[Federal Register Volume 65, Number 90 (Tuesday, May 9, 2000)]
[Notices]
[Pages 26836-26839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11513]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 00076]


Cooperative Agreement for Early Hearing Detection and 
Intervention (EHDI) Tracking, Research, and Integration With Other 
Newborn Screening Programs; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year 2000 funds for a cooperative agreement 
program to promote the implementation and integration of State-based 
surveillance and tracking systems for Early Hearing Detection and 
Intervention (EHDI) and other disorders detected by newborn screening.
    The purpose of the EHDI program includes screening newborns for 
hearing loss, audiologic evaluation to identify infants with hearing 
loss, and early intervention for children identified. This program 
addresses ``Healthy People 2010,'' a national activity to reduce 
morbidity and mortality and improve the quality of life. This 
announcement is related to the focus area Vision and Hearing. For the 
conference copy of ``Healthy People 2010,'' visit the internet site: 
http://www.health.gov/healthypeople>.

B. Eligible Applicants

    Assistance will be provided only to the health departments of 
States or their bona fide agents, including the District of Columbia, 
the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth 
of the Northern Mariana Islands, American Samoa, Guam, federally 
recognized Indian tribal governments, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau. Only one application from each State may be submitted.
    Two levels of cooperative agreements will be awarded:
    Level I: Eligible applicants for Level I funding are those that do 
not have an established State or regional centralized EHDI surveillance 
and tracking program, or are in the beginning stages of establishing 
their program and would like to expand or improve their existing 
surveillance and tracking program.
    Level II: Eligible applicants for Level II funding are those that 
have an existing State or regional centralized EHDI population-based 
(i.e., complete geographic coverage) surveillance and tracking program 
that includes data on at least 75 per cent of infants from a birth 
population of at least 30,000 live births per year. States with fewer 
births may form multi-State data collection regions in order to meet 
the eligibility requirements; these do not have to be composed of 
contiguous States. Level I applicants may belong only to one multi-
State regional data collection site.
    Applicants from multi-State regions must provide documentation from 
each State of their willingness to collaborate and pool data from each 
site in their proposed region. One State must be identified as the 
designated lead on a multi-State application. The lead State must 
submit the application and administer the award.

    Note: Effective January 1, 1996, Public Law 104-65 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code of 1986 which engages in lobbying

[[Page 26837]]

activities shall not be eligible to receive Federal funds 
constituting an award, grant (cooperative agreement), contract, 
loan, or any other form.

C. Availability of Funds

    Approximately $2,300,000 will be available in FY 2000 to fund up to 
13 awards. It is expected that up to nine awards will be made to Level 
I applicants, ranging from $100,000-$150,000. It is expected that up to 
two awards will be made to Level II option 1 applicants and up to two 
awards will be made to Level II option 2 applicants. Level II awards 
are expected to range from $250,000-$350,000.
    It is expected that awards will begin on or about September 1, 
2000, and will be made for a 12-month budget period within a project 
period of up to five years, depending on availability of funds. Funding 
estimates may vary and are subject to change. Continuation awards 
within the approved project period will be made on the basis of 
satisfactory progress as evidenced by required reports and 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.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1 (Recipient 
Activities'either Level I or Level II). CDC will be responsible for the 
activities listed under 2 (CDC Activities).

