[Federal Register: October 20, 2005 (Volume 70, Number 202)]
[Notices]
[Page 61135-61136]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc05-55]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Recommendations for Implementing a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.
-----------------------------------------------------------------------
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 The draft guidance document is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 The draft guidance, when finalized, would supersede the draft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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may also be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draft guidance document.
Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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