82 FR 2368 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 5 (January 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 5 (January 9, 2017)
| Page Range | 2368-2369 | |
| FR Document | 2017-00143 |
[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)] [Notices] [Pages 2368-2369] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00143] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System 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. DATES: The meeting will be held on February 23, 2017, from 8 a.m. to 6 p.m. ADDRESSES: Hilton Washington, DC/North, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's phone number is 301-977- 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. FOR FURTHER INFORMATION CONTACT: Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002, [email protected], 301-796-6683, 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/ [[Page 2369]] 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 February 23, 2017, the committee will discuss and make recommendations on clinical information related to the de novo request for the Sentinel[supreg] Cerebral Protection System, a first of a kind embolic protection device to be used with transcatheter aortic valve replacement (TAVR) procedures. 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 February 9, 2017. 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 February 1, 2017. 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 February 2, 2017. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. 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 AnnMarie Williams at [email protected] or 301-796- 5966 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: January 4, 2017. Janice M. Soreth, Associate Commissioner, Special Medical Programs. [FR Doc. 2017-00143 Filed 1-6-17; 8:45 am] BILLING CODE 4164-01-P
![2368 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices
ADDRESSES: You may submit comments copies total. One copy will include the the notice of revised draft guidance
by any of the following methods: information you claim to be confidential availability will provide adequate time
with a heading or cover note that states for interested persons to submit
Electronic Submissions
‘‘THIS DOCUMENT CONTAINS comments without significantly
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The delaying Agency decision making on
following way: Agency will review this copy, including these important issues.
• Federal eRulemaking Portal: the claimed confidential information, in Dated: January 3, 2017.
https://www.regulations.gov. Follow the its consideration of comments. The
instructions for submitting comments. Leslie Kux,
second copy, which will have the
Comments submitted electronically, Associate Commissioner for Policy.
claimed confidential information
including attachments, to https:// [FR Doc. 2017–00094 Filed 1–6–17; 8:45 am]
redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on BILLING CODE 4164–01–P
the docket unchanged. Because your https://www.regulations.gov. Submit
comment will be made public, you are both copies to the Division of Dockets
solely responsible for ensuring that your DEPARTMENT OF HEALTH AND
Management. If you do not wish your
comment does not include any HUMAN SERVICES
name and contact information to be
confidential information that you or a made publicly available, you can
third party may not wish to be posted, Food and Drug Administration
provide this information on the cover
such as medical information, your or sheet and not in the body of your [Docket No. FDA–2016–N–0001]
anyone else’s Social Security number, or comments and you must identify this
confidential business information, such information as ‘‘confidential.’’ Any Circulatory System Devices Panel of
as a manufacturing process. Please note information marked as ‘‘confidential’’ the Medical Devices Advisory
that if you include your name, contact will not be disclosed except in Committee; Notice of Meeting
information, or other information that accordance with 21 CFR 10.20 and other AGENCY: Food and Drug Administration,
identifies you in the body of your applicable disclosure law. For more HHS.
comments, that information will be information about FDA’s posting of ACTION: Notice.
posted on https://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access SUMMARY: The Food and Drug
with confidential information that you the information at: http://www.fda.gov/ Administration (FDA) announces a
do not wish to be made available to the regulatoryinformation/dockets/ forthcoming public advisory committee
public, submit the comment as a default.htm. meeting of the Circulatory System
written/paper submission and in the Docket: For access to the docket to Devices Panel of the Medical Devices
manner detailed (see ‘‘Written/Paper read background documents or the Advisory Committee. The general
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments function of the committee is to provide
Written Submissions received, go to https:// advice and recommendations to the
www.regulations.gov and insert the Agency on FDA’s regulatory issues. The
Submit written submissions in the meeting will be open to the public.
docket number(s), found in brackets in
following ways:
the heading of this document, into the DATES: The meeting will be held on
• Mail/Hand delivery/Courier (for
‘‘Search’’ box and follow the prompts February 23, 2017, from 8 a.m. to 6 p.m.
written/paper submissions): Division of
and/or go to the Division of Dockets ADDRESSES: Hilton Washington, DC/
Dockets Management (HFA–305), Food
Management, 5630 Fishers Lane, Rm. North, Salons A, B, C and D, 620 Perry
and Drug Administration, 5630 Fishers
1061, Rockville, MD 20852. Pkwy., Gaithersburg, MD 20877. The
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments FOR FURTHER INFORMATION CONTACT: Tara hotel’s phone number is 301–977–8900.
