81 FR 39930 - Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 118 (June 20, 2016)

Page Range		39930-39931
FR Document		2016-14418

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs 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 81 Issue 118 (Monday, June 20, 2016)

[Federal Register Volume 81, Number 118 (Monday, June 20, 2016)]
[Notices]
[Pages 39930-39931]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14418]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Bone, Reproductive and Urologic Drugs 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 Bone, Reproductive and 
Urologic Drugs 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 October 19, 2016, from 8:15 a.m. to 
5 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.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, email: [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: The committee will discuss the efficacy and safety of new 
drug

[[Page 39931]]

application (NDA) 201656 (desmopressin), 0.75 mcg/0.1 mL and 1.5 mcg/
0.1 mL nasal spray, submitted by Serenity Pharmaceuticals, LLC, for the 
proposed treatment of adult onset nocturia.
    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 
October 4, 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 September 26, 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 27, 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 Kalyani Bhatt 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 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-14418 Filed 6-17-16; 8:45 am]
 BILLING CODE 4164-01-P

39930 Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices

class III (premarket approval) if there is FDA must publish in the Federal DEPARTMENT OF HEALTH AND
insufficient information to support Register its final determination HUMAN SERVICES
classifying a device into class I or class regarding the exemption of the device
II and the device is a life sustaining or that was the subject of the notice. If FDA Food and Drug Administration
life supporting device, or is for a use fails to respond to a petition under this
[Docket No. FDA–2016–N–0001]
which is of substantial importance in section within 180 days of receiving it,
preventing impairment of human health the petition shall be deemed granted. Bone, Reproductive and Urologic
or presents a potential unreasonable risk Drugs Advisory Committee; Notice of
of illness or injury. II. Criteria for Exemption
Meeting
Most generic types of devices that There are a number of factors FDA
were on the market before the date of may consider to determine whether a AGENCY: Food and Drug Administration,
the 1976 amendments (May 28, 1976) 510(k) is necessary to provide HHS.
(generally referred to as preamendments reasonable assurance of the safety and ACTION: Notice.
devices) have been classified by FDA effectiveness of a class II device. These
under the procedures set forth in section factors are discussed in the guidance the SUMMARY: The Food and Drug
513(c) and (d) of the FD&C Act through Agency issued on February 19, 1998, Administration (FDA) announces a
the issuance of classification regulations entitled ‘‘Procedures for Class II Device forthcoming public advisory committee
into one of these three regulatory Exemptions from Premarket meeting of the Bone, Reproductive and
classes. Devices introduced into Notification, Guidance for Industry and Urologic Drugs Advisory Committee.
interstate commerce for the first time on CDRH Staff’’ (Ref. 1). The general function of the committee is
or after May 28, 1976 (generally referred to provide advice and recommendations
to as postamendments devices), are III. Proposed Class II Device to the Agency on FDA’s regulatory
classified through the premarket Exemptions issues. The meeting will be open to the
notification process under section FDA has received the following public.
510(k) of the FD&C Act (21 U.S.C. petition requesting an exemption from DATES: The meeting will be held on
360(k)). Section 510(k) of the FD&C Act premarket notification for a class II October 19, 2016, from 8:15 a.m. to 5
and the implementing regulations, 21 device: Martin O’Connor, Germaine p.m.
CFR part 807, require persons who Laboratories, Inc., 11030 Wye Dr., San
intend to market a new device to submit ADDRESSES: FDA White Oak Campus,
Antonio, TX 78217, for its Method,
a premarket notification (510(k)) 10903 New Hampshire Ave., Bldg. 31
Metallic Reduction, Glucose (urinary,
containing information that allows FDA Conference Center, the Great Room (Rm.
