21 CFR 607.37 - Inspection of establishment registrations and blood product listings.

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§ 607.37 Inspection of establishment registrations and blood product listings.

(a) Any registration on Form FDA 2830 (Blood Establishment Registration and Product Listing) filed in paper or electronic format by the registrant will be available for inspection under section 510(f) of the act, through the Center for Biologics Evaluation and Research Blood Establishment Registration Database Web site by using the CBER electronic Web-based application or by going in person to the Food and Drug Administration, Division of Dockets Management Public Reading Room (see address in § 20.120(a) of this chapter). 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) Other requests for information regarding blood establishment registrations and blood product listings should be directed to the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002.

[80 FR 18092, Apr. 3, 2015]

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United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 607 after this date.

  • 2015-04-03; vol. 80 # 64 - Friday, April 3, 2015
    1. 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 3, 2015.
      21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271