[Federal Register Volume 69, Number 34 (Friday, February 20, 2004)]
[Notices]
[Pages 7958-7962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3687]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Integrating Prevention Services for Persons with Bleeding and 
Clotting Disorders

    Announcement Type: Competing Continuation-Initital.
    Funding Opportunity Number: PA 04013.
    Catalog of Federal Domestic Assistance Number: 93.283.
    Key Dates:
    Letter of Intent Deadline: March 8, 2004.
    Application Deadline: April 5, 2004.

I. Funding Opportunity Description

    Authority: This program is authorized under Section 301(a) and 
317(k)(2) and [42 U.S.C. 247b(k)(2)] of the Public Health Service 
Act, as amended.

    Purpose and Research Objectives: The purpose of the program is to 
(1) determine the efficacy of integrated multi-disciplinary care and 
prevention services for persons with hemophilia, other hereditary 
bleeding disorders including women with bleeding disorders, and 
thrombophilia to reduce morbidity and mortality associated with 
bleeding and clotting diseases; (2) assess unmet needs for service 
delivery and identify outreach strategies designed to improve access to 
care; (3) develop effective messages aimed at disease management and 
prevention; and (4) foster the development of training programs to 
enhance provider skills for the delivery of hemostasis and thrombosis 
care.
    This program addresses the ``Healthy People 2010'' focus area(s) of 
access to quality health services, disability and secondary conditions, 
educational and community-based programs, and public health 
infrastructure.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for CDC: To improve the health and quality 
of life of Americans with disabilities.
    Information learned from this program evaluation will have 
immediate benefit for the program and the patients with bleeding and 
clotting disorders receiving prevention services.
    Activities: Recipient activities for this program are as follows:
    1. Using the principles of the multi-disciplinary comprehensive 
care model utilized in hemophilia treatment center prevention programs, 
implement the model in a health care setting that features strong 
clinical, outreach, education, support and provider training programs 
for persons with hemophilia, other hereditary bleeding disorders 
including women with bleeding disorders, and thrombophilia.
    Specifically:
     Identify unmet needs of target populations and 
establish outreach mechanisms to improve access to care for persons 
with bleeding and clotting disorders for the purpose of evaluating 
prevention interventions.
     Determine strategies that will address unmet 
needs, assess the efficacy of prevention activities and improve access 
to under-served populations such as women with bleeding disorders and 
individuals with thrombophilia.
     Conduct outreach efforts to increase prevention 
intervention awareness and availability of comprehensive care among the 
affected population and referring providers and establish referral 
patterns.

[[Page 7959]]

     Facilitate communication with other sub-
specialties concerning awareness and prevention of the complications of 
bleeding and clotting disorders.
    2. Develop and implement a plan that will provide clinical 
expertise for diagnosing underlying causes of coagulation disorders and 
provide management and prevention services. Experience with bleeding 
and clotting disorders should be a preferred requirement for clinical 
expertise.
     Collaborate with clinical programs designed to 
improve the treatment of bleeding and clotting disorders.
     Develop training programs to educate physicians 
and other providers in management of bleeding and clotting disorders.
    3. Develop education and awareness programs for affected 
populations to increase knowledge and assist consumers in making 
informed decisions.
     Establish mechanisms for consumer input and 
education and assist in fostering locally-based consumer organizations 
to assist in care evaluation.
     Develop educational materials and distribute as 
needed.
     Develop methods (i.e. utilizing consumers) to 
assist with the delivery of prevention messages through peer-led 
prevention education, outreach, and support.
    4. Evaluate the model for feasibility and effectiveness.
     Implement data collection and evaluation systems 
to document unmet needs for integrated diagnostic, management and 
prevention services for persons with hemophilia, other hereditary 
bleeding disorders including women with bleeding disorders, and 
thrombophilia in their clinics.
     Establish follow-up with patients to determine 
the impact of multi-disciplinary care management for persons with 
coagulation disorders.
    5. Publish and disseminate program results.
    CDC Responsibilities: In this cooperative agreement, the CDC 
Scientist within the Division of Hereditary Blood Disorders (DHBD) in 
the National Center on Birth Defects and Developmental Disabilities is 
an equal partner with scientific and programmatic involvement during 
the conduct of the project through technical assistance, advice, and 
coordination.
    This Scientist will:
    1. Participate in the development of common protocols.
    2. Participate in the analysis, interpretation, and reporting of 
findings in the scientific literature and other media to the community 
at large and the public policy community within the Federal government.
    3. Participate in data management, analysis of data, and 
interpretation and dissemination of findings.
    4. Provide scientific consultation and technical assistance in the 
design and conduct of the project, including intervention models, 
outcome measures, and analytical approaches in participation with the 
recipient organizations.

