Select Updates for Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 41987-41989 [2020-15081]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / Notices Health, 1090 Tusculum Avenue, MS C– 34, Cincinnati, Ohio 45226. Instructions: All submissions received must include the Agency name and Docket Number. All relevant comments received in conformance with the https://www.regulations.gov suitability policy will be posted without change to https://www.regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Rashaun Roberts, Ph.D., Designated Federal Officer, NIOSH, CDC, 1090 Tusculum Avenue, Mailstop C–24, Cincinnati, Ohio 45226, Telephone (513) 533–6800, Toll Free 1(800)CDC– INFO, Email ocas@cdc.gov. 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Matters to Be Considered: The agenda will include discussions on the following: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; SEC Petitions Update; Completed Site Profile Review for W.R Grace Company (Erwin, Tennessee); Update on Site Profile Review for Idaho National Laboratory Site (Burial Ground and other Exposure Scenarios), and Hanford (Richland, Washington); SEC Petition Reviews for Superior Steel (Carnegie, Pennsylvania; 1952–2957), and Reduction Pilot Plant (Huntington, West Virginia; 1976–1978), and a Board Work Session. Agenda items are subject to change as priorities dictate. Meeting Information: The USA tollfree dial-in number is 1–866–659–0537; the pass code is 9933701. Web conference by Skype: meeting Connection: https://webconf.cdc.gov/ zab6/yzdq02pl?sl=1. Public Participation Comments received are part of the public record and are subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/ near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted into the docket. CDC does not accept comment by email. Oral Public Comment: An oral public comment session will be held on August 26, 2020 at 5:15 p.m., EDT and conclude at 6:15 p.m., EDT or following the final call for public comment, whichever comes first. Written Public Comment: Written comments will also be accepted from those unable to attend the public session per the instructions provided in the address section above. Written comments received in advance of the meeting will be included in the official record of the meeting. The Director, Strategic Business Initiatives Unit, Office of the Chief PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 41987 Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2020–15028 Filed 7–10–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–2494] Select Updates for Peripheral Vascular Atherectomy Devices—Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice of availability. AGENCY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Select Updates for Peripheral Vascular Atherectomy Devices—Premarket Notification (510(k)) Submissions.’’ FDA has developed this draft guidance to propose select updates to certain sections of the existing FDA guidance document ‘‘Peripheral Vascular Atherectomy Devices—Premarket Notification (510(k)) Submissions.’’ This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by September 11, 2020 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 E:\FR\FM\13JYN1.SGM 13JYN1 41988 Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES 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–2494 for ‘‘Select Updates for Peripheral Vascular Atherectomy Devices—Premarket Notification (510(k)) Submissions.’’ 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. • 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 VerDate Sep<11>2014 20:25 Jul 10, 2020 Jkt 250001 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. 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 ‘‘Select Updates for Peripheral Vascular Atherectomy Devices—Premarket Notification (510(k)) Submissions’’ to the Office of Policy, Guidance and Policy Development, 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: Jhumur Banik, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2223, Silver Spring, MD 20993–0002, 240–402–5239. SUPPLEMENTARY INFORMATION: I. Background FDA has developed this draft guidance to propose select updates to the FDA guidance document ‘‘Peripheral Vascular Atherectomy Devices—Premarket Notification (510(k)) Submissions.’’ The existing guidance on atherectomy devices remains in effect, in its current form, until this draft guidance is finalized. FDA intends to incorporate this draft PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 guidance into one final guidance document after obtaining and considering public comment on these select updates. FDA does not intend to substantively change the sections of the existing atherectomy guidance that are not affected by this select update. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Select Updates for Peripheral Vascular Atherectomy Devices— Premarket Notification (510(k)) Submissions.’’ 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. III. 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. Persons unable to download an electronic copy of ‘‘Select Updates for Peripheral Vascular Atherectomy Devices— Premarket Notification (510(k)) Submissions’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 19047 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). The collections of information in the following FDA regulations have been approved by OMB as listed in the following table: 21 CFR part or guidance 807, subpart E .... 820 ...................... E:\FR\FM\13JYN1.SGM 13JYN1 Topic Premarket notification. Quality System Regulations. OMB control No. 0910–0120 0910–0073 Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES Dated: July 8, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. 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 [FR Doc. 2020–15081 Filed 7–10–20; 8:45 am] anyone else’s Social Security number, or BILLING CODE 4164–01–P confidential business information, such as a manufacturing process. Please note that if you include your name, contact DEPARTMENT OF HEALTH AND information, or other information that HUMAN SERVICES identifies you in the body of your comments, that information will be Food and Drug Administration posted on https://www.regulations.gov. [Docket No. FDA–2019–D–0358] • If you want to submit a comment with confidential information that you Cancer Clinical Trial Eligibility Criteria: do not wish to be made available to the Minimum Age Considerations for public, submit the comment as a Inclusion of Pediatric Patients; written/paper submission and in the Guidance for Industry and Institutional manner detailed (see ‘‘Written/Paper Review Boards; Availability Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions AGENCY: Food and Drug Administration, Submit written/paper submissions as HHS. follows: ACTION: Notice of availability. • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets SUMMARY: The Food and Drug Management Staff (HFA–305), Food and Administration (FDA or Agency) is Drug Administration, 5630 Fishers announcing the availability of a final Lane, Rm. 1061, Rockville, MD 20852. guidance for industry and institutional • For written/paper comments review boards (IRBs) entitled ‘‘Cancer submitted to the Dockets Management Clinical Trial Eligibility Criteria: Staff, FDA will post your comment, as Minimum Age Considerations for well as any attachments, except for Inclusion of Pediatric Patients.’’ This information submitted, marked and guidance is one in a series of guidances identified, as confidential, if submitted that provide recommendations as detailed in ‘‘Instructions.’’ regarding eligibility criteria for clinical Instructions: All submissions received trials of drugs or biological products must include the Docket No. FDA– regulated by the Center for Drug 2019–D–0358 for ‘‘Cancer Clinical Trial Evaluation and Research (CDER) and the Eligibility Criteria: Minimum Age Center for Biologics Evaluation and Considerations for Inclusion of Pediatric Research (CBER) for the treatment of Patients.’’ Received comments will be cancer. Specifically, this guidance placed in the docket and, except for includes recommendations on the those submitted as ‘‘Confidential inclusion of pediatric patients (i.e., Submissions,’’ publicly viewable at children and adolescents) in clinical https://www.regulations.gov or at the trials for cancer treatments. This Dockets Management Staff between 9 guidance finalizes the draft guidance a.m. and 4 p.m., Monday through entitled ‘‘Cancer Clinical Trial Friday, 240–402–7500. Eligibility Criteria: Minimum Age for • Confidential Submissions—To Pediatric Patients’’ that published on submit a comment with confidential March 13, 2019. information that you do not wish to be DATES: The announcement of the made publicly available, submit your guidance is published in the Federal comments only as a written/paper Register on July 13, 2020. submission. You should submit two copies total. One copy will include the ADDRESSES: You may submit either information you claim to be confidential electronic or written comments on with a heading or cover note that states Agency guidances at any time as ‘‘THIS DOCUMENT CONTAINS follows: CONFIDENTIAL INFORMATION.’’ The Electronic Submissions Agency will review this copy, including Submit electronic comments in the the claimed confidential information, in following way: • Federal eRulemaking Portal: https:// its consideration of comments. The second copy, which will have the www.regulations.gov. Follow the claimed confidential information instructions for submitting comments. redacted/blacked out, will be available Comments submitted electronically, for public viewing and posted on including attachments, to https:// https://www.regulations.gov. Submit www.regulations.gov will be posted to both copies to the Dockets Management the docket unchanged. Because your Staff. If you do not wish your name and comment will be made public, you are solely responsible for ensuring that your contact information to be made publicly VerDate Sep<11>2014 20:25 Jul 10, 2020 Jkt 250001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 41989 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)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993–0002, 240–402–0489; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry and IRBs entitled ‘‘Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients.’’ This guidance provides E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 41987-41989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15081]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2494]


