80 FR 72971 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 225 (November 23, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 225 (November 23, 2015)
| Page Range | 72971-72972 | |
| FR Document | 2015-29768 |
[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)] [Notices] [Pages 72971-72972] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29768] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues. [[Page 72972]] Date and Time: The meeting will be held on Friday, February 19, 2016, from 8 a.m. to 6 p.m. Location: Hilton Washington, DC/North, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number is 301- 977- 8900. Contact Person: Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm.1643, 10903 New Hampshire Ave., Silver Spring, MD 20993, [email protected], 301 796-7047, 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. Agenda: The Committee will discuss the premarket application for the DIAM Spinal Stabilization System. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5. DDD is confirmed radiographically with one or more of the following factors: (1) Patients must have greater than 2 millimeters of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. 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 12, 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 February 4, 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 February 5, 2016. 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 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: November 13, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-29768 Filed 11-20-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices 72971
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to ingredient for which a 586A or pending
Submissions’’ and ‘‘Instructions’’). read background documents or the request had been previously submitted
electronic and written/paper comments and withdrawn.
Written/Paper Submissions
received, go to http:// This draft guidance is being issued
Submit written/paper submissions as www.regulations.gov and insert the consistent with FDA’s good guidance
follows: docket number, found in brackets in the practices regulation (21 CFR 10.115).
• Mail/Hand delivery/Courier (for heading of this document, into the The draft guidance, when finalized, will
written/paper submissions): Division of ‘‘Search’’ box and follow the prompts represent the current thinking of FDA
Dockets Management (HFA–305), Food and/or go to the Division of Dockets on the withdrawal of 586A requests and
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. pending requests under the SIA. It does
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. not establish any rights for any person
• For written/paper comments Submit written requests for single and is not binding on FDA or the public.
submitted to the Division of Dockets copies of this draft guidance to the You can use an alternative approach if
Management, FDA will post your Division of Drug Information, Center for it satisfies the requirements of the
comment, as well as any attachments, Drug Evaluation and Research, Food applicable statutes and regulations.
except for information submitted, and Drug Administration, 10001 New
marked and identified, as confidential, Hampshire Ave., Hillandale Building, II. Electronic Access
if submitted as detailed in 4th Floor, Silver Spring, MD 20993– Persons with access to the Internet
‘‘Instructions.’’ 0002. Send one self-addressed adhesive may obtain the draft guidance at either
Instructions: All submissions received
label to assist that office in processing http://www.fda.gov/Drugs/Guidance
must include the Docket No. FDA–
your requests. See the SUPPLEMENTARY ComplianceRegulatoryInformation/
2015–D–4012 for ‘‘Sunscreen
INFORMATION section for electronic Guidances/default.htm or http://
Innovation Act: Withdrawal of a 586A
access to the draft guidance document. www.regulations.gov.
Request or Pending Request; Draft
Guidance for Industry.’’ Received FOR FURTHER INFORMATION CONTACT: III. Paperwork Reduction Act of 1995
comments will be placed in the docket Kristen Hardin, Center for Drug
Evaluation and Research, Food and This draft guidance contains
and, except for those submitted as collections of information that are
‘‘Confidential Submissions,’’ publicly Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5443, exempt from the Paperwork Reduction
viewable at http://www.regulations.gov
Silver Spring, MD 20993, 240–402– Act of 1995 (44 U.S.C. 3501–3520)
or at the Division of Dockets
4246. (PRA). Section 586D(a)(1)(C) of the
Management between 9 a.m. and 4 p.m.,
FD&C Act (21 U.S.C 360fff–4(a)(1)(C))
Monday through Friday. SUPPLEMENTARY INFORMATION:
• Confidential Submissions—To states that the PRA shall not apply to
submit a comment with confidential I. Background collections of information made for
information that you do not wish to be FDA is announcing the availability of purposes of guidance under section
made publicly available, submit your a draft guidance for industry entitled 586D(a).
comments only as a written/paper ‘‘Sunscreen Innovation Act: Withdrawal Dated: November 16, 2015.
submission. You should submit two of a 586A Request or Pending Request.’’ Leslie Kux,
copies total. One copy will include the This draft guidance provides Associate Commissioner for Policy.
information you claim to be confidential background information on the [FR Doc. 2015–29634 Filed 11–20–15; 8:45 am]
with a heading or cover note that states sunscreen OTC monograph process and BILLING CODE 4164–01–P
‘‘THIS DOCUMENT CONTAINS the new procedures under the SIA (Pub.
