[Federal Register: February 20, 2004 (Volume 69, Number 34)]
[Notices]
[Page 7958-7962]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20fe04-59]
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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:
GrantsInfo@nih.gov
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:
scrudder@cdc.gov.
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: scrudder@cdc.gov, 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: rjaeger@cdc.gov.
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