17056 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR section Number of 

record-keepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,320 

1There are no capital costs or operating and maintenance costs associated with this collection. 

We base our estimate of burden for 

the recordkeeping provisions of 

§ 179.25(e) on our experience regulating 

the safe use of radiation as a direct food 

additive. The number of firms who 

process food using irradiation is 

extremely limited. We estimate that 

there are four irradiation plants whose 

business is devoted primarily (i.e., 

approximately 100 percent) to 

irradiation of food and other agricultural 

products. Four other firms also irradiate 

small quantities of food. We estimate 

that this irradiation accounts for no 

more than 10 percent of the business for 

each of these firms. Therefore, the 

average estimated burden is based on 

four facilities devoting 100 percent of 

their business to food irradiation (4 × 

300 hours = 1200 hours for 

recordkeeping annually), and four 

facilities devoting 10 percent of their 

business to food irradiation (4 × 30 

hours = 120 hours for recordkeeping 

annually). 

No burden has been estimated for the 

labeling requirements in §§ 179.21(b)(1), 

179.21(b)(2), and 179.26(c) because the 

information to be disclosed is 

information that has been supplied by 

FDA. Under 5 CFR 1320.3(c)(2), the 

public disclosure of information 

originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public is 

not subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act. 

Dated: March 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07263 Filed 3–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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, patricio.garcia@

fda.hhs.gov, 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 PatientContact), 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 (ACPowered 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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–F–0171] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Food Labeling; Calorie Labeling of 

Articles of Food in Vending Machines 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Food Labeling; Calorie Labeling of 

Articles of Food in Vending Machines’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

February 5, 2015, the Agency submitted 

a proposed collection of information 

entitled ‘‘Food Labeling; Calorie 

Labeling of Articles of Food in Vending 

Machines’’ to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0782. The 

approval expires on March 31, 2018. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: March 25, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07265 Filed 3–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0868] 

Development and Submission of Near 

Infrared Analytical Procedures; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Development and 

Submission of Near Infrared Analytical 

Procedures.’’ This draft guidance 

provides recommendations to 

applicants of new drug applications 

(NDAs) and abbreviated new drug 

applications (ANDAs) regarding the 

development and submission of near 

infrared (NIR) analytical procedures 

used during the manufacture and 

analysis of pharmaceuticals. This draft 

guidance only pertains to the 

development and validation of NIR 

analytical procedures and does not 

provide recommendations concerning 

the set up and qualification of NIR 

instruments or their maintenance and 

calibration. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by June 1, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: John 

L. Smith, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1757. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Development and Submission of Near 

Infrared Analytical Procedures.’’ This 

draft guidance provides 

recommendations to applicants of NDAs 

and ANDAs regarding the development 

and submission of NIR analytical 

procedures used during the manufacture 

and analysis of pharmaceuticals 

(including raw materials, in-process 

materials and intermediates, and 

finished products). It also provides 

recommendations regarding how the 

concepts described in the International 

Conference on Harmonisation (ICH) 

guidance for industry, ‘‘Q2(R1) 

Validation of Analytical Procedures: 

Text and Methodology’’ (http://

www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

ucm265700.htm) and ‘‘PAT—A 

Framework for Innovative 

Pharmaceutical Development, 

Manufacturing, and Quality Assurance’’ 

(http://www.fda.gov/downloads/Drugs/

Guidances/ucm070305.pdf) can be 

applied to the development, validation, 


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