84146 Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 8 U.S.C. 1522(a)(3). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–26552 Filed 12–1–23; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2564] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Channels of Trade 

Policy for Commodities With Residues 

of Pesticide Chemicals, for Which 

Tolerances Have Been Revoked, 

Suspended, or Modified by the 

Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations 

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 January 3, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0562. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Channels of Trade Policy for 

Commodities With Residues of 

Pesticide Chemicals, for Which 

Tolerances Have Been Revoked, 

Suspended, or Modified by the 

Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations 

OMB Control Number 0910–0562— 

Extension 

This information collection supports 

FDA guidance. The Food Quality 

Protection Act of 1996 (Pub. L. 104– 

170), which amended the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) (Pub. L. 80–104) and the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), established a new safety 

standard for pesticide residues in food, 

with an emphasis on protecting the 

health of infants and children. The 

Environmental Protection Agency (EPA) 

is responsible for regulating the use of 

pesticides (under FIFRA) and for 

establishing tolerances or exemptions 

from the requirement for tolerances for 

residues of pesticide chemicals in food 

commodities (under the FD&C Act). 

EPA may, for various reasons, e.g., as 

part of a systematic review or in 

response to new information concerning 

the safety of a specific pesticide, 

reassess whether a tolerance for a 

pesticide residue continues to meet the 

safety standard in section 408 of the 

FD&C Act (21 U.S.C. 346a). When EPA 

determines that a pesticide’s tolerance 

level does not meet that safety standard, 

the registration for the pesticide may be 

canceled under FIFRA for all or certain 

uses. In addition, the tolerances for that 

pesticide may be lowered or revoked for 

the corresponding food commodities. 

Under section 408(l)(2) of the FD&C 

Act, when the registration for a 

pesticide is canceled or modified due to, 

in whole or in part, dietary risks to 

humans posed by residues of that 

pesticide chemical on food, the effective 

date for the revocation of such tolerance 

(or exemption in some cases) must be no 

later than 180 days after the date such 

cancellation becomes effective or 180 

days after the date on which the use of 

the canceled pesticide becomes 

unlawful under the terms of the 

cancellation, whichever is later. 

When EPA takes such actions, food 

derived from a commodity that was 

lawfully treated with the pesticide may 

not have cleared the channels of trade 

by the time the revocation or new 

tolerance level takes effect. The food 

could be found by FDA, the Agency that 

is responsible for monitoring pesticide 

residue levels and enforcing the 

pesticide tolerances in most foods (the 

U.S. Department of Agriculture has 

responsibility for monitoring residue 

levels and enforcing pesticide tolerances 

in meat, poultry, catfish, and certain egg 

products), to contain a residue of that 

pesticide that does not comply with the 

revoked or lowered tolerance. We would 

normally deem such food to be in 

violation of the law by virtue of it 

bearing an illegal pesticide residue. The 

food would be subject to FDA 

enforcement action as an ‘‘adulterated’’ 

food. However, the channels of trade 

provision of the FD&C Act addresses the 

circumstances under which a food is not 

unsafe solely due to the presence of a 

residue from a pesticide chemical for 

which the tolerance has been revoked, 

suspended, or modified by EPA. The 

channels of trade provision (section 

408(l)(5) of the FD&C Act) states that 

food containing a residue of such a 

pesticide shall not be deemed 

‘‘adulterated’’ by virtue of the residue, if 

the residue is within the former 

tolerance, and the responsible party can 

demonstrate to FDA’s satisfaction that 

the residue is present as the result of an 

application of the pesticide at a time 

and in a manner that were lawful under 

FIFRA. 

To assist respondents with the 

information collection, we have 

developed the guidance document 

entitled ‘‘Channels of Trade Policy for 

Commodities With Residues of Pesticide 

Chemicals, for Which Tolerances Have 

Been Revoked, Suspended, or Modified 

by the Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations’’ (May 2005). The 

guidance represents FDA’s current 

thinking on its planned enforcement 

approach to the channels of trade 

provision of the FD&C Act and how that 

provision relates to FDA-regulated 

products with residues of pesticide 

chemicals for which tolerances have 

been revoked, suspended, or modified 

by EPA under dietary risk 

considerations. The guidance can be 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices 84147 

found at the following link: https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

guidance-industry-channels-tradepolicy-commodities-residues-pesticidechemicals-which-tolerances. 

