[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 [www.gpo.gov]
[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, 
[email protected], 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:
     For certification of electronic signatures for submissions 
sent through FDA's Electronic Submissions Gateway Program, submit to: 
[email protected]; or
     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 https://www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement. 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]
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