CONFIDENTIAL INFORMATION’’. The L. 113–195, enacted November 26,
Agency will review this copy, including 2014), for reviewing 586A requests DEPARTMENT OF HEALTH AND
the claimed confidential information, in (requests made under section 586A of HUMAN SERVICES
its consideration of comments. The the FD&C Act (21 U.S.C. 360fff–1) and
second copy, which will have the pending requests for nonprescription Food and Drug Administration
claimed confidential information sunscreen active ingredients (the SIA
redacted/blacked out, will be available process). This draft guidance provides [Docket No. FDA–2015–N–0001]
for public viewing and posted on http:// recommendations for the general
Orthopaedic and Rehabilitation
www.regulations.gov. Submit both withdrawal process for 586A requests
Devices Panel of the Medical Devices
copies to the Division of Dockets and pending requests. At certain stages
Advisory Committee; Notice of Meeting
Management. If you do not wish your of the SIA process, a sponsor who
name and contact information to be submitted the 586A request or pending AGENCY: Food and Drug Administration,
made publicly available, you can request might seek to have it HHS.
provide this information on the cover withdrawn, or a request may be ACTION: Notice.
sheet and not in the body of your withdrawn due to the sponsor’s failure
comments and you must identify this to act on the request and failure to This notice announces a forthcoming
information as ‘‘confidential.’’ Any respond to communications from FDA. meeting of a public advisory committee
information marked as ‘‘confidential’’ This draft guidance addresses the of the Food and Drug Administration
will not be disclosed except in expected effect of a withdrawal on key (FDA). The meeting will be open to the
accordance with 21 CFR 10.20 and other phases of the SIA process, including public.
wgreen on DSK2VPTVN1PROD with NOTICES
applicable disclosure law. For more withdrawals made prior to or after the Name of Committee: Orthopaedic and
information about FDA’s posting of initial eligibility determination, the Rehabilitation Devices Panel of the
comments to public dockets, see 80 FR submission of safety and efficacy data, Medical Devices Advisory Committee.
56469, September 18, 2015, or access the filing determination, or the GRASE General Function of the Committee:
the information at: http://www.fda.gov/ determination. This draft guidance also To provide advice and
regulatoryinformation/dockets/ discusses the submission of a new 586A recommendations to the Agency on
default.htm. request for the same sunscreen FDA’s regulatory issues.
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![72972 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices
Date and Time: The meeting will be Procedure: Interested persons may DEPARTMENT OF HEALTH AND
held on Friday, February 19, 2016, from present data, information, or views, HUMAN SERVICES
8 a.m. to 6 p.m. orally or in writing, on issues pending
Location: Hilton Washington, DC/ before the committee. Written Food and Drug Administration
North, Salons A, B, C, and D, 620 Perry submissions may be made to the contact [Docket No. FDA–2015–D–3990]
Pkwy., Gaithersburg, MD 20877. The person on or before February 12, 2016.
hotel telephone number is 301–977- Oral presentations from the public will Sunscreen Innovation Act: Section
8900. be scheduled between approximately 1 586C(c) Advisory Committee Process;
Contact Person: Sara Anderson, Draft Guidance for Industry;
Center for Devices and Radiological p.m. and 2 p.m. Those individuals
interested in making formal oral Availability
Health, Food and Drug Administration,
Bldg. 66, Rm.1643, 10903 New presentations should notify the contact AGENCY: Food and Drug Administration,
Hampshire Ave., Silver Spring, MD person and submit a brief statement of HHS.
20993, Sara.Anderson@fda.hhs.gov, 301 the general nature of the evidence or
ACTION: Notice of availability.
