Proposed Changes to the Graduate Psychology Education Program, 11212-11213 [2018-05064]
Download as PDF
<![CDATA[
11212
Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices
Addendum to ICH M7; Assessment and
Control of DNA Reactive (Mutagenic)
Impurities in Pharmaceuticals to Limit
Potential Carcinogenic Risk,’’ available
at https://www.gpo.gov/fdsys/pkg/FR2015-09-18/pdf/2015-23389.pdf. The
notice gave interested persons an
opportunity to submit comments by
November 27, 2015.
After consideration of the comments
received and revisions to the guideline,
a final draft of the guideline was
submitted to the ICH Assembly and
endorsed by the regulatory Agencies in
June 2017.
This final guidance provides guidance
on acceptable intake limits derived for
some chemicals that are considered to
be mutagenic carcinogens and are also
commonly used in the synthesis of
pharmaceuticals or are useful examples
to illustrate the principles for deriving
compound-specific intakes described in
the ICH M7 guidance. This guidance is
intended to provide guidance for new
drug substances and new drug products
during their clinical development and
subsequent applications for marketing.
The default method from ICH M7 of
linear extrapolation from the cancer
potency estimate, TD50 is used as the
primary method to derive the acceptable
intakes for carcinogens with likely
mutagenic mode of action. After
consideration of the comments received,
hydroxylamine monograph was deleted
from the final guidance. Relevant
editorial changes were also made to
improve clarity and to incorporate the
ICH M7(R1) Addendum guidance.
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 ‘‘M7: Assessment
and Control of DNA Reactive
(Mutagenic) Impurities in
Pharmaceuticals to Limit Potential
Carcinogenic Risk.’’ 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. This guidance
is not subject to Executive Order 12866.
daltland on DSKBBV9HB2PROD with NOTICES
II. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
VerDate Sep<11>2014
18:17 Mar 13, 2018
Jkt 244001
Dated: March 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05118 Filed 3–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Proposed Changes to the Graduate
Psychology Education Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Request for Public Comment on
the Graduate Psychology Education
Program.
AGENCY:
The Graduate Psychology
Education (GPE) Program is authorized
by section 756 of the Public Health
Service Act and administered by HRSA.
The program provides financial support
to organizations and institutions that
train doctoral-level psychologists. This
notice seeks public comment to inform
and guide policy and planning
associated with the GPE Program.
DATES: Individuals and organizations
interested in providing information
must submit written comments no later
than April 13, 2018. To receive
consideration, comments must be
received no later than 11:59 p.m.
Eastern Time on that date.
ADDRESSES: Interested parties should
submit their comments to Cynthia
Harne, Public Health Analyst and
Project Officer for the GPE Program,
Division of Nursing and Public Health,
Behavioral and Public Health Branch,
Bureau of Health Workforce, HRSA,
5600 Fishers Lane, Room 11N–90C,
Rockville, Maryland 20857; phone (301)
443–7661; fax (301) 443–0791; or email
charne@hrsa.gov. Please include the
title of this notice, ‘‘Request for
Comment: GPE Program’’ in the subject
line of the email. Response to this
request is voluntary. Responders are free
to address any or all of the questions
listed below. This request is for
information and planning purposes only
and should not be construed as a
solicitation or as an obligation on the
part of the federal government. All
submitted comments will be available to
the public by request in their entirety.
FOR FURTHER INFORMATION CONTACT:
Cynthia Harne, Public Health Analyst,
Division of Nursing and Public Health,
Behavioral and Public Health Branch,
Bureau of Health Workforce, Health
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Resources and Services Administration,
at the contact information listed above.
SUPPLEMENTARY INFORMATION: The GPE
Program was established in 2002 to
assist American Psychological
Association (APA) accredited doctoral
programs and internships in meeting the
costs to plan, develop, operate, or
maintain graduate psychology education
programs to train health service
psychologists to work with vulnerable
populations. The purpose of the current
program (Funding Opportunity
Announcement HRSA–16–059) is to
prepare doctoral-level psychologists to
provide behavioral health care,
including mental health and substance
use disorder prevention and treatment
services, in settings that provide
integrated primary and behavioral
health services to underserved and/or
rural populations. The program is
designed to foster an integrated and
interprofessional approach to address
access to behavioral health care for
underserved and/or rural populations.
Given the value of feedback from
stakeholders, HRSA is seeking
comments from interested parties
including current and former grant
recipients, former applicants to the
program, doctoral psychology schools
and programs, and health care delivery
sites that provide behavioral health
experiential training to students. The
purpose is to identify doctoral-level
health service psychologist training
needs, salient issues and challenges in
the delivery of behavioral health
services, including substance use, and
to provide individual recommendations
to maximize the reach, capacity and
success of the GPE Program in
addressing Opioid Use Disorder and
other behavioral health concerns. This
information may be used by HRSA will
consider the input as it develops future
technical assistance and funding
opportunities, and strategic planning to
meet the training demands of the
behavioral health workforce.
Graduate Psychology Program in FY
2019—Proposal for Public Comment
HRSA seeks comments on how the
GPE program (and the students it
supports) can help address the opioid
epidemic. In your comments, please
address one or more of the following:
1. What do you see as the most
prevalent behavioral health and public
health trends or concerns that should be
addressed in developing the
psychologist workforce?
2. What do you see as the role for
doctoral-level health psychologists in
addressing the opioid epidemic?
3. What are the didactic and
experiential training needs in preparing
E:\FR\FM\14MRN1.SGM
14MRN1
Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices
doctoral-level health psychologists to
effectively address substance use
disorder (SUD) including opioid use?
4. If your institution has received in
the past, is currently receiving, or
applied for but did not receive GPE
funding, what features or requirements
of the GPE Program were easy to
incorporate and/or beneficial in the
development and implementation of
your program, and which ones posed
challenges? Please provide specific
examples. If your institution did not
apply for GPE funding, what features or
requirements of the GPE Program posed
challenges to the development of your
program or dissuaded your institution
from applying to the program?
5. What health workforce training
strategies within the experiential
training sites could the GPE Program
address to increase access to integrated
behavioral health/primary care services
in underserved and/or rural
populations? Please provide a
description of practice.
6. Type and site including geographic
locations (e.g., large health system,
private practices, group practices,
Federally Qualified Health Center, etc.).
Dated: March 8, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018–05064 Filed 3–13–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Privacy Act of 1974; System of
Records
Office of the Secretary (OS),
Department of Health and Human
Services (HHS).
ACTION: Notice of a modified system of
records.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
as amended, HHS is altering an existing
department-wide system of records,
‘‘Records About Restricted Dataset
Requesters,’’ System Number 09–90–
1401. This system of records covers
records about individuals within and
outside HHS who request restricted
datasets and software products from
HHS (e.g., for health-related scientific
research and study purposes), when
HHS maintains the requester records in
a system from which they are retrieved
directly by an individual requester’s
name or other personal identifier. The
system of records currently covers
records maintained by three HHS
Operating Divisions. It is being altered
to include records maintained by a
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:17 Mar 13, 2018
Jkt 244001
fourth Operating Division, the National
Institutes of Health (NIH), and to
include three revised and five new
routine uses, some of which will apply
to all records in the system and some of
which will apply to only NIH’s records.
The alterations affect the System
Locations, Legal Authorities, Purposes,
Retention, System Manager, and
Routine Uses sections of the System of
Records Notice (SORN).
DATES: In accordance with 5 U.S.C.
552a(e)(4) and (11), this notice is
applicable March 14, 2018, subject to a
30-day period in which to comment on
the new and revised routine uses,
described below. Please submit any
comments by April 13, 2018.
