72124 Federal Register / Vol. 70, No. 230 / Thursday, December 1, 2005 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Response Total Hours 

810.14 2 1 2 16 32 

810.15(a) through (d) 2 1 2 16 32 

810.15(e) 10 1 10 1 10 

810.16 2 12 24 40 960 

810.17 2 1 2 8 16 

Total 1,082 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The following burden estimates are 

based on FDA’s experience with 

voluntary recalls under 21 CFR part 7. 

FDA expects no more than two 

mandatory recalls per year, as most 

recalls are done voluntarily. 

Section 810.10(d)—FDA estimates 

that it will take approximately 8 hours 

for the person named in a cease 

distribution and notification order to 

gather and submit the information 

required by this section. 

The total estimated annual burden is 

16 hours. 

Section 810.11(a)—Based on 

experience in similar situations, FDA 

expects that there will be only one 

request for a regulatory hearing per year 

and that it will take approximately 8 

hours to prepare this request. 

Section 810.12(a) and (b)—Based on 

experience in similar situations, FDA 

expects that there will be only one 

written request for a review of a cease 

distribution and notification order per 

year and that it will take approximately 

8 hours to prepare this request. 

Section 810.14—Based upon its 

experience with voluntary recalls, FDA 

estimates that it will take approximately 

16 hours to develop a strategy for 

complying with the order. 

Section 810.15(a) through (d)—Based 

upon its experience with voluntary 

recalls, FDA estimates that it will take 

approximately 16 hours to notify each 

health professional, user facility, or 

individual of the order. 

Section 810.15(e)—Based upon its 

experience with voluntary recalls, FDA 

estimates that there will be 

approximately five consignees per recall 

(10 per year) who will be required to 

notify their consignees of the order. 

FDA estimates that it will take them 

about 1 hour to do so. 

Section 810.16—FDA estimates that it 

would take no more than 40 hours to 

assemble and prepare a written status 

report required by a recall. The status 

reports are prepared by manufacturers 

six to twelve times each year. Therefore, 

each manufacturer would spend no 

more than 480 hours each year 

preparing status reports. If there were 

two FDA invoked recalls each year, the 

total burden hours estimated would be 

960 hours each year. 

Section 810.17—Based on experience 

with similar procedures, FDA estimates 

that it would take 8 hours to draft a 

written request for termination of a 

cease distribution and notification or 

mandatory recall order. 

Dated: November 23, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–23519 Filed 11–30–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0438] 

Draft Guidance for Industry on Safety, 

Efficacy, and Pharmacokinetic Studies 

to Support Marketing of Immune 

Globulin Intravenous (Human) as 

Replacement Therapy for Primary 

Humoral Immunodeficiency; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Safety, Efficacy, 

and Pharmacokinetic Studies to Support 

Marketing of Immune Globulin 

Intravenous (Human) as Replacement 

Therapy for Primary Humoral 

Immunodeficiency,’’ dated November 

2005. The draft guidance document 

provides recommendations for testing 

the safety, efficacy, and 

pharmacokinetics of immune globulin 

intravenous (human) (IGIV) products as 

replacement therapy in primary 

humoral immunodeficiency. The draft 

guidance document is intended to assist 

sponsors with the design of clinical 

trials to assess IGIV as replacement 

therapy in primary humoral 

immunodeficiency. 

DATES: Submit written or electronic 

comments on the draft guidance by 

March 1, 2006, to ensure their adequate 

consideration in the preparation of the 

final guidance. General comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling the Center 

for Biologics Evaluation and Research at 

1–800–835–4709 or 301–827–1800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Paula S. McKeever, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

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