Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74939 

those injuries over time, inaction by 

voluntary standards organizations to address 

the blade-contact hazard effectively, and the 

high societal costs of these injuries, the 

Commission believes a performance 

requirement is necessary to reduce the 

unreasonable risk of blade-contact injuries on 

all table saws. 

(2) Later effective date. The proposed rule 

would require an effective date that is 36 

months after the final rule is published in the 

Federal Register. An effective date later than 

36 months could further reduce the impact 

of the rule on manufacturers because it 

would allow them additional time to benefit 

from the development of new AIM 

technologies by diverse suppliers, spread the 

costs of developing or negotiating for the 

rights to use AIM technology, modify the 

design of their table saws to incorporate the 

AIM technology, and retool their factories for 

production. However, almost certainly, a 

later effective date would also delay the 

ubiquitous availability of table saws with 

AIM technology into the market. Because we 

anticipate that a longer period will not be 

necessary for commercial availability of AIM 

technologies from diverse suppliers, the 

Commission finds that a 36-month effective 

date from the issuance of a final rule is an 

appropriate length of time. 

(3) Exempt contractor and cabinet saws, or 

industrial saws, from a product safety rule. 

The Commission considered whether to 

exempt certain types of saws commonly used 

by professional, commercial, or industrial 

users, based on their size, weight, power, or 

electrical specifications. Based on the 

severity of injuries and recurring hazard 

patterns of blade-contact injuries, coupled 

with the high societal costs of these injuries, 

though, a performance requirement is 

necessary to reduce the unreasonable risk of 

blade-contact injuries on all table saws. 

Moreover, there is no clear dividing line 

between consumer and professional saws. 

(4) Limit the applicability of the rule to 

some, but not all, table saws. The 

Commission considered limiting the scope of 

the rule to a subset of table saws to allow 

manufacturers to produce both table saw 

models with AIM technology, and models 

without AIM technology. However, based on 

the severity of injuries and recurring hazard 

patterns of blade-contact injuries, coupled 

with the high societal costs of these injuries, 

the Commission finds that a performance 

requirement is necessary to reduce the 

unreasonable risk of blade-contact injuries on 

all table saws. 

(5) Information and education campaign. 

The Commission considered whether to 

conduct an information and education 

campaign informing consumers about the 

dangers of blade-contact hazards, and the 

benefits of AIM technology. Although such a 

campaign could help inform consumers, 

without a performance requirement this 

approach would not be sufficient to address 

the unreasonable risk of blade-contact 

injuries on table saws. 

Alberta E. Mills, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2023–23898 Filed 10–31–23; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2011–N–0179] 

RIN 0910–AI75 

Prior Notice: Adding Requirement To 

Submit Mail Tracking Number for 

Articles of Food Arriving by 

International Mail and Timeframe for 

Post-Refusal and Post-Hold 

Submissions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing to amend its prior 

notice regulations to add a requirement 

that the prior notice for articles of food 

arriving by international mail include 

the name of the mail service and a mail 

tracking number and add a requirement 

that prior notice and food facility 

registration information be submitted 

within a certain timeframe, after certain 

notices of refusal or hold have been 

issued (‘‘post-refusal’’ and ‘‘post-hold’’ 

submission). We are also proposing 

certain technical changes, including 

those that reflect expanded capabilities 

of the Automated Broker Interface/ 

Automated Commercial Environment/ 

International Trade Data System (ABI/ 

ACE/ITDS) and the Prior Notice 

Systems Interface (PNSI). These 

amendments, if finalized, will improve 

program efficiency and better enable 

FDA to protect the U.S. food supply and 

public health. 

DATES: Either electronic or written 

comments on the proposed rule must be 

submitted by January 30, 2024. Submit 

written comments (including 

recommendations) on the collection of 

information under the Paperwork 

Reduction Act of 1995 (PRA) by January 

2, 2024. 

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 

January 30, 2024. 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 Comments 

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 below (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– 

2011–N–0179 for ‘‘Information Required 

in Prior Notice of Imported Food.’’ 

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, at 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74940 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

1Note that FDA intends to consider enforcement 

discretion when there is no prior notice if the food 

is offered for import for non-commercial purposes 

with a non-commercial shipper. See Compliance 

Policy Guide ‘‘Sec. 110.310 Prior Notice of 

Imported Food Under the Public Health Security 

and Bioterrorism Preparedness and Response Act of 

2002,’’ announced in the Federal Register on May 

6, 2009 (74 FR 20955). 

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. 

Submit comments on the information 

collection under the PRA to the Office 

of Management and Budget (OMB) at 

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 title of this 

proposed collection is ‘‘Prior Notice of 

Imported Food Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002.’’ 

FOR FURTHER INFORMATION CONTACT: 

With regard to the proposed rule: Peter 

Ajuonuma, Office of Regulatory Affairs, 

Food and Drug Administration, 12420 

Parklawn Dr., Rockville, MD 20852, 

301–796–2277, Peter.Ajuonuma@

fda.hhs.gov. 

With regard to the information 

collection: Domini Bean, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–706– 

5733, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Table of Abbreviations/Commonly Used 

Acronyms in This Document 

III. Background 

A. Introduction 

B. Need for the Regulation 

C. History of the Rulemaking 

IV. Legal Authority 

V. Description of the Proposed Rule 

VI. Proposed Effective Date 

VII. Preliminary Economic Analysis of 

Impacts 

A. Introduction 

B. Summary of Costs and Benefits 

VIII. Analysis of Environmental Impact 

IX. Paperwork Reduction Act of 1995 

X. Federalism 

XI. Consultation and Coordination With 

Indian Tribal Governments 

XII. Reference 

I. Executive Summary 

A. Purpose of the Proposed Rule 

FDA uses prior notice information to, 

among other things, determine what 

products should be inspected upon 

arrival into the United States. The 

proposed rule, if finalized, would: (1) 

amend § 1.281(b)(10) (21 CFR 

1.281(b)(10)) to add a requirement for 

people submitting prior notice for 

articles of food arriving by international 

mail to provide the name of the mail 

service and the mail tracking number; 1

(2) amend §§ 1.283 and 1.285 (21 CFR 

1.283 and 1.285) to add a requirement 

that prior notice be submitted within 10 

calendar days from the date a notice of 

refusal or hold was issued and that food 

facility registration be submitted within 

30 calendar days from the date a notice 

of refusal or hold was issued; and (3) 

make certain technical amendments. 

