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copies of the draft guidance to the 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access to the draft guidance document.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a draft guidance for industry entitled 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 This draft guidance 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this draft guidance provides information 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This draft guidance reflects a unified 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46073 

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 the 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–5846 for ‘‘ANDA 

Submissions—Refuse-to-Receive 

Standards: Questions and Answers.’’ 

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 

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.fda.gov

/regulatoryinformation/dockets/ 

default.htm. 

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 

‘‘ANDA Submissions—Refuse-toReceive Standards: Questions and 

Answers.’’ This draft guidance is 

intended to assist applicants preparing 

to submit 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-to-Receive Standards’’ and the 

filing process, in general. 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 

DMFs, product quality, and BE and 

clinical reviews, and are intended to 

clarify the deficiencies that may cause 

FDA to RTR an ANDA. FDA evaluates 

each submitted ANDA individually to 

determine whether the Agency can 

receive it for review. When FDA decides 

to receive an ANDA, it means the 

Agency has made a threshold 

determination that the ANDA is a 

substantially complete application (i.e., 

an ANDA that, on its face, is sufficiently 

complete to permit a substantive 

review). FDA’s regulations at 21 CFR 

314.101 provide the regulatory authority 

by which FDA may in certain cases, and 

will in others, RTR an ANDA. 

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 ‘‘ANDA Submissions—Refuse-toReceive Standards.’’ 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. This 

guidance is not subject to Executive 

Order 12866. 

II. 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. 2017–21187 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 


asabaliauskas on DSKBBXCHB2PROD with NOTICES