81 FR 60358 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 170 (September 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 170 (September 1, 2016)
| Page Range | 60358-60359 | |
| FR Document | 2016-21045 |
[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)] [Notices] [Pages 60358-60359] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21045] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 October 5, 2016, from 8 a.m. to 6 p.m. ADDRESSES: Gaithersburg Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD 20879. The hotel's telephone number is 301-948- 8900. 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: Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2648, Silver Spring, MD 20993, [email protected], 301-796-0400, 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 [[Page 60359]] 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 October 5, 2016, during session I, the topic to be addressed will be reclassification of quantitative Cytomegalovirus (CMV) viral load devices from class III (Premarket approval) to class II (510(k)). A nucleic acid-based in vitro diagnostic device for the quantitation of CMV viral load, within the context of transplant patient management, is a post-amendment device classified into class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)). To date, the following product code has been established for CMV viral load devices: PAB (Cytomegalovirus (CMV) DNA Quantitative Assay). During session II, the topics to be addressed include appropriate initial classification for qualitative or quantitative viral load devices for Epstein-Barr virus (EBV), BK virus (BK), JC virus (JCV), Human Herpesvirus 6 (HHV6), and Adenovirus infections. FDA is seeking expert recommendations to assess the potential risks and benefits of these devices when used in patients following solid-organ or stem cell transplantation. 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 September 29, 2016. Oral presentations from the public will be scheduled on October 5, 2016, 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 September 21, 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 September 22, 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 November 9, 2016. Comments received on or before September 21, 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: August 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-21045 Filed 8-31-16; 8:45 am] BILLING CODE 4164-01-P
![60358 Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices
accepted. FDA may limit the number of Ave., Gaithersburg, MD 20879. The and, except for those submitted as
participants from each organization hotel’s telephone number is 301–948– ‘‘Confidential Submissions,’’ publicly
based on space limitations. Registration 8900. Answers to commonly asked viewable at http://www.regulations.gov
on the day of the public meeting will be questions including information or at the Division of Dockets
provided on a space available basis regarding special accommodations due Management between 9 a.m. and 4 p.m.,
beginning at 8:30 a.m. Those who are to a disability, visitor parking, and Monday through Friday.
unable to attend the meeting in person transportation may be accessed at: • Confidential Submissions—To
can register to view a live Web cast of http://www.fda.gov/ submit a comment with confidential
the meeting. You will be asked to AdvisoryCommittees/ information that you do not wish to be
indicate in your registration if you plan AboutAdvisoryCommittees/ made publicly available, submit your
to attend in person or via the Web cast. ucm408555.htm. You may submit comments only as a written/paper
FDA will post the agenda approximately comments as follows: submission. You should submit two
5 days before the workshop at http:// copies total. One copy will include the
Electronic Submissions
www.fda.gov/BiologicsBloodVaccines/ information you claim to be confidential
NewsEvents/ Submit electronic comments in the with a heading or cover note that states
WorkshopsMeetingsConferences/ following way: ‘‘THIS DOCUMENT CONTAINS
ucm490175.htm. • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
If you need special accommodations www.regulations.gov. Follow the Agency will review this copy, including
because of disability, please contact instructions for submitting comments. the claimed confidential information, in
Chris Nguyen (see FOR FURTHER Comments submitted electronically, its consideration of comments. The
INFORMATION CONTACT) at least 7 days in including attachments, to http:// second copy, which will have the
advance of the meeting. www.regulations.gov will be posted to claimed confidential information
Transcripts: Please be advised that as the docket unchanged. Because your redacted/blacked out, will be available
soon as possible after a transcript of the comment will be made public, you are for public viewing and posted on http://
public workshop is available, it will be solely responsible for ensuring that your www.regulations.gov. Submit both
accessible at: http://www.fda.gov/ comment does not include any copies to the Division of Dockets
BiologicsBloodVaccines/NewsEvents/ confidential information that you or a Management. If you do not wish your
WorkshopsMeetingsConferences/ third party may not wish to be posted, name and contact information to be
ucm490175.htm. such as medical information, your or made publicly available, you can
anyone else’s Social Security number, or provide this information on the cover
Dated: August 26, 2016.
confidential business information, such sheet and not in the body of your
Leslie Kux,
as a manufacturing process. Please note comments and you must identify this
Associate Commissioner for Policy. that if you include your name, contact information as ‘‘confidential.’’ Any
[FR Doc. 2016–21046 Filed 8–31–16; 8:45 am] information, or other information that information marked as ‘‘confidential’’
BILLING CODE 4164–01–P identifies you in the body of your will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
posted on http://www.regulations.gov. applicable disclosure law. For more
DEPARTMENT OF HEALTH AND • If you want to submit a comment information about FDA’s posting of
HUMAN SERVICES with confidential information that you comments to public dockets, see 80 FR
do not wish to be made available to the 56469, September 18, 2015, or access
Food and Drug Administration public, submit the comment as a the information at: http://www.fda.gov/
[Docket No. FDA–2016–N–1660] written/paper submission and in the regulatoryinformation/dockets/
manner detailed (see ‘‘Written/Paper default.htm.
