Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices 41623 

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 

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 

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 


sradovich on DSK3GMQ082PROD with NOTICES
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. 

SUMMARY: 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 

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 

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. 

SUMMARY: 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 


sradovich on DSK3GMQ082PROD with NOTICES