as
described in subparagraph (A).'';
(C) in paragraph (5)--
(i) by striking ``implement or improve'' and
inserting ``establish, improve, or maintain'';
and
(ii) by adding at the end the following:
``The Secretary shall redistribute any funds
that are so returned among the remaining
grantees under this section in accordance with
the formula described in subsection
(a)(2)(B).'';
(4) in the matter preceding paragraph (1) in subsection (d),
by striking ``In implementing or improving'' and all that
follows through ``(a)(1)(B)'' and inserting ``In establishing,
improving, or maintaining a controlled substance monitoring
program under this section, a State shall comply, or with
respect to a State that applies for a grant under subparagraph
(B) or (C) of subsection (a)(1)'';
(5) in subsections (e), (f)(1), and (g), by striking
``implementing or improving'' each place it appears and
inserting ``establishing, improving, or maintaining'';
(6) in subsection (f)--
(A) in paragraph (1)(B) by striking ``misuse of a
schedule II, III, or IV substance'' and inserting
``misuse of a controlled substance included in schedule
II, III, or IV of section 202(c) of the Controlled
Substance Act''; and
(B) by adding at the end the following:
``(3) Evaluation and reporting.--Subject to subsection (g), a
State receiving a grant under subsection (a) shall provide the
Secretary with aggregate data and other information determined
by the Secretary to be necessary to enable the Secretary--
``(A) to evaluate the success of the State's program
in achieving its purposes; or
``(B) to prepare and submit the report to Congress
required by subsection (k)(2).
``(4) Research by other entities.--A department, program, or
administration receiving nonidentifiable information under
paragraph (1)(D) may make such information available to other
entities for research purposes.'';
(7) by redesignating subsections (h) through (n) as
subsections (i) through (o), respectively;
(8) in subsections (c)(1)(A)(iv) and (d)(4), by striking
``subsection (h)'' each place it appears and inserting
``subsection (i)'';
(9) by inserting after subsection (g) the following:
``(h) Education and Access to the Monitoring System.--A State
receiving a grant under subsection (a) shall take steps to--
``(1) facilitate prescriber use of the State's controlled
substance monitoring system; and
``(2) educate prescribers on the benefits of the system both
to them and society.'';
(10) by amending subsection (l), as redesignated, to read as
follows:
``(l) Preference.--Beginning 3 years after the date on which funds
are first appropriated to carry out this section, the Secretary, in
awarding any competitive grant under title V that is related to drug
abuse (as determined by the Secretary) and for which only States or
tribes are eligible to apply, may give preference to eligible States
with applications approved under this section, to eligible States or
tribes with existing controlled substance monitoring programs that meet
minimum requirements under this section, or to eligible States or
tribes that put forth a good faith effort to meet those requirements
(as determined by the Secretary).''.
(11) in subsection (m)(1), as redesignated, by striking
``establishment, implementation, or improvement'' and inserting
``establishment, improvement, or maintenance'';
(12) in subsection (n)(8), as redesignated, by striking ``and
the District of Columbia'' and inserting ``, the District of
Columbia, and any commonwealth or territory of the United
States''; and
(13) by amending subsection (o), as redesignated, to read as
follows:
``(o) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $15,000,000 for fiscal year
2011 and $10,000,000 for each of fiscal years 2012 and 2013.''.
Purpose and Summary
H.R. 5710, the ``National All Schedules Prescription
Electronic Reporting Reauthorization Act of 2010'', was
introduced by Rep. Whitfield (R-KY), along with 12 cosponsors
from the Committee, and referred to the Committee on Energy and
Commerce on July 1, 2010.
The goal of H.R. 5710 is to authorize continued support to
states to establish and maintain prescription drug monitoring
programs (PDMPs). Toward that end, the bill amends and
reauthorizes the controlled substance monitoring program under
the Public Health Service Act.
Background and Need for Legislation
The abuse of prescription medications is a growing public
health concern in the United States. According to the 2010
National Drug Control Strategy released by the White House,
prescription drug abuse is the fastest growing drug problem in
the United States.\1\ Several recent studies underscore this
point:
---------------------------------------------------------------------------
\1\The 2010 National Drug Control Strategy, at 29 (online at http:/
/www.whitehousedrugpolicy.gov/publications/policy/ndcs10/ndcs2010.pdf).
