Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17055 

Contact: LCDR Holly Berilla, 

Committee Management Officer and 

Acting Designated Federal Official, 

CSAT National Advisory Council, 1 

Choke Cherry Road, Rockville, 

Maryland 20857 (mail). Telephone: 

(240) 276–1252. Fax: (240) 276–2252. 

Email: holly.berilla@samhsa.hhs.gov. 

Summer King, 

Statistician, SAMHSA. 

[FR Doc. 2015–07284 Filed 3–30–15; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0473] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Irradiation in the 

Production, Processing, and Handling 

of Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on our 

proposed collection of certain 

information. Under the Paperwork 

Reduction Act of 1995 (the PRA), 

Federal Agencies must publish notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

allow 60 days for public comment. This 

notice invites comments on the 

information collection provisions of our 

requirements for food irradiation 

processors. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 1, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, we are publishing this 

notice of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, we invite 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of our functions, including whether the 

information will have practical utility; 

(2) the accuracy of our estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Irradiation in the Production, 

Processing, and Handling of Food—21 

CFR Part 179 (OMB Control Number 

0910–0186)—Extension 

Under sections 201(s) and 409 of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 321(s) and 

348), food irradiation is subject to 

regulation under the food additive 

premarket approval provisions of the 

FD&C Act. The regulations providing for 

uses of irradiation in the production, 

processing, and handling of food are 

found in part 179 (21 CFR part 179). To 

ensure safe use of a radiation source, 

§ 179.21(b)(1) requires that the label of 

sources bear appropriate and accurate 

information identifying the source of 

radiation and the maximum (or 

minimum and maximum) energy of the 

emitted radiation. Section 179.21(b)(2) 

requires that the label or accompanying 

labeling bear adequate directions for 

installation and use and a statement 

supplied by us that indicates maximum 

dose of radiation allowed. Section 

179.26(c) requires that the label or 

accompanying labeling bear a logo and 

a radiation disclosure statement. Section 

179.25(e) requires that food processors 

who treat food with radiation make and 

retain, for 1 year past the expected shelf 

life of the products up to a maximum of 

3 years, specified records relating to the 

irradiation process (e.g., the food 

treated, lot identification, scheduled 

process, etc.). The records required by 

§ 179.25(e) are used by our inspectors to 

assess compliance with the regulation 

that establishes limits within which 

radiation may be safely used to treat 

food. We cannot ensure safe use without 

a method to assess compliance with the 

dose limits, and there are no practicable 

methods for analyzing most foods to 

determine whether they have been 

treated with ionizing radiation and are 

within the limitations set forth in part 

179. Records inspection is the only way 

to determine whether firms are 

complying with the regulations for 

treatment of foods with ionizing 

radiation. 

Description of respondents: 

Respondents are businesses engaged in 

the irradiation of food. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

record-keepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

179.25(e), large processors ................................................. 4 300 1,200 1 1,200 

179.25(e), small processors ................................................ 4 30 120 1 120 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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. 


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