Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices 67013

statutory requirements, and to report on

planned versus actual performance. The

plan was published in November 1998.

This report identifies accomplishments

against that plan. As this report shows,

in fiscal year 1999, FDA achieved

significant gains in the six FDAMA

objectives by combining the agency’s

traditional principles and practices with

new approaches. In keeping with its

traditional values, FDA continued

providing a broad spectrum of consumer

protections based on rigorous sciencebased standards. To strengthen its

performance, FDA developed

partnerships with stakeholders and

stimulated cooperation and

participation by making its activities

more understandable and accessible to

stakeholders. FDA’s accomplishments

include the following:

• New drugs and biological products

are being reviewed and released to the

public in record time,

• A nationwide food safety

surveillance network has now been

established which is helping to

significantly reduce food-related

illnesses and deaths, and

• Millions of consumers have wider

and more timely access to information

about their new medications.

FDA will continue working with

Congress and our stakeholders to

improve performance and to work

towards meeting our statutory

obligations under FDAMA.

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28616 Filed 11–7–00; 8:45 am]

BILLING CODE 4160–01–F

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.

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-tofamily 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-HHSEducation 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/glorder3.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: hrsagac@hrsa.gov.

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

jjohns@hrsa.gov/, 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/suldocs/aces/

aces140.html.

Letter of Intent: Notification of intent

to apply can be made in one of three

ways: telephone, 301–443–2370; email,

iforsman@hrsa.gov; 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: iforsman@hrsa.gov/ (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

pfagan@hrsa.gov/ (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

67014 Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices

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 LaborHHS-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

Federal Register / Vol. 65, No. 217 / Wednesday, November 8, 2000 / Notices 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 familyto-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]

BILLING CODE 4160–15–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4565–N–27]

Notice of Proposed Information

Collection For the Federal National

Mortgage Association and the Federal

Home Loan Mortgage Corporation;

Comment Request

AGENCY: Office of the Assistant

Secretary for Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: January 8, 2001.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Wayne Eddins, Reports Management

Officer, Department of Housing and

Urban Development, 451 7th Street,

SW., L’Enfant Plaza Building, Room

8001, Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT:

Allen Fishbein, Senior Advisor for

Government Sponsored Enterprises

Oversight, Department of Housing and

Urban Development, 451 7th Street,

SW., Washington, DC 20410, telephone

(202) 708–3600, extension 2117, or

Sandra Fostek, Office of Government

Sponsored Enterprises Oversight, at

(202) 708–2224, extension 2233 (these

are not toll-free numbers) for copies of

available information.

SUPPLEMENTARY INFORMATION: The

Department is submitting the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).

This Notice is soliciting comments

from members of the public and affected

agencies concerning the proposed

collection of information to: (1) Evaluate

whether the proposed collection is

necessary for the proper performance of

the functions of the agency, including

whether the information will have

practical utility; (2) Evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information; (3) Enhance the quality,

utility, and clarity of the information to

be collected; and (4) Minimize the

burden of the collection of information

on those who are to respond; including

the use of appropriate automated

collection techniques or other forms of

information technology, e.g., permitting

electronic submission of responses.

This Notice also lists the following

information:

Title of Proposal: Regulation of the

Federal National Mortgage Association

(Fannie Mae) and the Federal Home

Loan Mortgage Corporation (Freddie

Mac).

OMB Control Number, if applicable:

2502–0514.

Description of the need for the

information and proposed use: This

notice requests a revision of a currently

approved collection to accommodate

additional data requirements

necessitated by HUD’s recent

publication of a new implementing

regulation to the Federal Housing

Enterprises Financial Safety and

Soundness Act of 1992 (FHEFSSA). On

October 31, 2000, HUD published a rule

at 24 CFR Part 81, to become effective

January 1, 2001, which increased the

levels of required affordable housing

goal performance for Fannie Mae and

Freddie Mac (the GSEs). The rule also

implemented certain changes to HUD’s

counting rules relative to how mortgages

will be credited towards the housing

goals and provided special incentives

whereby the GSEs could earn additional

housing goals credit for certain loan

purchase activities. HUD’s collection of