Submission of Quality Metrics Data; Revised Draft Guidance for Industry; Extension of Comment Period, 2367-2368 [2017-00094]
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Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices
tribes.’’ Finally, ACF recently issued the
ACF Principles for Working with
Federally Recognized Indian Tribes,
effective October 20, 2016, that affirmed
ACF’s commitment to receive input
from elected tribal representatives as
well as ‘‘to otherwise ensure human
services coordination around issues
affecting AI/AN populations.’’
Consistent with the above affirmative
statements of the value of feedback from
AI/AN partners and stakeholders, ACF
is requesting information from AI/AN
tribes, tribal organizations, and
stakeholders (including grantees). The
purpose is to identify issues and
challenges facing AI/AN populations as
well as to inform ACF of tribes’ and
tribal organizations’ recommendations,
promising practices, and innovations to
address the needs of AI/AN children,
youth, families, and communities. This
information may, in turn, be used by
ACF in the development of future
rulemaking and technical assistance,
formation of legislative proposals and
research agendas, and strategic planning
in consultation with tribes.
II. Request for Information
As President Obama stated in his
Presidential Proclamation—National
Native American Heritage Month (2016):
sradovich on DSK3GMQ082PROD with NOTICES
Let us continue to build on the
advancements we have made, because
enduring progress will depend on our
dedication to honoring our trust and treaty
responsibilities. With sustained effort and
unwavering optimism, we can ensure a
vibrant and resilient Indian Country filled
with possibility and prosperity.
In this RFI, we seek feedback and
recommendations related to how ACF
partners with tribes and how to make
progress in the future. The following
questions are not exhaustive, and we
encourage commenters to provide any
additional information they believe
relevant to ACF’s work with and on
behalf of American Indians and Alaska
Natives. You may provide general
comments, respond to all questions
posed in section II of this RFI, or
respond to one or more questions. If you
respond to any of the questions in
section II, please identify the number
that corresponds to the question(s) you
are responding to. Include our agency
name and the docket number on all
submissions. Please do not include
confidential information, or otherwise
sensitive or protected information with
your responses.
(1) Are there challenges to AI/AN
tribes and tribal organizations posed by
non-federal match or cost sharing
requirements in any applicable ACF
programs? Please be specific as to the
program or programs you are referring to
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as well as provide as much detail as
possible in describing challenges or
difficulties posed and any specific
recommendations you wish to provide.
(2) Are there challenges to AI/AN
tribes and tribal organizations posed by
administrative cost caps required under
some ACF grant programs? Please be
specific as to the program or programs
you are referring to as well as provide
as much detail as possible in describing
challenges or difficulties posed and any
specific recommendations you wish to
provide.
(3) Are there instances for which you
believe waiver authority, additional
waiver authority allowed under block
grants, would benefit tribes under any
ACF programs? Please be specific as to
the program or programs you are
referring to as well as provide as much
detail as possible in describing
challenges or difficulties posed and any
specific recommendations you wish to
provide.
(4) For ACF programs that currently
have waiver authority for tribes, do you
recommend ACF streamline the
processes under which AI/AN tribes
and tribal organizations apply for or
request waivers of statutory or
regulatory requirements across ACF
grant programs? Please be specific as to
the program or programs you are
referring to as well as provide as much
detail as possible in describing where
you believe additional streamlining is
needed, along with any specific
recommendations you wish to provide.
(5) Are there regulatory or
administrative barriers that present
challenges to AI/AN tribes and tribal
organizations in the implementation of
ACF grant programs? Please be specific
about what those regulatory or
administrative barriers are as well as
recommendations for addressing them.
(6) Can you identify practices,
policies, and procedures in ACF or
elsewhere that are particularly effective
in meeting the needs of AI/AN tribes,
tribal organizations, families, and
communities? Please be specific as to
the program or programs you are
referring to as well as provide as much
detail as possible in describing effective
and responsive practices, policies, and
procedures.
(7) Related to data, what would you
recommend ACF either collect (if it does
not already) or analyze that would be
most useful to inform our work with
AI/AN tribes and tribal organizations?
Please be specific and provide as much
detail as possible.
(8) Do you have recommendations for
how ACF could better share data related
to AI/AN grantee program performance,
outcomes, and sustainability? Please be
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specific, including recommended use of
technological or other means of data
sharing.
