Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee, Renewal, 71104-71105 [2016-24816]
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Federal Register / Vol. 81, No. 199 / Friday, October 14, 2016 / Notices
Opportunity Reconciliation Act of 1996
(PRWORA), Public Law 104–193. Tribal
entities with approved Tribal plans for
Administration for Children and
implementation of the TANF program
Families
are required by Section 412(h) of the
Social Security Act to report financial
Submission for OMB Review;
data. Form ACF–196T provides for the
Comment Request
collection of data regarding Federal
Title: Form ACF–196: TANF Financial expenditures. Failure to collect this data
would seriously compromise the
Report for Tribes.
Administration for Children and
OMB No.: 0970–0345.
Families’ (ACF) ability to monitor
Description: Tribes use Form ACF–
expenditures. This information is also
196T to report expenditures for the
used to estimate outlays and may be
Tribal TANF grant. Authority to collect
used to prepare ACF budget
and report this information is found in
submissions to Congress. Financial
the Personal Responsibility and Work
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
management of the program would be
seriously compromised if the
expenditure data were not collected. 45
CFR part 286 Subpart E requires the
strictest controls on funding
requirements, which necessities review
of documentation in support of Tribal
expenditures for reimbursement.
Comments received from previous
efforts to implement a similar Tribal
TANF report Form ACF–196T were
used to guide ACF in the development
of the product presented with this
submittal.
Respondents: All Tribal TANF
Agencies.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF–196T ........................................................................................................
72
4
1.5
432
Estimated Total Annual Burden
Hours: 432.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–24829 Filed 10–13–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Dermatologic
and Ophthalmic Drugs Advisory
Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Dermatologic and
Ophthalmic Drugs Advisory Committee
by the Commissioner of Food and Drugs
(the Commissioner). The Commissioner
has determined that it is in the public
interest to renew the Dermatologic and
Ophthalmic Drugs Advisory Committee
for an additional 2 years beyond the
charter expiration date. The new charter
will be in effect until October 7, 2018.
DATES: Authority for the Dermatologic
and Ophthalmic Drugs Advisory
Committee will expire on October 7,
2016, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, email: DODAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
SUMMARY:
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Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Dermatologic and Ophthalmic Drugs
Advisory Committee. The committee is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Dermatologic
and Ophthalmic Drugs Advisory
Committee advises the Commissioner or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective drugs for human use and,
as required, any other product for which
the Food and Drug Administration has
regulatory responsibility. The
Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of dermatologic and
ophthalmic disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core
of nine voting members including two
Chairpersons. Members and the
Chairpersons are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of dermatology, ophthalmology, internal
medicine, pathology, immunology,
epidemiology or statistics, and other
related professions. Members will be
invited to serve for overlapping terms of
up to 4 years. Almost all non-Federal
members of this committee serve as
Special Government Employees. The
core of voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
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Federal Register / Vol. 81, No. 199 / Friday, October 14, 2016 / Notices
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
DermatologicandOphthalmic
DrugsAdvisoryCommittee/
ucm094782.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: October 7, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–24816 Filed 10–13–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2483]
Software as a Medical Device: Clinical
Evaluation; International Medical
Device Regulators Forum; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance entitled ‘‘Software as a
Medical Device (SaMD): Clinical
Evaluation.’’ The draft guidance was
prepared under the auspices of the
International Medical Device Regulators
Forum (IMDRF), formerly the Global
Harmonization Task Force. The draft
guidance pertains to the conduct of
clinical evaluation of Software as a
Medical Device (SaMD) and focuses on
the general principles of clinical
evaluation, which includes establishing
the scientific validity, clinical
performance, and analytical validity for
a SaMD. The draft guidance is intended
to provide globally harmonized
principles of when and what type of
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clinical evaluation is appropriate based
on the risk of the SaMD. This draft
guidance is not final nor is it in effect
at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 13,
2016.
ADDRESSES: You may submit comments
as follows:
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/Paper Submissions
Submit written/paper submissions as
follows:
• 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–
2016–D–2483 for ‘‘Software as a
Medical Device (SaMD): Clinical
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71105
Evaluation.’’ 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, 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.
An electronic copy of the guidance
document is available for download
from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Software as a
Medical Device (SaMD): Clinical
Evaluation’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
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[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)]
[Notices]
[Pages 71104-71105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24816]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory
Committee, Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee by
the Commissioner of Food and Drugs (the Commissioner). The Commissioner
has determined that it is in the public interest to renew the
Dermatologic and Ophthalmic Drugs Advisory Committee for an additional
2 years beyond the charter expiration date. The new charter will be in
effect until October 7, 2018.
DATES: Authority for the Dermatologic and Ophthalmic Drugs Advisory
Committee will expire on October 7, 2016, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, email: DODAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee.
The committee is a discretionary Federal advisory committee established
to provide advice to the Commissioner. The Dermatologic and Ophthalmic
Drugs Advisory Committee advises the Commissioner or designee in
discharging responsibilities as they relate to helping to ensure safe
and effective drugs for human use and, as required, any other product
for which the Food and Drug Administration has regulatory
responsibility. The Committee reviews and evaluates available data
concerning the safety and effectiveness of marketed and investigational
human drug products for use in the treatment of dermatologic and
ophthalmic disorders and makes appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core of nine voting members
including two Chairpersons. Members and the Chairpersons are selected
by the Commissioner or designee from among authorities knowledgeable in
the fields of dermatology, ophthalmology, internal medicine, pathology,
immunology, epidemiology or statistics, and other related professions.
Members will be invited to serve for overlapping terms of up to 4
years. Almost all non-Federal members of this committee serve as
Special Government Employees. The core of voting members may include
one technically qualified member, selected by the Commissioner or
designee, who is identified with consumer interests and is recommended
by either a
[[Page 71105]]
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting member who is identified with industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmicDrugsAdvisoryCommittee/ucm094782.htm or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no change has been made to the
committee name or description of duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: October 7, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-24816 Filed 10-13-16; 8:45 am]
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