80 FR 13392 - Ear, Nose, and Throat 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 49 (March 13, 2015)

Page Range		13392-13393
FR Document		2015-05675

Federal Register, Volume 80 Issue 49 (Friday, March 13, 2015)

[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13392-13393]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05675]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Ear, Nose, and Throat Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 13393]]

    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: Ear, Nose, and Throat 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.
    Date and Time: The meeting will be held on April 30 and May 1, 2015 
from 8 a.m. to 6 p.m.
    Location: 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.
    Contact Person: Patricio Garcia, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1535, Silver Spring MD 20993-0002, 
[email protected], 301-796-6875, 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: On April 30, 2015, the committee will discuss and make 
recommendations regarding the classification of Hearing Protectors, 
Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile 
Hearing Aid Devices, and Vestibular Analysis Apparatuses. These devices 
are considered preamendments devices since they were in commercial 
distribution prior to May 28, 1976, when the Medical Devices Amendments 
became effective. Hearing Protectors are currently regulated under the 
heading, ``Protector, Hearing (Insert),'' Product Code EWD, as 
unclassified under the 510(k) premarket notification authority. 
Circumaural Hearing Protectors are currently regulated under the 
heading, ``Protector, Hearing (Circumaural),'' Product Code EWE, as 
unclassified under the 510(k) premarket notification authority. Middle 
Ear Inflation Devices are currently regulated under the heading, 
``Device, Inflation, Middle Ear,'' Product Code MJV, as unclassified 
under the 510(k) premarket notification authority. Tactile Hearing Aid 
Devices are currently regulated under the heading, ``Hearing Aid, 
Tactile,'' Product Code LRA, as unclassified under the 510(k) premarket 
notification authority. Vestibular Analysis Apparatuses are currently 
regulated under the heading, ``Apparatus, Vestibular Analysis,'' 
Product Code LXV, as unclassified under the 510(k) premarket 
notification authority. FDA is seeking committee input on the risks, 
safety and effectiveness and the regulatory classification of Hearing 
Protectors, Circumaural Hearing Protectors, Middle Ear Inflation 
Devices, Tactile Hearing Aid Devices, and Vestibular Analysis 
Apparatuses.
    On May 1, 2015 the committee will discuss key issues related to a 
potential pre- to post-market shift in clinical data requirements for 
modifications to cochlear implants in pediatric patients. These issues 
are categorized into three broad areas for discussion:
    1. Cochlear implant changes (e.g. sound processing features, 
patient characteristics) that may be suitable for this pre- to post-
market shift in clinical data requirements.
    2. Appropriate premarket clinical data requirements to support pre- 
to post-market shift (e.g. leveraging clinical data from adults and/or 
older children).
    3. Clinical study design considerations (e.g. study endpoints and 
test metrics, subject characteristics) for post market studies to 
confirm safety and effectiveness and inform future labeling.
    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 
April 22, 2015. Oral presentations from the public will be scheduled 
between approximately 8:45 a.m. and 9:45 a.m. on April 30, 2015 and 
between approximately 1 p.m. and 2 p.m. on May 1, 2015. 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 
April 14, 2015. 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 April 16, 2015.
    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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact at James Clark at 
[email protected], or 301-796-5293 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: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05675 Filed 3-12-15; 8:45 am]
BILLING CODE 4164-01-P

