81_FR_52602 81 FR 52450 - Statement of Organization, Functions and Delegations of Authority

81 FR 52450 - Statement of Organization, Functions and Delegations of Authority

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 152 (August 8, 2016)

Page Range52450-52451
FR Document2016-18730

Federal Register, Volume 81 Issue 152 (Monday, August 8, 2016)
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52450-52451]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18730]


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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 81 
FR 25680 dated April 29, 2016).
    This notice reflects organizational changes in the Health Resources 
and Services Administration (HRSA), HIV/AIDS Bureau (RV). Specifically, 
this notice: (1) Establishes the Office of Program Support; (RV3); (2) 
transfers the organizational development, training and technological 
functions from the Office of Operations and Management (RV2) and the 
communications, grantee oversight and customer service functions from 
the Office of the Associate Administrator (RV) to the newly established 
Office of Program Support (RV3); and (3) updates the functional 
statement for the Office of Operations and Management (RV2), the 
Division of Administrative Operations (RV21), and the Office of the 
Associate Administrator (RV).

Chapter RV--HIV/AIDS Bureau

Section RV-10, Organization

    Delete the organization for the Office of the Associate 
Administrator (RA) in its entirety and replace with the following:
    The HIV/AIDS Bureau is headed by the Associate Administrator, who 
reports directly to the Administrator, Health Resources and Services 
Administration.
    (1) Office of the Associate Administrator (RV);
    (2) Office of Operations and Management (RV2);
    a. Division of Administrative Operations (RV21);
    (3) Office of Program Support (RV3);
    (4) Division of Policy and Data (RVA);
    (5) Division of Metropolitan HIV/AIDS Programs (RV5);
    (6) Division of State HIV/AIDS Programs (RVD);
    (7) Division of Community HIV/AIDS Programs (RV6); and
    (8) Office of HIV/AIDS Training and Capacity Development (RVT);
    a. Division of Domestic Programs; and
    b. Division of Global Programs.

Section RV-20, Functions

    This notice reflects organizational changes in the Health Resources 
and Services Administration (HRSA), HIV/AIDS Bureau (RV). Specifically, 
this notice: (1) Establishes the Office of Program Support; (RV3); (2) 
transfers the organizational development, training and technological 
functions from the Office of Operations and Management (RV2) and the 
communications, grantee oversight and customer service functions from 
the Office of the Associate Administrator (RV) to the newly established 
Office of Program Support (RV3); and (3) updates the functional 
statement for the Office of Operations and Management (RV2), the 
Division of Administrative Operations (RV21), and the Office of the 
Associate Administrator (RV).
    Delete the function for the following: (1) Office of the Associate 
Administrator (RV); (2) Office of Operations and Management (RV2); and 
the Division of

[[Page 52451]]

Administrative Operations (RV21); replace in their entirety.

Office of the Associate Administrator (RV)

    The Office of the Associate Administrator provides leadership and 
direction for the HIV/AIDS programs and activities of the Bureau and 
oversees its relationship with other national health programs. 
Specifically: (1) promotes the implementation of the National HIV/AIDS 
Strategy within the Agency and among Agency-funded programs; (2) 
coordinates the formulation of an overall strategy and policy for 
programs established by Title XXVI of the PHS Act as amended by the 
Ryan White HIV/AIDS Treatment Extension Act of 2009, P.L. 111-87; (3) 
coordinates the internal functions of the Bureau and its relationships 
with other Agency Bureaus and Offices; (4) establishes HIV/AIDS program 
objectives, alternatives, and policy positions consistent with broad 
Administration guidelines; (5) provides leadership for and oversight of 
the Bureau's budgetary development and implementation processes; (6) 
provides clinical leadership to Ryan White-funded programs and global 
HIV/AIDS programs; (7) oversees the implementation of the Global HIV/
AIDS Program as part of the President's Emergency Plan for AIDS Relief; 
(8) serves as a principal contact and advisor to the Department and 
other parties on matters pertaining to the planning and development of 
HIV/AIDS-related health delivery systems; (9) reviews HIV/AIDS related 
program activities to determine their consistency with established 
policies; (10) develops and oversees operating policies and procedures 
for the Bureau; (11) oversees and directs the planning, implementation, 
and evaluation of special studies related to HIV/AIDS and public health 
within the Bureau; (12) prioritizes technical assistance needs in 
consultation with each division/office; (13) plans, implements, and 
evaluates the Bureau's national technical assistance resource training 
center Web site and other distance learning modalities; (14) represents 
the Agency in HIV/AIDS related conferences, consultations, and meetings 
with other Operating Divisions, Office of the Assistant Secretary for 
Health, the Department of State, and the White House; and (15) oversees 
Bureau Executive Secretariat functions and coordinates HRSA responses 
and comments on HIV/AIDS-related reports, position papers, guidance 
documents, correspondence, and related issues, including Freedom of 
Information Act requests.

Office of Operations and Management (RV2)

    The Office of Operations and Management provides expertise 
guidance, leadership, and support in the areas of general 
administration, fiscal operations, and contract administration. The 
Office of Operations and Management is responsible for providing 
direction on all budgetary, administrative, human resources, 
operations, facility management and contracting functions for the HIV/
AIDS Bureau. The Office also oversees and coordinates all Bureau 
program integrity activities.

Division of Administrative Operations (RV21)

    The Division of Administrative Operations is responsible for the 
administrative, human resources operations, facility management and 
contracting functions for the Bureau. Specifically, these functions are 
carried out in the Administrative Services and Contracting Services 
Team.

Office of Program Support (RV3)

    The Office of Program Support provides expertise, guidance, 
leadership, and support in the areas of organizational development, 
communications, grantee oversight, and customer service to support 
program implementation. Specifically, the Office of Program Support: 
(1) enhances the coordination of program support, grants management, 
and technical assistance across the entire Bureau; (2) plans, 
implements and evaluates HAB staff development and education to enable 
employees to meet the mission of the Bureau; (3) streamlines 
communications, clearance activities and development of consistent, 
quality presentations; (4) improves the Bureau's external facing 
communication efforts; (5) facilitates transparency in sharing the 
Bureau's data using internal and external resources; (6) provides 
leadership for and oversees Bureau's grants processes; (7) coordinates 
the grants liaison activities; (8) supports grantee oversight and 
improves customer service and technical assistance to grantees; (9) 
serves as the Bureau's primary liaison with the Office of Federal 
Assistance Management; (10) supports systems development to improve 
program efficiencies and management; (11) provides support with the 
implementation of staff development, organizational development and 
training activities; (12) plans, develops, implements and evaluates the 
Bureau's organizational and staff development, and staff training 
activities inclusive of guiding action steps addressing annual Employee 
Viewpoint Survey results; and (13) coordinates the development and 
distribution of all Bureau communication activities, materials and 
products internally and externally.

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: August 1, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016-18730 Filed 8-5-16; 8:45 am]
 BILLING CODE 4165-15-P



                                                  52450                         Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices

                                                     Docket: For access to the docket to                  (among girls), and disease severity                   from the Office of Operations and
                                                  read background documents or the                        necessitating colectomy are more                      Management (RV2) and the
                                                  electronic and written/paper comments                   common in children.                                   communications, grantee oversight and
                                                  received, go to http://                                   This draft guidance is being issued                 customer service functions from the
                                                  www.regulations.gov and insert the                      consistent with FDA’s good guidance                   Office of the Associate Administrator
                                                  docket number, found in brackets in the                 practices regulation (21 CFR 10.115).                 (RV) to the newly established Office of
                                                  heading of this document, into the                      The draft guidance, when finalized, will              Program Support (RV3); and (3) updates
                                                  ‘‘Search’’ box and follow the prompts                   represent the current thinking of FDA                 the functional statement for the Office of
                                                  and/or go to the Division of Dockets                    on clinical trial endpoints for UC. It                Operations and Management (RV2), the
                                                  Management, 5630 Fishers Lane, Rm.                      does not establish any rights for any                 Division of Administrative Operations
                                                  1061, Rockville, MD 20852.                              person and is not binding on FDA or the               (RV21), and the Office of the Associate
                                                     Submit written requests for single                   public. You can use an alternative                    Administrator (RV).
                                                  copies of the draft guidance to the                     approach if it satisfies the requirements
                                                                                                          of the applicable statutes and                        Chapter RV—HIV/AIDS Bureau
                                                  Division of Drug Information, Center for
                                                  Drug Evaluation and Research, Food                      regulations.                                          Section RV–10, Organization
                                                  and Drug Administration, 10001 New                      II. The Paperwork Reduction Act of                       Delete the organization for the Office
                                                  Hampshire Ave., Hillandale Building,                    1995                                                  of the Associate Administrator (RA) in
                                                  4th Floor, Silver Spring, MD 20993–                                                                           its entirety and replace with the
                                                  0002. Send one self-addressed adhesive                     This draft guidance refers to
                                                                                                          previously approved collections of                    following:
                                                  label to assist that office in processing                                                                        The HIV/AIDS Bureau is headed by
                                                  your requests. See the SUPPLEMENTARY                    information that are subject to review by
                                                                                                          the Office of Management and Budget                   the Associate Administrator, who
                                                  INFORMATION section for electronic
                                                                                                          (OMB) under the Paperwork Reduction                   reports directly to the Administrator,
                                                  access to the draft guidance document.                                                                        Health Resources and Services
                                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                          Act of 1995 (44 U.S.C. 3501–3520). The
                                                                                                          collections of information in 21 CFR                  Administration.
                                                  Kevin Bugin, Center for Drug Evaluation                                                                          (1) Office of the Associate
                                                  and Research, Food and Drug                             parts 312 and 314 have been approved
                                                                                                          under OMB control numbers 0910–0014                   Administrator (RV);
                                                  Administration, 10903 New Hampshire                                                                              (2) Office of Operations and
                                                  Ave., Bldg. 22, Rm. 5232, Silver Spring,                and 0910–0001, respectively.
                                                                                                                                                                Management (RV2);
                                                  MD 20993–0002, 301–796–2302.                            IV. Electronic Access                                    a. Division of Administrative
                                                  SUPPLEMENTARY INFORMATION:                                Persons with access to the Internet                 Operations (RV21);
                                                                                                          may obtain the draft guidance at either                  (3) Office of Program Support (RV3);
                                                  I. Background
                                                                                                          http://www.fda.gov/Drugs/Guidance                        (4) Division of Policy and Data (RVA);
                                                     FDA is announcing the availability of                ComplianceRegulatoryInformation/                         (5) Division of Metropolitan HIV/