To effectively carry out its 

responsibility to detect food articles 

offered for import that are adulterated or 

pose a public health risk, FDA must be 

able to identify and inspect food items 

that are imported by international mail. 

Receiving the name of the mail service 

and a mail tracking number for articles 

of food arriving by international mail 

would enable FDA to better coordinate 

with the U.S. Postal Service (USPS), 

U.S. Customs and Border Protection 

(CBP), and other Agencies, to track and 

inspect articles that have been identified 

as a possible bioterrorism risk. 

Currently, FDA does not receive the 

name of the mail service or tracking 

numbers for articles of food arriving by 

international mail. This makes it 

difficult for FDA to stop articles from 

being delivered to U.S. recipients that 

FDA believes pose a bioterrorism risk. 

Having the name of the mail service and 

tracking numbers for articles of food 

arriving by international mail would 

help FDA better plan its operations and 

stop such articles from being delivered. 

Many foods are regularly imported by 

mail, and in FDA’s experience, these 

foods can present similar risks to the 

U.S. food supply as other imported 

foods. Further, FDA’s presence at 

international mail facilities supports 

that people are increasingly using the 

mail system to import foods, including 

foods that could pose a significant risk 

to public health. The use of the mail 

system to import food highlights the 

need for FDA to have the name of the 

mail service and tracking number to 

adequately monitor and refuse or hold 

specific food shipments. 

Additionally, requiring a reasonable 

timeframe for post-refusal and post-hold 

submissions of prior notice and food 

facility registration may reduce the 

amount of time articles subject to refusal 

or holds are held at ports of entry, thus 

reducing associated monetary charges. It 

would also enable FDA to utilize its 

resources more effectively by 

delineating the post-refusal and posthold submission timeframe. Without a 

date by which such submissions must 

be made, FDA has spent longer periods 

of time (e.g., weeks and months) 

reviewing multiple replacement noncompliant prior notice or registration 

submissions. 

Finally, regarding the technical 

changes to the regulations, FDA’s PNSI 

was developed to receive prior notice 

information for import submissions that 

could not be accommodated in the 

Automated Commercial System (ACS), 

mainly mail and baggage submissions, 

and prior notice for foods refused under 

section 801(m) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 381(m)). ACE, ACS’s successor 

system, can now accommodate such 

submissions. Therefore, we also propose 

to amend § 1.280(a)(2) (21 CFR 

1.280(a)(2)) to remove the requirement 

that prior notice of foods arriving by 

international mail be submitted through 

FDA PNSI. If finalized as proposed, 

prior notice for food arriving by 

international mail can be submitted 

through the PNSI or through the U.S. 

CBP ABI/ACE/ITDS. Further, we 

propose to amend § 1.281(a)(5)(iv), 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74941 

2 In 2003, the U.S. Treasury Department 

transferred to the Department of Homeland Security 

its regulatory authority relating to the requirements 

for prior notice. See Department of Treasury Order 

No. 100–16. 

3The prior notice regulation specifies that 

‘‘international mail’’ means foreign national mail 

services and does not include express consignment 

operators or carriers or other private delivery 

services unless such service is operating under 

contract as an agent or extension of a foreign mail 

service (21 CFR 1.276(b)(8)). 

4There are no longer any transaction types that 

cannot be made through ACE. 

(b)(4)(iv), and (c)(5)(iv) to crossreference product coding requirements 

for infant formula under § 106.80 (21 

CFR 106.80). These regulations 

currently cross-reference § 106.90 (21 

CFR 106.90) when referring to lot or 

code number requirements for infant 

formula. Section 106.90 establishes 

requirements related to current good 

manufacturing practice, while § 106.80 

establishes product coding requirements 

for infant formula. Therefore, if 

finalized as proposed, § 1.281(a)(5)(iv), 

(b)(4)(iv), and (c)(5)(iv) will be amended 

to refer to § 106.80 instead of § 106.90. 

B. Summary of the Major Provisions of 

the Proposed Rule 

FDA proposes to amend 

§§ 1.281(b)(10), 1.283(a)(6) and (c), 

1.285(g) and (i), and 1.280(a)(2). 

Currently, § 1.281(b)(10), which applies 

to articles arriving by international mail, 

requires only the submission of the 

anticipated date of mailing. If this 

amendment is finalized as proposed, 

§ 1.281(b)(10) will include an additional 

requirement to submit the name of the 

mail service and mail tracking number 

in the prior notice to FDA for food 

articles arriving by international mail. 

Sections 1.283(a)(6) and (c) and 

1.285(g) and (i), with few exceptions 

and if other requirements are met, 

require an article of food that has been 

refused under section 801(m) of the 

FD&C Act (no prior notice or inaccurate 

prior notice) or held under section 

801(1) of the FD&C Act (importation 

from unregistered foreign facility that is 

required to register) to be treated as 

general order merchandise under CBP 

regulations if no prior notice is 

submitted or resubmitted, or no 

registration is provided. However, these 

sections do not provide a timeframe 

within which such submissions must be 

made. If this amendment is finalized as 

proposed, § 1.283(c)(1) and (2) will 

require submission or resubmission of 

prior notice within 10 calendar days 

from the date the notice of refusal was 

issued. We believe that 10 days is an 

appropriate timeframe because it allows 

time for certain persons who want to file 

a request for FDA review pursuant to 

§ 1.283(d), to file their request, receive 

a response of the review decision, and 

submit or resubmit prior notice if 

necessary. 

In addition, if finalized as proposed, 

§ 1.285(i)(1) will require submission of a 

valid registration within 30 calendar 

days from the date a notice of hold was 

issued. We believe that 30 days is an 

appropriate timeframe in this context 

because it allows time to obtain and 

submit a valid registration if necessary. 

