83 FR 22080 - 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 83, Issue 92 (May 11, 2018)

Page Range		22080-22081
FR Document		2018-10050

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.

Federal Register, Volume 83 Issue 92 (Friday, May 11, 2018)

[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22080-22081]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1726]


Circulatory System Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 June 12, 2018, from 8 a.m. to 6 p.m.

ADDRESSES: Hilton Washington, DC North/Gaithersburg, Salons A, B, C, 
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone 
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: https://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, 
Evella.Washington@fda.hhs.gov; 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 website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee

[[Page 22081]]

information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: On June 12, 2018, the committee will discuss, make 
recommendations, and vote on the premarket approval application 
sponsored by Cordis, Inc. for the INCRAFT AAA Stent Graft System, which 
is intended for the endovascular treatment of infra-renal abdominal 
aortic aneurysms in patients with appropriate anatomy. The INCRAFT 
device is being evaluated in the INSPIRATION study, a multicenter, 
prospective, non-randomized investigation. The study met its primary 
safety and effectiveness endpoints, but results also showed higher than 
anticipated rates of certain adverse events. The committee discussion 
will focus on how these events impact the long-term safety and 
effectiveness, as well as the benefit/risk profile of the device.
    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 website 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 website after the meeting. Background material is 
available at https://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 June 
5, 2018. Oral presentations from the public will be scheduled on June 
12, 2018, 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 May 25, 2018. 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 May 29, 2018.
    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 Annmarie.Williams@fda.hhs.gov, 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 website at https://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: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10050 Filed 5-10-18; 8:45 am]
 BILLING CODE 4164-01-P