---------------------------------------------------------------------------
In a study released in July 2010, the Substance
Abuse and Mental Health Services Administration (SAMHSA) found
that between 1998 and 2008 there was a 400% increase in
admissions for those aged 12 and over reporting abuse of
prescription pain relievers.\2\
---------------------------------------------------------------------------
\2\Substance Abuse Treatment Admissions Involving Abuse of Pain
Relievers: 1998-2008 (July 15, 2010) (online at http://oas.samhsa.gov/
2k10/230/230PainRelvr2k10Web.pdf).
---------------------------------------------------------------------------
In a report published in June 2010, the Centers
for Disease Control and Prevention (CDC) noted that emergency
department visits associated with non-medical use of
prescription controlled substances doubled between 2004 and
2008, reaching a million visits.\3\
---------------------------------------------------------------------------
\3\Centers for Disease Control and Prevention, Emergency Department
Visits Involving Nonmedical Use of Selected Prescription Drugs--United
States, 2004-2008 (June 18, 2010) (online at http://www.cdc.gov/mmwr/
preview/mmwrhtml/mm5923a1.htm).
---------------------------------------------------------------------------
In a 2008 study, SAMHSA found that youths between
the ages of 12 and 17 abuse prescription drugs more than
cocaine, heroin, and methamphetamine combined.\4\ It also
showed that the scale of the problem is vast: more than six
million Americans used a prescription medication for nonmedical
purposes in a one-month period. The study further found that
70% of people who abuse prescription pain relievers obtained
them from friends or relatives who had obtained them from a
doctor.
---------------------------------------------------------------------------
\4\Results from the 2008 National Survey on Drug Use and Health, at
15-30 (online at
http://www.oas.samhsa.gov/nsduh/2k8nsduh/2k8Results.pdf).
---------------------------------------------------------------------------
The National All-Schedules Prescription Electronic
Reporting Act (NASPER), enacted in 2005, created a Department
of Health and Human Services (HHS) grant program administered
by SAMHSA for states to establish PDMPs.\5\ PDMPs track drug
prescriptions, with the goal of preventing overuse and illegal
diversion. Approximately 40 states maintain PDMPs or have laws
that authorize their establishment.\6\ To be eligible for a
NASPER grant, state programs must track drugs that fall under
schedules II, III, and IV of the Controlled Substances Act, and
must adhere to certain privacy, reporting, and interoperability
requirements.
---------------------------------------------------------------------------
\5\P.L. 109-60.
\6\Substance Abuse and Mental Health Services Administration,
SAMHSA FY2011 Congressional Budget Justification (online at samhsa.gov/
Budget/FY2011/SAMHSA_FY11CJ.pdf).
---------------------------------------------------------------------------
The 2005 law authorized $15 million in each of FY2006 and
FY2007, and $10 million each year for FY2008 through FY2010. In
FY2009 and in FY2010, Congress appropriated $2 million to
support NASPER grants in 13 states.
Committee Consideration
H.R. 5710, the ``National All Schedule Prescription
Electronic Reporting Reauthorization Act of 2010'', was
introduced by Rep. Whitfield (R-KY) and referred to the
Committee on Energy and Commerce on July 1, 2010. The bill was
subsequently referred to the Subcommittee on Health on July 13,
2010. On July 22, 2010, the Subcommittee on Health conducted a
legislative hearing on the bill and afterwards met in open
markup session to consider H.R. 5710. An amendment in the
nature of a substitute (manager's amendment) by Rep. Pallone
was adopted by a voice vote. Subsequently, H.R. 5710 was
favorably forwarded to the full Committee, amended, by a voice
vote.
On July 28, 2010, the Committee on Energy and Commerce met
in open markup session and considered H.R. 5710 as approved by
the Subcommittee. Subsequently, the Committee ordered H.R. 5710
favorably reported to the House, as amended by the Subcommittee
on Health, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. A
motion by Mr. Waxman ordering H.R. 5710 reported to the House,
as amended by the Subcommittee on Health on July 22, 2010, was
approved by a voice vote. There were no record votes taken
during consideration of this bill.