(9) Are there elements of the
application process that could
potentially discourage AI/AN tribes or
organizations from applying for ACF
grants? If so, please specify what those
elements are and explain why those
elements could potentially discourage
prospective AI/AN applicants and any
recommendations for addressing such
barriers.
III. Response to Comments
Because of the large number of public
comments we normally receive, we are
not able to acknowledge or respond to
them individually. However, comments
will be accepted on this RFI through
https://www.Regulations.gov where you
will be able to track your own
comments and view other comments we
receive.
Dated: January 3, 2017.
Mark H. Greenberg
Acting Assistant Secretary for Children and
Families.
Dated: January 3, 2017.
Stacey Ecoffey,
Acting Deputy Assistant Secretary for Native
American Affairs and Acting Commissioner
Administration for Native Americans.
[FR Doc. 2017–00111 Filed 1–6–17; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–2537]
Submission of Quality Metrics Data;
Revised Draft Guidance for Industry;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA) is extending the
comment period for the notice of
revised draft guidance availability that
appeared in the Federal Register of
November 25, 2016. The Agency is
taking this action in response to
requests for an extension to allow
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the notice of revised draft
guidance availability published on
November 25, 2016 (81 FR 85226).
Submit either electronic or written
comments by March 27, 2017.
SUMMARY:
E:\FR\FM\09JAN1.SGM
09JAN1
2368
Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices
You may submit comments
by any of the following methods:
ADDRESSES:
sradovich on DSK3GMQ082PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written Submissions
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–D–2537 for ‘‘Submission of
Quality Metrics Data; Revised Draft
Guidance for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
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21:14 Jan 06, 2017
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copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
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(s), 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.
FOR FURTHER INFORMATION CONTACT: Tara
Gooen Bizjak, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2109,
Silver Spring, MD 20993–0002, 301–
796–3257 or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 25, 2016,
FDA published a notice of revised draft
guidance availability with a 60-day
comment period. Comments on the
notice of revised draft guidance
availability will inform FDA’s
development and proposed
implementation of a voluntary phase of
the quality metrics program.
FDA is extending the comment period
for an additional 60 days, until March
27, 2017. The Agency believes that a 60day extension of the comment period for
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the notice of revised draft guidance
availability will provide adequate time
for interested persons to submit
comments without significantly
delaying Agency decision making on
these important issues.
Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00094 Filed 1–6–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Circulatory System
Devices Panel of the Medical Devices
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public.
DATES: The meeting will be held on
February 23, 2017, from 8 a.m. to 6 p.m.
ADDRESSES: Hilton Washington, DC/
North, Salons A, B, C and D, 620 Perry
Pkwy., Gaithersburg, MD 20877. The
hotel’s phone number is 301–977–8900.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Evella Washington, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G640, Silver Spring,
MD 20993–0002, Evella.Washington@
fda.hhs.gov, 301–796–6683, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
SUMMARY:
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09JAN1
Agencies
[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2367-2368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00094]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-2537]
Submission of Quality Metrics Data; Revised Draft Guidance for
Industry; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period for the notice of revised draft guidance availability
that appeared in the Federal Register of November 25, 2016. The Agency
is taking this action in response to requests for an extension to allow
interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the notice of revised
draft guidance availability published on November 25, 2016 (81 FR
85226). Submit either electronic or written comments by March 27, 2017.
[[Page 2368]]
ADDRESSES: You may submit comments by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-D-2537 for ``Submission of Quality Metrics Data; Revised Draft
Guidance for Industry.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
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(s), 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.
FOR FURTHER INFORMATION CONTACT: Tara Gooen Bizjak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 301-
796-3257 or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 25,
2016, FDA published a notice of revised draft guidance availability
with a 60-day comment period. Comments on the notice of revised draft
guidance availability will inform FDA's development and proposed
implementation of a voluntary phase of the quality metrics program.
FDA is extending the comment period for an additional 60 days,
until March 27, 2017. The Agency believes that a 60-day extension of
the comment period for the notice of revised draft guidance
availability will provide adequate time for interested persons to
submit comments without significantly delaying Agency decision making
on these important issues.
Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00094 Filed 1-6-17; 8:45 am]
BILLING CODE 4164-01-P