796–7047, or FDA Advisory Committee arguments they wish to present, the
Information Line, 1–800–741–8138 names and addresses of proposed SUMMARY: The Food and Drug
(301–443–0572 in the Washington, DC participants, and an indication of the Administration (FDA or Agency) is
area). A notice in the Federal Register approximate time requested to make announcing the availability of a draft
about last minute modifications that their presentation on or before February guidance for industry entitled
impact a previously announced 4, 2016. Time allotted for each ‘‘Sunscreen Innovation Act: Section
advisory committee meeting cannot presentation may be limited. If the 586C(c) Advisory Committee Process.’’
always be published quickly enough to number of registrants requesting to This draft guidance explains the process
provide timely notice. Therefore, you speak is greater than can be reasonably by which FDA intends to carry out the
should always check the Agency’s Web accommodated during the scheduled section of the Federal Food, Drug, and
site at http://www.fda.gov/ open public hearing session, FDA may Cosmetic Act (the FD&C Act), as
AdvisoryCommittees/default.htm and conduct a lottery to determine the amended by the Sunscreen Innovation
scroll down to the appropriate advisory speakers for the scheduled open public Act (SIA), which governs the convening
committee meeting link, or call the of advisory committees and the number
hearing session. The contact person will
advisory committee information line to of requests to be considered per
notify interested persons regarding their
learn about possible modifications meeting. The recommendations in this
before coming to the meeting. request to speak by February 5, 2016.
draft guidance apply to 586A requests
Agenda: The Committee will discuss Persons attending FDA’s advisory submitted under the FD&C Act and to
the premarket application for the DIAM committee meetings are advised that the pending requests as defined by the SIA
Spinal Stabilization System. The DIAM Agency is not responsible for providing that seek a determination from FDA on
Spinal Stabilization System is indicated access to electrical outlets. whether a nonprescription sunscreen
for skeletally mature patients that have active ingredient, or a combination of
FDA welcomes the attendance of the
low back pain (with or without nonprescription sunscreen active
public at its advisory committee
radicular pain) with current episode ingredients, is generally recognized as
lasting less than 1 year in duration meetings and will make every effort to
accommodate persons with disabilities. safe and effective for use under
secondary to moderate lumbar specified conditions and should be
degenerative disc disease (DDD) at a If you require accommodations due to a
disability, please contact AnnMarie included in the over-the-counter (OTC)
single level from L2–L5. DDD is sunscreen drug monograph. The SIA
confirmed radiographically with one or Williams at 301–796–5966 at least 7
describes specific circumstances under
more of the following factors: (1) days in advance of the meeting.
which FDA is ‘‘not’’ required to convene
Patients must have greater than 2 FDA is committed to the orderly or submit requests to the
millimeters of decreased disc height conduct of its advisory committee Nonprescription Drugs Advisory
compared to the adjacent level; (2) meetings. Please visit our Web site at Committee (NDAC). We are issuing this
scarring/thickening of the ligamentum http://www.fda.gov/ draft guidance pursuant to the SIA,
flavum, annulus fibrosis, or facet joint AdvisoryCommittees/ which directs FDA to issue four
capsule; or (3) herniated nucleus AboutAdvisoryCommittees/ guidances on various topics, including
pulposus. The DIAM device is ucm111462.htm for procedures on this draft guidance.
implanted via a minimally invasive
public conduct during advisory DATES: Although you can comment on
posterior approach.
FDA intends to make background committee meetings. any guidance at any time (see 21 CFR
material available to the public no later Notice of this meeting is given under 10.115(g)(5)), to ensure that the Agency
than 2 business days before the meeting. the Federal Advisory Committee Act (5 considers your comment on this draft
If FDA is unable to post the background U.S.C. app. 2). guidance before it begins work on the
material on its Web site prior to the final version of the guidance, submit
Dated: November 13, 2015. either electronic or written comments
meeting, the background material will
Jill Hartzler Warner, on the draft guidance by January 22,
be made publicly available at the
location of the advisory committee Associate Commissioner for Special Medical 2016.
meeting, and the background material Programs.
ADDRESSES: You may submit comments
wgreen on DSK2VPTVN1PROD with NOTICES
will be posted on FDA’s Web site after [FR Doc. 2015–29768 Filed 11–20–15; 8:45 am] as follows:
the meeting. Background material is BILLING CODE 4164–01–P
available at http://www.fda.gov/ Electronic Submissions
AdvisoryCommittees/Calendar/ Submit electronic comments in the
default.htm. Scroll down to the following way:
appropriate advisory committee meeting • Federal eRulemaking Portal: http://
link. www.regulations.gov. Follow the
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Document Created: 2018-03-01 11:18:21
Document Modified: 2018-03-01 11:18:21
| 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. | |
| FR Citation | 80 FR 72971 |
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