82 FR 41623 - Federal Advisory Committee, Diversity and Digital Empowerment
FEDERAL COMMUNICATIONS COMMISSION Federal Register Volume 82, Issue 169 (September 1, 2017)
Federal Register Volume 82, Issue 169 (September 1, 2017)
| Page Range | 41623-41624 | |
| FR Document | 2017-18550 |
[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)] [Notices] [Pages 41623-41624] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]; or Brenda Villanueva, Deputy Designated Federal Officer, (202) 418-7005, [email protected]. 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 [email protected] 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
![Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices 41623
Respondents: Business or other for- Fund (RAF) to ensure that Americans Committee on Diversity and Digital
profit entities, not-for-profit institutions, living in the most remote areas in the Empowerment (ACDDE).
and state, local or tribal governments. nation, where the cost of deploying DATES: Monday, September 25, 2017,
Number of Respondents and traditional terrestrial broadband beginning at 10:00 a.m.
Responses: 750 respondents and 750 networks is extremely high, can obtain ADDRESSES: Federal Communications
responses. affordable access through alternative Commission, 445 12th Street SW., Room
Estimated Time per Response: 1.5 technology platforms, including satellite TW–C305, Washington, DC 20554.
hours. and unlicensed wireless services. FOR FURTHER INFORMATION CONTACT:
Frequency of Response: On occasion To implement these reforms and
reporting requirement. Jamila Bess Johnson, Designated Federal
conduct competitive bidding for CAF, Officer, Federal Communications
Obligation To Respond: Required to
MF, and RAF support, the Commission Commission, Media Bureau, (202) 418–
obtain or retain benefits. Statutory
adopted new rules containing 2608, Jamila-Bess.Johnson@fcc.gov; or
authority for this information collection
information collection requirements that Brenda Villanueva, Deputy Designated
47 U.S.C. 154, 254 and 303(r).
Total Annual Burden: 1,125 hours. would be used to determine whether an Federal Officer, (202) 418–7005,
Total Annual Cost: No cost. applicant is generally qualified to bid Brenda.Villanueva@fcc.gov.
Nature and Extent of Confidentiality: for universal service support. The SUPPLEMENTARY INFORMATION: This
There is no need for confidentiality. Commission also adopted rules meeting is open to members of the
Information collected in each containing information collection public. The FCC will accommodate as
application for universal service support requirements that would be used to many attendees as possible; however,
will be made available for public determine whether an applicant is admittance will be limited to seating
inspection, and the Commission is not specifically qualified to bid for Phase I availability. The Commission will also
requesting that respondents submit of the Mobility Fund and Tribal provide audio and video coverage of the
confidential information to the Mobility Fund. meeting over the Internet at
Commission as part of the pre-auction Because support under Phase I of the www.fcc.gov/live. Oral statements at the
application process. Respondents Mobility Fund and Tribal Mobility Fund meeting by parties or entities not
seeking to have information collected on has been awarded, the Commission is represented on the ACDDE will be
an application for universal service revising the currently approved permitted to the extent time permits and
support withheld from public information collection to remove the at the discretion of the ACDDE Chair
inspection may request confidential information collections requirements and the DFO. Members of the public
treatment of such information pursuant that apply specifically to applicants may submit comments to the ACDDE in
to section 0.459 of the Commission’s seeking to participate in competitive the FCC’s Electronic Comment Filing
rules, 47 CFR 0.459. bidding for Mobility Fund Phase I and System, ECFS, at www.fcc.gov/ecfs.
Privacy Act Impact Assessment: No Tribal Mobility Fund Phase I support Comments to the ACDDE should be
impact(s). and to retain only those information filed in GN Docket No. 17–208.
Needs and Uses: The Commission collections requirements that apply Open captioning will be provided for
will use the information collected to generally to applicants seeking to this event. Other reasonable
determine whether applicants are participate in competitive bidding for accommodations for persons with
eligible to participate in auctions for universal service support. The disabilities are available upon request.