13392 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices

Dated: March 10, 2015. ADDRESSES: Submit electronic With respect to the following
William N. Parham, III, comments on the collection of collection of information, we invite
Director, Paperwork Reduction Staff, Office information to http:// comments on these topics: (1) Whether
of Strategic Operations and Regulatory www.regulations.gov. Submit written the proposed collection of information
Affairs. comments on the collection of is necessary for the proper performance
[FR Doc. 2015–05796 Filed 3–12–15; 8:45 am] information to the Division of Dockets of our functions, including whether the
BILLING CODE 4120–01–P Management (HFA–305), Food and Drug information will have practical utility;
Administration, 5630 Fishers Lane, Rm. (2) the accuracy of our estimate of the
1061, Rockville, MD 20852. All burden of the proposed collection of
DEPARTMENT OF HEALTH AND comments should be identified with the information, including the validity of
HUMAN SERVICES docket number found in brackets in the the methodology and assumptions used;
heading of this document. (3) ways to enhance the quality, utility,
Food and Drug Administration and clarity of the information to be
FOR FURTHER INFORMATION CONTACT: FDA
[Docket No. FDA–2008–N–0397] collected; and (4) ways to minimize the
PRA Staff, Office of Operations, Food
burden of the collection of information
Agency Information Collection and Drug Administration, 8455
on respondents, including through the
Activities; Proposed Collection; Colesville Rd., COLE–14526, Silver
use of automated collection techniques,
Comment Request; State Enforcement Spring, MD 20993–0002, PRAStaff@
when appropriate, and other forms of
Notifications fda.hhs.gov.
information technology.
AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: Under the State Enforcement Notifications—21
HHS. PRA (44 U.S.C. 3501–3520), Federal CFR 100.2(d) (OMB Control Number
ACTION: Notice. agencies must obtain approval from the 0910–0275)—Extension
Office of Management and Budget
SUMMARY: The Food and Drug (OMB) for each collection of Section 310(b) of the Federal Food,
Administration (FDA) is announcing an information they conduct or sponsor. Drug, and Cosmetic Act (the FD&C Act)
opportunity for public comment on the ‘‘Collection of information’’ is defined (21 U.S.C. 337(b)) authorizes a State to
proposed collection of certain in 44 U.S.C. 3502(3) and 5 CFR enforce certain sections of the FD&C Act
information by the Agency. Under the 1320.3(c) and includes Agency requests in their own name and within their own
Paperwork Reduction Act of 1995 (the or requirements that members of the jurisdiction. However, before doing so,
PRA), Federal Agencies are required to public submit reports, keep records, or a State must provide notice to FDA
publish notice in the Federal Register provide information to a third party. according to 21 CFR 100.2. The
concerning each proposed collection of Section 3506(c)(2)(A) of the PRA (44 information required in a letter of
information, including each proposed U.S.C. 3506(c)(2)(A)) requires Federal notification under § 100.2(d) enables us
extension of an existing collection of Agencies to provide a 60-day notice in to identify the food against which a
information, and to allow 60 days for the Federal Register concerning each State intends to take action and to
public comment in response to the proposed collection of information, advise that State whether Federal
notice. This notice invites comments on including each proposed extension of an enforcement action against the food has
reporting requirements contained in existing collection of information, been taken or is in process. With certain
existing FDA regulations governing before submitting the collection to OMB narrow exceptions, Federal enforcement
State enforcement notifications. for approval. To comply with this action precludes State action under the
DATES: Submit either electronic or requirement, we are publishing notice of FD&C Act.
written comments on the collection of the proposed collection of information We estimate the burden of this
information by May 12, 2015. set forth in this document. collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
respondents responses
respondents response

100.2(d) ................................................................................ 1 1 1 10 10
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated reporting burden for submit enforcement notifications DEPARTMENT OF HEALTH AND
§ 100.2(d) is minimal because informing us when it intends to take HUMAN SERVICES
enforcement notifications are seldom enforcement action under the FD&C Act
used by States. During the last 3 years, against a particular food located in the Food and Drug Administration
we have not received any new State.
enforcement notifications; therefore, we Dated: March 9, 2015. [Docket No. FDA–2015–N–0001]
estimate that one or fewer notifications
mstockstill on DSK4VPTVN1PROD with NOTICES

Leslie Kux, Ear, Nose, and Throat Devices Panel of
will be submitted annually. Although
we have not received any new Associate Commissioner for Policy. the Medical Devices Advisory
enforcement notifications in the last 3 [FR Doc. 2015–05668 Filed 3–12–15; 8:45 am] Committee; Notice of Meeting
years, we believe these information BILLING CODE 4164–01–P
AGENCY: Food and Drug Administration,
collection provisions should be HHS.
extended to provide for the potential
future need of a State government to ACTION: Notice.

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Document Created: 2015-12-18 11:41:30
Document Modified: 2015-12-18 11:41:30

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 13392

80 FR 13392 - Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 49 (March 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration