# 21 CFR § 1271.23: How is a waiver from the electronic format requirements requested?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.23

## Section

- **Citation:** 21 CFR § 1271.23
- **Heading:** How is a waiver from the electronic format requirements requested?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION > PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS > Subpart B—Procedures for Registration and Listing

## Text

(a) You may request a waiver from the requirement in § 1271.22 that information must be provided to FDA in electronic format. Submission of a request for waiver does not excuse timely compliance with the registration and listing requirements. FDA will grant a waiver request if FDA determines that the use of electronic means for submission of registration and listing information is not reasonable for the registrant making the waiver request.
(b) Waiver requests under this section must be submitted in writing and must include the specific reasons why electronic submission is not reasonable for the registrant and a U.S. telephone number and mailing address where FDA can contact the registrant. Waiver requests may be sent to the Center for Biologics Evaluation and Research (CBER), Document Control Center (see addresses in § 600.2 of this chapter).
(c) If FDA grants the waiver request, FDA may limit its duration and will specify terms of the waiver and provide information on how to submit establishment registration, listings, other information, and updates, as applicable.
[81 FR 60224, Aug. 31, 2016]

## Nearby sections

- [21 CFR § 1271.1 § 1271.1 What are the purpose and scope of this part?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.1.md)
- [21 CFR § 1271.3 § 1271.3 How does FDA define important terms in this part?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.3.md)
- [21 CFR § 1271.10 § 1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.10.md)
- [21 CFR § 1271.15 § 1271.15 Are there any exceptions from the requirements of this part?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.15.md)
- [21 CFR § 1271.20 § 1271.20 If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.20.md)
- [21 CFR § 1271.21 § 1271.21 When do I register, submit an HCT/P list, and submit updates?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.21.md)
- [21 CFR § 1271.22 § 1271.22 How do I register and submit an HCT/P list?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.22.md)
- [21 CFR § 1271.23 § 1271.23 How is a waiver from the electronic format requirements requested?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.23.md)
- [21 CFR § 1271.25 § 1271.25 What information is required for establishment registration and HCT/P listing?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.25.md)
- [21 CFR § 1271.26 § 1271.26 When must I amend my establishment registration?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.26.md)
- [21 CFR § 1271.27 § 1271.27 Will FDA assign me a registration number?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.27.md)
- [21 CFR § 1271.37 § 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.37.md)
- [21 CFR § 1271.45 § 1271.45 What requirements does this subpart contain?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.45.md)
- [21 CFR § 1271.47 § 1271.47 What procedures must I establish and maintain?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.47.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.23. Check the current official text before relying on it. Not legal advice.