Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices 20991

administrative policy changes spread

over several decades.’’ (GAO, 1996)

Nevertheless, many (though not all) of

the Medicaid questions to which people

need answers are repetitive and

sometimes simple. Clear, honest, userfriendly answers to frequently asked

questions are often a feature of Web

sites on any topic and may be one of the

best uses of the Internet.

ADD is proposing to fund one project

to build an Internet site that will

provide relevant content and attractive

information on what is possible under

the Medicaid program. The site should

be user-friendly and useful to a broad

range of users, including people with

developmental and other related

disabilities, their families, their

advocates, DD network members, state

policymakers, regional HCFA staff, and

other interested persons. The site

should be responsive to the needs and

wants of its users, and should collect

and measure user satisfaction. It should

post frequently asked questions (FAQs)

about Medicaid with their answers, and

should encourage frank and open

‘‘human’’ interchanges between users.

The site must be accessible to people

with a broad range of disabilities.

Proposing organizations must show that

they (1) are credible sources of

information to people with

developmental disabilities and (2) that

they intend to comply with accessibility

standards and go beyond compliance to

improve access as much as possible.

Special care should be taken to make

the site useful and attractive to young

persons with developmental and other

disabilities.

Proposed Fiscal Year 2000 Priority Area

3: Managing Our Program Knowledge

Through Web Improvement

The Developmental Disabilities

Assistance and Bill of Rights Act (DD

Act) provides authorization for three

State Programs and a national program

that seek to increase the independence,

productivity, and inclusion of persons

with developmental disabilities.

A Developmental Disabilities Council

(DD Council) in each State promotes,

through systemic change, capacity

building, and advocacy activities, the

development of a comprehensive

consumer-centered system of

coordinated and culturally competent

services, supports, and other assistance.

The priority areas addressed by DD

Councils include employment,

community living, child development,

and system coordination and

community education.

The Protection and Advocacy (P&A)

System provides for the protection and

advocacy of legal and human rights. The

P&A System advocate on behalf of, and

provide advocacy services to persons

with developmental disabilities in issue

areas related to their disabilities,

including: education, abuse and neglect,

institutional and habitation services,

guardianship issues, and housing issues.

The University Affiliated Program

(UAPs) are public and private non-profit

agencies in the States and territories,

each affiliated with a university. Each

UAP receives annual discretionary

funding for operational and

administrative support, which provides

a platform for interdisciplinary training,

clinical and community-based service

activities, technical assistance to

community services personnel, and

information/dissemination activities.

In addition to State-based programs,

ADD funds research and demonstration

grants in an effort to address and

increase our understanding of issues of

national scope. The Projects of National

Significance (PNS) program focuses on

the most pressing issues affecting

people with developmental disabilities

and their families. Project issues

transcend the borders of States and

territories, while project designs are

oriented to permit local implementation

of practical solutions.

Each of these programs has a

uniqueness and breadth of knowledge

that if managed through modern

technology would result in a knowledge

resource warehouse. The nation cannot

afford a digital divide between these

programs and between these programs

and those they serve. With these

programs in mind, ADD is interested in

funding a project for the development or

enhancement of a model website whose

design features are easily employable by

each program; its approach on the

cutting edge. It should be seen as the

beginning of a new form of cyber

architecture with a focus on continuous

improvement that will enable those

programs to improve their use of the

web and their ability to hyperlink to

others.

This new model website would

enhance the ability of ADD’s programs

to exchange information and build upon

ongoing diverse enterprises throughout

the developmental disabilities

community. At the same time, the

contributions and achievements of these

programs towards the quality of life of

persons with disabilities and their

families should be easily disseminated

and accessible. It should support the

development of strategies, technologies,

and media channels for the management

of knowledge generated/produced by

these programs. This site should operate

as an information center as well as a

networking tool for the programs and

others. This website is not about

outcomes exclusively but content and

access to content that affects the lives of

people with developmental disabilities

and their families. ADD envisions that

the first year would begin with the

UAPs and the PNS projects with the

understanding the model website be

inclusive of the other programs over the

duration of the project. It is expected

that the site would be open to everyone;

including the average citizen, people

working in each program, and people

working in related programs. Also, it

should be accessible to people with a

broad range of disabilities utilizing the

most current accessibility standards.

ADD would be supportive of applicants

that represent a consortia of UAPSs and

DD Councils.

(Federal Catalog of Domestic Assistance

Number 93.631—Developmental

Disabilities—Projects of National

Significance)

Dated: April 7, 2000.

Sue Swenson,

Commissioner, Administration on

Developmental Disabilities.

[FR Doc. 00–9748 Filed 4–18–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–4202]

Agency Information Collection

Activities; Announcement of OMB

Approval; Application to Market a New

Drug, Biologic, or an Antibiotic Drug

for Human Use

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Application to Market a New Drug,

Biologic, or an Antibiotic Drug for

Human Use’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 2, 2000 (65

FR 4979), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

20992 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0338. The

approval expires on March 31, 2003. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: April 12, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–9714 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0969]

Risk Assessment of the Public Health

Impact of Streptogramin Resistance in

Enterococcus faecium Attributable to

the Use of Streptogramins in Animals;

Request for Comments and for

Scientific Data and Information

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments

and for scientific data and information.