It also allows time to file a request for 

FDA review pursuant to § 1.285(j), 

receive a response of the review 

decision, and submit or resubmit 

registration if necessary. If a prior notice 

is not submitted or resubmitted, or a 

registration is not provided within the 

timeframe, these changes will require 

the article to be dealt with as set forth 

in CBP regulations relating to general 

order merchandise. Unless otherwise 

agreed to by CBP and FDA, the article 

may only be sold for export or 

destroyed. 

FDA also proposes to amend 

§ 1.280(a)(2). This regulation currently 

requires prior notice of articles of food 

imported or offered for import by 

international mail, and other transaction 

types that cannot be made through ABI/ 

ACE/ITDS, to be submitted through 

FDA PNSI. At this time, there are no 

longer any transaction types that cannot 

be made through ABI/ACE/ITDS. 

Therefore, this proposed amendment 

would remove the requirement that only 

the FDA PNSI be used for the 

submission of prior notice for articles of 

food arriving by international mail. 

Finally, FDA proposes to amend 

§ 1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) 

to refer to § 106.80 instead of § 106.90. 

C. Legal Authority 

Section 801(m) of the FD&C Act 

directs FDA to issue regulations 

requiring prior notice to FDA of an 

article of food that is imported or 

offered for import into the United States 

for the purpose of enabling such article 

to be inspected at ports of entry into the 

United States. Section 801(l) of the 

FD&C Act requires that an article of food 

that is imported or offered for import 

into the United States and that is from 

a foreign facility for which a registration 

has not been submitted to FDA under 

section 415 of the FD&C Act (21 U.S.C. 

350d) be held at the port of entry for the 

article until the foreign facility is so 

registered. Additionally, section 701(b) 

of the FD&C Act (21 U.S.C. 371(b)) 

authorizes FDA and CBP to prescribe 

regulations for the efficient enforcement 

of section 801 of the FD&C Act.2

D. Costs and Benefits 

We estimate the costs of the proposed 

rule, as accrued to submitters or 

transmitters of prior notices to read and 

understand the rule, and to gather and 

provide international mail tracking 

information, to be negligible. The 

proposed rule, if finalized, would not 

significantly increase costs to small 

entities. See the Preliminary Economic 

Analysis of Impacts for a detailed cost 

and benefit analysis. 

II. Table of Abbreviations/Commonly 

Used Acronyms in This Document 

Abbreviation/ 

acronym What it means 

ABI .................... Automated Broker Interface. 

ACE .................. Automated Commercial Environment. 

CBP .................. U.S. Customs and Border Protection. 

CPG .................. Compliance Policy Guide. 

E.O. .................. Executive Order. 

FD&C Act ......... Federal Food, Drug, and Cosmetic Act. 

FSMA ............... FDA Food Safety Modernization 

Act. 

GMP ................. Good Manufacturing Practice. 

OMB ................. Office of Management and Budget. 

PNSI ................. Prior Notice System Interface. 

USPS ................ U.S. Postal Service. 

III. Background 

A. Introduction 

FDA proposes to amend the prior 

notice regulation as follows: (1) amend 

§ 1.281(b)(10) to add a requirement to 

provide the name of the mail service 

and mail tracking number for articles of 

food imported or offered for import by 

international mail; 3 (2) amend 

§ 1.283(c) to require submission or 

resubmission of prior notice within 10 

calendar days from the date the notice 

of refusal under section 801(m) of the 

FD&C Act was issued and § 1.285(i) to 

require submission of food facility 

registration within 30 calendar days 

from the date the notice of hold under 

section 801(l) of the FD&C Act was 

issued; and (3) amend § 1.280(a)(2) to 

remove the requirement that articles of 

food imported or offered for import by 

international mail, and other transaction 

types that cannot be made through 

ACE,4 be submitted through FDA PNSI, 

and amend § 1.281(a)(5)(iv), (b)(4)(iv), 

and (c)(5)(iv) to cross-reference § 106.80 

instead of § 106.90. Section 307 of the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(the Bioterrorism Act) (Pub. L. 107–188) 

added section 801(m) to the FD&C Act 

and requires FDA to establish 

regulations requiring the submission of 

prior notice of food that is imported or 

offered for import into the United 

States. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74942 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

5 In March 2003, U.S. Customs Service was 

subsumed by the newly formed CBP (see Homeland 

Security Act of 2002, Pub. L. 107–296 (2002)) 

(https://www.cbp.gov/about/history#:∼:text=On%20

March%201%2C%202003%2C%20U.S.,boundaries

%20and%20ports%20of%20entry). 

B. Need for the Regulation 

The information in a prior notice 

enables FDA to target import 

inspections more effectively, thereby 

helping to protect our nation’s food 

supply against terrorist acts and other 

public health emergencies. FDA 

regulations require that specific 

information about food articles 

imported or offered for import into the 

United States be submitted in advance 

of arrival of the food. 

Currently, FDA does not require 

submission of the name of the 

international mail service or the mail 

tracking number for food articles 

imported by international mail; 

therefore, FDA has limited ability to 

track or locate the movement of food 

articles imported by international mail, 

which could pose a public health risk. 

Receiving the name of the mail carrier 

and the mail tracking number for food 

articles imported by international mail 

would assist FDA in conducting 

investigations and surveillance 

operations in response to a food-related 

emergency. Access to the name of the 

mail service and the tracking number 

would also enable FDA to act quickly to 

identify the affected food articles and 

prevent contamination of the food 

supply. It would also help to improve 

emergency response time, as FDA and 

other Agencies would be better 

equipped to identify, alert, and secure 

those facilities or entities that could be 

potentially impacted by a bioterrorism 

incident. Requiring the submission of 

this information would bolster FDA’s 

efforts to prevent violative and 

potentially dangerous food shipments 

from entering the United States at 

international mail facilities, and also 

could help FDA to track, identify, 

inspect, and contain such shipments. 

With this information available, FDA 

could better utilize its resources and 

plan its operations, given its knowledge 

of the movement, location, and time of 

the food’s arrival to the U.S. port of 

entry. 

