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Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

---
identifier: "/us/fr/2023-03073"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals"
title_number: 0
title_name: "Federal Register"
section_number: "2023-03073"
section_name: "Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals"
positive_law: false
currency: "2023-02-14"
last_updated: "2023-02-14"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2023-03073"
document_type: "notice"
publication_date: "2023-02-14"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "88 FR 9521"
fr_volume: 88
docket_ids:
  - "Docket Nos. FDA-2013-N-0134"
  - "FDA-2016-D-2565"
  - "FDA-2013-N-0514"
  - "FDA-2015-N-0030"
  - "FDA-2021-N-0584"
  - "FDA-2021-N-1026"
  - "FDA-2013-N-0557"
  - "FDA-2014-N-0053"
  - "FDA-2013-N-0190"
  - "FDA-2019-N-0305"
  - "FDA-2019-N-2854"
  - "FDA-2019-N-5553"
  - "FDA-2017-D-0085"
  - "FDA-2016-N-2544"
  - "FDA-2019-N-2778"
  - "FDA-2012-N-0977"
  - "FDA-2010-D-0319"
  - "and FDA-2018-N-3728"
fr_action: "Notice."
---

#  Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of  Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

**FOR FURTHER INFORMATION CONTACT:**

JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, *[email protected].*

**SUPPLEMENTARY INFORMATION:**

The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at *https://www.reginfo.gov/public/do/PRAMain.* An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

| Title of collection | OMB control No. | Date approval expires |
| --- | --- | --- |
| Mammography Standards Quality Act Requirements | 0910-0309 | 11/30/2025 |
| 510(k) Third-Party Review Program | 0910-0375 | 11/30/2025 |
| Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization | 0910-0607 | 11/30/2025 |
| Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act | 0910-0800 | 11/30/2025 |
| Pilot to Develop Standardized Reporting Forms for Federally Funded Public Health Projects and Agreements | 0910-0909 | 11/30/2025 |
| Text Analysis of Proprietary Drug Name Interpretations | 0910-0910 | 11/30/2025 |
| Postmarket Surveillance of Medical Devices | 0910-0449 | 12/31/2025 |
| Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods | 0910-0560 | 12/31/2025 |
| Warning Plans for Smokeless Tobacco Products | 0910-0671 | 12/31/2025 |
| Deeming Tobacco Products To Be Subject to the FD&C Act | 0910-0768 | 12/31/2025 |
| Premarket Tobacco Product Applications and Recordkeeping Requirements | 0910-0879 | 12/31/2025 |
| Right to Try Act: Reporting Requirements | 0910-0893 | 12/31/2025 |
| Substances Generally Recognized as Safe: Best Practices for Convening a GRAS Panel | 0910-0911 | 12/31/2025 |
| Medical Devices—Quality System Regulation; 21 CFR part 820 | 0910-0073 | 1/31/2026 |
| Threshold of Regulation for Substances Used in Food-Contact Articles | 0910-0298 | 1/31/2026 |
| Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents | 0910-0312 | 1/31/2026 |
| Mailing of Important Information About Drugs | 0910-0754 | 1/31/2026 |
| Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs | 0910-0882 | 1/31/2026 |

Dated: February 8, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.