27332 Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Guidance section FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Section II; Human Food ..................... 3942a 37,134 .5 18,567 .5 (30 minutes) .... 9,284 

Section III; Animal Food .................... 3942b 1,120 .5 560 .5 (30 minutes) .... 280 

Total ............................................ ........................ ........................ ........................ ........................ .............................. 9,564 

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

Consistent with the estimates found 

in our Preventive Controls for Human 

Food Rule, we estimate that 

approximately 37,134 human food 

facilities will each spend approximately 

30 minutes (0.5 hour) reporting their 

status as a qualified facility to FDA 

every 2 years. Thus, dividing this figure 

by two to determine the annual burden, 

we estimate there will be 18,567 

responses and 9,284 burden hours 

associated with this information 

collection element. 

Similarly, and consistent with the 

estimates found in our Preventive 

Controls for Animal Food Rule, we 

estimate that approximately 1,120 

animal food facilities will each spend 

approximately 30 minutes (0.5 hour) 

reporting their status as a qualified 

facility to FDA every 2 years. Thus, 

dividing this figure by two to determine 

the annual burden, we estimate there 

will be 560 responses and 280 burden 

hours associated with this information 

collection element. 

The draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 117 have been approved under 

OMB control number 0910–0751. The 

collections of information in 21 CFR 

part 507 have been approved under 

OMB control number 0910–0789. 

Dated: June 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12615 Filed 6–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0073] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by July 12, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0186. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Irradiation in the Production, 

Processing, and Handling of Food 

OMB Control Number 0910–0186— 

Extension 

This information collection supports 

FDA regulations. Specifically, under 

sections 201(s) and 409 of the Federal 

Food, Drug, and Cosmetic Act (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 FDA 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 FDA 

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. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices 27333 

In the Federal Register of January 26, 

2018, (83 FR 3734), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

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

179.25(e); records for small processors .............................. 4 30 120 1 120 

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

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

Upon review of the information 

collection we have retained the 

currently approved burden estimate. 

FDA’s estimate of the recordkeeping 

burden under § 179.25(e) is based on 

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 = 1,200 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 disclosures are 

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 OMB 

under the Paperwork Reduction Act of 

1995. 

Dated: June 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12614 Filed 6–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–D–0155] 

General Principles for Evaluating the 

Human Food Safety of New Animal 

Drugs Used in Food-Producing 

Animals; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry (GFI) #3 entitled 

‘‘General Principles for Evaluating the 

Human Food Safety of New Animal 

Drugs Used in Food-Producing 

Animals.’’ This guidance describes the 

type of information that the FDA’s 

Center for Veterinary Medicine (CVM) 

recommends sponsors provide to 

address the human food safety of new 

animal drugs used in food-producing 

animals. The human food safety 

evaluation of new animal drugs used in 

food-producing animals helps ensure 

that food derived from treated animals 

is safe for human consumption. CVM 

developed this guidance to inform 

sponsors of the scientific data and/or 

information that may provide an 

acceptable basis to determine that the 

residue of a new animal drug in or on 

food, when consumed, presents a 

reasonable certainty of no harm to 

humans. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 12, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2005–D–0155 for ‘‘General Principles 

for Evaluating the Human Food Safety 

of New Animal Drugs Used in FoodProducing Animals.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 


sradovich on DSK3GMQ082PROD with NOTICES