25934 Federal Register / Vol. 65, No. 87 / Thursday, May 4, 2000 / Notices

contamination of equipment, reagents,

and/or supplies.

• RNA work areas must be separated

from DNA work areas.

Specimen Integrity

• Requirements to ensure

identification of the subject being

testing include: date of birth; gender;

ethnicity; patient or family number;

specimen source; time of collection; and

name of person obtaining sample

Validation of Tests

Analytic validation:

• Laboratories must verify or

establish reproducibility for each

method within and between runs, and

between technologists.

• Methodology must be appropriate

for conditions being evaluated.

• Quality control parameters must be

applicable.

• Reagents must be validated.

Clinical Validation: Laboratories must

consider the following clinical

parameters for test validation:

• A positive confirmatory test must

have a defined positive predictive value

which can be communicated to the care

giver.

• Where the disease prevalence is

more frequent than 1/10,000, the

validity must be documented in at least

10 positive probands (including cell

lines or DNA/RNA) prior to offering the

test.

• Predictive value should be defined

in terms of ethnic populations, when

applicable

C. Issue: These recommendations are

based on what the CLIAC considers to

be good laboratory practice in genetic

testing. They represent extensions to

existing requirements to specifically

address some of the unique aspects of

genetic testing. Are these sufficiently

comprehensive, adequate, or are they

not needed?

Proficiency Testing (PT)

A. Current CLIA Requirement: Under

493.801 Condition; Enrollment and

testing of samples—a laboratory must

enroll in an approved proficiency

testing program for each specialty for

which it seeks certification. Currently,

no PT requirement exists, because there

is no genetic specialty, therefore the

following PT requirement applies.

Under 493.1703 Standard; Comparison

of test results—when a laboratory

performs tests for which PT is

unavailable, the laboratory must have a

system for verifying the accuracy and

reliability of its test results at least twice

a year.

B. CLIAC Recommendation: The

CLIAC recommended including the

following new provision:

• When an approved PT program

does not exist for the test, the

regulations should require alternatives

(to be performed three times per year,

on five specimens per event). Examples

include: Split samples sent to another

laboratory; blinded test samples; test

samples in duplicate by separate

technologists, in a blinded manner; and

other equivalent approaches

C. Issue: Requiring PT would provide

a basis for evaluating the accuracy of

genetic testing.

Post-Analytic Phase

Special Reporting Requirements

A. Current CLIA Requirement: Under

493.1109 Standard; Test report—a

laboratory must, upon request, make

available to clients a list of test methods

and information that may affect the

interpretation of test results, such as

interferences.

B. CLIAC Recommendation:

Laboratory reports must include the

following, as applicable, as they relate

to the interpretation of the test result:

—Interpretation.

—Comments.

—Recommendations for further

testing or clinical consultation.

—Summary of the test method and its

limitations.

• When individual interpretation of

the test result is required, the signature

of the Director or designee must appear

on the report.

• A means to quickly contact the

Laboratory Director/Technical

Supervisor, in addition to address, must

be indicated on the report.

• Any reference to family members in

a test report must utilize standardized

pedigree nomenclature or numeric

indicators, instead of individual names.

• Specific requirements for reporting

molecular genetic testing include:

—A list of the mutant alleles tested.

—The rate detection of the panel.

— A revised assessment of likelihood

based on test results, as applicable.

—Important clinical implications for

other family members should be

provided, as applicable.

—Variables that affect test

interpretation (e.g. ethnicity) must be

specified in the report, and limitations

of the testing must be defined.

C. Issue: Requiring laboratories to

provide this information could increase

the accuracy of interpretation of genetic

testing reports, but may increase the

laboratories’ burden.

Record/Specimen Retention

A. Current CLIA Requirement: Under

493.1109 Standard; Test report—the

laboratory must retain the original or an

exact duplicate of each test report for a

period of at least two years after the date

of reporting.

B. CLIAC Recommendation:

• Copies of patient reports of genetic

testing shall be retrievable for a

minimum of 10 years, or longer if

required by State law. Electronic reports

are acceptable.

• The laboratory must have a policy

defining specimen retention policies.

