Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 47749 

guidance concerns the implementation 

of the Prescription Drug User Fee 

Amendments of 2017 (PDUFA VI) and 

certain proposed changes in policies 

and procedures surrounding its 

application. Because PDUFA VI created 

significant changes to the user fee 

program, this draft guidance serves to 

provide an explanation about the new 

fee structure and types of fees for which 

applicants are responsible. 

PDUFA VI provides two different fee 

types that applicants pay: application 

and program fees. This draft guidance 

describes when these fees are incurred 

and the process for which applicants 

can submit payments. The draft 

guidance also provides information on 

consequences of failing to pay PDUFA 

VI fees as well as the process for 

submitting a reconsideration and 

appeals request. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 assessing user fees under the 

Prescription Drug User Fee 

Amendments of 2017. 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may obtain the draft guidance at either 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/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, https://www.fda.gov/ 

BiologicsBloodVaccines/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or https://

www.regulations.gov. 

Dated: October 10, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22192 Filed 10–12–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5974] 

‘‘Determining Whether To Submit an 

Abbreviated New Drug Application or a 

505(b)(2) Application;’’ Draft Guidance 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 

‘‘Determining Whether to Submit an 

ANDA or a 505(b)(2) Application.’’ This 

guidance is intended to serve as a 

foundational guidance to assist 

applicants in determining which one of 

the abbreviated approval pathways 

under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) is 

appropriate for the submission of a 

marketing application to FDA. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 12, 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: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

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 http://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–5974 for ‘‘Determining Whether 

to Submit an ANDA or a 505(b)(2) 

Application.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://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 http:// 

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.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 http://

www.regulations.gov and insert the 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
47750 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 

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., Rm. 1670, Silver 

Spring, MD 20993, 240–402–7930, 

elizabeth.giaquinto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Determining Whether to Submit an 

ANDA or a 505(b)(2) Application.’’ This 

guidance is intended to serve as a 

foundational guidance to assist 

applicants in determining which one of 

the abbreviated approval pathways 

under the FD&C Act is appropriate for 

the submission of a marketing 

application to FDA. This guidance 

highlights criteria for submitting 

applications under the abbreviated 

approval pathways described in section 

505(j) and 505(b)(2) of the FD&C Act (21 

U.S.C. 355(j) and 21 U.S.C. 355(b)(2), 

respectively), identifies considerations 

to help potential applicants determine 

whether an application would be more 

appropriately submitted under section 

505(j) or under section 505(b)(2) of the 

FD&C Act, and provides direction to 

potential applicants on requesting 

assistance from FDA in making this 

determination. 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) (the Hatch-Waxman 

Amendments) added section 505(b)(2) 

and 505(j) of the FD&C Act, which 

describe abbreviated approval pathways 

for drug products regulated by the 

Agency under the FD&C Act. The HatchWaxman Amendments reflect 

Congress’s efforts to balance the need to 

‘‘make available more low cost generic 

drugs by establishing a generic drug 

approval procedure’’ with new 

incentives for drug development in the 

form of exclusivities and patent term 

extensions. With the passage of the 

Hatch-Waxman Amendments, the FD&C 

Act describes different routes for 

obtaining approval of two broad 

categories of drug applications: New 

drug applications (NDAs) and 

abbreviated new drug applications 

(ANDAs). 

This guidance focuses on those 

applications that can be submitted as 

ANDAs under section 505(j) of the 

FD&C Act, petitioned ANDAs under 

section 505(j)(2)(C) of the FD&C Act, or 

NDAs under section 505(b)(2) of the 

FD&C Act. This guidance does not 

discuss stand-alone NDAs. 

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 factors for applicants to consider 

when determining whether to submit an 

ANDA or a 505(b)(2) application. 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. 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 collections 

of information in 21 CFR 314.94 have 

been approved under OMB control 

number 0910–0001. The collection of 

information for controlled 

correspondence and pre-ANDA meeting 

requests 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 

http://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or http://

www.regulations.gov. 

Dated October 10, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22196 Filed 10–12–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5991] 

Agricultural Biotechnology Education 

and Outreach Initiative; Public 

Meetings; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meetings; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the following public 

meetings entitled ‘‘Agricultural 

Biotechnology Education and Outreach 

Initiative.’’ The purpose of the public 

meetings is to provide the public with 

an opportunity to share information, 

experiences, and suggestions to help 

inform the development of this 

education and outreach initiative. 

DATES: The public meetings will be held 

on November 7, 2017, in Charlotte, 

North Carolina, and on November 14, 

2017, in San Francisco, California. 

Submit either electronic or written 

comments by November 17, 2017. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public meetings will be 

held at: 

• The Omni Charlotte, 132 East Trade 

St., Charlotte, NC 28202 on November 7, 

2017, and 

• The San Francisco Marriott 

Marquis, 780 Mission St., San 

Francisco, CA 94103 on November 14, 

2017. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before November 17, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of November 17, 2017. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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 


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