Universal Service Fund support. On Commission also requests that the title Requests for such accommodations
November 18, 2011, the Commission of this information collection be should be submitted via email to
released an order comprehensively changed to ‘‘Section 1.21001, fcc504@fcc.gov or by calling the
reforming and modernizing the Participation in Competitive Bidding for Consumer and Governmental Affairs
universal service and intercarrier Support; Section 1.21002, Prohibition of Bureau at (202) 418–0530 (voice), (202)
compensation systems to ensure that Certain Communications During the 418–0432 (TTY). Such requests should
robust, affordable voice and broadband Competitive Bidding Process’’ to reflect include a detailed description of the
service, both fixed and mobile, are the revised information collection. accommodation needed. In addition,
available to Americans throughout the Federal Communications Commission. please include a way for the FCC to
nation. Connect America Fund et al., Katura Jackson, contact the requester if more
Order and Further Notice of Proposed information is needed to fulfill the
Federal Register Liaison Officer, Office of the
Rulemaking, 26 FCC Rcd 17663 (2011) Secretary. request. Please allow at least five days’
(USF/ICC Transformation Order). In notice; last minute requests will be
[FR Doc. 2017–18542 Filed 8–31–17; 8:45 am]
adopting the USF/ICC Transformation accepted, but may not be possible to
BILLING CODE 6712–01–P
Order, the Commission created the accommodate.
Connect America Fund (CAF) to help Proposed Agenda: At this meeting,
make broadband available to homes, FEDERAL COMMUNICATIONS the agenda will include introduction of
businesses, and community anchor COMMISSION members of the ACDDE, including the
institutions in areas that do not, or Committee Chair and Vice Chair,
would not otherwise, have broadband. Federal Advisory Committee, Diversity establish working groups that will assist
In addition, the Commission created the and Digital Empowerment ACDDE in carrying out its work, and
Connect America Mobility Fund (MF) to generally discuss the Committee’s
ensure the availability of mobile AGENCY: Federal Communications mission to provide recommendations to
sradovich on DSK3GMQ082PROD with NOTICES
broadband networks in areas where a Commission. the FCC on how to empower
private-sector business case is lacking ACTION: Notice. disadvantaged communities and
and a separate and complementary one- accelerate the entry of small businesses,
time Tribal Mobility Fund Phase I to SUMMARY: In this document, the Federal including those owned by women and
accelerate mobile voice and broadband Communications Commission (FCC or minorities, into the media, digital news
availability in Tribal areas. Finally, the Commission) announces the first and information, and audio and video
Commission created the Remote Areas meeting and agenda of the Advisory 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 gain approval of a new drug application reasons of safety or effectiveness. We
well as recommendations on how to (NDA). have carefully reviewed our files for
ensure that disadvantaged communities The 1984 amendments include what records concerning the withdrawal of
are not denied the wide range of is now section 505(j)(7) of the Federal NIZORAL (ketoconazole) tablets, 200
opportunities made possible by next- Food, Drug, and Cosmetic Act (21 U.S.C. mg, from sale. We have also
generation networks. This agenda may 355(j)(7)), which requires FDA to independently evaluated relevant
be modified at the discretion of the publish a list of all approved drugs. literature and data for possible
ACDDE Chair and the DFO. FDA publishes this list as part of the postmarketing adverse events. We have
‘‘Approved Drug Products With reviewed the available evidence and
Federal Communications Commission.
Therapeutic Equivalence Evaluations,’’ determined that this drug product was
Thomas Horan,
which is known generally as the not withdrawn from sale for reasons of
Chief of Staff, Media Bureau. ‘‘Orange Book.’’ Under FDA regulations, safety or effectiveness.
[FR Doc. 2017–18550 Filed 8–31–17; 8:45 am] drugs are removed from the list if the Accordingly, the Agency will
BILLING CODE 6712–01–P Agency withdraws or suspends continue to list NIZORAL
approval of the drug’s NDA or ANDA (ketoconazole) tablets, 200 mg, in the
for reasons of safety or effectiveness or ‘‘Discontinued Drug Product List’’
DEPARTMENT OF HEALTH AND if FDA determines that the listed drug section of the Orange Book. The
HUMAN SERVICES was withdrawn from sale for reasons of ‘‘Discontinued Drug Product List’’
safety or effectiveness (21 CFR 314.162). delineates, among other items, drug
Food and Drug Administration A person may petition the Agency to products that have been discontinued
determine, or the Agency may from marketing for reasons other than
[Docket No. FDA–2017–N–5079] determine on its own initiative, whether safety or effectiveness. FDA will not
a listed drug was withdrawn from sale begin procedures to withdraw approval
Determination That NIZORAL for reasons of safety or effectiveness. of approved ANDAs that refer to
(Ketoconazole) Tablets, 200 Milligrams, This determination may be made at any NIZORAL. Additional ANDAs that refer
Were Not Withdrawn From Sale for time after the drug has been withdrawn to NIZORAL (ketoconazole) tablets, 200
Reasons of Safety or Effectiveness from sale, but must be made prior to mg, may also be approved by the
AGENCY: Food and Drug Administration, approving an ANDA that refers to the Agency as long as they meet all other
HHS. listed drug (§ 314.161 (21 CFR 314.161)). legal and regulatory requirements for
FDA may not approve an ANDA that the approval of ANDAs. If FDA
ACTION: Notice.
does not refer to a listed drug. determines that labeling for this drug
SUMMARY: The Food and Drug NIZORAL (ketoconazole) tablets, 200 product should be revised to meet
Administration (FDA or Agency) has mg, is the subject of NDA 018–533 and current standards, the Agency will
determined that NIZORAL was originally held by Johnson & advise ANDA applicants to submit such
(ketoconazole) tablets, 200 milligrams Johnson Research and Development, labeling.
(mg), were not withdrawn from sale for L.L.C., now known as Janssen Research Dated: August 28, 2017.
reasons of safety or effectiveness. This & Development, L.L.C. (Janssen). It was
Anna K. Abram,
determination means that FDA will not initially approved on June 12, 1981.
NIZORAL should be used only when Deputy Commissioner for Policy, Planning,
begin procedures to withdraw approval Legislation, and Analysis.
of abbreviated new drug applications other effective antifungal therapy is not
available or tolerated and the potential [FR Doc. 2017–18548 Filed 8–31–17; 8:45 am]
(ANDAs) that refer to NIZORAL, and it BILLING CODE 4164–01–P
will allow FDA to continue to approve benefits are considered to outweigh the
ANDAs that reference NIZORAL as long potential risks. NIZORAL is indicated
as they meet relevant legal and for the treatment of the following
systemic fungal infections in patients DEPARTMENT OF HEALTH AND
regulatory requirements. HUMAN SERVICES
who have failed or who are intolerant to
FOR FURTHER INFORMATION CONTACT: other therapies: blastomycosis,
Robin Fastenau, Center for Drug Food and Drug Administration
coccidioidomycosis, histoplasmosis,
Evaluation Research, Food and Drug chromomycosis, and [Docket No. FDA–2017–N–4302]
Administration, 10903 New Hampshire paracoccidioidomycosis.
Ave., Bldg. 51, Rm. 6236, Silver Spring, In a letter dated May 22, 2008, Electronic Study Data Submission;
MD 20993–0002, 240–402–4510. Janssen, which at that time was Data Standards; Support End Date for
SUPPLEMENTARY INFORMATION: In 1984, operating as Johnson & Johnson Study Data Tabulation Model Version
Congress enacted the Drug Price Pharmaceutical Research & 1.2, Implementation Guide Version
Competition and Patent Term Development, L.L.C., acting on behalf of 3.1.2, and Implementation Guide
Restoration Act of 1984 (Pub. L. 98–417) Ortho-McNeil-Janssen Pharmaceuticals, Version 3.1.2, Amendment 1
(the 1984 amendments), which Inc., notified FDA that NIZORAL AGENCY: Food and Drug Administration,
authorized the approval of duplicate (ketoconazole) tablets, 200 mg, were HHS.
versions of drug products under an being discontinued and requested ACTION: Notice.
ANDA procedure. ANDA applicants withdrawal of NDA 018–533. In the
must, with certain exceptions, show that Federal Register of October 13, 2015 (80 SUMMARY: The Food and Drug
the drug for which they are seeking Administration’s (FDA or Agency)
sradovich on DSK3GMQ082PROD with NOTICES
FR 61426), FDA announced that it was
approval contains the same active withdrawing approval of NDA 018–533, Center for Biologics Evaluation and
ingredient in the same strength and effective November 12, 2015. Research (CBER) and Center for Drug
dosage form as the ‘‘listed drug,’’ which After reviewing Agency records and Evaluation and Research (CDER) are
is a version of the drug that was based on the information we have at this announcing the end of support for
previously approved. ANDA applicants time, FDA has determined under Version 1.2 of Clinical Data Interchange
do not have to repeat the extensive § 314.161 that NIZORAL (ketoconazole) Standards Consortium Study Data
clinical testing otherwise necessary to tablets, 200 mg, were not withdrawn for Tabulation Model (SDTM) and an
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Document Created: 2017-09-01 01:50:42
Document Modified: 2017-09-01 01:50:42
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Monday, September 25, 2017, beginning at 10:00 a.m. | |
| Contact | Jamila Bess Johnson, Designated Federal Officer, Federal Communications Commission, Media Bureau, (202) 418-2608, [email protected]; or Brenda Villanueva, Deputy Designated Federal Officer, (202) 418-7005, [email protected] | |
| FR Citation | 82 FR 41623 |
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