[Federal Register Volume 69, Number 57 (Wednesday, March 24, 2004)]
[Notices]
[Pages 13861-13864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6486]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Funding Opportunity Title: Notice of Funding Availability (NOFA) 
for the Drug-Addiction-Treatment-Act-of-2000 (DATA) (Title XXXV of the 
Children's Health Act of 2000) Physician Clinical Support System (Short 
Title: DATA Physician Clinical Support System)

    Announcement Type: Initial.
    Funding Opportunity Number: TI 04-005.
    Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.
    Due Date for Applications: June 2, 2004.
    (Note: Letters from State Single Point of Contact (SPOC) in 
response to E.O. 12372 are due August 1, 2004.)

SUMMARY: The Substance Abuse and Mental Health Services Administration 
(SAMHSA), Center for Substance Abuse Treatment (CSAT), announces the 
availability of FY 2004 funds for the Drug-Addiction-Treatment-Act-of-
2000 (DATA) (Title XXXV of the Children's Health Act of 2000) Physician 
Clinical Support System (Short Title: DATA Physician Clinical Support 
System). A synopsis of this funding opportunity, as well as many other 
Federal Government funding opportunities, is also available at the 
Internet site: http://www.grants.gov.
    For complete instructions, potential applicants must obtain a copy 
of SAMHSA's standard Infrastructure Grants Program Announcement (INF-04 
PA (MOD)), and the PHS 5161-1 (Rev. 7/00) application form before 
preparing and submitting an application. The INF-04 PA (MOD) describes 
the general program design and provides instructions for applying for 
all SAMHSA Infrastructure Grants, including the DATA Physician Clinical 
Support System. SAMHSA's Infrastructure Grants provide funds to 
increase the capacity of mental health and/or substance abuse service 
systems to support effective programs and services. Additional 
instructions and specific requirements for this funding opportunity are 
described below.

I. Funding Opportunity Description

    Authority: Section 509 of the Public Health Service Act, as amended 
and subject to the availability of funds.
    The purpose of the DATA Physician Clinical Support System 
cooperative agreement is to develop a coordinated, clinical support 
program for physicians who are treating addicted patients with 
buprenorphine products. The target participants for the clinical 
support system are primary care physicians, pain specialists, 
psychiatrists and other non-addiction medical practitioners, who are 
often reluctant to treat addicted patients and are not as familiar with 
opioid addiction treatment as addictions specialists are. However, 
addictions specialists will also be encouraged to participate in the 
DATA Physician Clinical Support System or to serve as mentors.
    Applicants are expected to develop a coherent, well-designed 
program to assist physicians in developing the skills and confidence to 
treat addicted patients, thereby reducing resistance and barriers to 
the availability of treatment. By enlisting the assistance of 
professional medical groups and other organizations, the grantee will 
offer physicians the information and consultation they need to provide 
safe and effective buprenorphine treatment.
    Applicants must select activities from the following list of 
infrastructure development activities, as appropriate to their proposed 
project:
     Provider/network development (i.e., physician 
clinical support network/system development to inform physicians of 
established standards of care);
     Organizational/structural change (e.g., to 
increase access to and efficiency of services);
     Development of the physician workforce;
     Development of interagency coordination 
mechanisms (between national professional medical organizations or 
related organizations); and
     Quality improvement efforts.
    Applicants must demonstrate the ability to provide consultative 
services, telephone consultation, on-site training, observation of 
practice, and peer mentoring to physicians treating patients for opioid 
addiction. Applicants may propose other activities, such as conducting 
a limited number of regional meetings or online Web conferences to 
improve physician workforce performance.
    Physician support activities must focus on the following content 
areas:
     Assessment and diagnosis using the Diagnostic 
and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR);
     Induction, maintenance, and detoxification 
protocols;
     Strategies to avoid complications and treat 
them;
     Ancillary medications;
     Recommended visit and monitoring schedules;
     Special psychosocial strategies on motivating 
patients, setting limits, or implementing contingency plans;
     Medically supervised withdrawal and opioid 
withdrawal scales;
     Referrals to counseling, other ancillary 
services, or self-help groups;
     Diagnosis and treatment of psychiatric co-
morbidities or co-occurring disorders, including, but not limited to, 
chronic pain, poly-substance abuse, hepatitis C and HIV disease;
     HIV screening, counseling, testing, and 
referrals;
     Referrals to higher levels of care;
     Special needs patients, including pregnant, 
adolescent, and elderly patients; and
     Important patient recovery indicators.
    Background: The need for medication-assisted treatment for opioid 
addiction greatly exceeds the Nation's treatment capacity. To address 
this long-standing problem, the Drug Addiction Treatment Act of 2000 
(DATA) was enacted to allow trained, qualified physicians to prescribe 
specifically approved narcotic medications for the treatment of opioid 
addiction in their offices or settings outside traditional opioid 
treatment programs.
    The Food and Drug Administration approved two brand-name 
medications containing buprenorphine for this treatment in 2002. SAMHSA 
was assigned responsibility to assist with training physicians under 
DATA. Approximately 4,000 physicians have been trained and 2,500 are 
approved to prescribe these medications. Yet, the stigma of addiction 
tends to discourage primary care physicians from obtaining training and 
treating this population.