Committee Oversight Findings and Recommendations
In accordance with clause 3(c)(1) of rule XIII and clause
2(b)(1) of rule X of the Rules of the House of Representatives,
the oversight findings and recommendations of the Committee are
reflected in the descriptive portions of this report, including
the finding that abuse of prescription drugs is of growing
concern in the United States.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Regarding compliance with clause 3(c)(2) of rule XIII of
the Rules of the House of Representatives, the Committee finds
that H.R. 5710 would result in no new budget authority,
entitlement authority, or tax expenditures or revenues.
Statement of General Performance Goals and Objectives
In accordance with clause 3(c)(4) of rule XIII of the Rules
of the House of Representatives, the performance goals and
objectives of the Committee are reflected in the descriptive
portions of this report, including the goal to provide
continuing support to prescription drug monitoring programs.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
constitutional authority for H.R. 5710 is provided under
Article I, section 8, clauses 3 and 18 of the Constitution of
the United States.
Earmarks and Tax and Tariff Benefits
H.R. 5710 does not contain any congressional earmarks,
limited tax benefits, or limited tariff benefits as defined in
clause 9(d), 9(e), or 9(f) of rule XXI of the Rules of the
House of Representatives.
Federal Advisory Committee Statement
The Committee finds that the legislation does not establish
or authorize the establishment of an advisory committee within
the definition of 5 U.S.C. App., section 5(b) of the Federal
Advisory Committee Act.
Applicability of Law to the Legislative Branch
Section 102(b)(3) of Public Law 104-1 requires a
description of the application of this bill to the legislative
branch where the bill relates to terms and conditions of
employment or access to public services and accommodations.
H.R. 5710 contains no such provisions.
Federal Mandates Statement
Section 423 of the Congressional Budget and Impoundment
Control Act of 1974 (as amended by section 101(a)(2) of the
Unfunded Mandates Reform Act, P. L. 104-4) requires a statement
on whether the provisions of the report include unfunded
mandates. In compliance with this requirement the Committee
adopts as its own the estimates of federal mandates prepared by
the Director of the Congressional Budget Office.
Committee Cost Estimate
Pursuant to clause 3(d)(2) of rule XIII of the Rules of the
House of Representatives, the Committee adopts as its own the
cost estimate of H.R. 5710 prepared by the Director of the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
Congressional Budget Office Cost Estimate
With respect to the requirements of clause 3(c)(3) of rule
XIII of the Rules of the House of Representatives and section
402 of the Congressional Budget Act of 1974, the Committee has
received the following cost estimate for H.R. 5710 from the
Director of Congressional Budget Office:
August 27, 2010.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 5710, the National
All Schedules Prescription Electronic Reporting Reauthorization
Act of 2010, as ordered reported on July 28, 2010.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Ellen Werble.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 5710--National All Schedules Prescription Electronic Reporting
Reauthorization Act of 2010
H.R. 5710 would reauthorize funding for grants to states
and territories to establish, improve, and maintain an
electronic database system for monitoring the dispensing of
controlled substances. The database would be used to identify,
and report to appropriate authorities, the potential unlawful
diversion or misuse of controlled substances. The bill also
would require the Secretary of Health and Human Services to
monitor the states' efforts to achieve interoperability of the
database system for the purpose of sharing information with
bordering states. In 2010, $2 million was appropriated for
these purposes.
The bill would authorize the appropriation of $15 million
in fiscal year 2011 and $10 million a year for fiscal years
2012 through 2015. Assuming appropriation of those amounts, and
based on spending patterns for similar programs, CBO estimates
that implementing H.R. 5710 would cost $50 million over the
2011-2015 period as shown in the following table. The costs of
this legislation fall within budget function 550 (health).
Enacting H.R. 5710 would not affect direct spending or
revenues; therefore, pay-as-you-go procedures do not apply.
