Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Notices 66111

be obtained from Ms. Linda LaChanse,

Program Analyst, Training and

Technical Support Systems Branch,

Division of HIV/AIDS Prevention,

National Center for HIV/STD/TB

Prevention, Centers for Disease Control

and Prevention (CDC), 1600 Clifton

Road, NE., Mailstop E–40, Atlanta, GA

30333, telephone (404) 639–0964.

Please refer to Announcement

Number 802 when requesting

information, submitting your Letter of

Intent and submitting the invited

application in response to the

announcement.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) through

the Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800. Single copies of CDC’s

Strategic Plan for Preventing Human

Immunodeficiency Virus (HIV) Infection

(July 8, 1992) can be obtained by calling

the CDC National AIDS Clearinghouse at

(800) 458–5231.

Dated: December 11, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–32867 Filed 12–16–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Head Start Program; Notice of Award

AGENCY: Administration on Children,

Youth and Families, Administration for

Children and Families, HHS.

ACTION: Notice of Sole Source Award to

Administer the Head Start Child

Development Credentialing Program.

SUMMARY: The Head Start Bureau

announces its intention to enter into a

noncompetitively awarded cooperative

agreement with The Council for Early

Childhood Professional Recognition to

administer the Child Development

Associate (CDA) Credentialing Program.

The CDA Program is a national project

to credential qualified caregivers who

work with children birth to age five in

a variety of public and private agency

settings, and in a variety of roles,

including as center-based caregivers of

infants and toddlers or preschool age

children, as home visitors, or as family

child care providers.

If there are organizations interested in

competing for this grant to administer

the Head Start Child Development

Credentialing Program, they are

requested to express their interest by

contacting either E. Dollie Wolverton or

Lynda Perez by January 16, 1998.

DATES: Effective on January 16, 1998.

FOR FURTHER INFORMATION CONTACT: E.

Dollie Wolverton, Head Start Bureau,

ACYF, P.O. Box 1182, Washington, D.C.

20013, (202) 205–8418 (Not a toll free

call); or Lynda Perez, Grants Officer,

Head Start Bureau, ACYF, P.O. Box

1182, Washington, D.C. 20013, (202)

205–7359 (Not a toll free call).

SUPPLEMENTARY INFORMATION:

I. Background

The project period for this cooperative

agreement will be four years. The award

is approximately $1,000,000 annually.

The authority for this credentialing

program is section 648(e) of the Head

Start Act (42 U.S.C. 9843).

The Head Start Program is committed

to staff development for all individuals

employed in local programs to increase

the understanding and skills necessary

to carry out their jobs, as well as

professional development leading to

credentials and degrees. In addition to

ongoing staff development, section

648A of the Head Start Act directs the

Secretary to ensure that each of the

55,000 Head Start classrooms for

preschool-age children has a qualified

teacher, with a minimum of a CDA

credential.

Those who are credentialed include

prekindergarten staff from the various

military sectors, child care, churchaffiliated preschools, Title I schoolbased programs, and Head Start. Also,

the revised Head Start Program

Performance Standards, which become

effective January 1, 1998, include new

standards for infant and toddler

programs and the requirement that

infant and toddler teachers also be

qualified by January 1, 1999, and

thereafter within one year of hire,

holding a CDA credential at a minimum.

Beginning in 1972, ACYF has

supported various organizations to

administer the CDA National

Credentialing Program. These

organizations included a Consortium of

several child development and early

childhood education associations and

the Bank Street College of Education.

The first decade of this credential award

program was unstable and problematic

due, in large measure, to the fact that

the grant was recompeted frequently,

leading to several changes in

administering organizations and

resulting breaks in services. The general

instability and under-use of the CDA

credential system caused concern to the

Department and the Congress. The

Department requested that the National

Association for the Education of Young

Children create a non-profit subsidiary

to become a free standing organization

that would permanently administer the

CDA credentialing program.

Accordingly, the Council for Early

Childhood Professional Recognition was

established to administer the national

CDA Credentialing Program through a

cooperative agreement. The intent of

maintaining a permanent home for the

national Child Development Associate

credentialing program was reinforced in

1992, when Section 7 of the 1992

Juvenile Justice Act, entitled, ‘‘Head

Start Training Improvement,’’ amended

the Head Start Act, requiring the

funding of an organization to administer

a centralized child development

credential and national assessment

program.

II. Reason for Sole Source Award

The Council for Early Childhood

Professional Recognition has effectively

restored public confidence in the CDA

Credential and increased the number of

credentials awarded. The number of

candidates credentialed each year has

steadily grown from about 2,000

credentialed candidates annually to

nearly 8,000 per year. As of June 1997,

nearly 83,000 teachers, home visitors

and family child care providers have

been credentialed. The Council has also

increased the recognition and credibility

of the CDA Credential among the States,

and now 47 States, the District of

Columbia and Puerto Rico recognize the

Child Development Associate credential

as the requirement for the licensing of

a child care center. This provides those

certified with the CDA credential with

the mobility to move from State-to-State

with State recognition of their credential

and qualifications.