Providing the name of the 

international mail service and the 

tracking number in the prior notice will 

also enable FDA to effectively 

coordinate a quicker response with 

other Agencies in the event of any 

suspected act of bioterrorism or public 

health emergency. For instance, if FDA 

receives information indicating that a 

particular international mail package 

contains a food article that could be 

affected by a bioterrorist incident or 

other food-related public health 

emergencies, FDA alerts CBP and USPS 

about the food article and the potential 

risk it may pose. Knowing the tracking 

number of that suspected contaminated 

food and the mail service carrier would 

help FDA, CBP, and USPS to track the 

origin and location of the international 

mail. The mail package could then be 

more easily identified and separated 

from other foods or incoming mail to 

safely conduct inspection to determine 

the degree of risk the article of food 

poses. This would enable FDA to 

prevent the article of food from entering 

the U.S. food supply chain more swiftly. 

Moreover, articles of food imported or 

offered for import without a prior notice 

or with inadequate prior notice are 

subject to refusal of admission or hold 

under section 801(m) of the FD&C Act. 

Articles of food imported or offered for 

import from an unregistered foreign 

food facility that is required to register 

are subject to being held under section 

801(l) of the FD&C Act. If an article of 

food is refused admission under section 

801(m) or held under section 801(l), 

certain persons may submit a request, 

within 5 calendar days of the refusal or 

hold, asking FDA to review whether the 

article is subject to the prior notice 

requirements, whether the information 

submitted in a prior notice is complete 

and accurate, or whether the facility 

associated with the article is subject to 

food facility registration requirements 

(§§ 1.283(d) and 1.285(j)). Alternatively, 

submitters or transmitters can attempt to 

come into compliance by submitting or 

resubmitting prior notice after refusal of 

admission (§ 1.283(c)), or by obtaining 

and providing a registration number for 

post-hold submissions (§ 1.285(i)). 

Requests for review under §§ 1.283(d) 

and 1.285(j) may not be used to submit 

or resubmit prior notice or obtain a 

registration number. 

Currently, FDA regulations do not 

require a timeframe within which an 

article of food must be brought into 

compliance by submitting or 

resubmitting prior notice or submitting 

a registration number if the article of 

food is refused or held. As a result, 

when articles of food are refused or held 

under section 801(m)(1) or section 

801(l) of the FD&C Act, they may be 

refused or held for several weeks while 

submitters or transmitters submit 

multiple replacement non-compliant 

prior notice or registration submissions 

to be reviewed by FDA. This practice 

consumes significant amounts of FDA 

reviewers’ time and may lead to 

importers incurring large demurrage 

charges (i.e., monetary charges due to a 

failure of goods to leave port). 

C. History of the Rulemaking 

The Bioterrorism Act amended the 

FD&C Act and created the requirement 

that FDA receive certain information 

about imported foods before their arrival 

in the United States. On February 3, 

2003, FDA and the Department of 

Treasury (U.S. Customs Service) 5 issued 

a joint notice of proposed rulemaking 

(68 FR 5428), requiring submission to 

FDA of prior notice of human and 

animal food that is imported or offered 

for import into the United States. On 

October 10, 2003, FDA issued an 

interim final rule (68 FR 58974) that 

requires the submission to FDA of prior 

notice of food, including animal food, 

that is imported or offered for import 

into the United States. In 2008, 2011, 

and 2017, FDA finalized and issued 

amendments to the prior notice 

regulation (see 73 FR 66294, November 

7, 2008, as amended at 76 FR 25542, 

May 5, 2011; 82 FR 15627, March 30, 

2017) to further improve the 

implementation of the prior notice 

requirement. 

For articles not arriving by 

international mail, the prior notice rule 

requires the submission of anticipated 

arrival information and planned 

shipment information to provide FDA 

with information necessary for planning 

examinations and communicating with 

CBP for enforcement and examination 

purposes (see § 1.281(a)(11) and (17), 68 

FR 58974 at 59009 and 59011). Further, 

FDA requires the identification of the 

carrier because the information is 

necessary to enable FDA and CBP to 

identify the appropriate article of food 

for inspection or holding when the food 

arrives in the United States (see 

§ 1.281(a)(16), 68 FR 58974 at 59011). 

The 2008 final rule added the ability, 

under § 1.281(a)(11), to submit the 

tracking number for food articles 

arriving by express consignment 

operator or carrier, as part of the 

anticipated arrival information of the 

food or planned shipment information 

(73 FR 66294 at 66297). In the 2017 

amendment to the prior notice rule, we 

removed certain limitations regarding 

the submission of a tracking number (82 

FR 15627 at 15628). In doing so, we 

reiterated the importance of the tracking 

number to learn the information that 

FDA needs to make entry 

determinations, such as port, date, and 

time of arrival. In the 2017 amendment, 

we also eliminated some requirements 

for submitting prior notice due to the 

expanded capabilities of ACE, such as 

the requirement to submit articles that 

have been refused under section 

801(m)(1) of the FD&C Act or subpart I 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74943 

in FDA PNSI. ACE can now 

accommodate this type of entry and 

others it previously could not, such as 

articles of food arriving through 

international mail and baggage entries. 

The amendments described in this 

proposed rule would further align the 

prior notice rule with requirements that 

exist for food not arriving by 

international mail and better reflect 

ACE’s expanded capabilities. 

In addition, in the 2003 interim final 

rule, we stated that under § 1.283(a)(6), 

if no prior notice, correction (i.e., prior 

notice resubmission), or request for FDA 

review is submitted in a timely fashion, 

following a refusal under section 801(m) 

of the FD&C Act, the food will be dealt 

with as set forth in CBP regulations 

relating to general order merchandise, 

except that it may only be sold for 

export or destroyed as agreed to by CBP 

and FDA (68 FR 58974 at 59020 and 

59021). Similarly, we stated that under 

§ 1.285(g), if an article of food is placed 

under hold under section 801(l) of the 

FD&C Act and no registration or request 

for FDA review is submitted in a timely 

fashion, the food will be dealt with as 

set forth in CBP regulations relating to 

general order merchandise, except that 

it may only be sold for export or 

destroyed as agreed to by CBP and FDA 

(68 FR 58974 at 59076). 

