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Biologics, Blood & Vaccines

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1 What’s New from CBER
Vaccines
2 Product Deviations
Blood & Blood
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Vaccines
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approved for approved for Papillomavirus
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Approvals infection, (Shingles) LEARN MORE
common in
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Regulatory - Register a Blood
Information Establishment
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Questions about Blood, ISBT label, Find a Blood or Tissue Bank
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Consumers & Healthcare 800-835-4709
Professionals 301-827-1800

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octma@cber.fda.gov

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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

Code of Federal Regulations – Biologics Enforced Center for Biologics

Evaluation and Research
1401 Rockville Pike, Suite
Guidances & SOPs 200N
Rockville, MD 20852-1448
Guidances by Topic & Year
Resources for You Manual of SOPs Media Inquiries

Consumers & Healthcare About CBER

Providers Imports & Exports
Compliance Program Guidance Manual – Imported CBER-Regulated
Industry
Products
Export Certificates
Importing Samples for Research Use Only

Other Topics
Compliance Activities
Enforcement
Post-Market Activities

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1 Goes to Blood Establishment Registration Page (the next page)

Biologics, Blood & Vaccines The URLS, in order, are:

http://www.fda.gov/cdrh/devadvice/341.html
2 http://www.cfsan.fda.gov/%7Efurls/ovffreg.html
http://www.fda.gov/cder/drls/registration_listing.htm
Biologics, Blood & Vaccines > Guidance, Compliance & Regulatory Information
Biologics, Blood &
Vaccines Establishment Registration When I reorganized the text on the Blood Registration and Electornic Form instructions
3 pages, the link to the Public Query (http://www.fda.gov/cber/blood/bldregdata.htm) got
Guidance, “lost.” That is, it didn’t seem to fit on the blood reg page. I have found a home for it
Compliance & Blood Establishment Registration here. Most of the text on the current blood reg page (http://www.fda.gov/cber/blood/
Email Page
Regulatory bldreg.htm) is on my redesigned blood reg page (the next page, titled Blood
Information Electronic Submission Print Page Establishment Registration). However, the text about the public query didn’t fit, so I
3 1 removed it. I am hoping that the link itself, which says “Query” is strong enough to get
Electronic Submission Instructions Bookmark and share
Establishment a user to the query page, where the info can be presented.
Query the Database Get email updates
Registration
MORE: Blood Establishment Registration Subscribe to RSS

Blood Establishment Tissue Establishment Registration

Registration
Electronic Submission
Tissue Establishment Electronic Submission Instructions
Registration
MORE: Tissue Establishment Registration

Other Establishment Registrations

Resources for You Device Establishment Registration (CDRH)

2
Food Facility Registration (CFSAN)
Consumers & Healthcare
Drug Estalishments (CDER)
Providers
Industry

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Biologics, Blood & Vaccines

Biologics, Blood & Vaccines > Guidance, Compliance & Regulatory Information > Establishment Registration
Biologics, Blood &
Vaccines
Blood Establishment Registration
Guidance, Who Must Register?
Compliance & Email Page 1 I found this part of the instructions confusing. The first part of the instructions talks
All owners or operators of establishments that manufacture blood products are
Regulatory required to register with the FDA, pursuant to section 510 of the Federal Food, Print Page about registering the establishment. This part talks about registering products made by
Information Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65. the establishment and gives deadlines for product registration. Are there two processes
(registering the establishment and registering products) or just one? If there are two
Establishments that perform certain manufacturing steps are considered to be processes, do they have different deadlines? There’s no deadline given for registering
Establishment Hospital Blood Banks and must register. See instructions for Item 10.2 for the establishment, only for registering products made by the establishment.
Registration these manufacturing steps.

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)).

Query the Database When Must I Register?

Printable Form FDA-2830
Help by Phone or E-mail
Tissue Establishment
Registration
A list of every blood product manufactured, prepared, or processed for
commercial distribution must be submitted. Products must be registered and
listed within five days of beginning operation, and annually between November 1
15 and December 31. Blood product listings must be updated every June and
December.
How Do I Register?
You can:
o Submit the information electronically
o Download form FDA-2830, Blood Establishment Registration and Product
Listing and mail it to us

Submit Electronically or By Mail

Electronic Submission
Electronic Submission Instructions
Printable Form FDA-2830
Resources for You
Help by Phone or E-mail
Consumers & Healthcare
Professionals Page Last Reviewed:
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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

Establishment Print Page

Registration
Blood Establishment
Registration
Electronic Submission
Electronic Submission
Instructions
Query the Database
Printable Form FDA-2830
Help by Phone or E-mail
Tissue Establishment
Registration
IN THIS ARTICLE: Now that I’m looking at this more closely, I have a few recommendations on language.
2
Other Names Page Assuming that I am understanding the situation correctly, I recommend that you:
Introduction
o Rename the links to “Online Form FDA-2830” and “Online Form Instructions”. These
General Instructions Reporting Official Page
emphasize that this is just the web-enabled version.
Navigation U.S. Agent Page o Change references to “application” to “online form”.
Saving Information Owner Type Page
2 Individual Page Descriptions Type of Establishment Page
1 This is a long document, I am showing only as much as will fit on a standard length Visio
Select Establishment Page Products Page 3
page.
Registration Profile Page Additional Products Page
Active Users Page Report Page
Other Submissions Pending Validation Errors Page
Page Reporting Problems
Status Page Paperwork Reduction Act
Legal Name/Location Page Statement

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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