Center for Biologics Evaluation and Research eSubmitter Program for Electronic Submission of Postmarketing Adverse Event Reports for Human Vaccine Products, 25679-25680 [2016-10025]
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Federal Register / Vol. 81, No. 83 / Friday, April 29, 2016 / Notices
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SUPPLEMENTARY INFORMATION: In the
Federal Register of March 9, 2016, (81
FR 12511), FDA published a notice of a
public workshop with a deadline of
April 20, 2016, to request comments on
the workshop topics concerning the use
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considerations for protein- and peptidebased LC/MS devices.
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for the notice of the public workshop
until June 2, 2016. The Agency believes
that the extension allows adequate time
for interested persons to submit
comments without significantly
VerDate Sep<11>2014
18:31 Apr 28, 2016
Jkt 238001
delaying decision making on these
important issues.
Dated: April 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–10106 Filed 4–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1160]
Center for Biologics Evaluation and
Research eSubmitter Program for
Electronic Submission of
Postmarketing Adverse Event Reports
for Human Vaccine Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency), Center
for Biologics Evaluation and Research
(CBER) is announcing the availability of
a Vaccine Adverse Event Reporting
System (VAERS) eSubmitter program for
the electronic submission of
postmarketing individual case safety
reports (ICSRs) and ICSR attachments of
adverse events for human vaccine
products (VAERS eSubmitter program).
The VAERS eSubmitter program is a
free software program for voluntary use
that is intended to help persons subject
to mandatory postmarketing
requirements for vaccines including
applicants, manufacturers, packagers,
and distributors to electronically submit
ICSRs and ICSR attachments as required
by the final rule titled ‘‘Postmarketing
Safety Reports for Human Drug and
Biological Products; Electronic
Submission Requirements.’’ The VAERS
eSubmitter program creates a simple
and efficient mechanism for the secure
electronic submission of postmarketing
ICSRs and ICSR attachments into the
VAERS database without the need for an
internal database that is compatible
with the International Conference on
Harmonisation (ICH)-based direct
database to database submission system.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Bioinformatics Support Staff, Office of
Review Management, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
CBERICSRSUBMISSIONS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
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25679
I. Background
FDA is announcing the availability of
the VAERS eSubmitter program for the
electronic submissions of postmarketing
ICSRs and ICSR attachments of adverse
events for human vaccine products. The
VAERS eSubmitter program is available
for voluntary use by applicants and
others required to report postmarketing
adverse events, as described above, to
submit an initial or follow-up ICSR
document for human vaccine products.
The eSubmitter application software,
which can be downloaded free of
charge, assists users in the preparation
of submissions that contain the
minimum elements necessary for FDA
to perform a comprehensive review.
The eSubmitter ICSR template for
vaccines is designed to ensure that those
submitting postmarketing ICSRs and
ICSR attachments include necessary
information in these regulatory
submissions. It is also designed to guide
users of the system as they complete the
ICSR file creation and submission
process. The VAERS eSubmitter
program will help to improve the
consistency, quality, and completeness
of ICSR submissions and make the
submission and review process more
user-friendly for those required to report
postmarketing adverse events for human
vaccine products.
FDA published in the Federal
Register of June 10, 2014 (79 FR 33072),
a final rule titled ‘‘Postmarketing Safety
Reports for Human Drug and Biological
Products; Electronic Submission
Requirements,’’ which requires, in part,
that applicants and other adverse event
reporters submit postmarketing ICSRs
and ICSR attachments to CBER in an
electronic format that the Agency can
process, review, and archive. The final
rule became effective June 10, 2015.
Postmarketing ICSRs and ICSR
attachments sent to CBER for human
vaccines are processed into the VAERS
database. As discussed in the preamble
to the final rule and in CBER’s final
guidance for industry ‘‘Providing
Submissions in Electronic Format—
Postmarketing Safety Reports for
Vaccines,’’ dated August 2015 (August
2015 Guidance), FDA is providing two
voluntary options for electronic
submission of ICSRs and ICSR
attachments into VAERS: (1) Direct
database to database submission
through the Electronic Submissions
Gateway (ESG), and (2) submission of
safety reports through the VAERS
eSubmitter program as described on the
CBER eSubmitter Web page (available
at: https://www.fda.gov/ForIndustry/
FDAeSubmitter/ucm191387.htm).
Applicants and others required to report
E:\FR\FM\29APN1.SGM
29APN1
25680
Federal Register / Vol. 81, No. 83 / Friday, April 29, 2016 / Notices
postmarketing adverse events can
choose either option to electronically
submit ICSRs and ICSR attachments to
VAERS.
The ICSR eSubmitter software is a
government-issued software provided in
support of the Government Paperwork
Elimination Act of 1998 (44 U.S.C.
3504). As users of the eSubmitter
software, applicants and others required
to report postmarketing adverse events
are not required to perform their own
file validation process. The purpose of
the ICSR eSubmitter template is to
facilitate the electronic submission of
postmarketing vaccine safety reports
using internationally adopted data
standards to enhance regulatory review,
exchange and dissemination of vaccine
safety information. Applicants and
others who choose to use the eSubmitter
program for required postmarketing
reporting of adverse events for human
vaccine products must first download
the eSubmitter software and then
manually enter information into the
ICSR template form to create each
electronic ICSR or ICSR attachment for
submission to FDA through the ESG for
uploading to the VAERS database.
Further information on submitting
ICSRs and ICSR attachments using
eSubmitter is included in the August
2015 Guidance (available at: https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
Vaccines/default.htm), and on the CBER
eSubmitter Web page referenced above.
Dated: April 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–10025 Filed 4–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 80 FR 19981–19982
dated April 6, 2016).
This notice reflects organizational
changes in the Health Resources and
18:31 Apr 28, 2016
Jkt 238001
Chapter RA2—Office of Civil Rights,
Diversity and Inclusion
Section RA2—00, Mission
The mission of the Office of Civil
Rights, Diversity and Inclusion is to
protect and serve the rights of all HRSA
employees, applicants and beneficiaries
of federal funds by enforcing federal
laws, policies and practices prohibiting
discrimination, resolves workplace
disputes and conflict at the earliest
possible stage, and helps to leverage
diversity throughout HRSA.
Section RAE–10, Organization
Delete the organization for the Office
of the Administrator (RA) in its entirety
and replace with the following:
Rename the Office of Equal
Opportunity, Civil Rights and Diversity
Management to the Office of Civil
Rights, Diversity and Inclusion within
the Office of the Administrator. The
Office of the Administrator is headed by
the Administrator, who reports directly
to the Secretary, Department of Health
and Human Services.
(1) Immediate Office of the
Administrator (RA);
(2) Office of Legislation (RAE);
(3) Office of Communications (RA6);
(4) Office of Health Equity (RAB);
(5) Office of Civil Rights, Diversity
and Inclusion (RA2);
(6) Office of Planning, Analysis and
Evaluation (RA5);
(7) Office of Women’s Health (RAW);
and
(8) Office of Global Health (RAI).
Section RA2–20, Functions
Statement of Organization, Functions
and Delegations of Authority
VerDate Sep<11>2014
Services Administration (HRSA), Office
of the Administrator (RA). Specifically,
this notice: (1) Renames the Office of
Equal Opportunity, Civil Rights and
Diversity Management (RA2) to the
Office of Civil Rights, Diversity and
Inclusion (RA2); and (2) updates the
functional statement for Office of Civil
Rights, Diversity and Inclusion (RA2).
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA), Office
of the Administrator (RA). Specifically,
this notice: (1) Updates the functional
statement.
Delete the function for the Office of
Equal Opportunity, Civil Rights and
Diversity Management and replace in its
entirety.
coordination and management of the
equal opportunity, civil rights, and
diversity and inclusion activities.
Specifically: (1) Provides advice,
counsel, and recommendations to HRSA
personnel, including regional offices, on
equal opportunity, civil rights, and
diversity and inclusion issues; (2)
analyzes Agency data to determine
underrepresentation and/or
underutilization of diverse groups in the
workforce; (3) identifies barriers and
devises strategies to eliminate those
barriers; (4) manages the equal
employment opportunity complaint
process for HRSA civilian employees;
(5) manages the equal employment
opportunity complaint process for
Public Health Service (PHS)
Commissioned Corps personnel under
the provisions of PHS Personnel
Instruction 6 and issues
recommendations to the Surgeon
General; (6) approves and executes
equal opportunity complaint settlement
agreements; (7) develops and directs
implementation of the requirements of
Section 504 of the Rehabilitation Act of
1973, Title VI of the Civil Rights Act of
1964, the Age Discrimination Act of
1975, the Americans With Disabilities
Act, The Genetic Information
Nondiscrimination Act of 2008, and
Section 1557 of the Affordable Care Act,
as they apply to HRSA and recipients of
HRSA funds; (8) provides
comprehensive EEO, Civil Rights and
Diversity and Inclusion training to
HRSA’s supervisors, managers and
employees to prevent discrimination
and harassment in the workplace; (9)
applies all applicable laws, guidelines,
rules and regulations; and (10) provides
leadership and guidance in HRSA’s
efforts to develop and maintain a
diverse and inclusive workforce.
Delegations of Authority
All delegations of authority and redelegations of authority made to HRSA
officials that were in effect immediately
prior to this reorganization, and that are
consistent with this reorganization,
shall continue in effect pending further
re-delegation.
