[Federal Register Volume 65, Number 217 (Wednesday, November 8, 2000)]
[Notices]
[Pages 67013-67015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Universal Newborn Hearing Screening and Intervention

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of availability of funds.

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SUMMARY: The Health Resources and Services Administration (HRSA) 
announces that approximately $5 million in fiscal year (FY) 2001 funds 
is anticipated for 25 to 31 grants to States for the implementation of 
universal physiologic newborn hearing screening prior to hospital 
discharge with linkages to medical home, ongoing family-to-family 
support, diagnostic evaluation by three months of age, and enrollment 
in a program of early intervention by six months of age for those 
infants identified with hearing loss. All awards will be made under the 
program authority of Title VI of the Labor-HHS-Education Appropriations 
Act for FY 2000 (Pub. L. 106-113). This Universal Newborn Hearing 
Screening and Intervention Program (CFDA #93.251) will be administered 
by the Maternal and Child Health Bureau (MCHB), HRSA. Projects will be 
approved for a 4-year period, with awards at average yearly amounts 
ranging from $100,000 to $200,000. Funding for Universal Newborn 
Hearing Screening and Intervention grants is contingent upon the 
availability of FY 2001 funds.

DATES: Entities which intend to submit an application for this grant 
program are expected to notify MCHB's Division of Services for Children 
with Special Health Care Needs by November 10, 2000. The deadline for 
receipt of applications is December 8, 2000. Applications will be 
considered ``on time'' if they are either received on or before the 
deadline date or postmarked on or before the deadline date. The project 
award date is March 31, 2001.

ADDRESSES: To receive a complete application kit, applicants may 
telephone the HRSA Grants Application Center at 1-877-477-2123 (1-877-
HRSA-123) beginning November 3, 2000, or register on-line at: http://www.hrsa.dhhs.gov/, or by accessing http://www.hrsa.gov/g__order3.htm 
directly. This program uses the standard Form PHS 5161-1 (rev. 7/00) 
for applications (approved under OMB No. 0920-0428). Applicants must 
use Catalog of Federal Domestic Assistance (CFDA) number 93.251 when 
requesting application materials. The CFDA is a Government wide 
compendium of enumerated Federal programs, projects, services, and 
activities which provide assistance. All applications should be mailed 
or delivered to: Grants Management Officer, MCHB; HRSA Grants 
Application Center, 1815 N. Fort Meyer Drive, Suite 300, Arlington, 
Virginia 22209; telephone: 1-877-477-2123; E-mail: [email protected].
    This application guidance and the required forms for the Universal 
Newborn Screening and Intervention program may be downloaded in either 
WordPerfect 6.1 or Adobe Acrobat format (.pdf) from the MCHB Home Page 
at http://www.mchb.hrsa.gov/. Please contact Joni Johns, at 301/443-
2088, or [email protected]/, if you need technical assistance in 
accessing the MCHB Home Page via the Internet.
    This announcement will appear in the Federal Register and on the 
HRSA Home Page at: http://www.hrsa.dhhs.gov/. Federal Register notices 
are found by following instructions at: http://www.access.gpo.gov/
su__docs/aces/aces140.html.

    Letter of Intent: Notification of intent to apply can be made in 
one of three ways: telephone, 301-443-2370; email, [email protected]; 
mail, MCHB, HRSA; Division of Children with Special Health Care Needs; 
Parklawn Building, Room 18A-18; 5600 Fishers Lane; Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Irene Forsman, M.S., R.N., 301/443-
2370, email: [email protected]/ (for questions specific to project 
activities of the program, program objectives, or the required Letter 
of Intent which is further described in the application kit); Paulette 
Faga, 301/443-6934, email [email protected]/ (for grants policy, 
budgetary, and business questions).

SUPPLEMENTARY INFORMATION:

Universal Newborn Hearing Screening and Intervention Program 
Background and Objectives

    HRSA's Maternal and Child Health Bureau has been involved in 
newborn screening and genetic testing for more than a decade. In 1989, 
Dr. C. Everett Koop, then Surgeon General, urged that all infants with 
significant hearing loss be identified by 12 months of age, and 
encouraged inclusion of this goal in the Public Health Service's 
``National Healthy People Goals 2000.'' Since then, MCHB, acting in 
concert with the Centers for Disease Control and prevention (CDC) and 
the National Institutes of Health (NIH), has made substantial progress 
in the adoption of universal newborn hearing screening and early 
intervention as the standard of care in the United States. The new 
``Healthy People 2010'' includes a revised newborn hearing screening 
goal of identifying all newborns with significant hearing loss and 
enrolling them in a program of early intervention by age 6 months. All 
relevant professional organizations, including the American Academy of 
Pediatrics, have endorsed the concept.
    Also in 1989, MCHB's Division of Services for Children with Special 
Health Needs began efforts under the Special Projects of Regional and 
National Significance (SPRANS) authority of the Maternal and Child 
Health (MCH) Block Grant (Title V of the Social Security Act) to 
support implementation of universal newborn hearing screening prior to 
discharge through a series of demonstration projects to assess the 
effectiveness of new technologies and to provide