1. Recipient Activities

Level I
    a. Establish and implement a State or regional 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, identification, and intervention).
    b. Develop standardized data collection and tracking methods (i.e., 
linking with birth certificate files) and forms, and data analysis plan 
in collaboration with other recipients.
    c. Collect standardized EHDI data (including the type of hearing 
loss and type of intervention services)from appropriate sources, such 
as birthing hospitals, diagnostic centers and/or intervention programs.
    d. Develop mechanisms to identify and collect standardized data on 
infants/children with late onset or progressive hearing loss.
    e. Use State or regional EHDI data in order to obtain outcome data 
such as: unexpected clusters of infants with hearing loss in particular 
regions at particular times; unexpected differences in measure of EHDI 
screening performance between participating birthing hospitals; false 
positive rates; loss to follow-up rates.
    f. Document concerns from parents and professionals about the EHDI 
process.
    g. Collaborate with State programs such as Maternal and Child 
Health, Part C of the Individuals with Disabilities Education Act, 
private service programs, and advocacy groups to build a coordinated 
EHDI infrastructure.
    h. Integrate with other screening programs that identify children 
with special health care needs such as newborn blood spot screening and 
birth defects surveillance.
    i. Prepare and publish manuscript(s) which describes the tracking 
system, definitions, methodology, collaborative relationships, data 
collection, findings, and recommendations across sites. Collaboration 
with other participating sites is encouraged.
    j. Develop an evaluation plan to monitor progress on activities and 
to assess the timeliness, completeness, and success of the project.
Level II
    Level II applicants will be responsible for all required Level I 
activities, plus implementing either Option 1 or Option 2 below, but 
not both options.
    Option 1. Under this option, Level II applicants will collaborate 
with other recipients to develop and participate in a common set of 
activities. Level II applicants are encouraged to develop collaborative 
relationships with universities. They will:
    a. Share information and collaborate with other Level II 
recipients, and with other federal and national agencies (such as, but 
not limited to, Health Resources and Services Administration, National 
Institute on Deafness and other Communication Disorders, Directors of 
Speech and Hearing Programs in State Health and Welfare Agencies, Joint 
Committee on Infant Hearing, and advocacy groups) to develop a set of 
core research questions and analytic guidelines for one or more of the 
following areas:
    i. costs of EHDI programs,
    ii. causes and associated factors for hearing loss,
    iii. benefits of early identification and intervention for children 
with hearing loss,
    iv. psychological and family issues.
    b. Collaborate with other award recipients to implement a common 
research and analytic plan and analyze data.
    c. Collaborate with other Level II award recipients in an 
anonymized research data set. Data analysis will be conducted at the 
State and federal levels with the data being maintained at the 
individual applicant sites.
    d. Collect biological samples for children identified with hearing 
loss.
    Option 2. Under this option, Level II applicants will be 
responsible for activities that build on the integration of EHDI with 
other newborn screening and monitoring systems. They will:
    a. Collaborate with programs that perform State newborn blood spot 
screening to identify an annual birth cohort of infants for further 
monitoring. Each program will select two conditions to include in their 
cohort; either PKU or glactosemia as one condition, and either 
congenital hypothyroidism or hemoglobinopathies as the other.
    b. Develop a plan that is integrated with the EHDI tracking system 
to determine the effectiveness of the program in identifying and 
tracking infants with the selected conditions.
    c. Develop a plan to annually document the services received and 
the condition (i.e., medical and developmental complications) for each 
affected child included in the cohorts.
    d. Collaborate with other Level II/Option 2 award recipients to 
develop a data system for the cohorts that can be integrated with other 
newborn screening activities and can serve as a model for other State 
programs.

2. CDC Activities

    a. Provide technical assistance as needed on the design, 
development, and evaluation methods and approaches used for State-based 
EHDI tracking and surveillance.
    b. Provide technical assistance as needed on the development of 
research questions and analytic guidance;
    c. Provide technical assistance as needed for the collection and 
analysis of data across sites.
    d. Facilitate collaborative efforts to compile and disseminate 
program results through presentations and publications.

E. Application Content

    Use the information in the Program Requirements, Application 
Content,

[[Page 26838]]

Evaluation Criteria, and Other Requirements sections to develop the 
application content. Forms are in the application kit. Applications 
will be evaluated on the criteria listed, so it is important to follow 
them in describing the program plan. The applicant should provide a 
detailed description of first-year activities and briefly describe 
future-year objectives and activities.
    The application must contain the following:
    Cover Letter: A one-page cover letter should state the Level and 
Option for which the applicant is applying and explain how the 
applicant fulfills eligibility requirements.
    Abstract and Table of Contents: 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 clearly state which level of activities the applicant is 
applying for: Level I, Level II-Option 1, or Level II-Option 2. The 
abstract should briefly summarize the program for which funds are 
requested, the activities to be undertaken, and the applicant's 
organization structure. The abstract should precede the Program 
Narrative. A table of contents that provides page numbers for each of 
the following sections should follow the abstract (all pages must be 
numbered).
    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 at least one project staff person to attend two two-day 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 25 double-spaced 
pages for Level I applicants and no more than 35 double-spaced pages 
for Level II applicants, printed on one side, with one inch margins, 
and unreduced font (12 pitch). The narrative must contain the following 
sections:
a. Understanding the Problem and Current Status
b. Goals and Objectives
c. Description of Program and Methodology
d. Evaluation Plan
e. Collaborative Efforts
f. Staffing and Management System (One-page CV or resume for each key 
personnel must be included in an attachment)
g. Organizational Structure and Facilities (Must include an 
organizational chart)
h. Human Subjects Review

F. Submission and Deadline

Letter of Intent

    A letter of intent (LOI) is requested to enable CDC to determine 
the level of interest in the announcement. The LOI should specify the 
level (Level I or Level II, and the option if applying for Level II 
funding) for which the applicant is applying. Include name, address, 
and telephone number. The LOI is requested on or before June 6, 2000. 
Submit the letter of intent to the Grants Management Specialist 
identified in the ``Where to Obtain Additional Information'' section of 
this announcement.

