Statement of Organization, Functions and Delegations of Authority, 25680 [2016-10048]
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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]
PO 00000
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Acting Administrator.
BILLING CODE 4165–15–P
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[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Page 25680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10048]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Statement of Organization, Functions and Delegations of Authority
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 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).
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
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.
Office of Civil Rights, Diversity and Inclusion (RA2)
Serves as the focal point for HRSA's formulation, implementation,
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 re-delegations 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.
James Macrae,
Acting Administrator.
[FR Doc. 2016-10048 Filed 4-28-16; 8:45 am]
BILLING CODE 4165-15-P
