Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices 67729 

vaccine market and would give 

Schering-Plough shares of 

approximately eighty-five percent and 

seventy-two percent in the markets for 

live fowl cholera vaccine and live MG 

vaccines, respectively. 

The competitive concerns can be 

characterized as unilateral in nature. 

Schering-Plough and Organon 

BioSciences are each other’s closest 

competitors in all of the relevant 

markets. Consumers have benefitted 

from the price competition between 

Schering-Plough and Organon 

BioSciences. If unremedied, the 

proposed acquisition would likely cause 

higher prices and reduce incentives to 

improve service or product quality, 

resulting in significant harm to 

consumers in the U.S. markets for these 

vaccines. 

The Consent Agreement 

The proposed Consent Agreement 

remedies the competitive harm caused 

by the proposed transaction. Pursuant to 

the Consent Agreement, ScheringPlough must divest or license all of the 

assets relating to Schering-Plough’s live 

vaccine for the Georgia 98 strain of 

infectious bronchitis (Avimune IB98), 

Intervet’s live fowl cholera vaccine 

(CHOLERVAC-PM-1) and ScheringPlough’s live MG vaccine (F VAXMG)(‘‘the assets to be divested’’), to the 

Fort Dodge division of Wyeth, within 

ten days after the date Schering-Plough 

acquires Organon BioSciences. The 

assets to be divested include research 

and development, customer, supplier 

and manufacturing contracts and any 

intellectual property including existing 

licenses, but excluding trademarks. Fort 

Dodge plans to bring all manufacturing 

of the three vaccines in-house to its own 

manufacturing facilities and to add the 

three to its own portfolio of poultry 

vaccines. While Fort Dodge undertakes 

the process of obtaining USDA 

regulatory approvals and bringing 

vaccine production in-house, ScheringPlough will provide Fort Dodge with the 

vaccines pursuant to a supply and 

transition services agreement with a 

term of two years, and an option to 

extend it another year, individually for 

each of the three vaccines, if required. 

The acquirer of the divested assets 

must receive the prior approval of the 

Commission. The Commission’s goal in 

evaluating possible purchasers of 

divested assets is to maintain the 

competitive environment that existed 

prior to the acquisition. A proposed 

acquirer of divested assets must not 

itself present competitive problems. 

Wyeth, headquartered in Madison, 

New Jersey, is a global leader in 

pharmaceuticals, consumer health care 

products and animal health care 

products. In 2006, it had net sales of $20 

billion. Wyeth’s Fort Dodge Animal 

Health division offers a broad range of 

biological and pharmaceutical products 

for the companion animal, equine, 

livestock, swine and poultry industries. 

Significantly, Wyeth already has an 

established poultry vaccine line 

comprised of internally developed 

vaccines as well as several vaccines that 

it has acquired and transferred to its 

manufacturing facilities. Fort Dodge has 

its own distribution network and an 

experienced sales force with existing 

relationships with major poultry 

producers. The three vaccines being 

divested to Fort Dodge are all 

established products that have been on 

the market for at least two years. Fort 

Dodge has its own manufacturing 

facilities with excess capacity and 

intends to bring the manufacturing of all 

of the products it is acquiring from 

Schering-Plough in-house. For these 

reasons, Wyeth is a strong buyer that 

appears well positioned to replace the 

competition lost by the acquisition. 

If the Commission determines that 

Wyeth is not an acceptable acquirer of 

the assets to be divested, the parties 

must unwind the sale and divest the 

Products within six months of the date 

the Order becomes final to another 

Commission-approved acquirer. If the 

parties fail to divest within six months, 

the Commission may appoint a trustee 

to divest the Product assets. 

The proposed remedy contains 

several provisions to ensure that the 

divestitures are successful. The Order 

requires Schering-Plough to provide 

transitional services to enable the 

Commission-approved acquirer to 

obtain all of the necessary approvals 

from the USDA. These transitional 

services include technology transfer 

assistance to manufacture the Products 

in substantially the same manner and 

quality employed or achieved by 

Schering-Plough and Akzo-Nobel. 

The Commission has appointed Dr. 

David A. Espeseth to oversee the 

implementation of the Order as the 

Interim Monitor Trustee. Dr. Espeseth 

retired in 1998 from a career at the 

USDA, where his last position was as 

Special Assistant to the Deputy 

Administrator of Veterinary Services 

and where he spent the majority of his 

37 years regulating veterinary biologic 

products (vaccines). Today, he is a 

consultant to animal health companies, 

assisting with regulatory issues before 

the USDA and technology transfers. Dr. 

Espeseth’s strengths are his strong 

regulatory background, his experience 

overseeing technology transfers, and 

experience resolving disputes between 

companies and the USDA. 

Dr. Espeseth is an excellent candidate 

to handle the expected duties and 

responsibilities of the Interim Monitor 

Trustee in this matter. He has the 

requisite capability and applicable 

knowledge to ensure the proper transfer 

of the divested assets, oversee the 

transfer of the relevant technology, 

monitor the critical manufacturing and 

supply activities of the Respondent, 

ensure the Respondent’s compliance 

with the Order and related agreements, 

respond to Commission needs, and 

perform other related services as may be 

required. Accordingly, the Commission 

has appointed Dr. Espeseth as the 

Interim Monitor Trustee. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed Consent Agreement, and it is 

not intended to constitute an official 

interpretation of the proposed Order or 

to modify its terms in any way. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. E7–23291 Filed 11–29–07: 8:45 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the National Biodefense 

Science Board 

AGENCY: Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services is hereby giving notice that the 

National Biodefense Science Board 

(NBSB) will be holding its inaugural 

meeting. The meeting is open to the 

public. 

DATES: The meeting will be held on 

December 17, 2007, from 9 a.m. to 5 

p.m., and on December 18, 2007, from 

9 a.m. to 5 p.m. 

ADDRESSES: The Ronald Reagan 

Building and International Trade 

Center, Atrium Ballroom, 1300 

Pennsylvania Avenue, NW., 

Washington, DC 2004. Phone: 202–312–

1300. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Leigh A. Sawyer, DVM, MPH, 

Executive Director, National Biodefense 

Science Board, Office of the Assistant 

Secretary for Preparedness and 

Response, U.S. Department of Health 

and Human Services, 200 Independence 


rwilkins on PROD1PC63 with NOTICES
67730 Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices 

Avenue, SW., Room 450G, Washington, 

DC 20201; 202–205–3815; fax: 202–690–

7412; e-mail address: 

leigh.sawyer@hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to section 319M of the Public Health 

Service Act (42 U.S.C. 247d–7f) as 

added by section 402 of the Pandemic 

and All-Hazards Preparedness Act (Pub. 

L. 109–417) the Secretary of Health and 

Human Services is required to establish 

the National Biodefense Science Board 

and hold the inaugural meeting of the 

Board prior to December 19, 2007. 

The Board shall provide expert advice 

and guidance to the Secretary on 

scientific, technical and other matters of 

special interest to the Department of 

Health and Human Services regarding 

current and future chemical, biological, 

nuclear, and radiological (CBRN) agents, 

whether naturally occurring, accidental, 

or deliberate. 

The agenda will include topics related 

to current and future challenges to 

national preparedness related to CBRN 

agents, and will include discussions 

regarding matters that the Board will 

consider in greater depth. A tentative 

schedule will be made available on 

December 2, 2007 at the NBSB Web site, 

http://www.hhs.gov/aspr/omsph/nbsb. 

Any member of the public interested 

in presenting oral comments at the 

meeting may notify the Contact person 

listed on this notice by December 10, 

2007. Interested individuals and 

representatives of an organization may 

submit a letter of intent and a brief 

description of the organization 

represented. Both printed and electronic 

copies are requested for the record. In 

addition, any interested person may file 

written comments with the committee. 

All written comments must be received 

prior to December 10, 2007 and should 

be sent by e-mail with ‘‘NBSB Public 

Comment’’ as the subject line or by 

regular mail to the Contact person listed 

above. Individuals who plan to attend 

and need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should 

notify the designated Contact person by 

December 10, 2007. 

Dated: November 26, 2007. 

RADM W. Craig Vanderwagen, 

Assistant Secretary for Preparedness and 

Response, U.S. Department of Health and 

Human Services. 

[FR Doc. 07–5885 Filed 11–29–07; 8:45 am] 

BILLING CODE 4150–37–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Meeting 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following advisory 

committee meeting. 

