[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10448-10449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1006]


Providing Regulatory Submissions in Electronic Format--Certain 
Human Pharmaceutical Product Applications and Related Submissions Using 
the eCTD Specifications (Revision 7); Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a final guidance for industry entitled 
``Providing Regulatory Submissions in Electronic Format--Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the 
eCTD Specifications (Revision 7).'' FDA has identified certain 
submission types that warrant an exemption (Type III drug master files 
(DMFs)) or a long-term waiver (certain positron emission tomography 
(PET) drug products and certain Type II DMFs supporting PET drugs or 
noncommercial submissions or applications) from the requirement to 
submit to the Agency in electronic common technical document (eCTD) 
format. In addition, this guidance outlines certain circumstances where 
FDA may determine that a short-term waiver from eCTD submission 
requirements could be granted. This guidance finalizes the revised 
draft guidance of the same title issued in July 2019 and replaces the 
final guidance issued in January 2019 (Revision 6).

DATES: The announcement of the guidance is published in the Federal 
Register on February 24, 2020.

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-2014-N-1006 for ``Providing Regulatory Submissions in Electronic 
Format--Certain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications (Revision 7).'' 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.govinfo.gov/content/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

[[Page 10449]]

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 this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dorothy West, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6332, Silver Spring, MD 20993-0002, 301-
796-0164; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications (Revision 7).'' This guidance 
provides information regarding submission types that warrant an 
exemption or long-term waiver from Agency eCTD requirements. In 
addition, this guidance outlines certain circumstances where FDA will 
consider granting short-term waivers from eCTD submission requirements. 
This guidance is intended to address current concerns raised with FDA 
regarding the burden of complying with eCTD submission requirements, 
which could have unintended public health consequences.
    This guidance finalizes the draft guidance entitled ``Providing 
Regulatory Submissions in Electronic Format--Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the 
Electronic Common Technical Document Specifications (Revision 7)'' 
issued on July 16, 2019 (84 FR 33949). The Agency received comments on 
the draft guidance requesting that FDA clarify certain requirements 
relating to Type III DMF submissions. The Agency considered these 
comments and made technical and editorial changes for clarity, where 
appropriate. For example, ``noncommercial products'' was changed to 
``noncommercial INDs'' to clarify the type of submissions referenced in 
that section of the guidance. In addition, the FDA Electronic 
Submissions Gateway (ESG) waiver request submission option has been 
removed to avoid confusion when selecting from the ESG drop-down 
options.
    This 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 ``Providing Regulatory Submissions in 
Electronic Format--Certain Human Pharmaceutical Product Applications 
and Related Submissions Using the eCTD Specifications (Revision 7).''
    FDA guidances ordinarily contain standard language explaining that 
guidances should be viewed only as recommendations unless specific 
regulatory or statutory requirements are cited. FDA is not including 
this standard language in this guidance because this guidance contains 
binding provisions. In section 745A(a) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 379k-1(a)), Congress granted 
explicit authorization to FDA to specify in guidance the format for the 
electronic submissions required under that section and required that 
FDA ``shall'' issue such guidance. Accordingly, this guidance explains 
such requirements under section 745A(a) of the FD&C Act, indicated by 
the use of the words must or required, and therefore is not subject to 
the usual restrictions in FDA's good guidance practice regulations, 
such as the requirement that guidances not establish legally 
enforceable responsibilities. See e.g., 21 CFR 10.115(d).

II. 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. 3501-3521). The 
collections of information in 21 CFR part 312 have been approved under 
OMB control number 0910-0014; the collections of information in 21 CFR 
part 314 have been approved under OMB control number 0910-0001; and the 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or 
https://www.regulations.gov.

    Dated: February 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03522 Filed 2-21-20; 8:45 am]
BILLING CODE 4164-01-P