(a) Waiver for an individual entity. (1) If FDA tentatively determines that we should modify or revoke a waiver for an individual entity, we will notify the person that had received the waiver in writing of our tentative determination that the waiver should be modified or revoked. The notice will provide the waiver recipient 60 days in which to submit information stating why the waiver should not be modified or revoked.

(2) Upon consideration of any information submitted by the waiver recipient, we will respond in writing stating our decision whether to modify or revoke the waiver and the reasons for the decision. If we modify or revoke the waiver, the effective date of the decision will be 1 year after the date of our response to the waiver recipient, unless otherwise stated in the response.

(b) Waiver for a type of entity. (1) If FDA tentatively determines that we should modify or revoke a waiver for a type of entity, we will provide the following notifications:

(i) We will notify the person that originally requested the waiver (if we granted the waiver in response to a petition) in writing at the address identified in the petition.

(ii) We will publish a notice in the Federal Register of our tentative determination that the waiver should be modified or revoked and the reasons for our tentative decision. The notice will establish a public docket so that interested persons may submit written comments on our tentative determination.

(2) After considering any comments timely submitted, we will publish a notice in the Federal Register of our decision whether to modify or revoke the waiver and the reasons for the decision. If we do modify or revoke the waiver, the effective date of the decision will be 1 year after the date of publication of the notice, unless otherwise stated in the notice.