[Federal Register Volume 68, Number 78 (Wednesday, April 23, 2003)]
[Notices]
[Pages 20006-20010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9977]


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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: 
[email protected].
    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: [email protected].


[[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