Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Guidance for Industry and Food and Drug Administration Staff; Availability, 61011-61013 [2020-21462]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (https://www.ich.org/). ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensusdriven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry. As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. In June 2020, the ICH Assembly endorsed the draft guideline entitled ‘‘M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers’’ and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Safety Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Safety Expert Working Group. The draft Q&A guidance is intended to clarify, promote the convergence of, and improve the harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided when developing drugs, completing marketing authorization applications, and using drug master files. This is important because since the ICH M7 Guideline was finalized, the worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities. To facilitate the implementation of the ICH M7 Guideline, the ICH M7 Implementation Working Group has developed a series of Q&As. The scope of this draft Q&A guidance follows that of the ICH M7 Guideline. This draft guidance has been left in the original ICH format. The final guidance will be reformatted and edited VerDate Sep<11>2014 18:14 Sep 28, 2020 Jkt 250001 to conform with FDA’s good guidance practices regulation (21 CFR 10.115) and style before publication. The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers.’’ 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. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required. However, this draft guidance refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 601 has been approved under OMB control number 0910–0338. The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, and the collection of information under 21 CFR parts 210 and 211 have been approved under OMB control number 0910–0139. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.regulations.gov, https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, or https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances. Dated: September 22, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–21461 Filed 9–28–20; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 61011 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1446] Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; 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, we, or Agency) is announcing the availability of the final guidance entitled ‘‘Self-Monitoring Blood Glucose Test Systems for Overthe-Counter Use.’’ This guidance described studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs), which are for over-the-counter (OTC) home use by lay users. This guidance is not meant to address blood glucose monitoring test systems (BGMS) that are intended for prescription point-of-care use in professional healthcare settings (e.g., hospitals, physician offices, long-term care facilities). DATES: The announcement of the guidance is published in the Federal Register on September 29, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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 E:\FR\FM\29SEN1.SGM 29SEN1 61012 Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). jbell on DSKJLSW7X2PROD with NOTICES 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– 2013–D–1446 for ‘‘Self-Monitoring Blood Glucose Test Systems for Overthe-Counter Use.’’ 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 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 ‘‘Self-Monitoring Blood Glucose Test Systems for Overthe-Counter Use’’ 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: Leslie Landree, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3566, Silver Spring, MD 20993–0002, 301–796–6147. SUPPLEMENTARY INFORMATION: I. Background On October 11, 2016 (81 FR 70120), FDA published a final guidance entitled, ‘‘Self-Monitoring Blood Glucose Test Systems for Over-theCounter Use.’’ This guidance described studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for SMBGs, which are for home use by lay users. On November 30, 2018, FDA published a notice of availability in the Federal Register (83 FR 61640) of a draft guidance that proposed revisions to the guidance. FDA proposed modifications based on feedback received from stakeholders and to better align with the evolving understanding and development of these types of devices. FDA considered comments received on the draft guidance and we made revisions as appropriate in response to the comments, including a minor edit encouraging manufacturers to consider design features that will aid in user accessibility and a technical edit in hemoglobin testing concentration. This guidance replaces the existing final guidance of the same title issued on October 11, 2016. This guidance is not meant to address BGMS that are intended for prescription point-of-care use in professional healthcare settings (e.g., hospitals, physician offices, long-term care facilities). FDA addresses those device types in another guidance entitled, ‘‘Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.’’ 1 This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Self-Monitoring Blood Glucose Test Systems for Overthe-Counter Use.’’ 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/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance is also available at https:// www.regulations.gov. Persons unable to download an electronic copy of ‘‘SelfMonitoring Blood Glucose Test Systems for Over-the-Counter Use’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1756 and title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521) is not required for this guidance. The collections of information in the following FDA guidance and regulations 1 https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/self-monitoringblood-glucose-test-systems-over-counter-use-0. VerDate Sep<11>2014 18:14 Sep 28, 2020 Jkt 250001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1 Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices 61013 have been approved by OMB as listed in the following table: Topic 807, subpart E ............................................................................ ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. 800, 801, and 809 ....................................................................... 820 .............................................................................................. Premarket notification ................................................................ Q-Submissions ........................................................................... 0910–0120 0910–0756 Medical Device Labeling Regulations ........................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. 0910–0485 0910–0073 Dated: September 23, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–21462 Filed 9–28–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0410] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will take place virtually on November 6, 2020, from 10 a.m. Eastern Time to 4 p.m. Eastern Time. SUMMARY: Please note that due to the impact of this COVID–19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https:// www.fda.gov/AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2018 N–0410. The docket will close on November 5, 2020. Submit either electronic or ADDRESSES: jbell on DSKJLSW7X2PROD with NOTICES OMB control No. 21 CFR part or guidance VerDate Sep<11>2014 18:14 Sep 28, 2020 Jkt 250001 written comments on this public meeting by November 5, 2020. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 5, 2020. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 5, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before October 23, 2020, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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–N–0410 for ‘‘Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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. Please call 240–402–7500 ahead of the meeting time to verify access. • 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.’’ FDA 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 E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61011-61013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21462]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1446]


Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 
Use; 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, we, or Agency) is 
announcing the availability of the final guidance entitled ``Self-
Monitoring Blood Glucose Test Systems for Over-the-Counter Use.'' This 
guidance described studies and information that FDA recommends be used 
when submitting premarket notifications (510(k)s) for self-monitoring 
blood glucose test systems (SMBGs), which are for over-the-counter 
(OTC) home use by lay users. This guidance is not meant to address 
blood glucose monitoring test systems (BGMS) that are intended for 
prescription point-of-care use in professional healthcare settings 
(e.g., hospitals, physician offices, long-term care facilities).

DATES: The announcement of the guidance is published in the Federal 
Register on September 29, 2020.

ADDRESSES: You may submit either electronic or written comments on 
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

[[Page 61012]]

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-2013-D-1446 for ``Self-Monitoring Blood Glucose Test Systems for 
Over-the-Counter Use.'' 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 
``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use'' 
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: Leslie Landree, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3566, Silver Spring, MD 20993-0002, 301-796-6147.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 11, 2016 (81 FR 70120), FDA published a final guidance 
entitled, ``Self-Monitoring Blood Glucose Test Systems for Over-the-
Counter Use.'' This guidance described studies and information that FDA 
recommends be used when submitting premarket notifications (510(k)s) 
for SMBGs, which are for home use by lay users.
    On November 30, 2018, FDA published a notice of availability in the 
Federal Register (83 FR 61640) of a draft guidance that proposed 
revisions to the guidance. FDA proposed modifications based on feedback 
received from stakeholders and to better align with the evolving 
understanding and development of these types of devices.
    FDA considered comments received on the draft guidance and we made 
revisions as appropriate in response to the comments, including a minor 
edit encouraging manufacturers to consider design features that will 
aid in user accessibility and a technical edit in hemoglobin testing 
concentration. This guidance replaces the existing final guidance of 
the same title issued on October 11, 2016.
    This guidance is not meant to address BGMS that are intended for 
prescription point-of-care use in professional healthcare settings 
(e.g., hospitals, physician offices, long-term care facilities). FDA 
addresses those device types in another guidance entitled, ``Blood 
Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' 
\1\
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-blood-glucose-test-systems-over-counter-use-0.
---------------------------------------------------------------------------

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Self-Monitoring Blood Glucose Test Systems 
for Over-the-Counter Use.'' 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance is also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Self-Monitoring Blood 
Glucose Test Systems for Over-the-Counter Use'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 1756 and title to identify 
the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required 
for this guidance. The collections of information in the following FDA 
guidance and regulations

[[Page 61013]]

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
``Requests for Feedback on       Q-Submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
------------------------------------------------------------------------


    Dated: September 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21462 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P

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