Meeting of the National Vaccine Advisory Committee, 54050-54051 [E9-25366]

Download as PDF 54050 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices Agreement No.: 011383–042. Title: Venezuelan Discussion Agreement. ¨ Parties: Hamburg-Sud, Seaboard Marine Ltd., King Ocean Service de Venezuela, and SeaFreight Line, Ltd. Filing Party: Wayne R. Rohde, Esq.; Sher & Blackwell LLP; 1850 M Street, NW.; Suite 900; Washington, DC 20036. Synopsis: The amendment would add Compania Sud Americana de Vapores S.A. as a party to the agreement. Agreement No.: 012083. Title: Hanjin/APL Mediterranean Space Charter Agreement. Parties: American President Lines, Ltd.; and Hanjin Shipping Co., Ltd. Filing Parties: Eric C. Jeffrey, Esq.; Goodwin Procter LLP; 901 New York Avenue, NW.; Washington, DC 20001. Synopsis: The agreement authorizes Hanjin to charter space to APL in the trade between the U.S. East Coast and ports in Italy and Spain. Agreement No.: 012084. Title: HLAG/Maersk Line Gulf-South America Slot Charter Agreement. Parties: A.P. Moller-Maersk A/S and Hapag-Lloyd AG. Filing Party: Wayne R. Rohde, Esq.; Sher & Blackwell LLP; 1850 M Street, NW.; Suite 900; Washington, DC 20036. Synopsis: The agreement authorizes Hapag-Lloyd to charter space to Maersk Line in the trade between U.S. Gulf Coast ports and ports in Mexico, the Dominican Republic, Brazil, Argentina and Uruguay. By Order of the Federal Maritime Commission. Dated: October 16, 2009. Tanga S. FitzGibbon, Assistant Secretary. [FR Doc. E9–25323 Filed 10–20–09; 8:45 am] BILLING CODE 6730–01–P GENERAL SERVICES ADMINISTRATION jlentini on DSKJ8SOYB1PROD with NOTICES Federal Travel Regulation (FTR); Relocation Allowances—Data Dictionary and Collection Process for Transaction-Level Relocation Data; Notice of a Proposed Bulletin and Proposed Rule AGENCY: Office of Governmentwide Policy, General Services Administration (GSA). ACTION: Notice of a proposed bulletin and a proposed rule. SUMMARY: This notice announces that GSA is posting online a proposed FTR bulletin on collection of relocation data, concurrent with a proposed rule. The proposed FTR Bulletin 10–XX provides VerDate Nov<24>2008 17:33 Oct 20, 2009 Jkt 220001 the proposed data dictionary for both of these data collection processes. Proposed FTR Bulletin 10–XX may be viewed on GSA’s Web site, at https:// www.gsa.gov/relopolicy, and the proposed rule appears elsewhere in this issue of the Federal Register. By this Notice, GSA is seeking comment on the proposed bulletin. Among the questions for which GSA is seeking comment are: • Have we identified the right data elements to allow managers to identify and modulate useful adjustments in policy and to identify and support proposed regulatory and legislative changes? • Should any data elements be added or deleted? • Have we described the data elements correctly, in the definitions, coding, field lengths, and suggested data sources? GSA is taking the somewhat unusual step of concurrently publishing the proposed FTR bulletin and proposed rule because GSA believes that the final products will be improved by comments from Federal agencies, relocation service companies, and relocation software providers. Once GSA has issued the FTR bulletin, GSA will modify it as needed. Modifications will be based on input from the industry and/or Federal agencies and will be discussed with the Executive Relocation Steering Committee (an interagency body chartered by GSA) before implementation. DATES: GSA requests that Federal agencies and providers of relocation services and software comment on the proposed bulletin no later than December 21, 2009. This notice is effective October 21, 2009. FOR FURTHER INFORMATION CONTACT: Mr. Henry Maury, Office of Governmentwide Policy (M), Office of Travel, Transportation, and Asset Management (MT), General Services Administration, at (202) 208–7928 or via e-mail at henry.maury@gsa.gov. Please cite FTR Bulletin 10–XX. Dated: June 29, 2009. Stan Kaczmarczyk, Acting Associate Administrator, Office of Governmentwide Policy. [FR Doc. E9–25333 Filed 10–20–09; 8:45 am] BILLING CODE 6820–14–P PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science. ACTION: Notice. SUMMARY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting via teleconference. The meeting is open to the public. Pre-registration is not required, however, individuals who wish to participate in the public comment session should either e-mail nvpo@hhs.gov or call 202–690–5566 to register and RSVP. DATES: The meeting will be held on Friday, November 6, 2009, from 3 p.m. to 5 p.m. EST. ADDRESSES: The meetings will occur by teleconference. To attend, please call 1–888–677–1385, passcode ’’NVAC’’. Please call up to 15 minutes prior to the start of the conference call to facilitate attendance. FOR FURTHER INFORMATION CONTACT: Ms. Andrea Krull, Public Health Advisor, National Vaccine Program Office, Department of Health and Human Services, Room 443–H, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. Phone: (202) 690–5566; Fax: (202) 260– 1165; e-mail: nvpo@hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public Health Service Act (42 U.S.C. Section 300aa–1), the Secretary of Health and Human Services was mandated to establish the National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The National Vaccine Advisory Committee (NVAC) was established to provide advice and make recommendations to the Director of the National Vaccine Program, on matters related to the Program’s responsibilities. The Assistant Secretary for Health serves as Director of the National Vaccine Program. This is a special meeting of the NVAC. Discussions will