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GUIDANCE DOCUMENT

Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide Guidance for Industry June 2011

Final

Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide

Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121). According to the Small Business Administration, a “small business” within the blood industry is an enterprise with $10 million in average annual receipts.1 This guidance is intended to help you, a small entity that collects blood or blood components for transfusion or for further manufacturing (blood or blood components), better understand and comply with the regulatory framework set forth in Title 21 Code of Federal Regulations 630.6 (21 CFR 630.6).


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010