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Register Blood Bank Scenario v4 Blood Topic Page
Register Blood Bank Scenario v4 Blood Topic Page
Register Blood Bank Scenario v4 Blood Topic Page
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Consumers & Healthcare 800-835-4709
Professionals 301-827-1800
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FDA Homepage Food Drugs Medical Devices Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Combination Products
1 This is a rewrite of the text on the Industry page: http://www.fda.gov/cber/
manufacturer.htm.
Biologics, Blood & Vaccines
The Industry page refers to both the “Manufacturers Assistance Branch” and the
“Manufacturers Assistance and Technical Training Branch”. I didn’t know which name
Biologics, Blood & Vaccines was current, so I used the shorter of the two in this wireframe.
Biologics, Blood &
Vaccines The page now has an announcement for a training program that closed on February 21.
Guidance, I did not include this announcement in this wireframe.
Guidance, Compliance & Regulatory Information
Compliance &
The Manufacturers Assistance Branch can answer questions on many policy and Email Page
Regulatory procedural topics including: 2 These are the same general phone numbers shown in the Contact Us module. Are there
Information o Information on clinical investigators Print Page more specific numbers to use?
1
o How to report an adverse event
Bookmark and share
Acts, Rules & o How to submit an application online (electronic submission) Is the e-mail address an individual’s name or an acronym for the Manufacturers
Regulations o How to submit an Investigational New Drug Application (IND) to administer Get email updates Assistance and Technical Training Branch? If the latter, can it be in all CAPS, so it will
an investigational product to humans
Subscribe to RSS look more like an acronym?
Guidances Please contact us:
o Phone: 800-835-4709 or 301-827-1800 2
Establishment o E-mail: matt@cber.fda.gov
Registration
We answer questions and provide training to:
o Large and small manufacturers
Compliance Activities o Trade associations
Enforcement
Acts, Rules & Regulations Contact Us
Post-Market Activities Public Health Service Act 800-835-4709
301-827-1800
Rules
Imports & Exports
Comprehensive List of Laws Enforced octma@cber.fda.gov
Other Topics
Compliance Activities
Enforcement
Post-Market Activities
FDA Homepage Food Drugs Medical Devices Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Combination Products
1 Goes to Blood Establishment Registration Page (the next page)
FDA Homepage Food Drugs Medical Devices Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Combination Products
Blood Establishment Blood establishments outside the United States that import or offer for import
Registration blood products into the U.S. are required to register. The name of the United
States agent, the name of each importer, and each person who imports or
Electronic Submission offers for import these blood products must also be provided.
Electronic Submission Hospital Transfusion Services certified under the Medicare program are exempt
Instructions from registration (see 21 CFR 607.65(f)).
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FDA Homepage Food Drugs Medical Devices Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Combination Products
THIS PAGE IS NOT NEEDED FOR THE AUGUST USABILITY TEST. IT IS JUST AN
Biologics, Blood & Vaccines ILLUSTRATION OF HOW THE ELECTRONIC INSTRUCTIONS COULD BE MAPPED TO A
CONTENT PAGE.
Biologics, Blood & Vaccines > Guidance, Compliance & Regulatory Information > Establishment Registration > Blood Establishment Registration
Biologics, Blood & 1 Text from the Instructions page that had to go somewhere. I eliminated the statement
Vaccines about the Paperwork Reduction Act because it is listed in the table of contents.
Guidance, Compliance & Electronic Submission Instructions
I did some very mild editing -- couldn’t help myself.
Regulatory Information Email Page
Introduction
Resources for You Please review all pre-populated data for accuracy and completeness. Correct
any incorrect items as you navigate through the application.
Consumers & Healthcare YOU MUST NOTIFY FDA WITHIN 5 DAYS IF YOU CHANGE LOCATION.
Professionals
The Electronic Blood Establishment Registration and Product Listing system is
Industry
referred to as eBER. The blood establishment and product listing process is
referred to as registration and listing.
General Instructions 3
o Complete a separate eBER record for each establishment.
o Complete all sections. The U.S. Agent section applies only to non-U.S.
non-U.S. military blood establishments.
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