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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. 2005D-0438]

# 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  The draft guidance document provides recommendations for testing the safety, efficacy, and pharmacokinetics of immune globulin intravenous (human) (IGIV) products as replacement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  The draft guidance document is intended to assist sponsors with the design of clinical trials to assess IGIV as replacement therapy in primary humoral immunodeficiency.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 Submit written or electronic comments on the draft guidance by March 1, 2006, to ensure their adequate consideration in the preparation of the final guidance.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                         Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration,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  The draft guidance may also be obtained by mail by calling the Center for Biologics Evaluation and Research at 1-800-835-4709 or 301-827-1800.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the                         **SUPPLEMENTARY INFORMATION**                         section for electronic access to the draft guidance document.                    

                        Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.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                           ( print 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