64440 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: September 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20229 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–2286] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Voluntary National 

Retail Food Regulatory Program 

Standards 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 October 19, 

2023. 

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 0910–0621. 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. 

Voluntary National Retail Food 

Regulatory Program Standards 

OMB Control Number 0910–0621— 

Revision 

This information collection helps 

support implementation of FDA’s 

Voluntary National Retail Food 

Regulatory Program Standards (the 

Retail Program Standards). Regulatory 

Program Standards play a critical role in 

an integrated food safety system and 

serve as the foundation for mutual 

reliance between FDA and other 

regulatory agencies that work to ensure 

food safety. The Retail Program 

Standards define what constitutes a 

highly effective and responsive program 

for the regulation of foodservice and 

retail food establishments. The Retail 

Program Standards are intended to 

provide a foundation upon which 

continuous improvements can be made 

with the ultimate goal to reduce the 

occurrence of factors that cause and 

contribute to foodborne illness. In 

support of this goal, FDA works 

cooperatively with our State, local, 

Territorial, and Tribal partners using a 

risk-based approach to leverage limited 

resources. We engage in education and 

outreach efforts to facilitate 

collaboration with our partners in food 

safety. The Retail Program Standards 

represent an important component of a 

comprehensive strategic approach to 

help ensure the safety and security of 

the food supply at the retail level. 

Respondents to the information 

collection are State, local, Territorial, 

and Tribal governments. 

The Retail Program Standards were 

revised most recently in August 2022 

and include the following elements: (1) 

regulatory foundation; (2) trained 

regulatory staff; (3) inspection program 

based on Hazard Analysis and Critical 

Control Point principles; (4) uniform 

inspection program, (5) foodborne 

illness and food defense preparedness 

and response; (6) compliance and 

enforcement; (7) industry and 

community relations; (8) program 

support and resources; and (9) program 

assessment. These elements are 

enumerated and discussed on our 

website at https://www.fda.gov/food/ 

voluntary-national-retail-foodregulatory-program-standards/ 

voluntary-national-retail-foodregulatory-program-standards-august2022 along with worksheets and 

assessments that allow FDA to 

determine conformance with the Retail 

Program Standards. State, local, 

territorial, tribal, and Federal regulatory 

agencies that participate in the 

voluntary program are required to report 

information demonstrating that a 

program self-assessment, a risk factor 

study of the regulated industry, and an 

independent outside audit (verification 

audit) have been completed. The 

information also includes Form FDA 

3958, ‘‘Voluntary National Retail Food 

Regulatory Program Standards FDA 

National Registry Report,’’ which may 

be completed electronically at https://

www.fda.gov/food/voluntary-nationalretail-food-regulatory-programstandards/voluntary-national-retailfood-regulatory-program-standardsaugust-2022. 

Finally, we are revising the 

information collection to include 

additional Agency resources. We have 

created a dedicated emailbox at 

retailfoodprotectionteam@fda.hhs.gov to 

receive requests for program 

documentation and have developed the 

following instruments to support the 

standardization of food safety 

inspection officer candidates: 

• Proposed Form FDA 5017, 

‘‘Standardized Retail Food Safety 

Inspection Officer Waiver of Annual 

Maintenance Requirement Form,’’ 

pertains to requests for waivers from 

maintenance requirements, referenced 

in section 3–403 of the ‘‘FDA 

Procedures for Standardization of Retail 

Food Safety Inspection Officers.’’ FDA 

uses the information submitted on Form 

FDA 5017 to determine a food safety 

inspection officer’s eligibility for 

restandardization. 

• Proposed Form FDA 5018, 

‘‘Standardized Retail Food Safety 

Inspection Officer Annual Maintenance 

Form,’’ provides verification that a food 

safety inspection officer has met 

program standardization requirements 

in accordance with section 3–403 of the 

‘‘FDA Procedures for Standardization of 

Retail Food Safety Inspection Officers.’’ 

• Proposed Form FDA 5019, 

‘‘Standardized Food Safety Inspection 

Officer Nomination Form,’’ allows FDA 

to collect qualification information from 

food safety inspection officer 

candidates. 

In the Federal Register of August 30, 

2023 (88 FR 42372) FDA 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: 


ddrumheller on DSK120RN23PROD with NOTICES1
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