[Federal Register Volume 70, Number 190 (Monday, October 3, 2005)]
[Notices]
[Pages 57609-57610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19727]


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

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Draft Guidance for Industry and FDA Review Staff on Collection of 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.

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

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 The draft guidance provides blood establishments and 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 The draft guidance is intended to 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 The draft guidance contains recommendations for appropriate 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 When finalized, this draft guidance 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may 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to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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://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://www.fda.gov/cber/guidelines.htm or 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