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
27334 Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: Julia 

Oriani, Center for Veterinary Medicine 

(HFV–151), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0788, 

julia.oriani@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 21, 

2016 (81 FR 47397), FDA published the 

notice of availability for a draft revised 

GFI #3 entitled ‘‘General Principles for 

Evaluating the Human Food Safety of 

New Animal Drugs Used in FoodProducing Animals’’ giving interested 

persons until September 19, 2016, to 

comment on the draft revised GFI. FDA 

received several comments on the draft 

revised GFI, and those comments were 

considered as the guidance was 

finalized. Revisions to the document 

were made for accuracy and 

clarification based on comments 

received from the public, including 

reinsertion of information specific to 

endogenous sex steroids, and minor 

editorial edits. The guidance announced 

in this notice finalizes the draft revised 

GFI dated July 2016. 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘General Principles 

for Evaluating the Human Food Safety 

of New Animal Drugs Used in FoodProducing Animals.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 514 have been approved 

under OMB control number 0910–0032. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

https://www.regulations.gov. 

Dated: June 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12607 Filed 6–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine: Notice of 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Board of Scientific 

Counselors, Lister Hill National Center 

for Biomedical Communications. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for review, discussion, and evaluation of 

individual intramural programs and 

projects conducted by the National 

Library of Medicine, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors, Lister Hill National Center for 

Biomedical Communications. 

Date: September 6–7, 2018. 

Open: September 6, 2018, 9:00 a.m. to 

12:00 p.m. 

Agenda: Review of research and 

development programs and preparation of 

reports of the Lister Hill National Center for 

Biomedical Communications. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, The Lindberg Room, 

8600 Rockville Pike, Bethesda, MD 20892. 

Closed: September 6, 2018, 12:00 p.m. to 

4:30 p.m. 

Agenda: To review and evaluate personal 

qualifications, performance, and competence 

of individual investigators. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, The Lindberg Room, 

8600 Rockville Pike, Bethesda, MD 20892. 

Closed: September 7, 2018, 9:00 a.m. to 

10:00 a.m. 

Agenda: To review and evaluate personal 

qualifications, performance, and competence 

of individual investigators. 


sradovich on DSK3GMQ082PROD with NOTICES