Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 64441 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Voluntary national retail program standards (August 2022) Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

Program self-assessments for element Nos. 1 through 8 .. 500 1 500 92.3 ................ 46,150 

Program element No. 9; risk factor study and intervention 

strategy.

500 1 500 333 ................. 166,500 

Program Verification audit ................................................... 500 1 500 46.15 .............. 23,075 

Program records; associated documentation/maintenance 

of worksheets, assessments, associated program tools.

500 1 500 94.29 .............. 47,145 

FDA Form 3958; VNRFP National Registry Report ............ 500 1 500 0.1 (6 minutes) 50 

Requests for program documentation (dedicated email) .... 500 3 1,500 0.1 (6 minutes) 150 

Proposed Form FDA 5017; Waiver of Annual Maintenance 

Requirement.

10 1 10 0.35 (21 minutes).3.5 

Proposed Form FDA 5018; Food Safety Inspection Officer 

Annual Maintenance.

130 1 130 0.35 (21 minutes).43 

Proposed Form FDA 5019; Food Safety Inspection Officer 

Nomination.

14 1 14 0.35 (21 minutes).5 

Total .............................................................................. ........................ ........................ 4,154 ........................ 283,121.5 

1There are no capital or operational and maintenance costs associated with this collection of information. 

Our estimate of burden for the 

associated program activities as 

identified in table 1 is based on our 

experience with the information 

collection, along with other regulatory 

standards programs we administer. 

Upon reorganizing the collection to 

reflect the cumulative activities, we 

have accounted for burden that may be 

attributable recordkeeping for risk-factor 

studies and verification tasks that may 

have been previously overlooked. The 

burden we attribute to completing and 

submitting FDA Form 3958, ‘‘Voluntary 

National Retail Food Regulatory 

Program Standards FDA National 

Registry Report,’’ is exclusive of other 

program records, which we account for 

in row 4. We have also accounted for 

burden we assume will be attendant to 

the completion and submission of 

newly developed Agency forms. As a 

result of these changes and adjustments, 

the information collection reflects an 

increase of 235,776.5 hours and 1,654 

responses annually. 

Dated: September 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20226 Filed 9–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3743] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Electronic 

Records; Electronic Signatures 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection applicable to the electronic 

record signature provisions found in 

Agency regulations. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

November 20, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 20, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 


ddrumheller on DSK120RN23PROD with NOTICES1
64442 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–N–3743 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Good 

Laboratory Practice Requirements for 

Nonclinical Laboratory Studies.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

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: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

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) and) 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 3, 2023 (88 FR 13018), 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/aboutesg/appendix-g-letters-non-repudiationagreement. 

We estimate the burden of the 

information collection as follows: 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 64443 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

§ 11.100; submission of nonrepudiation letters ................... 5,000 1 5,000 1 5,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

record per 

recordkeepers 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

§ 11.10; controls for closed systems ................................... 2,500 1 2,500 20 50,000 

§ 11.30; controls for open systems ...................................... 2,500 1 2,500 20 50,000 

§ 11.50; signature manifestations ........................................ 5,000 1 5,000 20 100,000 

§ 11.300; controls for identifications and passwords ........... 5,000 1 5,000 20 100,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 300,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

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. 

Dated: September 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20233 Filed 9–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No.FDA–2023–D–2482] 

Regulatory Considerations for 

Prescription Drug Use-Related 

Software; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Regulatory Considerations for 

Prescription Drug Use-Related 

Software.’’ This draft guidance describes 

FDA’s application of its drug labeling 

authorities to certain software outputs 

that are disseminated by or on behalf of 

a drug sponsor for use with a 

prescription drug or a prescription drugled, drug-device combination product, 

which is assigned to the Center for Drug 

Evaluation and Research or the Center 

for Biologics Evaluation and Research as 

the lead center. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 18, 2023 to ensure that the 

Agency considers your comments on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–D–2482 for ‘‘Regulatory 

Considerations for Prescription Drug 

Use-Related Software.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 


ddrumheller on DSK120RN23PROD with NOTICES1