Providing Regulatory Submissions in Electronic Format: Investigational New Drug Application Safety Reports; Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” The draft guidance describes the electronic format sponsors will be required to use when they electronically submit to FDA investigational new drug (IND) safety reports to the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 The draft guidance, once finalized and effective, will require sponsors submitting the specified IND safety reports electronically to submit the reports to FDA using the FDA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Submit either electronic or written comments on the draft guidance by December 30, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 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. 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.