We anticipate that food bearing 

lawfully applied residues of pesticide 

chemicals that are the subject of future 

EPA action to revoke, suspend, or 

modify their tolerances, will remain in 

the channels of trade after the 

applicable tolerance is revoked, 

suspended, or modified. If we encounter 

food bearing a residue of a pesticide 

chemical for which the tolerance has 

been revoked, suspended, or modified, 

we intend to address the situation in 

accordance with provisions of the 

guidance. In general, we anticipate that 

the party responsible for food found to 

contain pesticide chemical residues 

(within the former tolerance) after the 

tolerance for the pesticide chemical has 

been revoked, suspended, or modified 

will be able to demonstrate that such 

food was handled, e.g., packed or 

processed, during the acceptable 

timeframes cited in the guidance by 

providing appropriate documentation to 

FDA as discussed in the guidance 

document. We are not suggesting that 

firms maintain an inflexible set of 

documents where anything less or 

different would likely be considered 

unacceptable. Rather, we are leaving it 

to each firm’s discretion to maintain 

appropriate documentation to 

demonstrate that the food was so 

handled during the acceptable 

timeframes. Examples of documentation 

that we anticipate will serve this 

purpose consist of documentation 

associated with packing codes, batch 

records, and inventory records. These 

are types of documents that many food 

processors routinely generate as part of 

their basic food-production operations. 

Description of Respondents: The 

likely respondents to this collection of 

information are firms in the produce 

and food processing industries that 

handle food products that may contain 

residues of pesticide chemicals after the 

tolerances for the pesticide chemicals 

have been revoked, suspended, or 

modified. 

In the Federal Register of August 2, 

2023 (88 FR 50880), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received 2 comments, 

one of which was not PRA related and 

will not be addressed in this document. 

The other comment questioned the 

utility of pesticide application records 

used to demonstrate a pesticide was 

applied at an acceptable time and in a 

lawful manner for crops commingled 

with other commodities. The channels 

of trade provision (section 408(l)(5) of 

the FD&C Act) states that food 

containing a residue of such a pesticide 

shall not be deemed ‘‘adulterated’’ by 

virtue of the residue, if the residue is 

within the former tolerance, and the 

responsible party can demonstrate to 

FDA’s satisfaction that the residue is 

present as the result of an application of 

the pesticide at a time and in a manner 

which were lawful under FIFRA. We 

leave it to each firm’s discretion to 

maintain appropriate documentation to 

demonstrate that the food was so 

handled during the acceptable 

timeframes. Pesticide spray records may 

be used as a documentation to 

demonstrate the residues in food are 

from an application of the pesticide at 

a time and in a manner which were 

lawful under FIFRA. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Submission of documentation .............................................. 1 1 1 3 3 

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

We expect the total number of 

pesticide tolerances that are revoked, 

suspended, or modified by EPA under 

dietary risk considerations in the next 3 

years to remain at a low level, as there 

have been no changes to the safety 

standard for pesticide residues in food 

since 1996. Thus, we expect the number 

of submissions we receive under the 

guidance document to also remain at a 

low level. However, to avoid counting 

this burden as zero, we have estimated 

the burden at one respondent making 

one submission a year for a total of one 

annual submission. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

record 

Total hours 

Develop documentation process ......................................... 1 1 1 16 16 

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


ddrumheller on DSK120RN23PROD with NOTICES1
84148 Federal Register / Vol. 88, No. 231 / Monday, December 4, 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: November 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26564 Filed 12–1–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–1929] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Orphan Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 3, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0167. 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. 

Orphan Drugs—21 CFR Part 316 

OMB Control Number 0910–0167— 

Extension 

This information collection helps 

support implementation of sections 525, 

526, 527, and 528 of the Federal Food, 

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

U.S.C. 360aa, 360bb, 360cc, and 360dd), 

as well as related guidance and Agency 

forms. Sections 525, 526, 527, and 528 

of the FD&C Act pertain to the 

development of drugs for rare diseases 

or conditions, including biological 

products and antibiotics, otherwise 

known or referred to as ‘‘orphan drugs.’’ 