[[Page 13862]]

Also, the lack of physician experience, concerns over practical issues, 
and limited understanding of the appropriate role of medication in 
opioid treatment all appear to be factors in the slow adoption of this 
form of treatment intervention by the medical profession.

II. Award Information

    1. Estimated Funding Available/Number of Awards: It is expected 
that up to $500,000 will be available to fund one award in FY 2004. The 
maximum allowable award for this Category I--Small Infrastructure Grant 
Award is $500,000 in total costs (direct and indirect) per year for up 
to 3 years. Proposed budgets cannot exceed the allowable amount in any 
year of the proposed project. The actual amount available for the award 
may vary, depending on unanticipated program requirements and the 
number and quality of the applications received. Annual continuations 
will depend on the availability of funds, grantee progress in meeting 
program goals and objectives, and timely submission of required data 
and reports.
    2. Funding Instrument: Cooperative Agreement.
    Roles and Responsibilities of Federal Staff: Federal staff members 
will:
     Participate in the selection of physician and 
non-physician members of a steering committee that will plan, 
implement, and coordinate the support system;
     Assist the grantee to plan for health care 
infrastructure development;
     Help to establish measures of cost-
effectiveness;
     Assist the grantee to meet quality improvement 
goals;
     Ensure that consultation services are provided 
to the regions of the country with the greatest need;
     Provide advice and assistance in developing the 
evaluation;
     Foster learning and collaboration and coordinate 
with other SAMHSA-funded activities, such as the DATA waiver program, 
the DATA evaluation, and Addiction Technology Transfer Centers (ATTCs); 
and
     Provide some of the on-site training, 
observation of practice, consultative services, peer mentoring, and 
other services envisioned under this program.
    The Government Project Officer (GPO) will serve as a voting member 
of the steering committee, but will not chair the committee.
    Roles and Responsibilities of Grantee: The grantee will be required 
to establish a steering committee to oversee the development of the 
Physician Clinical Support System and determine the direction of the 
project. Steering committee membership will be comprised of 
representatives from participating national professional medical 
organizations authorized by law to conduct DATA training, other 
stakeholders, and the GPO. The steering committee will be required to 
meet, at a minimum, yearly and confer by conference call quarterly to 
develop strategies to bring the project to fruition. The grantee is 
also expected to implement and evaluate the program in full cooperation 
with SAMSHA staff members and contractors. The grantee also will be 
required to:
     Comply with all aspects of the terms and 
conditions of the cooperative agreement (to be issued with the award);
     Participate in selecting a chairperson for the 
steering committee;
     Provide required reports, including those 
related to the Government Performance and Results Act (GPRA); and
     Respond to requests for information or data 
related to the program.

III. Eligibility Information

    1. Eligible Applicants: Eligibility is limited to the national 
professional medical organizations authorized by DATA to carry out 
training. These are the American Society of Addiction Medicine, the 
American Academy of Addiction Psychiatry, the American Medical 
Association, the American Osteopathic Association, and the American 
Psychiatric Association. While any of these entities may apply 
individually, SAMHSA encourages a consortium comprised of all or 
several eligible organizations to apply. If a consortium is formed for 
this purpose, a single organization in the consortium must be the legal 
applicant, the recipient of the award, and the entity legally 
responsible for satisfying the grant requirements. If a consortium 
submits an application, the application must include a written 
agreement outlining the roles and responsibilities of each 
participating national professional medical organization. This 
agreement must be signed by an authorized official of each member of 
the consortium and attached to the application as a new Appendix 4, 
``Roles and Responsibilities of Participating National Professional 
Medical Organizations.'' These eligibility criteria supersede the 
criteria specified in Section III-1 of the INF-04 PA (MOD).
    2. Cost Sharing or Matching is not required.
    3. Other: Applicants must also meet certain application formatting 
and submission requirements or the application will be screened out and 
will not be reviewed. These requirements are described in Section IV-2 
below, as well as in the INF-04 PA (MOD).

IV. Application and Submission Information

    1. Address to Request Application Package: Complete application 
kits may be obtained from the National Clearinghouse for Alcohol and 
Drug Information (NCADI) at 1-800-729-6686. When requesting an 
application kit for this program, the applicant must specify the 
funding opportunity title (DATA Physician Clinical Support System) and 
the funding opportunity number (TI 04-005). All information necessary 
to apply, including where to submit applications and application 
deadline instructions, is included in the application kit. The PHS 
5161-1 application form is also available electronically via SAMHSA's 
World Wide Web Home Page: http://www.samhsa.gov/ (Click on `Grant 
Opportunities') and the INF-04 PA (MOD) is available electronically at 
http://www.samhsa.gov/grants/2004/standard/Infrastructure/index.asp.
    When submitting an application, be sure to type ``TI 04-005, DATA 
Physician Clinical Support System'' in Item Number 10 on the face page 
of the application form. Also, SAMHSA applicants are required to 
provide a DUNS Number on the face page of the application. To obtain a 
DUNS Number, access the Dun and Bradstreet Web site at http://www.dunandbradstreet.com or call 1-866-705-5711.
    2. Content and Form of Application Submission: Information 
including required documents, required application components, and 
application formatting requirements is available in the INF-04 PA (MOD) 
in Section IV-2.

Checklist for Formatting Requirements and Screenout Criteria for SAMHSA 
Grant Applications

    SAMHSA's goal is to review all applications submitted for grant 
funding. However, this goal must be balanced against SAMHSA's 
obligation to ensure equitable treatment of applications. For this 
reason, SAMHSA has established certain formatting requirements for its 
applications. If you do not adhere to these requirements, your 
application will be screened out and returned to you without review.
    [squ] Use the PHS 5161-1 application.
    [squ] Applications must be received by the application deadline. 
Applications received after this date must have a proof of mailing date 
from the carrier dated at least 1 week prior to the due

[[Page 13863]]

date. Private metered postmarks are not acceptable as proof of timely 
mailing. Applications not received by the application deadline or not 
postmarked at least 1 week prior to the application deadline will not 
be reviewed.
    [squ] Information provided must be sufficient for review.
    [squ] Text must be legible.
     Type size in the Project Narrative cannot exceed 
an average of 15 characters per inch, as measured on the physical page. 
(Type size in charts, tables, graphs, and footnotes will not be 
considered in determining compliance.)
     Text in the Project Narrative cannot exceed 6 
lines per vertical inch.
    [squ] Paper must be white paper and 8.5 inches by 11.0 inches in 
size.
    [squ] To ensure equity among applications, the amount of space 
allowed for the Project Narrative cannot be exceeded.
     Applications would meet this requirement by 
using all margins (left, right, top, bottom) of at least one inch each, 
and adhering to the page limit for the Project Narrative stated in the 
INF-04 PA (MOD).
     Should an application not conform to these 
margin or page limits, SAMHSA will use the following method to 
determine compliance: The total area of the Project Narrative 
(excluding margins, but including charts, tables, graphs and footnotes) 
cannot exceed 58.5 square inches multiplied by the page limit. This 
number represents the full page less margins, multiplied by the total 
number of allowed pages.
     Space will be measured on the physical page. 
Space left blank within the Project Narrative (excluding margins) is 
considered part of the Project Narrative, in determining compliance.
    [squ] The page limit for Appendices stated in the INF-04 PA (MOD) 
cannot be exceeded.
    To facilitate review of your application, follow these additional 
guidelines. Failure to adhere to the following guidelines will not, in 
itself, result in your application being screened out and returned 
without review. However, the information provided in your application 
must be sufficient for review. Following these guidelines will help 
ensure your application is complete, and will help reviewers to 
consider your application.
    [squ] The 10 application components required for SAMHSA 
applications should be included. These are:
     Face Page (Standard Form 424, which is in PHS 
5161-1)
     Abstract
     Table of Contents
     Budget Form (Standard Form 424A, which is in PHS 
5161-1)
     Project Narrative and Supporting Documentation
     Appendices
     Assurances (Standard Form 424B, which is in PHS 
5161-1)
     Certifications (a form in PHS 5161-1)
     Disclosure of Lobbying Activities (Standard Form 
LLL, which is in PHS 5161-1)
     Checklist (a form in PHS 5161-1)
    [squ] Applications should comply with the following requirements:
     Provisions relating to confidentiality, 
participant protection and the protection of human subjects, as 
indicated in the INF-04 PA (MOD).
     Budgetary limitations as indicated in Sections 
I, II, and IV-5 of the INF-04 PA (MOD).
     Documentation of nonprofit status as required in 
the PHS 5161-1.
    [squ] Pages should be typed single-spaced with one column per page.
    [squ] Pages should not have printing on both sides.
    [squ] Please use black ink, and number pages consecutively from 
beginning to end so that information can be located easily during 
review of the application. The cover page should be page 1, the 
abstract page should be page 2, and the table of contents page should 
be page 3. Appendices should be labeled and separated from the Project 
Narrative and budget section, and the pages should be numbered to 
continue the sequence.
    [squ] Send the original application and two copies to the mailing 
address in the funding announcement. Please do not use staples, paper 
clips, and fasteners. Nothing should be attached, stapled, folded, or 
pasted. Do not use heavy or lightweight paper, or any material that 
cannot be copied using automatic copying machines. Odd-sized and 
oversized attachments such as posters will not be copied or sent to 
reviewers. Do not include videotapes, audiotapes, or CD-ROMs.
    3. Submission Dates and Times: Applications must be received by 
June 2, 2004. You will be notified by postal mail that your application 
has been received. Additional submission information is available in 
the INF-04 PA (MOD) in Section IV-3.
    4. Intergovernmental Review: Because the DATA Physician Clinical 
Support System program is national in scope, applicants are not 
required to comply with the requirements of Executive Order 12372 or 
the Public Health System Impact Statement (PHSIS) as detailed in 
Section IV-4 of the INF-04 PA (MOD).
    5. Funding Restrictions: Information concerning funding 
restrictions is available in the INF-04 PA (MOD) in Section IV-5. Funds 
for the DATA Physician Clinical Support System program may not be used 
for the following activities allowed in the INF 04-PA (MOD) in Section 
I-2:
     Needs assessment;
     Strategic planning;
     Financing/coordination of funding streams;
     Policy development to support needed service 
improvements (e.g., rate-setting activities, establishment of standards 
of care, development/revision of credentialing, licensure, or 
accreditation requirements);
     Performance measurement development; or
     Data infrastructure/MIS development.
    In addition, the grantee may not use funds for training physicians 
to qualify for the DATA waiver. SAMHSA already has adequate mechanisms 
in place to subsidize the 8-hour training that is required for some 
candidates to meet DATA qualification requirements.

V. Application Review Information

    1. Evaluation Criteria: Applications will be reviewed against the 
Evaluation Criteria and requirements for the Project Narrative 
specified in the INF-04 PA (MOD). The following information describes 
the exceptions or limitations to the INF-04 PA (MOD) and provides 
special requirements that pertain only to the DATA Physician Clinical 
Support System program. Applicants for the DATA Physician Clinical 
Support System program are required to discuss the following 
requirements in their applications, in addition to the requirements 
specified in the INF-04 PA (MOD):
    1.1 In ``Section A: Statement of Need'':
    a. Applicants must address the issues/needs of the target 
population. The target population for this program is the population of 
persons with opioid addiction disorders. The catchment area is the 
Nation as a whole.
    b. Applicants do not have to respond to the fourth bullet, which 
requires applicants to ``* * * show that identified needs are 
consistent with priorities of the State or county that has primary 
responsibility for the service delivery system.''
    1.2 In ``Section B: Proposed Approach':
    Applicants must describe how stakeholders and other organizations 
that choose to participate in the proposed project will collaborate 
with each other in implementing the DATA Physician Clinical Support 
System.
    1.3 Applicants must provide ``Roles and Responsibilities of 
Participating

[[Page 13864]]

National Professional Medical Organizations,'' as a new Appendix 4 of 
the application rather than the Letter to the SSA as described in 
Section IV-2.2 in the INF-04 PA (MOD).
    1.4 Applicants do not have to include Appendix 5, Copy of State or 
County Strategic Plan, as specified in the INF-04 PA (MOD) in their 
applications.
    1.5 Performance Measurement: All SAMHSA grantees are required to 
collect and report certain data so that SAMHSA can meet its obligations 
under the Government Performance and Results Act (GPRA). The DATA 
Physician Clinical Support System grantee will be required to report on 
the following:
     Number of consultation events, training events, 
technical assistance events or contacts;
     Number of physicians participating in each 
event;
     Percentage of physicians satisfied with 
educational and support services offered; and
     Percentage of physicians who report that 
consultation or training events resulted in appropriate practice 
change(s).
    Applicants must document their ability to collect and report on 
these measures in ``Section D: Evaluation and Data.'' The grantee will 
be required to use the relevant data collection instruments approved by 
OMB for collecting customer satisfaction data, e.g., the CSAT Baseline 
Meeting Satisfaction Survey, the CSAT Follow-up Meeting Satisfaction 
Survey, the CSAT Baseline Training Satisfaction Survey, or the CSAT 
Follow-up Training Satisfaction Survey. These instruments are available 
at http://www.csat-gpra.samhsa.gov/knowledge.cfm. Hard copies of the 
instruments are available in the application kits distributed by 
SAMHSA's National Clearinghouse for Alcohol and Drug Information 
(NCADI). Training and technical assistance on data collection and entry 
will be provided by CSAT.
    2. Review and Selection Process: Information about the review and 
selection process is available in the INF-04 PA (MOD) in Section V-2.

VI. Award Administration Information

    Award administration information, including award notices, 
administrative and national policy requirements, and reporting 
requirements are available in the INF-04 PA (MOD) in Section VI. 
SAMHSA's standard terms and conditions are available at http://www.samhsa.gov/grants/2004/useful_info.asp.

VII. Agency Contact for Additional Information

    For questions concerning program issues, contact: Raymond Hylton, 
RN, MSN, SAMHSA/Center for Substance Abuse Treatment, DPT, 5600 Fishers 
Lane, Rockwall II, Suite 618, Rockville, MD 20857; 301-443-6502; e-
mail: [email protected].
    For questions on grants management issues, contact: Kathleen 
Sample, SAMHSA/Division of Grants Management, 5600 Fishers Lane, 
Rockwall II, Suite 630, Rockville, MD 20857; (301) 443-9667; e-mail: 
[email protected].

Daryl Kade,
Director, Office of Policy, Planning and Budget, Substance Abuse and 
Mental Health Services Administration.
[FR Doc. 04-6486 Filed 3-23-04; 8:45 am]
BILLING CODE 4162-20-P