[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.37]

[Page 686]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS--Table of Contents
 
           Subpart B--Procedures for Registration and Listing
 
Sec. 1271.37  Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?

    (a) A copy of the Form FDA 3356 filed by each establishment will be 
available for public inspection at the Office of Communication, 
Training, and Manufacturers Assistance (HFM-48), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448. In addition, there will be 
available for inspection at each of the Food and Drug Administration 
district offices the same information for firms within the geographical 
area of such district office. Upon request and receipt of a self-
addressed stamped envelope, verification of a registration number or the 
location of a registered establishment will be provided. The following 
information submitted under the HCT/P requirements is illustrative of 
the type of information that will be available for public disclosure 
when it is compiled:
    (1) A list of all HCT/P's;
    (2) A list of all HCT/P's manufactured by each establishment;
    (3) A list of all HCT/P's discontinued; and
    (4) All data or information that has already become a matter of 
public record.
    (b) You should direct your requests for information regarding HCT/P 
establishment registrations and HCT/P listings to the Office of 
Communication, Training and Manufacturers Assistance (HFM-48), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448.

                       PARTS 1272-1299 [RESERVED]