# 2026-19284: Public Input Sought on Rare Disease Drug Reporting Rules

2026-19284, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-09-21, effective Submit written comments (including recommendations) on the collection of information by October 21, 2026.; PRIA reads it as touching household money (as of 2026-09-28).

- Canonical: https://policyrisk.com/federal-register/2026-19284
- As of: 2026-09-28
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-19284
- Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 59780
- Published: 2026-09-21
- Effective: Submit written comments (including recommendations) on the collection of information by October 21, 2026.
- Comments close: 2026-10-21
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-09-28

## In one line

Public Input Sought on Rare Disease Drug Reporting Rules

## Summary

The FDA is asking for public feedback on their plan to keep collecting info about orphan drugs—special medicines for rare diseases. This helps make sure drug makers follow rules and get the right approvals, keeping the process smooth and fair. Comments are open until October 21, 2026, and this review won’t cost anyone extra but keeps important protections in place.

## Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

## Effects PRIA read

- Orphan Drug Reporting — Big Time Burden: cost, medium. If you sponsor drugs for rare diseases, FDA will continue collecting required records and forms under OMB Control Number 0910-0167. FDA estimates this collection generates 6,744 annual records and a total of 193,830 hours of burden each year (for example, 2,210 annual-report records at 3 hours each…
- Electronic Submission & Secure Email Fee Risk: cost, low. If you submit orphan designation materials, you may need to register for the CDER NextGen portal or send encrypted email; FDA notes new NextGen users must register and that there may be a fee for a commercial enterprise to obtain a digital certificate for encrypted email. This could create a small…

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## Sources
- [2026-19284 on federalregister.gov](https://www.federalregister.gov/documents/2026/09/21/2026-19284/agency-information-collection-activities-submission-for-office-of-management-and-budget-review)
- [2026-19284 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-09-21/pdf/2026-19284.pdf)

## Related
- [Previous: 2026-19283, Agency Information Collection Activities; Proposed Collection; Comment Request;…](https://policyrisk.com/federal-register/2026-19283)
- [Next: 2026-19285, Competitive Postal Products](https://policyrisk.com/federal-register/2026-19285)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-19284 (as of 2026-09-28).