(a) The Food and Drug Administration shall notify the designated Department official, the Office of Management and Budget (Information Systems Division), and the Congress of proposals to change or establish Privacy Act Record Systems in accordance with procedures of the Department and the Office of Management and Budget.

(b) The Food and Drug Administration shall issue a notice, in accordance with paragraph (d) of this section and §21.20(b), of any change in a Privacy Act Record System which:

(1) Increases the number or types of individuals about whom records are maintained;

(2) Expands the type or amount of information about individuals that is maintained;

(3) Increases the number of categories of agencies or other persons who may have access to those records;

(4) Alters the manner in which the records are organized so as to change the nature or scope of those records, such as the combining of two or more existing systems;

(5) Modifies the way in which the system operates or its location(s) in a manner that alters the process by which individuals can exercise their rights under this part, such as the ways in which they seek access or request amendment of a record; or

(6) Changes the equipment configuration on which the system is operated so as to create the potential for greater access, such as adding a telecommunications capability.

(c) The Food and Drug Administration shall issue a notice of its intention to establish new Privacy Act Record Systems in accordance with paragraph (d) of this section and §21.20(b).

(d) Notices under paragraphs (b) and (c) of this section shall be published in the Federal Register for comment at least 30 days prior to implementation of the proposed changes or establishment of new systems. Interested persons shall have the opportunity to submit written data, views, or arguments on such proposed new uses or systems.