[Federal Register Volume 66, Number 73 (Monday, April 16, 2001)]
[Notices]
[Pages 19503-19507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement #01048]


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

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a cooperative agreement 
program in Early Hearing Detection and Intervention.
    This program addresses the ``Healthy People 2010'' focus area of 
Vision and Hearing.
    The purpose of this cooperative agreement is to: (1) assist States 
in developing or enhancing a sustainable, centralized EHDI tracking and 
surveillance system, (2) integrate the EHDI system with other newborn 
screening programs, and (3) conduct applied research. Early Hearing 
Detection and Intervention (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.

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 or Territory may be 
submitted.

[[Page 19504]]

    Two levels of cooperative agreements will be awarded: Level I: 
Eligible applicants for Level I funding are States or Territories that 
(1) do not have an established State centralized EHDI surveillance and 
tracking program, or (2) are in the beginning stages of establishing a 
centralized EHDI tracking and surveillance, 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.
    Level II: Eligible applicants for Level II are those States that 
(1) have an existing State-wide, centralized, electronic, population-
based (i.e., complete geographic coverage) surveillance and tracking 
program or (2) States that have a regional centralized, electronic, 
EHDI surveillance and tracking program that includes data on at least 
85 per cent of all live births in the region from a birth population of 
at least 10,000 live births per year. Level II States must have 
integrated or be in the process of integrating the EHDI tracking and 
surveillance system with other newborn screening systems, such as blood 
spot screening and birth defects registries.
    States that were awarded FY 2000 Level I funds under CDC Program 
Announcement 00076 and meet the Level II component criteria may request 
additional funds from this FY 2001 announcement for Level II 
activities.

    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 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 $1,900,000 will be available in FY 2001 to fund up to 
10 awards. It is expected that up to 7 awards will be made to Level I 
applicants, ranging from $100,000 to $150,000. It is expected that up 
to 3 awards will be made to Level II applicants. Level II awards are 
expected to range from $250,000 to $350,000. Awards for States with 
existing Level I awards requesting funds for Level II activities will 
range from an additional $150,000 to $200,000.
    It is expected that awards will begin on or about August 1, 2001, 
and will be made for a 12-month budget period within a project period 
of up to four years. 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 Level I and Level II recipients will be responsible for activities 
under Section 1. (Recipient Activities). CDC will be responsible for 
the activities listed under Section 2. (CDC Activities).
1. Recipient Activities
Level I
    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);
    c. Develop strategies to collect standardized EHDI data (including 
the type of hearing loss and type of intervention services) from 
multiple sources, e.g. birthing hospitals, diagnostic centers, 
audiologists, physician, intervention programs;
    d. 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;
    e. Develop mechanisms to identify and collect standardized data on 
infants/children with late onset or progressive hearing loss;
    f. Outline an analytic plan to use State EHDI data in order to 
obtain outcome data such as: 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 measure of EHDI screening performance between 
participating birthing hospitals; false positive rates; loss to follow-
up rates;
    g. Document concerns from parents and professionals about the EHDI 
process;
    h. 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);
    i. Collaborate with State programs such as Maternal and Child 
Health, Part C, private service programs, and advocacy groups to build 
a coordinated EHDI infrastructure;
    j. Develop an evaluation plan to monitor progress on activities and 
to assess the timeliness, completeness, and success of the project; and
    k. Prepare and publish manuscript(s) which describe(s) the tracking 
system, definitions, methodology, collaborative relationships, data 
collection, findings, and recommendations across sites. Collaboration 
with other participating sites is encouraged.
Level II Research Activities
    Level II applicants will be responsible for all Level I activities. 
They will also be responsible for activities that build on the 
integration of EHDI with other newborn screening and monitoring systems 
in order to design and carry out the additional Level II activities.
    Level II recipients will collaborate with other Level II recipients 
to develop and participate in a common set of activities. Applicants 
are encouraged to develop collaborative relationships with universities 
in carrying out the Level II activities. The recipients will:
    a. Share information and collaborate with other Level I and 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);
    b. Work with other Level II recipients to identify genetic and 
other causes of hearing loss. Develop a common data set from a 
population-based set of children with hearing loss identified from the 
State EHDI programs. Collect biological samples from these children;
    c. Choose an additional research area such as one of the following 
and develop a research plan:
    1. costs and effectiveness of EHDI programs,
    2. benefits of early identification and intervention for children 
with hearing loss,

