E7-24385. 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.

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 The guidance announced in this notice finalizes the draft guidance of the same title dated September 2005, and supersedes the guidance entitled “Revised Guideline for the Collection of Platelets, Pheresis,” dated October 1988.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 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 §§ 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 §§ 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.