30742 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

collection of information to OMB for 

review and clearance. 

Animal Food Labeling; Declaration of 

Certifiable Color Additives 

OMB Control Number 0910–0721— 

Extension 

This information collection is 

associated with requirements under 

§ 501.22(k) (21 CFR 501.22(k)) in which 

animal food manufacturers must declare 

the presence of certified and 

noncertified color additives in their 

animal food products on the product 

label. We issued this regulation in 

response to the Nutrition Labeling and 

Education Act of 1990 (Pub. L. 101–535) 

to make animal food regulations 

consistent with the regulations 

regarding the declaration of color 

additives on human food labels and to 

provide animal owners with 

information on the color additives used 

in animal food. Animal owners use the 

information to become knowledgeable 

about the foods they purchase for their 

animals. Color additive information 

enables a consumer to comparison shop 

and to avoid substances to which their 

animals may be sensitive. 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers of pet 

food products that contain color 

additives. In the Federal Register of 

February 20, 2018 (83 FR 7198), FDA 

published a 60-day notice requesting 

public comment on the proposed 

collection of information. 

(Comment) One comment was 

received that supported FDA’s need for 

the information collection and 

characterized the burden of the 

information collection as low compared 

to the importance of informative food 

labels. The comment did not suggest 

revising our estimate of the burden. 

However, it suggested we should 

provide greater detail about how we 

estimated the number of respondents 

and the flow of new products. 

(Response) We based our estimate of 

the number of respondents on the 

number of pet food manufacturers 

subject to this regulation. The figure of 

3,120 used in table 1 was derived from 

the number of establishments listed 

under North American Industrial 

Classification System codes 311111 and 

311119, including very small 

establishments. As noted in the 60-day 

notice, we based our estimate of the 

flow of new products on A.C. Nielsen 

data for the number of animal food 

product units for sale (for which sales 

of the products are greater than zero) in 

the latest year for which data is 

available, stated to be 25,874. Then, we 

assumed that the flow of new products 

would be 10 percent per year, for a 

figure of 2,587 new products per year. 

That figure was used in table 1 as our 

estimate of the total annual disclosures. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR Section/activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden per 

disclosure Total hours 

501.22(k); labeling of color additive or 

lake of color additive; labeling of color 

additives not subject to certification.

3,120 0.8292 2,587 0.25 (15 minutes) ...... 647 

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

The requirement became effective 

November 18, 2013; thus, we estimate 

that the burden associated with the 

labeling requirements under § 501.22(k) 

applies only to new product labels. 

Because the vast majority of animal food 

products that contain certified color 

additives are pet foods, we limit our 

burden estimate to reviewing labels for 

the use of certified color additives to pet 

food manufacturers subject to this 

regulation. Based on A.C. Nielsen data, 

we estimate that the number of animal 

food product units subject to § 501.22(k) 

for which sales of the products are 

greater than zero is 25,874. Assuming 

that the flow of new products is 10 

percent per year, then 2,587 new animal 

food products subject to § 501.22(k) will 

become available on the market each 

year. We also estimate that there are 

approximately 3,120 manufacturers of 

pet food subject to either § 501.22(k)(1) 

or (2). Assuming the approximately 

2,587 new products are split equally 

among the firms, then each firm would 

prepare labels for approximately 0.8292 

new products per year (2,587 new 

products—3,120 firms is approximately 

0.8292 labels per firm). We expect that 

firms prepare the required labeling for 

their products in a manner that takes 

into account at one time all information 

required to be disclosed on their 

product labels. Based on our experience 

with reviewing pet food labeling, we 

estimate that firms would require less 

than 0.25 hour (15 minutes) per product 

to comply with the requirement to 

include the color additive information 

pursuant to § 501.22(k). The total 

burden of this activity is 647 hours 

(2,587 labels × 0.25 hour/label is 

approximately 647 hours). The burden 

for this information collection has not 

changed since the last OMB approval. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14059 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2398] 

Development of Non-Traditional 

Therapies for Bacterial Infections; 

Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Development of 

Non-Traditional Therapies for Bacterial 

Infections.’’ The purpose of the public 

workshop is to discuss the general 

development considerations of nontraditional therapies, including preclinical development, early clinical 

studies, and phase 3 clinical trial 

designs to evaluate safety and efficacy. 

