Federal Register / Vol. 65, No. 94 / Monday, May 15, 2000 / Notices 31001

TRANSACTIONS GRANTED EARLY TERMINATION, 04/24/2000–05/05/2000—Continued

Transaction No. Acquiring person Acquired person Acquired entities

20002858 .......... Q-Media Services Corporation ........ Estate of Pierre Peladeau ............... Print Northwest L.P.

20002862 .......... IT Group, Inc .................................... W&H Pacific, Inc .............................. W&H Pacific, Inc.

20002864 .......... Welsh, Carson, Anderson & Stowe

VIII, L.P.

Politic Acquisition Corp .................... Politic Acquisition Corp.

20002865 .......... WCAS Capital Partners III, L.P ....... Politic Acquisition Corp .................... Politic Acquisition Corp.

20002866 .......... Science Applications International

Corporation.

VeriSign, Inc .................................... VeriSign, Inc.

20002892 .......... National Bank of Egypt .................... Arab American Bank ........................ Arab American Bank

20002895 .......... Berkshire Fund V, Limited Partnership.USA Jet Airlines, Inc ........................ USA Jet Airlines, Inc.

20002902 .......... Einhorn Verwaltungsgesellschaft ..... Gerald L. Lennard ............................ PGP Industries, Inc.

20002908 .......... International Business Machines

Corporation.

Scott A. Blum Separate Property

Trust U/D/T 8/2/95.

eDevelopments.com Inc.

20002916 .......... Prime 66 Partners, L.P .................... The Warnaco Group, Inc ................. The Warnaco Group, Inc.

20002917 .......... Centennial Fund IV, L.P .................. 24/7 Media, Inc ................................ 24/7 Media, Inc.

20002918 .......... Great Plains Software, Inc ............... Solomon Software, Inc .................... Solomon Software, Inc.

20002925 .......... Activated Communications Limited

Partnership.

Mr. Arthur Liu ................................... Way Broadcasting, Inc.

20002926 .......... Mr. Arthur Liu ................................... Activated Communications Limited

Partnership.

Activated Communications Limited Partnership.

20002929 .......... Agfa-Gevaert N.V ............................ Emerson Electric, Co ....................... Krautkramer-Branson.

20002935 .......... HNC Software, Inc ........................... Simon B. Ruddick ............................ High Touch Technologies.

20002939 .......... eGain Communications Corporation Inference Corporation ...................... Inference Corporation.

20002944 .......... GS Capital Partners III, L.P ............. SiPix Group Limited ......................... SiPix Group Limited.

20002955 .......... Dial Corporation (The) ..................... Procter & Gamble Company, (The) Procter & Gamble Company, (The).

FOR FURTHER INFORMATION CONTACT:

Sandra M. Peay or Parcellena P.

Fielding, Contact Representatives,

Federal Trade Commission, Premerger

Notification Office, Bureau of

Competition, Room 303, Washington,

DC 20580, (202) 326–3100.

By Direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 00–12127 Filed 5–12–00; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00083]

National Trauma Information and

Exchange Program; Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of funds in Fiscal Year (FY)

2000 for a grant to develop a National

Trauma Information and Exchange

Program (TIEP).

The purpose of TIEP is to make data

and information on trauma care in the

United States more accessible to a broad

spectrum of individuals and

organizations, including trauma care

professionals and professional

associations, trauma centers and other

acute care hospitals, trauma care

systems, emergency medical services

(EMS) systems, injury researchers and

research organizations, public health

agencies, health care payers, and the

general public. CDC is committed to

achieving the health promotion and

disease prevention objectives of

‘‘Healthy People 2010.’’

This announcement is related to

Injury and Violence Prevention focus

areas.

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and by governments and

their agencies; that is, universities,

colleges, research institutions, hospitals,

other public and private nonprofit

organizations, State and local

governments or their bona fide agents,

and Federally recognized Indian tribal

governments, Indian tribes, or Indian

tribal organizations.

C. Availability of Funds

Approximately $387,500 is available

in FY 2000 to fund one new award. 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 up to 3 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 the activities to achieve

the purpose of this program, the

recipient will be responsible for the

following activities:

1. Provide a full-time director/

coordinator with authority and

responsibility to carry-out the

requirements of the program.

2. Provide qualified staff, other

resources, and knowledge to implement

the components of the program.

3. Develop and implement a

comprehensive plan to periodically

update a detailed description of trauma

centers in the United States, including

key personnel, as well as their

capabilities.

4. Develop and implement a plan that

enables an exchange of information

among trauma centers and trauma

organizations nationwide.

5. Develop and implement a plan for

a uniform surveillance system for

trauma centers that will enable

researchers and research organizations

to conduct research on quality of trauma

care and trauma center and trauma

system effectiveness.

