80_FR_50172 80 FR 50013 - Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines; Guidance for Industry; Availability

80 FR 50013 - Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 159 (August 18, 2015)

Page Range50013-50014
FR Document2015-20312

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Providing Submissions in Electronic Format--Postmarketing Safety Reports for Vaccines; Guidance for Industry.'' The guidance document provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national vaccine safety surveillance program that is co-sponsored by the Centers for Disease Control and Prevention (CDC) and FDA. FDA published in the Federal Register a final rule requiring that certain postmarketing safety reports for human drug and biological products, including vaccines, be submitted to FDA in an electronic format that the Agency can process, review, and archive. The guidance is intended to help applicants required to submit postmarketing safety reports involving vaccine products to comply with the final rule. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2014, and supersedes the document entitled ``Guidance for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS-1)'' dated September 1998.

Federal Register, Volume 80 Issue 159 (Tuesday, August 18, 2015) 
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50013-50014]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0903]


Providing Submissions in Electronic Format--Postmarketing Safety 
Reports for Vaccines; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a document entitled ``Providing Submissions in 
Electronic Format--Postmarketing Safety Reports for Vaccines; Guidance 
for Industry.'' The guidance document provides information and 
recommendations pertaining to the electronic submission of 
postmarketing safety reports involving vaccine products marketed for 
human use with approved biologics license applications (BLAs), 
including individual case safety reports (ICSRs) and attachments to 
ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting 
System (VAERS). VAERS is a national vaccine safety surveillance program 
that is co-sponsored by the Centers for Disease Control and Prevention 
(CDC) and FDA. FDA published in the Federal Register a final rule 
requiring that certain postmarketing safety reports for human drug and 
biological products, including vaccines, be submitted to FDA in an 
electronic format that the Agency can process, review, and archive. The 
guidance is intended to help applicants required to submit 
postmarketing safety reports involving vaccine products to comply with 
the final rule. The guidance announced in this notice finalizes the 
draft guidance of the same title, dated July 2014, and supersedes the 
document entitled ``Guidance for Industry: How to Complete the Vaccine 
Adverse Event Report System Form (VAERS-1)'' dated September 1998.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

[[Page 50014]]


ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), 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 the office in 
processing your requests. The guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., 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 document entitled 
``Providing Submissions in Electronic Format--Postmarketing Safety 
Reports for Vaccines; Guidance for Industry.'' The guidance document 
provides information and recommendations pertaining to the electronic 
submission of postmarketing safety reports involving vaccine products 
marketed for human use with approved BLAs, including ICSRs and ICSR 
attachments, into VAERS. VAERS is a national vaccine safety 
surveillance program established in response to the National Childhood 
Vaccine Injury Act of 1986, which requires health professionals and 
vaccine manufacturers to report specific adverse events that occur 
after the administration of routinely recommended vaccines. VAERS is 
co-sponsored by CDC and FDA. The guidance is applicable to vaccine 
products marketed for human use with approved BLAs for which CBER has 
regulatory responsibility. The guidance does not apply to any other 
biological product. Postmarketing ICSRs and ICSR attachments for 
biological products, which are not addressed by the guidance, are 
processed into the FDA Adverse Event Reporting System database.
    In the Federal Register of June 10, 2014 (79 FR 33072), FDA 
published a final rule requiring that certain postmarketing safety 
reports for human drug and biological products, including vaccines, be 
submitted to FDA in an electronic format that the Agency can process, 
review, and archive. The guidance is intended to help those applicants 
required to submit postmarketing safety reports involving vaccine 
products to comply with the final rule.
    In the Federal Register of July 18, 2014 (79 FR 42022), FDA 
announced the availability of the draft guidance of the same title 
dated July 2014. FDA received a few comments on the draft guidance and 
those comments were considered as the guidance was finalized. The 
guidance includes changes to clarify the reporting requirements and 
technical process for submitting reports to VAERS. In addition, 
editorial changes were made to improve clarity. The guidance announced 
in this notice finalizes the draft guidance dated July 2014 and 
supersedes the document entitled ``Guidance for Industry: How to 
Complete the Vaccine Adverse Event Report System Form (VAERS-1)'' dated 
September 1998.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Providing Submissions in Electronic Format--
Postmarketing Safety Reports for Vaccines. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This 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 
collections of information in 21 CFR part 310 and part 314 have been 
approved under OMB control number 0910-0230. The collections of 
information in 21 CFR 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), and 
600.80(h)(2) (Form FDA 3500A), have been approved under OMB control 
number 0910-0770. The collection of information in 21 CFR part 600 is 
approved under OMB control number 0910-0308. The collection of 
information in Form FDA 3500A is approved under OMB control number 
0910-0291.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20312 Filed 8-17-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50013 • H.6: Manufacturer Evaluation type (including in vitro diagnostic been approved under OMB control Conclusion Codes: 12 (Design devices), and expected number of number 0910–0291. deficiency) malfunction events. FDA may contact Dated: August 12, 2015. • H.10: To correct the condition, the the manufacturer to request Leslie Kux, beds were taken out of service. supplemental information if this Associate Commissioner for Policy. Technicians have examined the beds information is needed in order to [FR Doc. 2015–20309 Filed 8–17–15; 8:45 am] and have opened up a Corrective and complete our review of the request. The Preventive Action (CAPA) to address manufacturer must provide the BILLING CODE 4164–01–P the design issue. supplemental information within 15 days of FDA’s request; otherwise, the D. Appropriate Candidates DEPARTMENT OF HEALTH AND Agency will consider the nomination Appropriate candidates for the pilot HUMAN SERVICES withdrawn. program are manufacturers who: Food and Drug Administration 1. Are currently submitting reports to F. Manufacturer Notification FDA using the paper Form FDA 3500A FDA intends to notify manufacturers or the electronic MDR (eMDR) format. [Docket No. FDA–2014–D–0903] who are selected for this pilot program 2. Manufacture class I devices and/or within 45 days from receiving their Providing Submissions in Electronic those class II devices that are not nomination or any supplemental Format—Postmarketing Safety Reports permanently implantable, life information requested by FDA. Once for Vaccines; Guidance for Industry; supporting, or life sustaining. FDA has selected the candidates for this Availability 3. Currently use or are willing to use pilot, FDA will notify subsequent eMDR to submit summary malfunction applicants by email that the nomination AGENCY: Food and Drug Administration, reports to the FDA during the pilot period has closed. HHS. period. ACTION: Notice. 