In the 2008 final rule, we ‘‘made a 

minor change in the text of § 1.283(a)(6) 

by replacing the phrase, ‘in a timely 

fashion,’ with the phrase, ‘in accordance 

with paragraph (d) [of § 1.283],’ to 

clarify that the timeliness of a request 

for FDA review is found at paragraph (d) 

[of that section]. We made a similar 

change in § 1.285(g)’’ (73 FR 66294 at 

66370). That change requires requests 

for FDA review under §§ 1.283(d) and 

1.285(j) to be submitted within 5 

calendar days of the refusal or hold and 

removes the requirement that postrefusal and post-hold submissions be 

submitted in a timely fashion or be 

subject to any timeframe. However, 

§§ 1.283(a)(6) and 1.285(g) state that, if 

an article of food is refused or held 

under section 801(m) or (l) of the FD&C 

Act, and no prior notice is submitted or 

resubmitted, or no registration is 

provided, the food must be dealt with as 

set forth in CBP regulations relating to 

general order merchandise. 

It is difficult for FDA to administer 

these provisions without a requirement 

for when the prior notice must be 

submitted or resubmitted or for when 

registration must be provided. There is 

currently no uniform and predictable 

date by which such submissions must 

be made before the article is treated as 

CBP general order merchandise. As 

such, there have been instances where 

articles are refused or held for 

prolonged periods of time (e.g., weeks 

and months) while submitters or 

transmitters submit multiple 

replacement non-compliant prior notice 

or registration submissions that must be 

reviewed by FDA. This is not an 

effective use of FDA resources and 

personnel and can lead to the 

accumulation of large demurrage 

charges for those articles that are subject 

to hold or refusal. This proposed rule 

would amend such provisions by 

imposing a timeframe for post-refusal 

and post-hold submissions. 

IV. Legal Authority 

We are issuing this proposed rule 

under section 801(m) of the FD&C Act, 

which directs FDA to implement a 

regulation requiring prior notification to 

FDA of food that is imported or offered 

for import into the United States; 

section 801(l) of the FD&C Act, which 

requires that a food article being 

imported or offered for import into the 

United States that is from a foreign 

facility for which a registration has not 

been submitted under section 415 of the 

FD&C Act be held at the port of entry 

until the foreign facility is so registered; 

and section 701(b) of the FD&C Act, 

which authorizes FDA and CBP to 

jointly issue regulations for the efficient 

enforcement of section 801 of the FD&C 

Act. 

In the 2003 interim final rule, we 

stated that the planned shipment 

information is necessary to ensure the 

effective enforcement of section 801(m) 

of the FD&C Act (68 FR 58974 at 59012). 

The tracking information is considered 

part of the planned shipment 

information as it is currently allowed to 

be submitted under § 1.281(a)(17). In 

both the 2003 and 2008 final rules, we 

explained that certain information not 

explicitly mentioned in section 801(m) 

of the FD&C Act is required for the 

efficient enforcement of the 

Bioterrorism Act (68 FR 58974 at 59001 

and 73 FR 66294 at 66340). We now 

tentatively determine that, for articles of 

food arriving by international mail, the 

name of the mail service and the mail 

tracking number is necessary for the 

efficient enforcement of section 801(m) 

of the FD&C Act. Additionally, we 

tentatively determine that imposing a 

timeframe on post-refusal and post-hold 

submissions of prior notice and food 

facility registration is necessary for the 

efficient enforcement of sections 801(m) 

and 801(l) of the FD&C Act. 

V. Description of the Proposed Rule 

The proposed rule, if finalized, will 

amend §§ 1.281(b)(10) to require the 

submission of the name of the mail 

service and mail tracking number in the 

prior notice for articles of food sent by 

international mail. Currently, 

§ 1.281(b)(10) requires only the 

submission of the anticipated date of 

mailing. If the proposed rule is 

finalized, § 1.281(b)(10) will include an 

additional requirement to submit the 

name of the international mail service 

used in mailing the article and the mail 

tracking number in the prior notice of 

the article to FDA, for food articles 

arriving by international mail. We 

believe international mail packages 

usually bear tracking numbers that 

could be used to track the mail or 

identify its country of origin. We 

welcome comments regarding any 

country where a tracking number is not 

issued for international mail. 

The proposed rule will also amend 

§§ 1.283(a)(6) and (c), and 1.285(g) and 

(i)(1) to require post-refusal and posthold submissions of prior notice to be 

submitted within 10 calendar days and 

post-refusal and post-hold submissions 

of registration be submitted within 30 

calendar days from the date the notice 

of refusal or hold was issued. If the prior 

notice or registration requirements are 

not met within these timeframes, the 

article shall be dealt with as set forth in 

CBP regulations relating to general order 

merchandise. Unless otherwise agreed 

to by CBP and FDA, the article may only 

be sold for export or destroyed. We 

believe that 30 calendar days is an 

appropriate timeframe for registration 

submissions because it gives time to 

obtain and submit a valid registration, 

as well as time to file a request for 

review by FDA and receive a response 

of the review decision, and to submit 

the required information, if necessary. 

However, we are willing to consider 

other timeframes. Therefore, FDA 

invites public comment on whether 30 

calendar days would be an appropriate 

timeframe for registration submission or 

if a different timeframe would be more 

appropriate. For comments suggesting a 

timeframe, we request an explanation of 

the reason. 

If finalized, the proposed change to 

§ 1.280(a)(2) will remove the 

requirement that articles of food arriving 

by international mail be submitted in 

FDA PNSI. This change will allow a 

prior notice submitter to use CBP’s ABI/ 

ACE/ITDS as an alternative to FDA 

PNSI to submit prior notice of articles 

of food imported or offered for import 

by international mail. 

This proposal would also make 

technical amendments to 

§ 1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) 

to correct a cross-reference in the 

regulation to § 106.80 instead of 

§ 106.90. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74944 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

VI. Proposed Effective Date 

FDA is proposing that the final rule 

based on this proposal become effective 

30 days after the date of publication in 

the Federal Register. 

