Federal Advisory Committee, Diversity and Digital Empowerment, 41623-41624 [2017-18550]
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Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices
Respondents: Business or other forprofit entities, not-for-profit institutions,
and state, local or tribal governments.
Number of Respondents and
Responses: 750 respondents and 750
responses.
Estimated Time per Response: 1.5
hours.
Frequency of Response: On occasion
reporting requirement.
Obligation To Respond: Required to
obtain or retain benefits. Statutory
authority for this information collection
47 U.S.C. 154, 254 and 303(r).
Total Annual Burden: 1,125 hours.
Total Annual Cost: No cost.
Nature and Extent of Confidentiality:
There is no need for confidentiality.
Information collected in each
application for universal service support
will be made available for public
inspection, and the Commission is not
requesting that respondents submit
confidential information to the
Commission as part of the pre-auction
application process. Respondents
seeking to have information collected on
an application for universal service
support withheld from public
inspection may request confidential
treatment of such information pursuant
to section 0.459 of the Commission’s
rules, 47 CFR 0.459.
Privacy Act Impact Assessment: No
impact(s).
Needs and Uses: The Commission
will use the information collected to
determine whether applicants are
eligible to participate in auctions for
Universal Service Fund support. On
November 18, 2011, the Commission
released an order comprehensively
reforming and modernizing the
universal service and intercarrier
compensation systems to ensure that
robust, affordable voice and broadband
service, both fixed and mobile, are
available to Americans throughout the
nation. Connect America Fund et al.,
Order and Further Notice of Proposed
Rulemaking, 26 FCC Rcd 17663 (2011)
(USF/ICC Transformation Order). In
adopting the USF/ICC Transformation
Order, the Commission created the
Connect America Fund (CAF) to help
make broadband available to homes,
businesses, and community anchor
institutions in areas that do not, or
would not otherwise, have broadband.
In addition, the Commission created the
Connect America Mobility Fund (MF) to
ensure the availability of mobile
broadband networks in areas where a
private-sector business case is lacking
and a separate and complementary onetime Tribal Mobility Fund Phase I to
accelerate mobile voice and broadband
availability in Tribal areas. Finally, the
Commission created the Remote Areas
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Fund (RAF) to ensure that Americans
living in the most remote areas in the
nation, where the cost of deploying
traditional terrestrial broadband
networks is extremely high, can obtain
affordable access through alternative
technology platforms, including satellite
and unlicensed wireless services.
To implement these reforms and
conduct competitive bidding for CAF,
MF, and RAF support, the Commission
adopted new rules containing
information collection requirements that
would be used to determine whether an
applicant is generally qualified to bid
for universal service support. The
Commission also adopted rules
containing information collection
requirements that would be used to
determine whether an applicant is
specifically qualified to bid for Phase I
of the Mobility Fund and Tribal
Mobility Fund.
Because support under Phase I of the
Mobility Fund and Tribal Mobility Fund
has been awarded, the Commission is
revising the currently approved
information collection to remove the
information collections requirements
that apply specifically to applicants
seeking to participate in competitive
bidding for Mobility Fund Phase I and
Tribal Mobility Fund Phase I support
and to retain only those information
collections requirements that apply
generally to applicants seeking to
participate in competitive bidding for
universal service support. The
Commission also requests that the title
of this information collection be
changed to ‘‘Section 1.21001,
Participation in Competitive Bidding for
Support; Section 1.21002, Prohibition of
Certain Communications During the
Competitive Bidding Process’’ to reflect
the revised information collection.
Federal Communications Commission.
Katura Jackson,
Federal Register Liaison Officer, Office of the
Secretary.
[FR Doc. 2017–18542 Filed 8–31–17; 8:45 am]
BILLING CODE 6712–01–P
FEDERAL COMMUNICATIONS
COMMISSION
Federal Advisory Committee, Diversity
and Digital Empowerment
Federal Communications
Commission.
ACTION: Notice.
