83 FR 61640 - Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 231 (November 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 231 (November 30, 2018)
| Page Range | 61640-61642 | |
| FR Document | 2018-26028 |
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)] [Notices] [Pages 61640-61642] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26028] ----------------------------------------------------------------------- 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Drug Administration [Docket No. FDA-2013-D-1446] Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Self-Monitoring Blood Glucose Test Systems for Over-the- Counter Use.'' This draft guidance document describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test [[Page 61641]] systems (SMBGs) that 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, and long-term care facilities). This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by February 28, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-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. 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.thefederalregister.org/fdsys/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 draft guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance. Submit written requests for a single hard copy of the draft guidance document entitled ``Self-Monitoring Blood Glucose Test Systems for Over-the- Counter Use'' to the Office of the Center Director, 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. 4623, Silver Spring, MD 20993-0002, 301-796-6147. SUPPLEMENTARY INFORMATION: I. Background On October 11, 2016, FDA published a final guidance entitled ``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.'' This guidance document described studies and information that FDA recommends be used when submitting 510(k)s for SMBGs that are for OTC home use by lay users. FDA is now proposing to make modifications to the final guidance based on feedback received from stakeholders, which the Agency believes will better align with the evolving understanding and development of these types of devices. When finalized, this draft guidance will replace the final guidance of the same title issued on October 11, 2016. This draft 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, and long term-care facilities). FDA addresses those device types in another guidance entitled, ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' 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 ``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. This guidance is not subject to Executive Order 12866. 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 [[Page 61642]] Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft guidance document 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 GUD 1756 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. 3501-3520). The collections of information in the following FDA guidance and 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 0910-0120 Notification. ``Requests for Feedback on Medical Q-Submissions....... 0910-0756 Device Submissions: The Pre- Submission Program and Meetings with Food and Drug Administration Staff''. 800, 801, and 809................. Medical Device 0910-0485 Labeling Regulations. 820............................... Current Good 0910-0073 Manufacturing Practice (CGMP); Quality System (QS) Regulation. ------------------------------------------------------------------------ Dated: November 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26028 Filed 11-29-18; 8:45 am] BILLING CODE 4164-01-P
![61640 Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
Federal Register (63 FR 68780) as part of Medicare’s ‘‘coverage with concerning such matters as financial
announcing establishment of the MCAC evidence development’’ initiative. holdings, consultancies, and research
was published on December 14, 1998. grants or contracts in order to permit
II. Provisions of the Notice
The MCAC name was updated to more evaluation of possible sources of
accurately reflect the purpose of the As of June 2019, there will be 20 financial conflict of interest. Department
committee and on January 26, 2007, the membership terms expiring. Of the 20 policy prohibits multiple committee
Secretary published a notice in the memberships expiring, 1 is an industry memberships. A federal advisory
Federal Register (72 FR 3853), representative and the remaining 19 committee member may not serve on
announcing that the Committee’s name membership openings are for the at- more than one committee within an
changed to the Medicare Evidence large standing MEDCAC membership. agency at the same time.
Development & Coverage Advisory All nominations must be Members are invited to serve for
Committee (MEDCAC). The current accompanied by curricula vitae. overlapping 2-year terms. A member
Secretary’s Charter for the MEDCAC is Nomination packages should be sent to may continue to serve after the
available on the CMS website at: http:// Leah Cromwell or Maria Ellis at the expiration of the member’s term until a
www.cms.hhs.gov/FACA/Downloads/ address listed in the ADDRESSES section successor is named. Any interested
medcaccharter.pdf, or you may obtain a of this notice. Nominees are selected person may nominate one or more
copy of the charter by submitting a based upon their individual qualified persons. Self-nominations are
request to the contact listed in the FOR qualifications. Nominees for also accepted. Individuals interested in
FURTHER INFORMATION section of this membership must have expertise and the representative positions must
notice. experience in one or more of the include a letter of support from the
The MEDCAC is governed by following fields: organization or interest group they
provisions of the Federal Advisory • Clinical medicine including would represent.
Committee Act, Public Law 92–463, as subspecialties III. Collection of Information
amended (5 U.S.C. App. 2), which sets • Administrative medicine
forth standards for the formulation and • Public health This document does not impose
use of advisory committees, and is • Biological and physical sciences information collection requirements,
authorized by section 222 of the Public • Epidemiology and biostatistics that is, reporting, recordkeeping or
Health Service Act as amended (42 • Clinical trial design third-party disclosure requirements.
