The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on collection of information under FDA's current good manufacturing practice (CGMP) regulations for positron emission tomography (PET) drug products. PET is a medical imaging modality involving the use of a unique type of radiopharmaceutical drug product.
This is a notice published in the Federal Register by Health and Human Services Department, Food and Drug Administration. Notices communicate information, guidance, or policy interpretations but may not create new binding obligations.
This document is classified as a notice. It may or may not create enforceable regulatory obligations depending on its specific content.
Notice.
Either electronic or written comments on the collection of information must be submitted by November 24, 2025.
| Document Number | 2025-18620 |
| FR Citation | 90 FR 46218 |
| Type | Notice |
| Published | Sep 25, 2025 |
| Effective Date | - |
| RIN | - |
| Docket ID | Docket No. FDA-2025-N-3656 |
| Pages | 46218–46220 (3 pages) |
| Text Fetched | No |
| Part | Name | Agency |
|---|---|---|
| No linked CFR parts | ||
| Type | Proposed | Final | Method | Conf |
|---|---|---|---|---|
| No paired documents | ||||
| Doc # | Type | Title | Published |
|---|---|---|---|
| 2025-23859 | Notice | Agency Information Collection Activities... | Dec 29, 2025 |
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