Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 37232-37234 [2024-08933]

Download as PDF 37232 Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices public will have the option to participate, and the advisory committee meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. Answers to commonly asked questions about FDA advisory committee meetings, including information regarding special accommodations due to a disability, visitor parking, and transportation, may be accessed at: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. For those unable to attend in person, the meeting will also be webcast and will be available at the following link: https://fda.zoomgov.com/j/1604157441 ?pwd=YkVzZ28vNHQrVXh3 ZlhrTmlHaFVzZz09. ddrumheller on DSK120RN23PROD with NOTICES1 FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Office of Science, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 1–877– 287–1373, email: TPSAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On June 26, 2024, the Center for Tobacco Product’s TPSAC will convene for one open session, during which the committee will discuss the renewal of a risk modification order, submitted by Swedish Match USA, Inc. for the following loose snus and portioned snus products: • MR0000020: General Loose • MR0000021: General Dry Mint Portion Original Mini • MR0000022: General Portion Original Large • MR0000024: General Classic Blend Portion White Large—12 ct • MR0000025: General Mint Portion White Large • MR0000027: General Nordic Mint Portion White Large—12 ct • MR0000028: General Portion White Large VerDate Sep<11>2014 18:02 May 03, 2024 Jkt 262001 • MR0000029: General Wintergreen Portion White Large Additional discussion about broader Modified Risk Tobacco Products program developments related to the conceptualization and measurement of consumer understanding will also occur. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/ or video conferencing platform. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 20, 2024. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. EST on June 26, 2024. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT) and submit a brief statement describing the general nature of the evidence or arguments they wish to present and the names and email addresses of proposed participants, whether they would like to present online or in person, on or before June 11, 2024, by 5 p.m. Eastern Time. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. Similarly, room for interested persons to participate inperson may be limited. If the number of registrants requesting to speak in-person during the open public hearing is greater than can be reasonably accommodated in the venue for the inperson portion of the advisory PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 committee meeting, FDA may conduct a lottery to determine the speakers who will be invited to participate in person. The contact person will notify interested persons regarding their request to speak by June 12, 2024. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Serina HunterThomas at least 7 days in advance of the meeting (see FOR FURTHER INFORMATION CONTACT). FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform in conjunction with the physical meeting room (see location). This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. The conditions for issuance of a waiver under 21 CFR 10.19 are met. Dated: May 1, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–09786 Filed 5–3–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–5365] Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\06MYN1.SGM Notice of availability. 06MYN1 Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.’’ This draft guidance, when finalized, will describe the factors FDA intends to assess when deciding to issue an enforcement policy regarding test manufacturers’ offering of certain unapproved tests and unapproved uses of approved tests during a declared emergency. This draft guidance is not final nor is it for implementation at this time. DATES: Submit either electronic or written comments on the draft guidance by July 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: 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’’). ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 18:02 May 03, 2024 Jkt 262001 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– 2023–D–5365 for ‘‘Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.’’ 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-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 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 37233 from the internet. See the section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency’’ 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 selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Toby Lowe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993–0002, 301–796–6512. SUPPLEMENTARY INFORMATION: SUPPLEMENTARY INFORMATION I. Background During an emergency, appropriately safe and effective diagnostic tests are critical to the diagnosis, treatment, tracking, and interruption of transmission of infectious diseases during outbreaks, as well as for diagnosing and treating diseases or conditions caused by chemical, biological, radiological, and nuclear threat agents. FDA is issuing this draft guidance that, when finalized, will describe the factors FDA plans to assess in deciding whether to issue an enforcement policy regarding test manufacturers’ offering of certain unapproved tests and unapproved uses of approved tests for the diagnosis of a disease or other condition to help quickly increase test availability when appropriate during a declared emergency under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance describes the factors FDA intends to assess when issuing an enforcement policy including: (1) the need for accelerated availability of tests; (2) the known or potential risks of such tests; (3) the availability of appropriate alternative tests that are authorized or approved; and (4) the availability of sufficient mitigations to address risks of false results. When issuing an enforcement policy, FDA generally intends to describe the circumstances in which the Agency intends to exercise enforcement discretion, including, for example, when the test has been validated. FDA may also identify the initial duration in which an enforcement policy is intended to be in effect. This draft guidance is being issued consistent with FDA’s good guidance E:\FR\FM\06MYN1.SGM 06MYN1 37234 Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.’’ 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 draft 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 and https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Persons unable to download an electronic copy of ‘‘Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency’’ may send an email request to CDRH- 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 OMB under the PRA (44 U.S.C. 3501–3521). The collections of information in the following table have been approved by OMB: 21 CFR part or guidance Topic 807, subpart E ......................................................................... 814, subparts A through E ...................................................... 814, subpart H ......................................................................... 812 ........................................................................................... 860, subpart D ......................................................................... 800, 801, 809, and 830 ........................................................... Premarket notification .............................................................. Premarket approval ................................................................. Humanitarian Use Devices; Humanitarian Device Exemption Investigational Device Exemption ........................................... De Novo classification process ............................................... Medical Device Labeling Regulations; Unique Device Identification. Emergency Use Authorization ................................................. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 0910–0485 Medical Device Reporting ....................................................... CLIA Administrative Procedures; CLIA Waivers ..................... 0910–0437 0910–0607 ‘‘Emergency Use Authorization of Medical Products and Related Authorities’’. 803 ........................................................................................... ‘‘Administrative Procedures for CLIA Categorization’’ and ‘‘Recommendations: Clinical Laboratory Improvement Amendments of 1988’’ (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’. Dated: April 22, 2024. Lauren K. Roth, Associate Commissioner for Policy. Institutes of Health, 6700B Rockledge Drive, Room 2118, Bethesda, MD 20892, (301) 443–2861, marmillotp@ mail.nih.gov. Additionally, the meeting end time on May 8, 2024, has changed from 3:30 p.m. to 3:45 p.m. The meeting on May 7, 2024, is partially closed to the public in accordance with provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended, and the meeting on May 8, 2024, is open to the public. [FR Doc. 2024–08933 Filed 4–29–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting ddrumheller on DSK120RN23PROD with NOTICES1 Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00007009 and complete title to identify the guidance you are requesting. Notice is hereby given of a change in the meeting of the National Advisory Council on Alcohol Abuse and Alcoholism, May 7, 2024, 10:00 a.m. to May 8, 2024, 3:30 p.m., National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Conference Rooms A, B, & C, Bethesda, MD 20817 which was published in the Federal Register on April 9, 2024, FR Doc. 2024–07500, 89 FR 24846. This notice is being amended to replace the Contact Person from Ranga V. Srinivas, Ph.D. to Philippe Marmillot, Ph.D. Director, Office of Extramural Activities, Office of Extramural Activities, National Institute on Alcohol Abuse and Alcoholism, National VerDate Sep<11>2014 18:02 May 03, 2024 Jkt 262001 Dated: April 30, 2024. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–09727 Filed 5–3–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 OMB control No. 0910–0595 provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–NS– 24–021: HEAL Initiative: Individual Differences in Human Pain Conditions. Date: June 3–4, 2024. Time: 8:30 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: North Bethesda Marriott Hotel & Conference Center, Montgomery County Conference Center Facility, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Mark Allen Vosvick, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, Bethesda, MD 20892, 301–402–4128, mark.vosvick@nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Motor Function, Speech and Rehabilitation Study Section. Date: June 3–4, 2024. Time: 9:00 a.m. to 7:00 p.m. E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37232-37234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08933]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-5365]


