[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18541-18542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07332]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0039]


Electronic Submissions; Update to the Specifications for 
Preparing and Submitting Postmarket Individual Case Safety Reports for 
Vaccines; Technical Specification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) Center for 
Biologics Evaluation and Research (CBER) is announcing the availability 
of version 2.2 of the Specifications for Preparing and Submitting 
Postmarket Individual Case Safety Reports (ICSRS) for Vaccines 
(Specifications). The version update is not applicable to CBER-
regulated drug products marketed for human use with approved New Drug 
Applications (NDAs) and Abbreviated New Drug Applications (ANDAs); 
CBER-regulated therapeutic biological products marketed for human use 
with approved Biologic License Applications (BLAs); Whole Blood or 
blood components; and human cells, tissues, and cellular and tissue-
based products (HCT/Ps) regulated solely under the Public Health 
Service Act.

ADDRESSES: You may submit either electronic or written comments 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-2021-N-0039 for ``Electronic Submissions; Update to the 
Specifications for Preparing and Submitting Postmarket Individual Case 
Safety Reports for Vaccines; Technical Specification''. Received 
comments, those filed in a timely manner (see ADDRESSES), 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, 240-402-7500.
     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.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 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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Victoria Wagman, Center for Biologics 
Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

[[Page 18542]]

I. Background

    CBER is announcing the availability of version 2.2 of the 
Specifications for Preparing and Submitting Postmarket ICSRs for 
Vaccines (available at https://www.fda.gov/industry/about-esg/cber-vaccine-icsr-implementation). The version update has been prepared to 
accommodate the submission of certain reports for combination products 
required by an FDA rule, ``Postmarketing Safety Reporting for 
Combination Products'', published in the Federal Register of December 
20, 2016 (81 FR 92603) (available at https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products). In addition, version 2.2 includes 
updated business rules (Appendix I of the Specifications) which provide 
details on data field specifications as well as updated sample 
Extensible Markup Language (XML) ICSR test files (available at https://www.fda.gov/industry/about-esg/cber-vaccine-icsr-implementation). The 
version update is not applicable to CBER-regulated drug products 
marketed for human use with approved NDAs and ANDAs; CBER-regulated 
therapeutic biological products marketed for human use with approved 
BLAs); Whole Blood or blood components; and HCT/Ps regulated solely 
under section 361 of the Public Health Service Act (42 U.S.C. 264).
    Vaccine manufacturers and others responsible for reporting ICSRs 
for vaccines can now transition to reporting in the updated version 
2.2. Instructions to transition are available at https://www.fda.gov/vaccines-blood-biologics/getting-started-icsr-submission-fdas-electronic-vaccine-adverse-event-reporting-system-evaers. Manufacturers 
can contact the CBER ICSR Submissions Coordinator 
(CBERICSRSubmissions@fda.hhs.gov) to inform of their intent to 
transition to version 2.2 of the Specifications for Preparing and 
Submitting Postmarket Individual Case Safety Reports for Vaccines. 
Although manufacturers are encouraged to transition to the updated 
version 2.2, CBER continues to accept reports in version 1.0 until 
further notice.

    Dated: April 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07332 Filed 4-8-21; 8:45 am]
BILLING CODE 4164-01-P