AGENCY:
In this document, the Federal
Communications Commission (FCC or
Commission) announces the first
meeting and agenda of the Advisory
SUMMARY:
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41623
Committee on Diversity and Digital
Empowerment (ACDDE).
DATES: Monday, September 25, 2017,
beginning at 10:00 a.m.
ADDRESSES: Federal Communications
Commission, 445 12th Street SW., Room
TW–C305, Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
Jamila Bess Johnson, Designated Federal
Officer, Federal Communications
Commission, Media Bureau, (202) 418–
2608, Jamila-Bess.Johnson@fcc.gov; or
Brenda Villanueva, Deputy Designated
Federal Officer, (202) 418–7005,
Brenda.Villanueva@fcc.gov.
SUPPLEMENTARY INFORMATION: This
meeting is open to members of the
public. The FCC will accommodate as
many attendees as possible; however,
admittance will be limited to seating
availability. The Commission will also
provide audio and video coverage of the
meeting over the Internet at
www.fcc.gov/live. Oral statements at the
meeting by parties or entities not
represented on the ACDDE will be
permitted to the extent time permits and
at the discretion of the ACDDE Chair
and the DFO. Members of the public
may submit comments to the ACDDE in
the FCC’s Electronic Comment Filing
System, ECFS, at www.fcc.gov/ecfs.
Comments to the ACDDE should be
filed in GN Docket No. 17–208.
Open captioning will be provided for
this event. Other reasonable
accommodations for persons with
disabilities are available upon request.
Requests for such accommodations
should be submitted via email to
fcc504@fcc.gov or by calling the
Consumer and Governmental Affairs
Bureau at (202) 418–0530 (voice), (202)
418–0432 (TTY). Such requests should
include a detailed description of the
accommodation needed. In addition,
please include a way for the FCC to
contact the requester if more
information is needed to fulfill the
request. Please allow at least five days’
notice; last minute requests will be
accepted, but may not be possible to
accommodate.
Proposed Agenda: At this meeting,
the agenda will include introduction of
members of the ACDDE, including the
Committee Chair and Vice Chair,
establish working groups that will assist
ACDDE in carrying out its work, and
generally discuss the Committee’s
mission to provide recommendations to
the FCC on how to empower
disadvantaged communities and
accelerate the entry of small businesses,
including those owned by women and
minorities, into the media, digital news
and information, and audio and video
programming industries, including as
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41624
Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices
owners, suppliers, and employees, as
well as recommendations on how to
ensure that disadvantaged communities
are not denied the wide range of
opportunities made possible by nextgeneration networks. This agenda may
be modified at the discretion of the
ACDDE Chair and the DFO.
Federal Communications Commission.
Thomas Horan,
Chief of Staff, Media Bureau.
[FR Doc. 2017–18550 Filed 8–31–17; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5079]
Determination That NIZORAL
(Ketoconazole) Tablets, 200 Milligrams,
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that NIZORAL
(ketoconazole) tablets, 200 milligrams
(mg), were not withdrawn from sale for
reasons of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to NIZORAL, and it
will allow FDA to continue to approve
ANDAs that reference NIZORAL as long
as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Robin Fastenau, Center for Drug
Evaluation Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 240–402–4510.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
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gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
NIZORAL (ketoconazole) tablets, 200
mg, is the subject of NDA 018–533 and
was originally held by Johnson &
Johnson Research and Development,
L.L.C., now known as Janssen Research
& Development, L.L.C. (Janssen). It was
initially approved on June 12, 1981.
NIZORAL should be used only when
other effective antifungal therapy is not
available or tolerated and the potential
benefits are considered to outweigh the
potential risks. NIZORAL is indicated
for the treatment of the following
systemic fungal infections in patients
who have failed or who are intolerant to
other therapies: blastomycosis,
coccidioidomycosis, histoplasmosis,
chromomycosis, and
paracoccidioidomycosis.
