28238 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 

in regulatory submissions. Technical 

specifications guidances are available at: 

https://www.fda.gov/ForIndustry/ 

DataStandards/default.htm. 

II. Establishment of a Docket 

FDA is establishing a public docket so 

that anyone can share information, 

comments, and ideas on any matters 

related to the use of technical 

specifications that are not specific to the 

documents or issues addressed in other 

dockets. This information will give the 

Agency insight into stakeholders’ 

experiences and views regarding the use 

of technical specifications guidances 

and the data standards they contain. 

The docket also permits anyone to share 

information, comments, or ideas that are 

specific to one or more technical 

specifications guidances. Instructions 

regarding how to submit comments to 

specific technical specifications 

documents have been posted within the 

docket. 

This docket will be open for comment 

simultaneously with several other 

dockets that are specific to particular 

electronic common technical document 

(eCTD) submissions and FDA data 

standards documents. (For more 

information on eCTD submissions and 

FDA data standards, see https://

www.fda.gov/Drugs/ 

DevelopmentApprovalProcess/ 

FormsSubmissionRequirements/ 

ElectronicSubmissions/ucm153574.htm 

and https://www.fda.gov/ForIndustry/ 

DataStandards/default.htm, 

respectively). Do not submit comments 

to this general docket that have already 

been submitted to other dockets. As 

FDA finalizes specific documents or 

requests comments on specific issues for 

which another docket exists, the Agency 

will generally consider only those 

comments that have been submitted to 

that specific docket. Do not submit 

comments related to another specific 

docket to this general technical 

specifications docket, as the Agency 

may not consider them. FDA will not 

respond directly to questions or requests 

submitted to this docket but will 

consider any submitted information in 

its work to develop and issue technical 

specifications guidances. 

Dated: June 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12969 Filed 6–15–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2155] 

Foods Produced Using Animal Cell 

Culture Technology; Public Meeting; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing a public meeting entitled 

‘‘Foods Produced Using Animal Cell 

Culture Technology.’’ FDA is holding 

the public meeting to provide the public 

with an opportunity to provide 

comments related to the production of 

foods using animal cell culture 

technology. 

DATES: The public meeting will be held 

on July 12, 2018, from 8:30 a.m. until 3 

p.m. EST. Submit either electronic or 

written comments on this public 

meeting by September 25, 2018. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held at the Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition, Wiley 

Auditorium, 5001 Campus Dr., College 

Park, MD 20740. 

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 September 25, 2018. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of September 25, 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–2155 for ‘‘Foods Produced 

Using Animal Cell Culture Technology; 

Public Meeting; Request for Comments.’’ 

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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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 


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Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28239 

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: 

Juanita Yates, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1731, 

Juanita.yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Technological advances and 

consumer interest are spurring 

development of commercial-scale 

production of foods that are intended to 

resemble traditional meat, poultry, and 

seafood but are manufactured using, 

generally, a small amount of cells from 

the type of animal the food is intended 

to resemble. The collected cells are 

multiplied using nontraditional food 

technologies adapted from cell culture 

applications widely used in research 

and increasingly in medicine. We 

expect that most or all starter cells for 

food applications will come from living 

animals for the foreseeable future for 

commercial and marketing reasons (for 

example, firms currently working on 

developing these food applications 

appear to be targeting consumers 

motivated by animal welfare concerns). 

Currently, animal cells can be produced 

from the starter cells in bioreactors, a 

scaled-up application of traditional cell 

culture techniques. Firms are also 

working to commercialize processes by 

which cells can be cultured using 

biocompatible scaffolding or other 

techniques to permit the formation of 

complex tissues, similar to strategies 

being explored for therapeutic organ or 

tissue replacement. In either case, a 

significant technical challenge with 

respect to the use of animal cell culture 

technology to develop foods intended to 

resemble traditional meat, poultry, and 

seafood products involves the 

development of the growth medium 

used to multiply the cells and ensure 

that they differentiate into the correct 

cell types. Commercial incentives are 

driving research into non-animal 

derived components for such media 

instead of traditional animal-derived 

materials. Finally, after creation, both 

suspension-cultured (unstructured) and 

scaffold-cultured (structured) products 

would be further processed using 

traditional food technologies, including 

seasoning, forming, and packaging. 

Just as we have been in the past with 

respect to rapidly evolving areas of 

technological innovation in food, FDA 

will be involved in the regulation of 

foods generated by animal cell culture 

technology in light of our broad 

statutory authority and our extensive 

expertise and experience in relevant 

scientific areas. Currently, FDA 

evaluates microbial, algal, and fungal 

cells generated by large-scale culture 

and used as direct food ingredients, 

administers safety assessment programs 

for a broad array of food ingredients and 

foods derived from genetically 

engineered plants, manages safety issues 

associated with animal cell culture 

technology in therapeutic settings, and 

manages risks associated with the 

processing, manufacture, and packaging 

of food incorporating seafood tissues. 

Under the Federal Food, Drug, and 

Cosmetic Act, FDA has jurisdiction over 

‘‘food,’’ which includes ‘‘articles used 

for food’’ and ‘‘articles used for 

components of any such article.’’ Thus, 

as a starting point, both substances used 

in the manufacture of these products of 

animal cell culture technology and the 

products themselves that will be used 

for food are subject to FDA’s jurisdiction 

and applicable statutory and regulatory 

food safety and food labeling 

requirements. 