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------------------
2011-
2011 2012 2013 2014 2015 2015
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Authorization Level................................. 15 10 10 10 10 55
Estimated Outlays................................... 5 14 12 10 10 50
----------------------------------------------------------------------------------------------------------------
H.R. 5710 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act. Funds
authorized in the bill would benefit states that implement and
administer a monitoring system for controlled substances.
The CBO staff contact for this estimate is Ellen Werble.
This estimate was approved by Peter H. Fontaine, Assistant
Director for Budget Analysis.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the short title of the Act may be
cited as the ``National All Schedules Prescription Electronic
Reporting Reauthorization Act of 2010''.
Section 2. Amendment to purpose
Section 2 amends the purpose of the Act to include giving
healthcare providers accurate prescription history information
to identify patients at risk for addiction and prevent negative
health outcomes; and to give law enforcement, regulatory, and
licensing authorities the ability to investigate drug diversion
and inappropriate prescribing practices.
Section 3. Amendments to controlled substance monitoring program
Section 3 does the following:
Expands permitted use of funds to include
maintaining existing programs. Under current law, states can
use NASPER funds to ``establish and implement'' or ``make
improvements to'' a prescription drug monitoring programs.
Specifies that state interoperability plans must
include timelines for implementation, and directs the Secretary
to monitor such efforts. Under current law, states adjacent to
other states with NASPER grants must submit a plan for
interoperability among the states' systems.
Directs that funds returned by states with
terminated grants or programs be redistributed based on the
existing allocation formula.
Requires states that are not in compliance with
all reporting requirements to submit a plan for entering
compliance.
Establishes the requirement that states give the
HHS Secretary aggregate data and other information needed to
evaluate the success of a state's program and to fulfill
congressional reporting requirements.
It is the opinion of the Committee that the program should
be implemented in a manner that optimizes the ability of local,
state, and federal health agencies to conduct public health
research and surveillance based on program data. States
receiving funds should be encouraged to make deidentified
information available for such purposes, consistent with
applicable privacy laws.
Permits entities receiving nonidentifiable,
summary data from a PDMP to make such data available to other
entities for research purposes.
Requires states to take certain steps to promote
prescriber use of the monitoring system and education on the
system's benefits.
Clarifies language regarding granting preference
in certain other SAMHSA programs to states that have
prescription drug monitoring programs.
Makes commonwealths and territories of the United
States eligible for NASPER grants.
Authorizes $15 million for FY2011 and $10 million
for FY2012 and FY2013.
Explanation of Amendments
During the Subcommittee on Health's consideration of H.R.
5710, the Subcommittee agreed to a manager's amendment offered
by Subcommittee Chairman Pallone (D-NJ). This amendment makes
certain technical corrections; changes the authorization period
to three years, so that the next reauthorization can take into
account the results of an agency evaluation of the program
scheduled to be completed in 2012; and clarifies language
regarding granting preference in certain other SAMHSA programs
to states that have prescription drug monitoring programs.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
NATIONAL ALL SCHEDULES PRESCRIPTION ELECTRONIC REPORTING ACT OF 2005
* * * * * * *
SEC. 2. PURPOSE.
It is the purpose of this Act to--
[(1) foster the establishment of State-administered
controlled substance monitoring systems in order to
ensure that health care providers have access to the
accurate, timely prescription history information that
they may use as a tool for the early identification of
patients at risk for addiction in order to initiate
appropriate medical interventions and avert the tragic
personal, family, and community consequences of
untreated addiction; and]
(1) foster the establishment of State-administered
controlled substance monitoring systems in order to
ensure that--
(A) health care providers have access to the
accurate, timely prescription history
information that they may use as a tool for the
early identification of patients at risk for
addiction in order to initiate appropriate
medical interventions and avert the tragic
personal, family, and community consequences of
untreated addiction; and
(B) appropriate law enforcement, regulatory,
and State professional licensing authorities
have access to prescription history information
for the purposes of investigating drug
diversion and prescribing and dispensing
practices of errant prescribers or pharmacists;
and
* * * * * * *
----------
PUBLIC HEALTH SERVICE ACT
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
PART P--ADDITIONAL PROGRAMS
* * * * * * *
SEC. 399O. CONTROLLED SUBSTANCE MONITORING PROGRAM.