submitted to the Division of Dockets Gooen Bizjak, Center for Drug Answers to commonly asked questions
Management, FDA will post your Evaluation and Research, Food and including information regarding special
comment, as well as any attachments, Drug Administration, 10903 New accommodations due to a disability,
except for information submitted, Hampshire Ave., Bldg. 51, Rm. 2109, visitor parking, and transportation may
marked and identified, as confidential, Silver Spring, MD 20993–0002, 301– be accessed at: http://www.fda.gov/
if submitted as detailed in 796–3257 or Stephen Ripley, Center for AdvisoryCommittees/AboutAdvisory
‘‘Instructions.’’ Biologics Evaluation and Research, Committees/ucm408555.htm.
Instructions: All submissions received Food and Drug Administration, 10903 FOR FURTHER INFORMATION CONTACT:
must include the Docket No. FDA– New Hampshire Ave., Bldg. 71, Rm. Evella Washington, Center for Devices
2015–D–2537 for ‘‘Submission of 7301, Silver Spring, MD 20993–0002, and Radiological Health, Food and Drug
Quality Metrics Data; Revised Draft 240–402–7911. Administration, 10903 New Hampshire
Guidance for Industry.’’ Received SUPPLEMENTARY INFORMATION: In the Ave., Bldg. 66, Rm. G640, Silver Spring,
comments will be placed in the docket Federal Register of November 25, 2016, MD 20993–0002, Evella.Washington@
and, except for those submitted as FDA published a notice of revised draft fda.hhs.gov, 301–796–6683, or FDA
‘‘Confidential Submissions,’’ publicly guidance availability with a 60-day Advisory Committee Information Line,
viewable at https://www.regulations.gov comment period. Comments on the 1–800–741–8138 (301–443–0572 in the
or at the Division of Dockets notice of revised draft guidance Washington, DC area). A notice in the
Federal Register about last minute
sradovich on DSK3GMQ082PROD with NOTICES
Management between 9 a.m. and 4 p.m., availability will inform FDA’s
Monday through Friday. development and proposed modifications that impact a previously
• Confidential Submissions—To implementation of a voluntary phase of announced advisory committee meeting
submit a comment with confidential the quality metrics program. cannot always be published quickly
information that you do not wish to be FDA is extending the comment period enough to provide timely notice.
made publicly available, submit your for an additional 60 days, until March Therefore, you should always check the
comments only as a written/paper 27, 2017. The Agency believes that a 60- Agency’s Web site at http://
submission. You should submit two day extension of the comment period for www.fda.gov/AdvisoryCommittees/
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![Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2369
default.htm and scroll down to the accommodate persons with disabilities. diagnosis of Zika virus infection, subject
appropriate advisory committee meeting If you require accommodations due to a to the terms of any authorization issued
link, or call the advisory committee disability, please contact AnnMarie under the FD&C Act. The Authorization,
information line to learn about possible Williams at AnnMarie.Williams@ which includes an explanation of the
modifications before coming to the fda.hhs.gov or 301–796–5966 at least 7 reasons for issuance, is reprinted in this
meeting. days in advance of the meeting. document.
FDA is committed to the orderly DATES: The Authorization is effective as
SUPPLEMENTARY INFORMATION:
conduct of its advisory committee of December 9, 2016.
Agenda: On February 23, 2017, the
meetings. Please visit our Web site at ADDRESSES: Submit written requests for
committee will discuss and make
http://www.fda.gov/Advisory single copies of the EUA to the Office
recommendations on clinical
Committees/AboutAdvisoryCommittees/ of Counterterrorism and Emerging
information related to the de novo
ucm111462.htm for procedures on Threats, Food and Drug Administration,
request for the Sentinel® Cerebral
public conduct during advisory 10903 New Hampshire Ave., Bldg. 1,
Protection System, a first of a kind
committee meetings. Rm. 4338, Silver Spring, MD 20993–
embolic protection device to be used Notice of this meeting is given under
with transcatheter aortic valve 0002. Send one self-addressed adhesive
the Federal Advisory Committee Act label to assist that office in processing
replacement (TAVR) procedures. (5 U.S.C. app. 2).
