[Federal Register Volume 72, Number 241 (Monday, December 17, 2007)]
[Notices]
[Pages 71418-71419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24385]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0330]


Guidance for Industry and Food and Drug Administration Review 
Staff: 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 document entitled ``Guidance for Industry and FDA 
Review Staff: Collection of Platelets by Automated Methods,'' dated 
December 2007. The guidance document provides to blood establishments 
and FDA staff revised recommendations for the collection of Platelets 
by automated methods (plateletpheresis). The 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 document contains recommendations for appropriate 
criteria for a biologics license application or supplement for 
manufacturing Platelets, Pheresis. The guidance announced in this 
notice finalizes the draft guidance of the same title dated September 
2005, and supersedes the guidance entitled ``Revised Guideline for the 
Collection of Platelets, Pheresis,'' dated October 1988.

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, suite 200N, 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

[[Page 71419]]

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 either 
http://www.fda.gov/dockets/ecomments or http://www.regulations.gov.

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 and FDA Review Staff: Collection of Platelets 
by Automated Methods,'' dated December 2007. The guidance provides to 
blood establishments and FDA staff revised recommendations for the 
collection of Platelets by automated methods (plateletpheresis). In 
recent years, many improvements have been made in automated blood cell 
separator technology, platelet storage stability, 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. This guidance replaces the 
draft guidance of the same title, and supersedes the guidance entitled 
``Revised Guideline for the Collection of Platelets, Pheresis,'' dated 
October 1988.
    In the Federal Register of October 3, 2005 (70 FR 57609), FDA 
announced the availability of the draft guidance of the same title 
dated September 2005. FDA received numerous comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. A summary of changes includes: (1) Revised recommendations 
for donor selection and management, (2) revised recommendations for 
collection performance qualification criteria, and (3) revised 
recommendations on quality control monitoring. The guidance announced 
in this notice finalizes the draft guidance dated September 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 
requirements 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 part 211 (21 CFR part 211), subpart J 
(Records and Reports) have been approved under OMB control number 0910-
0139; the collections of information in part 606 (21 CFR part 606), 
subpart I (Records and Reports) have been approved under OMB control 
numbers 0910-0116 and 0910-0458; the collections of information in 
Sec. Sec.  606.100(b) and (c), 606.110(a), 606.121, 606.122, 21 CFR 
640.25, and 21 CFR 640.27 have been approved under OMB control number 
0910-0116; the collections of information in Sec. Sec.  211.22, 211.80, 
211.100(b), and 211.160 have been approved under OMB control number 
0910-0139; the collections of information in 21 CFR 610.2 have been 
approved under OMB control number 0910-0206; and the collections of 
information in 21 CFR 601.12 and 610.60 have been approved under OMB 
control number 0910-0338.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the 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.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

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: December 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24385 Filed 12-14-07; 8:45 am]
BILLING CODE 4160-01-S