[Federal Register Volume 84, Number 210 (Wednesday, October 30, 2019)]
[Notices]
[Pages 58158-58160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23666]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3953]


Providing Regulatory Submissions in Electronic Format: 
Investigational New Drug Application Safety Reports; Draft Guidance for 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 Agency) is announcing 
the availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format: IND Safety Reports.'' The 
draft guidance describes the electronic format sponsors will be 
required to use when they electronically submit to FDA investigational 
new drug (IND) safety reports to the Center for Drug Evaluation and 
Research (CDER) or the Center for Biologics Evaluation and Research 
(CBER) for serious and unexpected suspected adverse reactions that are 
required under the Agency's regulations. FDA is establishing the 
electronic format requirements described in this guidance under the 
Federal Food, Drug, and Cosmetic Act (FD&C Act). The draft guidance, 
once finalized and effective, will require sponsors submitting the 
specified IND safety reports electronically to submit the reports to 
FDA using the FDA Adverse Event Reporting System (FAERS) as structured 
data elements and will provide sponsors with a reporting format that is 
consistent with the International Council for Harmonisation (ICH) 
E2B(R2) format guidelines and reporting requirements to other 
regulatory agencies. Additional technical specification documents and 
instructions for submitting IND safety reports, including ``Electronic 
Submission of IND Safety Reports Technical Conformance Guide'' and an 
updated technical specifications document entitled ``Specifications for 
Preparing and Submitting Electronic ICSRs and ICSR Attachments'' are 
available on the FAERS Electronic Submission web page (available at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm).

DATES: Submit either electronic or written comments on the draft 
guidance by December 30, 2019 to ensure that the Agency considers your 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

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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-2019-D-3953 for ``Providing Regulatory Submissions in Electronic 
Format: IND Safety Reports.'' 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 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 the draft 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 the 
Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Meredith K. Chuk, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, MD 20993-0002, 301-796-2340; 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 draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format: IND 
Safety Reports.'' The draft guidance describes the electronic format 
sponsors will be required to use when they electronically submit to FDA 
IND safety reports to CDER and CBER for serious and unexpected 
suspected adverse reactions that are required under 21 CFR 
312.32(c)(1)(i). FDA is establishing the electronic format requirements 
described in this guidance under section 745A(a) of the FD&C Act. In 
section 745A(a) of the FD&C Act, Congress granted explicit statutory 
authorization to FDA to specify in guidance the format for the 
electronic submissions required under that section. The draft guidance, 
once finalized, will require sponsors submitting the specified IND 
safety reports electronically to submit the reports to FDA using FAERS 
as structured data elements. Additional technical specification 
documents and instructions for submitting IND safety reports, including 
``Electronic Submission of IND Safety Reports Technical Conformance 
Guide'' and an updated technical specifications document entitled 
``Specifications for Preparing and Submitting Electronic ICSRs and ICSR 
Attachments,'' are available on the FAERS Electronic Submission web 
page (available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm)).
    The draft guidance, when finalized, will represent the current 
thinking of FDA on ``Providing Regulatory Submissions in Electronic 
Format: IND Safety Reports.'' The electronic format requirements 
specified in this guidance will be effective 24 months after the 
publication of the final guidance on this topic. Before the effective 
date of this requirement, FDA will accept the IND safety reports 
described in this guidance to FAERS as part of a voluntary submission 
program.

II. Paperwork Reduction Act of 1995

    This draft 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. 3501-3520). The 
collection of information under 21 CFR 312.10 for submitting waiver 
requests and under 21 CFR 312.32 for submitting IND safety reports and 
reporting serious and unexpected adverse events has been approved under 
OMB control number 0910-0014. The collection of information for 
submitting Forms FDA 3500 and 3500A has been approved under OMB control 
number 0910-0291. The collection of information for submitting periodic 
adverse drug experience reports has been approved under OMB control 
number 0910-0230.

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The collection of information for FDA adverse event reporting and 
electronic submissions using the Electronic Submission Gateway and the 
Safety Reporting Portal has been approved under OMB control number 
0910-0645.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: October 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23666 Filed 10-29-19; 8:45 am]
BILLING CODE 4164-01-P


