81 FR 40890 - International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 121 (June 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 121 (June 23, 2016)
| Page Range | 40890-40891 | |
| FR Document | 2016-14845 |
[Federal Register Volume 81, Number 121 (Thursday, June 23, 2016)] [Notices] [Pages 40890-40891] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14845] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1280] International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled ``FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines'' supplements the ``E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification'' final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS. DATES: Submit either electronic or written comments on the Regional Implementation Specifications document at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2016-D-1280 for ``FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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, [[Page 40891]] 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 Avenue, 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: Suranjan De, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4307, Silver Spring, MD 20993, 240-402-0498, or [email protected]; 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 On February 21, 2014, FDA issued a Federal Register notice (79 FR 9908) announcing the availability of a final guidance for industry entitled ``E2B (R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification'' (ICH E2B(R3) guidance) and an appendix to the guidance entitled ``ICSRs: Appendix to the Implementation Guide--Backwards and Forward Compatibility'' (BFC appendix). The ICH E2B(R3) guidance and BFC appendix were issued as a package that included schema files and additional technical information to be used for creating compatible ICSR files. The preface to the ICH E2B(R3) implementation guidance makes clear that any future ``technical specifications document associated with that guidance would be provided as a stand-alone document'' but incorporated by reference into that guidance. Accordingly, in this notice, we are announcing the availability of a technical specifications document that will be incorporated into that final guidance. This technical specifications document, which is available on the FDA Guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm274966.htm, is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and any ICSR attachments) to CDER and CBER. This document describes FDA's technical approach for submitting ICSRs, for incorporating its regionally controlled terminology, and for adding its regional data elements that are not addressed in the ICH E2B (R3) guidance for the following FDA-regulated products: Drug products marketed for human use with approved new drug applications and abbreviated new drug applications; prescription drug products marketed for human use without an approved application; nonprescription (over- the-counter) human drug products marketed without an approved application; and biological products marketed for human use with approved biologic license applications. II. Electronic Access Persons with access to the Internet may obtain a copy of the FDA Regional Implementation Specifications for ICH E2B(R3) at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm115894.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov. Dated: June 17, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-14845 Filed 6-22-16; 8:45 am] BILLING CODE 4164-01-P
![40890 Federal Register / Vol. 81, No. 121 / Thursday, June 23, 2016 / Notices
FDA regrets that it was unable to Implementation: Postmarket Submission Instructions: All submissions received
publish this notice 15 days prior to the of Individual Case Safety Reports must include the Docket No. FDA–
June 28 and 29, 2016, Pediatric (ICSRs) for Drugs and Biologics, 2016–D–1280 for ‘‘FDA Regional
Oncology Subcommittee of the Excluding Vaccines’’ supplements the Implementation Specifications for ICH
Oncologic Drugs Advisory Committee ‘‘E2B(R3) Electronic Transmission of E2B(R3) Implementation: Postmarket
meeting. Because the Agency believes Individual Case Safety Reports (ICSRs) Submission of Individual Case Safety
there is some urgency to bring these Implementation Guide—Data Elements Reports for Drugs and Biologics,
issues to public discussion and and Message Specification’’ final Excluding Vaccines.’’ Received
qualified members of the Pediatric guidance for industry and describes comments will be placed in the docket
Oncology Subcommittee of the FDA’s technical approach for receiving and, except for those submitted as
Oncologic Drugs Advisory Committee ICSRs, for incorporating regionally ‘‘Confidential Submissions,’’ publicly
meeting were available at this time, the controlled terminology, and for adding viewable at http://www.regulations.gov
Commissioner of Food and Drugs region-specific data elements when or at the Division of Dockets
concluded that it was in the public reporting to FAERS. Management between 9 a.m. and 4 p.m.,
interest to hold this meeting even if DATES: Submit either electronic or Monday through Friday.
there was not sufficient time for the written comments on the Regional • Confidential Submissions—To
customary 15-day public notice. Implementation Specifications submit a comment with confidential
This notice is issued under the document at any time. information that you do not wish to be
Federal Advisory Committee Act (5 ADDRESSES: You may submit comments made publicly available, submit your
U.S.C. app. 2) and 21 CFR part 14, as follows: comments only as a written/paper
relating to the advisory committees. submission. You should submit two
Electronic Submissions copies total. One copy will include the
Dated: June 16, 2016.