ADDRESSES: The public should submit
written comments, by mail or email, to
Beth Kramer, HHS Privacy Act Officer,
200 Independence Avenue SW, Suite
729H, Washington, DC 20201, or
beth.kramer@hhs.gov. Comments
received will be available for review at
this location without redaction, unless
otherwise advised by the commenter. To
review comments in person, please
contact Beth Kramer at beth.kramer@
hhs.gov or (202) 690–6941.
FOR FURTHER INFORMATION CONTACT:
General questions about the system of
records should be submitted by mail,
email, or phone to Beth Kramer, HHS
Privacy Act Officer, at 200
Independence Avenue SW, Suite 729H,
Washington, DC 20201; beth.kramer@
hhs.gov or (202) 690–6941.
SUPPLEMENTARY INFORMATION: This
department-wide system of records was
established April 2015 (see 80 FR
17447) and has not been previously
revised. It covers records about
individuals within and outside HHS
who request restricted datasets and
software products from HHS, when HHS
maintains the requester records in a
system from which they are retrieved
directly by an individual requester’s
name or other personal identifier. It
currently includes records maintained
by three HHS Operating Divisions. It is
being revised to add records maintained
by a fourth Operating Division, the
National Institutes of Health (NIH),
which NIH plans to begin retrieving
directly by personal identifier, and to
include three revised and five new
routine uses, some of which will apply
to all records in the system and some of
which will apply to only NIH’s records.
The alterations made to add NIH’s
records affect the System Location,
Legal Authorities, Purposes, Retention,
System Manager, and Routine Uses
sections of the System of Records Notice
(SORN). One new purpose was added to
the ‘‘Purposes’’ section, which will
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
11213
apply to all records, not just NIH
records, stating that records may be
used to evaluate accomplishment of
HHS functions related to the purposes
of this system of records and to evaluate
performance of contractors utilized by
HHS to accomplish those functions.
Minor wording and formatting changes
have been made throughout the SORN
to conform to the SORN template
prescribed in OMB Circular A–108. The
new and revised routine uses are as
follows:
• Routine use 1 has been revised to
add ‘‘including ancillary functions, such
as compiling reports and evaluating
program effectiveness and contractor
performance.’’
• Routine use 2 has been revised to
add ‘‘including ancillary functions’’ and
to add a last sentence stating: ‘‘For
example, disclosure may be made to
qualified experts not within the
definition of HHS employees as
prescribed in HHS regulations, for
opinions as a part of the controlled data
access process.’’
• Routine use 10 has been revised to
use wording prescribed in OMB
Memorandum M–17–12 issued January
3, 2017.
• Routine uses 11 through 15 are
new. Routine use 11 is a new routine
use prescribed by OMB Memorandum
M–17–12.
‘‘Restricted’’ datasets and software
products are those that HHS makes
affirmatively available to qualified
members of the public but provides
subject to restrictions, because they
contain identifiable data and/or
anonymized data that has the potential,
when combined with other data, to
identify the particular individuals, such
as patients or providers, whose
information is represented in the data.
The datasets and products are made
available through an on-line or paperbased ordering and delivery system that
provides them to qualified requesters
electronically or by mail.
The restrictions are necessary to
protect the privacy of individuals whose
information is represented in the
datasets or software products. The
restrictions typically limit the data
requester to using the data for research,
analysis, study, and aggregate statistical
reporting; prohibit any attempt to
identify any individual or establishment
represented in the data; and require
specific security measures to safeguard
the data from unauthorized access. HHS
is required by law to impose, monitor,
and enforce the restrictions (see, for
example, provisions in the Confidential
Information Protection and Statistical
Efficiency Act of 2002 (CIPSEA), 44
U.S.C. 3501 at note). To impose and
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11212-11213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05064]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Proposed Changes to the Graduate Psychology Education Program
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Request for Public Comment on the Graduate Psychology Education
Program.
-----------------------------------------------------------------------
SUMMARY: The Graduate Psychology Education (GPE) Program is authorized
by section 756 of the Public Health Service Act and administered by
HRSA. The program provides financial support to organizations and
institutions that train doctoral-level psychologists. This notice seeks
public comment to inform and guide policy and planning associated with
the GPE Program.