Microbiology Devices Panel of the Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Medical Devices Advisory Committee;
Written/Paper Submissions read background documents or the
Notice of Meeting; Establishment of a
Submit written/paper submissions as electronic and written/paper comments
Public Docket; Request for Comments
follows: received, go to http://
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
HHS. written/paper submissions): Division of docket number, found in brackets in the
ACTION: Notice; establishment of a Dockets Management (HFA–305), Food heading of this document, into the
public docket; request for comments. and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
SUMMARY: The Food and Drug • For written/paper comments Management, 5630 Fishers Lane, Rm.
Administration (FDA) announces a submitted to the Division of Dockets 1061, Rockville, MD 20852.
forthcoming public advisory committee Management, FDA will post your FOR FURTHER INFORMATION CONTACT:
meeting of the Microbiology Devices comment, as well as any attachments, Aden Asefa, Center for Devices and
Panel of the Medical Devices Advisory except for information submitted, Radiological Health, Food and Drug
Committee. The general function of the marked and identified, as confidential, Administration, 10903 New Hampshire
committee is to provide advice and if submitted as detailed in Ave., Bldg. 66, Rm. 2648, Silver Spring,
recommendations to the Agency on ‘‘Instructions.’’ MD 20993, aden.asefa@fda.hhs.gov,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FDA’s regulatory issues. The meeting Instructions: All submissions received 301–796–0400, or FDA Advisory
will be open to the public. FDA is must include the Docket No. FDA– Committee Information Line, 1–800–
establishing a docket for public 2016–N–1660 for ‘‘Microbiology Devices 741–8138 (301–443–0572 in the
comment on this document. Panel of the Medical Devices Advisory Washington, DC area). A notice in the
DATES: The meeting will be held on Committee; Notice of Meeting; Federal Register about last minute
October 5, 2016, from 8 a.m. to 6 p.m. Establishment of a Public Docket; modifications that impact a previously
ADDRESSES: Gaithersburg Holiday Inn, Request for Comments.’’ Received announced advisory committee meeting
Ballroom, Two Montgomery Village comments will be placed in the docket cannot always be published quickly
VerDate Sep<11>2014 17:14 Aug 31, 2016 Jkt 238001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1](https://thefederalregister.org/doc/81_FR_60528/page/1.svg)
![Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices 60359
enough to provide timely notice. brief statement of the general nature of DEPARTMENT OF HEALTH AND
Therefore, you should always check the the evidence or arguments they wish to HUMAN SERVICES
Agency’s Web site at http:// present, the names and addresses of
www.fda.gov/AdvisoryCommittees/ proposed participants, and an Food and Drug Administration
default.htm and scroll down to the indication of the approximate time [Docket No. FDA–2016–N–0001]
appropriate advisory committee meeting requested to make their presentation on
link, or call the advisory committee or before September 21, 2016. Time Advisory Committee; Endocrinologic
information line to learn about possible allotted for each presentation may be and Metabolic Drugs Advisory
modifications before coming to the limited. If the number of registrants Committee, Renewal
meeting. requesting to speak is greater than can AGENCY: Food and Drug Administration,
SUPPLEMENTARY INFORMATION: be reasonably accommodated during the HHS.
Agenda: On October 5, 2016, during scheduled open public hearing session,
session I, the topic to be addressed will ACTION:Notice; renewal of advisory
FDA may conduct a lottery to determine committee.
be reclassification of quantitative the speakers for the scheduled open
Cytomegalovirus (CMV) viral load public hearing session. The contact SUMMARY: The Food and Drug
devices from class III (Premarket person will notify interested persons Administration (FDA) is announcing the
approval) to class II (510(k)). A nucleic regarding their request to speak by renewal of the Endocrinologic and
acid-based in vitro diagnostic device for September 22, 2016. Metabolic Drugs Advisory Committee by
the quantitation of CMV viral load, the Commissioner of Food and Drugs
within the context of transplant patient Persons attending FDA’s advisory
committee meetings are advised that the (the Commissioner). The Commissioner
management, is a post-amendment has determined that it is in the public
device classified into class III under Agency is not responsible for providing
interest to renew the Endocrinologic
section 513(f)(1) of the Federal Food, access to electrical outlets.
and Metabolic Drugs Advisory
Drug, and Cosmetic Act (21 U.S.C. FDA is establishing a docket for Committee for an additional 2 years
360c(f)(1)). To date, the following public comment on this document. The beyond the charter expiration date. The
product code has been established for docket number is FDA–2016–N–1660. new charter will be in effect until
CMV viral load devices: PAB The docket will close on November 9, August 27, 2018.
