Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 38911 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6213, 

Silver Spring, MD 20993–0002, 301– 

348–3035. 

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was withdrawn from sale for reasons of 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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. 

CORDARONE (amiodarone 

hydrochloride) tablets, 200 mg, are the 

subject of NDA 018972, held by Wyeth 

Pharmaceuticals, Inc. (a subsidiary of 

Pfizer, Inc.), and initially approved on 

December 24, 1985. CORDARONE is 

indicated for the treatment of the 

following documented, life-threatening 

recurrent ventricular arrhythmias when 

these have not responded to 

documented adequate doses of other 

available antiarrhythmics or when 

alternative agents could not be tolerated: 

(1) Recurrent ventricular fibrillation and 

(2) recurrent hemodynamically unstable 

ventricular tachycardia. 

In correspondence dated February 7, 

2017, Pfizer, Inc. notified FDA that 

CORDARONE (amiodarone 

hydrochloride) tablets, 200 mg, were 

being discontinued, and FDA moved the 

drug product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Lachman Consultant Services, Inc. 

submitted a citizen petition dated 

January 25, 2017 (Docket No. FDA– 

2017–P–0495), under 21 CFR 10.30, 

requesting that the Agency determine 

whether CORDARONE (amiodarone 

hydrochloride) tablets, 200 mg, were 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that CORDARONE 

(amiodarone hydrochloride) tablets, 200 

mg, were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that 

CORDARONE (amiodarone 

hydrochloride) tablets, 200 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

CORDARONE (amiodarone 

hydrochloride) 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 CORDARONE 

(amiodarone hydrochloride) 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 this 

drug product. Additional ANDAs for 

this drug product 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 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–17302 Filed 8–15–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–3966] 

Upsher-Smith Laboratories, Inc.; 

Withdrawal of Approval of an 

Abbreviated New Drug Application for 

ZALEPLON 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

withdrawing approval of an abbreviated 

new drug application (ANDA) for 

ZALEPLON Capsules, 5 milligrams (mg) 

and 10 mg, held by Upsher-Smith 

Laboratories, Inc. (Upsher-Smith), 6701 

Evenstad Dr., Maple Grove, MN 55369. 

Upsher-Smith has voluntarily requested 

that approval of this application be 

withdrawn, and has waived its 

opportunity for a hearing. 

DATES: Effective August 16, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Stefanie Kraus, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6215, 

Silver Spring, MD 20993–0002, 301– 

796–9585. 

SUPPLEMENTARY INFORMATION: On June 6, 

2008, FDA approved ANDA 078706 for 

ZALEPLON Capsules, 5 mg and 10 mg, 

submitted by Upsher-Smith. According 

to annual reports Upsher-Smith filed 

with the Agency, Upsher-Smith stopped 

distributing these products by April 6, 

2010. In a letter dated August 9, 2011, 

FDA informed Upsher-Smith that it had 

concerns about the validity of 

bioequivalence data submitted with 

ANDA 078706 from studies conducted 

by a certain contract research 

organization, establishing 

bioequivalence of Upsher-Smith’s 

product to the reference listed drug, 

SONATA (ZALEPLON) Capsules, 5 mg 

and 10 mg. In that letter, FDA directed 

Upsher-Smith to supplement its ANDA 

with either: (1) New bioequivalence 

studies or (2) re-assays of the samples 

from the original bioequivalence 

studies. Upsher-Smith did not respond 

to this letter. FDA then sent another 

letter to Upsher-Smith on August 19, 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
38912 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 

2016, requesting that Upsher-Smith 

provide the requested bioequivalence 

data within 30 calendar days or 

voluntarily seek withdrawal of ANDA 

078706 under section 314.150(d) (21 

CFR 314.150(d)). 

In a letter dated September 15, 2016, 

Upsher-Smith informed FDA that it did 

not intend to submit the requested 

bioequivalence data and requested that 

the Agency withdraw approval of 

ANDA 078706 for ZALEPLON Capsules 

under section 314.150(d). In that letter, 

Upsher-Smith also waived any 

opportunity for a hearing otherwise 

provided under section 314.150(a). 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 355(e)) and 

314.150(d), approval of ANDA 078706, 

and all amendments and supplements 

thereto, is withdrawn (see DATES). 

Distribution of this product in interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the FD&C Act (21 U.S.C. 

355(a) and 331(d)). 

Dated: August 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–17301 Filed 8–15–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Solicitation of Nominations for 

Appointment to the Tick-Borne 

Disease Working Group; Amendment 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice; amendment. 