FDA intends to make background your request or include a fax number to
material available to the public no later Dated: January 4, 2017. which the Authorization may be sent.
than 2 business days before the meeting. Janice M. Soreth, See the SUPPLEMENTARY INFORMATION
If FDA is unable to post the background Associate Commissioner, Special Medical section for electronic access to the
material on its Web site prior to the Programs. Authorization.
meeting, the background material will [FR Doc. 2017–00143 Filed 1–6–17; 8:45 am] FOR FURTHER INFORMATION CONTACT:
be made publicly available at the BILLING CODE 4164–01–P Carmen Maher, Office of
location of the advisory committee Counterterrorism and Emerging Threats,
meeting, and the background material Food and Drug Administration, 10903
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND New Hampshire Ave., Bldg. 1, Rm.
the meeting. Background material is HUMAN SERVICES 4347, Silver Spring, MD 20993–0002,
available at http://www.fda.gov/ 301–796–8510 (this is not a toll free
Food and Drug Administration
AdvisoryCommittees/Calendar/ number).
default.htm. Scroll down to the [Docket No. FDA–2016–N–4586] SUPPLEMENTARY INFORMATION:
appropriate advisory committee meeting
link. Authorization of Emergency Use of an I. Background
Procedure: Interested persons may In Vitro Diagnostic Device for Section 564 of the FD&C Act (21
present data, information, or views, Detection of Zika Virus; Availability U.S.C. 360bbb–3) as amended by the
orally or in writing, on issues pending AGENCY: Food and Drug Administration, Project BioShield Act of 2004 (Pub. L.
before the committee. Written HHS. 108–276) and the Pandemic and All-
submissions may be made to the contact ACTION: Notice. Hazards Preparedness Reauthorization
person on or before February 9, 2017. Act of 2013 (Pub. L. 113–5) allows FDA
Oral presentations from the public will SUMMARY: The Food and Drug to strengthen the public health
be scheduled between approximately Administration (FDA) is announcing the protections against biological, chemical,
1 p.m. and 2 p.m. Those individuals issuance of an Emergency Use nuclear, and radiological agents. Among
interested in making formal oral Authorization (EUA) (the Authorization) other things, section 564 of the FD&C
presentations should notify the contact for an in vitro diagnostic device for Act allows FDA to authorize the use of
person and submit a brief statement of detection of the Zika virus in response an unapproved medical product or an
the general nature of the evidence or to the Zika virus outbreak in the unapproved use of an approved medical
arguments they wish to present, the Americas. FDA issued this product in certain situations. With this
names and addresses of proposed Authorization under the Federal Food, EUA authority, FDA can help assure
participants, and an indication of the Drug, and Cosmetic Act (the FD&C Act), that medical countermeasures may be
approximate time requested to make as requested by ELITechGroup Inc. used in emergencies to diagnose, treat,
their presentation on or before February Molecular Diagnostics. The or prevent serious or life-threatening
1, 2017. Time allotted for each Authorization contains, among other diseases or conditions caused by
presentation may be limited. If the things, conditions on the emergency use biological, chemical, nuclear, or
number of registrants requesting to of the authorized in vitro diagnostic radiological agents when there are no
speak is greater than can be reasonably device. The Authorization follows the adequate, approved, and available
accommodated during the scheduled February 26, 2016, determination by the alternatives.
open public hearing session, FDA may Secretary of Health and Human Services Section 564(b)(1) of the FD&C Act
conduct a lottery to determine the (HHS) that there is a significant provides that, before an EUA may be
speakers for the scheduled open public potential for a public health emergency issued, the Secretary of HHS must
hearing session. The contact person will that has a significant potential to affect declare that circumstances exist
notify interested persons regarding their national security or the health and justifying the authorization based on
security of U.S. citizens living abroad one of the following grounds: (1) A
sradovich on DSK3GMQ082PROD with NOTICES
request to speak by February 2, 2017.
Persons attending FDA’s advisory and that involves Zika virus. On the determination by the Secretary of
committee meetings are advised that the basis of such determination, the Homeland Security that there is a
Agency is not responsible for providing Secretary of HHS declared on February domestic emergency, or a significant
access to electrical outlets. 26, 2016, that circumstances exist potential for a domestic emergency,
FDA welcomes the attendance of the justifying the authorization of involving a heightened risk of attack
public at its advisory committee emergency use of in vitro diagnostic with a biological, chemical, radiological,
meetings and will make every effort to tests for detection of Zika virus and/or or nuclear agent or agents; (2) a
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Document Created: 2018-10-24 11:12:10
Document Modified: 2018-10-24 11:12:10
| 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. | |
| Dates | The meeting will be held on February 23, 2017, from 8 a.m. to 6 p.m. | |
| Contact | Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002, [email protected], 301-796-6683, 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 | 82 FR 2368 |
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