82 FR 3005 - Statement of Organization, Functions, and Delegations of Authority

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 6 (January 10, 2017)

Page Range		3005-3006
FR Document		2017-00312
Federal Register, Volume 82 Issue 6 (Tuesday, January 10, 2017)
[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Notices]
[Pages 3005-3006]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00312]


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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
Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices 3005

of the FD&C Act (21 U.S.C. 353(e)) to II. Electronic Access DEPARTMENT OF HEALTH AND
require, under section 503(e)(2)(A) of HUMAN SERVICES
the FD&C Act (as amended), annual Persons with access to the Internet
reporting by wholesale distributors, may obtain the draft guidance at either Statement of Organization, Functions,
beginning on January 1, 2015. Section http://www.fda.gov/Drugs/Guidance and Delegations of Authority
503(e)(2)(B) of the FD&C Act (as ComplianceRegulatoryInformation/
Guidances/default.htm, http:// Part A, Office of the Secretary,
amended) requires FDA to make certain Statement of Organization, Function
information about wholesale www.fda.gov/BiologicsBloodVaccines/
and Delegations of Authority for the
distributors’ licensure available to the GuidanceComplianceRegulatory
Department of Health and Human
public on FDA’s Web site. Section 205 Information/Guidances/default.htm, or
Services (HHS) is being amended at
of the DSCSA added section 584 to the https://www.regulations.gov. Chapter AC, ‘‘Office of the Assistant
FD&C Act (21 U.S.C. 360eee–3); under III. Paperwork Reduction Act of 1995 Secretary for Health (OASH), as last
section 584 of the FD&C Act (as amended at 75 FR 53304–53305, dated
amended), 3PL facilities are required to Under the Paperwork Reduction Act August 31, 2010. This amendment
report annually, beginning on November of 1995 (44 U.S.C. 3501–3520) (PRA), reflects the realignment of personnel
27, 2014. Federal Agencies must obtain approval oversight, administration and
FDA previously published the draft from the Office of Management and management functions for the Office of
guidance ‘‘DSCSA Implementation: Budget (OMB) for each collection of Adolescent Health in the OASH.
Annual Reporting by Prescription Drug information they conduct or sponsor. Specifically, this notice establishes the
Wholesale Distributors and Third-Party ‘‘Collection of information’’ is defined Division of Research and Evaluation, the
Logistics Providers’’ (Annual Reporting in 44 U.S.C. 3502(3) and 5 CFR Division of Strategic Communications,
1320.3(c) and includes Agency requests and the Division of Program Operations
draft guidance), which described who
or requirements that members of the within the Office of Adolescent Health.
must report, what should be reported,
public submit reports, keep records, or The changes are as follows:
when to report, and how to report I. Under Part A, Chapter AC, under
(December 9, 2014, 79 FR 73083). The provide information to a third party.
Office of the Assistant Secretary for
Annual Reporting draft guidance is This draft guidance addresses Health, make the following changes:
available on the Wholesale Distributor proposed information collections that A. Under Section ACR.20,
and Third-Party logistics Providers are subject to review by OMB under the Organization, ‘‘M. Office of Adolescent
Reporting Web page at http:// PRA. These information collections Health (ACR)’’ replace the entire section
www.fda.gov/Drugs/DrugSafety/Drug were also addressed in the draft with:
IntegrityandSupplyChainSecurity/Drug guidance entitled ‘‘Drug Supply Chain The Office of Adolescent Health is
SupplyChainSecurityAct/ Security Act Implementation: Annual headed by a Director who reports to the
ucm423749.htm. This draft guidance Reporting by Prescription Drug Assistant Secretary for Health.
supplements the information in the Wholesale Distributors and Third-Party B. Under Section ACR. 20, Functions,
Annual Reporting draft guidance by Logistics Providers,’’ the availability of ‘‘M. Office of Adolescent Health (ACR)’’
addressing questions and comments that which was announced in a notice replace the entire section with:
FDA received about annual reporting published in the Federal Register of 1. Office of Adolescent Health (ACR).
since publication of the Annual December 9, 2014. In that Federal The Office of Adolescent Health (OAH),
Reporting draft guidance. Topics Register notice, FDA published a 60-day headed by the Director of the Office of
covered in this guidance include Adolescent Health, is responsible for
notice requesting public comment on
clarifications about who must report, implementing the provisions assigned to
the proposed collections of information
what should be reported, when to it under Section 1708 of the Public
(79 FR 73083). This draft guidance
report, and how to report. This guidance Health Service Act (42 U.S.C. 300u–7).
provides further clarification regarding The Office, by providing Department-
also addresses questions related to the those information collections.
public availability of reported wide leadership working with PHS
information. In compliance with the PRA, FDA agencies and other HHS Operating
intends to submit these proposed Divisions and Staff Divisions and the
This draft guidance is being issued collections of information to OMB for private sector, establishes, coordinates
consistent with FDA’s good guidance review and approval, including and advocates policies, programs and
practices regulation (21 CFR 10.115). providing notice of that submission and activities for the improvement of
FDA intends to finalize this draft adolescent health. OAH supports grant
opportunity for the public to comment
guidance and the Annual Reporting programs, evaluation and research
to OMB on the proposed information
draft guidance in one unified final studies, services, prevention and health
collections. In accordance with the PRA,
guidance on annual reporting promotion activities, training,
the agency will inform the public of
requirements under the DSCSA. Once education, partnership engagement, and
OMB approval, including the associated
issued that unified final guidance will information dissemination activities.
currently valid OMB control number,
represent the current thinking of FDA The Office: (1) Oversees operations and
regarding annual reporting by before conducting or sponsoring a
collection of information. administrative management, personnel
prescription drug wholesale distributors management, and budget formulation
and third-party logistics providers. It
pmangrum on DSK3GDR082PROD with NOTICES

Dated: January 4, 2017. and execution for programs managed
will not establish any rights for any Leslie Kux, within OAH; (2) coordinates legislative
person and will not be binding on FDA Associate Commissioner for Policy. and policy activities related to
or the public. You will be able to use an [FR Doc. 2017–00233 Filed 1–9–17; 8:45 am] adolescent health and OAH programs;
alternative approach to that described in (3) coordinates correspondence control
BILLING CODE 4164–01–P
the final guidance if it satisfies the and executive secretariat functions; (4)
requirements of the applicable statutes serves as a focal point within HHS to
and regulations. coordinate the continuing

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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
FR Citation		82 FR 3005