The use of animal cell culture 

technology as a method of food 

production and manufacturing involves 

many interesting issues from both 

technical and regulatory perspectives. 

FDA believes that all stakeholders will 

benefit from a robust and open dialogue 

that explores these issues and gathers 

relevant data and information. The 

primary subject of this notice is food 

safety, but FDA recognizes the 

importance of other issues related to 

foods produced through animal cell 

culture technology such as naming. 

Although not the primary subject of this 

notice, FDA welcomes comment on 

these other issues and expects that they 

will be the focus of future engagement 

with stakeholders and the public. 

II. Topics for Discussion at the Public 

Meeting 

FDA is holding the public meeting to 

provide the public with an opportunity 

to provide comments related to 

production of foods using animal cell 

culture technology. We invite interested 

persons, including those participating in 

the public meeting, to provide 

information on topics such as the 

following (a more detailed agenda will 

be made available prior to the meeting): 

• FDA has evaluated a variety of 

foods produced by cell culture, 

including microbial (e.g., probiotics), 

algal (e.g., spirulina), and fungal 

products (e.g., mycoprotein). What 

considerations specific to animal cell 

culture technology would be 

appropriate to include in evaluation of 

food produced by this method of 

manufacture? 

• FDA has issued guidance on how to 

assess the effects of significant 

manufacturing process changes on the 

safety of a food ingredient. (See 

‘‘Guidance for Industry: Assessing the 

Effects of Significant Manufacturing 

Process Changes, Including Emerging 

Technologies, on the Safety and 

Regulatory Status of Food Ingredients 

and Food Contact Substances, Including 

Food Ingredients that Are Color 

Additives’’ at https://www.fda.gov/ 

RegulatoryInformation/Guidances/ 

ucm300661.htm.) What kinds of 

variations in manufacturing methods 

would be relevant to safety for foods 

produced by animal cell culture 

technology? 

• FDA has a variety of pre- and 

postmarket programs for evaluating the 

safety of substances used in the 

production and manufacture of foods, 

including, for example, food additive 

and color additive regulations and 

preventive control requirements. What 

kinds of substances would be used in 

the manufacture of foods produced 

using animal cell culture technology 

and what considerations would be 

appropriate in evaluating the safety of 

these uses? 

• Are the hazards associated with 

production of foods using animal cell 

culture technology different from those 

associated with traditional food 

production/processing (such as, for 

example, insanitary conditions, 

improper temperature controls, or 

control of contaminants)? Is there a need 

for unique control measures to address 

the hazards associated with production 

of foods using animal cell culture 

technology? 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 


amozie on DSK3GDR082PROD with NOTICES1
28240 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 

website: https://www.fda.gov/ 

Food/NewsEvents/WorkshopsMeetings

Conferences/default.htm. Please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting must 

register by July 5, 2018. 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 you need special accommodations 

due to a disability, please contact 

Juanita Yates (see FOR FURTHER

INFORMATION CONTACT) no later than June 

28, 2018. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment 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, and 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 

July 3, 2018. Speakers will be limited to 

making oral remarks; there will not be 

an opportunity to display materials such 

as slide shows, videos, or other media 

during the meeting. All requests to make 

oral presentations must be received by 

June 28, 2018. No commercial or 

promotional material will be permitted 

to be presented or distributed at the 

public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. Webcast participants are 

asked to preregister at https://

www.fda.gov/ 

Food/NewsEvents/WorkshopsMeetings

Conferences/default.htm. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/ 

Food/NewsEvents/WorkshopsMeetings

Conferences/default.htm. 

Other Issues for Consideration: A 

summary of key information on 

participating in the meeting follows: 

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING

Date Address Preregister Electronic address 

Request to 

make an oral 

presentation 

Special 

accommodations 

Submit either electronic or written 

comments 

July 12, 2018, 

from 8:30 a.m. 

until 3 p.m. EDT.

Food and Drug Administration, Center 

for Food Safety and 

Applied Nutrition, 

Wiley Auditorium, 

5001 Campus 

Drive, College Park, 

MD 20740.

July 5, 2018: 

Closing date 

for registration.

https://www.fda.gov/ 

Food/NewsEvents/ 

WorkshopsMeetings

Conferences/default.htm.

June 28, 2018 June 28, 2018: Closing date to request 

special accommodations due to a 

disability.

Submit Comments by September 

25, 2018 to: https://

www.regulations.gov, or Dockets Management Staff (HFA– 

305), Food and Drug Administration, 5630 Fishers Lane, 

Rm. 1061, Rockville, MD 

20852. 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12939 Filed 6–15–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2016] 

Epidermolysis Bullosa: Developing 

Drugs for Treatment of Cutaneous 

Manifestations; Draft 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 draft 

guidance for industry entitled 

‘‘Epidermolysis Bullosa: Developing 

Drugs for Treatment of Cutaneous 

Manifestations.’’ The purpose of this 

draft guidance is to assist sponsors with 

the development of drugs for treatment 

or prevention of the serious cutaneous 

manifestations of the heterogeneous 

group of disorders collectively known as 

epidermolysis bullosa (EB). There is an 

unmet medical need for EB patients due 

to the paucity of effective treatment 

options. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 17, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 


amozie on DSK3GDR082PROD with NOTICES1