Select Updates for Peripheral Vascular Atherectomy Devices--
Premarket Notification Submissions; Draft Guidance for Industry and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Select Updates for 
Peripheral Vascular Atherectomy Devices--Premarket Notification 
(510(k)) Submissions.'' FDA has developed this draft guidance to 
propose select updates to certain sections of the existing FDA guidance 
document ``Peripheral Vascular Atherectomy Devices--Premarket 
Notification (510(k)) Submissions.'' This draft guidance is not final 
nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by September 11, 2020 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

[[Page 41988]]

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-2494 for ``Select Updates for Peripheral Vascular 
Atherectomy Devices--Premarket Notification (510(k)) Submissions.'' 
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.
     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.
    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 
``Select Updates for Peripheral Vascular Atherectomy Devices--Premarket 
Notification (510(k)) Submissions'' to the Office of Policy, Guidance 
and Policy Development, 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: Jhumur Banik, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2223, Silver Spring, MD 20993-0002, 240-402-5239.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this draft guidance to propose select updates to 
the FDA guidance document ``Peripheral Vascular Atherectomy Devices--
Premarket Notification (510(k)) Submissions.'' The existing guidance on 
atherectomy devices remains in effect, in its current form, until this 
draft guidance is finalized. FDA intends to incorporate this draft 
guidance into one final guidance document after obtaining and 
considering public comment on these select updates. FDA does not intend 
to substantively change the sections of the existing atherectomy 
guidance that are not affected by this select update.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Select 
Updates for Peripheral Vascular Atherectomy Devices--Premarket 
Notification (510(k)) Submissions.'' 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.

III. 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. Persons unable to download an 
electronic copy of ``Select Updates for Peripheral Vascular Atherectomy 
Devices--Premarket Notification (510(k)) Submissions'' may send an 
email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 19047 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 
the following FDA regulations have been approved by OMB as listed in 
the following table:

------------------------------------------------------------------------
                                                             OMB control
      21 CFR part or guidance                 Topic              No.
------------------------------------------------------------------------
807, subpart E.....................  Premarket notification    0910-0120
820................................  Quality System            0910-0073
                                      Regulations.
------------------------------------------------------------------------



[[Page 41989]]

    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15081 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P

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