CDC Scientific Program Administrator (SPA)

    CDC will appoint an SPA, apart from the DHBD Scientist, who will:
    1. Serve as the Program Official for the funded research 
institutions.
    2. Carry out continuous review of all activities to ensure 
objectives are being met. As such, the SPA may attend Coordination 
Committee meetings for purposes of assessing overall progress and for 
program evaluation purposes.
    3. Provide scientific consultation and technical assistance in the 
conduct of the funded projects as requested.
    4. Conduct site visits to recipient institutions to determine the 
adequacy of the research and to monitor performance against approved 
project objectives.
    Collaborative Responsibilities: The planning and implementation of 
the cooperative aspects of the study will be effected by a Coordination 
Committee consisting of the Principal Investigators from each 
participating institution and the DHBD Scientist. This Coordinating 
Committee will formulate a research plan for cooperative research that 
will incorporate recipient research plans into uniform and compatible 
study designs and data collection protocols. Such support will be 
designed to contribute to effective program outcomes through allocation 
of resources among the participating cooperative agreement entities.
    At periodic coordination committee meetings, the group will: (1) 
Make recommendations on study protocols and data collection approaches; 
(2) discuss the target populations that have been or will be recruited; 
(3) identify and recommend solutions to unexpected study problems; and 
(4) discuss ways to efficiently coordinate and combine common study 
activities and best practices.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: $1,000,000.
    Approximate Number of Awards: Four.
    Approximate Average Award: $250,000 (This amount is for the first 
12-month budget period, and includes both direct and indirect costs).
    Ceiling of Award Range: $350,000 in initial budget period.
    Anticipated Award Date: June 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Three years. Throughout the project period, 
CDC's commitment to continuation of awards will be conditioned on the 
availability of funds, evidence of satisfactory progress by the 
recipient (as documented in required reports), and the determination 
that continued funding is in the best interest of the Federal 
Government.

III. Eligibility Information

    III.1. Eligible applicants: Eligible applicants are limited to 
those already funded under Program Announcement 01085: Integrating 
Prevention Services for Persons with Bleeding and Clotting Disorders. 
This program was originally announcement in 2001 and was full and open 
competition. Funding was awarded to initiate the pilot program, 
however, in the first two years, only the data collection development 
phase was completed. Implementation and final approval from 
institutional review boards was in process at the end of the project 
period. The pilot process and these awardees have produced the 
background necessary for the projects to now demonstrate the 
effectiveness of comprehensive care models under development based on 
the foundations established by these institutional projects.
    Therefore, the eligible applicants are:
Duke University, Durham, North Carolina
Hemophilia Foundation of Michigan, Ann Arbor, Michigan
Mountain States Regional Hemophilia and Thrombosis Center, Denver, 
Colorado
UMDNJ-Robert Wood Johnson University Hospital, New Brunswick, NJ.
    III.2. Cost Sharing or Matching: Matching funds are not required 
for this program.
    III.3. Other: If you request a funding amount greater than the 
ceiling of the award range, your application will be considered 
nonresponsive, and will not be entered into the review process. You 
will be notified that your application did not meet the submission 
requirements. Based upon budget constraints, requests above this 
average

[[Page 7960]]

award level are suject to reduction in accordance with available 
resources.
    If your application is incomplete or non-responsive to the 
requirements listed below, it will not be entered into the review 
process. You will be notified that your application did not meet 
submission requirements.
    Individuals Eligible to Become Principal Investigators: Any 
individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support. Individuals from under-represented 
racial and ethnic groups as well as individuals with disabilities are 
always encouraged to apply for CDC programs.

    Note: Title 2 of the United States Code Section 1611 states that 
an organization described in Section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant, or loan.