SUMMARY: A notice was published in the 

Federal Register on Monday, July 17, 

2017 (Vol. 82, No. 135, pages 32711– 

32712), to solicit nominations of 

individuals who are interested in being 

considered for appointment to the TickBorne Disease Working Group (Working 

Group). The nomination period is 

scheduled to end close of business on 

August 16, 2017. The notice is being 

amended to extend the solicitation 

period for one week to allow more time 

for interested individuals to submit 

nominations. 

DATES: The solicitation period has been 

extended. All nominations are due to be 

submitted on or before August 23, 2017. 

ADDRESSES: All nominations should be 

sent to: CAPT Richard Henry; Office of 

the Assistant Secretary for Health; 

Department of Health and Human 

Services; 330 C Street SW., Suite L100, 

Washington, DC 20024. Nomination 

materials, including attachments, also 

may be submitted electronically to 

tickbornedisease@hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Richard Henry, Office of the 

Assistant Secretary for Health; 

Department of Health and Human 

Services; Telephone: (202) 795–7615; 

Email address: richard.henry@hhs.gov. 

Dated: August 10, 2017. 

Donald Wright, 

Acting Assistant Secretary for Health. 

[FR Doc. 2017–17323 Filed 8–15–17; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Presidential Advisory 

Council on Combating AntibioticResistant Bacteria 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that a meeting is scheduled to be held 

for the Presidential Advisory Council on 

Combating Antibiotic-Resistant Bacteria 

(Advisory Council). The meeting will be 

open to the public; a public comment 

session will be held during the meeting. 

Pre-registration is required for members 

of the public who wish to attend the 

meeting and who wish to participate in 

the public comment session. Individuals 

who wish to attend the meeting and/or 

send in their public comment via email 

should send an email to CARB@hhs.gov. 

Registration information is available on 

the Web site http://www.hhs.gov/ash/ 

carb/ and must be completed by 

September 5, 2017; all in-person 

attendees must pre-register by this date. 

Additional information about registering 

for the meeting and providing public 

comment can be obtained at http://

www.hhs.gov/ash/carb/ on the Meetings 

page. 

DATES: The meeting is scheduled to be 

held on September 13, 2017, from 9:00 

a.m. to 5:00 p.m. ET, and September 14, 

2017, from 9:00 a.m. to 3:00 p.m. ET 

(times are tentative and subject to 

change). The confirmed times and 

agenda items for the meeting will be 

posted on the Web site for the Advisory 

Council at http://www.hhs.gov/ash/ 

carb/ when this information becomes 

available. Pre-registration for attending 

the meeting in person is required to be 

completed no later than September 5, 

2017; public attendance at the meeting 

is limited to the available space. 

ADDRESSES: U.S. Department of Health 

and Human Services, Hubert H. 

Humphrey Building, Great Hall, 200 

Independence Avenue SW., 

Washington, DC 20201. 

The meeting can also be accessed 

through a live webcast on the day of the 

meeting. For more information, visit 

http://www.hhs.gov/ash/carb/. 

FOR FURTHER INFORMATION CONTACT: 

Jomana Musmar, Acting Designated 

Federal Officer, Presidential Advisory 

Council on Combating AntibioticResistant Bacteria, Office of the 

Assistant Secretary for Health, U.S. 

Department of Health and Human 

Services, Room 715H, Hubert H. 

Humphrey Building, 200 Independence 

Avenue SW., Washington, DC 20201. 

Phone: (202) 690–5566; email: CARB@

hhs.gov. 

SUPPLEMENTARY INFORMATION: Under 

Executive Order 13676, dated 

September 18, 2014, authority was given 

to the Secretary of HHS to establish the 

Advisory Council, in consultation with 

the Secretaries of Defense and 

Agriculture. Activities of the Advisory 

Council are governed by the provisions 

of Public Law 92–463, as amended (5 

U.S.C. App.), which sets forth standards 

for the formation and use of federal 

advisory committees. 

The Advisory Council will provide 

advice, information, and 

recommendations to the Secretary of 

HHS regarding programs and policies 

intended to support and evaluate the 

implementation of Executive Order 

13676, including the National Strategy 

for Combating Antibiotic-Resistant 

Bacteria and the National Action Plan 

for Combating Antibiotic-Resistant 

Bacteria. The Advisory Council shall 

function solely for advisory purposes. 

In carrying out its mission, the 

Advisory Council will provide advice, 

information, and recommendations to 

the Secretary regarding programs and 

policies intended to preserve the 

effectiveness of antibiotics by 

optimizing their use; advance research 

to develop improved methods for 

combating antibiotic resistance and 

conducting antibiotic stewardship; 

strengthen surveillance of antibioticresistant bacterial infections; prevent 

the transmission of antibiotic-resistant 

bacterial infections; advance the 

development of rapid point-of-care and 

agricultural diagnostics; further research 


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