Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Guidance for Industry and Food and Drug Administration Staff; Availability, 61004-61006 [2020-21463]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES 61004 Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices expiration date. The new charter will be in effect until August 27, 2022. DATES: Authority for the Cardiovascular and Renal Drugs Advisory Committee will expire on August 27, 2022, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Joyce Yu, Division of Advisory Committee and Consultant Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993–0002, 301– 796–9001, email: CRDAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under 41 CFR 102–3, FDA is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee (Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cardiovascular and renal disorders and makes appropriate recommendations to the Commissioner of Food and Drugs. Under its Charter, the Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. Federal members will serve as Regular Government Employees or Ex-Officios. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumeroriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. There may also be alternate industry representative. Further information regarding the most recent charter and other information can be found at https:// VerDate Sep<11>2014 18:14 Sep 28, 2020 Jkt 250001 www.fda.gov/advisory-committees/ cardiovascular-and-renal-drugsadvisory-committee/cardiovascularand-renal-drugs-advisory-committeecharter or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the Committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: September 18, 2020. Lauren K. Roth, Associate Commissioner for Policy. Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Correction In the Federal Register of Tuesday, July 21, 2020 (85 FR 44096), appearing on page 44096 in FR Doc. 2020–15727, the following correction is made: On page 44096, in the table, the entries for ANDAs 076203 and 077456 are removed. Dated: September 21, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–21456 Filed 9–28–20; 8:45 am] BILLING CODE 4164–01–P [FR Doc. 2020–21465 Filed 9–28–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1227] Roerig Division of Pfizer Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 [Docket No. FDA–2013–D–1445] Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 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 or Agency) is announcing the availability of a final guidance entitled ‘‘Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.’’ This guidance describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) that are for prescription point-of-care use. 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: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on July 21, 2020. The document announced the withdrawal of approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of August 20, 2020. The document indicated that FDA was withdrawing approval of the following two ANDAs after receiving a withdrawal request from Kadmon Pharmaceuticals, LLC., 119 Commonwealth Dr., Warrendale, PA 15086: ANDA 076203, Ribavirin Capsules, 200 milligrams (mg) and ANDA 077456, Ribavirin Tablets, 200 mg, 400 mg, and 600 mg. Before FDA withdrew the approval of these ANDAs, Kadmon Pharmaceuticals, LLC. informed FDA that it did not want the approval of the ANDAs withdrawn. Because Kadmon Pharmaceuticals, LLC., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 076203 and 077456 are still in effect. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug SUMMARY: Food and Drug Administration 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 E:\FR\FM\29SEN1.SGM 29SEN1 Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES 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– 2013–D–1445 for ‘‘Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 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 VerDate Sep<11>2014 18:14 Sep 28, 2020 Jkt 250001 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 ‘‘Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 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 selfaddressed 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 70122), FDA published a final guidance entitled ‘‘Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.’’ That guidance document described studies and information that FDA recommends be used when submitting 510(k)s for BGMSs that are for prescription point-of-care use. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 61005 On November 30, 2018, FDA published a notice of availability in the Federal Register (83 FR 61648) 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 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 revised guidance replaces the existing final guidance of the same title issued on October 11, 2016. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on ‘‘Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 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 ‘‘Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1755 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 guidances and regulations have been approved by OMB as listed in the following table: E:\FR\FM\29SEN1.SGM 29SEN1 61006 Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices 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. CLIA Waiver Applications .......................................................... 0910–0485 0910–0073 Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization (42 CFR 493.17). 0910–0607 Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices—Guidance for Industry and Food and Drug Administration Staff. Administrative Procedures for CLIA Categorization—Guidance for Industry and Food and Drug Administration Staff. Dated: September 23, 2020. Lauren K. Roth, Associate Commissioner for Policy. 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: [FR Doc. 2020–21463 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–2020–D–1548] Failure To Respond to an Abbreviated New Drug Application Complete Response Letter Within the Regulatory Timeframe; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.’’ This guidance is intended to assist applicants in responding to complete response letters (CRLs) to abbreviated new drug applications (ANDAs) submitted to FDA under the Federal Food, Drug, and Cosmetic Act. This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL as well as the actions that FDA may take if the applicant fails to respond to a CRL. In addition, this guidance recommends information an applicant may submit in its request for an extension to respond to a CRL as well as a non-exhaustive list of factors that FDA will consider in determining whether such a request is reasonable. DATES: Submit either electronic or written comments on the draft guidance by November 30, 2020 to ensure that the Agency considers your comment on this SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES OMB control No. 21 CFR part or guidance VerDate Sep<11>2014 18:14 Sep 28, 2020 Jkt 250001 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.’’ PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 0910–0598 Instructions: All submissions received must include the Docket No. FDA– 2020–D–1548 for ‘‘Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.’’ 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 E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61004-61006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21463]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1445]


Blood Glucose Monitoring Test Systems for Prescription Point-of-
Care 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 or Agency) is announcing 
the availability of a final guidance entitled ``Blood Glucose 
Monitoring Test Systems for Prescription Point-of-Care Use.'' This 
guidance describes studies and information that FDA recommends be used 
when submitting premarket notifications (510(k)s) for blood glucose 
monitoring systems (BGMSs) that are for prescription point-of-care use.

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

[[Page 61005]]

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-2013-D-1445 for ``Blood Glucose Monitoring Test Systems for 
Prescription Point-of-Care 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 
``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 
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 70122), FDA published a final guidance 
entitled ``Blood Glucose Monitoring Test Systems for Prescription 
Point-of-Care Use.'' That guidance document described studies and 
information that FDA recommends be used when submitting 510(k)s for 
BGMSs that are for prescription point-of-care use.
    On November 30, 2018, FDA published a notice of availability in the 
Federal Register (83 FR 61648) 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 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 revised guidance replaces the existing final 
guidance of the same title issued on October 11, 2016.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
current thinking of FDA on ``Blood Glucose Monitoring Test Systems for 
Prescription Point-of-Care 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 ``Blood Glucose Monitoring 
Test Systems for Prescription Point-of-Care Use'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 1755 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 
guidances and regulations have been approved by OMB as listed in the 
following table:

[[Page 61006]]



------------------------------------------------------------------------
                                                            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.
Recommendations for Clinical     CLIA Waiver                   0910-0598
 Laboratory Improvement           Applications.
 Amendments of 1988 (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices--Guidance
 for Industry and Food and Drug
 Administration Staff.
Administrative Procedures for    Administrative                0910-0607
 CLIA Categorization--Guidance    Procedures for
 for Industry and Food and Drug   Clinical Laboratory
 Administration Staff.            Improvement Amendments
                                  of 1988 Categorization
                                  (42 CFR 493.17).
------------------------------------------------------------------------


    Dated: September 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21463 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P

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