46070 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions for 

membership: Caryn Cohen, Office of 

Science, Center for Tobacco Products, 

Food and Drug Administration, Center 

for Tobacco Products, Document 

Control Center, Building 71, Rm. G335, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 1–877–287– 

1373 (choose Option 5), TPSAC@

fda.hhs.gov. 

Information about becoming a 

member on an FDA advisory committee 

can also be obtained by visiting FDA’s 

Web site by using the following link: 

https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nomination for voting 

members on the Tobacco Products 

Scientific Advisory Committee. 

I. General Description of the Committee 

Duties 

The Tobacco Products Scientific 

Advisory Committee (the Committee) 

advises the Commissioner of Food and 

Drugs (the Commissioner) or designee in 

discharging responsibilities related to 

the regulation of tobacco products. The 

Committee reviews and evaluates safety, 

dependence, and health issues relating 

to tobacco products and provides 

appropriate advice, information, and 

recommendations to the Commissioner. 

II. Criteria for Voting Members 

The Committee consists of 12 

members including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

individuals knowledgeable in the fields 

of medicine, medical ethics, science, or 

technology involving the manufacture, 

evaluation, or use of tobacco products. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. The Committee includes 

nine technically qualified voting 

members, selected by the Commissioner 

or designee. The nine voting members 

include seven members who are 

physicians, dentists, scientists, or health 

care professionals practicing in the area 

of oncology, pulmonology, cardiology, 

toxicology, pharmacology, addiction, or 

any other relevant specialty. The nine 

voting members also include one 

member who is an officer or employee 

of a State or local government or of the 

Federal Government, and one member 

who is a representative of the general 

public. Almost all non-Federal members 

of this committee serve as Special 

Government Employees. Members will 

be invited to serve for terms of up to 4 

years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the advisory committee. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee and a signed copy of the 

Acknowledgement and Consent form 

available at the FDA Advisory 

Nomination Portal (see ADDRESSES). 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will ask 

potential candidates to provide detailed 

information concerning such matters 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 27, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21173 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–2530] 

Determination That SPECTAZOLE 

(Econazole Nitrate) Topical Cream, 1%, 

Was 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 SPECTAZOLE 

(econazole nitrate) topical cream, 1%, 

was 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 this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Nisha Shah, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6222, Silver Spring, 

MD 20993–0002, 301–796–4455. 

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, a drug is 

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. 

SPECTAZOLE (econazole nitrate) 

topical cream, 1%, is the subject of NDA 

018751, held by Alvogen Malta 

Operations Ltd., and initially approved 

on December 23, 1982. SPECTAZOLE is 

indicated for topical application in the 

treatment of tinea pedis, tinea cruris, 

and tinea corporis caused by 

Trichophyton rubrum, Trichophyton 

mentagrophytes, Trichophyton 

tonsurans, Microsporum canis, 

Microsporum audouini, Microsporum 

gypseum, and Epidermophyton 

floccosum; in the treatment of 

cutaneous candidiasis; and in the 

treatment of tinea versicolor. 

SPECTAZOLE (econazole nitrate) 

topical cream, 1%, is currently listed in 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46071 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Lachman Consultant Services, Inc. 

submitted a citizen petition dated April 

21, 2017 (Docket No. FDA–2017–P– 

2530), under 21 CFR 10.30, requesting 

that the Agency determine whether 

SPECTAZOLE (econazole nitrate) 

topical cream, 1%, was 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 SPECTAZOLE (econazole 

nitrate) topical cream, 1%, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that SPECTAZOLE 

(econazole nitrate) topical cream, 1%, 

was withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

SPECTAZOLE (econazole nitrate) 

topical cream, 1%, 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 SPECTAZOLE 

(econazole nitrate) topical cream, 1%, 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: September 27, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21174 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5739] 

Formal Meetings Between the Food 

and Drug Administration and 

Abbreviated New Drug Application 

Applicants of Complex Products Under 

Generic Drug User Fee Act; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Formal 

Meetings Between FDA and ANDA 

Applicants of Complex Products Under 

GDUFA.’’ This draft guidance describes 

an enhanced pathway for discussions 

between FDA and a prospective 

applicant preparing to submit (or an 

applicant that has submitted) to FDA an 

abbreviated new drug application 

(ANDA) for a complex product. 

Specifically, this draft guidance 

provides information on requesting and 

conducting product development 

meetings, pre-submission meetings, and 

mid-review-cycle meetings with FDA. 

This draft guidance will assist 

applicants in generating and submitting 

a meeting request and the associated 

meeting package to FDA for complex 

products to be submitted under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) and as contemplated in the 

commitments made by FDA in 

connection with the reauthorization of 

the Generic Drug User Fee Amendments 

for Fiscal Years (FYs) 2018–2022 

(GDUFA II). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 4, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to Dockets Management Staff, 

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– 

2017–D–5739 for ‘‘Formal Meetings 

Between FDA and ANDA Applicants of 

Complex Products Under GDUFA; Draft 

Guidance for Industry; Availability.’’ 

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 

Dockets Management Staff 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 Dockets Management 

Staff. If you do not wish your name and 


asabaliauskas on DSKBBXCHB2PROD with NOTICES