Source: https://www.federalregister.gov/documents/2005/10/03/05-19727/draft-guidance-for-industry-and-fda-review-staff-on-collection-of-platelets-by-automated-methods
Timestamp: 2017-08-22 05:08:23
Document Index: 598510132

Matched Legal Cases: ['arts 211', 'arts 211', 'art 211', 'art 606', '§\u2009211', '§\u2009610', '§\u2009601']

Federal Register :: Draft Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods; Availability
Submit written or electronic comments on the draft guidance by January 3, 2006, to ensure their adequate consideration in preparation of the final guidance.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.
70 FR 57609
05-19727
https://www.federalregister.gov/d/05-19727 https://www.federalregister.gov/d/05-19727
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 The draft guidance provides blood establishments and FDA staff revised recommendations for the collection of Platelets by automated methods (plateletpheresis). The draft guidance is intended to help blood establishments ensure donor safety and the safety, purity, and potency of Platelets collected by an automated blood cell separator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 The draft guidance contains recommendations for appropriate criteria for a biologics license application or supplement for manufacturing Platelets, Pheresis. When finalized, this draft guidance will replace the October 1988 “Revised Guideline for the Collection of Platelets, Pheresis.”
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 The draft guidance provides blood establishments and FDA staff revised recommendations for the collection of Platelets by automated methods (plateletpheresis).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 Start Printed Page 57610the 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.
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; §§ 211.22, 211.80, 211.100(b), and 211.160 were approved under OMB control number 0910-0139; § 610.2 was approved under OMB control number 0910-0206; and §§ 601.12 and 610.60 were approved under OMB Control No. 0910-0338.
[FR Doc. 05-19727 Filed 9-30-05; 8:45 am]