SUMMARY: The Food and Drug

Administration (FDA), Center for

Veterinary Medicine (CVM), is

announcing plans to develop a

prototypic risk assessment (RA) model

that accounts for the transfer of

resistance determinants from bacteria in

food-producing animals to bacteria in

humans. The agency requests comments

on their approach to the RA model and

requests that scientific data and

information relevant to the conduct of

the RA be submitted. This model will be

applied to assess the association

between the development of

streptogramin (quinupristin/dalfopristin

(QD)) resistant Enterococcus faecium in

humans and the use of virginiamycin in

food-producing animals. The center will

attempt to use the RA model to quantify

the human health impact attributable

both to direct acquisition of resistant E.

faecium from food-producing animals

and to the transfer of resistance

determinants from E. faecium in foodproducing animals to E. faecium in

humans.

DATES: Submit written comments,

scientific data, and information by June

19, 2000.

ADDRESSES: Single copies of ‘‘A

Proposed Framework for Evaluating and

Assuring the Human Safety of the

Microbial Effects of Antimicrobial New

Animal Drugs Intended for Use in FoodProducing Animals’’ (hereinafter

referred to as the Framework Document)

is discussed in the SUPPLEMENTARY

INFORMATION section of this document

and may be obtained by writing to the

Communications Staff (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist the

office in processing your request. This

document is also available through

CVM’s homepage on the Internet at

http://www.fda.gov/cvm/fda/mappgs/

antitoc.html. Submit written comments,

scientific data, and information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Nicholas E. Weber, Center for Veterinary

Medicine (HFV–150), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–6986,

FAX 301–594–2298, or e-mail

nweber@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In theFederal Register of January 6,

1999 (64 FR 887), FDA published a

notice of availability of a discussion

paper (the Framework Document). This

Framework Document sets out a

conceptual risk-based process for

evaluating the microbial safety of

antimicrobial drugs intended for use in

food-producing animals. The proposed

RA furthers the tenets of the Framework

Document by developing a RA model to

quantify the potential human health

impact of resistant bacteria acquired

from animals via food.

Thus, CVM proposes to conduct its

second antimicrobial resistance RA. A

draft of CVM’s first antimicrobial

resistance RA model and associated

documents are available on CVM’s

homepage on the Internet at http://

www.fda.gov/cvm/fda/mappgs/ra/

risk.html. The first RA modeled the

human health impact of

fluoroquinolone resistant

Campylobacter infections associated

with the consumption of chicken. CVM

proposes to develop a second RA that

will account for both the acquisition of

resistant bacteria and the transfer of

resistance determinants from bacteria in

food-producing animals to bacteria in

humans. This model will be applied to

assess the association between the

presence of streptogramin (QD) resistant

Enterococci faecium in humans and the

use of streptogramins (virginiamycin) in

food-producing animals as an example

of risk attributed to transference of

resistance determinants.

In September 1999, FDA’s Center for

Drug Evaluation and Research approved

SynercidTM, a streptogramin (QD), for

use in human medicine for treatment of

vancomycin resistant E. faecium (VREF)

bacteremias as well as for treatment of

Staphylococcus aureus and

Streptococcus pyogenes skin and soft

tissue infections. At the current time,

QD is considered to be the last line of

therapy for VREF. Another

streptogramin, virginiamycin, has been

used in food-producing animals for 26

years. The initial approval was for

chickens, but virginiamycin was

subsequently approved for use in

turkeys, swine, and most recently in

cattle. This RA will seek to quantify the

public-health risk attributable to the use

of virginiamycin in food-producing

animals. Enterococcus faecium that

develop resistance due to exposure to

virginiamycin also demonstrate reduced

susceptibility to QD. These resistant

strains of E. faecium can contaminate

meat products and thereby enter the

human intestine. It is thought that these

resistant strains contaminating meat

products may cause problems for the

human in two major ways: By becoming

host-adapted or by transferring

resistance determinants to endogenous

human E. faecium.

It is generally believed that the

indigenous intestinal microflora of

healthy humans inhibit colonization by

bacteria from exogenous sources. In the

case of illness requiring antibiotic

therapy however, associated

perturbations due to drug treatment may

result in colonization by organisms not

included in the flora of healthy

individuals. This scenario could result

in the intestinal colonization and

proliferation of antibiotic resistant

bacteria from the external environment.

Enterococcal infections comprise 20 to

30 percent of over 2 million hospitalacquired infections per year in the

United States (Ref. 1). VREF infections

are almost exclusively hospital

infections and account for about 14

percent of all enterococcal infections,

although this varies widely (5 to 70

percent) from hospital to hospital,

according to hospital vancomycin use,

teaching versus nonteaching hospital

status, and hospital size (number of

beds) (Refs. 1 and 2). This translates to

about 70,000 VREF infections per year

which will most likely be treated with

QD . Among VREF bacteremic patients

treated with QD, emerging resistance