[[Page 67014]]

technical assistance to a number of hospitals and States in 
establishing and maintaining universal newborn hearing screening and 
intervention programs. Resources developed by these projects can be 
found on-line at: http://www.usa.edu:8080/-ncham/consort.html, and 
http://www.colorado.edu/slhs/MDNC/index.html. This grant program will 
continue to operate in conjunction with the State Title V programs.
    In 1999, following more than a decade of pioneering work in 
universal newborn hearing screening in hospitals nationwide, MCHB 
released a guide for hospitals wishing to initiate newborn hearing 
screening and intervention programs. The publication, ``Early 
Identification of Hearing Loss--Implementing Universal Newborn Hearing 
Screening Programs,'' is available free to hospitals and birthing 
centers around the country through the National Maternal and Child 
Health Clearinghouse and on the World Wide Web at http://www.nmchc.org. 
The guide is organized into areas to be considered in setting up this 
type of program, such as determining protocol in the participating 
hospital; choosing equipment; training; financing; managing data; and 
talking to parents, physicians, and hospital staff.
    By the year 2000, about 35 percent of newborns were being screened 
for hearing loss before discharge. Hundreds of hospitals operate 
screening programs. Evidence is clear that implementation of universal 
newborn hearing screening substantially lowers the age at which 
children with congenital permanent hearing loss are identified and that 
children who are identified early do better on school related measures. 
In addition, technology is available to conduct cost-efficient, 
physiological screening universally prior to hospital discharge. In 
1993, less than 5 percent of all infants were screened for hearing loss 
prior to hospital discharge. Most established programs are now able to 
screen more than 95 percent of all newborns prior to discharge and 
parental acceptance of the screening programs is high. Typically, one 
to three percent of those screened require referral for diagnostic 
evaluation. The cost of screening is approximately $25-$30 per infant.
    As of September 200, about 24 States had enacted laws regarding 
hearing screening for all newborns. However, the vast majority of 
hospitals in this country still do not screen all infants prior to 
discharge.
    Congressional support to expand universal newborn hearing screening 
and intervention to all States grew throughout the 1990's. In November 
1999, Congress acted through both the appropriations and authorization 
processes to target increased resources to encourage State efforts. New 
legislative authority, enacted under Title VI of the Labor-HHS-
Education Appropriations Act for FY 2000 (Pub. L. 106-113), represented 
a milestone in the effort to give newborns a healthy start in life.
    In March 2000, using $3 million in FY 2000 funds appropriated under 
the new authority, MCHB was able to increase support for newborn 
hearing screening and intervention by awarding grants, totaling $3 
million, to 22 States. These four-year grants are the most recent steps 
toward assuring that once babies are screened and diagnosed with a 
hearing loss, they and their families receive appropriate services that 
are coordinated at the community level with early intervention 
programs, ongoing family-to-family support and the child's medical 
home, i.e., regular source of primary health care. Diagnosis is 
recommended by 3 months of age; intervention by 6 months.
    The grants to be awarded under this announcement will extend the 
initiative MCHB began in March 2000, to an additional 25 to 31 States 
in FY 2001.

Authorization

    Title VI of the Departments of Labor-HHS-Education Appropriations 
Act for FY 2000 (Pub. L. 106-113).

Purpose

    The purpose of these grants is to provide funds to States for the 
implementation of programs of statewide universal physiologic newborn 
hearing screening prior to hospital discharge with linkages to medical 
home, ongoing family-to-family support, diagnostic evaluation by three 
months of age, and enrollment in a program of early intervention by six 
months of age for those infants identified with hearing loss.

Eligibility

    This program is open to State agencies with the capacity to 
implement a statewide universal newborn hearing screening and 
intervention program for all newborn infants in the State.

Funding Level/Project Period

    The total funding level for these grants is $5 million annually 
over a four-year project period, from March 31, 2001 through March 30, 
2005. The project period consists of one or more budget periods, each 
generally of one year duration.
    Funding for this grant program is contingent upon the availability 
of FY 2001 funds. Continuation of any project from one budget period to 
the next is subject to satisfactory performance, availability of funds, 
and program priorities. The initial budget period is expected to be 12 
months, with subsequent budget periods being 12 months.
    An estimated 25 to 31 awards will be made annually, with average 
first-year awards ranging from $100,000 to $200,000.

