[Federal Register: April 23, 2003 (Volume 68, Number 78)]
[Notices]
[Page 20006-20010]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ap03-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 03055]
Cooperative Agreement for Early Hearing Detection and
Intervention (EHDI) Tracking, Surveillance, and Integration; Notice of
Availability of Funds
Application Deadline: June 9, 2003.
A. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under sections 301(a) and 317(C) of the
Public Health Service Act, (42 U.S.C. sections 241(a) and 247b-4), as
amended. The Catalog of Federal Domestic Assistance number is 93.283.
B. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 2003,funds for a cooperative agreement
program for Early Hearing Detection and Intervention (EHDI). This
program addresses the ``Healthy People 2010'' focus area of Vision and
Hearing.
The purpose of the program is to (1) develop or enhance a
sustainable, centralized EHDI tracking and surveillance system, and (2)
integrate the EHDI system with other newborn screening programs. EHDI
is a national initiative to improve the communicative, cognitive, and
social outcomes of children with hearing loss through a program of
services and research.
Measurable outcomes of the program will be in alignment with one or
more of the following performance goals for the National Center on
Birth Defects and Disabilities: Prevent birth defects and developmental
disabilities and improve the health and quality of life of Americans
with disabilities.
[[Page 20007]]
C. Eligible Applicants
Applications may be submitted by State and local governments or
their bona fide agents, including the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of
the Northern Marianna Islands, American Samoa, Guam, the Federated
States of Micronesia, the Republic of the Marshall Islands, the
Republic of Palau and Federally recognized Indian Tribal Governments.
Only one application from each State or Territory may be submitted.
To be eligible, applicants must document that they:
1. Do not have an established State centralized EHDI surveillance
and tracking program;
2. Are in the beginning stages of establishing a centralized EHDI
surveillance and tracking program; or
3. Already have a program but would like to refine their existing
surveillance and tracking program to integrate it with other newborn
screening and tracking programs.
The applicant must include this documentation in the cover letter
of the application. If it is not included, then the application will be
determined as ``non-responsive'' and returned without review.
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501c(4) of the Internal Revenue
Code that engages in lobbying activities is not eligible to receive
Federal funds constituting an award, grant or loan.
D. Funding
Availability of Funds
Approximately $300,000 is available in FY 2003, to fund two awards.
It is expected that the average award will be $150,000, ranging from
$110,000 to $150,000. It is expected that the awards will begin on or
about September 1, 2003, and will be made for a 12-month budget period
within a project period of up to two years. Funding estimates may
change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required reports
and the availability of funds.
Use of Funds
Project funds may not be used to supplant other available applicant
or collaborating agency funds or to supplant State funds available for
screening, diagnosis, intervention or tracking for hearing loss or
other disorders detected by newborn screening. Project funds may not be
used for construction, for lease or purchase of facilities or space, or
for patient care.
Recipient Financial Participation
Matching funds are not required for this program.
E. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities listed in 1.
Recipient Activities, and CDC will be responsible for the activities
listed in 2. CDC Activities.
1. Recipient Activities
a. Establish and implement a State surveillance and data tracking
system to assure minimal loss to follow-up by monitoring the status and
progress of infants through the three components of the EHDI program
(screening, detection, and intervention).
b. Establish methods for populating the EHDI data base (e.g.,
linking with the electronic birth certificate) to develop strategies
for collecting standardized EHDI data (including the type of hearing
loss and type of intervention services) from multiple sources, (e.g.
birthing hospitals, diagnostic centers, audiologists, physicians,
intervention programs.) Develop and enumerate reporting systems that
will ensure that tracking and surveillance data collected from multiple
sources will be used so that there is minimal loss to follow-up.
c. Develop mechanisms to identify and collect standardized data on
infants/children with late onset or progressive hearing loss.
