Statement of Organization, Functions, and Delegations of Authority, 3005-3006 [2017-00312]
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Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
of the FD&C Act (21 U.S.C. 353(e)) to
require, under section 503(e)(2)(A) of
the FD&C Act (as amended), annual
reporting by wholesale distributors,
beginning on January 1, 2015. Section
503(e)(2)(B) of the FD&C Act (as
amended) requires FDA to make certain
information about wholesale
distributors’ licensure available to the
public on FDA’s Web site. Section 205
of the DSCSA added section 584 to the
FD&C Act (21 U.S.C. 360eee–3); under
section 584 of the FD&C Act (as
amended), 3PL facilities are required to
report annually, beginning on November
27, 2014.
FDA previously published the draft
guidance ‘‘DSCSA Implementation:
Annual Reporting by Prescription Drug
Wholesale Distributors and Third-Party
Logistics Providers’’ (Annual Reporting
draft guidance), which described who
must report, what should be reported,
when to report, and how to report
(December 9, 2014, 79 FR 73083). The
Annual Reporting draft guidance is
available on the Wholesale Distributor
and Third-Party logistics Providers
Reporting Web page at https://
www.fda.gov/Drugs/DrugSafety/Drug
IntegrityandSupplyChainSecurity/Drug
SupplyChainSecurityAct/
ucm423749.htm. This draft guidance
supplements the information in the
Annual Reporting draft guidance by
addressing questions and comments that
FDA received about annual reporting
since publication of the Annual
Reporting draft guidance. Topics
covered in this guidance include
clarifications about who must report,
what should be reported, when to
report, and how to report. This guidance
also addresses questions related to the
public availability of reported
information.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
FDA intends to finalize this draft
guidance and the Annual Reporting
draft guidance in one unified final
guidance on annual reporting
requirements under the DSCSA. Once
issued that unified final guidance will
represent the current thinking of FDA
regarding annual reporting by
prescription drug wholesale distributors
and third-party logistics providers. It
will not establish any rights for any
person and will not be binding on FDA
or the public. You will be able to use an
alternative approach to that described in
the final guidance if it satisfies the
requirements of the applicable statutes
and regulations.
VerDate Sep<11>2014
14:59 Jan 09, 2017
Jkt 241001
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501–3520) (PRA),
Federal Agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
This draft guidance addresses
proposed information collections that
are subject to review by OMB under the
PRA. These information collections
were also addressed in the draft
guidance entitled ‘‘Drug Supply Chain
Security Act Implementation: Annual
Reporting by Prescription Drug
Wholesale Distributors and Third-Party
Logistics Providers,’’ the availability of
which was announced in a notice
published in the Federal Register of
December 9, 2014. In that Federal
Register notice, FDA published a 60-day
notice requesting public comment on
the proposed collections of information
(79 FR 73083). This draft guidance
provides further clarification regarding
those information collections.
In compliance with the PRA, FDA
intends to submit these proposed
collections of information to OMB for
review and approval, including
providing notice of that submission and
opportunity for the public to comment
to OMB on the proposed information
collections. In accordance with the PRA,
the agency will inform the public of
OMB approval, including the associated
currently valid OMB control number,
before conducting or sponsoring a
collection of information.
Dated: January 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00233 Filed 1–9–17; 8:45 am]
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3005
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Statement of Organization, Functions,
and Delegations of Authority
Part A, Office of the Secretary,
Statement of Organization, Function
and Delegations of Authority for the
Department of Health and Human
Services (HHS) is being amended at
Chapter AC, ‘‘Office of the Assistant
Secretary for Health (OASH), as last
amended at 75 FR 53304–53305, dated
August 31, 2010. This amendment
reflects the realignment of personnel
oversight, administration and
management functions for the Office of
Adolescent Health in the OASH.
Specifically, this notice establishes the
Division of Research and Evaluation, the
Division of Strategic Communications,
and the Division of Program Operations
within the Office of Adolescent Health.
The changes are as follows:
I. Under Part A, Chapter AC, under
Office of the Assistant Secretary for
Health, make the following changes:
A. Under Section ACR.20,
Organization, ‘‘M. Office of Adolescent
Health (ACR)’’ replace the entire section
with:
The Office of Adolescent Health is
headed by a Director who reports to the
Assistant Secretary for Health.
B. Under Section ACR. 20, Functions,
‘‘M. Office of Adolescent Health (ACR)’’
replace the entire section with:
1. Office of Adolescent Health (ACR).
The Office of Adolescent Health (OAH),
headed by the Director of the Office of
Adolescent Health, is responsible for
implementing the provisions assigned to
it under Section 1708 of the Public
Health Service Act (42 U.S.C. 300u–7).
The Office, by providing Departmentwide leadership working with PHS
agencies and other HHS Operating
Divisions and Staff Divisions and the
private sector, establishes, coordinates
and advocates policies, programs and
activities for the improvement of
adolescent health. OAH supports grant
programs, evaluation and research
studies, services, prevention and health
promotion activities, training,
education, partnership engagement, and
information dissemination activities.
The Office: (1) Oversees operations and
administrative management, personnel
management, and budget formulation
and execution for programs managed
within OAH; (2) coordinates legislative
and policy activities related to
adolescent health and OAH programs;
(3) coordinates correspondence control
and executive secretariat functions; (4)
serves as a focal point within HHS to
coordinate the continuing
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pmangrum on DSK3GDR082PROD with NOTICES
3006
Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
implementation of health objectives for
adolescents, assures liaison occurs with
relevant HHS agencies and offices, and
facilitates access to services for
adolescents; (5) negotiates and awards
grants and enters into cooperative
agreements and contracts with public
and nonprofit entities; (6) enters into
interagency agreements with other PHS/
Federal organizations in support of
adolescent health; (7) ensures the
appropriate exercise of delegated
authorities and responsibilities; (8)
develops a broad range of health
information and health promotion
materials; (9) supports the planning and
conduct of research and evaluation
studies; (10) designs, manages and
monitors evaluation studies, and
information collection review and
approval processes; (11) assesses the
focus and impact of ongoing programs
and activities, and prepares evaluation
studies and reports; (12) disseminates
information about program activities
and research evaluation studies,
including in peer reviewed
publications; (13) oversees the
implementation and administration of
competitive grants and cooperative
agreements, monitors grantee activities,
and prepares analytical reports on
program trends; (14) provides training
and technical assistance for grant
programs and professionals working
with adolescents, manages capacity
building needs for grant programs, and
assesses performance of grantee
operations; (15) supports the replication
and use of evidence-based approaches
and fosters innovative strategies in
programs serving adolescents; (16)
manages the development of grant
funding announcements and contract
scopes of work and the review and
award of program grants; (17) manages
information, education and awareness
activities, and media and press
relations; (18) develops and coordinates
strategic plans and special initiatives;
(19) oversees public health information
and promotes OAH programs and
partnerships; (20) manages exhibits and
develops visual and other graphic and
social media materials regarding
adolescent health, and ensures
compliance with 508 requirements; (21)
manages adolescent health information,
including the OAH Web site and social
media, consistent with the policies of
the HHS Assistant Secretary for Public
Affairs; (22) coordinates, develops,
researches, and prepares briefing
materials on issues of adolescent health.
II. Delegations of Authority. Directives
or orders made by the Secretary,
Assistant Secretary for Health, or
Director, Office of Adolescent Health,
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all delegations and re-delegations of
authority made to officials and
employees of affected organizational
components will continue in them or
their successors pending further redelegation, provided they are consistent
with this reorganization.
III. Funds, Personnel, and Equipment.
Transfer of organizations and functions
affected by this reorganization shall be
accompanied by direct and support
funds, positions, personnel, records,
equipment, supplies, and other
resources.
Dated: January 5, 2017.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2017–00312 Filed 1–9–17; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information From
Organizations Utilizing Business
Models Supporting Private Sector
Vaccine Management
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
This is a Request for
Information (RFI) about business
models, existing, under development or
planned, that support health care
providers for any of the components
related to private-sector immunization
services (e.g., excluding vaccines
provided through federal and state
programs, such as the Vaccines for
Children Program, Children’s Health
Insurance Program, Medicaid, and
Medicare): Vaccine purchase,
distribution, storage and handling,
inventory management, reporting to
Immunization Information Systems
(IIS), including models for populating
IIS directly/automatically from
electronic health records (EHRs),
immunization coverage assessment,
forecasting vaccine demand, and billing.
The RFI is being issued by the National
Vaccine Program Office (NVPO) of the
U.S. Department of Health and Human
Services.
The NVPO is located in the Office of
the Assistant Secretary for Health
(ASH), Office of the Secretary (OS), U.S.
Department of Health and Human
Services (HHS). The NVPO is
responsible for coordinating and
ensuring collaboration among the many
federal agencies involved in vaccine and
immunization activities.
SUMMARY:
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The National Vaccine Program was
established in compliance with Title
XXI of the Public Health Service Act
(Pub. L. 99–660) (§ 2101) (42 U.S. Code
300aa–et seq (PDF—78 KB)) to achieve
optimal prevention of human infectious
diseases through immunization and to
achieve optimal prevention against
adverse reactions to vaccines.
Development of a National Vaccine Plan
(NVP) has been mandated to the NVPO
as a mechanism for the Director of the
National Vaccine Program (the Assistant
Secretary for Health) to communicate
priorities for both federal and nonfederal stakeholders regarding vaccine
research and the development, testing,
licensing, production, procurement,
distribution, and effective use of
vaccines in order to carry out the
program’s responsibilities. Goal 4 of the
plan, Ensure a Stable Supply of, Access
to, and Better Use of Recommended
Vaccines in the United States, focuses in
part on increasing and improving access
to vaccines in health care provider
settings. This RFI seeks information on
innovative business models to support
health care providers to increase and
improve their ability to provide
immunization services, as described
below.
In its efforts to promote vaccination
coverage across the lifespan, the NVPO
is seeking information about business
models, existing, under development or
planned, that enable health care
providers to offer vaccines to their
privately-insured/private-pay patients.
The NVPO is most interested in
innovative business models aimed at
reducing any of the barriers to
implementing vaccination services such
as vaccine purchase, billing, storage and
handling, IIS reporting, including
models for populating IIS directly/
automatically from EHRs, forecasting
vaccine demand, and managing private
vaccine inventories. In addition, the
NVPO is interested in models that can
demonstrate improvements in the
immunization coverage rates of the
patients seen in the health care settings
utilizing such models as well as
improvements in reporting to IIS.
DATES: Information from Organizations
Utilizing Business Models Supporting
Private Sector Vaccine Management
responsive to this RFI should be
submitted as described in the
ADDRESSES section below no later than
midnight, 12:00 a.m. EDT on January 25,
2017.
ADDRESSES: Information from
Organizations Utilizing Business
Models Supporting Private Sector
Vaccine Management responsive to this
RFI should be submitted in Portable
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]]>Agencies
[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Notices]
[Pages 3005-3006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00312]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Statement of Organization, Functions, and Delegations of
Authority
Part A, Office of the Secretary, Statement of Organization,
Function and Delegations of Authority for the Department of Health and
Human Services (HHS) is being amended at Chapter AC, ``Office of the
Assistant Secretary for Health (OASH), as last amended at 75 FR 53304-
53305, dated August 31, 2010. This amendment reflects the realignment
of personnel oversight, administration and management functions for the
Office of Adolescent Health in the OASH. Specifically, this notice
establishes the Division of Research and Evaluation, the Division of
Strategic Communications, and the Division of Program Operations within
the Office of Adolescent Health. The changes are as follows:
I. Under Part A, Chapter AC, under Office of the Assistant
Secretary for Health, make the following changes:
A. Under Section ACR.20, Organization, ``M. Office of Adolescent
Health (ACR)'' replace the entire section with:
The Office of Adolescent Health is headed by a Director who reports
to the Assistant Secretary for Health.