This reorganization is effective upon
date of signature.
Dated: April 21, 2016.
Office of Civil Rights, Diversity and
Inclusion (RA2)
James Macrae,
Serves as the focal point for HRSA’s
formulation, implementation,
[FR Doc. 2016–10048 Filed 4–28–16; 8:45 am]
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Acting Administrator.
BILLING CODE 4165–15–P
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]]>Agencies
[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Pages 25679-25680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10025]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1160]
Center for Biologics Evaluation and Research eSubmitter Program
for Electronic Submission of Postmarketing Adverse Event Reports for
Human Vaccine Products
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 a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program
for the electronic submission of postmarketing individual case safety
reports (ICSRs) and ICSR attachments of adverse events for human
vaccine products (VAERS eSubmitter program). The VAERS eSubmitter
program is a free software program for voluntary use that is intended
to help persons subject to mandatory postmarketing requirements for
vaccines including applicants, manufacturers, packagers, and
distributors to electronically submit ICSRs and ICSR attachments as
required by the final rule titled ``Postmarketing Safety Reports for
Human Drug and Biological Products; Electronic Submission
Requirements.'' The VAERS eSubmitter program creates a simple and
efficient mechanism for the secure electronic submission of
postmarketing ICSRs and ICSR attachments into the VAERS database
without the need for an internal database that is compatible with the
International Conference on Harmonisation (ICH)-based direct database
to database submission system.
FOR FURTHER INFORMATION CONTACT: Bioinformatics Support Staff, Office
of Review Management, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, CBERICSRSUBMISSIONS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of the VAERS eSubmitter program
for the electronic submissions of postmarketing ICSRs and ICSR
attachments of adverse events for human vaccine products. The VAERS
eSubmitter program is available for voluntary use by applicants and
others required to report postmarketing adverse events, as described
above, to submit an initial or follow-up ICSR document for human
vaccine products. The eSubmitter application software, which can be
downloaded free of charge, assists users in the preparation of
submissions that contain the minimum elements necessary for FDA to
perform a comprehensive review.
The eSubmitter ICSR template for vaccines is designed to ensure
that those submitting postmarketing ICSRs and ICSR attachments include
necessary information in these regulatory submissions. It is also
designed to guide users of the system as they complete the ICSR file
creation and submission process. The VAERS eSubmitter program will help
to improve the consistency, quality, and completeness of ICSR
submissions and make the submission and review process more user-
friendly for those required to report postmarketing adverse events for
human vaccine products.
FDA published in the Federal Register of June 10, 2014 (79 FR
33072), a final rule titled ``Postmarketing Safety Reports for Human
Drug and Biological Products; Electronic Submission Requirements,''
which requires, in part, that applicants and other adverse event
reporters submit postmarketing ICSRs and ICSR attachments to CBER in an
electronic format that the Agency can process, review, and archive. The
final rule became effective June 10, 2015. Postmarketing ICSRs and ICSR
attachments sent to CBER for human vaccines are processed into the
VAERS database. As discussed in the preamble to the final rule and in
CBER's final guidance for industry ``Providing Submissions in
Electronic Format--Postmarketing Safety Reports for Vaccines,'' dated
August 2015 (August 2015 Guidance), FDA is providing two voluntary
options for electronic submission of ICSRs and ICSR attachments into
VAERS: (1) Direct database to database submission through the
Electronic Submissions Gateway (ESG), and (2) submission of safety
reports through the VAERS eSubmitter program as described on the CBER
eSubmitter Web page (available at: https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm191387.htm). Applicants and others required to report
[[Page 25680]]
postmarketing adverse events can choose either option to electronically
submit ICSRs and ICSR attachments to VAERS.
The ICSR eSubmitter software is a government-issued software
provided in support of the Government Paperwork Elimination Act of 1998
(44 U.S.C. 3504). As users of the eSubmitter software, applicants and
others required to report postmarketing adverse events are not required
to perform their own file validation process. The purpose of the ICSR
eSubmitter template is to facilitate the electronic submission of
postmarketing vaccine safety reports using internationally adopted data
standards to enhance regulatory review, exchange and dissemination of
vaccine safety information. Applicants and others who choose to use the
eSubmitter program for required postmarketing reporting of adverse
events for human vaccine products must first download the eSubmitter
software and then manually enter information into the ICSR template
form to create each electronic ICSR or ICSR attachment for submission
to FDA through the ESG for uploading to the VAERS database. Further
information on submitting ICSRs and ICSR attachments using eSubmitter
is included in the August 2015 Guidance (available at: https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/default.htm), and on the CBER eSubmitter Web page referenced above.
Dated: April 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10025 Filed 4-28-16; 8:45 am]
BILLING CODE 4164-01-P