d. Outline an analytic plan to use EHDI data in order to obtain
outcome data such as: Number/percent of infants screened, referred,
evaluated, and enrolled in intervention programs; unexpected clusters
of infants with hearing loss in particular regions at particular times;
unexpected differences in EHDI screening performance between
participating birthing hospitals; false positive rates; loss to follow-
up rates.
e. Document concerns from parents and professionals about the EHDI
process.
f. Establish or use existing EHDI advisory committee with
appropriate representation of parents and professionals to provide
guidance and assistance in the development of the EHDI program.
g. Design the program so that it can be integrated with other
screening and tracking programs that identify children with special
health care needs such as newborn blood spot screening, birth defects
registries, fetal alcohol syndrome surveillance, and Part C of the
Individuals with Disabilities Education Act (IDEA) (http://www.nectac.org
).
h. Collaborate with State programs such as Maternal and Child
Health (MCH) (http://www.mchb.hrsa.gov), part C of IDEA, private
service programs, and advocacy groups to build a coordinated EHDI
infrastructure.
i. Develop an evaluation plan to monitor progress on activities and
to assess the timeliness, completeness, and success of the project.
j. Prepare and publish manuscript(s) that describe(s) the tracking
system, definitions, methodology, collaborative relationships, data
collection, findings, and recommendations across sites. Collaboration
with other participating sites is encouraged.
k. Share information and collaborate with other recipients, and
with CDC and other Federal and national agencies.
2. CDC Activities
a. Provide technical assistance such as presenting the need,
benefits, and description of a comprehensive, state-based EHDI tracking
and surveillance program, reviewing draft legislation, etc. to state
agencies and interested parties.
b. Assist in designing, developing, and evaluating methodologies
and approaches used in state-based data collection and analysis of data
across sites.
c. Facilitate collaborative efforts to compile and disseminate
program results through presentations and publications.
d. Assist in analyzing surveillance data related to EHDI.
e. Assist in designing, developing, and evaluating plans to improve
the access of children with hearing loss to health services and
intervention programs.
f. Provide a reference point for sharing state-based data and
information pertinent to the surveillance and tracking of hearing loss.
F. Content
Letter of Intent (LOI)
A LOI is requested for this program. The LOI should identify the
program announcement number, program title and the proposed project
director. The LOI should be no more than 2 pages, single-spaced,
printed on one side, with one-inch margins, and unreduced 12-point
font. The LOI will be used to determine the level of interest in the
announcement, and assist CDC in planning for the application review
process.
[[Page 20008]]
Applications
The Program Announcement title and number must appear in the
application. Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. Your application will be evaluated on the criteria
listed, so it is important to follow them in laying out your program
plan. Applications should include the following items, in the following
order:
Cover Letter: A one-page cover letter stating that the applicant is
applying and how the applicant fulfills eligibility requirements.
Table of Contents: A table of contents that provides page numbers
for each of the following sections (all pages must be numbered).
Abstract: A one-page, single-spaced, typed abstract must be
submitted with the application. The heading should include the title of
the grant program, project title, organization name and address,
project director and telephone number. The abstract should briefly
summarize the project for which funds are requested, the activities to
be undertaken, and the applicant's organization structure. The abstract
should precede the program narrative.
Budget and Budget Justification: The budget should be reasonable,
clearly justified, and consistent with the intended use of the
agreement funds. The applicant must include a detailed first-year
budget justification with future annual projections. Budgets should
include costs for travel for two project staff to attend annual
meetings. The applicant should provide a budget justification for each
budget item. Proposed sub-contracts should identify the name of the
contractor, if known; describe the services to be performed; provide an
itemized budget and justification for the estimated costs of the
contract; specify the period of performance; and describe the method of
selection.
