[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]
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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Draft Guidance for Industry on Safety, Efficacy, and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.
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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 The draft guidance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 The draft
guidance document is intended to assist sponsors with the design of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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may also be obtained by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for electronic access to the draft guidance document.
Submit written comments on the draft guidance to the Division of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