(a) Grants.--
(1) In general.--Each fiscal year, the Secretary
shall award a grant to each State with an application
approved under this section to enable the State--
(A) to establish and implement a State
controlled substance monitoring program; [or]
(B) to make improvements to an existing State
controlled substance monitoring program[.]; or
(C) to maintain and operate an existing
State-controlled substance monitoring program.
* * * * * * *
[(b) Development of Minimum Requirements.--Prior to awarding
a grant under this section, and not later than 6 months after
the date on which funds are first appropriated to carry out
this section, after seeking consultation with States and other
interested parties, the Secretary shall, after publishing in
the Federal Register proposed minimum requirements and
receiving public comments, establish minimum requirements for
criteria to be used by States for purposes of clauses (ii),
(v), (vi), and (vii) of subsection (c)(1)(A).]
(b) Minimum Requirements.--The Secretary shall maintain and,
as appropriate, supplement or revise (after publishing proposed
additions and revisions in the Federal Register and receiving
public comments thereon) minimum requirements for criteria to
be used by States for purposes of clauses (ii), (v), (vi), and
(vii) of subsection (c)(1)(A).
(c) Application Approval Process.--
(1) In general.--To be eligible to receive a grant
under this section, a State shall submit an application
to the Secretary at such time, in such manner, and
containing such assurances and information as the
Secretary may reasonably require. Each such application
shall include--
(A) with respect to a State that intends to
use funds under the grant as provided for in
subsection (a)(1)(A)--
(i) * * *
* * * * * * *
(iv) criteria for meeting the uniform
electronic format requirement of
[subsection (h)] subsection (i);
* * * * * * *
(B) with respect to a State that intends to
use funds under the grant as provided for in
subsection [(a)(1)(B)] (a)(1)(B) or (a)(1)(C)--
(i) a budget cost estimate for the
controlled substance monitoring
[program to be improved] program to be
improved or maintained under the grant;
* * * * * * *
(iv) assurances of compliance with
all other requirements of this section
or a statement describing why such
compliance is not feasible or is
contrary to the best interests of
[public health] public health or public
safety in such State.
* * * * * * *
(3) Interoperability.--[If a State that submits]
(A) In general.--If a State that submits an
application under this subsection
geographically borders another State that is
operating a controlled substance monitoring
program under subsection (a)(1) on the date of
submission of such application, and such
applicant State has not achieved
interoperability for purposes of information
sharing between its monitoring program and the
monitoring program of such border State, such
applicant State shall, as part of the plan
under paragraph (1)(B)(iii), describe the
manner in which the applicant State will
achieve interoperability between the monitoring
programs of such States and include timelines
for full implementation of such
interoperability.
(B) Monitoring of efforts.--The Secretary
shall monitor State efforts to achieve
interoperability, as described in subparagraph
(A).
* * * * * * *
(5) Return of funds.--If the Secretary withdraws
approval of a State's application under this section,
or the State chooses to cease to [implement or improve]
establish, improve, or maintain a controlled substance
monitoring program under this section, a funding
agreement for the receipt of a grant under this section
is that the State will return to the Secretary an
amount which bears the same ratio to the overall grant
as the remaining time period for expending the grant
funds bears to the overall time period for expending
the grant (as specified by the Secretary at the time of
the grant). The Secretary shall redistribute any funds
that are so returned among the remaining grantees under
this section in accordance with the formula described
in subsection (a)(2)(B).
(d) Reporting Requirements.--[In implementing or improving a
controlled substance monitoring program under this section, a
State shall comply, or with respect to a State that applies for
a grant under subsection (a)(1)(B)] In establishing, improving,
or maintaining a controlled substance monitoring program under
this section, a State shall comply, or with respect to a State
that applies for a grant under subparagraph (B) or (C) of
subsection (a)(1) submit to the Secretary for approval a
statement of why such compliance is not feasible or is contrary
to the best interests of public health in such State, with the
following:
(1) * * *
* * * * * * *
(4) The State shall require dispensers to report
information under this section in accordance with the
electronic format specified by the Secretary under
[subsection (h)] subsection (i), except that the State
may waive the requirement of such format with respect
to an individual dispenser that is unable to submit
such information by electronic means.
(e) Database.--In [implementing or improving] establishing,
improving, or maintaining a controlled substance monitoring
program under this section, a State shall comply with the
following:
(1) * * *
* * * * * * *
(f) Use and Disclosure of Information.--
(1) In general.--Subject to subsection (g), in
[implementing or improving] establishing, improving, or
maintaining a controlled substance monitoring program
under this section, a State may disclose information
from the database established under subsection (e) and,
in the case of a request under subparagraph (D),
summary statistics of such information, only in
response to a request by--
(A) * * *
(B) any local, State, or Federal law
enforcement, narcotics control, licensure,
disciplinary, or program authority, who
certifies, under the procedures determined by
the State, that the requested information is
related to an individual investigation or
proceeding involving the unlawful diversion or
[misuse of a schedule II, III, or IV substance]
misuse of a controlled substance included in
schedule II, III, or IV of section 202(c) of
the Controlled Substance Act, and such
information will further the purpose of the
investigation or assist in the proceeding;
* * * * * * *
(3) Evaluation and reporting.--Subject to subsection
(g), a State receiving a grant under subsection (a)
shall provide the Secretary with aggregate data and
other information determined by the Secretary to be
necessary to enable the Secretary--
(A) to evaluate the success of the State's
program in achieving its purposes; or
(B) to prepare and submit the report to
Congress required by subsection (k)(2).
(4) Research by other entities.--A department,
program, or administration receiving nonidentifiable
information under paragraph (1)(D) may make such
information available to other entities for research
purposes.
(g) Limitations.--In [implementing or improving]
establishing, improving, or maintaining a controlled substance
monitoring program under this section, a State--
(1) * * *
* * * * * * *
(h) Education and Access to the Monitoring System.--A State
receiving a grant under subsection (a) shall take steps to--
(1) facilitate prescriber use of the State's
controlled substance monitoring system; and
(2) educate prescribers on the benefits of the system
both to them and society.
[(h)] (i) Electronic Format.--The Secretary shall specify a
uniform electronic format for the reporting, sharing, and
disclosure of information under this section.
[(i)] (j) Rules of Construction.--
(1) * * *
* * * * * * *
[(j)] (k) Studies and Reports.--
(1) * * *
* * * * * * *
[(k) Preference.--Beginning 3 years after the date on which
funds are first appropriated to carry out this section, the
Secretary, in awarding any competitive grant that is related to
drug abuse (as determined by the Secretary) and for which only
States are eligible to apply, shall give preference to any
State with an application approved under this section. The
Secretary shall have the discretion to apply such preference to
States with existing controlled substance monitoring programs
that meet minimum requirements under this section or to States
that put forth a good faith effort to meet those requirements
(as determined by the Secretary).]
(l) Preference.--Beginning 3 years after the date on which
funds are first appropriated to carry out this section, the
Secretary, in awarding any competitive grant under title V that
is related to drug abuse (as determined by the Secretary) and
for which only States or tribes are eligible to apply, may give
preference to eligible States with applications approved under
this section, to eligible States or tribes with existing
controlled substance monitoring programs that meet minimum
requirements under this section, or to eligible States or
tribes that put forth a good faith effort to meet those
requirements (as determined by the Secretary).
[(l)] (m) Advisory Council.--
(1) Establishment.--A State may establish an advisory
council to assist in the [establishment,
implementation, or improvement] establishment,
improvement, or maintenance of a controlled substance
monitoring program under this section.
* * * * * * *
[(m)] (n) Definitions.--For purposes of this section:
(1) * * *
* * * * * * *
(8) The term ``State'' means each of the 50 States
[and the District of Columbia], the District of
Columbia, and any commonwealth or territory of the
United States.
* * * * * * *
[(n) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated--
[(1) $15,000,000 for each of fiscal years 2006 and
2007; and
[(2) $10,000,000 for each of fiscal years 2008, 2009,
and 2010.]
(o) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $15,000,000
for fiscal year 2011 and $10,000,000 for each of fiscal years
2012 and 2013.
* * * * * * *