[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.2]

[Page 5-6]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 600_BIOLOGICAL PRODUCTS: GENERAL--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  600.2  Mailing addresses.


    (a) Licensed biological products regulated by the Center for 
Biologics Evaluation and Research (CBER). Unless otherwise stated in 
paragraphs (c) or (d) of this section, or as otherwise prescribed by FDA 
regulation, all submissions to CBER referenced in parts 600 through 680 
of this chapter, as applicable, must be sent to: Document Control Center 
(HFM-99), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Examples of such submissions include: Biologics license 
applications (BLAs) and their amendments and supplements, adverse 
experience reports, biological product deviation reports, fatality 
reports, and other correspondence. Biological products samples must not 
be sent to this address but must be sent to the address in paragraph (c) 
of this section.
    (b) Licensed biological products regulated by the Center for Drug 
Evaluation and Research (CDER). Unless otherwise stated in paragraphs 
(b)(1), (b)(2), (b)(3), or (c) of this section, or as otherwise 
prescribed by FDA regulation, all submissions to CDER referenced in 
parts 600, 601, and 610 of this chapter, as applicable, must be sent to: 
CDER Therapeutic Biological Products Document Room, Center for Drug 
Evaluation and Research, Food and Drug Administration, 12229 Wilkins 
Ave., Rockville, MD 20852. Examples of such submissions include: BLAs 
and their amendments and supplements, and other correspondence.
    (1) Biological Product Deviation Reporting (CDER). All biological 
product deviation reports required under Sec.  600.14 must be sent to: 
Division of Compliance Risk Management and Surveillance (HFD-330), 
Office of Compliance, Center for Drug Evaluation and Research, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
    (2) Postmarketing Adverse Experience Reporting (CDER). All 
postmarketing reports required under Sec.  600.80 must be sent to: 
Central Document Room, Center for Drug Evaluation and Research, Food and 
Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266.
    (3) Advertising and Promotional Labeling (CDER). All advertising and 
promotional labeling supplements required under Sec.  601.12(f) of this 
chapter must be sent to: Division of Drug Marketing, Advertising and 
Communication (HFD-42), Center for Drug Evaluation and Research, Food 
and Drug Administration, 5600 Fishers Lane, rm. 8B45, Rockville, MD 
20857.

[[Page 6]]

    (c) Samples and Protocols for licensed biological products regulated 
by CBER or CDER. (1) Biological product samples and/or protocols, other 
than radioactive biological product samples and protocols, required 
under Sec. Sec.  600.13, 600.22, 601.15, 610.2, 660.6, 660.36, or 660.46 
of this chapter must be sent by courier service to: Sample Custodian 
(ATTN: HFM-672), Food and Drug Administration, Center for Biologics 
Evaluation and Research, Bldg: NLRC-B, rm. 113, 5516 Nicholson Lane, 
Kensington, MD 20895. The protocol(s) may be placed in the box used to 
ship the samples to CBER. A cover letter should not be included when 
submitting the protocol with the sample unless it contains pertinent 
information affecting the release of the lot.
    (2) Radioactive biological products required under Sec.  610.2 of 
this chapter must be sent by courier service to: Sample Custodian (ATTN: 
HFM-672), Food and Drug Administration, Center for Biologics Evaluation 
and Research, Nicholson Lane Research Center, c/o Radiation Safety 
Office, National Institutes of Health, 21 Wilson Dr., rm. 107, Bethesda, 
MD 20892-6780.
    (d) Vaccine Adverse Event Reporting System (VAERS). All VAERS 
reports as specified in Sec.  600.80(c) must be sent to: Vaccine Adverse 
Event Reporting System (VAERS), P.O. Box 1100, Rockville, MD 20849-1100.
    (e) Address information for submissions to CBER and CDER other than 
those listed in parts 600 through 680 of this chapter are included 
directly in the applicable regulations.
    (f) Obtain updated mailing address information for biological 
products regulated by CBER at http://www.fda.gov/cber/pubinquire.htm, or 
for biological products regulated by CDER at http://www.fda.gov/cder/
biologics/default.htm.

[70 FR 14981, Mar. 24, 2005]