79624 Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 

(Salmo salar) bearing a single copy of 

the a-form of the opAFP–GHc2 

recombinant DNA (rDNA) construct at 

the a-locus in the E.O.-1a lineage. AAS 

is designed to exhibit a rapid-growth 

phenotype. The November 19, 2015, 

NADA approval allowed for the AAS to 

be produced at a facility on Prince 

Edward Island (PEI), Canada, and grown 

at a facility in Panama (that has 

subsequently closed) and allowed for 

sale of food harvested from AAS in the 

United States. 

As part of the NADA review process 

under the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321, et seq.) 

and consistent with the mandates in the 

National Environmental Policy Act of 

1969 (NEPA) (42 U.S.C. 4321, et seq.) 

and FDA’s environmental impact 

considerations regulations (21 CFR part 

25), FDA’s Center for Veterinary 

Medicine prepared an EA dated 

November 12, 2015, for the original 

approval of the rDNA construct as 

integrated in the genome of AAS. Based 

on the 2015 EA and the specific 

conditions that were established in the 

NADA, FDA determined the action 

would not individually or cumulatively 

have a significant effect on the quality 

of the human environment in the United 

States. Therefore, FDA prepared a 

finding of no significant impact 

(FONSI). Based on the findings in the 

2015 EA, FDA also made a ‘‘no effect’’ 

determination under the Endangered 

Species Act (ESA) (16 U.S.C. 1531, et 

seq.), concluding that AAS, when 

produced and reared under the 

conditions in the application, and as 

described in the 2015 EA, would not 

jeopardize the continued existence of 

U.S. populations of threatened or 

endangered Atlantic salmon or result in 

the destruction or adverse modification 

of their critical habitat. 

Subsequently, several organizations 

filed suit in the U.S. District Court, 

Northern District of California, 

challenging, among other things, FDA’s 

evaluations under NEPA and the ESA 

for the 2015 NADA approval. On 

November 5, 2020, the Court found that 

‘‘FDA did not . . . meaningfully analyze 

what might happen to normal salmon in 

the event the engineered salmon did 

survive and establish themselves in the 

wild. Even if this scenario was unlikely, 

the FDA was still required to assess the 

consequences of it coming to pass.’’ The 

Court ordered FDA to complete the 

analysis and reconsider its ‘‘no effect’’ 

determination under the ESA together 

with a revised NEPA evaluation. See 

Inst. for Fisheries Res. v. United States 

Food and Drug Adm’n, 499 F. Supp. 3d 

657, 660 (N.D. Cal. 2020). However, the 

Court did not vacate the approval; the 

approval remains in effect. 

To address the November 5, 2020, 

Court opinion, we prepared a draft 

amended EA, titled ‘‘Draft Amended 

Environmental Assessment for 

Production of AquAdvantage Salmon at 

the Bay Fortune and Rollo Bay Facilities 

on Prince Edward Island, Canada.’’ We 

requested that the public review that 

draft amended EA and submit 

comments to the docket (87 FR 69032, 

November 17, 2022). We also held a 

virtual public meeting on December 15, 

2022, at which we solicited comment on 

the draft amended EA (87 FR 69030, 

November 17, 2022). 

In that draft amended EA, we 

expanded our assessment beyond that in 

the 2015 EA to include an exhaustive 

analysis of the likelihood and severity of 

harms that could occur if AAS and 

AquAdvantage broodstock (collectively 

referred to in the amended EA as ABT 

Salmon) are assumed to be present in 

the U.S. aquatic environment. We 

outlined the pathways necessary for 

ABT Salmon to escape confinement 

from the PEI facilities and migrate to 

and establish a persistent population in 

the United States. We also evaluated the 

potential pathways for disease 

(including pathogen and parasite) 

transmission from ABT Salmon and 

from the production of ABT Salmon at 

facilities on PEI to wild fish 

populations. In addition, we identified 

and evaluated the potential harms 

(consequences) to the U.S. environment 

and the endangered Atlantic salmon of 

the Gulf of Maine Distinct Population 

Segment if these highly unlikely 

scenarios were to occur. Finally, we 

revisited whether there is a potential for 

significant impacts on the U.S. 

environment under NEPA, and whether 

the action could result in effects on 

threatened and endangered Atlantic 

salmon and their critical habitat in the 

United States under the ESA. 

We note that the information and 

analyses in the draft amended EA 

reflected comments and input received 

from the National Marine Fisheries 

Service and the Fish and Wildlife 

Service during an ESA technical 

assistance review. 

We received 1,728 comment 

submissions on the draft amended EA. 

Please refer to ‘‘Summary Responses to 

Public Comments on the November 

2022 AAS Draft Amended 

Environmental Assessment’’ (https://

www.fda.gov/media/181568/download?

attachment) for a summary and FDA 

review of these comments. 

FDA is announcing the availability of 

an EA entitled ‘‘Amended 

Environmental Assessment for 

Production of AquAdvantage Salmon at 

the Bay Fortune and Rollo Bay Facilities 

on Prince Edward Island, Canada.’’ This 

document can be found at https://

animaldrugsatfda.fda.gov/adafda/ 

views/#/home/previewsearch/141- 

454#eaid. 

We have also prepared and are 

making available a FONSI and, based on 

the findings in the EA, have made a ‘‘no 

effect’’ determination under the ESA, 

concluding that AAS, when produced 

and reared under the conditions as 

described in the EA, will not jeopardize 

the continued existence of U.S. 

populations of threatened or endangered 

Atlantic salmon or result in the 

destruction or adverse modification of 

their critical habitat. This document can 

be found at https://animaldrugsatfda.

fda.gov/adafda/views/#/home/ 

previewsearch/141-454#eaid. 