IV. Application and Submission Information

    IV.1 Address to Request Application Package: To apply for this 
funding opportunity, use application form PHS 398 (OMB number 0925-0001 
rev. 5/2001). Forms and instructions are available in an interactive 
format on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    Forms and instructions are also available in an interactive format 
on the National Institutes of Health (NIH) Web site at the following 
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.
    IV.2. Content and Form of Application Submission: Letter of Intent 
(LOI):
    The LOI must be written in the following format:
     Maximum number of pages: Two.
     Font size: 12-point unreduced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One-inch margins.
     Printed only on one side of page.
     Single spaced.
     Written in English; avoid jargon. The LOI must 
contain the following information: Name, address, and telephone number 
of the proposed Principal Investigator, number and title of this 
program announcement, names of other key personnel, designations of 
collaborating institutions and entities, and an outline of the proposed 
work, recruitment approach, and expected outcomes.
    Application: Follow the PHS 398 application instructions for 
content and formatting of your application. For further assistance with 
the PHS 398 application form, contact PGO-TIM staff at (770) 488-2700, 
or contact GrantsInfo, Telephone (301) 435-0714, E-mail: 
[email protected]
    Your research plan should address activities to be conducted over 
the entire project period. The application should include a separate 
typed abstract of the proposal consisting of no more than one single-
spaced page. The application should include a table of contents for the 
project narrative and all related attachments. Additional information 
may be included in the application appendices. The appendices will not 
be counted toward the narrative page limit. This additional information 
may include curriculum and resumes for key project staff, 
organizational charts, letters of support, etc.; and should be limited 
to those items relevant to the requirements of this announcement.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. Your DUNS number must be entered 
on line 11 of the face page of the PHS 398 application form. The DUNS 
number is a nine-digit identification number, which uniquely identifies 
business entities. Obtaining a DUNS number is easy and there is no 
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com 
or call 1-866-705-5711. For more information, see the CDC Web site at: 
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''
    IV.3. Submission Dates and Times:
    LOI Deadline Date: March 8, 2004.
    CDC requests that you send a LOI if you intend to apply for this 
program. Although the LOI is not required, not binding, and does not 
enter into the review of your subsequent application, the LOI will be 
used to gauge the level of interest in this program, and will allow CDC 
to plan the application review.
    Application Deadline Date: April 5, 2004.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4 p.m. eastern time on the deadline 
date. If you send your application by the United States Postal Service 
or commercial delivery service, you must ensure that the carrier will 
be able to guarantee delivery of the application by the closing date 
and time. If CDC receives your application after closing due to: (1) 
carrier error, when the carrier accepted the package with a guarantee 
for delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, you will be given the opportunity to 
submit documentation of the carrier's guarantee. If the documentation 
verifies a carrier problem, CDC will consider the application as having 
been received by the deadline.
    This announcement is the definitive guide on application submission 
address and deadline. It supersedes information provided in the 
application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    If you have a question about the receipt of your application, first 
contact your courier. If you still have a question, contact the PGO-TIM 
staff at: 770-488-2700. Before calling, please wait three days after 
the application deadline. This will allow time for applications to be 
processed and logged.
    IV.4. Intergovernmental Review of Applications: Executive Order 
12372 does not apply to this program.
    IV.5. Funding Restrictions: Restrictions, which must be taken into 
account while writing your budget are that project funds cannot be used 
to supplant other available applicant or collaborating agency funds for 
construction or for lease or purchase of facilities or space.
    If you are requesting indirect costs in oyr budget, you must 
include a copy of your indirect cost rate agreement. If you indirect 
cost rate is a provisional rate, the agreement must be less than 12 
months from the application due date.
    IV.6. Other Submission Requirements:
    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or E-mail to: Sally Crudder, Health Scientist, CDC 
National Center on Birth Defects and Developmental Disabilities, CDC, 
1600 Clifton Road, MS. E-64, Atlanta, GA 30333, e-mail address: 
[email protected].
    Application Submission Address: Submit the original and five copies 
of your application by mail or express

[[Page 7961]]

delivery service to: Technical Information Management--PA 04013, 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted by fax or e-mail at this time.