DATES: The public workshop will be 

held on August 21, 2018, from 8:30 a.m. 

to 4:30 p.m. and August 22, 2018, from 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30743 

8:30 a.m. to 12 noon. Submit either 

electronic or written comments on this 

public workshop by August 15, 2018. 

See the SUPPLEMENTARY INFORMATION

section for registration date and 

information. 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://www.

fda.gov/AboutFDA/WorkingatFDA/ 

BuildingsandFacilities/WhiteOak

CampusInformation/ucm241740.htm. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before August 15, 2018. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight eastern time on August 

15, 2018. Comments received by mail/ 

hand delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2018–N–2398 for ‘‘Development of NonTraditional Therapies for Bacterial 

Infections; Public Workshop.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly 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. 

FOR FURTHER INFORMATION CONTACT: Lori 

Benner and/or Jessica Barnes, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6221, 

Silver Spring, MD 20993–0002, 301– 

796–1300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing a public 

workshop regarding development of 

non-traditional therapies for bacterial 

infections. Discussions will focus on 

pre-clinical development, early stage 

clinical trials, and phase 3 clinical trial 

designs to evaluate safety and efficacy of 

non-traditional therapies intended to 

serve as primary or adjunctive therapy 

to existing antibacterial drugs. 

II. Topics for Discussion at the Public 

Workshop 

FDA is particularly interested in 

discussing pre-clinical and clinical 

development of several types of nontraditional therapies, including 

monoclonal antibodies, 

immunomodulators, lysins, and other 

non-traditional therapies. 

The Agency encourages health care 

providers, other U.S. Government 

Agencies, academic experts, industry, 

and other stakeholders to attend this 

public workshop. 

III. Participating in the Public 

Workshop 

Registration: Registration is free and 

based on space availability, with 

priority given to early registrants. 

Persons interested in attending this 

public workshop must register online by 

August 14, 2018, midnight Eastern 

Time. To register, please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, email, and 

telephone to NonTraditionalTherapies

Workshop2018@fda.hhs.gov. 

Early registration is recommended 

because seating is limited; therefore, 

FDA may limit the number of 

participants from each organization. 

Registrants will receive confirmation 

when they have been accepted. If time 

and space permit, onsite registration on 

the day of the public workshop will be 

provided beginning at 7:30 a.m. We will 

let registrants know if registration closes 

before the day of the public workshop. 


sradovich on DSK3GMQ082PROD with NOTICES
30744 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

If you need special accommodations 

due to a disability, please contact Jessica 

Barnes or Lori Benner (see FOR FURTHER

INFORMATION CONTACT) no later than 

August 13, 2018. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session or participate 

in a specific session, and which topic(s) 

you wish to address. We will do our 

best to accommodate requests to make 

public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations or request time for a joint 

presentation. Following the close of 

registration, we will determine the 

amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

August 10, 2018. All requests to make 

oral presentations must be received by 

the close of registration on August 6, 

2018. If selected for presentation, any 

presentation materials must be emailed 

to NonTraditionalTherapiesWorkshop

2018@fda.hhs.gov no later than August 

14, 2018. No commercial or promotional 

material will be permitted to be 

presented or distributed at the public 

workshop. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast at the following site: 

https://collaboration.fda.gov/dcontpfbi/. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the website addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. A link to the transcript will 

also be available on the internet at 

https://www.fda.gov/Drugs/NewsEvents/ 

ucm606052.htm. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14048 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6209] 

Assessing User Fees Under the 

Biosimilar User Fee Amendments of 

2017; 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 entitled 

‘‘Assessing User Fees Under the 

Biosimilar User Fee Amendments of 

2017.’’ This guidance concerns FDA’s 

implementation of the Biosimilar User 

Fee Amendments of 2017 (BsUFA II) 

and certain changes in policies and 

procedures surrounding its application. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 29, 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– 

2017–D–6209 for ‘‘Assessing User Fees 

Under the Biosimilar User Fee 

Amendments of 2017.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

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 


sradovich on DSK3GMQ082PROD with NOTICES