Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28237 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1216] 

Technical Specifications for Electronic 

Submissions; Establishment of a 

Public Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

establishing a public docket to receive 

information, recommendations, and 

comments on matters related to the 

Agency’s publication of technical 

specifications, which explain, clarify, 

and define the specific use of data 

standards in new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), biologics license 

applications (BLAs), and certain 

investigational new drug applications 

(INDs) to the Center for Biologics 

Evaluation and Research (CBER) and the 

Center for Drug Evaluation and Research 

(CDER). This docket is intended for 

general comments related to technical 

specifications that are not specific to 

documents or issues that are the subject 

of other dockets, or for comments 

specific to electronic submission 

guidances. 

DATES: The announcement of this 

establishment of a public docket is 

published in the Federal Register on 

June 18, 2018. 

ADDRESSES: You may submit either 

electronic or written comments to this 

docket 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– 

2018–D–1216 for ‘‘Technical 

Specifications for Electronic 

Submissions; Establishment of a Public 

Docket.’’ 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 laws. 

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: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1115, Silver Spring, 

MD 20993–0002, 301–796–5333, 

ronald.fitzmartin@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 745A of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 379k–1) requires that 

submissions under section 505(b), (i), or 

(j) of the FD&C Act (21 U.S.C. 355(b), (i), 

or (j)) and submissions under section 

351(a) or (k) of the Public Health Service 

Act (42 U.S.C. 262(a) or (k)) be 

submitted in the electronic format 

specified by FDA, beginning no earlier 

than 24 months after FDA issues a final 

guidance specifying an electronic 

submission format. 

The Agency has concluded it is not 

feasible to describe and implement the 

electronic format or formats that would 

apply to all the submissions covered by 

section 745A(a) in one guidance 

document. Therefore, FDA issued the 

guidance for industry ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Submissions under Section 

745A(a) of the Federal Food, Drug, and 

Cosmetic Act,’’ which describes how 

FDA interprets the electronic 

submission requirements of section 

745A(a) of the FD&C Act (see https://

www.fda.gov/downloads/drugs/ 

guidances/ucm384686.pdf). 

To assist sponsors in the submission 

of data in standardized electronic format 

in NDAs, ANDAs, BLAs, and certain 

INDs, CBER and CDER have developed 

technical specifications guidances 

which provide useful technical 

specifications, recommendations, and 

general considerations for submitting 

standardized data and related 

information in electronic format. 

Technical specifications guidances are 

guidances that explain, clarify, and 

define the specific use of data standards 


amozie on DSK3GDR082PROD with NOTICES1
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 


amozie on DSK3GDR082PROD with NOTICES1