Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA, the 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.

DATES:

Submit written comments (including recommendations) on the collection of information by February 12, 2024.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910–0303. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Electronic Records; Electronic Signatures—21 CFR Part 11

OMB Control Number 0910–0303—Revision

This information collection supports implementation of statutory and regulatory authorities that govern criteria for the acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records. Agency regulations in part 11 (21 CFR part 11) provide for the submission of records and reports and establish that information may be submitted to FDA electronically provided that we have stated our ability to accept the records electronically in an Agency-established public docket and that the other requirements of part 11 are met. The regulations apply to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in Agency regulations and to electronic records submitted under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in Agency regulations.

Regulations in part 11, subpart B (§§ 11.10 through 11.70) require the establishment of standard operating procedures to ensure appropriate use of and precautions for systems using electronic records and signatures, including the following: (1) § 11.10 specifies procedures and controls for persons who use closed systems to create, modify, maintain, or transmit electronic records; (2) § 11.30 specifies procedures and controls for persons who use open systems to create, modify, maintain, or transmit electronic records; and (3) § 11.50 specifies procedures and controls for persons who use electronic signatures.

Regulations in subpart C (§§ 11.100 through 11.300) require specific controls to ensure the security and integrity of electronic signatures based upon use of identification codes in combination with passwords.

On March 2, 2023 (88 FR 13018) (Docket No. FDA–2019–N–0646), we revised the regulations. Before using an electronic signature in an electronic record required by FDA, a person must submit a letter of nonrepudiation to FDA (§ 11.100(c)). Letters of nonrepudiation are required under § 11.100(c)(1) to certify that a person's electronic signatures are intended to be the legally binding equivalent of traditional handwritten signatures. The regulations were amended to update the address for submission of a certification in paper form and to provide an option for electronic submission. The regulations were also amended to communicate that information on where to submit the certification may be found on FDA's website, currently available at: https://www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement.

In the Federal Register of September 19, 2023 (88 FR 64441), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

We estimate the burden of this collection of information as follows:

Based on a review of the information collection since our last request for OMB approval, we have increased our estimated burden. We assume 5,000 nonrepudiation letters will be submitted annually. We arrived at this figure by looking at the average number of nonrepudiation letters received through March 2023. We further assume that half of the estimated respondents will establish controls for open systems and half will establish controls for closed systems. Finally, we assume all respondents will establish controls for the remaining technical specifications required by the regulations.