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topical cream, 1%, was withdrawn from 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withdrawn for reasons of safety or 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was withdrawn for reasons of safety or 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not withdrawn from sale for reasons of 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
46072 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Giaquinto Friedman, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1670, 

Silver Spring, MD 20993–0002, 240– 

402–7930, elizabeth.giaquinto@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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 an 

applicant (or prospective applicant) 

preparing to submit an ANDA for a 

complex product to FDA. 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 reflects a unified 

approach to all formal meetings between 

FDA and ANDA applicants or 

prospective ANDA applicants for 

complex products. This draft guidance 

is intended to assist ANDA applicants 

and prospective ANDA applicants in 

generating and submitting to FDA a 

meeting request and the associated 

meeting package for these complex 

products, as defined in this guidance, to 

be submitted under section 505(j) of the 

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

contemplated in GDUFA II. 

As part of the commitments FDA 

made in connection with GDUFA II, 

FDA agreed to develop a program to 

assist ANDA applicants and prospective 

ANDA applicants of complex products 

before the submission of an ANDA to 

FDA. As stated in the ‘‘GDUFA 

Reauthorization Performance Goals and 

Program Enhancements Fiscal Years 

2018–2022’’ (GDUFA II Goals or 

Commitment Letter), this pre-ANDA 

program is intended to: 

. . . clarify regulatory expectations for 

prospective applicants early in product 

development, assist applicants to develop 

more complete submissions, promote a more 

efficient and effective ANDA review process, 

and reduce the number of review cycles 

required to obtain ANDA approval, 

particularly for [complex products](GDUFA 

II Commitment Letter at 14). 

To facilitate development of complex 

products that may be submitted in an 

ANDA, FDA and industry agreed to a 

series of meetings between ANDA 

applicants and prospective ANDA 

applicants and FDA to discuss the 

proposed complex product and support 

submission of a high-quality, 

approvable ANDA. 

In addition to developing a robust 

pre-ANDA program, FDA agreed to 

respond to requests for and conduct 

meetings related to the development of 

complex products submitted on or after 

October 1, 2017, within specific 

timeframes. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Formal Meetings Between FDA and 

ANDA Applicants of Complex Products 

Under GDUFA.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collection of 

information has been approved under 

OMB control number 0910–0797. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or https://www.

regulations.gov. 

Dated: September 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21190 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–5846] 

Abbreviated New Drug Applications 

Submissions—Refuse-To-Receive 

Standards: Questions and Answers; 

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 ‘‘ANDA 

Submissions—Refuse-to-Receive 

Standards: Questions and Answers.’’ 

This draft guidance is intended to assist 

applicants preparing to submit 

abbreviated new drug applications 

(ANDAs) and certain prior approval 

supplements (PASs) to ANDAs. This 

guidance provides answers to questions 

we have received from applicants 

regarding the guidance for industry, 

‘‘ANDA Submissions—Refuse-toReceive Standards’’ (RTR Standards 

guidance). The questions and answers 

address general issues about the 

organization of an ANDA, filing 

decisions made by FDA, the review of 

and deficiencies related to Drug Master 

Files (DMFs), product quality, and 

bioequivalence (BE) and clinical 

reviews, and are intended to clarify the 

deficiencies that may cause FDA to 

refuse to receive (RTR) an ANDA. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 4, 2017 to ensure that the 


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