Narrative: The narrative should be no more than 30, double-spaced
pages. The narrative is to be printed on one side, with one-inch
margins, and unreduced 12-point font. The narrative must contain the
following sections:
a. Understanding the Problem and Current Status
b. Goals and Objectives
c. Description of Program and Methodology (Include a timeline for
the entire two-year project period.)
d. Collaborative Efforts
e. Evaluation Plan
f. Staffing and Management System (A one-page CV or resume for each
key personnel must be included in an attachment). Plan must also
provide details of the role of each key personnel.
g. Organizational Structure and Facilities (Must include an
organizational chart)
h. Human Subjects Review
G. Submission and Deadline
Letter of Intent (LOI) Submission
On or before May 13, 2003, submit the LOI to the Public Health
Analyst identified in the ``Where to Obtain Additional Information''
section of this announcement.
Application Forms
Submit the signed original and two copies of PHS 5161-1 (OMB Number
0937-0189). Forms can be found at the following Internet address:
www.cdc.gov/od/pgo/forminfo.htm.
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) at: 770-488-2700. Application forms can be mailed to you.
Submission Date, Time, and Address
The application must be received by 4 p.m. eastern time June 9,
2003. Submit the application to: Technical Information Management--
PA03055, CDC Procurement and Grants Office, 2920 Brandywine
Road, Atlanta, GA 30341-4146.
Applications may not be submitted electronically.
CDC Acknowledgement of Application Receipt
A postcard will be mailed by PGO-TIM, notifying you that CDC has
received your application.
Deadline
Letters of intent and applications shall be considered as meeting
the deadline if they are received before 4 p.m. eastern time on the
deadline date. Any applicant who sends their application by the United
States Postal Service or commercial delivery services must ensure that
the carrier will be able to guarantee delivery of the application by
the closing date and time. If an application is received 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, CDC will upon receipt of proper
documentation, consider the application as having been received by the
deadline.
Any application that does not meet the above criteria will not be
eligible for competition, and will be discarded. The applicant will be
notified of their failure to meet the submission requirements.
H. Evaluation Criteria
Application
Applicants are required to provide measures of 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 section ``B. Purpose'' 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.
An independent review group appointed by CDC will evaluate each
application against the following criteria:
1. Description of Program and Methodology (35 percent).
a. Extent to which applicant describes the methods they will use to
address all recipient activities, such as: (1) Establishing and
implementing an EHDI tracking and surveillance system; (2) describing
methods of populating the data base; (3) standardizing data from
multiple sources; (4) developing strategies for reporting system; (5)
documenting methods for collecting data on infants/children with late
onset or progressive hearing loss; (6) designing analytic plan; (7)
documenting concerns; (8) describing advisory committee; (9) describing
plans for integrating data sets; (10) collaborating with other state
programs; (11) developing an evaluation plan; (12) preparing
manuscripts; and (13) collaborating and sharing information.
b. Extent to which applicant provides a time line which includes
activities to be accomplished, and personnel responsible to complete
the project. The timeline should address activities to be conducted
over the entire two-year project period.
2. Understanding the Problem and Current Status (20 percent).
a. Extent to which the applicant has a clear, concise understanding
of the requirements and purpose of the cooperative agreement.
b. Extent to which the applicant understands the challenges,
barriers, and problems associated with developing and implementing an
EHDI tracking and surveillance program.
c. Extent to which the applicant describes the need for funds to
develop/enhance an EHDI tracking and surveillance program in their
State.
[[Page 20009]]
d. Extent to which the applicant describes the target population
and the current status of their existing EHDI program, e.g., number of
birthing hospitals with and without universal hearing screening
program; number of infants born, number of infants screened, identified
and referred to intervention; protocol for screening and referral,
including informed consent information.
e. Extent to which applicant describes (1) their current EHDI
tracking and surveillance system (if any exists); (2) other relevant
tracking, surveillance systems, or registries in the State; and (3)
linkages with other relevant systems.
f. Extent to which applicant describes diagnostic facilities and
intervention services available in the State for infants/children with
hearing loss.
g. Extent to which applicant shows willingness and interest to
integrate EHDI surveillance and tracking system with other newborn
screening program activities.