                                                  a draft guidance for industry entitled                  Guidances/default.htm or http://                      AIDS Programs (RV5);
                                                  ‘‘Ulcerative Colitis: Clinical Trial                    www.regulations.gov.                                     (6) Division of State HIV/AIDS
                                                  Endpoints.’’ The purpose of this draft                                                                        Programs (RVD);
                                                  guidance is to assist sponsors in the                     Dated: August 3, 2016.
                                                                                                                                                                   (7) Division of Community HIV/AIDS
                                                  clinical development of drugs for the                   Leslie Kux,                                           Programs (RV6); and
                                                  treatment of UC in adult and pediatric                  Associate Commissioner for Policy.                       (8) Office of HIV/AIDS Training and
                                                  patients. Specifically, this draft                      [FR Doc. 2016–18716 Filed 8–5–16; 8:45 am]            Capacity Development (RVT);
                                                  guidance addresses FDA’s current                        BILLING CODE 4164–01–P                                   a. Division of Domestic Programs; and
                                                  thinking regarding efficacy endpoints                                                                            b. Division of Global Programs.
                                                  for UC clinical trials.
                                                     UC is a chronic, relapsing disease                   DEPARTMENT OF HEALTH AND                              Section RV–20, Functions
                                                  characterized by diffuse mucosal                        HUMAN SERVICES                                           This notice reflects organizational
                                                  inflammation of the colon. UC involves                                                                        changes in the Health Resources and
                                                  the rectum and it may extend                            Health Resources and Services                         Services Administration (HRSA), HIV/
                                                  proximally in a contiguous pattern to                   Administration                                        AIDS Bureau (RV). Specifically, this
                                                  affect part of the colon or the entire                                                                        notice: (1) Establishes the Office of
                                                                                                          Statement of Organization, Functions
                                                  colon. Clinical manifestations of active                                                                      Program Support; (RV3); (2) transfers
                                                                                                          and Delegations of Authority
                                                  disease include bloody diarrhea (with or                                                                      the organizational development,
                                                  without mucus), urgency, tenesmus,                         This notice amends Part R of the                   training and technological functions
                                                  abdominal pain, weight loss, fever, and                 Statement of Organization, Functions                  from the Office of Operations and
                                                  malaise. In patients with extensive or                  and Delegations of Authority of the                   Management (RV2) and the
                                                  severe inflammation, acute                              Department of Health and Human                        communications, grantee oversight and
                                                  complications such as severe bleeding                   Services (HHS), Health Resources and                  customer service functions from the
                                                  and toxic megacolon may occur. There                    Services Administration (HRSA) (60 FR                 Office of the Associate Administrator
                                                  is an increased risk of colorectal cancer               56605, as amended November 6, 1995;                   (RV) to the newly established Office of
                                                  in UC patients compared to the general                  as last amended at 81 FR 25680 dated                  Program Support (RV3); and (3) updates
                                                  population; risk factors include long                   April 29, 2016).                                      the functional statement for the Office of
                                                  duration of disease, extensive colonic                     This notice reflects organizational                Operations and Management (RV2), the
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                                                  involvement, severe inflammation and                    changes in the Health Resources and                   Division of Administrative Operations
                                                  epithelial dysplasia, and childhood-                    Services Administration (HRSA), HIV/                  (RV21), and the Office of the Associate
                                                  onset disease. The signs and symptoms                   AIDS Bureau (RV). Specifically, this                  Administrator (RV).
                                                  of UC in adults and children are similar;               notice: (1) Establishes the Office of                    Delete the function for the following:
                                                  however, abdominal pain, disease                        Program Support; (RV3); (2) transfers                 (1) Office of the Associate Administrator
                                                  involving the entire colon, extra-                      the organizational development,                       (RV); (2) Office of Operations and
                                                  intestinal manifestations, proctitis                    training and technological functions                  Management (RV2); and the Division of