4. Are in compliance with the G. FDA Review Medical Device Reporting regulation in All reports received under the pilot SUMMARY: The Food and Drug 21 CFR part 803. program will be reviewed and processed Administration (FDA or Agency) is E. Procedures in the same manner as individual announcing the availability of a medical device reports that are document entitled ‘‘Providing 1. Nomination submitted under part 803. A version of Submissions in Electronic Format— A manufacturer of class I devices and the report releasable under FOIA will be Postmarketing Safety Reports for those class II devices that are not accessible through the public MAUDE Vaccines; Guidance for Industry.’’ The permanently implantable, life database. guidance document provides supporting, or life sustaining may information and recommendations H. Duration of the Pilot pertaining to the electronic submission nominate themselves for participation in the pilot program by submitting a FDA intends for the pilot program to of postmarketing safety reports nomination to 227pilot@fda.hhs.gov. run for 2 calendar quarters for each involving vaccine products marketed for FDA intends to acknowledge receipt of candidate and will continue until the 2 human use with approved biologics nominations via return email. The calendar quarters have been completed license applications (BLAs), including following information will assist FDA in for all candidates. At its discretion, FDA individual case safety reports (ICSRs) processing and responding to may terminate the pilot program before and attachments to ICSRs (ICSR nominations: the close of this period, or FDA may attachments), into the Vaccine Adverse • Name of manufacturer extend the pilot program beyond the 2 Event Reporting System (VAERS). • Registration number calendar quarters. The decision to VAERS is a national vaccine safety • Contact name, address, phone terminate or extend the pilot will be surveillance program that is co- number, and email address announced in the Federal Register. sponsored by the Centers for Disease • Model or catalog number for the Control and Prevention (CDC) and FDA. I. Evaluation FDA published in the Federal Register device(s) that you are requesting to include in the pilot, and FDA intends to evaluate all a final rule requiring that certain • Product classification code for the information and feedback received from postmarketing safety reports for human device(s) that you are requesting to the candidates and to use the drug and biological products, including include in the pilot. You may access the information and experiences gained vaccines, be submitted to FDA in an Product Classification Code database at from the pilot program to develop electronic format that the Agency can http://www.accessdata.fda.gov/scripts/ criteria for summary reporting on a process, review, and archive. The cdrh/cfdocs/cfPCD/classification.cfm. quarterly basis for devices subject to guidance is intended to help applicants section 519(a)(1)(B)(ii) of the FD&C Act. required to submit postmarketing safety 2. FDA Consideration reports involving vaccine products to III. Paper Reduction Act of 1995 comply with the final rule. The Acceptance of nominations will start 2 weeks following the publication date This notice refers to previously guidance announced in this notice of this Federal Register notice. Because approved collections of information that finalizes the draft guidance of the same asabaliauskas on DSK5VPTVN1PROD with NOTICES only a limited number of candidates are are subject to review by the Office of title, dated July 2014, and supersedes needed, FDA will use its discretion in Management and Budget (OMB) under the document entitled ‘‘Guidance for choosing candidates based on the the Paperwork Reduction Act of 1995 Industry: How to Complete the Vaccine eligibility criteria in this Federal (44 U.S.C. 3501–3520). The collections Adverse Event Report System Form Register notice in section II.D. of information in 21 CFR part 803 have (VAERS–1)’’ dated September 1998. Appropriate Candidates, the needs of been approved under OMB control DATES: Submit either electronic or the pilot to include a diversity of number 0910–0437; the collections of written comments on Agency guidances manufacturers with regard to device information in Form FDA 3500A have at any time. VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\18AUN1.SGM 18AUN1

50014 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices ADDRESSES: Submit written requests for final rule requiring that certain III. Comments single copies of the guidance to the postmarketing safety reports for human Interested persons may submit either Office of Communication, Outreach and drug and biological products, including electronic comments regarding this Development, Center for Biologics vaccines, be submitted to FDA in an document to http://www.regulations.gov Evaluation and Research (CBER), Food electronic format that the Agency can or written comments to the Division of and Drug Administration, 10903 New process, review, and archive. The Dockets Management (see ADDRESSES). It Hampshire Ave., Bldg. 71, Rm. 3128, guidance is intended to help those is only necessary to send one set of Silver Spring, MD 20993–0002. Send applicants required to submit comments. Identify comments with the one self-addressed adhesive label to postmarketing safety reports involving docket number found in brackets in the assist the office in processing your vaccine products to comply with the heading of this document. Received requests. The guidance may also be final rule. comments may be seen in the Division obtained by mail by calling CBER at In the Federal Register of July 18, of Dockets Management between 9 a.m. 1–800–835–4709 or 240–402–8010. See 2014 (79 FR 42022), FDA announced the and 4 p.m., Monday through Friday, and the SUPPLEMENTARY INFORMATION section availability of the draft guidance of the will be posted to the docket at http:// for electronic access to the guidance same title dated July 2014. FDA www.regulations.gov. document. received a few comments on the draft Submit electronic comments on the guidance and those comments were IV. Electronic Access guidance to http://www.regulations.gov. considered as the guidance was Persons with access to the Internet Submit written comments to the finalized. The guidance includes may obtain the guidance at either http:// Division of Dockets Management (HFA– changes to clarify the reporting www.fda.gov/BiologicsBloodVaccines/ 305), Food and Drug Administration, requirements and technical process for GuidanceComplianceRegulatory 5630 Fishers Lane, Rm. 1061, Rockville, submitting reports to VAERS. In Information/Guidances/default.htm or MD 20852. addition, editorial changes were made http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Paul to improve clarity. The guidance Dated: August 12, 2015. E. Levine, Jr., Center for Biologics announced in this notice finalizes the Leslie Kux, Evaluation and Research, Food and draft guidance dated July 2014 and Associate Commissioner for Policy. Drug Administration, 10903 New supersedes the document entitled ‘‘Guidance for Industry: How to [FR Doc. 2015–20312 Filed 8–17–15; 8:45 am] Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– Complete the Vaccine Adverse Event BILLING CODE 4164–01–P 402–7911. Report System Form (VAERS–1)’’ dated SUPPLEMENTARY INFORMATION: September 1998. DEPARTMENT OF HEALTH AND This guidance is being issued I. Background HUMAN SERVICES consistent with FDA’s good guidance FDA is announcing the availability of practices regulation (21 CFR 10.115). Food and Drug Administration a document entitled ‘‘Providing The guidance represents the current Submissions in Electronic Format— thinking of FDA on Providing [Docket No. FDA–2015–N–2853] Postmarketing Safety Reports for Submissions in Electronic Format— Electronic Study Data Submission; Vaccines; Guidance for Industry.’’ The Postmarketing Safety Reports for Data Standards; Support for Study guidance document provides Vaccines. It does not establish any rights Data Tabulation Model Implementation information and recommendations for any person and is not binding on Guide Version 3.2 pertaining to the electronic submission FDA or the public. You can use an of postmarketing safety reports alternative approach if it satisfies the AGENCY: Food and Drug Administration, involving vaccine products marketed for requirements of the applicable statutes HHS. human use with approved BLAs, and regulations. ACTION: Notice. including ICSRs and ICSR attachments, II. Paperwork Reduction Act of 1995 SUMMARY: The Center for Biologics into VAERS. VAERS is a national vaccine safety surveillance program This guidance refers to previously Evaluation and Research (CBER) and the established in response to the National approved collections of information Center for Drug Evaluation and Research Childhood Vaccine Injury Act of 1986, found in FDA regulations. These (CDER) are announcing support for the which requires health professionals and collections of information are subject to 3.2 version (see section II. Exceptions) vaccine manufacturers to report specific review by the Office of Management and of Clinical Data Interchange Standards adverse events that occur after the Budget (OMB) under the Paperwork Consortium (CDISC) Study Data administration of routinely Reduction Act of 1995 (44 U.S.C. 3501– Tabulation Model Implementation recommended vaccines. VAERS is co- 3520). The collections of information in Guide (SDTM IG 3.2), an update to the sponsored by CDC and FDA. The 21 CFR part 310 and part 314 have been FDA Data Standards Catalog (Catalog), guidance is applicable to vaccine approved under OMB control number and availability of validation rules for products marketed for human use with 0910–0230. The collections of the 3.2 version. SDTM IG 3.2 has been approved BLAs for which CBER has information in 21 CFR 310.305(e)(2), available from CDISC since December regulatory responsibility. The guidance 314.80(g)(2), 329.100(c)(2), and 2013. FDA is encouraging sponsors and does not apply to any other biological 600.80(h)(2) (Form FDA 3500A), have applicants to use SDTM IG 3.2 (see asabaliauskas on DSK5VPTVN1PROD with NOTICES product. Postmarketing ICSRs and ICSR been approved under OMB control section II. Exceptions) in investigational attachments for biological products, number 0910–0770. The collection of study data provided in regulatory which are not addressed by the information in 21 CFR part 600 is submissions to CBER and to CDER. guidance, are processed into the FDA approved under OMB control number FOR FURTHER INFORMATION CONTACT: Ron Adverse Event Reporting System 0910–0308. The collection of Fitzmartin, Center for Drug Evaluation database. information in Form FDA 3500A is and Research, Food and Drug In the Federal Register of June 10, approved under OMB control number Administration, 10903 New Hampshire 2014 (79 FR 33072), FDA published a 0910–0291. Ave., Bldg. 51, Rm. 1192, Silver Spring, VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\18AUN1.SGM 18AUN1


Document Created: 2015-12-15 12:04:28
Document Modified: 2015-12-15 12:04:28
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on Agency guidances at any time.
ContactPaul E. Levine, Jr., 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 Citation80 FR 50013 
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