3. Goals and Objectives (10 percent).
a. Extent to which applicant clearly describes the short-term and
long-term goals, and measurable objectives of the project.
b. Extent to which applicant's goals and objectives are realistic
and are consistent with the stated goals and purpose of this
announcement.
c. 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 the proposed plan for the
inclusion of both sexes and racial and ethnic minority populations for
appropriate representation and justification when representation is
limited or absent.
4. Collaborative Efforts (10 percent).
a. Extent to which applicant describes their methods for
collaboration with multiple data sources (include written assurances)
such as hospitals, diagnostic centers, and intervention service
providers.
b. Extent to which collaborative relationships are documented which
will facilitate linkage with other screening programs. (Letters of
agreement and cooperation from collaborating programs should be
included.)
c. Extent to which collaborative efforts with other relevant
programs are documented (such as MCH, IDEA part C, etc.)
d. Extent to which applicant states their willingness to work
collaboratively with other funded States and to modify their projects
if necessary in order to allow anonymized pooled data sets of
standardized data.
5. Evaluation Plan (10 percent).
Extent to which applicant describes an evaluation plan that will
monitor progress toward their goals, and assess timeliness,
completeness, and success of the objectives and activities of the
project.
6. Staffing and Management System (10 percent).
a. Extent to which key personnel have skills and experience to
develop and implement an EHDI tracking and surveillance system.
b. Extent of the managerial ability to coordinate the tracking,
surveillance, and research, and integration components of the project.
c. Extent to which expertise in abstracting screening,
identification, and intervention records are demonstrated.
d. Extent to which expertise in epidemiologic methods, public
health surveillance, data management and computer programming is
demonstrated.
e. Extent to which there is sufficient dedicated staff time to
develop and implement an EHDI tracking and surveillance system and to
integrate the EHDI system with other newborn screening systems (include
percentage of time each staff member will contribute to the project).
7. Organizational Structure and Facilities (5 percent).
Extent to which the organization structure and facilities/space/
equipment are adequate to carry out the activities of the program.
8. Human Subjects Review (not scored).
Does the application adequately address the requirements of title
45 CFR part 46 for the protection of human subjects? Not 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.
9. Budget (not scored).
The budget will be evaluated for the extent to which it is
reasonable, clearly justified, and consistent with the intended use of
the cooperative agreement funds.
I. Other Requirements
Technical Reporting Requirements
Provide CDC with the original plus two copies of:
Interim progress report, no less than 90 days before the end of the
budget period. The progress report will serve as your non-competing
continuation application, and must contain the following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Detailed Line-Item Budget and Justification.
e. Additional Requested Information.
2. Financial status report, no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
Additional Requirements
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment I of the
program announcement, as posted on the CDC Web site.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-7 Executive Order 12372 Review
AR-9 Paperwork Reduction Act
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
J. Where To Obtain Additional Information
This and other CDC announcements, the necessary applications, and
associated forms can be found on the CDC Web site, Internet address:
http://www.cdc.gov. Click on ``Funding'' then ``Grants and Cooperative
Agreements''.
For general questions about this announcement, contact: Technical
Information Management, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341-4146. Telephone: 770-488-2700.
For business management and budget assistance, contact: Sheryl
Heard, Grants Management Specialist, Procurement and Grants Office,
Centers for Disease Control and Prevention, 2920 Brandywine Road,
Atlanta, GA 30341-4146. Telephone: 770-488-2723. E-mail address:
SHeard@cdc.gov. For program technical assistance, contact: Lee Ann B. Ramsey, BBA,
GCPH, Public Health Analyst, Centers for Disease Control and
Prevention, National Center on Birth Defects and Developmental
Disabilities, 1600 Clifton Road, NE, Mailstop F-35, Atlanta, GA 30333.
Telephone: 404-498-3034. E-mail Address: LRamsey@cdc.gov.
[[Page 20010]]
Dated: April 17, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 03-9977 Filed 4-22-03; 8:45 am]
BILLING CODE 4163-18-P