Jill Hartzler Warner, Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states
Associate Commissioner for Special Medical
Programs. • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
[FR Doc. 2016–14827 Filed 6–22–16; 8:45 am]
instructions for submitting comments. Agency will review this copy, including
BILLING CODE 4164–01–P
Comments submitted electronically, the claimed confidential information, in
including attachments, to http:// its consideration of comments. The
DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to second copy, which will have the
HUMAN SERVICES the docket unchanged. Because your claimed confidential information
comment will be made public, you are redacted/blacked out, will be available
Food and Drug Administration solely responsible for ensuring that your for public viewing and posted on http://
comment does not include any www.regulations.gov. Submit both
[Docket No. FDA–2016–D–1280] copies to the Division of Dockets
confidential information that you or a
third party may not wish to be posted, Management. If you do not wish your
International Conference on
such as medical information, your or name and contact information to be
Harmonisation; Electronic
anyone else’s Social Security number, or made publicly available, you can
Transmission of Postmarket Individual
confidential business information, such provide this information on the cover
Case Safety Reports for Drugs and
as a manufacturing process. Please note sheet and not in the body of your
Biologics, Excluding Vaccines;
that if you include your name, contact comments and you must identify this
Availability of Food and Drug
information, or other information that information as ‘‘confidential.’’ Any
Administration Regional
identifies you in the body of your information marked as ‘‘confidential’’
Implementation Specifications for ICH
comments, that information will be will not be disclosed except in
E2B(R3) Reporting to the Food and
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
Drug Administration Adverse Event
Reporting System • If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
AGENCY: Food and Drug Administration, do not wish to be made available to the comments to public dockets, see 80 FR
HHS. public, submit the comment as a 56469, September 18, 2015, or access
ACTION: Notice of availability. written/paper submission and in the the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’). default.htm.
Administration (FDA) is announcing the Docket: For access to the docket to
availability of its FDA Adverse Event Written/Paper Submissions read background documents or the
Reporting System (FAERS) Regional Submit written/paper submissions as electronic and written/paper comments
Implementation Specifications for the follows: received, go to http://
International Conference on • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Harmonisation (ICH) E2B(R3) written/paper submissions): Division of docket number, found in brackets in the
Specification. FDA is making this Dockets Management (HFA–305), Food heading of this document, into the
technical specifications document and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
available to assist interested parties in Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
asabaliauskas on DSK3SPTVN1PROD with NOTICES
electronically submitting individual • For written/paper comments Management, 5630 Fishers Lane, Rm.
case safety reports (ICSRs) (and ICSR submitted to the Division of Dockets 1061, Rockville, MD 20852.
attachments) to the Center for Drug Management, FDA will post your Submit written requests for single
Evaluation and Research (CDER) and the comment, as well as any attachments, copies of this guidance to the Division
Center for Biologics Evaluation and except for information submitted, of Drug Information, Center for Drug
Research (CBER). This document, marked and identified, as confidential, Evaluation and Research, Food and
entitled ‘‘FDA Regional Implementation if submitted as detailed in Drug Administration, 10001 New
Specifications for ICH E2B(R3) ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
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![Federal Register / Vol. 81, No. 121 / Thursday, June 23, 2016 / Notices 40891
4th Floor, Silver Spring, MD 20993– document describes FDA’s technical DATES: Comments must be submitted to
0002; or the Office of Communication, approach for submitting ICSRs, for the online docket via http://
Outreach and Development, Center for incorporating its regionally controlled www.regulations.gov, or reach the
Biologics Evaluation and Research, terminology, and for adding its regional Docket Management Facility, on or
Food and Drug Administration, 10903 data elements that are not addressed in before July 25, 2016.
New Hampshire Avenue, Bldg. 71, Rm. the ICH E2B (R3) guidance for the ADDRESSES: You may submit comments
3128, Silver Spring, MD 20993–0002. following FDA-regulated products: Drug identified by docket number USCG–
Send one self-addressed adhesive label products marketed for human use with 2016–0374 using the Federal
to assist that office in processing your approved new drug applications and eRulemaking Portal at http://
requests. See the SUPPLEMENTARY abbreviated new drug applications; www.regulations.gov. See the ‘‘Public
INFORMATION section for electronic prescription drug products marketed for Participation and Request for
access to the guidance document. human use without an approved Comments’’ portion of the
FOR FURTHER INFORMATION CONTACT: application; nonprescription (over-the- SUPPLEMENTARY INFORMATION section for
Suranjan De, Office of Surveillance and counter) human drug products marketed further instructions on submitting
Epidemiology, Center for Drug without an approved application; and comments.
Evaluation and Research, Food and biological products marketed for human
FOR FURTHER INFORMATION CONTACT: For
Drug Administration, 10903 New use with approved biologic license
further information about this notice,
Hampshire Ave., Bldg. 22, Rm. 4307, applications.
call or email Chief Petty Officer Jamie L.