6. Develop and implement a plan for

the dissemination of available

information on trauma, trauma centers,

and trauma care systems to the public,

researchers and healthcare practitioners.

E. Application Content

Use the information in the Program

Requirement, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

31002 Federal Register / Vol. 65, No. 94 / Monday, May 15, 2000 / Notices

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 30 pages double-spaced, printed on

one side, with one inch margins, and

unreduced font. The application must

include a one-page abstract and

summary of the proposed effort.

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 14, 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

an independent review. (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. Background and Need (40 percent)

The extent to which the applicant

describes the background and need for

a comprehensive trauma information

program including; development,

current challenges in organizing and

delivering trauma care, challenges of

developing and maintaining trauma

systems, implementation and evaluation

of a plan to periodically update a

detailed description of trauma centers in

the United States, development of a

plan to exchange information and link

resources of trauma centers and a plan

for a uniform surveillance program.

2. Methods (30 percent)

The extent to which the applicant

provides a detailed description of all

proposed activities required to

implement a comprehensive trauma

information and exchange program

including letters of support and

collaboration needed to achieve each

objective and the overall program

goal(s). The extent to which the

applicant provides a reasonable,

logically sequenced and complete

schedule for implementing all activities.

The extent to which position

descriptions, lines of command, and

collaborations are appropriate to

accomplishing the program goal(s) and

objectives. The extent to which the

applicant describes a plan and

implementation dissemination of

available trauma information.

3. Evaluation (10 percent)

The extent to which the proposed

evaluation plan is detailed and capable

of documenting program process and

outcome measures. The extent to which

the applicant demonstrates staff and/or

collaborator availability, expertise, and

capacity to perform the evaluation.

4. Staff and Resources (20 percent)

The extent to which the applicant can

provide adequate facilities, staff and/or

collaborators, including a full-time

coordinator and resources to accomplish

the proposed goal(s)and objectives

during the project period. The extent to

which the applicant demonstrates staff

and/or collaborator availability,

expertise, previous experience, and

capacity to perform the undertaking

successfully.

5. Budget and Justification (not scored)

The extent to which the applicant

provides a detailed budget and narrative

justification consistent with the stated

objectives and planned program

activities. CDC may not approve or fund

all proposed activities. The applicant

should be precise about the program

purpose of each budget item. Proposed

contracts should identify the name of

the contractor, if known; describe the

services to be performed; provide an

itemized budget and justification for the

estimated costs of the contract; specify

the period of performance, and method

of selection.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Semi-annual progress reports;

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. (List all applicable requirements by

number and title. The Grants

Management Branch will include the

applicable descriptions in the

application kit.)

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–13 Prohibition on Use of CDC

Funds for Certain Gun Control

Activities

AR–14 Accounting System

Requirements

AR–15 Proof of Non-Profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 301(a), 317(k)(2), 391, 392, 394,

and 394A (42 U.S.C. 241(a), 247b(k)(2),

280b, 280b–1, 280b–2, 280b–3) of the

Public Health Service Act, as amended.

The Catalog of Federal Domestic

Assistance number is 93.136.

J. Where to Obtain Additional

Information

See the CDC home page on the

Internet: http://www.cdc.gov for this

and other program announcements,

click on funding.

To receive additional written

information and to request an

application kit, call 1–888–GRANTS4

(1–888–472–6874). You will be asked to

leave your name and address and will

be instructed to identify the

announcement number of interest.

Please refer to Program Announcement

00083 when you request information.

After reviewing the Program

Announcement for business

management assistance contact: Sheryl

Heard, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office,

Announcement 00083, Centers for

Disease Control and Prevention (CDC),

2920 Brandywine Road, Suite 3000,

Atlanta, GA, 30341–4146, Telephone

(770) 488–2723, Email address:

Sheard@cdc.gov

For program technical assistance

contact: Paul Burlack Centers for

Disease Control and Prevention (CDC),

National Center for Injury Prevention

and Control, 4770 Buford Highway NE,

Mailstop F–41, Atlanta, GA, 30341–

3724, Telephone (770) 488–4031, Email

address: pburlack@cdc.gov.

Federal Register / Vol. 65, No. 94 / Monday, May 15, 2000 / Notices 31003

Dated: May 9, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–12107 Filed 5–12–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1219]

Biological Products; Bacterial

Vaccines and Related Biological

Products; Implementation of Efficacy

Review; Proposed Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a

proposed order to accept the

conclusions and recommendations of

advisory review panels concerning the

safety, effectiveness, and labeling of

certain bacterial vaccines and related

biological products that were previously

classified into Category IIIA (remaining

on the market pending further studies in

support of effectiveness). On the basis of

the advisory review panel findings, FDA

is proposing to reclassify the relevant

Category IIIA products into Category I

(safe, effective, and not misbranded) or

Category II (unsafe, ineffective, or

misbranded). This action is being taken

under the reclassification procedures.