[[Page 19505]]

    3. psychological and family issues related to hearing loss.
    d. Collaborate with other Level II recipients to develop a common 
set of research questions, and implement a common research protocol and 
analytic plan; and
    e. Collaborate with other Level II recipients in a pooled 
anonymized data set. Data analysis will be conducted at the State and 
federal levels.
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; and
    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, 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 stating whether the applicant 
is applying for: Level I funding only, (2) Level II funding, or (3) 
already funded for Level I activities and is requesting additional 
funds for Level II Activity. If applying for Level II, applicant must 
explain how the applicant fulfills eligibility requirements.
    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.
    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 clearly 
state for which level of activities the applicant is applying (Level I, 
Level II, or Research only). 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.
    Table of Contents: A table of contents that provides page numbers 
for each of the following sections should follow the abstract (all 
pages must be numbered).
    Narrative: The narrative for Level I applicants should be no more 
than 25 double-spaced pages. For Level II applicants, the narrative 
should be no more than 35 double-spaced pages. For applicants with 
existing Level I awards who are requesting additional Level II funds, 
the narrative should be no more than 25 pages and must include an 
update of all activities required by Program Announcement 00076. The 
narrative is to be 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. Collaborative Efforts
    e. Evaluation Plan
    f. Staffing and Management System (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

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 for which the applicant is applying. Include name, address, and 
telephone number for key contact.
    The LOI is requested on or before May 11, 2001. 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 June 11, 2001 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 
evaluated by the review panel and will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review panel appointed by CDC.
1. 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;
    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 
programs; 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

[[Page 19506]]

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; and
    g. Extent to which applicant shows willingness to integrate EHDI 
surveillance and tracking system with other newborn screening program 
activities.
2. Goals and Objectives (10 percent)
    a. Extent to which applicant clearly describes the short- 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; and
    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 percent)
    a. Extent to which applicant describes the methods they will use to 
address all Level I activities, such as: establishing and implementing 
an EHDI tracking and surveillance system; describing methods of 
populating the data base; standardizing data from multiple sources; 
developing strategies for reporting system; documenting methods for 
collecting data on infants/children with late onset or progressive 
hearing loss; designing analytic plan, documenting concerns; and 
preparing manuscripts;
    b. Extent to which applicant describes plan for integrating EHDI 
data with other newborn screening systems;
    c. (Level II States Only) Extent to which applicant demonstrates 
that their State meets the criteria to be a Level II State, i.e., has a 
state-wide or regional annual birth population of >10,000);
    d. (Level II States Only) Extent to which applicant describes a 
feasible plan for designing and implementing Level II activities, 
including the specific plan for a study of genetic and other causes of 
hearing loss, and the collection of biologic samples;
    e. (Level II States Only) Extent to which applicant demonstrates 
willingness to collaborate with other recipients to develop a research 
plan and carry out the research project that allows for anonymized 
pooling of data; and
    f. (Level I and Level II) Extent to which applicant provides a time 
line which includes activities to be accomplished and personnel 
responsible to complete the project.
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, Part C, etc.);
    d. (Level II States only) Extent to which applicant is willing to 
work collaboratively with other agencies and Level II recipients to 
develop multi-site research questions and analytic guidelines; and
    e. 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, 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; and
    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 organization structure and facilities/space/
equipment are adequate to carry out the activities of the program.
8. Human Subjects Review (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 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.

H. Other Requirements

    Recipients will regularly share anonymized individual State EHDI 
data with other award recipients.
    Recipients will 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; and
    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
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.

[[Page 19507]]

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 #01048 when you request information.
    For business management technical assistance, contact: Sonia 
Rowell, 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: April 10, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-9315 Filed 4-13-01; 8:45 am]
BILLING CODE 4163-18-P