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                                                                                Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices                                                  52451

                                                  Administrative Operations (RV21);                       including Freedom of Information Act                  evaluates the Bureau’s organizational
                                                  replace in their entirety.                              requests.                                             and staff development, and staff training
                                                                                                                                                                activities inclusive of guiding action
                                                  Office of the Associate Administrator                   Office of Operations and Management
                                                                                                                                                                steps addressing annual Employee
                                                  (RV)                                                    (RV2)
                                                                                                                                                                Viewpoint Survey results; and (13)
                                                     The Office of the Associate                            The Office of Operations and                        coordinates the development and
                                                  Administrator provides leadership and                   Management provides expertise                         distribution of all Bureau
                                                  direction for the HIV/AIDS programs                     guidance, leadership, and support in the              communication activities, materials and
                                                                                                          areas of general administration, fiscal               products internally and externally.
                                                  and activities of the Bureau and
                                                                                                          operations, and contract administration.
                                                  oversees its relationship with other                                                                          Delegations of Authority
                                                                                                          The Office of Operations and
                                                  national health programs. Specifically:
                                                                                                          Management is responsible for                           All delegations of authority and re-
                                                  (1) promotes the implementation of the
                                                                                                          providing direction on all budgetary,                 delegations of authority made to HRSA
                                                  National HIV/AIDS Strategy within the
                                                                                                          administrative, human resources,                      officials that were in effect immediately
                                                  Agency and among Agency-funded
                                                                                                          operations, facility management and                   prior to this reorganization, and that are
                                                  programs; (2) coordinates the
                                                                                                          contracting functions for the HIV/AIDS                consistent with this reorganization,
                                                  formulation of an overall strategy and
                                                                                                          Bureau. The Office also oversees and                  shall continue in effect pending further
                                                  policy for programs established by Title
                                                                                                          coordinates all Bureau program integrity              re-delegation.
                                                  XXVI of the PHS Act as amended by the                   activities.
                                                  Ryan White HIV/AIDS Treatment                                                                                   This reorganization is effective upon
                                                  Extension Act of 2009, P.L. 111–87; (3)                 Division of Administrative Operations                 date of signature.
                                                  coordinates the internal functions of the               (RV21)                                                  Dated: August 1, 2016.
                                                  Bureau and its relationships with other                   The Division of Administrative                      James Macrae,
                                                  Agency Bureaus and Offices; (4)                         Operations is responsible for the                     Acting Administrator.
                                                  establishes HIV/AIDS program                            administrative, human resources                       [FR Doc. 2016–18730 Filed 8–5–16; 8:45 am]
                                                  objectives, alternatives, and policy                    operations, facility management and
                                                                                                                                                                BILLING CODE 4165–15–P
                                                  positions consistent with broad                         contracting functions for the Bureau.
                                                  Administration guidelines; (5) provides                 Specifically, these functions are carried
                                                  leadership for and oversight of the                     out in the Administrative Services and                DEPARTMENT OF HEALTH AND
                                                  Bureau’s budgetary development and                      Contracting Services Team.                            HUMAN SERVICES
                                                  implementation processes; (6) provides
                                                  clinical leadership to Ryan White-                      Office of Program Support (RV3)
                                                                                                                                                                National Institutes of Health
                                                  funded programs and global HIV/AIDS                       The Office of Program Support
                                                  programs; (7) oversees the                              provides expertise, guidance,                         National Institute on Alcohol Abuse
                                                  implementation of the Global HIV/AIDS                   leadership, and support in the areas of               and Alcoholism, Notice of Closed
                                                  Program as part of the President’s                      organizational development,                           Meetings
                                                  Emergency Plan for AIDS Relief; (8)                     communications, grantee oversight, and
                                                  serves as a principal contact and advisor               customer service to support program                     Pursuant to section 10(d) of the
                                                  to the Department and other parties on                  implementation. Specifically, the Office              Federal Advisory Committee Act, as
                                                  matters pertaining to the planning and                  of Program Support: (1) enhances the                  amended (5 U.S.C. App.), notice is
                                                  development of HIV/AIDS-related                         coordination of program support, grants               hereby given of the following meetings.
                                                  health delivery systems; (9) reviews                    management, and technical assistance                    The meetings will be closed to the
                                                  HIV/AIDS related program activities to                  across the entire Bureau; (2) plans,                  public in accordance with the
                                                  determine their consistency with                        implements and evaluates HAB staff                    provisions set forth in sections
                                                  established policies; (10) develops and                 development and education to enable                   552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
                                                  oversees operating policies and                         employees to meet the mission of the                  as amended. The grant applications and
                                                  procedures for the Bureau; (11) oversees                Bureau; (3) streamlines                               the discussions could disclose
                                                  and directs the planning,                               communications, clearance activities                  confidential trade secrets or commercial
                                                  implementation, and evaluation of                       and development of consistent, quality                property such as patentable material,
                                                  special studies related to HIV/AIDS and                 presentations; (4) improves the Bureau’s              and personal information concerning
                                                  public health within the Bureau; (12)                   external facing communication efforts;                individuals associated with the grant
                                                  prioritizes technical assistance needs in               (5) facilitates transparency in sharing               applications, the disclosure of which
                                                  consultation with each division/office;                 the Bureau’s data using internal and                  would constitute a clearly unwarranted
                                                  (13) plans, implements, and evaluates                   external resources; (6) provides                      invasion of personal privacy.
                                                  the Bureau’s national technical                         leadership for and oversees Bureau’s
                                                                                                                                                                  Name of Committee: National Institute on
                                                  assistance resource training center Web                 grants processes; (7) coordinates the                 Alcohol Abuse and Alcoholism Initial
                                                  site and other distance learning                        grants liaison activities; (8) supports               Review Group; Biomedical Research Review
                                                  modalities; (14) represents the Agency                  grantee oversight and improves                        Subcommittee.
                                                  in HIV/AIDS related conferences,                        customer service and technical                          Date: October 18, 2016.
                                                  consultations, and meetings with other                  assistance to grantees; (9) serves as the               Time: 8 a.m. to 5 p.m.
                                                  Operating Divisions, Office of the                      Bureau’s primary liaison with the Office                Agenda: To review and evaluate grant
                                                  Assistant Secretary for Health, the                     of Federal Assistance Management; (10)                applications.
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                                                  Department of State, and the White                      supports systems development to                         Place: National Institute of Alcohol Abuse
                                                  House; and (15) oversees Bureau                         improve program efficiencies and                      and Alcoholism, National Institutes of
                                                                                                                                                                Health, Conference Room 3002–3004, 5635
                                                  Executive Secretariat functions and                     management; (11) provides support with                Fishers Lane, Rockville, MD 20852.
                                                  coordinates HRSA responses and                          the implementation of staff                             Contact Person: Philippe Marmillot, Ph.D.,
                                                  comments on HIV/AIDS-related reports,                   development, organizational                           Scientific Review Officer, National Institute
                                                  position papers, guidance documents,                    development and training activities; (12)             on Alcohol Abuse and Alcoholism, National
                                                  correspondence, and related issues,                     plans, develops, implements and                       Institutes of Health, 5635 Fishers Lane, Room



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Document Created: 2016-08-06 03:08:15
Document Modified: 2016-08-06 03:08:15
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
FR Citation81 FR 52450 

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