C. Issue: Maintaining reports for a

longer period of time may be beneficial

but this could be burdensome.

Dated: April 27, 2000.

Jeffrey Koplan,

Director, Centers for Disease Control and

Prevention.

[FR Doc. 00–11093 Filed 5–3–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00107]

Population-Based Surveillance of

Autism Spectrum Disorders and Other

Developmental Disabilities; Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

program for Population-Based

Surveillance of Autism Spectrum

Disorders and other Developmental

Disabilities. CDC is committed to

achieving the health promotion and

disease prevention objectives of

‘‘Healthy People 2010.’’ This

announcement is related to the focus

area of Maternal, Infant and Child

Health. http://www.health.gov/

healthypeople.

The purpose of the program is to:

Enhance an existing system or develop

and implement a new system to

undertake a multiple source

surveillance methodology, from existing

data records, for determining the

prevalence of autism and other

developmental disabilities, such as

mental retardation, cerebral palsy, and

vision and hearing impairments, in 3–10

year-old children within a

geographically-defined area

(combination of States, Statewide, or

regions within a State).

B. Eligible Applicants

Assistance will be provided only to

the health departments of States or their

Federal Register / Vol. 65, No. 87 / Thursday, May 4, 2000 / Notices 25935

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.

Applicants must document a

surveillance population of at least

30,000 live per births per year within a

State, area of a state (such as the

catchment of a local health agency), or

a combination of States.

Note: Only one application will be

accepted from each State or combination of

States, and the latter must specify which

State is the lead applicant.

C. Availability of Funds

Approximately $300,000 is available

in FY 2000 to fund two awards. Each

award is expected to be approximately

$150,000. It is expected that the awards

will begin on or about September 30,

2000, and will be made for a 12-month

budget period within a project period of

five years. Funding estimates may

change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

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), and CDC

will be responsible for the activities

listed under 2. (CDC Activities).

1. Recipient Activities

a. To develop or enhance a

surveillance program for autism and

other developmental disabilities:

i. Develop surveillance case

definition(s);

ii. Develop multiple source

surveillance methodology; and

iii. Develop data collection

instruments and methods for obtaining

information from medical/clinical and

school records.

b. Establish a multiple-source

methodology to ascertain cases of

autism and generate population-based

prevalence estimates by developing

collaborative relationships with

appropriate professionals and

organizations.

c. Develop a plan for training

community service providers to

improve case ascertainment.

d. Implement quality assurance

procedures, including clinical

validation of diagnoses in a sample of

cases, to ensure that study protocols are

being followed.

e. Develop an evaluation plan for

estimating the completeness of the

surveillance system.

f. Compile and disseminate the

findings of the project.

2. CDC Activities

a. Assist recipient in the development

and implementation of surveillance

activities including the development of

a standardized surveillance case

definition.

b. Provide current scientific

information on surveillance methods.

c. Provide assistance in the

development of an evaluation plan for

the completeness of the surveillance

system.

E. Application Content

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 25 double-spaced pages, printed on

one side, with one inch margins,

unreduced font, unbound, and

unstapled.

F. Submission and Deadline

Application

Submit the original and two copies of

PHS 5161–1 (OMB Number 0937–0189).

Forms are in the application kit.

On or before July 7, 2000, submit the

application 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 of the Problem (20

Percent)

(a) The extent to which the applicant

has a clear, concise understanding of the

requirements, objectives, and purposes

of the cooperative agreement.

(b) The extent to which the

application reflects an understanding of

the complexities of autism and

developmental disabilities surveillance.

2. Technical Approach (30 Percent)

The extent to which the applicant

describes the planning process,

including specific planning objectives,

strategies for achieving these objectives,

and describes an approach to

surveillance of autism and other

developmental disabilities. The

applicant should demonstrate its

collaboration with health and education

services that would be appropriate

sources of cases for the surveillance

system (by letters of support). 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:

(a) The proposed plan for the

inclusion of both sexes and racial and

ethnic minority populations for

appropriate representation.

(b) The proposed justification when

representation is limited or absent.

