Sunshine Act Meeting, 72125 [05-23575]

Download as PDF Federal Register / Vol. 70, No. 230 / Thursday, December 1, 2005 / Notices Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency,’’ dated November 2005. IGIV products are prepared from large pools of plasma collected from large numbers of individual healthy donors, and therefore contain antibodies against many bacterial, viral, and other infectious agents. This draft guidance provides recommendations for the design of clinical trials to assess the safety and efficacy of IGIV products when used as replacement therapy in primary humoral immunodeficiency. The draft guidance is intended to assist in the preparation of the clinical/ biostatistical and human pharmacokinetic sections of the biologics license application (BLA). This draft guidance does not address additional sections of a BLA for an IGIV product for this indication, such as chemistry, manufacturing, and controls (CMC), and preclinical toxicology. The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collection(s) of information in the guidance was approved under OMB control number 0910–0338. III. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Division of VerDate Aug<31>2005 14:47 Nov 30, 2005 Jkt 208001 Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. INTERNATIONAL TRADE COMMISSION IV. Electronic Access [USITC SE–05–043] Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/ohrms/dockets/ default.htm. 72125 Sunshine Act Meeting Dated: November 17, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–23520 Filed 11–30–05; 8:45 am] BILLING CODE 4160–01–S INTERNATIONAL TRADE COMMISSION [USITC SE–05–044] Sunshine Act Meeting United States International Trade Commission. TIME AND DATE: December 7, 2005 at 11 a.m. PLACE: Room 101, 500 E Street, SW., Washington, DC 20436, Telephone: (202) 205–2000. STATUS: Open to the public. MATTERS TO BE CONSIDERED: 1. Agenda for future meetings: None. 2. Minutes. 3. Ratification List. 4. Inv. No. 731–TA–1098 (Preliminary) (Liquid Sulfur Dioxide from Canada)—briefing and vote. (The Commission is currently scheduled to transmit its determination to the Secretary of Commerce on or before December 8, 2005; Commissioners’ opinions are currently scheduled to be transmitted to the Secretary of Commerce on or before December 15, 2005.) 5. Inv. Nos. 731–TA–639 and 640 (Second Review) (Forged Stainless Steel Flanges from India and Taiwan)— briefing and vote. (The Commission is currently scheduled to transmit its determination and Commissioners’ opinions to the Secretary of Commerce on or before December 16, 2005.) 6. Outstanding action jackets: None. In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting. AGENCY HOLDING THE MEETING: By order of the Commission. Issued: November 29, 2005. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. 05–23574 Filed 11–29–05; 2:43 pm] BILLING CODE 7020–02–P PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 United States International Trade Commission. TIME AND DATE: December 5, 2005 at 2 p.m. PLACE: Room 101, 500 E Street, SW., Washington, DC 20436, Telephone: (202) 205–2000. STATUS: Open to the public. MATTERS TO BE CONSIDERED: 1. Agenda for future meetings: None. 2. Minutes. 3. Ratification List. 4. Inv. No. 731–TA–1090 (Final) (Superalloy Degassed Chromium from Japan)—briefing and vote. (The Commission is currently scheduled to transmit its determination and Commissioners’ opinions to the Secretary of Commerce on or before December 15, 2005.) 5. Outstanding action jackets: None. In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting. AGENCY HOLDING THE MEETING: By order of the Commission. Issued: November 28, 2005. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. 05–23575 Filed 11–29–05; 2:43 pm] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Notice of Lodging of Amended Consent Decree Under the Comprehensive Environmental Response, Compensation and Liability Act In accordance with 28 CFR 50.7 and Section 122 of the Comprehensive Response, Compensation and Liability Act (‘‘CERCLA’’), 42 U.S.C. 9622, the Department of justice gives notice that on November 4, 2005, a proposed revised consent decree in United States v. DeMert & Dougherty, Inc., No. 2:02CV434 (N.D. Ind.), was lodged with the United States District Court for the Northern District of Indiana. The United States’ complaint seeks the recovery, pursuant to CERCLA Section 107, 42 U.S.C. 9607, of unreimbursed costs that have been incurred by the United States at the American Chemical Service, Inc. Superfund Site in Griffith, Lake County, Indiana (‘‘ACS Site’’), as well as well as E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 70, Number 230 (Thursday, December 1, 2005)]
[Notices]
[Page 72125]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23575]


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INTERNATIONAL TRADE COMMISSION

[USITC SE-05-043]


Sunshine Act Meeting

Agency Holding the Meeting: United States International Trade 
Commission.

Time and Date: December 5, 2005 at 2 p.m.

Place: Room 101, 500 E Street, SW., Washington, DC 20436, Telephone: 
(202) 205-2000.

Status: Open to the public.

Matters to be Considered:
    1. Agenda for future meetings: None.
    2. Minutes.
    3. Ratification List.
    4. Inv. No. 731-TA-1090 (Final) (Superalloy Degassed Chromium from 
Japan)--briefing and vote. (The Commission is currently scheduled to 
transmit its determination and Commissioners' opinions to the Secretary 
of Commerce on or before December 15, 2005.)
    5. Outstanding action jackets: None.
    In accordance with Commission policy, subject matter listed above, 
not disposed of at the scheduled meeting, may be carried over to the 
agenda of the following meeting.

    By order of the Commission.

    Issued: November 28, 2005.
Marilyn R. Abbott,
Secretary to the Commission.
[FR Doc. 05-23575 Filed 11-29-05; 2:43 pm]
BILLING CODE 7020-02-P
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