Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Guidance for Industry and Food and Drug Administration Staff; Availability, 79624-79626 [2024-22332]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:51 Sep 27, 2024 Jkt 262001 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 PO 00000 Frm 00124 Fmt 4703 Sfmt 4703 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/141454#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. 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 SUMMARY: E:\FR\FM\30SEN1.SGM 30SEN1 Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices Agency guidances at any time as follows: ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:51 Sep 27, 2024 Jkt 262001 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-201509-18/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. PO 00000 Frm 00125 Fmt 4703 Sfmt 4703 79625 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 E:\FR\FM\30SEN1.SGM 30SEN1 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 1002, 1005, 1010, 1020, 1030, 1040, and 1050; form FDA 2579 and form FDA 2877. 800, 801, and 809 ................................................................... 812 ........................................................................................... ‘‘Allegations of Regulatory Misconduct’’ form .......................... Reporting and Recordkeeping for Electronic Products—General Requirements. Labeling ................................................................................... Investigational Device Exemption ........................................... Voluntary Allegations of Regulatory Misconduct .................... Dated: September 25, 2024. Lauren K. Roth, Associate Commissioner for Policy. ACTION: 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 Food and Drug Administration, HHS. 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. SUMMARY: [FR Doc. 2024–22332 Filed 9–27–24; 8:45 am] AGENCY: Notice. OMB Control No. 0910–0025 0910–0485 0910–0078 0910–0769 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. 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). SUPPLEMENTARY INFORMATION: TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB Title of collection OMB control No. ddrumheller on DSK120RN23PROD with NOTICES1 New Plant Varieties Intended for Food Use ................................................................................................ Food and Cosmetic Export Certificates ....................................................................................................... Biological Products; General Records and Postmarket Adverse Experience Reporting ............................ Voluntary Total Product Life Cycle Advisory Program Pilot ........................................................................ VerDate Sep<11>2014 17:51 Sep 27, 2024 Jkt 262001 PO 00000 Frm 00126 Fmt 4703 Sfmt 9990 E:\FR\FM\30SEN1.SGM 0910–0583 0910–0793 0910–0308 0910–0930 30SEN1 Date approval expires 9/30/2027 9/30/2027 9/30/2027 9/30/2027

Agencies

[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79624-79626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22332]


-----------------------------------------------------------------------

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

[[Page 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 x-ray 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 X-Ray 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 X-ray, 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

[[Page 79626]]

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-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-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 [email protected] 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,   Reporting and                  0910-0025
 1040, and 1050; form FDA 2579   Recordkeeping for
 and form FDA 2877.              Electronic Products--
                                 General Requirements.
800, 801, and 809.............  Labeling.............          0910-0485
812...........................  Investigational                0910-0078
                                 Device Exemption.
``Allegations of Regulatory     Voluntary Allegations          0910-0769
 Misconduct'' form.              of Regulatory
                                 Misconduct.
------------------------------------------------------------------------


    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

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