U.S.C. 217A). • Health care data management and Consequently, there is no need for
We are requesting nominations for analysis review by the Office of Management and
candidates to serve on the MEDCAC. • Patient advocacy Budget under the authority of the
Nominees are selected based upon their • Health care economics Paperwork Reduction Act of 1995 (44
individual qualifications and not solely • Medical ethics U.S.C. 3501 et seq.).
as representatives of professional • Other relevant professions Dated: November 21, 2018.
associations or societies. We wish to We are looking particularly for Kate Goodrich,
ensure adequate representation of the experts in a number of fields. These Director, Center for Clinical Standards and
interests of both women and men, include cancer screening, genetic Quality, Chief Medical Officer, Centers for
members of all ethnic groups, and testing, clinical epidemiology, Medicare & Medicaid Services.
physically challenged individuals. psychopharmacology, screening and [FR Doc. 2018–26090 Filed 11–29–18; 8:45 am]
Therefore, we encourage nominations of diagnostic testing analysis, and vascular BILLING CODE 4120–01–P
qualified candidates who can represent surgery. We also need experts in
these interests. biostatistics in clinical settings,
The MEDCAC consists of a pool of dementia treatment, minority health, DEPARTMENT OF HEALTH AND
100 appointed members including: 90 observational research design, stroke HUMAN SERVICES
at-large standing members (10 of whom epidemiology, and women’s health.
are patient advocates), and 10 The nomination letter must include a Food and Drug Administration
representatives of industry interests. statement that the nominee is willing to [Docket No. FDA–2013–D–1446]
Members generally are recognized serve as a member of the MEDCAC and
authorities in clinical medicine appears to have no conflict of interest Self-Monitoring Blood Glucose Test
including subspecialties, administrative that would preclude membership. We Systems for Over-the-Counter Use;
medicine, public health, biological and are requesting that all curricula vitae Draft Guidance for Industry and Food
physical sciences, epidemiology and include the following: and Drug Administration Staff;
biostatistics, clinical trial design, health • Date of birth Availability
care data management and analysis, • Place of birth AGENCY: Food and Drug Administration,
patient advocacy, health care • Social security number HHS.
economics, medical ethics or other • Title and current position
ACTION: Notice of availability.
relevant professions. • Professional affiliation
The MEDCAC works from an agenda • Home and business address SUMMARY: The Food and Drug
provided by the Designated Federal • Telephone and fax numbers Administration (FDA or Agency) is
Official. The MEDCAC reviews and • Email address announcing the availability of the draft
evaluates medical literature and • List of areas of expertise guidance for industry and FDA staff
amozie on DSK3GDR082PROD with NOTICES1
technology assessments, and hears In the nomination letter, we are entitled ‘‘Self-Monitoring Blood Glucose
public testimony on the evidence requesting that nominees specify Test Systems for Over-the-Counter Use.’’
available to address the impact of whether they are applying for a patient This draft guidance document describes
medical items and services on health advocate position, for an at-large studies and information that FDA
outcomes of Medicare beneficiaries. The standing position, or as an industry recommends be used when submitting
MEDCAC may also advise the Centers representative. Potential candidates will premarket notifications (510(k)s) for
for Medicare & Medicaid Services (CMS) be asked to provide detailed information self-monitoring blood glucose test
VerDate Sep<11>2014 17:00 Nov 29, 2018 Jkt 247001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\30NON1.SGM 30NON1](https://thefederalregister.org/doc/83_FR_61871/page/1.svg)
![61642 Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
Health guidance documents is available for Over-the-Counter Use’’ may send an information. These collections of
at https://www.fda.gov/MedicalDevices/ email request to CDRH-Guidance@ information are subject to review by the
DeviceRegulationandGuidance/ fda.hhs.gov to receive an electronic Office of Management and Budget
GuidanceDocuments/default.htm. This copy of the document. Please use the (OMB) under the Paperwork Reduction
draft guidance document is also document number GUD 1756 to identify Act of 1995 (44 U.S.C. 3501–3520). The
available at https:// the guidance you are requesting. collections of information in the
www.regulations.gov. Persons unable to IV. Paperwork Reduction Act of 1995 following FDA guidance and regulations
download an electronic copy of ‘‘Self- have been approved by OMB as listed in
This draft guidance refers to
Monitoring Blood Glucose Test Systems previously approved collections of the following table:
OMB control
21 CFR part or guidance Topic no.
807, subpart E ............................................................................ Premarket Notification ................................................................ 0910–0120
‘‘Requests for Feedback on Medical Device Submissions: The Q-Submissions ........................................................................... 0910–0756
Pre-Submission Program and Meetings with Food and Drug
Administration Staff’’.
800, 801, and 809 ...................................................................... Medical Device Labeling Regulations ........................................ 0910–0485
820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System 0910–0073
(QS) Regulation.