VII. Preliminary Economic Analysis of 

Impacts 

A. Introduction 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 14094, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). 

Executive Orders 12866, 13563, and 

14094 direct us to assess all benefits, 

costs, and transfers of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). Rules 

are ‘‘significant’’ under Executive Order 

12866 Section 3(f)(1) (as amended by 

Executive Order 14094) if they ‘‘have an 

annual effect on the economy of $200 

million or more (adjusted every 3 years 

by the Administrator of [the Office of 

Information and Regulatory Affairs 

(OIRA)] for changes in gross domestic 

product); or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, territorial, or tribal 

governments or communities.’’ OIRA 

has determined that this proposed rule 

is not a significant regulatory action 

under Executive Order 12866 Section 

3(f)(1). 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because the proposed change to prior 

notice requirements would not 

significantly increase costs to small 

entities, we propose to certify that the 

proposed rule will not have a significant 

economic impact on a substantial 

number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes estimates of anticipated 

impacts, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $177 

million, using the most current (2022) 

Implicit Price Deflator for the Gross 

Domestic Product. This proposed rule 

would not result in an expenditure in 

any year that meets or exceeds this 

amount. 

B. Summary of Costs and Benefits 

This proposed rule would amend 

existing prior notice regulations to 

require the submission of tracking 

information for food articles imported 

using international mail. To estimate 

costs and benefits associated with the 

proposed rule, we assume that the 

appropriate baseline is the state of the 

world with current prior notice 

regulations. We then compare the likely 

impacts of the proposed rule against this 

baseline. The costs of the proposed rule, 

if finalized, accrue to submitters or 

transmitters of prior notices for reading 

and understanding the rule and the 

additional time needed to gather and 

provide the tracking information. When 

annualized over a period of 10 years, we 

estimate these costs range from 

approximately $0.04 million to $0.50 

million at a 3 percent rate of discount. 

At a 7 percent rate of discount, these 

costs range from approximately $0.04 

million to $0.52 million. Our primary 

annualized estimates are approximately 

$0.27 million and $0.28 million at 3 and 

7 percent rates of discount, respectively. 

We estimate benefits in the form of 

cost-savings which accrue to 

transmitters of prior notices and to FDA. 

These cost-savings range in annualized 

value from approximately $0.04 million 

to $0.18 million for both 3 and 7 percent 

rates of discount. The primary 

annualized value is $0.09 million for 

both rates of discount. These estimates 

are summarized in table 1. 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Benefits: 

Annualized Monetized $millions/year .................................................... $0.09 

0.09 

$0.04 

0.04 

$0.18 

0.18 

2021 

2021 

7 

3 

10 

10 

Annualized Quantified ........................................................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ..............................................................................................

Costs: 

Annualized Monetized $millions/year .................................................... 0.28 

0.27 

0.04 

0.04 

0.52 

0.50 

2021 

2021 

7 

3 

10 

10 

Annualized Quantified ........................................................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ..............................................................................................

Transfers: 

Federal Annualized Monetized $millions/year ....................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To ................................................................................................. From: To: 

Other Annualized Monetized $millions/year .......................................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To ................................................................................................. From: To: 

Effects: 

State, Local or Tribal Government: None. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74945 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE—Continued 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Small Business: None. 

Wages: 

Growth: 

We have developed a comprehensive 

Preliminary Economic Analysis of 

Impacts that assesses the impacts of the 

proposed rule. The full preliminary 

analysis of economic impacts is 

available in the docket for this proposed 

rule (Ref. 1) and at https://www.fda.gov/ 

about-fda/reports/economic-impactanalyses-fda-regulations. 

VIII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(h) that this proposed action is of 

a type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IX. Paperwork Reduction Act of 1995 

This proposed rule contains 

information collection provisions that 

are subject to review by OMB under the 

PRA (44 U.S.C. 3501–3521). A 

description of these provisions is given 

in the Description section of this 

document with an estimate of the 

annual reporting. Included in the 

estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing each 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. 

Title: Prior Notice of Imported Food 

Under the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002; OMB Control No. 

0910–0520—Revision. 

Description: FDA is amending its 

regulations governing notification 

requirements for articles of food being 

imported or offered for import into the 

United States and is making 

corresponding changes to the 

information collection. Specifically, we 

are revising the data elements required 

in prior notice notifications under 

section 801(m) of the FD&C Act to 

include mail service name and mail 

tracking number. 

FDA intends to use the information to 

better identify, track, contain, and 

inspect articles of food sent through 

international mail that it has reason to 

believe present a bioterrorism threat or 

public health concern. We believe 

having the name of the mail service and 

the mail tracking number will improve 

our ability to identify and prevent such 

food articles from entering the U.S. food 

supply, as well as reduce challenges 

associated with locating articles without 

this information. 

Description of Respondents: Persons 

submitting prior notice for articles of 

food imported or offered for import into 

the United States. 

Burden: FDA estimates the burden of 

this collection of information as follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR section Number of 

respondents 

Average 

number of 

responses per 

respondent 

Total annual 

responses 

Average 

one-time 

burden per 

respondent 

(in minutes) 

Average 

burden per 

response 

(in minutes) 

Total annual 

hours 

1.281(b)(10) ............................................................................... 5,460 143 781,219 30 4 54,811 

Based on 2021 fiscal year data from 

our Online Reporting Analysis Decision 

Support System, we estimate that 

26,200 persons submit prior notice 

through PNSI. We assume 5,460, or 

roughly 20 percent, are importing or 

offering for import articles of food by 

international mail. The proposed 

requirement to submit tracking 

information applies only to persons 

importing or offering for import articles 

of food by international mail. The 

number of prior notices for international 

mail entries per respondent per year 

ranges from 1 to approximately 5,000. 

The average number of prior notice 

submissions for international mail 

entries per person per year is 

approximately 143. Of the more than 18 

million prior notices received by FDA 

per year, approximately 781,219 are 

identified as ‘‘mail.’’ 

