National Advisory Council on the National Health Service Corps, 13635-13636 [2017-04975]
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Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg 75, Rm. 4736,
Silver Spring, MD 20993, 240–402–
7960, Stephanie.Choi@fda.hhs.gov; or
Robert Lionberger, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg 75, Rm. 4722,
Silver Spring, MD 20993, 240–402–
7957, Robert.Lionberger@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
In July 2012, Congress passed GDUFA
(Title III of the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144)). GDUFA is
designed to enhance public access to
safe, high-quality generic drugs and
modernize the generic drug program. To
support this goal, FDA agreed in the
GDUFA commitment letter to work with
industry and interested stakeholders on
identifying regulatory science research
priorities specific to generic drugs for
each fiscal year covered by GDUFA. The
commitment letter outlines FDA’s
performance goals and procedures
under the GDUFA program for the years
2012–2017. The commitment letter can
be found at https://www.fda.gov/
downloads/ForIndustry/UserFees/
GenericDrugUserFees/UCM282505.pdf.
II. Topics for Discussion at the Public
Workshop
The purpose of the May public
workshop is to obtain input from
industry and other interested
stakeholders on the identification of
generic drug regulatory science
priorities for FY 2018. FDA is holding
this public workshop because the
Agency intends to continue its
regulatory science initiatives upon
reauthorization of GDUFA (i.e., GDUFA
II) for FYs 2018–2022 (see Generic Drug
User Fees; Public Meeting; Request for
Comments, 81 FR 66035, September 26,
2016). To help fulfill its mission, FDA
is particularly interested in receiving
input on the following topics:
• Opportunities for scientific or
technical advancements that would help
to overcome specific barriers for
industry that currently limit the
availability of generic drug products.
• Innovative approaches to preapproval development of generic drugs,
including new methodologies for
product design and manufacturing, and
design and conduct of in vitro, ex vivo,
and clinical studies and identification of
scientifically robust strategies for
demonstration of bioequivalence for
various product classes.
• Innovation in scientific approaches
to evaluating the therapeutic
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equivalence of generic drug products
throughout their life cycle.
• Identification of high-impact public
health issues involving generic drugs
that can be addressed by the prioritized
allocation of FY 2018 funding for
regulatory science research.
• Identification of specific issues
related to generic drug products where
scientific recommendations and/or
clarifications are needed in developing
and/or revising FDA’s guidance for
industry.
• Strategies for enhancing quality and
equivalence risk management during
generic drug product development,
during regulatory review, and/or
throughout the drug product’s life cycle.
FDA will consider all comments made
at this workshop or received through the
docket (see ADDRESSES) as it develops its
FY 2018 regulatory science priorities.
Additional information concerning
GDUFA, including the text of the law
and the commitment letter, can be
found at https://www.fda.gov/gdufa.
III. Participating in the Public
Workshop
Registration: To register to attend
‘‘Generic Drug User Fee Amendments of
2012; Regulatory Science Initiatives;
Public Workshop’’ in-person, or to
attend virtually via web cast, please
send an email to
GDUFARegulatoryScience@fda.hhs.gov
by April 5, 2017. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone. Any person without email
access can register by contacting
Stephanie Choi (see FOR FURTHER
INFORMATION CONTACT). If you need
special accommodations because of a
disability, please contact Stephanie
Choi (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the
workshop.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by April 5, 2017, midnight
eastern standard time. Early registration
is recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during
the public comment session and which
topic(s) you wish to address. We will do
our best to accommodate requests to
make public comments. Individuals and
organizations with common interests are
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13635
urged to consolidate or coordinate their
presentations. Following the close of
registration, FDA will determine the
amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
will select and notify participants by
April 19, 2017. All requests to make oral
presentations must be received by the
close of registration on April 5, 2017,
midnight eastern standard time. If
selected for presentation, any
presentation materials must be emailed
to GDUFARegulatoryScience@
fda.hhs.gov no later than April 26, 2017.
No commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Streaming Webcast of the Public
Workshop: This public workshop will
also be web cast. To join via the web
cast, please go to https://
collaboration.fda.gov/gpw517/. Please
register in advance for web cast per the
instructions provided in this section.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses in this
document, as of the date this document
publishes in the Federal Register, but
Web sites are subject to change over
time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A link to the transcript
will also be available on the Internet at
https://www.fda.gov/GDUFARegScience.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–04981 Filed 3–13–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on the
National Health Service Corps
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, notice
SUMMARY:
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13636
Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
is hereby given that a meeting is
scheduled for National Advisory
Council on the National Health Service
Corps (NACNHSC). This meeting will be
open to the public.
DATES: The meeting will be held on
March 22, 2017 from 1:00 p.m.–4:00
p.m. EDT.
ADDRESSES: This meeting will be held in
a webinar and conference call format.
Webinar information can be found on
the Web site at: https://nhsc.hrsa.gov/
corpsexperience/aboutus/
nationaladvisorycouncil/
meetingsummaries/.
Agenda: The members of the
NACNHSC will discuss provider
retention in rural areas, the redesign of
Area Health Education Centers, as well
as provide an update on Health
Professional Shortage Area scoring.
Agenda items are subject to change as
priorities dictate. The NACNHSC final
agenda will be available on the
NACNHSC Web site 3 days in advance
of the meeting.
Information about the NACNHSC and
the agenda for this meeting can be
obtained by accessing the following
Web site: https://nhsc.hrsa.gov/
corpsexperience/aboutus/
nationaladvisorycouncil/
meetingsummaries/.
FOR FURTHER INFORMATION CONTACT:
Anyone requesting information
regarding the NACNHSC should contact
CAPT Shari Campbell, Designated
Federal Official, Bureau of Health
Workforce (BHW), HRSA in one of three
ways: (1) Send a request to the following
address: CAPT Shari Campbell,
Designated Federal Official, BHW,
HRSA, 5600 Fishers Lane, Room
14N108, Rockville, Maryland 20857; (2)
call (301) 594–4251; or (3) send an email
to scampbell@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
NACNHSC makes recommendations
with respect to their responsibilities
under Subpart II, Part D of Title III of
the Public Health Service Act, as
amended (National Health Service
Corps and Health Professional Shortage
Area Designations), and shall review
and comment upon regulations
promulgated by the Secretary under
Subpart II.
Members of the public will have the
opportunity to provide comments. Oral
comments will be honored in the order
they are requested and may be limited
as time allows. Requests to make oral
comments or provide written comments
to the NACNHSC should be sent to
Monica-Tia Bullock at MBullock@
hrsa.gov by March 17, 2017. Individuals
who plan to attend and need special
assistance, such as sign language
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interpretation or other reasonable
accommodations, should contact
Monica-Tia Bullock at MBullock@
hrsa.gov by March 17.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017–04975 Filed 3–13–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–New]
60-Day Notice Template for Request
for Generic Clearance for the
Collection of Routine Customer
Feedback on HHS Communications
U.S. Department of Health and
Human Services (HHS).
ACTION: Notice and request for
comments. Office of the Assistant
Secretary for Public Affairs is requesting
OMB approval for a new Generic
Clearance for the Collection of Routine
Customer Feedback by OMB.
AGENCY:
Department of Health and
Human Services, The Office of the
Secretary (OS), as part of its continuing
effort to reduce paperwork and
respondent burden, invites the general
public to take this opportunity to
comment on the ‘‘Generic Clearance for
the Collection of Qualitative Feedback
on Agency Service Delivery’’ for
approval under the Paperwork
Reduction Act (PRA). This collection
was developed as part of a Federal
Government-wide effort to streamline
the process for seeking feedback from
the public on service delivery. This
notice announces our intent to submit
this collection to OMB for approval and
solicits comments on specific aspects
for the proposed information collection.
DATES: Consideration will be given to all
comments received by May 15, 2017.
ADDRESSES: Submit comments by one of
the following methods:
• Web site: www.regulations.gov.
