Meeting of the National Biodefense Science Board, 67729-67730 [07-5885]

Download as PDF Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices rwilkins on PROD1PC63 with NOTICES 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 VerDate Aug<31>2005 17:29 Nov 29, 2007 Jkt 214001 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 67729 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 Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: 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 E:\FR\FM\30NON1.SGM 30NON1 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. 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. rwilkins on PROD1PC63 with NOTICES SUPPLEMENTARY INFORMATION: 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 VerDate Aug<31>2005 16:27 Nov 29, 2007 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting 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] Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. BILLING CODE 4151–05–M 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. 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 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. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH). AGENCY: Announcement of report availability and request for comment. ACTION: 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. 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. DATES: 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. ADDRESSES: SUPPLEMENTARY INFORMATION: E:\FR\FM\30NON1.SGM 30NON1

Agencies

[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Pages 67729-67730]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5885]


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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

[[Page 67730]]

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