CFR

607.37—Inspection of establishment registrations and blood product listings.

(a) A copy of the Form FD-2830 (Blood Establishment Registration and Product Listing) filed by the registrant will be available for inspection under section 510(f) of the act, at the Department of Health and Human Services, Food and Drug Administration, Office of Communication, Training and Manufacturers' Assistance (HFM-40), Center for Biologics Evaluation and Research (see mailing addresses in § 600.2 of this chapter ). In addition, for domestic firms, the same information will be available for inspection at each of the Food and Drug Administration district offices for firms within the geographical area of such district office. Upon request and receipt of a self-addressed stamped envelope, verification of registration number, or location of registered establishment will be provided. The following information submitted under the blood product listing requirements is illustrative of the type of information that will be available for public disclosure when it is compiled:

(1) A list of all blood products.

(2) A list of all blood products manufactured by each establishment.

(3) A list of blood products discontinued.

(4) All data or information that has already become a matter of public knowledge.

(b) Requests for information regarding blood establishment registrations and blood product listings should be directed to the Department of Health and Human Services, Food and Drug Administration, Office of Communication, Training and Manufacturers' Assistance (HFM-40), Center for Biologics Evaluation and Research (see mailing addresses in § 600.2 of this chapter ).

Code of Federal Regulations

[40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 55 FR 11014, Mar. 26, 1990; 66 FR 59159, Nov. 27, 2001; 70 FR 14984, Mar. 24, 2005]

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