The Council is efficiently and costeffectively administering the National

CDA Credentialing Program at a time

when the demand for the credential has

greatly increased. This allows the

Council to maintain the assessment and

credentialing fee to the candidate (the

majority are low-income) at $325.

Because of the mandate for qualified

teachers of infants and toddlers and

preschool age children, welfare reform,

and the President’s intended expansion

of the Head Start Program to serve one

million eligible children by the year

2002, the need for qualified,

credentialed staff is an urgent matter,

particularly given the annual turnover

rate of 17 percent among Head Start

staff. To address the expansion of the
66112 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Notices

Head Start Program and the expansion

of services by other agencies providing

child care and early childhood

education, it is estimated that

approximately 8,000 CDA candidates

will require assessment and a credential

award during each of the next four

years.

In the face of these challenges, the

Department seeks to ensure the

continuity of the administration of this

unique national credentialing program,

which provides affordable credentialing

award services which are nationally

recognized, cost effective, represent

quality standards for staff working with

children ages birth to five years, and

enjoy the confidence of the States,

institutions of higher learning, and the

field of early childhood.

(Catalog of Federal Domestic Assistance

Program Number 93.600, Project Head Start)

Dated: December 11, 1997.

James A. Harrell,

Deputy Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 97–32954 Filed 12–16–97; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0430]

Medical Devices; Guidance Document

for the Submission of Tumor

Associated Antigen Premarket

Notifications, [510(k)], to FDA;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Guidance Document for the

Submission of Tumor Associated

Antigen Premarket Notifications,

[510(k)], to FDA.’’ The guidance

document provides suggestions for the

nonclinical laboratory studies and the

design, conduct, and analysis of

appropriate clinical studies that the

Center for Devices and Radiological

Health (CDRH), FDA, believes will

provide reasonable assurance of the

safety and effectiveness of these devices.

The guidance document also sets forth

the review criteria and describes the

data to support a 510(k) submission.

The guidance accompanies a final rule,

which appears elsewhere in this issue of

the Federal Register, announcing the

reclassification of tumor associated

antigen immunological test systems

from class III (premarket approval) to

class II (special controls).

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written comments

concerning this guidance document to

the contact person listed below. Submit

written requests for single copies of

‘‘Guidance Document for the

Submission of Tumor Associated

Antigen Premarket Notifications,

[510(k)], to FDA’’ to the Division of

Small Manufacturers Assistance

(DSMA), Center for Devices and

Radiological Health (HFZ–220), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850. Send two selfaddressed adhesive labels to assist the

office in processing your request, or fax

your request to 301–443–8818. See the

SUPPLEMENTARY INFORMATION

section for electronic access to the

guidance document.

FOR FURTHER INFORMATION CONTACT:

Peter E. Maxim, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1293.

SUPPLEMENTARY INFORMATION:

I. Background

FDA issued an order (September 19,

1996) in the form of a letter reclassifying

tumor associated antigen immunological

test systems from class III to class II. The

order identified the premarket

notification guidance document for

tumor associated antigens as one of the

designated special controls. The

guidance document contains general

information on the definition of

qualifying devices and the

administrative requirements for

submitting a 510(k) to FDA. The

document also lists the types of

nonclinical (analytical) studies to be

included in the submission. These

studies include reagent characterization,

assay specificity, and device

performance characteristics to include

precision, linearity, interfering

substances, analytical sensitivity and

methods of comparison to another

device. Finally, the document provides

guidance on the design of clinical

studies to support a submission for a

new tumor marker intended to monitor

previously treated patients.

This guidance document represents

the agency’s current thinking on the

design of clinical studies expected to

support a 510(k) submission for new

tumor markers intended to monitor

previously treated patients. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulation, or both.

II. Requests for Comments

Interested persons may, at any time,

submit to the contact person listed

above written comments regarding this

guidance document. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document.

III. Electronic Access

In order to receive the ‘‘Guidance

Document for the Submission of Tumor

Associated Antigen Premarket

Notifications, [510(k)], to FDA’’ via your

fax machine, call the CDRH Facts-OnDemand system at 1–800–899–0381 or

301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number (957) followed by the

pound sign (#). Follow the remaining

voice prompts to complete your request.

Persons interested in obtaining a copy

of the guidance may also do so using the

World Wide Web (WWW). The CDRH

maintains an entry on the WWW for

easy access to the Web. Updated on a

regular basis, the CDRH home page

includes ‘‘Guidance Document for the

Submission of Tumor Associated

Antigen Premarket Notifications,

[510(k)], to FDA,’’ device safety alerts,

Federal Register reprints, information

on premarket submissions (including

lists of approved applications and

manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. ‘‘Guidance

Document for the Submission of Tumor

Associated Antigen Premarket

Notifications, [510(k)], to FDA’’ will be

available at http://www.fda.gov/cdrh/

ode/ed—cl.html.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

1–800–222–0185 (terminal settings are

8/1/N). Once the modem answers, press

Enter several times and select menu

choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES