Electronic Code of Federal Regulations
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e-CFR data is current as of February 25, 2021 |
Title 21 → Chapter I → Subchapter F → Part 607 → Subpart B → §607.37 |
Title 21: Food and Drugs
PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES
Subpart B—Procedures for Domestic Blood Product Establishments
§607.37 Public disclosure of establishment registration and blood product listing information.
(a) Except as provided in paragraph (b) of this section, all registration and listing information obtained under §§607.25, 607.26, and 607.30 will be made available for public disclosure through the Center for Biologics Evaluation and Research (CBER) 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 Freedom of Information Public Reading Room (see addresses in §20.120(a) of this chapter).
(b) FDA may find, in limited circumstances and on a case-by-case basis, that it would be consistent with the protection of the public health to exempt from public disclosure specific listing information obtained under §607.25 or §607.30.
(c) 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.
[81 FR 60223, Aug. 31, 2016]