Consideration of Enforcement Policies for Tests During a Section 
564 Declared Emergency; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

[[Page 37233]]

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Consideration of 
Enforcement Policies for Tests During a Section 564 Declared 
Emergency.'' This draft guidance, when finalized, will describe the 
factors FDA intends to assess when deciding to issue an enforcement 
policy regarding test manufacturers' offering of certain unapproved 
tests and unapproved uses of approved tests during a declared 
emergency. This draft guidance is not final nor is it for 
implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by July 5, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2023-D-5365 for ``Consideration of Enforcement Policies for Tests 
During a Section 564 Declared Emergency.'' 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 draft guidance document entitled 
``Consideration of Enforcement Policies for Tests During a Section 564 
Declared Emergency'' 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: Toby Lowe, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002, 301-796-6512.

SUPPLEMENTARY INFORMATION:

I. Background

    During an emergency, appropriately safe and effective diagnostic 
tests are critical to the diagnosis, treatment, tracking, and 
interruption of transmission of infectious diseases during outbreaks, 
as well as for diagnosing and treating diseases or conditions caused by 
chemical, biological, radiological, and nuclear threat agents. FDA is 
issuing this draft guidance that, when finalized, will describe the 
factors FDA plans to assess in deciding whether to issue an enforcement 
policy regarding test manufacturers' offering of certain unapproved 
tests and unapproved uses of approved tests for the diagnosis of a 
disease or other condition to help quickly increase test availability 
when appropriate during a declared emergency under section 564 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    This draft guidance describes the factors FDA intends to assess 
when issuing an enforcement policy including: (1) the need for 
accelerated availability of tests; (2) the known or potential risks of 
such tests; (3) the availability of appropriate alternative tests that 
are authorized or approved; and (4) the availability of sufficient 
mitigations to address risks of false results. When issuing an 
enforcement policy, FDA generally intends to describe the circumstances 
in which the Agency intends to exercise enforcement discretion, 
including, for example, when the test has been validated. FDA may also 
identify the initial duration in which an enforcement policy is 
intended to be in effect.
    This draft guidance is being issued consistent with FDA's good 
guidance

[[Page 37234]]

practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 
``Consideration of Enforcement Policies for Tests During a Section 564 
Declared Emergency.'' 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 draft 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 and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Consideration of Enforcement Policies 
for Tests During a Section 564 Declared Emergency'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number GUI00007009 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 
OMB under the PRA (44 U.S.C. 3501-3521). The collections of information 
in the following table have been approved by OMB:

------------------------------------------------------------------------
    21 CFR part or guidance             Topic           OMB control No.
------------------------------------------------------------------------
807, subpart E................  Premarket                      0910-0120
                                 notification.
814, subparts A through E.....  Premarket approval...          0910-0231
814, subpart H................  Humanitarian Use               0910-0332
                                 Devices;
                                 Humanitarian Device
                                 Exemption.
812...........................  Investigational                0910-0078
                                 Device Exemption.
860, subpart D................  De Novo                        0910-0844
                                 classification
                                 process.
800, 801, 809, and 830........  Medical Device                 0910-0485
                                 Labeling
                                 Regulations; Unique
                                 Device
                                 Identification.
``Emergency Use Authorization   Emergency Use                  0910-0595
 of Medical Products and         Authorization.
 Related Authorities''.
803...........................  Medical Device                 0910-0437
                                 Reporting.
``Administrative Procedures     CLIA Administrative            0910-0607
 for CLIA Categorization'' and   Procedures; CLIA
 ``Recommendations: Clinical     Waivers.
 Laboratory Improvement
 Amendments of 1988'' (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices''.
------------------------------------------------------------------------


    Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08933 Filed 4-29-24; 8:45 am]
BILLING CODE 4164-01-P

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