We estimate a one-time average 

burden of 30 minutes per respondent to 

learn the new requirement and 

coordinate with mail services to 

establish best practices for receiving and 

providing the information. In addition 

to the one-time burden, we estimate an 

average recurring annual burden of 4 

minutes per prior notice mail 

submission. The one-time total burden 

for all the 5,460 respondents amounts to 

163,800 minutes (5,460 × 30). The total 

recurring burden for all the 781,219 

mail entries is 3,124,876 minutes 

(781,219 × 4). Therefore, we estimate the 

average total annual recurring burden in 

hours to be 54,811 (163,800 + 3,124,876 

÷ 60). 

To ensure that comments on 

information collection are received, 

OMB recommends that written 

comments be submitted through https:// 

www.reginfo.gov/public/do/PRAMain 

(see ADDRESSES). All comments should 

be identified with the title of the 

information collection. 

In compliance with the PRA (44 

U.S.C. 3407(d)), we have submitted the 

information collection provisions of this 

proposed rule to OMB for review. These 


ddrumheller on DSK120RN23PROD with PROPOSALS1

I I I I I I 
74946 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

information collection requirements 

will not be effective until FDA 

publishes a final rule, OMB approves 

the information collection requirements, 

and the rule goes into effect. FDA will 

announce OMB approval of these 

requirements in the Federal Register. 

X. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that this proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the Executive 

Order and, consequently, a federalism 

summary impact statement is not 

required. 

XI. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that the 

rule does not contain policies that 

would have a substantial direct effect on 

one or more Indian Tribes, on the 

relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. FDA 

solicits comments from tribal officials 

on any potential impact on Indian 

Tribes from this proposed action. 

XII. Reference 

The following reference is on display 

in the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m. Monday through Friday; it is 

also available electronically at https://

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. Preliminary Regulatory Impact Analysis, 

Requirement for Submission of Mail 

Tracking Number or Tracking Code for 

Food Articles Arriving by International 

Mail; available at https://www.fda.gov/ 

about-fda/reports/economic-impactanalyses-fda-regulations. 

List of Subjects in 21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, FDA proposes to 

amend 21 CFR part 1 as follows: 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

■ 1. The authority citation for part 1 

continues to read as follows: 

Authority: 15 U.S.C. 1333, 1453, 1454, 

1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 

321, 331, 332, 333, 334, 335a, 342, 343, 350c, 

350d, 350j, 352, 355, 360b, 360ccc, 360ccc– 

1, 360ccc–2, 362, 371, 374, 381, 382, 384a, 

387, 387a, 387c, 393, and 2223; 42 U.S.C. 

216, 241, 243, 262, 264, 271. 

■ 2. In § 1.280 revise paragraph (a)(2) to 

read as follows: 

§ 1.280 How must you submit prior notice? 

(a) * * * 

(2) The FDA Prior Notice System 

Interface (FDA PNSI) at https://

www.access.fda.gov/. 

* * * * * 

■ 3. In § 1.281 revise paragraphs 

(a)(5)(iv), (b)(4)(iv), (10), and (11), and 

(c)(5)(iv) to read as follows: 

§ 1.281 What information must be in a 

prior notice? 

(a) * * * 

(5) * * * 

(iv) The lot or code numbers or other 

identifier of the food if required by the 

act or FDA regulations, e.g., low-acid 

canned foods, by § 113.60(c) of this 

chapter; acidified foods, by § 114.80(b) 

of this chapter; and infant formula, by 

§ 106.80 of this chapter; 

* * * * * 

(b) * * * 

(4) * * * 

(iv) The lot or code numbers or other 

identifier of the food if required by the 

act or FDA regulations, e.g., low-acid 

canned foods, by § 113.60(c) of this 

chapter; acidified foods, by § 114.80(b) 

of this chapter; and infant formula, by 

§ 106.80 of this chapter; 

* * * * * 

(10) The anticipated date of mailing, 

the name of the mail service, and the 

mail tracking number; 

(11) The name and address of the U.S. 

recipient; and 

* * * * * 

(c) * * * 

(5) * * * 

(iv) The lot or code numbers or other 

identifier of the food if required by the 

act or FDA regulations, e.g., low-acid 

canned foods, by § 113.60(c) of this 

chapter; acidified foods, by § 114.80(b) 

of this chapter; and infant formula, by 

§ 106.80 of this chapter; 

* * * * * 

■ 4. In § 1.283 revise paragraphs (a)(6), 

(c)(1), and (c)(2) to read as follows: 

§ 1.283 What happens to food that is 

imported or offered for import without 

adequate prior notice? 

(a) * * * 

(6) No post-refusal submission or 

request for review. If an article of food 

is refused under section 801(m)(1) of the 

act and no prior notice is submitted or 

resubmitted in accordance with 

paragraph (c) of this section, no request 

for FDA review is submitted in 

accordance with paragraph (d) of this 

section, or export has not occurred in 

accordance with paragraph (a)(5) of this 

section, the article of food shall be dealt 

with as set forth in CBP regulations 

relating to general order merchandise 

(19 CFR part 127), except that, unless 

otherwise agreed to by CBP and FDA, 

the article may only be sold for export 

or destroyed. 

* * * * * 

(c) * * * 

(1) If an article of food is refused 

under paragraph (a)(1)(i) of this section 

(no prior notice) and the food is not 

exported, prior notice must be 

submitted in accordance with §§ 1.280 

and 1.281(c) within 10 calendar days 

from the date the notice of refusal was 

issued. 

(2) If an article of food is refused 

under paragraph (a)(1)(ii) of this section 

(inaccurate prior notice) and the food is 

not exported, the prior notice should be 

canceled in accordance with § 1.282 and 

you must resubmit prior notice in 

accordance with §§ 1.280 and 1.281(c) 

within 10 calendar days from the date 

the notice of refusal was issued. 

* * * * * 

■ 5. In § 1.285 revise paragraphs (g) and 

(i)(1) to read as follows: 

§ 1.285 What happens to food that is 

imported or offered for import from 

unregistered facilities that are required to 

register under subpart H of this part? 