Silver Spring, MD 20993, 240–402– II. Electronic Access Merriman, U.S. Coast Guard; telephone
0498, or FAERSESUB@fda.hhs.gov; or 409–719–5033, email
Stephen Ripley, Center for Biologics Persons with access to the Internet
may obtain a copy of the FDA Regional jamie.l.merriman@uscg.mil.
Evaluation and Research, Food and
Implementation Specifications for ICH SUPPLEMENTARY INFORMATION:
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, E2B(R3) at http://www.fda.gov/drugs/ Public Participation and Comments
Silver Spring, MD 20993–0002, 240– guidancecomplianceregulatory
information/surveillance/adversedruge We encourage you to submit
402–7911. comments or related material in
ffects/ucm115894.htm, http://
SUPPLEMENTARY INFORMATION: response to this notice. We will
www.fda.gov/BiologicsBloodVaccines/
I. Background GuidanceComplianceRegulatory consider all submissions and may adjust
Information/Guidances/default.htm, or our final action based on your
On February 21, 2014, FDA issued a comments. If you submit a comment,
Federal Register notice (79 FR 9908) http://www.regulations.gov.
please include the docket number for
announcing the availability of a final Dated: June 17, 2016. this notice, indicate the specific section
guidance for industry entitled ‘‘E2B (R3) Leslie Kux, of this document to which each
Electronic Transmission of Individual Associate Commissioner for Policy. comment applies, and provide a reason
Case Safety Reports (ICSRs) [FR Doc. 2016–14845 Filed 6–22–16; 8:45 am] for each suggestion or recommendation.
Implementation Guide—Data Elements BILLING CODE 4164–01–P We encourage you to submit
and Message Specification’’ (ICH comments through the Federal
E2B(R3) guidance) and an appendix to eRulemaking Portal at http://
the guidance entitled ‘‘ICSRs: Appendix www.regulations.gov. If your material
DEPARTMENT OF HOMELAND
to the Implementation Guide— cannot be submitted using http://
SECURITY
Backwards and Forward Compatibility’’ www.regulations.gov, contact the person
(BFC appendix). The ICH E2B(R3) Coast Guard in the FOR FURTHER INFORMATION
guidance and BFC appendix were CONTACT section of this document for
issued as a package that included [Docket No. USCG–2016–0374]
alternate instructions. Documents
schema files and additional technical mentioned in this notice, and all public
Waterway Suitability Assessment for
information to be used for creating comments, are in our online docket at
Construction and Operation of
compatible ICSR files. The preface to http://www.regulations.gov and can be
Liquefied Gas Terminals; Sabine-
the ICH E2B(R3) implementation viewed by following that Web site’s
Neches Waterway, Vidor, TX
guidance makes clear that any future instructions. Additionally, if you go to
‘‘technical specifications document Coast Guard, DHS.
AGENCY: the online docket and sign up for email
associated with that guidance would be Notice and request for
ACTION: alerts, you will be notified when
provided as a stand-alone document’’ comments. comments are posted or a final rule is
but incorporated by reference into that published.
guidance. Accordingly, in this notice, SUMMARY: Jefferson Railport Terminal 1 We accept anonymous comments. All
we are announcing the availability of a (Texas) LLC, has submitted a Letter of comments received will be posted
technical specifications document that Intent and Preliminary Waterway without change to http://
will be incorporated into that final Suitability Assessment to the Coast www.regulations.gov and will include
guidance. Guard Captain of the Port (COTP), Port any personal information you have
This technical specifications Arthur, TX regarding the company’s provided. For more about privacy and
document, which is available on the plans to construct, own and operate a
asabaliauskas on DSK3SPTVN1PROD with NOTICES
the docket, you may review a Privacy
FDA Guidance Web page at http:// waterfront facility handling and storing Act notice regarding the Federal Docket
www.fda.gov/Drugs/Guidance Liquefied Hazardous Gas (LHG) at its Management System in the March 24,
ComplianceRegulatoryInformation/ Vidor, TX facility located on the Sabine- 2005, issue of the Federal Register (70
Guidances/ucm274966.htm, is to assist Neches Waterway. The Coast Guard is FR 15086).
interested parties in electronically notifying the public of this action to
submitting individual case safety solicit public comments on the Discussion, Basis, and Purpose
reports (ICSRs) (and any ICSR proposed increase in LHG marine traffic Under 33 CFR 127.007(a), an owner or
attachments) to CDER and CBER. This on the Sabine-Neches Waterway. operator planning to build a new facility
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Document Created: 2018-02-08 07:41:32
Document Modified: 2018-02-08 07:41:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the Regional Implementation Specifications document at any time. | |
| Contact | Suranjan De, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4307, Silver Spring, MD 20993, 240-402-0498, or [email protected]; 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. | |
| FR Citation | 81 FR 40890 |
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