83_FR_28354 83 FR 28237 - Technical Specifications for Electronic Submissions; Establishment of a Public Docket

83 FR 28237 - Technical Specifications for Electronic Submissions; Establishment of a Public Docket

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 117 (June 18, 2018)

Page Range28237-28238
FR Document2018-12969

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.

Federal Register, Volume 83 Issue 117 (Monday, June 18, 2018) 
[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28237-28238]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12969]



[[Page 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.thefederalregister.org/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, [email protected].

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

[[Page 28238]]

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

Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28237 DEPARTMENT OF HEALTH AND comments, that information will be posting of comments to public dockets, HUMAN SERVICES posted on https://www.regulations.gov. see 80 FR 56469, September 18, 2015, or • If you want to submit a comment access the information at: https:// Food and Drug Administration with confidential information that you www.gpo.gov/fdsys/pkg/FR-2015-09-18/ do not wish to be made available to the pdf/2015-23389.pdf. [Docket No. FDA–2018–D–1216] public, submit the comment as a Docket: For access to the docket to Technical Specifications for Electronic written/paper submission and in the read background documents or the Submissions; Establishment of a manner detailed (see ‘‘Written/Paper electronic and written/paper comments Public Docket Submissions’’ and ‘‘Instructions’’). received, go to https:// Written/Paper Submissions www.regulations.gov and insert the AGENCY: Food and Drug Administration, docket number, found in brackets in the HHS. Submit written/paper submissions as heading of this document, into the ACTION: Notice; establishment of a follows: ‘‘Search’’ box and follow the prompts public docket. • Mail/Hand delivery/Courier (for and/or go to the Dockets Management written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, SUMMARY: The Food and Drug Management Staff (HFA–305), Food and Rockville, MD 20852. Administration (FDA or Agency) is Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ron establishing a public docket to receive • For written/paper comments Fitzmartin, Center for Drug Evaluation information, recommendations, and submitted to the Dockets Management and Research, Food and Drug comments on matters related to the Staff, FDA will post your comment, as Administration, 10903 New Hampshire Agency’s publication of technical well as any attachments, except for Ave., Bldg. 51, Rm. 1115, Silver Spring, specifications, which explain, clarify, information submitted, marked and MD 20993–0002, 301–796–5333, and define the specific use of data identified, as confidential, if submitted ronald.fitzmartin@fda.hhs.gov. standards in new drug applications (NDAs), abbreviated new drug as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: applications (ANDAs), biologics license Instructions: All submissions received must include the Docket No. FDA– I. Background applications (BLAs), and certain 2018–D–1216 for ‘‘Technical Section 745A of the Federal Food, investigational new drug applications Specifications for Electronic Drug, and Cosmetic Act (FD&C Act) (21 (INDs) to the Center for Biologics Submissions; Establishment of a Public U.S.C. 379k–1) requires that Evaluation and Research (CBER) and the Docket.’’ Received comments will be submissions under section 505(b), (i), or Center for Drug Evaluation and Research placed in the docket and, except for (j) of the FD&C Act (21 U.S.C. 355(b), (i), (CDER). This docket is intended for those submitted as ‘‘Confidential or (j)) and submissions under section general comments related to technical Submissions,’’ publicly viewable at 351(a) or (k) of the Public Health Service specifications that are not specific to https://www.regulations.gov or at the Act (42 U.S.C. 262(a) or (k)) be documents or issues that are the subject Dockets Management Staff between 9 submitted in the electronic format of other dockets, or for comments a.m. and 4 p.m., Monday through specified by FDA, beginning no earlier specific to electronic submission Friday. than 24 months after FDA issues a final guidances. • Confidential Submissions—To guidance specifying an electronic DATES: The announcement of this submit a comment with confidential submission format. establishment of a public docket is information that you do not wish to be The Agency has concluded it is not published in the Federal Register on made publicly available, submit your feasible to describe and implement the June 18, 2018. comments only as a written/paper electronic format or formats that would ADDRESSES: You may submit either submission. You should submit two apply to all the submissions covered by electronic or written comments to this copies total. One copy will include the section 745A(a) in one guidance docket at any time as follows: information you claim to be confidential document. Therefore, FDA issued the with a heading or cover note that states guidance for industry ‘‘Providing Electronic Submissions ‘‘THIS DOCUMENT CONTAINS Regulatory Submissions in Electronic Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The Format—Submissions under Section following way: Agency will review this copy, including 745A(a) of the Federal Food, Drug, and • Federal eRulemaking Portal: the claimed confidential information, in Cosmetic Act,’’ which describes how https://www.regulations.gov. Follow the its consideration of comments. The FDA interprets the electronic instructions for submitting comments. second copy, which will have the submission requirements of section Comments submitted electronically, claimed confidential information 745A(a) of the FD&C Act (see https:// including attachments, to https:// redacted/blacked out, will be available www.fda.gov/downloads/drugs/ www.regulations.gov will be posted to for public viewing and posted on guidances/ucm384686.pdf). the docket unchanged. Because your https://www.regulations.gov. Submit To assist sponsors in the submission comment will be made public, you are both copies to the Dockets Management of data in standardized electronic format solely responsible for ensuring that your Staff. If you do not wish your name and in NDAs, ANDAs, BLAs, and certain comment does not include any contact information to be made publicly INDs, CBER and CDER have developed confidential information that you or a available, you can provide this technical specifications guidances third party may not wish to be posted, information on the cover sheet and not which provide useful technical amozie on DSK3GDR082PROD with NOTICES1 such as medical information, your or in the body of your comments and you specifications, recommendations, and anyone else’s Social Security number, or must identify this information as general considerations for submitting confidential business information, such ‘‘confidential.’’ Any information marked standardized data and related as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed information in electronic format. that if you include your name, contact except in accordance with 21 CFR 10.20 Technical specifications guidances are information, or other information that and other applicable disclosure laws. guidances that explain, clarify, and identifies you in the body of your For more information about FDA’s define the specific use of data standards VerDate Sep<11>2014 18:00 Jun 15, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\18JNN1.SGM 18JNN1

28238 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices in regulatory submissions. Technical DEPARTMENT OF HEALTH AND third party may not wish to be posted, specifications guidances are available at: HUMAN SERVICES such as medical information, your or https://www.fda.gov/ForIndustry/ anyone else’s Social Security number, or DataStandards/default.htm. Food and Drug Administration confidential business information, such [Docket No. FDA–2018–N–2155] as a manufacturing process. Please note II. Establishment of a Docket that if you include your name, contact Foods Produced Using Animal Cell information, or other information that FDA is establishing a public docket so Culture Technology; Public Meeting; identifies you in the body of your that anyone can share information, Request for Comments comments, that information will be comments, and ideas on any matters posted on https://www.regulations.gov. related to the use of technical AGENCY: Food and Drug Administration, • If you want to submit a comment specifications that are not specific to the HHS. with confidential information that you documents or issues addressed in other ACTION: Notice of public meeting; do not wish to be made available to the dockets. This information will give the request for comments. public, submit the comment as a Agency insight into stakeholders’ written/paper submission and in the experiences and views regarding the use SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper of technical specifications guidances Administration (FDA or we) is Submissions’’ and ‘‘Instructions’’). and the data standards they contain. announcing a public meeting entitled Written/Paper Submissions The docket also permits anyone to share ‘‘Foods Produced Using Animal Cell information, comments, or ideas that are Culture Technology.’’ FDA is holding Submit written/paper submissions as specific to one or more technical the public meeting to provide the public follows: with an opportunity to provide • Mail/Hand delivery/Courier (for specifications guidances. Instructions comments related to the production of written/paper submissions): Dockets regarding how to submit comments to Management Staff (HFA–305), Food and specific technical specifications foods using animal cell culture technology. Drug Administration, 5630 Fishers documents have been posted within the Lane, Rm. 1061, Rockville, MD 20852. docket. DATES: The public meeting will be held • For written/paper comments This docket will be open for comment on July 12, 2018, from 8:30 a.m. until 3 submitted to the Dockets Management simultaneously with several other p.m. EST. Submit either electronic or Staff, FDA will post your comment, as written comments on this public well as any attachments, except for dockets that are specific to particular meeting by September 25, 2018. See the information submitted, marked and electronic common technical document SUPPLEMENTARY INFORMATION section for identified, as confidential, if submitted (eCTD) submissions and FDA data registration date and information. as detailed in ‘‘Instructions.’’ standards documents. (For more information on eCTD submissions and ADDRESSES: The public meeting will be Instructions: All submissions received held at the Food and Drug must include the Docket No. FDA– FDA data standards, see https:// Administration, Center for Food Safety 2018–N–2155 for ‘‘Foods Produced www.fda.gov/Drugs/ and Applied Nutrition, Wiley Using Animal Cell Culture Technology; DevelopmentApprovalProcess/ Public Meeting; Request for Comments.’’ Auditorium, 5001 Campus Dr., College FormsSubmissionRequirements/ Park, MD 20740. Received comments, those filed in a ElectronicSubmissions/ucm153574.htm You may submit comments as timely manner (see ADDRESSES), will be and https://www.fda.gov/ForIndustry/ follows. Please note that late, untimely placed in the docket and, except for DataStandards/default.htm, filed comments will not be considered. those submitted as ‘‘Confidential respectively). Do not submit comments Electronic comments must be submitted Submissions,’’ publicly viewable at to this general docket that have already on or before September 25, 2018. The https://www.regulations.gov or at the been submitted to other dockets. As https://www.regulations.gov electronic Dockets Management Staff between FDA finalizes specific documents or filing system will accept comments 9 a.m. and 4 p.m., Monday through requests comments on specific issues for until midnight Eastern Time at the end Friday. which another docket exists, the Agency of September 25, 2018. Comments • Confidential Submissions—To will generally consider only those received by mail/hand delivery/courier submit a comment with confidential comments that have been submitted to (for written/paper submissions) will be information that you do not wish to be that specific docket. Do not submit considered timely if they are made publicly available, submit your comments related to another specific postmarked or the delivery service comments only as a written/paper docket to this general technical acceptance receipt is on or before that submission. You should submit two specifications docket, as the Agency date. copies total. One copy will include the may not consider them. FDA will not information you claim to be confidential Electronic Submissions with a heading or cover note that states respond directly to questions or requests submitted to this docket but will Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS consider any submitted information in following way: CONFIDENTIAL INFORMATION.’’ We • Federal eRulemaking Portal: will review this copy, including the its work to develop and issue technical https://www.regulations.gov. Follow the claimed confidential information, in our specifications guidances. instructions for submitting comments. consideration of comments. The second Dated: June 12, 2018. Comments submitted electronically, copy, which will have the claimed amozie on DSK3GDR082PROD with NOTICES1 Leslie Kux, including attachments, to https:// confidential information redacted/ Associate Commissioner for Policy. www.regulations.gov will be posted to blacked out, will be available for public [FR Doc. 2018–12969 Filed 6–15–18; 8:45 am] the docket unchanged. Because your viewing and posted on https:// comment will be made public, you are www.regulations.gov. Submit both BILLING CODE 4164–01–P solely responsible for ensuring that your copies to the Dockets Management Staff. comment does not include any If you do not wish your name and confidential information that you or a contact information to be made publicly VerDate Sep<11>2014 18:00 Jun 15, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\18JNN1.SGM 18JNN1


Document Created: 2018-06-18 15:50:42
Document Modified: 2018-06-18 15:50:42
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; establishment of a public docket.
DatesThe announcement of this establishment of a public docket is published in the Federal Register on June 18, 2018.
ContactRon 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, [email protected]
FR Citation83 FR 28237 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR