Statement of Organization, Functions and Delegations of Authority, 52450-52451 [2016-18730]
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52450
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Kevin Bugin, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5232, Silver Spring,
MD 20993–0002, 301–796–2302.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK3G9T082PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Ulcerative Colitis: Clinical Trial
Endpoints.’’ The purpose of this draft
guidance is to assist sponsors in the
clinical development of drugs for the
treatment of UC in adult and pediatric
patients. Specifically, this draft
guidance addresses FDA’s current
thinking regarding efficacy endpoints
for UC clinical trials.
UC is a chronic, relapsing disease
characterized by diffuse mucosal
inflammation of the colon. UC involves
the rectum and it may extend
proximally in a contiguous pattern to
affect part of the colon or the entire
colon. Clinical manifestations of active
disease include bloody diarrhea (with or
without mucus), urgency, tenesmus,
abdominal pain, weight loss, fever, and
malaise. In patients with extensive or
severe inflammation, acute
complications such as severe bleeding
and toxic megacolon may occur. There
is an increased risk of colorectal cancer
in UC patients compared to the general
population; risk factors include long
duration of disease, extensive colonic
involvement, severe inflammation and
epithelial dysplasia, and childhoodonset disease. The signs and symptoms
of UC in adults and children are similar;
however, abdominal pain, disease
involving the entire colon, extraintestinal manifestations, proctitis
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22:23 Aug 05, 2016
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(among girls), and disease severity
necessitating colectomy are more
common in children.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on clinical trial endpoints for UC. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
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).
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
parts 312 and 314 have been approved
under OMB control numbers 0910–0014
and 0910–0001, respectively.
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.
IV. 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 or https://
www.regulations.gov.
Dated: August 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18716 Filed 8–5–16; 8:45 am]
BILLING CODE 4164–01–P
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
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Frm 00054
Fmt 4703
Sfmt 4703
Chapter RV—HIV/AIDS Bureau
Section RV–10, Organization
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
E:\FR\FM\08AUN1.SGM
08AUN1
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
including Freedom of Information Act
requests.
Office of the Associate Administrator
(RV)
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Administrative Operations (RV21);
replace in their entirety.
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.
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 Whitefunded 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,
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22:23 Aug 05, 2016
Jkt 238001
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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
52451
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 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: August 1, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016–18730 Filed 8–5–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism, Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Initial
Review Group; Biomedical Research Review
Subcommittee.
Date: October 18, 2016.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Alcohol Abuse
and Alcoholism, National Institutes of
Health, Conference Room 3002–3004, 5635
Fishers Lane, Rockville, MD 20852.
Contact Person: Philippe Marmillot, Ph.D.,
Scientific Review Officer, National Institute
on Alcohol Abuse and Alcoholism, National
Institutes of Health, 5635 Fishers Lane, Room
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52450-52451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