B. Under Section ACR. 20, Functions, ``M. Office of Adolescent
Health (ACR)'' replace the entire section with:
1. Office of Adolescent Health (ACR). The Office of Adolescent
Health (OAH), headed by the Director of the Office of Adolescent
Health, is responsible for implementing the provisions assigned to it
under Section 1708 of the Public Health Service Act (42 U.S.C. 300u-7).
The Office, by providing Department-wide leadership working with PHS
agencies and other HHS Operating Divisions and Staff Divisions and the
private sector, establishes, coordinates and advocates policies,
programs and activities for the improvement of adolescent health. OAH
supports grant programs, evaluation and research studies, services,
prevention and health promotion activities, training, education,
partnership engagement, and information dissemination activities. The
Office: (1) Oversees operations and administrative management,
personnel management, and budget formulation and execution for programs
managed within OAH; (2) coordinates legislative and policy activities
related to adolescent health and OAH programs; (3) coordinates
correspondence control and executive secretariat functions; (4) serves
as a focal point within HHS to coordinate the continuing
[[Page 3006]]
implementation of health objectives for adolescents, assures liaison
occurs with relevant HHS agencies and offices, and facilitates access
to services for adolescents; (5) negotiates and awards grants and
enters into cooperative agreements and contracts with public and
nonprofit entities; (6) enters into interagency agreements with other
PHS/Federal organizations in support of adolescent health; (7) ensures
the appropriate exercise of delegated authorities and responsibilities;
(8) develops a broad range of health information and health promotion
materials; (9) supports the planning and conduct of research and
evaluation studies; (10) designs, manages and monitors evaluation
studies, and information collection review and approval processes; (11)
assesses the focus and impact of ongoing programs and activities, and
prepares evaluation studies and reports; (12) disseminates information
about program activities and research evaluation studies, including in
peer reviewed publications; (13) oversees the implementation and
administration of competitive grants and cooperative agreements,
monitors grantee activities, and prepares analytical reports on program
trends; (14) provides training and technical assistance for grant
programs and professionals working with adolescents, manages capacity
building needs for grant programs, and assesses performance of grantee
operations; (15) supports the replication and use of evidence-based
approaches and fosters innovative strategies in programs serving
adolescents; (16) manages the development of grant funding
announcements and contract scopes of work and the review and award of
program grants; (17) manages information, education and awareness
activities, and media and press relations; (18) develops and
coordinates strategic plans and special initiatives; (19) oversees
public health information and promotes OAH programs and partnerships;
(20) manages exhibits and develops visual and other graphic and social
media materials regarding adolescent health, and ensures compliance
with 508 requirements; (21) manages adolescent health information,
including the OAH Web site and social media, consistent with the
policies of the HHS Assistant Secretary for Public Affairs; (22)
coordinates, develops, researches, and prepares briefing materials on
issues of adolescent health.
II. Delegations of Authority. Directives or orders made by the
Secretary, Assistant Secretary for Health, or Director, Office of
Adolescent Health, all delegations and re-delegations of authority made
to officials and employees of affected organizational components will
continue in them or their successors pending further re-delegation,
provided they are consistent with this reorganization.
III. Funds, Personnel, and Equipment. Transfer of organizations and
functions affected by this reorganization shall be accompanied by
direct and support funds, positions, personnel, records, equipment,
supplies, and other resources.
Dated: January 5, 2017.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2017-00312 Filed 1-9-17; 8:45 am]
BILLING CODE 4150-28-P
