Providing Regulatory Submissions in Electronic Format: Investigational New Drug Application Safety Reports; Draft Guidance for Industry; Availability
| Published date | 30 October 2019 |
| Citation | 84 FR 58158 |
| Record Number | 2019-23666 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 84 Issue 210 (Wednesday, October 30, 2019)
[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]
-----------------------------------------------------------------------
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Investigational New Drug Application Safety Reports; Draft Guidance for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.
-----------------------------------------------------------------------
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the availability of a draft guidance for industry entitled ``Providing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draft guidance describes the electronic format sponsors will be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 The draft guidance,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
[[Page 58159]]
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.
[[Page 58160]]
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