Specifically, section 525 of the FD&C 

Act requires written recommendations 

on studies required for approval of a 

marketing application for a drug for a 

rare disease or condition. Section 526 of 

the FD&C Act provides for designation 

of drugs as orphan drugs when certain 

conditions are met; section 527 provides 

conditions under which a sponsor of an 

approved orphan drug enjoys exclusive 

FDA marketing approval for that drug 

for the orphan indication for a period of 

7 years; and, finally, section 528 is 

intended to encourage sponsors to make 

investigational orphan drugs available 

for treatment of persons in need on an 

open protocol basis before the drug has 

been approved for general marketing. 

Open protocols may permit patients 

who are not part of the formal clinical 

investigation to obtain treatment where 

adequate supplies exist and no 

alternative effective therapy is available. 

Agency regulations in part 316, 

subpart A (21 CFR part 316, subpart A) 

(§§ 316.1 through 316.4) identify the 

scope of coverage, applicable 

definitions, and statutory provisions 

applicable to orphan drugs. The 

regulations in part 316, subpart B 

(§§ 316.10 through 316.14) set forth 

content and format elements for written 

recommendation requests and discuss 

FDA providing or refusing to provide 

the requested written recommendations. 

Similarly, regulations in part 316, 

subpart C (§§ 316.20 through 316.30) 

prescribe content and format elements 

for requesting orphan drug designation; 

identify submission schedules for 

requisite information including 

amendments, updates, and reports; and 

provide for publication and revocation 

of orphan drug designation. Regulations 

in part 316, subparts D and E (§§ 316.31 

through 316.40) address orphan drug 

exclusive approval and open protocols 

for investigations, respectively. Finally, 

regulations in part 316, subpart F 

(§§ 316.50 through 316.52) provide for 

the issuance of guidance documents that 

apply to the orphan drug provisions of 

the FD&C Act and regulations in part 

316. The list is maintained on the 

internet and guidance documents are 

issued in accordance with our good 

guidance practices regulation in 21 CFR 

10.115, which provide for public 

comment at any time. 

The information collection includes 

the Agency guidance document entitled 

‘‘Meetings with the Office of Orphan 

Products Development: Guidance for 

Industry, Researchers, Patient Groups, 

and Food and Drug Administration 

Staff’’ (July 2015), available for 

download at: https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/meetings-officeorphan-products-development. It 

provides recommendations to industry, 

researchers, patient groups, and other 

stakeholders interested in requesting a 

meeting, including a teleconference, 

with the Office of Orphan Products 

Development (OOPD) on issues related 

to orphan drug designation requests, 

humanitarian use device designation 

requests, rare pediatric disease 

designation requests, funding 

opportunities through the Orphan 

Products Grants Program and the 

Pediatric Device Consortia Grants 

Program, and orphan product patientrelated topics of concern. It is also 

intended to assist OOPD staff in 

addressing such meeting requests. The 

guidance describes procedures for 

requesting, preparing, scheduling, 

conducting, and documenting such 

meetings and discusses background 

information we recommend be included 

in such requests. 

The information collection includes 

Form FDA 3671, Common EMEA/FDA 

Application for Orphan Medicinal 

Product, and Form FDA 4035, FDA 

Orphan Drug Designation Request Form, 

intended to benefit sponsors who desire 

to seek orphan designation of drugs 

intended for rare diseases or conditions 

from FDA. The form is a simplified 

method for sponsors to provide only the 

information required by § 316.20 for 

FDA decision making. Orphan drug 

designation requests and related 

submissions (amendments, annual 

reports, etc.), humanitarian use device 

designation, and rare pediatric disease 

designation requests and submissions 

may be submitted electronically by 

email to the OOPD. 

As communicated on our website at 

https://www.fda.gov/industry/medicalproducts-rare-diseases-and-conditions/ 

designating-orphan-product-drugs-andbiological-products, respondents may 

submit orphan drug designation 

requests electronically through the 

Center for Drug Evaluation and Research 

(CDER) NextGen portal, or by emailing 

the required information to 


ddrumheller on DSK120RN23PROD with NOTICES1