Federal Register / Vol. 62, No. 41 / Monday, March 3, 1997 / Notices 9433

respect to such contracts, pursuant to

ABN AMRO, 83 Fed. Res. Bull.

(1997)(order dated Dec. 11, 1996); and

in providing execution-only or clearingonly services with respect to financial

and non-financial futures and options

on futures contracts, pursuant to

Citicorp, 81 Fed. Res. Bull. 164 (1995).

D. Federal Reserve Bank of

Minneapolis (Karen L. Grandstrand,

Vice President) 250 Marquette Avenue,

Minneapolis, Minnesota 55480-2171:

1. Community First Bankshares, Inc.,

Fargo, North Dakota; to engage de novo

through its subsidiary, Community First

Financial, Inc., Fargo, North Dakota, in

permissible nonbanking activities of

making and servicing loans, pursuant to

§ 225.25(b)(1) of the Board’s Regulation

Y.

Board of Governors of the Federal Reserve

System, February 25, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–5119 Filed 2-28-97; 8:45 am]

BILLING CODE 6210-01-F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request Proposed

Projects

Title: Early Head Start Evaluation.

OMB No.: 0970–0143.

Description: The Head Start

Reauthorization Act of 1994 established

a special initiative creating funding for

services for families with infants and

toddlers. In response the Administration

on Children, Youth and Families

(ACYF) designated the Early Head Start

(EHS) program. In September 1995,

ACYE awarded grants to 68 local

programs to serve families with infants

and toddlers. ACYF awarded grants to

an additional 75 local programs in

September 1996.

EHS programs are designated to

produce outcomes in four domains: (1)

child development, (2) family

development, (3) staff development, and

(4) community development. The

Reauthorization required that this new

initiative be evaluated. To study the

effect of the initiative, ACYE awarded a

contract through a competitive

procurement to Mathematica Policy

Research, Inc. (MPR) with a subcontract

to Columbia University’s Center for

Young Children and Families. The

evaluation will be carried out from

October 1, 1995 through September 30,

2000. Data collection activities that are

the subject to this Federal Register

notice are intended for the second phase

of the EHS evaluation.

The sample for the child and family

assessments will be approximately

3,400 families who include a pregnant

women or a child under 12 months of

age, in 17 EHS study sites. Each family

will be randonly assigned to a treatment

group or a control group. The sample for

the child care assessments will include

the primary child care provider for the

focal child in each of the 3,400 study

sample families. The surveys and

assessments will be conducted through

computer-assisted telephone and

personal interviewing, pencil and paper

self-administered questionnaires,

structured observations and

videotaping. All data collection

instruments have been designed to

minimize the burden on respondents by

minimizing interviewing and

assessment time. Participation in the

study is voluntary and confidential.

The information will be used by

government managers, Congress and

others to identify the features and

evaluate the effectiveness of the EHS

program.

Respondents: Applicants to the Early

Head Start program and child care

providers for Early Head Start families

and control group families.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average

burden

hours per

response

Total burden hours

24-Month Parent Interview, Child Assessment, and Videotaping Protocol ..................... 1,412 1 2.5 3,530

Parent Services Follow-Up Interview:

12-Month Follow-Up .................................................................................................. 1,475 1 1 1,475

18-Month Follow-Up .................................................................................................. 1,412 1 1 1,412

24-Month Follow-Up .................................................................................................. 1,365 1 1 1,365

36-Month Follow-Up .................................................................................................. 1,334 1 1 1,334

Child Care Provider Interview:

Child Care Centers .................................................................................................... 408 1 .25 102

Center Directors ................................................................................................. 408 1 .17 69

Direct Provider ................................................................................................... 408 1 .17 69

Classroom Staff .................................................................................................. 119 1 .5 60

Family Child Care ...................................................................................................... 26 1 .17 4

Providers ................................................................................................................... 172 1 .5 86

Family Provider .................................................................................................. 38 1 .17 6

Assistants ........................................................................................................... .................... .................... .................... ....................

Relative Care Providers:

Relative Provider ................................................................................................ .................... .................... .................... ....................

Assistants ........................................................................................................... .................... .................... .................... ....................

Child Care Provider Observation Protocol:

Child Care Centers .................................................................................................... 408 1 2 816

Family Child Care ...................................................................................................... 119 1 2 238

Providers ................................................................................................................... 172 1 2 344

Relative Care Providers ............................................................................................ .................... .................... .................... ....................

Estimated Total Annual Burden Hours: 10,910
9434 Federal Register / Vol. 62, No. 41 / Monday, March 3, 1997 / Notices

In compliance with the requirements

of Section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments on: (a) whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: February 25, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–5147 Filed 2–28–97; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

[Docket No. 97M–0052]

Surgical Dynamics, Inc., a Division of

United States Surgical Corp.;

Premarket Approval of Ray Threaded

Fusion Cage (TFC)TM With

Instrumentation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Surgical

Dynamics, Inc., a division of United

States Surgical Corp., Norwalk, CT, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of the Ray Threaded Fusion Cage

(TFC)TM with instrumentation. After

reviewing the recommendation of the

Orthopedic and Rehabilitation Devices

Panel, FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of October 29, 1996,

of the approval of the application.

DATES: Petitions for administrative

review by April 2, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Samie M. Niver, Center for Devices and

Radiological Health (HFZ-410), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION: On June

14, 1995, Surgical Dynamics, Inc., a

division of United States Surgical Corp.,

Norwalk, CT 06856, submitted to CDRH

an application for premarket approval of

the Ray TFCTM with instrumentation.

This device is an intervertebral body

fusion device. It is indicated for use

with autogenous bone graft in patients

with degenerative disc disease (DDD) at

one or two levels from L2 to S1. These

DDD patients may also have up to Grade

I spondylolisthesis at the involved

level(s). The Ray TFCTM is to be

implanted via an open posterior surgical

approach. DDD is defined as back pain

of discogenic origin with degeneration

of the disc confirmed by history and

radiographic studies. These patients

should be skeletally mature and have

had 6 months of nonoperative therapy.

On May 23, 1996, the Orthopedic and

Rehabilitation Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On October 29, 1996, CDRH

approved the application by a letter to

the applicant from the Director of the

Office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 21 CFR 10.33(b).

A petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of review to be used,

the persons who may participate in the

review, the time and place where the

review will occur, and other details.

Petitioners may, at any time on or

before April 2, 1997, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: January 16, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–5076 Filed 2–28–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of December 1996:

Name: National Advisory Council on

Nurse Education and Practice

Date and Time: April 17–18, 1997, 8:30

a.m.