(c) A statement as to whether the

design of the study is adequate to

measure differences when warranted.

(d) A statement as to whether the

plans for recruitment and outreach for

study participants include the process

of establishing partnerships with

communities and recognition of mutual

benefits.

3. Capability and Experience (30

Percent)

The extent to which the applicant has

the professed skills and experience to

conduct a project of this nature,

including reputation in the field and

demonstrated experience in conducting

similar projects.

4. Staffing and Management Resources

(20 Percent)

The extent to which the applicant

demonstrates that the proposed Project

Director or Principal Investigator is

knowledgeable regarding autism,

developmental disabilities, and

surveillance issues, as evidenced by

publications, presentations, or other

materials that document prior work. The

extent to which the applicant

demonstrates that other project staff

25936 Federal Register / Vol. 65, No. 87 / Thursday, May 4, 2000 / Notices

have appropriate training and

experience in the field of autism, other

developmental disabilities, and

surveillance activities, as evidenced by

publications, presentations, or other

materials that document prior work.

Demonstration of the ability to provide

adequate facilities and other necessary

resources to carry out all proposed

activities.

5. Budget (Not Scored)

The extent to which the budget is

reasonable, clearly justified, and

consistent with the stated objectives and

proposed activities.

6. Human Subjects Requirements (Not

Scored)

The extent to which the applicant

complies with the Department of Health

and Human Services regulation (45 CFR

part 46) on the protection of human

subjects.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Semi-annual 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 status and

performance reports, 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 Attachment 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).

Please refer to Program

Announcement 00107 when you request

information. For business management

technical assistance, please 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, Email address:

mij3@cdc.gov.

For program technical assistance,

contact: Tom Horne, Principal

Management Officer, Developmental

Disabilities Branch, National Center for

Environmental Health, Centers for

Disease Control and Prevention (F–15),

4770 Buford Hwy, NE, Atlanta, GA

30341, Telephone: 770/488–7364, Email

address: tjh1@cdc.gov.

Dated: April 28, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–11092 Filed 5–3–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00103]

C. Everett Koop Community Health

Information Center—A National Model

for Physician-Based Community

Health Information Centers; Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a grant program entitled ‘‘C.

Everett Koop Community Health

Information Center—A National Model

for Physician-based Community Health

Information Centers.’’

CDC is committed to achieving the

health promotion and disease

prevention objectives of ‘‘Healthy

People 2010’’ a national activity to

reduce morbidity and mortality and

improve the quality of life. This

program addresses the ‘‘Healthy People

2010’’ focus area of Health

Communication.

For the conference copy of ‘‘Healthy

People 2010,’’ visit the internet site:

http://www.health.gov/healthypeople.

The purpose of the program is to

strengthen the C. Everett Koop

Community Health Information Center

(CHIC) by (1) conducting a follow-up

evaluation of CHIC as an effective model

for other community health information

centers, (2) disseminating the results of

the evaluation to professional medical

societies nationwide, and (3) conducting

a final assessment of the dissemination

and use of the model in other

communities.

B. Eligible Applicants

Assistance will be provided only to

the C. Everett Koop Community Health

Information Center, Philadelphia

College of Physicians, Philadelphia, PA.

No other applications are solicited. The

sole source justification is based on

congressional language in fiscal year

2000 CDC Appropriation, which

provides earmarked funding for the C.

Everett Koop Community Health

Information Center in Philadelphia, PA.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement, contract

loan, or any other form.

C. Availability of Funds

Approximately $200,000 is available

in FY 2000 to fund the C. Everett Koop

Community Health Information Center.

It is expected that the award will begin

on or about September 30, 2000, and

will be made for a 12-month budget

period within a project period of three

years. Funding estimates may change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the following:

1. Strengthening the CHIC program by

fully implementing the

recommendations of the 1999

evaluation related to (a) marketing,

promotion, and visibility, (b) resources,

and (c) accessibility (See attachment I

for recommendations).

2. Encouraging community

involvement by developing a network of

partners in providing current, complete,

and comprehensive health information,

and in increasing awareness of the

availability of information resources.

3. After the recommendations have

been fully implemented, developing a