Draft Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary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, 72124-72125 [05-23520]

Download as PDF 72124 Federal Register / Vol. 70, No. 230 / Thursday, December 1, 2005 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 21 CFR Section Annual Frequency per Response No. of Respondents 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 10 1 10 1 10 810.16 2 12 24 40 960 810.17 2 1 2 8 16 810.15(e) Total 1There 1,082 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 VerDate Aug<31>2005 14:47 Nov 30, 2005 Jkt 208001 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 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 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. 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 https:// 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: DATES: I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for E:\FR\FM\01DEN1.SGM 01DEN1 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]
[Pages 72124-72125]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23520]


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

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 https://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

[[Page 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 https://www.fda.gov/cber/guidelines.htm or https://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

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