Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 2
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13Contains Nonbinding Recommendations
Center for Biologics Evaluation and Research
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
. Submit written comments to the Division of Dockets Management,
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD
20852. Identify all comments with the docket number FDA- 2012-8226. Comments may not be
acted upon by the Agency until the document is next revised or updated.
Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an e-mail request to
CDRH-Guidance@fda.hhs.gov
to receive a copy of the guidance. Please use the document
number 1671 to identify the guidance you are requesting.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER)
by written request, Office of Communication, Outreach, and Development (OCOD), 10903 New
Hampshire Ave., WO71, Room 3128, Silver Spring, MD 20903, or by calling 1-800-835-4709 or
240-402-7800, by email,
ocod@fda.hhs.gov,
or from the Internet at
n/Guidances/default.htm.
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