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Biologics
Most Popular
Biologics
1 What’s New from CBER
Blood, Vaccines & 2 Product Deviations
Other Biologics

Safety & Availability Image Image Image

Report a Problem
Development &
Approvals
Recalls & Alerts
Guidance,
Compliance & ROTARIX Zostavax GARDASIL Product Approvals
Regulatory Vaccine Vaccine Human
Information approved for approved for Papillomavirus
prevention of prevention of Vaccine
Science & Research Rotavirus Herpes Zoster
LEARN MORE
Tools & Resources
infection, (Shingles)
common in Register a Blood
News & Events young children LEARN MORE - Establishment
About CBER LEARN MORE
Register a Tissue
- Establishment
Contact Information
Blood, Vaccines & Other Biologics Development & Approvals - See Approved Vaccines
Allergenics, Blood, Tissues, Vaccines, Licensing, Submit an Application...
Test Kits... - Subscribe to CBER Mailing
Resources for You Guidance, Compliance & Regulatory Lists
Information
Safety & Availability
Shortages, Recalls, Find a Blood or Acts, Rules & Regulations; Establishment
- Request a Form
Consumers & Healthcare
Professionals Tissue Establishment... Registration; Post-Market Activities;
Imports & Exports...
Industry

News & Events Contact Us

800-835-4709
301-827-1800
05/05/08 Pediatric Research Equity Act
octma@cber.fda.gov
05/02/08 51st Annual FDLI

05/02/08 Approval History Center for Biologics

Evaluation and Research
More News Items... 1401 Rockville Pike, Suite
200N
Rockville, MD 20852-1448

Consumers Healthcare Media Inquiries

Industry
Professionals
About CBER

Image Image

Image

Giving Blood, Product

Shortages Report a Problem Submissions,
Guidances
Learn more... Learn more...
Learn more...

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FDA Homepage Food Drugs Medical Devices Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Combination Products
1 Making this a bullet list would open up the page some.

Biologics Biologics

2 I did some wordsmithing here to eliminate the asterisk.

Biologics Guidance, Compliance & Regulatory Information Email Page

3 Maybe add a “Manufacturers’ Assistance” item to the Contact Us Module?
The Center for Biologics Evaluation and Research (CBER) has established a Print Page
Guidance,
Manufacturers Assistance Branch to provide assistance and training to industry, Bookmark and share
Compliance & including large and small manufacturers and trade associations, and to respond
Regulatory to requests for information regarding CBER policies and procedures. Get email updates
Information Manufacturers assistance is available in numerous areas including: clinical 1
investigator information, adverse event reporting procedures, electronic Subscribe to RSS
submissions guidance and requirements, and information on how to submit an
Acts, Rules &
Investigational New Drug Application (IND) to administer an investigational
Regulations product to humans.

Guidances If you have questions or are unable to find the information you need, please
2
contact us by phone or e-mail:
Establishment
Center for Biologics Evaluation and Research
Registration Office of Communication, Training & Manufacturers Assistance
Division of Manufacturers Assistance and Training 3
Compliance Activities Manufacturers Assistance and Technical Training Branch
800-835-4709 or 301-827-1800
matt@cber.fda.gov
Enforcement
CBER is reannouncing the invitation for participation in its Regulatory Site Visit
Post-Market Activities Training Program (RSVP). This training program is intended to give CBER
regulatory review, compliance, and other relevant staff an opportunity to visit
Imports & Exports biologics facilities. These visits are intended to allow CBER staff to directly
observe routine manufacturing practices and to give CBER staff a better
understanding of the biologics industry, including its challenges and operations.
Submit a written or electronic request for participation in this program by
February 21, 2008. See the Federal Register Notice "Regulatory Site Visit
Training Program" for further information.

Acts & Regulations

Resources for You Comprehensive List of Laws Enforced
Code of Federal Regulations – Biologics Enforced
Consumers & Healthcare
Public Health Service Act
Providers
Industry
Rules & SOPs
Guidances by Topic & Year
Manual of SOPs
Rules

Imports & Exports

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

Tissue Establishment Registration

Electronic Submission
Electronic Form Instructions
More...

Resources for You Other Establishment Registrations

Device Establishment Registration (CDRH)

Consumers & Healthcare 2
Providers Food Facility Registration (CFSAN)

Industry Drug Estalishments (CDER)

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Biologics
Biologics Biologics > Guidance, Compliance & Regulatory Information

Guidance, Blood Establishment Registration

Compliance & All owners or operators of establishments that manufacture blood products are
Regulatory Email Page
required to register with the FDA, pursuant to section 510 of the Federal Food,
Information Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65. A list of Print Page
every blood product manufactured, prepared, or processed for commercial
Establishment distribution must also be submitted. Products must be registered and listed
within 5 days of beginning operation, and annually between November 15 and
Registration December 31. Blood product listings must be updated every June and
December.

Blood Establishment Hospital Transfusion Services certified under the Medicare program are exempt
Registration from registration (see 21 CFR 607.65(f)). Establishments that perform certain
manufacturing steps are considered to be Hospital Blood Banks, which are
required to register. See instructions for Item 10.2 for these manufacturing
Tissue Establishment steps.
Registration
Blood establishments located outside of the United States that import or offer
for import blood products into the U.S. are required to register with FDA. The
name of the United States agent, the name of each importer, and each person
who imports or offers for import these blood products must also be provided.

Resources for You Form FDA-2830, Blood Establishment Registration and Product Listing, is used
for submission of registration and product listing information to the FDA. The
Consumers & Healthcare form (and accompanying instructions) may be downloaded to complete and
submit by mail. Alternatively, the information may be submitted electronically.
Professionals
Industry

Register Electronically or By Mail

Electronic Submission
Electronic Submission Instructions

Printable Form FDA-2830

Help by Phone or E-mail

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