DATES: Individuals and organizations interested in providing
information must submit written comments no later than April 13, 2018.
To receive consideration, comments must be received no later than 11:59
p.m. Eastern Time on that date.
ADDRESSES: Interested parties should submit their comments to Cynthia
Harne, Public Health Analyst and Project Officer for the GPE Program,
Division of Nursing and Public Health, Behavioral and Public Health
Branch, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, Room 11N-
90C, Rockville, Maryland 20857; phone (301) 443-7661; fax (301) 443-
0791; or email [email protected]. Please include the title of this
notice, ``Request for Comment: GPE Program'' in the subject line of the
email. Response to this request is voluntary. Responders are free to
address any or all of the questions listed below. This request is for
information and planning purposes only and should not be construed as a
solicitation or as an obligation on the part of the federal government.
All submitted comments will be available to the public by request in
their entirety.
FOR FURTHER INFORMATION CONTACT: Cynthia Harne, Public Health Analyst,
Division of Nursing and Public Health, Behavioral and Public Health
Branch, Bureau of Health Workforce, Health Resources and Services
Administration, at the contact information listed above.
SUPPLEMENTARY INFORMATION: The GPE Program was established in 2002 to
assist American Psychological Association (APA) accredited doctoral
programs and internships in meeting the costs to plan, develop,
operate, or maintain graduate psychology education programs to train
health service psychologists to work with vulnerable populations. The
purpose of the current program (Funding Opportunity Announcement HRSA-
16-059) is to prepare doctoral-level psychologists to provide
behavioral health care, including mental health and substance use
disorder prevention and treatment services, in settings that provide
integrated primary and behavioral health services to underserved and/or
rural populations. The program is designed to foster an integrated and
interprofessional approach to address access to behavioral health care
for underserved and/or rural populations.
Given the value of feedback from stakeholders, HRSA is seeking
comments from interested parties including current and former grant
recipients, former applicants to the program, doctoral psychology
schools and programs, and health care delivery sites that provide
behavioral health experiential training to students. The purpose is to
identify doctoral-level health service psychologist training needs,
salient issues and challenges in the delivery of behavioral health
services, including substance use, and to provide individual
recommendations to maximize the reach, capacity and success of the GPE
Program in addressing Opioid Use Disorder and other behavioral health
concerns. This information may be used by HRSA will consider the input
as it develops future technical assistance and funding opportunities,
and strategic planning to meet the training demands of the behavioral
health workforce.
Graduate Psychology Program in FY 2019--Proposal for Public Comment
HRSA seeks comments on how the GPE program (and the students it
supports) can help address the opioid epidemic. In your comments,
please address one or more of the following:
1. What do you see as the most prevalent behavioral health and
public health trends or concerns that should be addressed in developing
the psychologist workforce?
2. What do you see as the role for doctoral-level health
psychologists in addressing the opioid epidemic?
3. What are the didactic and experiential training needs in
preparing
[[Page 11213]]
doctoral-level health psychologists to effectively address substance
use disorder (SUD) including opioid use?
4. If your institution has received in the past, is currently
receiving, or applied for but did not receive GPE funding, what
features or requirements of the GPE Program were easy to incorporate
and/or beneficial in the development and implementation of your
program, and which ones posed challenges? Please provide specific
examples. If your institution did not apply for GPE funding, what
features or requirements of the GPE Program posed challenges to the
development of your program or dissuaded your institution from applying
to the program?
5. What health workforce training strategies within the
experiential training sites could the GPE Program address to increase
access to integrated behavioral health/primary care services in
underserved and/or rural populations? Please provide a description of
practice.
6. Type and site including geographic locations (e.g., large health
system, private practices, group practices, Federally Qualified Health
Center, etc.).
Dated: March 8, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018-05064 Filed 3-13-18; 8:45 am]
BILLING CODE 4165-15-P
