Blood Guidances > Guidance for Industry - Donors of Blood and Blood Components: Notification of Donor Deferral - Small Entity Compliance Guide

Guidance for Industry - Donors of Blood and Blood Components: Notification of Donor Deferral - Small Entity Compliance Guide1



This guidance is for immediate implementation.

FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(4)(i). Submit written comments on this guidance at anytime 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.regulations.gov 2. You should identify all comments with the Docket no. FDA-1998-N-1016 (formerly Docket no. 1998N-0607).

Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or email ocod@fda.hhs.gov, or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm 3.

For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above.



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Blood Guidances > Guidance for Industry - Donors of Blood and Blood Components: Notification of Donor Deferral - Small Entity Compliance Guide


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