DATES: Submit written comments on

this proposed order and the

reclassification of products should be

submitted by August 13, 2000. Data and

information submitted to FDA in

connection with these reclassified

products will be made publicly

available after June 14, 2000. Comments

concerning confidentiality should be

received by FDA before June 14, 2000.

ADDRESSES: Submit written comments

on the proposed order to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Comments may also be submitted

electronically at www.fda.gov/ohrms/

dockets. Copies of the reports from the

Vaccines and Related Biological

Products Advisory Committee (April

1984) and the Panel on Review of

Allergenic Extracts (December 1983) can

be obtained from the Office of

Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Requests for

copies that are accompanied by a selfaddressed adhesive label will assist that

office in processing your requests. The

documents may also be obtained by

mail either by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800 or by submitting a

request electronically at

www.CBERlINFO@CBER.FDA.GOV, or

by fax by calling the FAX Information

System at 1–888–CBER–FAX or 301–

827–3844.

FOR FURTHER INFORMATION CONTACT:

Steven Falter, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6343.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Review Procedures (21 CFR

601.25)

On July 1, 1972, responsibility for

regulating biological products under

section 351 of the Public Health Service

Act (PHS Act) (42 U.S.C. 262) was

transferred from the National Institutes

of Health to FDA (37 FR 12865, June 29,

1972). Section 351 of the PHS Act

provides statutory authority to license

biological products. In 1973, FDA

established a procedure to review the

safety, effectiveness, and labeling of all

biological products licensed prior to

July 1, 1972 (38 FR 4319, February 13,

1973). This process was eventually

codified in § 601.25 (21 CFR 601.25) (38

FR 32048 at 32052, November 20, 1973).

Under § 601.25, the Commissioner of

Food and Drugs assigned responsibility

for the initial review of all biological

products licensed prior to 1972 to nine

independent advisory review panels.

These panels consisted of qualified

nonFDA experts in order to ensure

public confidence in, and objectivity of

the reviews. Each of the advisory review

panels was assigned to review a specific

category of biological products.

In the Federal Register of June 19,

1974 (39 FR 21176), FDA eliminated

three previously planned panels (The

Panel on Review of In Vitro Diagnostic

Reagents; The Panel on Review of

Immune Serums, Antitoxins, and

Antivenins; and the Panel on Review of

Miscellaneous Biological Products) and

reassigned the review of the biological

products originally intended for review

by these three panels to the remaining

six advisory review panels: The Panel

on Review of Bacterial Vaccines and

Toxoids with Standards of Potency, The

Panel on Review of Bacterial Vaccines

and Bacterial Antigens with ‘‘no U.S.

Standards of Potency,’’ the Panel on

Review of Skin Test Antigens, The

Panel on Review of Allergenic Extracts,

The Panel on Review of Viral and

Rickettsial Vaccines, and the Panel on

Review of Blood and Blood Derivatives.

The advisory review panels for bacterial

vaccines and bacterial antigens with ‘‘no

U.S. standard of potency,’’ bacterial

vaccines and toxoids with standards of

potency, and skin test antigens reviewed

the products that are the subject of this

notice.

Under the review and classification

procedures specified in § 601.25, each

advisory review panel was charged with

preparing a report to the agency that: (1)

Evaluated the safety and effectiveness of

the biological product; (2) reviewed the

labeling of the biological product; and

(3) advised FDA on which biological

products under review were safe,

effective, and not misbranded. Each

advisory review panel report was to

include a statement classifying the

products into Category I, Category II, or

Category III. Category I designated those

biological products determined to be

safe, effective, and not misbranded.

Category II designated those biological

products determined to be unsafe,

ineffective or misbranded. Category III

designated those biological products

that did not fall within either Category

I or Category II because of insufficient

data and for which further testing was

therefore required. Category III products

were assigned to one of two

subcategories. Category IIIA products

were those that would be permitted to

remain on the market pending the

completion of further studies. Category

IIIB products were those for which the

panel report recommended license

revocation on the basis of the panel’s

assessment of potential risks and

benefits.

After reviewing the conclusions and

recommendations of the panels, FDA

would publish in the Federal Register a

proposed order containing: (1) A

statement designating the biological

products reviewed into Categories I, II,

IIIA or IIIB; (2) a description of the

testing necessary for Category IIIA

biological products; and (3) the

complete panel report. Under the

proposed order, FDA would revoke the

licenses of those products designated

into Category II and Category IIIB. After

reviewing public comments, FDA would

publish a final order on the matters

covered in the proposed order.