V. Application Review Information

    V.1. Criteria: You are required to provide measures of outcome and 
effectiveness that will demonstrate the accomplishment of the various 
identified objectives of the cooperative agreement. Measures of 
effectiveness must relate to the performance goals stated in the 
``Purpose'' section of this announcement. Measures must be objective 
and quantitative, and must measure the intended outcome. These measures 
of effectiveness must be submitted with the application and will be an 
element of evaluation.
    The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease and injury, and enhance health. In the written comments, 
reviewers will be asked to evaluate the application in order to judge 
the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.
    Under the evaluation criteria noted below, applicants must describe 
how they will address the program components as they relate to the 
Purpose and Research Objectives, and Recipient Activities as cited in 
this Announcement.
    Your application will be evaluated against the following criteria:
1. Methods and Activities: (30 points)
    a. The extent that the applicant's plan explains how the program 
activities are to be conducted and the extent that prevention methods 
proposed are: (1) Appropriate to accomplish stated goals and objectives 
and (2) feasible within programmatic and fiscal restrictions.
    b. The extent to which the applicant describes and documents the 
collaborative efforts of the proposed program to (1) Assess efficacy of 
prevention activities and (2) develop and implement prevention 
programs.
    c. The extent that the applicant incorporates gathering and using 
input from persons with bleeding disorders and thrombophilia and their 
family members, and local consumer and community based organizations, 
and the applicant's willingness to cooperate with consumers in the 
development and implementation of prevention services.
    d. The degree to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed research. This includes (1) The proposed plan 
for the inclusion of both sexes and racial and ethnic minority 
populations for appropriate representation; (2) the proposed 
justification when representation is limited or absent; (3) a statement 
as to whether the design of the study is adequate to measure 
differences when warranted; and (4) a statement as to whether the plans 
for recruitment and outreach for study participants include the process 
of establishing partnerships with community(ies) and recognition of 
mutual benefits.
2. Capacity: (30 points)
    a. The extent that the applicant provides multi-disciplinary, 
integrated, clinical and research-based prevention activities, 
outreach, education, support and provider training programs to persons 
with hemophilia, other hereditary bleeding disorders including women 
with bleeding disorders, and thrombophilia.
    b. The extent that the applicant documents and explains the scope 
and magnitude of previous experiences in providing a comprehensive, 
prevention program for hemophilia, thrombophilia, and women's bleeding 
disorders including diagnosis, management, outreach, education, and 
data collection utilizing the multi-disciplinary, comprehensive care 
model. The extent to which these services are prevention-oriented.
    c. The extent that the applicant demonstrates a collaborative 
relationship with well-established basic science and clinical research 
programs to provide the environment for broad based training and 
translation research.
3. Background and Need: (15 points)
    The extent that the target populations and catchment area are 
described in terms of known morbidity, demographics, sources of care, 
and existing data collection and surveillance. The extent the applicant 
identifies unmet needs and how they can appropriately address the 
issues of the target communities.
4. Program Management and Evaluation: (15 points)
    a. The extent of management experience for recruiting and 
implementing large public health prevention initiatives.
    b. The extent that management systems, including types, frequency, 
and methods of evaluation are used to ensure appropriate implementation 
of program activities.
5. Goals and Objectives: (10 points)
    The extent that the proposed goals and project objectives meet the 
required activities specified under ``Recipient Activities''; and are 
specific, measurable, time-phased, and realistic.
6. Budget: (Not Scored)
    This criteria includes the degree to which the budget is 
reasonable, clearly justified, accurate, and consistent with the 
purposes of this announcement. The budget justification will not be 
counted in the stated page limit.
7. Human Subjects: (Not Scored)
    Does the application adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects? This criteria will 
not be scored; however, an application can be disapproved if the 
research risks are sufficiently serious and protection against risks is 
so inadequate as to make the entire application unacceptable.
    V.2. Review and Selection Process: Applications will be reviewed 
for completeness by the Procurement and Grants Office (PGO), and for 
responsiveness by NCBDDD. Incomplete applications and applications that 
are non-responsive to the eligibility criteria will not advance through 
the review process. Applicants will be notified that their application 
did not meet submission requirements.

VI. Award Administration Information

    VI.1. Award Notices: Successful applicants will receive a Notice of 
Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA 
shall be the only binding, authorizing document between the recipient 
and CDC. The NGA will be signed by an authorized Grants Management 
Officer, and mailed to the recipient fiscal officer identified in the 
application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.
    VI.2. Administrative and National Policy Requirements: 45 CFR Parts 
74 and 92.
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://www.access.gpo.gov/nara/cfr/cfr_table-search.html.
    The following additional requirements apply to this project:
     AR-1 Human Subjects Requirements
     AR-2 Requirement for Inclusion of Women and 
Racial and Ethnic Minorities in Research

[[Page 7962]]

     AR-9 Paperwork Reduction Act Requirements
     AR-10 Smoke-Free Workplace Requirements
     AR-11 Healthy People 2010
     AR-12 Lobbying Restrictions
     AR-25 Release and Sharing of Data
    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
    VI.3. Reporting Requirements: You must provide CDC with an 
original, plus two copies of the following reports:
    Interim progress report, (PHS 2590, OMB Number 0925-0001, rev. 5/
2001) on March 22 of each subsequent budget year. The progress report 
will serve as your non-competing continuation application, and must 
contain the following elements:
    Current Budget Period Activities Objectives.
     Current Budget Period Financial Progress.
     New Budget Period Program Proposed Activity Objectives.
     Budget.
     Additional Requested Information.
     Measures of Effectiveness.
     Financial status report and annual report, no more than 90 days 
after the end of the budget period.
    Final financial and performance reports, no more than 90 days after 
the end of the project period.
    These reports must be sent to the Grants Management Specialist 
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section (PGO-TIM), CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-
2700.
    For program technical assistance, contact: Sally Crudder, Health 
Scientist, CDC National Center on Birth Defects and Developmental 
Disabilities, 1600 Clifton Road, Mailstop E-64, Atlanta, GA 30333, E-
mail Address: [email protected], Telephone: 404-371-5270.
    For financial, grants management, or budget assistance, contact: 
Rick Jaeger, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-
2727, E-mail: [email protected].

    Dated: February 13, 2004.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 04-3687 Filed 2-19-04; 8:45 am]
BILLING CODE 4163-18-P