non-quantitative) classified under 21
to determine whether the new device is 1503), Silver Spring, MD 20993–0002.
CFR 862.1340. FDA previously
‘‘substantially equivalent’’ within the Answers to commonly asked questions
announced that it received this petition
meaning of section 513(i) of the FD&C including information regarding special
in a notice entitled ‘‘Medical Devices;
Act to a legally marketed device that accommodations due to a disability,
Exemption from Premarket Notification:
does not require premarket approval. visitor parking, and transportation may
Method, Metallic Reduction, Glucose
On November 21, 1997, the President be accessed at: http://www.fda.gov/
(Urinary, Non-Quantitative) Test System
signed into law FDAMA (Pub. L. 105– AdvisoryCommittees/
in a Reagent Tablet Format’’ that
115). Section 206 of FDAMA, in part, AboutAdvisoryCommittees/
appeared in the Federal Register of May
added a new section, 510(m), to the ucm408555.htm.
4, 2016 (81 FR 26802). The document
FD&C Act. Section 510(m)(1) of the was published with the incorrect docket FOR FURTHER INFORMATION CONTACT:
FD&C Act requires FDA, within 60 days number. This notice includes the correct Kalyani Bhatt, Center for Drug
after enactment of FDAMA, to publish docket number for the petition. Evaluation and Research, Food and
in the Federal Register a list of each Drug Administration, 10903 New
type of class II device that does not IV. Reference Hampshire Ave., Bldg. 31, Rm. 2417,
require a report under section 510(k) of The following reference is on display Silver Spring, MD 20993–0002, 301–
the FD&C Act to provide reasonable in the Division of Dockets Management 796–9001, FAX: 301–847–8533, email:
assurance of safety and effectiveness. (see ADDRESSES) and is available for BRUDAC@fda.hhs.gov, or FDA Advisory
Section 510(m) of the FD&C Act further viewing by interested persons between Committee Information Line, 1–800–
provides that a 510(k) will no longer be 9 a.m. and 4 p.m., Monday through 741–8138 (301–443–0572 in the
required for these devices upon the date Friday; it is also available electronically Washington, DC area). A notice in the
of publication of the list in the Federal at http://www.regulations.gov. FDA has Federal Register about last minute
Register. FDA published that list in the
verified the Web site address, as of the modifications that impact a previously
Federal Register of January 21, 1998 (63
date this document publishes in the announced advisory committee meeting
FR 3142).
Section 510(m)(2) of the FD&C Act Federal Register, but Web sites are cannot always be published quickly
provides that 1 day after date of subject to change over time. enough to provide timely notice.
publication of the list under section 1. ‘‘Procedures for Class II Device Therefore, you should always check the
510(m)(1), FDA may exempt a device on Exemptions from Premarket Notification, Agency’s Web site at http://
its own initiative or upon petition of an Guidance for Industry and CDRH Staff,’’ www.fda.gov/AdvisoryCommittees/
interested person if FDA determines February 1998, (http://www.fda.gov/ default.htm and scroll down to the
asabaliauskas on DSK3SPTVN1PROD with NOTICES

downloads/MedicalDevices/ appropriate advisory committee meeting
that a 510(k) is not necessary to provide DeviceRegulationandGuidance/
reasonable assurance of the safety and link, or call the advisory committee
GuidanceDocuments/UCM080199.pdf). information line to learn about possible
effectiveness of the device. This section
requires FDA to publish in the Federal Dated: June 14, 2016. modifications before coming to the
Register a notice of intent to exempt a Leslie Kux, meeting.
device, or of the petition, and to provide Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION:
a 30-day comment period. Within 120 [FR Doc. 2016–14459 Filed 6–17–16; 8:45 am] Agenda: The committee will discuss
days of publication of this document, BILLING CODE 4164–01–P the efficacy and safety of new drug

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Document Created: 2016-06-18 00:09:03
Document Modified: 2016-06-18 00:09:03

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 October 19, 2016, from 8:15 a.m. to 5 p.m.
Contact		Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, FAX: 301-847-8533, email: [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 Citation		81 FR 39930

81 FR 39930 - Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 118 (June 20, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration