[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.

           *       *       *       *       *       *       *


                                  
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