Name: National Committee on Vital and 

Health Statistics (NCVHS). 

Time and Date: November 27, 2007 9 a.m.–

3:45 p.m. November 28, 2007 10 a.m.–3 p.m. 

Place: Hilton Embassy Row Hotel, 2015 

Massachusetts Avenue NW., Washington, 

DC, 202–265–1600. 

Status: Open. 

Purpose: At this meeting the Committee 

will hear presentations and hold discussions 

on several health data policy topics. On the 

morning and afternoon of the first day the 

Committee will hear updates from the 

Department and status reports from its 

subcommittees as well as a presentation from 

the Robert Graham Center on harmonizing 

primary care standards. 

On the morning of the second day the 

Committee will hear an update from the 

Office of the National Coordinator for Health 

Information Technology (ONCHIT) followed 

by Committee actions on selected topics from 

the subcommittees. In the afternoon there 

will be a follow up discussion to the ONCHIT 

presentation and an update from the 

subcommittees on current and planned 

activities. There will be a short discussion of 

future agendas before the meeting adjourns. 

The times shown above are for the full 

Committee meeting. Subcommittee breakout 

sessions are scheduled for late in the 

afternoon of the first day in the morning prior 

to the full Committee meeting on the second 

day. Agendas for these breakout sessions will 

be posted on the NCVHS Web site (URL 

below) when available. 

FOR FURTHER INFORMATION CONTACT: 

Substantive program information as 

well as summaries of meetings and a 

roster of committee members may be 

obtained from Marjorie S. Greenberg, 

Executive Secretary, NCVHS, National 

Center for Health Statistics, Centers for 

Disease Control and Prevention, 3311 

Toledo Road, Room 2402, Hyattsville, 

Maryland 20782, telephone (301) 458–

4245. Information also is available on 

the NCVHS home page of the HHS Web 

Site: http://www.ncvhs.hhs.gov/, where 

further information including an agenda 

will be posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment 

Opportunity on (301) 458–4EEO (4336) 

as soon as possible. 

Dated: November 19, 2007. 

James Scanlon, 

Deputy Assistant Secretary for Planning and 

Evaluation (SDP), Office of the Assistant 

Secretary for Planning and Evaluation. 

[FR Doc. 07–5876 Filed 11–29–07; 8:45 am] 

BILLING CODE 4151–05–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP); 

Center for the Evaluation of Risks to 

Human Reproduction (CERHR); 

Announcement of the Availability of 

the Bisphenol A Expert Panel Report; 

Request for Public Comment 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS); National Institutes of Health 

(NIH). 

ACTION: Announcement of report 

availability and request for comment. 

SUMMARY: CERHR announces the 

availability of the final bisphenol A 

expert panel report on November 26, 

2007, from the CERHR Web site (http:// 

cerhr.niehs.nih.gov) or in print from 

CERHR (see ADDRESSES below). The 

expert panel report is an evaluation of 

the reproductive and developmental 

toxicity of bisphenol A conducted by an 

independent, 12-member expert panel 

composed of scientists from the public 

and private sectors convened by 

CERHR. CERHR invites the submission 

of public comments on this report (see 

SUPPLEMENTARY INFORMATION below). 

The expert panel met twice in public 

session (March 5–7, 2007 and August 6–

8, 2007) to review and revise the draft 

expert panel report and reach 

conclusions regarding whether exposure 

to bisphenol A is a hazard to human 

development or reproduction. The 

expert panel also identified data gaps 

and research needs. 

DATES: The final bisphenol A expert 

panel report will be available for public 

comment on November 26, 2007. 

Written public comments on this report 

should be received by January 25, 2008. 

ADDRESSES: Comments on the expert 

panel report and any other 

correspondence should be sent to Dr. 

Michael D. Shelby, CERHR Director, 

NIEHS, P.O. Box 12233, MD EC–32, 

Research Triangle Park, NC 27709, fax: 

(919) 316–4511, or e-mail: 

shelby@niehs.nih.gov. Courier address: 

CERHR, 79 T.W. Alexander Drive, 

Building 4401, Room 103, Research 

Triangle Park, NC 27709. 

SUPPLEMENTARY INFORMATION: 


rwilkins on PROD1PC63 with NOTICES