Application

    Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189) on or before July 6, 2000 to the Grants Management Specialist 
identified in the ``Where to Obtain Additional Information'' section of 
this announcement.
Deadline
    Applications shall be considered as meeting the deadline if they 
are either:
    (a) Received on or before the deadline date; or
    (b) Sent on or before the deadline date and received in time for 
submission to the Objective Review Panel. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
Late Applications
    Applications which do not meet the criteria in (a) or (b) above are 
considered late applications, will not be considered, and will be 
returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.

1. Understanding the Problem (15%)

    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 an EHDI 
program in their respective State(s) or the current status of their 
respective State(s) existing EHDI program: Number of infants/children 
with hearing loss; number of infants born, number of birthing hospitals 
with and without UNHS programs; number of infants screened, identified 
and referred to intervention; protocol for screening and referral, 
including informed consent information; description of EHDI tracking 
and surveillance system (if any exists); description of other relevant 
tracking, surveillance systems, or registries in the State and linkages 
with these systems or plans to link; description of diagnostic 
facilities and intervention services available in the State for 
infants/children with hearing loss;
    d. Extent to which applicant shows willingness to integrate EHDI 
surveillance and tracking system with other newborn screening program 
activities.

2. Goals and Objectives (10%)

    a. Extent to which applicant clearly describes the short- and long-
term goals and objectives of the project;
    b. Extent to which applicant's goals and objectives are consistent 
with the stated 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.

3. Description of Program and Methodology (35%)

    a. Extent to which applicant describes target region and number of 
births/year in that region;
    b. Extent to which applicant addresses all activities of Program 
Requirements relevant to their chosen Level/Option;
    c. Extent to which applicant describes the methods to be used to 
carry out the activities and provides a time line which includes 
personnel and other resources to complete the project.

[[Page 26839]]

4. Evaluation Plan (15%)

    Extent to which applicant describes an evaluation plan that will 
monitor progress, and assess timeliness, completeness, and success of 
the project;

5. Collaborative Efforts (10%)

    a. Extent to which applicant describes their methods for 
collaboration with (and includes written assurances) from hospitals, 
diagnostic centers, and intervention services;
    b. Extent to which collaborative efforts with other screening 
programs are documented;
    c. (Level II only) Extent to which applicant is willing to work 
collaboratively with other agencies and recipients to develop multi-
site research questions and analytic guidelines. If additional research 
questions are proposed in order to address local concerns, extent to 
which the applicant provides a rationale and need for choosing those 
questions, a clear description of the methodology to be used, the 
resources available or needed to carry out the project;
    d. (Level II only) Extent to which applicant describes their plan 
for integrating the EHDI program with other screening programs such as 
blood spot screening and birth defect registries, (Letters of agreement 
and cooperation from collaborating screening programs should be 
included). Applicants must state their willingness to work 
collaboratively and to modify their projects if necessary in order to 
accommodate multi-site projects for the purpose of integration and 
standardization efforts.

6. Staffing and Management System (10%)

    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;

7. Organizational Structure and Facilities (5%)

    Extent to which organization structure and facilities/space/
equipment are adequate to carry out the activities of the program.

8. Human Subjects Requirements (Not Scored)

    The extent to which the applicant complies with the Department of 
Health and Human Services Regulations (45 CFR Part 46) regarding the 
protection of human subjects.

9. Budget (Not Scored)

    The extent to which the applicant provides a detailed budget and 
narrative justification consistent with stated objectives and planned 
program activities.

H. Other Requirements

    Provide CDC with the original plus two copies of:
    1. Semi-annual progress reports, no more than 30 days after the end 
of the report period.
    2. Financial status report, no more than 90 days after the end of 
the budget period;
    3. Final financial report and performance report, 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.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Addendum I in the 
application kit.


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 Requirements
AR-10   Smoke-Free Workplace Requirements
AR-11   Healthy People 2010
AR-12   Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301 and 317 of the Public 
Health Service Act, 42 U.S.C. sections 241 and 247b, as amended. The 
Catalog of Federal Domestic Assistance number is 93.283.

J. Where To Obtain Additional Information

    This and other documents may be downloaded through the CDC homepage 
on the Internet at http://www.cdc.gov (click on ``Funding''). Refer to 
Program Announcement 00076 when you request information.
    For business management technical assistance, contact: Mattie B. 
Jackson, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, 
Telephone number: 770-488-2718, E-mail address: [email protected].
    For program technical assistance, contact: June Holstrum, Ph.D., 
Early Hearing Detection and Intervention Program, National Center for 
Environmental Health, Centers for Disease Control and Prevention, 4770 
Buford Highway, NE, Mailstop F-15, Atlanta, GA 30341-3717, Telephone 
number: 770-488-7361, E-mail address: [email protected].

    Dated: May 3, 2000.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 00-11513 Filed 5-8-00; 8:45 am]
BILLING CODE 4163-18-P