(Cytomegalovirus (CMV) DNA 2016. Comments received on or before DATES: Authority for the Endocrinologic
Quantitative Assay). During session II, September 21, 2016, will be provided to and Metabolic Drugs Advisory
the topics to be addressed include the committee. Comments received after Committee will expire on August 27,
appropriate initial classification for that date will be taken into 2016, unless the Commissioner formally
qualitative or quantitative viral load
consideration by the Agency. determines that renewal is in the public
devices for Epstein-Barr virus (EBV), BK
For press inquiries, please contact the interest.
virus (BK), JC virus (JCV), Human
Herpesvirus 6 (HHV6), and Adenovirus Office of Media Affairs at fdaoma@ FOR FURTHER INFORMATION CONTACT:
infections. FDA is seeking expert fda.hhs.gov or 301–796–4540. LaToya Bonner, Center for Drug
recommendations to assess the potential Evaluation and Research, Food and
FDA welcomes the attendance of the
risks and benefits of these devices when Drug Administration, 10903 New
public at its advisory committee
used in patients following solid-organ or Hampshire Ave., Bldg. 31, Rm. 2417,
meetings and will make every effort to
stem cell transplantation. Silver Spring, MD 20993–0002, 301–
accommodate persons with disabilities. 796–9001, EMDAC@fda.hhs.gov.
FDA intends to make background If you require accommodations due to a
material available to the public no later SUPPLEMENTARY INFORMATION: Pursuant
disability, please contact Artair Mallett
than 2 business days before the meeting. to 41 CFR 102–3.65 and approval by the
at Artair.Mallett@fda.hhs.gov or 301–
If FDA is unable to post the background Department of Health and Human
796–9638, at least 7 days in advance of Services pursuant to 45 CFR part 11 and
material on its Web site prior to the
meeting, the background material will the meeting. by the General Services Administration,
be made publicly available at the FDA is committed to the orderly FDA is announcing the renewal of the
location of the advisory committee conduct of its advisory committee Endocrinologic and Metabolic Drugs
meeting, and the background material meetings. Please visit our Web site at Advisory Committee. The committee is
will be posted on FDA’s Web site after http://www.fda.gov/ a discretionary Federal advisory
the meeting. Background material is AdvisoryCommittees/ committee established to provide advice
available at http://www.fda.gov/ AboutAdvisoryCommittees/ to the Commissioner. The
AdvisoryCommittees/Calendar/ ucm111462.htm for procedures on Endocrinologic and Metabolic Drugs
default.htm. Scroll down to the public conduct during advisory Advisory Committee advises the
appropriate advisory committee meeting committee meetings. Commissioner or designee in
link. discharging responsibilities as they
Procedure: Interested persons may Notice of this meeting is given under relate to helping to ensure safe and
present data, information, or views, the Federal Advisory Committee Act (5 effective drugs for human use and, as
orally or in writing, on issues pending U.S.C. app. 2). required, any other product for which
before the committee. Written FDA has regulatory responsibility.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Dated: August 26, 2016.
submissions may be made to the contact Leslie Kux, The Committee reviews and evaluates
person on or before September 29, 2016. Associate Commissioner for Policy. data concerning the safety and
Oral presentations from the public will effectiveness of marketed and
[FR Doc. 2016–21045 Filed 8–31–16; 8:45 am]
be scheduled on October 5, 2016, investigational human drug products for
BILLING CODE 4164–01–P
between approximately 1 p.m. and 2 use in the treatment of endocrine and
p.m. Those individuals interested in metabolic disorders, and makes
making formal oral presentations should appropriate recommendations to the
notify the contact person and submit a Commissioner of Food and Drugs.
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Document Created: 2018-02-09 11:57:33
Document Modified: 2018-02-09 11:57:33
| 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; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on October 5, 2016, from 8 a.m. to 6 p.m. | |
| Contact | Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2648, Silver Spring, MD 20993, [email protected], 301-796-0400, 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 Citation | 81 FR 60358 |
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