surround issues related to the current status of the 2009 H1N1 influenza outbreak and response with a focus on vaccine activities. The Committee will discuss the actions of the various HHS agencies working on E:\FR\FM\21OCN1.SGM 21OCN1 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices H1N1 as it relates to the mission of NVAC. Representatives of state and local health associations will also provide their perspective. For this special meeting, members of the public are invited to attend by teleconference via a toll-free call-in phone number. The call-in number will be operator assisted to provide members of the public the opportunity to provide comments to the Committee. Public comment will be limited to no more than three minutes per speaker. Preregistration is required for public comment only. Individuals who plan to attend and need special assistance, such as accommodation for hearing impairment or other reasonable accommodations, should notify the designated contact person at least one week prior to the meeting. Any members of the public who wish to have printed material distributed to NVAC should submit materials to the Executive Secretary, NVAC, through the contact person listed above prior to close of business one week before the meeting (conference call). A draft agenda and any additional materials will be posted on the NVAC Web site (https://www.hhs.gov/nvpo/nvac/) prior to the meeting. Dated: October 15, 2009. Bruce Gellin, Deputy Assistant Secretary for Health, Director, National Vaccine Program Office, Executive Secretary, National Vaccine Advisory Committee. [FR Doc. E9–25366 Filed 10–20–09; 8:45 am] BILLING CODE 4150–44–P DEPARTMENT OF HEALTH AND HUMAN SERVICES jlentini on DSKJ8SOYB1PROD with NOTICES Performance Review Board Members Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95–454, requires notice of appointment of individuals to serve as a member of the Performance Review Board shall be published in the Federal Register. The following individuals are hereby appointed to serve on Performance Review Boards within the Department of Health and Human Services. These individuals supplement membership on existing Performance Review Boards. Office of the Secretary Moulds, Donald, Principal Deputy Assistant Secretary. Monahan, John, Director, Office of Global Health Affairs. VerDate Nov<24>2008 17:33 Oct 20, 2009 Jkt 220001 Centers for Disease Control and Prevention Branche, Christine, Associate Director for NIOSH. Health Resources and Services Administration (HRSA) Morford, Thomas G., Associate Administrator, Office of Operations. Indian Health Service (IHS) Karol M.D., Susan, Chief Medical Officer. Dated: October 16, 2009. Antonia T. Harris, Deputy Assistant Secretary for Human Resources, Department of Health and Human Services. [FR Doc. E9–25452 Filed 10–20–09; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0287] Wallace E. Gonsalves, Jr., MD: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Wallace E. Gonsalves, Jr., MD, from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Gonsalves was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Gonsalves failed to request a hearing. Dr. Gonsalves’ failure to request a hearing constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective October 21, 2009. ADDRESSES: Submit applications for special termination of debarment to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance Policy (HFC–230), Food and Drug PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 54051 Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–632–6844. SUPPLEMENTARY INFORMATION: I. Background Section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the act. On September 15, 2004, the U.S. District Court for the District of Rhode Island entered judgment against Dr. Gonsalves for two counts of product tampering in violation of 18 U.S.C. 1365(a) and two counts of drug adulteration in violation of 21 U.S.C. 331(k) and 333(a)(2). On September 14, 2004, the U.S. District Court for the District of Rhode Island accepted Dr. Gonsalves’ plea of guilty, made under a plea agreement, and entered judgment against Dr. Gonsalves for one count of conspiracy to sell drug samples in violation of 18 U.S.C. 371 and 21 U.S.C. 333(a)(2) and 353(c)(1), one count of unlawful sale of drug samples in violation of 21 U.S.C. 331(t), 333(b)(1), and 353(c)(1), and one count of health care fraud in violation of 18 U.S.C. 1347(a) and 2. FDA’s finding that debarment is appropriate is based on two convictions relating to adulteration of a drug (two separate vaccines) and one conviction relating to sale of drug samples. The factual basis for those convictions is as follows: From March of 2000 until on or about August 26, 2002, with the intent to defraud and mislead, Dr. Gonsalves caused a quantity of Measles, Mumps, and Rubella (MMR) and Varicella Virus (varicella) vaccine to be adulterated while the vaccine was being held for sale and administered to patients after being shipped in interstate commerce, by reducing the quality and strength of the vaccine and by failing to properly store and maintain the vaccine, thereby causing the vaccines to become adulterated. From July 3, 2000, and continuing until at least on or about August 16, 2002, Dr. Gonsalves knowingly sold and offered to sell quantities of drug samples for cash or other consideration. As a result of his convictions, FDA sent Dr. Gonsalves by certified mail on August 7, 2009, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding under section 306(a)(2)(B) of the act that Dr. Gonsalves was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. The E:\FR\FM\21OCN1.SGM 21OCN1

