[Federal Register Volume 70, Number 202 (Thursday, October 20, 2005)]
[Notices]
[Pages 61135-61136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20958]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0362]


Draft Guidance for Industry on Recommendations for Implementing a 
Collection Program for Source Plasma Containing Disease-Associated and 
Other Immunoglobulin Antibodies; 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: 
Recommendations for Implementing a Collection Program for Source Plasma 
Containing Disease-Associated and Other Immunoglobulin (IgG) 
Antibodies,'' dated October 2005. The draft guidance document is 
intended to assist source plasma manufacturers in submitting to FDA the 
appropriate information when implementing an IgG antibody collection 
program or when adding a new IgG antibody collection to an existing 
program. The draft guidance, when finalized, would supersede the draft 
reviewers' guide entitled ``Disease Associated Antibody Collection 
Program,'' dated October 1, 1995.

DATES: Submit written or electronic comments on the draft guidance by 
January 18, 2006 to ensure their adequate consideration in 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 
(CBER), Food and Drug Administration, 1401 Rockville Pike, 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 The draft guidance may also be 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 CBER 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draft guidance document.
    Submit written comments on the draft guidance to the Division of 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: Brenda R. Friend, 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 Industry: Recommendations for Implementing a Collection 
Program for Source Plasma Containing Disease-Associated and Other 
Immunoglobulin (IgG) Antibodies'' dated October 2005. The draft 
guidance, when finalized, would supersede the draft reviewers' guide, 
``Disease Associated Antibody Collection Program,'' dated October 1, 
1995. The document provides guidance to source plasma manufacturers in 
submitting the appropriate information to FDA when implementing an IgG 
antibody collection program or when adding a new IgG antibody 
collection to an existing program. The guidance identifies changes in 
collection programs that must be documented as minor changes in an 
annual report to FDA under Sec.  601.12(d) (21 CFR 601.12(d)). These 
collection programs include disease-associated IgG

[[Page 61136]]

antibodies and other existing IgG antibodies. The guidance also 
identifies labeling changes to be submitted as a supplement for changes 
being effected under Sec.  601.12(f)(2)(i)(E). The guidance neither 
includes recommendations related to implementing Immunoglobulin M 
antibody collection programs, nor does it include recommendations for 
donors who do not meet all donor suitability requirements under 21 CFR 
640.63.
    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 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 this 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 
written or electronic comments to ensure adequate consideration in 
preparation of the final 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 the 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: October 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20958 Filed 10-19-05; 8:45 am]
BILLING CODE 4160-01-S