Dated: September 24, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22308 Filed 9–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–4115] 

Clarification of Radiation Control 

Regulations for Manufacturers of 

Diagnostic X-Ray Equipment; 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Clarification of 

Radiation Control Regulations for 

Manufacturers of Diagnostic X-Ray 

Equipment.’’ This guidance provides 

clarification to industry and FDA staff of 

the Federal regulations that relate to 

diagnostic x-ray equipment. These 

regulations pertain to the recordkeeping, 

reporting, manufacturing, importing, 

and installation of an ‘‘electronic 

product’’ as defined in FDA regulations. 

This guidance supersedes FDA’s 1989 

guidance entitled ‘‘Clarification of 

Radiation Control Regulations for 

Diagnostic X-Ray Equipment.’’ 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 30, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 79625 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

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

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–4115 for ‘‘Clarification of 

Radiation Control Regulations for 

Manufacturers of Diagnostic X-Ray 

Equipment.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

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

Dockets Management Staff between 9 

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

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Clarification of 

Radiation Control Regulations for 

Manufacturers of Diagnostic X-Ray 

Equipment’’ to the Office of Policy, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request. 

FOR FURTHER INFORMATION CONTACT: 

Laurel Burk, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3668, Silver Spring, 

MD 20993–0002, 301–796–5933. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance provides clarification 

to industry and FDA staff of the Federal 

regulations that relate to diagnostic xray equipment. Under the Federal Food, 

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

diagnostic x-ray systems are considered 

to be both medical devices, under 

section 201(h) of the FD&C Act (21 

U.S.C. 321(h)), and electronic products, 

under section 531 of the FD&C Act (21 

U.S.C. 360hh). As such, they are subject 

to the provisions of the FD&C Act that 

apply to medical devices (e.g., sections 

510 and 520 of the FD&C Act (21 U.S.C. 

360 and 360j)), and their implementing 

regulations, as well as the provisions of 

the FD&C Act (sections 531 through 542 

of the FD&C Act (21 U.S.C. 360hh 

through 360ss)) that apply to electronic 

products, known as the Electronic 

Product Radiation Control (EPRC) 

provisions and their implementing 

regulations. FDA’s EPRC regulations 

pertain to the recordkeeping, reporting, 

manufacturing, importing, and 

installation of an ‘‘electronic product’’ 

as defined under 21 CFR 1000.3(j). This 

guidance supersedes FDA’s guidance 

entitled ‘‘Clarification of Radiation 

Control Regulations for Diagnostic XRay Equipment’’ (HHS Publication FDA 

89–8221 issued in March 1989). 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of December 17, 2018 (83 FR 

64584). FDA considered the comments 

received and revised the guidance as 

appropriate. Revisions include the 

addition of new questions and updates 

to existing questions in the sections 

related to alternate test methods to 

demonstrate compliance with 

performance standards, as well as the 

applicability of performance standards 

to x-ray based image-guidance used 

with radiation therapy devices, 

certification and associated labeling of 

certifiable components, assembly 

instructions, accidental radiation 

occurrence, and defects. In addition, 

FDA revised other questions and 

responses throughout the guidance to 

provide additional clarification and for 

editorial accuracy. Questions and 

responses related to certain reports that 

are no longer required were also 

removed (see ‘‘Radiological Health 

Regulations; Amendments to Records 

and Reports for Radiation Emitting 

Electronic Products; Amendments to 

Performance Standards for Diagnostic Xray, Laser, and Ultrasonic Products’’ 

published in the Federal Register of 

January 20, 2023 (88 FR 3638)). 

This guidance is being issued 

consistent with FDA’s good guidance 


ddrumheller on DSK120RN23PROD with NOTICES1
79626 Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Clarification of 

Radiation Control Regulations for 

Manufacturers of Diagnostic X-Ray 

Equipment.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

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

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Clarification of 

Radiation Control Regulations for 

Manufacturers of Diagnostic X-Ray 

Equipment’’ may send an email request 

to CDRH-Guidance@fda.hhs.gov to 

receive an electronic copy of the 

document. Please use the document 

number GUI01500029 and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in the following FDA table 

have been approved by OMB: 

21 CFR Part or FDA Form Topic OMB Control No. 

1002, 1005, 1010, 1020, 1030, 1040, and 1050; form FDA 

2579 and form FDA 2877.

Reporting and Recordkeeping for Electronic Products—General Requirements.0910–0025 

800, 801, and 809 ................................................................... Labeling ................................................................................... 0910–0485 

812 ........................................................................................... Investigational Device Exemption ........................................... 0910–0078 

‘‘Allegations of Regulatory Misconduct’’ form .......................... Voluntary Allegations of Regulatory Misconduct .................... 0910–0769 

Dated: September 25, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22332 Filed 9–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2024–N–0758, FDA– 

2024–N–2032, FDA–2023–N–3847, and FDA– 

2024–N–1201] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

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: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control No. Date approval 

expires 

New Plant Varieties Intended for Food Use ................................................................................................ 0910–0583 9/30/2027 

Food and Cosmetic Export Certificates ....................................................................................................... 0910–0793 9/30/2027 

Biological Products; General Records and Postmarket Adverse Experience Reporting ............................ 0910–0308 9/30/2027

Voluntary Total Product Life Cycle Advisory Program Pilot ........................................................................ 0910–0930 9/30/2027 


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