Dated: November 26, 2018. FDA is establishing a docket for that if you include your name, contact
Leslie Kux, public comment on this meeting. The information, or other information that
Associate Commissioner for Policy. docket number is FDA–2018–N–4282. identifies you in the body of your
[FR Doc. 2018–26028 Filed 11–29–18; 8:45 am] The docket will close on January 16, comments, that information will be
BILLING CODE 4164–01–P 2019. Submit either electronic or posted on https://www.regulations.gov.
written comments on this public • If you want to submit a comment
meeting by January 16, 2019. Please with confidential information that you
DEPARTMENT OF HEALTH AND note that late, untimely filed comments do not wish to be made available to the
HUMAN SERVICES will not be considered. Electronic public, submit the comment as a
comments must be submitted on or written/paper submission and in the
Food and Drug Administration before January 16, 2019. The https:// manner detailed (see ‘‘Written/Paper
[Docket No. FDA–2018–N–4282] www.regulations.gov electronic filing Submissions’’ and ‘‘Instructions’’).
system will accept comments until Written/Paper Submissions
Endocrinologic and Metabolic Drugs 11:59 p.m. Eastern Time at the end of
Advisory Committee; Notice of January 16, 2019. Comments received by Submit written/paper submissions as
Meeting; Establishment of a Public mail/hand delivery/courier (for written/ follows:
paper submissions) will be considered • Mail/Hand delivery/Courier (for
Docket; Request for Comments
timely if they are postmarked or the written/paper submissions): Dockets
AGENCY: Food and Drug Administration, delivery service acceptance receipt is on Management Staff (HFA–305), Food and
HHS. or before that date. Drug Administration, 5630 Fishers
ACTION: Notice; establishment of a Comments received on or before Lane, Rm. 1061, Rockville, MD 20852.
public docket; request for comments. January 3, 2019, will be provided to the • For written/paper comments
Committee. Comments received after submitted to the Dockets Management
SUMMARY: The Food and Drug that date will be taken into Staff, FDA will post your comment, as
Administration (FDA) announces a consideration by FDA. well as any attachments, except for
forthcoming public advisory committee You may submit comments as information submitted, marked and
meeting of the Endocrinologic and follows: identified, as confidential, if submitted
Metabolic Drugs Advisory Committee as detailed in ‘‘Instructions.’’
(the Committee). The general function of Electronic Submissions Instructions: All submissions received
the Committee is to provide advice and Submit electronic comments in the must include the Docket No. FDA–
recommendations to FDA on regulatory following way: 2018–N–4282 for ‘‘Endocrinologic and
issues. The meeting will be open to the • Federal eRulemaking Portal: Metabolic Drugs Advisory Committee;
public. FDA is establishing a docket for https://www.regulations.gov. Follow the Notice of Meeting; Establishment of a
public comment on this document. instructions for submitting comments. Public Docket; Request for Comments.’’
DATES: The meeting will be held on Comments submitted electronically, Received comments, those filed in a
January 17, 2019, from 8 a.m. to 5 p.m. including attachments, to https:// timely manner (see ADDRESSES), will be
ADDRESSES: FDA White Oak Campus, www.regulations.gov will be posted to placed in the docket and, except for
10903 New Hampshire Ave., Bldg. 31 the docket unchanged. Because your those submitted as ‘‘Confidential
Conference Center, the Great Room (Rm. comment will be made public, you are Submissions,’’ publicly viewable at
1503), Silver Spring, MD 20993–0002. solely responsible for ensuring that your https://www.regulations.gov or at the
amozie on DSK3GDR082PROD with NOTICES1
Answers to commonly asked questions comment does not include any Dockets Management Staff between 9
including information regarding special confidential information that you or a a.m. and 4 p.m., Monday through
accommodations due to a disability, third party may not wish to be posted, Friday.
visitor parking, and transportation may such as medical information, your or • Confidential Submissions—To
be accessed at: https://www.fda.gov/ anyone else’s Social Security number, or submit a comment with confidential
AdvisoryCommittees/AboutAdvisory confidential business information, such information that you do not wish to be
Committees/ucm408555.htm. as a manufacturing process. Please note made publicly available, submit your
VerDate Sep<11>2014 17:00 Nov 29, 2018 Jkt 247001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\30NON1.SGM 30NON1](https://thefederalregister.org/doc/83_FR_61871/page/3.svg)
Document Created: 2018-11-30 04:35:38
Document Modified: 2018-11-30 04:35:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by February 28, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Leslie Landree, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4623, Silver Spring, MD 20993-0002, 301-796-6147. | |
| FR Citation | 83 FR 61640 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR