[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Notices]
[Pages 46485-46486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13233]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0362]


Guidance for Industry on Implementing a Collection Program for 
Source Plasma Containing Disease-Associated and Other Immunoglobulin G 
(IgG) Antibodies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: 
Implementing a Collection Program for Source Plasma Containing Disease-
Associated and Other Immunoglobulin G (IgG) Antibodies,'' dated August 
2006. The 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. This guidance finalizes 
the draft guidance entitled ``Guidance for Industry: Recommendations 
for Implementing a Collection Program for Source Plasma Containing 
Disease-Associated and Other Immunoglobulin (IgG) Antibodies,'' dated 
October 2005, and supersedes the draft reviewers' guide entitled 
``Disease Associated Antibody Collection Program,'' dated October 1, 
1995.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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 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 guidance document.
    Submit written comments on the 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 document entitled 
``Guidance for Industry: Implementing a Collection Program for Source 
Plasma Containing Disease-Associated and Other Immunoglobulin G (IgG) 
Antibodies'' dated August 2006. The document supersedes 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 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.
    In the Federal Register of October 20, 2005 (70 FR 61135), FDA 
announced the availability of the draft guidance entitled ``Guidance 
for Industry: Recommendations for Implementing a Collection Program for 
Source Plasma Containing Disease-Associated and Other Immunoglobulin 
(IgG) Antibodies'' dated October 2005. FDA received one comment on the 
draft guidance. However, this comment related to the guidance process 
itself, not to the draft guidance. No changes other than editorial for 
clarification

[[Page 46486]]

have been made to the guidance. The guidance announced in this notice 
finalizes the draft guidance dated October 2005.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in Sec.  601.12(d) and (f)(2) have been 
approved under OMB control number 0910-0338.

III. Comments

    Interested persons may, at any time, submit written or electronic 
comments to the Division of Dockets Management (see ADDRESSES) 
regarding this 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 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 guidance at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-13233 Filed 8-11-06; 8:45 am]
BILLING CODE 4160-01-S