81_FR_42487 81 FR 42362 - Microbiology Devices Panel of the Medical Devices

81 FR 42362 - Microbiology Devices Panel of the Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 125 (June 29, 2016)

Page Range42362-42363
FR Document2016-15362

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Federal Register, Volume 81 Issue 125 (Wednesday, June 29, 2016) 
[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42362-42363]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1660]


Microbiology Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting; Establishment of a Public Docket; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Microbiology Devices Panel of 
the Medical Devices Advisory Committee. The general function of the 
committee is to provide advice and recommendations to the Agency on 
FDA's 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 be held on August 16, 2016, from 8 a.m. to 6 
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. You may 
submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-N-1660 for ``Microbiology Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting; Establishment of a Public 
Docket; Request for Comments.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Shanika Craig, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, 301-796-6639, 
[email protected], or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in 
the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: On August 16, 2016, the committee will discuss and make 
recommendations regarding the appropriateness of clearing or approving 
of over-the-counter (OTC) diagnostic tests for the detection of 
pathogens causing infectious diseases, focusing on respiratory and 
sexually transmitted infections (STI). Currently, there are no OTC 
diagnostic tests for infectious diseases cleared or approved by CDRH. 
The committee will evaluate the risks and benefits to individual 
patients and to public health associated with clearing or approving OTC 
diagnostic tests for infectious diseases. Serious risks such as false 
negative results, false positive results, patient loss to medical 
followup, and the impact on surveillance of reportable infections will

[[Page 42363]]

be addressed. Potential benefits such as reduction of infection 
transmission and increased access to testing will be discussed as well. 
The committee will also make recommendations on clinical study design, 
analytical study design, and acceptable performance criteria applicable 
to respiratory and STI diagnostic devices.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
August 2, 2016. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those individuals interested in 
making formal oral presentations should notify the contact person and 
submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation on or before July 15, 2016. Time allotted for 
each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak by July 21, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA is establishing a docket for public comment on this document. 
The docket number is FDA-2016-N-1660. The docket will close on 
September 16, 2016. Comments received on or before July 26, 2016, will 
be provided to the committee. Comments received after that date will be 
taken into consideration by the Agency.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Artair Mallett, at [email protected] or 301-
796-9638 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 23, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-15362 Filed 6-28-16; 8:45 am]
 BILLING CODE 4164-01-P

42362 Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices Dated: June 21, 2016. confidential business information, such sheet and not in the body of your Kathy Greenlee, as a manufacturing process. Please note comments and you must identify this Administrator and Assistant Secretary for that if you include your name, contact information as ‘‘confidential.’’ Any Aging. information, or other information that information marked as ‘‘confidential’’ [FR Doc. 2016–15304 Filed 6–28–16; 8:45 am] identifies you in the body of your will not be disclosed except in BILLING CODE 4151–01–P comments, that information will be accordance with 21 CFR 10.20 and other posted on http://www.regulations.gov. applicable disclosure law. For more • If you want to submit a comment information about FDA’s posting of DEPARTMENT OF HEALTH AND with confidential information that you comments to public dockets, see 80 FR HUMAN SERVICES do not wish to be made available to the 56469, September 18, 2015, or access public, submit the comment as a the information at: http://www.fda.gov/ Food and Drug Administration written/paper submission and in the regulatoryinformation/dockets/ [Docket No. FDA–2016–N–1660] manner detailed (see ‘‘Written/Paper default.htm. Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to Microbiology Devices Panel of the Written/Paper Submissions read background documents or the Medical Devices Advisory Committee; electronic and written/paper comments Notice of Meeting; Establishment of a Submit written/paper submissions as received, go to http:// Public Docket; Request for Comments follows: www.regulations.gov and insert the • Mail/Hand delivery/Courier (for docket number, found in brackets in the AGENCY: Food and Drug Administration, written/paper submissions): Division of heading of this document, into the HHS. Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts ACTION: Notice; establishment of a and Drug Administration, 5630 Fishers and/or go to the Division of Dockets public docket; request for comments. Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments Management, 5630 Fishers Lane, Rm. SUMMARY: The Food and Drug submitted to the Division of Dockets 1061, Rockville, MD 20852. Administration (FDA) announces a Management, FDA will post your FOR FURTHER INFORMATION CONTACT: forthcoming public advisory committee comment, as well as any attachments, Shanika Craig, Center for Devices and meeting of the Microbiology Devices except for information submitted, Radiological Health, Food and Drug Panel of the Medical Devices Advisory marked and identified, as confidential, Administration, 10903 New Hampshire Committee. The general function of the if submitted as detailed in Ave., Bldg. 66, Rm. 1613, Silver Spring, committee is to provide advice and ‘‘Instructions.’’ MD 20993–0002, 301–796–6639, recommendations to the Agency on Instructions: All submissions received Shanika.Craig@fda.hhs.gov, or FDA FDA’s regulatory issues. The meeting must include the Docket No. FDA– Advisory Committee Information Line, will be open to the public. FDA is 2016–N–1660 for ‘‘Microbiology Devices 1–800–741–8138 (301–443–0572 in the establishing a docket for public Panel of the Medical Devices Advisory Washington, DC area). A notice in the comment on this document. Committee; Notice of Meeting; Federal Register about last minute DATES: The meeting will be held on Establishment of a Public Docket; modifications that impact a previously August 16, 2016, from 8 a.m. to 6 p.m. Request for Comments.’’ Received announced advisory committee meeting ADDRESSES: FDA White Oak Campus, comments will be placed in the docket cannot always be published quickly 10903 New Hampshire Ave., Bldg. 31 and, except for those submitted as enough to provide timely notice. Conference Center, the Great Room (Rm. ‘‘Confidential Submissions,’’ publicly Therefore, you should always check the 1503), Silver Spring, MD 20993–0002. viewable at http://www.regulations.gov Agency’s Web site at http://www.fda. Answers to commonly asked questions or at the Division of Dockets gov/AdvisoryCommittees/default.htm including information regarding special Management between 9 a.m. and 4 p.m., and scroll down to the appropriate accommodations due to a disability, Monday through Friday. advisory committee meeting link, or call visitor parking, and transportation may • Confidential Submissions—To the advisory committee information line be accessed at: http://www.fda.gov/ submit a comment with confidential to learn about possible modifications AdvisoryCommittees/ information that you do not wish to be before coming to the meeting. AboutAdvisoryCommittees/ made publicly available, submit your SUPPLEMENTARY INFORMATION: ucm408555.htm. You may submit comments only as a written/paper Agenda: On August 16, 2016, the comments as follows: submission. You should submit two committee will discuss and make copies total. One copy will include the recommendations regarding the Electronic Submissions information you claim to be confidential appropriateness of clearing or approving Submit electronic comments in the with a heading or cover note that states of over-the-counter (OTC) diagnostic following way: ‘‘THIS DOCUMENT CONTAINS tests for the detection of pathogens • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The causing infectious diseases, focusing on www.regulations.gov. Follow the Agency will review this copy, including respiratory and sexually transmitted instructions for submitting comments. the claimed confidential information, in infections (STI). Currently, there are no Comments submitted electronically, its consideration of comments. The OTC diagnostic tests for infectious including attachments, to http:// second copy, which will have the diseases cleared or approved by CDRH. www.regulations.gov will be posted to claimed confidential information The committee will evaluate the risks the docket unchanged. Because your redacted/blacked out, will be available and benefits to individual patients and mstockstill on DSK3G9T082PROD with NOTICES comment will be made public, you are for public viewing and posted on http:// to public health associated with clearing solely responsible for ensuring that your www.regulations.gov. Submit both or approving OTC diagnostic tests for comment does not include any copies to the Division of Dockets infectious diseases. Serious risks such confidential information that you or a Management. If you do not wish your as false negative results, false positive third party may not wish to be posted, name and contact information to be results, patient loss to medical such as medical information, your or made publicly available, you can followup, and the impact on anyone else’s Social Security number, or provide this information on the cover surveillance of reportable infections will VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1

Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices 42363 be addressed. Potential benefits such as For press inquiries, please contact the committee meeting. This draft guidance reduction of infection transmission and Office of Media Affairs at fdaoma@ is not final nor is it in effect at this time. increased access to testing will be fda.hhs.gov or 301–796–4540. FDA is also requesting comment on discussed as well. The committee will FDA welcomes the attendance of the whether FDA should request that each also make recommendations on clinical public at its advisory committee advisory committee member who has an study design, analytical study design, meetings and will make every effort to appearance issue and who has received and acceptable performance criteria accommodate persons with disabilities. an authorization from FDA to applicable to respiratory and STI If you require accommodations due to a participate in an advisory committee diagnostic devices. disability, please contact Artair Mallett, meeting voluntarily publicly disclose at Artair.Mallett.Mallett@fda.hhs.gov or the authorization. FDA intends to make background 301–796–9638 at least 7 days in advance DATES: Although you can comment on material available to the public no later of the meeting. any guidance at any time (see 21 CFR than 2 business days before the meeting. FDA is committed to the orderly If FDA is unable to post the background 10.115(g)(5)), to ensure that the Agency conduct of its advisory committee material on its Web site prior to the considers your comments on this draft meetings. Please visit our Web site at meeting, the background material will guidance before it begins work on the http://www.fda.gov/Advisory be made publicly available at the final version of the guidance, submit Committees/AboutAdvisoryCommittees/ location of the advisory committee either electronic or written comments ucm111462.htm for procedures on meeting, and the background material on the draft guidance by September 27, public conduct during advisory will be posted on FDA’s Web site after 2016. committee meetings. the meeting. Background material is Notice of this meeting is given under ADDRESSES: You may submit comments available at http://www.fda.gov/ the Federal Advisory Committee Act (5 as follows: AdvisoryCommittees/Calendar/ U.S.C. app. 2). default.htm. Scroll down to the Electronic Submissions Dated: June 23, 2016. appropriate advisory committee meeting Submit electronic comments in the link. Jill Hartzler Warner, following way: Procedure: Interested persons may Associate Commissioner for Special Medical • Federal eRulemaking Portal: http:// Programs. www.regulations.gov. Follow the present data, information, or views, [FR Doc. 2016–15362 Filed 6–28–16; 8:45 am] orally or in writing, on issues pending instructions for submitting comments. before the committee. Written BILLING CODE 4164–01–P Comments submitted electronically, submissions may be made to the contact including attachments, to http:// person on or before August 2, 2016. Oral www.regulations.gov will be posted to DEPARTMENT OF HEALTH AND the docket unchanged. Because your presentations from the public will be HUMAN SERVICES scheduled between approximately 1 comment will be made public, you are p.m. and 2 p.m. Those individuals Food and Drug Administration solely responsible for ensuring that your interested in making formal oral comment does not include any [Docket No. FDA–2016–D–1399] confidential information that you or a presentations should notify the contact person and submit a brief statement of third party may not wish to be posted, Procedures for Evaluating Appearance such as medical information, your or the general nature of the evidence or Issues and Granting Authorizations for arguments they wish to present, the anyone else’s Social Security number, or Participation in Food and Drug confidential business information, such names and addresses of proposed Administration Advisory Committees; participants, and an indication of the as a manufacturing process. Please note Draft Guidance for the Public, Food that if you include your name, contact approximate time requested to make and Drug Administration Advisory their presentation on or before July 15, information, or other information that Committee Members, and Food and identifies you in the body of your 2016. Time allotted for each Drug Administration Staff; Availability presentation may be limited. If the comments, that information will be number of registrants requesting to AGENCY: Food and Drug Administration, posted on http://www.regulations.gov. speak is greater than can be reasonably HHS. • If you want to submit a comment accommodated during the scheduled ACTION: Notice. with confidential information that you open public hearing session, FDA may do not wish to be made available to the conduct a lottery to determine the SUMMARY: The Food and Drug public, submit the comment as a speakers for the scheduled open public Administration (FDA) is announcing the written/paper submission and in the hearing session. The contact person will availability of a draft guidance entitled manner detailed (see ‘‘Written/Paper notify interested persons regarding their ‘‘Procedures for Evaluating Appearance Submissions’’ and ‘‘Instructions’’). request to speak by July 21, 2016. Issues and Granting Authorizations for Participation in FDA Advisory Written/Paper Submissions Persons attending FDA’s advisory Committees; Guidance for the Public, Submit written/paper submissions as committee meetings are advised that the FDA Advisory Committee Members, and follows: Agency is not responsible for providing FDA Staff.’’ This draft guidance • Mail/Hand delivery/Courier (for access to electrical outlets. addresses FDA’s process, under written/paper submissions): Division of FDA is establishing a docket for Government-wide Federal regulations, Dockets Management (HFA–305), Food public comment on this document. The for evaluating whether an advisory and Drug Administration, 5630 Fishers mstockstill on DSK3G9T082PROD with NOTICES docket number is FDA–2016–N–1660. committee member has an appearance Lane, Rm. 1061, Rockville, MD 20852. The docket will close on September 16, issue that raises concerns about the • For written/paper comments 2016. Comments received on or before member’s participation in an advisory submitted to the Division of Dockets July 26, 2016, will be provided to the committee meeting and describes FDA’s Management, FDA will post your committee. Comments received after process for determining whether to comment, as well as any attachments, that date will be taken into authorize a member with an appearance except for information submitted, consideration by the Agency. issue to participate in the advisory marked and identified, as confidential, VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1


Document Created: 2018-02-08 07:43:03
Document Modified: 2018-02-08 07:43:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; establishment of a public docket; request for comments.
DatesThe meeting will be held on August 16, 2016, from 8 a.m. to 6 p.m.
ContactShanika Craig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, 301-796-6639, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
FR Citation81 FR 42362 
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