[Federal Register Volume 70, Number 230 (Thursday, December 1, 2005)]
[Notices]
[Pages 72124-72125]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry on Safety, Efficacy, and 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 The draft guidance 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 The draft 
guidance document is intended to assist sponsors with the design of 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DATES:  Submit written or electronic comments on the draft guidance by 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may also be obtained by 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for electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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 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

[[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 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