Statement of Organization, Functions and Delegations of Authority, 44358-44359 [2015-18415]
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44358
Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Notices
data to support analytical
methodologies. The recommendations
in this guidance apply to new drug
applications, abbreviated new drug
applications, biologics license
applications, and supplements to these
applications. The principles in this
guidance also apply to Type II drug
master files. This guidance does not
address investigational new drug
application (IND) methods validation
specifically, but the principles being
discussed may be helpful to sponsors
preparing INDs.
This guidance complements the
International Conference on
Harmonisation guidance ‘‘Q2(R1)
Validation of Analytical Procedures:
Text and Methodology.’’
In the Federal Register of February
19, 2014 (79 FR 9467), this guidance
was published as a draft guidance. We
have carefully reviewed and considered
the comments that were received on the
draft guidance and have made changes
for clarification.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on analytical
procedures and methods validation. 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.
II. The Paperwork Reduction Act of
1995
This 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 part 211, 21
CFR part 314, and 21 CFR part 601 have
been approved under OMB control
numbers 0910–0139, 0910–0001, and
0910–0338.
tkelley on DSK3SPTVN1PROD with NOTICES
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
VerDate Sep<11>2014
18:58 Jul 24, 2015
Jkt 235001
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov.
Dated: July 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18270 Filed 7–24–15; 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 80 FR 37639–37640
dated July 1, 2015).
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA),
Maternal and Child Health Bureau (RM).
Specifically, this notice: (1) Establishes
the Office of Policy and Planning
(RMA); (2) transfers the current Office of
Policy Coordination (RM10) function to
the newly established Office of Policy
and Planning (RMA); and (3) abolishes
the Office of Policy and Coordination
(RM10).
Chapter RM—Maternal and Child
Health Bureau
Section RM—00, Mission
To provide national leadership, in
partnership with key stakeholders, to
improve the physical and mental health,
safety and well-being of the maternal
and child health (MCH) population
which includes all of the nation’s
women, infants, children, adolescents,
and their families, including fathers and
children with special health care needs.
Section RM–10, Organization
Delete the organization for the
Maternal and Child Health Bureau (RM)
in its entirety and replace with the
following:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
The Maternal and Child Health
Bureau (RM) is headed by the Associate
Administrator, who reports directly to
the Administrator, Health Resources
and Services Administration. The
Maternal and Child Health Bureau
includes the following components:
(1) Office of the Associate
Administrator (RM);
(2) Office of Operations and
Management (RM1);
(3) Office of Policy and Planning
(RMA);
(4) Division of Services for Children
with Special Health Needs (RM2);
(5) Division of Child, Adolescent and
Family Health (RM3);
(6) Division of MCH Workforce
Development (RM4);
(7) Division of Healthy Start and
Perinatal Services (RM5);
(8) Division of State and Community
Health (RM6);
(9) Division of Home Visiting and
Early Childhood Systems (RM8); and
(10) Office of Epidemiology and
Research (RM9).
Section RM–20, Functions
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA),
Maternal and Child Health Bureau (RM).
Specifically, this notice: (1) Establishes
the Office of Policy and Planning
(RMA); (2) transfers the Office of Policy
Coordination (RM10) function to the
newly established Office of Policy and
Planning (RMA); and (3) abolishes the
Office of Policy and Coordination
(RM10).
Delete the function for the Office of
Policy Coordination (RM10), and
replace in its entirety.
Office of Policy and Planning (RMA)
The Office of Policy and Planning
(OPP) serves as the Maternal and Child
Health Bureau (MCHB) focal point for
the development of MCHB policy and
program planning. Specifically, the
Office: (1) Supports the Office of the
Associate Administrator in identifying,
planning, and implementing policy and
program priorities across MCHB; (2)
works closely with the Office of the
Associate Administrator to develop
strategic plans, facilitate program
alignment, and support special
initiatives; (3) advises and assists in the
development, coordination and
management of program and policy
documents, and responses to
departmental and HRSA initiatives; and
(4) coordinates with other components
within HRSA and HHS, federal
agencies, state and local governments,
and other public and private
organizations on issues affecting MCHB
programs and policies.
E:\FR\FM\27JYN1.SGM
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Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Notices
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: July 15, 2015.
James Macrae,
Acting Administrator.
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
tkelley on DSK3SPTVN1PROD with NOTICES
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 meeting.
The meeting 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 of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel Validation
of Pediatric Patient Reported Outcomes in
Chronic Diseases.
Date: August 13–14, 2015
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Kan Ma, Ph.D., Scientific
Review Officer, Scientific Review Branch,
National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH,
6701 Democracy Boulevard, Suite 814,
Bethesda, MD 20892, 301–451–4838, mak2@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
VerDate Sep<11>2014
18:58 Jul 24, 2015
Jkt 235001
Dated: July 21, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
[FR Doc. 2015–18244 Filed 7–24–15; 8:45 am]
BILLING CODE 4140–01–P
Dated: July 21, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–18245 Filed 7–24–15; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
[FR Doc. 2015–18415 Filed 7–24–15; 8:45 am]
44359
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 of
Neurological Disorders and Stroke Special
Emphasis Panel; E01 Parkinson’s Disease
Biomarker Samples.
Date: July 30, 2015.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Joel A. Saydoff, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center,
6001 Executive Boulevard, Suite 3205, MSC
9529, Bethesda, MD 20892–9529, 301–435–
9223, joel.saydoff@nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; K99/R00 Review.
Date: July 31, 2015.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Elizabeth A Webber, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center,
6001 Executive Boulevard, Suite 3208, MSC
9529, Bethesda, MD 20892–9529, 301–496–
1917, webbere@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council on Drug
Abuse.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting 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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council on Drug Abuse.
Date: September 1–2, 2015.
Closed: September 1, 2015, 1:00 p.m. to
4:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Open: September 2, 2015, 8:00 a.m. to 2:00
p.m.
Agenda: This portion of the meeting will
be open to the public for announcements and
reports of administrative, legislative, and
program developments in the drug abuse
field.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Notices]
[Pages 44358-44359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18415]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Statement of Organization, Functions and Delegations of Authority
This notice amends part R of the Statement of Organization,
Functions and Delegations of Authority of the Department of Health and
Human Services (HHS), Health Resources and Services Administration
(HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 80
FR 37639-37640 dated July 1, 2015).
This notice reflects organizational changes in the Health Resources
and Services Administration (HRSA), Maternal and Child Health Bureau
(RM). Specifically, this notice: (1) Establishes the Office of Policy
and Planning (RMA); (2) transfers the current Office of Policy
Coordination (RM10) function to the newly established Office of Policy
and Planning (RMA); and (3) abolishes the Office of Policy and
Coordination (RM10).
Chapter RM--Maternal and Child Health Bureau
Section RM--00, Mission
To provide national leadership, in partnership with key
stakeholders, to improve the physical and mental health, safety and
well-being of the maternal and child health (MCH) population which
includes all of the nation's women, infants, children, adolescents, and
their families, including fathers and children with special health care
needs.
Section RM-10, Organization
Delete the organization for the Maternal and Child Health Bureau
(RM) in its entirety and replace with the following:
The Maternal and Child Health Bureau (RM) is headed by the
Associate Administrator, who reports directly to the Administrator,
Health Resources and Services Administration. The Maternal and Child
Health Bureau includes the following components:
(1) Office of the Associate Administrator (RM);
(2) Office of Operations and Management (RM1);
(3) Office of Policy and Planning (RMA);
(4) Division of Services for Children with Special Health Needs
(RM2);
(5) Division of Child, Adolescent and Family Health (RM3);
(6) Division of MCH Workforce Development (RM4);
(7) Division of Healthy Start and Perinatal Services (RM5);
(8) Division of State and Community Health (RM6);
(9) Division of Home Visiting and Early Childhood Systems (RM8);
and
(10) Office of Epidemiology and Research (RM9).
Section RM-20, Functions
This notice reflects organizational changes in the Health Resources
and Services Administration (HRSA), Maternal and Child Health Bureau
(RM). Specifically, this notice: (1) Establishes the Office of Policy
and Planning (RMA); (2) transfers the Office of Policy Coordination
(RM10) function to the newly established Office of Policy and Planning
(RMA); and (3) abolishes the Office of Policy and Coordination (RM10).
Delete the function for the Office of Policy Coordination (RM10),
and replace in its entirety.
Office of Policy and Planning (RMA)
The Office of Policy and Planning (OPP) serves as the Maternal and
Child Health Bureau (MCHB) focal point for the development of MCHB
policy and program planning. Specifically, the Office: (1) Supports the
Office of the Associate Administrator in identifying, planning, and
implementing policy and program priorities across MCHB; (2) works
closely with the Office of the Associate Administrator to develop
strategic plans, facilitate program alignment, and support special
initiatives; (3) advises and assists in the development, coordination
and management of program and policy documents, and responses to
departmental and HRSA initiatives; and (4) coordinates with other
components within HRSA and HHS, federal agencies, state and local
governments, and other public and private organizations on issues
affecting MCHB programs and policies.
[[Page 44359]]
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: July 15, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015-18415 Filed 7-24-15; 8:45 am]
BILLING CODE 4165-15-P