Funding Priorities and/or Preferences

    Preference will be given to States without a Universal Newborn 
Hearing Screening and Intervention grant from MCHB.

Review Criteria

    Applications for this grant program will be reviewed on the basis 
of the extent to which they address the following criteria:
    (1) The degree to which the applicant provides a complete 
description of the current status of the State with respect to full 
implementation of a program of universal newborn hearing screening 
prior to hospital discharge, linkage to the infant's medical home, 
audiologic diagnosis by 3 months of age, ongoing family-to-family 
support and enrollment in a program of early intervention by 6 months.
    (2) The degree to which the applicant provides an implementation 
plan to achieve full implementation of a sustainable statewide 
universal newborn hearing screening program, defined as the screening 
of 95 percent of infants prior to hospital discharge or in the first 
month of life. Elements of such a plan include:
    (a) A state level advisory committee with appropriate 
representation of professionals who will be involved in the screening 
and followup program, families, and consumers of services for infants 
with hearing loss;
    (b) The structure of the screening program, including informed 
consent procedures; screening methodology, procedures and personnel; 
timing and responsibility for documenting and communicating results;
    (c) Procedures for assuring timely linkages of identified infants 
and families with the infant's medical home, ongoing family-to-family 
support and early intervention services (consistent with Part C of the 
Individuals with Disabilities Education Act (IDEA) [20 U.S.C. 1431 et 
seq.]).
    (d) Procedures for assuring that timely audiologic followup and 
diagnosis of infants suspected of hearing loss is

[[Page 67015]]

carried out, including the availability of appropriately trained 
audiology personnel;
    (e) A description of the data and tracking system for infants 
suspected to have or identified with significant hearing loss, 
including a description of relationships to other databases within the 
States that focus on infants and children, particularly the 
relationship of the newborn hearing screening data to the newborn 
metabolic screening data and tracking system and CDC's Early Hearing, 
Detection and Intervention (EHDI) reporting system; and
    (f) A plan for professional and public education about the state 
newborn hearing screening program.
    (3) The extent to which the estimated cost to the Government of the 
project is reasonable, considering the anticipated results;
    (4) The extent to which the project personnel are well qualified by 
training and/or experience for their roles in the project and the 
applicant organization has adequate facilities and personnel;
    (5) The extent to which the project will be integrated with the 
administration of MCH Block Grant programs and other related programs 
in the State.
    (6) The inclusion of a well developed plan for evaluation, which 
documents, with data support, the successes (or failures) at each stage 
of the screening and intervention program. Funded programs will be 
required to report annually throughout the life of the grant. Data 
reporting will include the number of infants screened, number referred 
for audiologic diagnosis, number and age of infants receiving 
audiologic diagnosis, number of infants with a medical home, referral 
to family-to-family support and number and age at which identified 
infants are enrolled in early intervention services. OMB approval for 
the data reporting will be sought, as required under the Paperwork 
Reduction Act of 1995.
    Applicants should pay strict attention to addressing the above 
criteria as they are the basis upon which their applications will be 
judged.

Executive Order 12372

    This program has been determined to be a program which is subject 
to the provisions of Executive Order 12372 concerning intergovernmental 
review of Federal programs by appropriate health planning agencies, as 
implemented by 45 CFR Part 100. Executive Order 12372 allows States the 
option of setting up a system for reviewing applications from within 
their States for assistance under certain Federal programs. The 
application packages to be made available under this notice will 
contain a listing of States which have chosen to set up such a review 
system and will provide a single point of contact (SPOC) in the States 
for review. Applicants (other than federally-recognized Indian tribal 
governments) should contact their State SPOCs as early as possible to 
alert them to the prospective applications and receive any necessary 
instructions on the State process. For proposed projects serving more 
than one State, the applicant is advised to contact the SPOC of each 
affected State. The due date for State process recommendations is 60 
days after the application deadline for new and competing awards. The 
granting agency does not guarantee to ``accommodate or explain'' for 
State process recommendations it receives after that date. (See Part 
148, Intergovernmental Review of PHS Programs under Executive Order 
12372 and 45 CFR Part 100 for a description of the review process and 
requirements).

    Dated: November 2, 2000.
Claude Earl Fox,
Administrator.
[FR Doc. 00-28617 Filed 11-7-00; 8:45 am]
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