Federal Register / Vol. 70, No. 230 / Thursday, December 1, 2005 / Notices 72125 

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 This draft guidance 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The draft guidance is intended to assist 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This draft guidance does not address 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The draft guidance is being issued 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The draft guidance, when finalized, will 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The draft guidance is being 

distributed for comment purposes only 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 A copy of the draft guidance 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 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

or http://www.fda.gov/ohrms/dockets/ 

default.htm. 

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 

AGENCY HOLDING THE 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. 

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 

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 

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 

72126 Federal Register / Vol. 70, No. 230 / Thursday, December 1, 2005 / Notices 

1 DeMert filed for bankruptcy under Chapter 11 

of the Bankruptcy Code in the U.S. District Court 

for the Northern District of Illinois in 1996, and the 

case was later converted to a Chapter 7 Bankruptcy. 

(In re: DeMert & Dougherty, Inc. (Bankr. N.D. I11. 

(Eastern Div. No. 96B90851)). Both the United 

States and the ACS Group filed proofs of claim. 

the implementation, pursuant to 

CERCLA Section 106, 42 U.S.C. 9606, of 

the United States Environmental 

Protection Agency’s selected remedy for 

the ACS Site. 

On January 11, 1996, DeMert & 

Dougherty, Inc., filed for bankruptcy 

under Chapter 11 of the bankruptcy 

Code in the U.S. District Court for the 

Northern District of Illinois. (In re: 

DeMert & Dougherty, Inc. (Bankr. N.D. 

I11. (Eastern Div. No. 96 B 0851))). The 

case was converted to a Chapter 7 

Bankruptcy on June 27, 1996. In that 

case, the United States filed a proof of 

claim pertaining to the costs that it 

incurred at the ACS Site. 

A consent decree lodged in 2002 

would have resolved DeMert’s liability 

as to the site and the United States’

claim in DeMert’s bankruptcy through 

the allowance of an allowed general 

unsecured claim of $2,225,000.1

Public Comments received by the 

Department of Justice from the group 

performing the remedy at the ACS Site 

(‘‘ACS Group’’) necessitated the 

withdrawal of the first consent decree 

and additional negotiations, which 

resulted in the proposed revised consent 

decree. The proposed revised decree 

would resolve DeMert’s liability at the 

ACS Site under CERCLA and resolve the 

competing claims of the United States 

and the ACS Group in DeMert’s 

bankruptcy action, as well as the claims 

that the ACS Group and DeMert may 

have against each other. In particular: 

(1) The ACS Group’s claim in DeMert’s 

bankruptcy would be allowed as a 

general unsecured claim for $2,225,000, 

while the United States bankruptcy 

claim would be deemed to have been 

withdrawn; one-half of the total amount 

paid to the ACS Group in the 

bankruptcy would be deposited in an 

account within the Superfund and be 

available to reimburse the ACS Group’s 

Operation and Maintenance costs at the 

Site; the remainder of the amount paid 

through the bankruptcy would be 

deposited in a different account within 

the Superfund for use by EPA in 

conducting or financing response 

actions connected with the ACS Site, or 

for use at other Sites; (2) the Trustee 

will assist the ACS Group in litigation 

resulting from actions taken by the ACS 

Group to obtain coverage under 

DeMert’s insurance policies; (3) DeMert 

assigns to the ACS Group DeMert’s 

rights to receive payments under 

DeMert’s insurance policies for the Site, 

and the Trustee will assist the ACS 

Group in litigation resulting from the 

ACS Group’s attempts to obtain 

coverage under DeMert’s insurance 

policies. The ACS Group would 

reimburse the Trustee for the fees and 

expenses incurred in assisting the ACS 

Group in such litigation. 

The Department of Justice will receive 

for a period of thirty (30) days from the 

date of this publication comments 

relating to the proposed Consent Decree. 

Comments should be addressed to the 

Assistant Attorney General, 

Environment and Natural Resources 

Division, P.O. Box 7611, U.S. 

Department of Justice, Washington, DC 

20044–7611, and should refer to United 

States v. Dougherty, Inc., D.J. Ref. 90–

11–3–1094. 

The Consent Decree may be examined 

at the Office of the United States 

Attorney, Northern District of Indiana, 

5400 Federal Plaza, Suite 1500, 

Hammond, Indiana 44320 (contact 

Assistant United States Attorney Wayne 

Ault, 219–937–5500), and at U.S. EPA 

Region 5, 77 W. Jackson Blvd., Chicago, 

Illinois (contact Assistant Regional 

Counsel Michael McClary (312–886–

7163)). During the public comment 

period, the proposed Amended Consent 

Decree may also be examined on the 

following Department of Justice Web 

site, http://www.usdoj.gov/enrd/ 

open.html. A copy of the Consent 

Decree may also be obtained by mail 

from the Consent Decree Library, P.O. 

Box 7611, U.S. Department of Justice, 

Washington, DC 20044–7611, or by 

faxing a request to Tonia Fleetwood, fax 

no. (202) 616–6583, phone confirmation 

number (202) 514–1547. In requesting a 

copy, please refer to the referenced case 

and enclose a check in the amount of 

$18.00 (25 cents per page reproduction 

costs) payable to the U.S. Treasury. 

William Brighton, 

Assistant Chief, Environmental, Enforcement 

Section, Environment and Natural Resources 

Division. 

[FR Doc. 05–23508 Filed 11–30–05 8:45 am] 

BILLING CODE 4410–15–M 

NATIONAL INSTITUTE FOR LITERACY 

National Institute for Literacy Advisory 

Board; Sunshine Act Meeting 

AGENCY: National Institute for Literacy. 

ACTION: Notice of closed meeting. 

SUMMARY: This notice sets forth the 

schedule and a summary of the agenda 

for an upcoming meeting of the National 

Institute for Literacy Advisory Board 

(Board). The notice also describes the 

functions of the Board. Notice of this 

meeting is required by section 10(a)(2) 

of the Federal Advisory Committee Act. 

DATE AND TIME: Closed session—

December 12, 2005 from 2 p.m. to 4 p.m. 

ADDRESSES: National Institute for 

Literacy, 1775 I Street, NW., Suite 730, 

Washington, DC 20006. 

FOR FURTHER INFORMATION CONTACT: Liz 

Hollis, Special Assistant to the Director; 

National Institute for Literacy, 1775 I 

Street, NW., Suite 730, Washington, DC 

20006; telephone number: (202) 233–

2072; e-mail: ehollis@nifl.gov. 

SUPPLEMENTARY INFORMATION: The Board 

is established under section 242 of the 

Workforce Investment Act of 1998, 

Public Law 105–220 (20 U.S.C. 9252). 

The Board consists of ten individuals 

appointed by the President with the 

advice and consent of the Senate. The 

Board advises and makes 

recommendations to the Interagency 

Group. The Interagency Group is 

composed of the Secretaries of 

Education, Labor, and Health and 

Human Services, and the three 

Secretaries administer the National 

Institute for Literacy (Institute). The 

Interagency Group considers the Board’s 

recommendations in planning the goals 

of the Institute and in implementing any 

programs to achieve those goals. 

Specifically, the Board performs the 

following functions: (a) Makes 

recommendations concerning the 

appointment of the Director and the 

staff of the Institute; (b) provides 

independent advice on operation of the 

Institute; and (c) receives reports from 

the Interagency Group and the 

Institute’s Director. 

The National Institute for Literacy 

Advisory Board meeting on December 

12, 2005 from 2 p.m. to 4 p.m. will be 

closed to the public to discuss the 

personnel, staffing and performance 

issues. This discussion relates to the 

internal personnel rules and practices of 

the Institute and is likely to disclose 

information of personal nature where 

disclosure would constitute a clearly 

unwarranted invasion of personnel 

privacy. The discussion must therefore 

be held in closed session under 

exemptions 2 and 6 of the Government 

in the Sunshine Act, 5 U.S.C. 552b(c)(2) 

and (6). Due to administrative issues 

associated with scheduling, this 

announcement will be published in the 

Federal Register less than 15 days prior 

to the date of the meeting. A summary 

of the activities at the closed session 

and related matters that are informative 

to the public and consistent with the 

policy of 5 U.S.C. 552b will be available 

to the public within 14 days of the 

meeting. Records are kept of all