Rule2023-04010
Change of Address; Technical Amendment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 2, 2023
Effective
March 2, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
Before using an electronic signature in an electronic record required by the Food and Drug Administration (FDA or Agency), a person must submit a letter of non-repudiation to FDA. Letters of non- repudiation are required to certify that a person's electronic signatures are intended to be the legally binding equivalent of traditional handwritten signatures. FDA is amending its regulations to update the address for submission of a certification in paper form and to provide an option for electronic submission. This amendment is to ensure accuracy and clarity in the Agency's regulations. This technical amendment is nonsubstantive.
Full Text
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<title>Federal Register, Volume 88 Issue 41 (Thursday, March 2, 2023)</title>
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<body><pre>[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Rules and Regulations]
[Page 13018]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04010]
[[Page 13018]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 11
[Docket No. FDA-2019-N-0646]
Change of Address; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: Before using an electronic signature in an electronic record
required by the Food and Drug Administration (FDA or Agency), a person
must submit a letter of non-repudiation to FDA. Letters of non-
repudiation are required to certify that a person's electronic
signatures are intended to be the legally binding equivalent of
traditional handwritten signatures. FDA is amending its regulations to
update the address for submission of a certification in paper form and
to provide an option for electronic submission. This amendment is to
ensure accuracy and clarity in the Agency's regulations. This technical
amendment is nonsubstantive.
DATES: This rule is effective March 2, 2023.
FOR FURTHER INFORMATION CONTACT: Elizabeth L. Kunkoski, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3332, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#e2878e8b98838087968acc89978c898d91898ba2848683cc8a8a91cc858d94"><span class="__cf_email__" data-cfemail="40252c293a21222534286e2b352e2b2f332b29002624216e2828336e272f36">[email protected]</span></a>, 301-796-6439.
SUPPLEMENTARY INFORMATION: Before using an electronic signature in an
electronic record required by FDA, a person must submit a letter of
non-repudiation to FDA (Sec. 11.100(c) 21 CFR 11.100(c)). Letters of
non-repudiation are required under Sec. 11.100(c)(1) to certify that a
person's electronic signatures are intended to be the legally binding
equivalent of traditional handwritten signatures. FDA is amending its
regulations in 21 CFR part 11 to update the address for submission of a
certification in paper form and to provide an option for electronic
submission. The new addresses are as follows:
<bullet> For certification of electronic signatures for submissions
sent through FDA's Electronic Submissions Gateway Program, submit to:
<a href="/cdn-cgi/l/email-protection#ce8b9d8986aba2be8aabbda58ea8aaafe0a6a6bde0a9a1b8"><span class="__cf_email__" data-cfemail="723721353a171e0236170119321416135c1a1a015c151d04">[email protected]</span></a>; or
<bullet> For certification of electronic signatures for submissions
not submitted through FDA's Electronic Submissions Gateway Program,
submit to: Jessica Bernhardt, Electronic Submissions Gateway, U.S. Food
and Drug Administration, 3WFN, Rm. 7C34, 12225 Wilkins Ave., Rockville,
MD 20852.
Information on where to submit the certification is currently found
on FDA's web page on Letters of Non-Repudiation Agreement at <a href="https://www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement">https://www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement</a>. This action is being taken to ensure accuracy and clarity in
the Agency's regulations.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553).
FDA has determined that notice and public comment are unnecessary
because this amendment makes only technical or non-substantive,
ministerial changes to reflect a change in electronic submission
capabilities and corrects the address for submission of a non-
repudiation letter. Such technical, non-substantive changes are
``routine determination[s], insignificant in nature and impact, and
inconsequential to the industry and to the public.'' (Mack Trucks, Inc.
v. EPA, 682 F.3d 87, 94 (D.C. Cir. 2012)) (quotation marks and citation
omitted). Accordingly, FDA for good cause finds that notice and public
procedure thereon are unnecessary for these changes in where and how
the certification is submitted.
In addition, we find good cause for these amendments to become
effective on the date of publication of this action. The APA allows an
effective date of less than 30 days after publication as ``provided by
the agency for good cause found and published with the rule'' (5 U.S.C.
553(d)(3)). A delayed effective date is unnecessary in this case
because the amendments do not impose any new regulatory requirements on
affected parties. As a result, affected parties do not need time to
prepare before the rule takes effect. Therefore, we find good cause for
this correction to become effective on the date of publication of this
action.
List of Subjects in 21 CFR Part 11
Computer technology, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
11 is amended as follows:
PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
0
1. The authority citation for part 11 continues to read as follows:
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
0
2. In Sec. 11.100, revise paragraph (c)(1) to read as follows:
Sec. 11.100 General requirements.
* * * * *
(c) * * *
(1) The certification shall be signed with a traditional
handwritten signature and submitted in electronic or paper form.
Information on where to submit the certification can be found on FDA's
web page on Letters of Non-Repudiation Agreement.
* * * * *
Dated: February 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04010 Filed 3-1-23; 8:45 am]
BILLING CODE 4164-01-P
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