Direct comments to Docket ID OMB–
2010–0021.
• Email:
Information.CollectionClearance@
hhs.gov.
• Phone: (202) 690–6162.
Comments submitted in response to
this notice may be made available to the
public through relevant Web sites. For
this reason, please do not include in
your comments information of a
confidential nature, such as sensitive
personal information or proprietary
information. If you send an email
SUMMARY:
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comment, your email address will be
automatically captured and included as
part of the comment that is placed in the
public docket and made available on the
Internet. Please note that responses to
this public comment request containing
any routine notice about the
confidentiality of the communication
will be treated as public comments that
may be made available to the public
notwithstanding the inclusion of the
routine notice.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrrette.funn@
HHS.GOV or (202) 795–7714.
SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery.
Abstract: The proposed information
collection activity provides a means to
garner qualitative customer and
stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
The solicitation of feedback will target
areas such as: Timeliness,
appropriateness, accuracy of
information, courtesy, efficiency of
service delivery, and resolution of
issues with service delivery. Responses
will be assessed to plan and inform
efforts to improve or maintain the
quality of service offered to the public.
If this information is not collected, vital
feedback from customers and
stakeholders on the Agency’s services
will be unavailable.
The Agency will only submit a
collection for approval under this
generic clearance if it meets the
following conditions:
• The collections are voluntary;
• The collections are low-burden for
respondents (based on considerations of
total burden hours, total number of
respondents, or burden-hours per
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Agencies
[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Pages 13635-13636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04975]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Council on the National Health Service Corps
AGENCY: Health Resources and Service Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, notice
[[Page 13636]]
is hereby given that a meeting is scheduled for National Advisory
Council on the National Health Service Corps (NACNHSC). This meeting
will be open to the public.
DATES: The meeting will be held on March 22, 2017 from 1:00 p.m.-4:00
p.m. EDT.
ADDRESSES: This meeting will be held in a webinar and conference call
format. Webinar information can be found on the Web site at: https://nhsc.hrsa.gov/corpsexperience/aboutus/nationaladvisorycouncil/meetingsummaries/.
Agenda: The members of the NACNHSC will discuss provider retention
in rural areas, the redesign of Area Health Education Centers, as well
as provide an update on Health Professional Shortage Area scoring.
Agenda items are subject to change as priorities dictate. The NACNHSC
final agenda will be available on the NACNHSC Web site 3 days in
advance of the meeting.
Information about the NACNHSC and the agenda for this meeting can
be obtained by accessing the following Web site: https://nhsc.hrsa.gov/corpsexperience/aboutus/nationaladvisorycouncil/meetingsummaries/.
FOR FURTHER INFORMATION CONTACT: Anyone requesting information
regarding the NACNHSC should contact CAPT Shari Campbell, Designated
Federal Official, Bureau of Health Workforce (BHW), HRSA in one of
three ways: (1) Send a request to the following address: CAPT Shari
Campbell, Designated Federal Official, BHW, HRSA, 5600 Fishers Lane,
Room 14N108, Rockville, Maryland 20857; (2) call (301) 594-4251; or (3)
send an email to scampbell@hrsa.gov.
SUPPLEMENTARY INFORMATION: The NACNHSC makes recommendations with
respect to their responsibilities under Subpart II, Part D of Title III
of the Public Health Service Act, as amended (National Health Service
Corps and Health Professional Shortage Area Designations), and shall
review and comment upon regulations promulgated by the Secretary under
Subpart II.
Members of the public will have the opportunity to provide
comments. Oral comments will be honored in the order they are requested
and may be limited as time allows. Requests to make oral comments or
provide written comments to the NACNHSC should be sent to Monica-Tia
Bullock at MBullock@hrsa.gov by March 17, 2017. Individuals who plan to
attend and need special assistance, such as sign language
interpretation or other reasonable accommodations, should contact
Monica-Tia Bullock at MBullock@hrsa.gov by March 17.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017-04975 Filed 3-13-17; 8:45 am]
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