In a letter dated May 22, 2008,
Janssen, which at that time was
operating as Johnson & Johnson
Pharmaceutical Research &
Development, L.L.C., acting on behalf of
Ortho-McNeil-Janssen Pharmaceuticals,
Inc., notified FDA that NIZORAL
(ketoconazole) tablets, 200 mg, were
being discontinued and requested
withdrawal of NDA 018–533. In the
Federal Register of October 13, 2015 (80
FR 61426), FDA announced that it was
withdrawing approval of NDA 018–533,
effective November 12, 2015.
After reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that NIZORAL (ketoconazole)
tablets, 200 mg, were not withdrawn for
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reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
NIZORAL (ketoconazole) tablets, 200
mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NIZORAL
(ketoconazole) tablets, 200 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to
NIZORAL. Additional ANDAs that refer
to NIZORAL (ketoconazole) tablets, 200
mg, may also be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18548 Filed 8–31–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4302]
Electronic Study Data Submission;
Data Standards; Support End Date for
Study Data Tabulation Model Version
1.2, Implementation Guide Version
3.1.2, and Implementation Guide
Version 3.1.2, Amendment 1
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Biologics Evaluation and
Research (CBER) and Center for Drug
Evaluation and Research (CDER) are
announcing the end of support for
Version 1.2 of Clinical Data Interchange
Standards Consortium Study Data
Tabulation Model (SDTM) and an
SUMMARY:
E:\FR\FM\01SEN1.SGM
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Agencies
[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)]
[Notices]
[Pages 41623-41624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18550]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
Federal Advisory Committee, Diversity and Digital Empowerment
AGENCY: Federal Communications Commission.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In this document, the Federal Communications Commission (FCC
or Commission) announces the first meeting and agenda of the Advisory
Committee on Diversity and Digital Empowerment (ACDDE).
DATES: Monday, September 25, 2017, beginning at 10:00 a.m.
ADDRESSES: Federal Communications Commission, 445 12th Street SW., Room
TW-C305, Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT: Jamila Bess Johnson, Designated
Federal Officer, Federal Communications Commission, Media Bureau, (202)
418-2608, Jamila-Bess.Johnson@fcc.gov; or Brenda Villanueva, Deputy
Designated Federal Officer, (202) 418-7005, Brenda.Villanueva@fcc.gov.
SUPPLEMENTARY INFORMATION: This meeting is open to members of the
public. The FCC will accommodate as many attendees as possible;
however, admittance will be limited to seating availability. The
Commission will also provide audio and video coverage of the meeting
over the Internet at www.fcc.gov/live. Oral statements at the meeting
by parties or entities not represented on the ACDDE will be permitted
to the extent time permits and at the discretion of the ACDDE Chair and
the DFO. Members of the public may submit comments to the ACDDE in the
FCC's Electronic Comment Filing System, ECFS, at www.fcc.gov/ecfs.
Comments to the ACDDE should be filed in GN Docket No. 17-208.
Open captioning will be provided for this event. Other reasonable
accommodations for persons with disabilities are available upon
request. Requests for such accommodations should be submitted via email
to fcc504@fcc.gov or by calling the Consumer and Governmental Affairs
Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). Such requests
should include a detailed description of the accommodation needed. In
addition, please include a way for the FCC to contact the requester if
more information is needed to fulfill the request. Please allow at
least five days' notice; last minute requests will be accepted, but may
not be possible to accommodate.
Proposed Agenda: At this meeting, the agenda will include
introduction of members of the ACDDE, including the Committee Chair and
Vice Chair, establish working groups that will assist ACDDE in carrying
out its work, and generally discuss the Committee's mission to provide
recommendations to the FCC on how to empower disadvantaged communities
and accelerate the entry of small businesses, including those owned by
women and minorities, into the media, digital news and information, and
audio and video programming industries, including as
[[Page 41624]]
owners, suppliers, and employees, as well as recommendations on how to
ensure that disadvantaged communities are not denied the wide range of
opportunities made possible by next-generation networks. This agenda
may be modified at the discretion of the ACDDE Chair and the DFO.
Federal Communications Commission.
Thomas Horan,
Chief of Staff, Media Bureau.
[FR Doc. 2017-18550 Filed 8-31-17; 8:45 am]
BILLING CODE 6712-01-P