[Federal Register: October 3, 2005 (Volume 70, Number 190)]
[Notices]
[Page 57609-57610]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03oc05-118]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0330]
Draft Guidance for Industry and FDA Review Staff on Collection of
Platelets by Automated Methods; 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 and
FDA Review Staff: Collection of Platelets by Automated Methods'' dated
September 2005. The draft guidance provides blood establishments and
FDA staff revised recommendations for the collection of Platelets by
automated methods (plateletpheresis). The draft guidance is intended to
help blood establishments ensure donor safety and the safety, purity,
and potency of Platelets collected by an automated blood cell separator
device. For the purpose of this document, Platelets collected by
automated methods will be referred to by the product name ``Platelets,
Pheresis.'' The draft guidance contains recommendations for appropriate
criteria for a biologics license application or supplement for
manufacturing Platelets, Pheresis. When finalized, this draft guidance
will replace the October 1988 ``Revised Guideline for the Collection of
Platelets, Pheresis.''
DATES: Submit written or electronic comments on the draft guidance by
January 3, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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, 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 The draft guidance may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 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to the draft guidance document.
Submit written comments on the draft guidance to the Division of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 and FDA Review Staff: Collection of Platelets
by Automated Methods'' dated September 2005. The draft guidance
provides blood establishments and FDA staff revised recommendations for
the collection of Platelets by automated methods (plateletpheresis).
FDA has received new information since the issuance of the October 1998
``Revised Guideline for
[[Page 57610]]
the Collection of Platelets, Pheresis.'' In addition, in recent years,
many improvements have been made in automated blood cell separator
technology and blood cell counting methods. Automated blood cell
separator devices are now capable of various plateletpheresis
collection procedures including, but not limited to, collection of
double and triple platelet components obtained during a single
procedure; use of in-process leukocyte reduction; collection of
concurrent plasma components; and collection of concurrent Red Blood
Cell components. When finalized, the draft guidance will replace the
October 1988 guideline.
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
collections of information in this guidance are under FDA's regulations
at parts 211, 601, 606, 610, and 640 (21 CFR parts 211, 601, 606, 610,
and 640). Part 211, subpart J (Records and Reports) was approved under
OMB control number 0910-0139; part 606, subpart I (Records and Reports)
was approved under OMB control numbers 0910-0116 and 0910-0458.
Sections 606.100(b) and (c), 606.110(a), 606.121, 606.122, 640.25, and
640.27 were approved under OMB control number 0910-0116; Sec. Sec.
211.22, 211.80, 211.100(b), and 211.160 were approved under OMB control
number 0910-0139; Sec. 610.2 was approved under OMB control number
0910-0206; and Sec. Sec. 601.12 and 610.60 were approved under OMB
Control No. 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 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: September 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19727 Filed 9-30-05; 8:45 am]
BILLING CODE 4160-01-S