Agencies

[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Pages 54050-54051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25366]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the National Vaccine Advisory Committee

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of Public Health and Science.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: As stipulated by the Federal Advisory Committee Act, the 
Department of Health and Human Services (HHS) is hereby giving notice 
that the National Vaccine Advisory Committee (NVAC) will hold a meeting 
via teleconference. The meeting is open to the public. Pre-registration 
is not required, however, individuals who wish to participate in the 
public comment session should either e-mail nvpo@hhs.gov or call 202-
690-5566 to register and RSVP.

DATES: The meeting will be held on Friday, November 6, 2009, from 3 
p.m. to 5 p.m. EST.

ADDRESSES: The meetings will occur by teleconference. To attend, please 
call 1-888-677-1385, passcode ''NVAC''. Please call up to 15 minutes 
prior to the start of the conference call to facilitate attendance.

FOR FURTHER INFORMATION CONTACT: Ms. Andrea Krull, Public Health 
Advisor, National Vaccine Program Office, Department of Health and 
Human Services, Room 443-H, Hubert H. Humphrey Building, 200 
Independence Avenue, SW., Washington, DC 20201. Phone: (202) 690-5566; 
Fax: (202) 260-1165; e-mail: nvpo@hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public 
Health Service Act (42 U.S.C. Section 300aa-1), the Secretary of Health 
and Human Services was mandated to establish the National Vaccine 
Program to achieve optimal prevention of human infectious diseases 
through immunization and to achieve optimal prevention against adverse 
reactions to vaccines. The National Vaccine Advisory Committee (NVAC) 
was established to provide advice and make recommendations to the 
Director of the National Vaccine Program, on matters related to the 
Program's responsibilities. The Assistant Secretary for Health serves 
as Director of the National Vaccine Program.
    This is a special meeting of the NVAC. Discussions will surround 
issues related to the current status of the 2009 H1N1 influenza 
outbreak and response with a focus on vaccine activities. The Committee 
will discuss the actions of the various HHS agencies working on

[[Page 54051]]

H1N1 as it relates to the mission of NVAC. Representatives of state and 
local health associations will also provide their perspective.
    For this special meeting, members of the public are invited to 
attend by teleconference via a toll-free call-in phone number. The 
call-in number will be operator assisted to provide members of the 
public the opportunity to provide comments to the Committee. Public 
comment will be limited to no more than three minutes per speaker. Pre-
registration is required for public comment only. Individuals who plan 
to attend and need special assistance, such as accommodation for 
hearing impairment or other reasonable accommodations, should notify 
the designated contact person at least one week prior to the meeting.
    Any members of the public who wish to have printed material 
distributed to NVAC should submit materials to the Executive Secretary, 
NVAC, through the contact person listed above prior to close of 
business one week before the meeting (conference call). A draft agenda 
and any additional materials will be posted on the NVAC Web site 
(https://www.hhs.gov/nvpo/nvac/) prior to the meeting.

    Dated: October 15, 2009.
Bruce Gellin,
Deputy Assistant Secretary for Health, Director, National Vaccine 
Program Office, Executive Secretary, National Vaccine Advisory 
Committee.
[FR Doc. E9-25366 Filed 10-20-09; 8:45 am]
BILLING CODE 4150-44-P
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