22080 Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices

ACTION: Notice. 314.161)). FDA may not approve an advise ANDA applicants to submit such
ANDA that does not refer to a listed labeling.
SUMMARY: The Food and Drug drug.
Administration (FDA or Agency) has Dated: May 7, 2018.
SODIUM IODIDE I 123 (sodium
determined that SODIUM IODIDE I 123 Leslie Kux,
iodide I-123), oral solution, 2 mCi/mL,
(sodium iodide I-123), oral solution, 2 is the subject of NDA 017630, held by Associate Commissioner for Policy.
millicuries (mCi)/milliliter (mL), was GE Healthcare, and initially approved [FR Doc. 2018–10099 Filed 5–10–18; 8:45 am]
not withdrawn from sale for reasons of on March 24, 1976. SODIUM IODIDE I BILLING CODE 4164–01–P
safety or effectiveness. This 123 is indicated for use in the
determination will allow FDA to evaluation of thyroid function or
approve abbreviated new drug morphology. DEPARTMENT OF HEALTH AND
applications (ANDAs) for sodium iodide SODIUM IODIDE I 123 (sodium HUMAN SERVICES
I 123, oral solution, 2 mCi/mL, if all iodide I-123), oral solution, 2 mCi/mL,
other legal and regulatory requirements is currently listed in the ‘‘Discontinued Food and Drug Administration
are met. Drug Product List’’ section of the Orange [Docket No. FDA–2018–N–1726]
FOR FURTHER INFORMATION CONTACT: Book.
Daniel Gottlieb, Center for Drug International Isotopes, Inc. submitted Circulatory System Devices Panel of
Evaluation and Research, Food and a citizen petition dated September 6, the Medical Devices Advisory
Drug Administration, 10903 New 2017 (Docket No. FDA–2017–P–5592), Committee; Notice of Meeting
Hampshire Ave., Bldg. 51, Rm. 6208, under 21 CFR 10.30, requesting that the
AGENCY: Food and Drug Administration,
Silver Spring, MD 20993–0002, 301– Agency determine whether SODIUM
HHS.
796–6650. IODIDE I 123 (sodium iodide I-123), oral
solution, 2 mCi/mL, was withdrawn ACTION: Notice.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price from sale for reasons of safety or SUMMARY: The Food and Drug
Competition and Patent Term effectiveness. Administration (FDA) announces a
Restoration Act of 1984 (Pub. L. 98–417) After considering the citizen petition forthcoming public advisory committee
(the 1984 amendments), which and reviewing Agency records and meeting of the Circulatory System
authorized the approval of duplicate based on the information we have at this Devices Panel of the Medical Devices
versions of drug products under an time, FDA has determined under Advisory Committee. The general
ANDA procedure. ANDA applicants § 314.161 that SODIUM IODIDE I 123 function of the committee is to provide
must, with certain exceptions, show that (sodium iodide I-123), oral solution, 2 advice and recommendations to the
the drug for which they are seeking mCi/mL, was not withdrawn from sale Agency on FDA’s regulatory issues. The
approval contains the same active for reasons of safety or effectiveness. meeting will be open to the public.
ingredient in the same strength and The petitioner has identified no data or
DATES: The meeting will be held on June
dosage form as the ‘‘listed drug,’’ which other information suggesting that
SODIUM IODIDE I 123 (sodium iodide 12, 2018, from 8 a.m. to 6 p.m.
is a version of the drug that was
I-123), oral solution, 2 mCi/mL, was ADDRESSES: Hilton Washington, DC
previously approved. ANDA applicants
withdrawn from sale for reasons of North/Gaithersburg, Salons A, B, C, and
do not have to repeat the extensive
safety or effectiveness. We have D, 620 Perry Pkwy., Gaithersburg, MD
clinical testing otherwise necessary to
gain approval of a new drug application carefully reviewed our files for records 20877. The hotel’s telephone number is
(NDA). concerning the withdrawal of SODIUM 301–977–8900. Answers to commonly
The 1984 amendments include what IODIDE I 123 (sodium iodide I-123), oral asked questions including information
is now section 505(j)(7) of the Federal solution, 2 mCi/mL, from sale. We have regarding special accommodations due
Food, Drug, and Cosmetic Act (21 U.S.C. also independently evaluated relevant to a disability, visitor parking, and
355(j)(7)), which requires FDA to literature and data for possible transportation may be accessed at:
publish a list of all approved drugs. postmarketing adverse events. We have https://www.fda.gov/
FDA publishes this list as part of the found no information that would AdvisoryCommittees/AboutAdvisory
‘‘Approved Drug Products With indicate that this drug product was Committees/ucm408555.htm.
Therapeutic Equivalence Evaluations,’’ withdrawn from sale for reasons of FOR FURTHER INFORMATION CONTACT:
which is known generally as the safety or effectiveness. Evella Washington, Center for Devices
‘‘Orange Book.’’ Under FDA regulations, Accordingly, the Agency will and Radiological Health, Food and Drug
drugs are removed from the list if the continue to list SODIUM IODIDE I 123 Administration, 10903 New Hampshire
Agency withdraws or suspends (sodium iodide I-123), oral solution, 2 Ave., Bldg. 66, Rm. G640, Silver Spring,
approval of the drug’s NDA or ANDA mCi/mL, in the ‘‘Discontinued Drug MD 20993–0002, Evella.Washington@
for reasons of safety or effectiveness or Product List’’ section of the Orange fda.hhs.gov; 301–796–6683, or FDA
if FDA determines that the listed drug Book. The ‘‘Discontinued Drug Product Advisory Committee Information Line,
was withdrawn from sale for reasons of List’’ delineates, among other items, 1–800–741–8138 (301–443–0572 in the
safety or effectiveness (§ 314.162 (21 drug products that have been Washington, DC area). A notice in the
CFR 314.162)). discontinued from marketing for reasons Federal Register about last minute
A person may petition the Agency to other than safety or effectiveness. modifications that impact a previously
determine, or the Agency may ANDAs that refer to SODIUM IODIDE I announced advisory committee meeting
determine on its own initiative, whether 123 (sodium iodide I-123), oral solution, cannot always be published quickly
sradovich on DSK3GMQ082PROD with NOTICES

a listed drug was withdrawn from sale 2 mCi/mL, may be approved by the enough to provide timely notice.
for reasons of safety or effectiveness. Agency as long as they meet all other Therefore, you should always check the
This determination may be made at any legal and regulatory requirements for Agency’s website at https://
time after the drug has been withdrawn the approval of ANDAs. If FDA www.fda.gov/AdvisoryCommittees/
from sale, but must be made prior to determines that labeling for this drug default.htm and scroll down to the
FDA’s approval of an ANDA that refers product should be revised to meet appropriate advisory committee meeting
to the listed drug (§ 314.161 (21 CFR current standards, the Agency will link, or call the advisory committee

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Document Created: 2018-11-02 09:49:40
Document Modified: 2018-11-02 09:49:40

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 June 12, 2018, 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 website at https://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		83 FR 22080

83 FR 22080 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 92 (May 11, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration