80_FR_17117 80 FR 17056 - Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

80 FR 17056 - Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 61 (March 31, 2015)

Page Range17056-17057
FR Document2015-07300

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of March 13, 2015. The amendment is being made to reflect a change in the April 30th Agenda portion of the document. There are no other changes.

Federal Register, Volume 80 Issue 61 (Tuesday, March 31, 2015) 
[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17056-17057]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07300]


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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; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Ear, Nose, and Throat Devices 
Panel of the Medical Devices Advisory Committee. This meeting was 
announced in the Federal Register of March 13, 2015. The amendment is 
being made to reflect a change in the April 30th Agenda portion of the 
document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: 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), code EN. Please call the Information Line for up-to-date 
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 13, 2015 
(80 FR 13392), FDA announced that a meeting of the Ear, Nose, and 
Throat Devices Panel of the Medical Devices Advisory Committee would be 
held on April 30 and May 1, 2015. On page 13393, in the first and 
second columns, the Agenda portion of the document is changed to read 
as follows:
    On April 30, 2015, the Agency is adding three Agenda items to the 
original five agenda items posted in the March 13, 2015, Federal 
Register document. The three additional items are: Speech Training Aids 
for the Hearing Impaired (Battery Powered or Non-Patient), Speech 
Training Aids for the Hearing Impaired (AC-powered and Patient-
Contact), and Nasal Septal Button Devices. The committee will discuss 
and make recommendations regarding the classification of Hearing 
Protectors, Circumaural Hearing Protectors, Tactile Hearing Aids, 
Speech Training Aids for the Hearing Impaired (Battery Powered or Non-
Patient), Speech Training Aids for the Hearing Impaired (AC-powered and 
Patient-Contact), Vestibular Analysis, Middle Ear Inflation Devices, 
and Nasal Septal Button Devices. 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. 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. Speech Training Aids for the Hearing Impaired 
(Battery Powered or Non-Patient) are currently regulated under the 
heading, ``Aids, Speech Training For The Hearing Impaired (Battery-
Operated or Non-Patient),'' Product Code LFA, as unclassified under the 
510(k) premarket notification authority. Speech Training Aids for the 
Hearing Impaired (AC-Powered and Patient-Contact) are currently 
regulated under the heading, ``Aids, Speech Training For The Hearing 
Impaired (AC-Powered and Patient-Contact),'' Product Code LEZ, 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. 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. Nasal Septal Button 
Devices are currently regulated under the heading, ``Button, Nasal 
Septal,'' Product Code LFB, 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, Tactile Hearing Aids, 
Speech Training Aids for the Hearing Impaired (Battery Powered or Non-
Patient), Speech Training Aids for the Hearing Impaired (AC-Powered and 
Patient-Contact), Vestibular Analysis, Middle Ear Inflation Devices, 
and Nasal Septal Button Devices.

[[Page 17057]]

    On May 1, 2015, the committee will discuss key issues related to a 
potential pre- to postmarket 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 
postmarket shift in clinical data requirements.
    2. Appropriate premarket clinical data requirements to support pre- 
to postmarket 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 postmarket 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.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: March 24, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-07300 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P

17056 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of Average Number of Total annual 21 CFR section records per burden per Total hours record-keepers records recordkeeper recordkeeping Total .............................................................................. ........................ ........................ ........................ ........................ 1,320 1 There are no capital costs or operating and maintenance costs associated with this collection. We base our estimate of burden for SUMMARY: The Food and Drug became effective. Hearing Protectors are the recordkeeping provisions of Administration (FDA) is announcing an currently regulated under the heading, § 179.25(e) on our experience regulating amendment to the notice of meeting of ‘‘Protector, Hearing (Insert),’’ Product the safe use of radiation as a direct food the Ear, Nose, and Throat Devices Panel Code EWD, as unclassified under the additive. The number of firms who of the Medical Devices Advisory 510(k) premarket notification authority. process food using irradiation is Committee. This meeting was Circumaural Hearing Protectors are extremely limited. We estimate that announced in the Federal Register of currently regulated under the heading, there are four irradiation plants whose March 13, 2015. The amendment is ‘‘Protector, Hearing (Circumaural),’’ business is devoted primarily (i.e., being made to reflect a change in the Product Code EWE, as unclassified approximately 100 percent) to April 30th Agenda portion of the under the 510(k) premarket notification irradiation of food and other agricultural document. There are no other changes. authority. Tactile Hearing Aid Devices products. Four other firms also irradiate FOR FURTHER INFORMATION CONTACT: are currently regulated under the small quantities of food. We estimate Patricio Garcia, Center for Devices and heading, ‘‘Hearing Aid, Tactile,’’ that this irradiation accounts for no Radiological Health, Food and Drug Product Code LRA, as unclassified more than 10 percent of the business for Administration, 10903 New Hampshire under the 510(k) premarket notification each of these firms. Therefore, the Ave., Bldg. 66, Rm. 1535, Silver Spring authority. Speech Training Aids for the average estimated burden is based on MD 20993–0002, patricio.garcia@ Hearing Impaired (Battery Powered or four facilities devoting 100 percent of fda.hhs.gov, 301–796–6875, or FDA Non-Patient) are currently regulated their business to food irradiation (4 × Advisory Committee Information Line, under the heading, ‘‘Aids, Speech 300 hours = 1200 hours for 1–800–741–8138 (301–443–0572 in the Training For The Hearing Impaired recordkeeping annually), and four Washington DC area), code EN. Please (Battery-Operated or Non-Patient),’’ facilities devoting 10 percent of their call the Information Line for up-to-date Product Code LFA, as unclassified business to food irradiation (4 × 30 information on this meeting. under the 510(k) premarket notification hours = 120 hours for recordkeeping SUPPLEMENTARY INFORMATION: In the authority. Speech Training Aids for the annually). Federal Register of March 13, 2015 (80 Hearing Impaired (AC-Powered and No burden has been estimated for the FR 13392), FDA announced that a Patient-Contact) are currently regulated labeling requirements in §§ 179.21(b)(1), meeting of the Ear, Nose, and Throat under the heading, ‘‘Aids, Speech 179.21(b)(2), and 179.26(c) because the Devices Panel of the Medical Devices Training For The Hearing Impaired (AC- information to be disclosed is Advisory Committee would be held on Powered and Patient-Contact),’’ Product information that has been supplied by April 30 and May 1, 2015. On page Code LEZ, as unclassified under the FDA. Under 5 CFR 1320.3(c)(2), the 13393, in the first and second columns, 510(k) premarket notification authority. public disclosure of information the Agenda portion of the document is Vestibular Analysis Apparatuses are originally supplied by the Federal changed to read as follows: currently regulated under the heading, Government to the recipient for the On April 30, 2015, the Agency is adding three Agenda items to the ‘‘Apparatus, Vestibular Analysis,’’ purpose of disclosure to the public is original five agenda items posted in the Product Code LXV, as unclassified not subject to review by the Office of March 13, 2015, Federal Register under the 510(k) premarket notification Management and Budget under the document. The three additional items authority. Middle Ear Inflation Devices Paperwork Reduction Act. are: Speech Training Aids for the are currently regulated under the Dated: March 23, 2015. heading, ‘‘Device, Inflation, Middle Hearing Impaired (Battery Powered or Leslie Kux, Ear,’’ Product Code MJV, as unclassified Non-Patient), Speech Training Aids for Associate Commissioner for Policy. the Hearing Impaired (AC-powered and under the 510(k) premarket notification [FR Doc. 2015–07263 Filed 3–30–15; 8:45 am] Patient-Contact), and Nasal Septal authority. Nasal Septal Button Devices BILLING CODE 4164–01–P Button Devices. The committee will are currently regulated under the discuss and make recommendations heading, ‘‘Button, Nasal Septal,’’ regarding the classification of Hearing Product Code LFB, as unclassified DEPARTMENT OF HEALTH AND Protectors, Circumaural Hearing under the 510(k) premarket notification HUMAN SERVICES Protectors, Tactile Hearing Aids, Speech authority. FDA is seeking committee Training Aids for the Hearing Impaired input on the risks, safety and Food and Drug Administration (Battery Powered or Non-Patient), effectiveness, and the regulatory Speech Training Aids for the Hearing classification of Hearing Protectors, asabaliauskas on DSK5VPTVN1PROD with NOTICES [Docket No. FDA–2015–N–0001] Impaired (AC-powered and Patient- Circumaural Hearing Protectors, Tactile Ear, Nose, and Throat Devices Panel of Contact), Vestibular Analysis, Middle Hearing Aids, Speech Training Aids for the Medical Devices Advisory Ear Inflation Devices, and Nasal Septal the Hearing Impaired (Battery Powered Committee; Amendment of Notice Button Devices. These devices are or Non-Patient), Speech Training Aids AGENCY: Food and Drug Administration, considered preamendments devices for the Hearing Impaired (AC-Powered HHS. since they were in commercial and Patient-Contact), Vestibular distribution prior to May 28, 1976, Analysis, Middle Ear Inflation Devices, ACTION: Notice. when the Medical Devices Amendments and Nasal Septal Button Devices. VerDate Sep<11>2014 18:32 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1

Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17057 On May 1, 2015, the committee will Articles of Food in Vending Machines’’ the set up and qualification of NIR discuss key issues related to a potential has been approved by the Office of instruments or their maintenance and pre- to postmarket shift in clinical data Management and Budget (OMB) under calibration. requirements for modifications to the Paperwork Reduction Act of 1995. DATES: Although you can comment on cochlear implants in pediatric patients. FOR FURTHER INFORMATION CONTACT: FDA any guidance at any time (see 21 CFR These issues are categorized into three PRA Staff, Office of Operations, Food 10.115(g)(5)), to ensure that the Agency broad areas for discussion: and Drug Administration, 8455 considers your comment on this draft 1. Cochlear implant changes (e.g. Colesville Rd., COLE–14526, Silver guidance before it begins work on the sound processing features, patient Spring, MD 20993–0002, PRAStaff@ final version of the guidance, submit characteristics) that may be suitable for fda.hhs.gov. either electronic or written comments this pre- to postmarket shift in clinical on the draft guidance by June 1, 2015. SUPPLEMENTARY INFORMATION: On data requirements. ADDRESSES: Submit written requests for 2. Appropriate premarket clinical data February 5, 2015, the Agency submitted a proposed collection of information single copies of the draft guidance to the requirements to support pre- to entitled ‘‘Food Labeling; Calorie Division of Drug Information, Center for postmarket shift (e.g. leveraging clinical Labeling of Articles of Food in Vending Drug Evaluation and Research, Food data from adults and/or older children.) 3. Clinical study design Machines’’ to OMB for review and and Drug Administration, 10001 New clearance under 44 U.S.C. 3507. An Hampshire Ave., Hillandale Building, considerations (e.g. study endpoints and Agency may not conduct or sponsor, 4th Floor, Silver Spring, MD 20993– test metrics, subject characteristics) for and a person is not required to respond 0002. Send one self-addressed adhesive postmarket studies to confirm safety and to, a collection of information unless it label to assist that office in processing effectiveness and inform future labeling. FDA intends to make background displays a currently valid OMB control your requests. See the SUPPLEMENTARY number. OMB has now approved the INFORMATION section for electronic material available to the public no later than 2 business days before the meeting. information collection and has assigned access to the draft guidance document. OMB control number 0910–0782. The Submit electronic comments on the If FDA is unable to post the background approval expires on March 31, 2018. A draft guidance to http:// material on its Web site prior to the copy of the supporting statement for this www.regulations.gov. Submit written meeting, the background material will information collection is available on comments to the Division of Dockets be made publicly available at the the Internet at http://www.reginfo.gov/ Management (HFA–305), Food and Drug location of the advisory committee public/do/PRAMain. Administration, 5630 Fishers Lane, Rm. meeting, and the background material 1061, Rockville, MD 20852. will be posted on FDA’s Web site after Dated: March 25, 2015. FOR FURTHER INFORMATION CONTACT: John the meeting. Background material is Leslie Kux, available at http://www.fda.gov/ L. Smith, Center for Drug Evaluation Associate Commissioner for Policy. and Research, Food and Drug AdvisoryCommittees/Calendar/ [FR Doc. 2015–07265 Filed 3–30–15; 8:45 am] default.htm. Scroll down to the Administration, 10903 New Hampshire appropriate advisory committee meeting BILLING CODE 4164–01–P Ave., Silver Spring, MD 20993–0002, link. 301–796–1757. This notice is issued under the SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND Federal Advisory Committee Act (5 HUMAN SERVICES I. Background U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. FDA is announcing the availability of Food and Drug Administration a draft guidance for industry entitled Dated: March 24, 2015. [Docket No. FDA–2015–D–0868] ‘‘Development and Submission of Near Jill Hartzler Warner, Infrared Analytical Procedures.’’ This Associate Commissioner for Special Medical Development and Submission of Near draft guidance provides Programs. Infrared Analytical Procedures; Draft recommendations to applicants of NDAs [FR Doc. 2015–07300 Filed 3–30–15; 8:45 am] Guidance for Industry; Availability and ANDAs regarding the development BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, and submission of NIR analytical HHS. procedures used during the manufacture ACTION: Notice. and analysis of pharmaceuticals DEPARTMENT OF HEALTH AND (including raw materials, in-process HUMAN SERVICES SUMMARY: The Food and Drug materials and intermediates, and Administration (FDA) is announcing the finished products). It also provides Food and Drug Administration availability of a draft guidance for recommendations regarding how the [Docket No. FDA–2011–F–0171] industry entitled ‘‘Development and concepts described in the International Submission of Near Infrared Analytical Conference on Harmonisation (ICH) Agency Information Collection Procedures.’’ This draft guidance guidance for industry, ‘‘Q2(R1) Activities; Announcement of Office of provides recommendations to Validation of Analytical Procedures: Management and Budget Approval; applicants of new drug applications Text and Methodology’’ (http:// Food Labeling; Calorie Labeling of (NDAs) and abbreviated new drug www.fda.gov/Drugs/ Articles of Food in Vending Machines applications (ANDAs) regarding the GuidanceCompliance asabaliauskas on DSK5VPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, development and submission of near RegulatoryInformation/Guidances/ HHS. infrared (NIR) analytical procedures ucm265700.htm) and ‘‘PAT—A ACTION: Notice. used during the manufacture and Framework for Innovative analysis of pharmaceuticals. This draft Pharmaceutical Development, SUMMARY: The Food and Drug guidance only pertains to the Manufacturing, and Quality Assurance’’ Administration (FDA) is announcing development and validation of NIR (http://www.fda.gov/downloads/Drugs/ that a collection of information entitled analytical procedures and does not Guidances/ucm070305.pdf) can be ‘‘Food Labeling; Calorie Labeling of provide recommendations concerning applied to the development, validation, VerDate Sep<11>2014 18:32 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1


Document Created: 2015-12-18 11:48:22
Document Modified: 2015-12-18 11:48:22
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactPatricio 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), code EN. Please call the Information Line for up-to-date information on this meeting.
FR Citation80 FR 17056 
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