* * * * * 

(g) No registration or request for 

review. If an article of food is placed 

under hold under section 801(l) of the 

act and no registration number is 

submitted in accordance with paragraph 

(i) of this section, or no request for FDA 

review is submitted in accordance with 

paragraph (j) of this section, or export 

has not occurred in accordance with 

paragraph (f) of this section, the food 

shall be dealt with as set forth in CBP 

regulations relating to general order 

merchandise. Unless otherwise agreed 

to by CBP and FDA, the article may only 

be sold for export or destroyed. 

* * * * * 

(i) * * * 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74947 

(1) To resolve a hold, if an article of 

food is held under paragraph (b) of this 

section because it is from a foreign 

facility that is not registered, the facility 

must be registered, and a valid 

registration number must be obtained 

and submitted to the FDA Division of 

Food Defense Targeting within 30 

calendar days from the date the notice 

of hold was issued. 

* * * * * 

Dated: October 26, 2023. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2023–24086 Filed 10–31–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 414, 425, and 495 

Office of the Secretary 

45 CFR Part 171 

RIN 0955–AA05 

21st Century Cures Act: Establishment 

of Disincentives for Health Care 

Providers That Have Committed 

Information Blocking 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS) and Office of 

the National Coordinator for Health 

Information Technology (ONC), 

Department of Health and Human 

Services (HHS). 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

implement the provision of the 21st 

Century Cures Act specifying that a 

health care provider determined by the 

HHS Inspector General to have 

committed information blocking shall 

be referred to the appropriate agency to 

be subject to appropriate disincentives 

set forth through notice and comment 

rulemaking. In particular, this 

rulemaking would establish for such 

health care providers a set of 

appropriate disincentives using 

authorities under applicable Federal 

law. 

DATES: To be assured consideration, 

written or electronic comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

January 2, 2024. 

ADDRESSES: You may submit comments, 

identified by RIN 0955–AA05, by any of 

the following methods (please do not 

submit duplicate comments). Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

• Federal eRulemaking Portal: Follow 

the instructions for submitting 

comments. Attachments should be in 

Microsoft Word, Microsoft Excel, or 

Adobe PDF; however, we prefer 

Microsoft Word. https://

www.regulations.gov. 

• Regular, Express, or Overnight Mail: 

Department of Health and Human 

Services, Office of the National 

Coordinator for Health Information 

Technology, Attention: 21st Century 

Cures Act: Establishment of 

Disincentives for Health Care Providers 

That Have Committed Information 

Blocking Proposed Rule, Mary E. 

Switzer Building, Mail Stop: 7033A, 330 

C Street SW, Washington, DC 20201. 

Please submit one original and two 

copies. 

• Inspection of Public Comments: All 

comments received before the close of 

the comment period will be available for 

public inspection, including any 

personally identifiable or confidential 

business information that is included in 

a comment. Please do not include 

anything in your comment submission 

that you do not wish to share with the 

general public. For example, people 

typically do not wish to, and generally 

should not, share with the general 

public information such as: any person’s 

social security number; date of birth; 

driver’s license number; state 

identification number or foreign country 

equivalent; passport number; financial 

account number; credit or debit card 

number; individually identifiable health 

information; or any business 

information that could be considered 

proprietary. We will post all comments 

that are received before the close of the 

comment period at https://

www.regulations.gov. 

• Docket: For access to the docket to 

read background documents or 

comments received, go to https://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Alexander Baker, Office of Policy, 

Office of the National Coordinator for 

Health Information Technology (ONC), 

(202) 690–7151, for general issues. 

Elizabeth Holland, Centers for 

Medicare & Medicaid Services (CMS), 

(443) 934–2532, for issues related to the 

Promoting Interoperability Program and 

the Promoting Interoperability 

performance category of the Merit-Based 

Incentive Payment System. 

Aryanna Abouzari, Centers for 

Medicare & Medicaid Services (CMS), 

(415) 744–3668 or 

SharedSavingsProgram@cms.hhs.gov, 

for issues related to the Medicare 

Shared Savings Program. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of Regulatory Action 

B. Summary of Major Provisions 

C. Costs and Benefits 

II. Background 

A. Statutory Basis 

B. Regulatory History 

1. ONC Cures Act Final Rule 

2. Office of Inspector General (OIG) Civil 

Money Penalties (CMP) Final Rule 

III. Provisions of the Proposed Regulation 

A. Relevant Statutory Terms and 

Provisions 

1. Appropriate Agency 

2. Authorities Under Applicable Federal 

Law 

3. Appropriate Disincentives 

B. Approach To Determination of 

Information Blocking and Application of 

Disincentives 

1. OIG Investigation and Referral 

2. General Provisions for Application of 

Disincentives 

3. Transparency for Information Blocking 

Determinations, Disincentives, and 

Penalties 

C. Appropriate Disincentives for Health 

Care Providers 

1. Background 

2. Medicare Promoting Interoperability 

Program for Eligible Hospitals and 

Critical Access Hospitals (CAHs) 

3. Promoting Interoperability Performance 

Category of the Medicare Merit-Based 

Incentive Payment System (MIPS) 

4. Medicare Shared Savings Program 

IV. Request for Information 

V. Collection of Information Requirements 

VI. Regulatory Impact Statement 

A. Executive Order No. 12866 

B. Regulatory Flexibility Act 

C. Unfunded Mandates Reform Act 

D. Executive Order 13132 

I. Executive Summary 

A. Purpose of Regulatory Action 

This proposed rule would implement 

the 21st Century Cures Act (Cures Act) 

provision for referral of a health care 

provider (individual or entity) 

determined by the HHS Office of 

Inspector General (OIG) to have 

committed information blocking ‘‘to the 

appropriate agency to be subject to 

appropriate disincentives using 

authorities under applicable Federal 

law, as the Secretary sets forth through 

notice and comment rulemaking’’ (42 

U.S.C. 300jj–52(b)(2)(B), Public Health 

Service Act (PHSA) section 

3022(b)(2)(B), as added by section 4004 

of the Cures Act (Pub. L. 114–255, Dec. 

13, 2016)). The proposals in this rule 

would establish disincentives for certain 

health care providers (as defined in 45 

CFR 171.102) that are also Medicareenrolled providers or suppliers. 


ddrumheller on DSK120RN23PROD with PROPOSALS1