46506 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 

1This date corrects the comment closing date of 

December 1, 2017, stated in the Federal Register 

notice announcing the initial AGDUFA 

reauthorization public meeting held on May 16, 

2016 (81 FR 23311, April 20, 2016). 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0655] 

Animal Generic Drug User Fee Act; 

Public Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the forthcoming 

public meeting entitled ‘‘Animal 

Generic Drug User Fee Act.’’ The topic 

to be discussed is proposed 

recommendations for the 

reauthorization of the Animal Generic 

Drug User Fee Act (AGDUFA III). The 

meeting will be open to the public. 

DATES: The public meeting will be held 

on November 2, 2017, from 1 p.m. to 4 

p.m. Submit either electronic or written 

comments on this public meeting by 

November 17, 2017. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held at 7500 Standish Pl., Rm. N149 

(first floor), Rockville, MD 20855. Free 

parking is available onsite. Attendees 

must provide a valid government issued 

photo ID (driver’s license, identification 

card, or passport) to enter the facility. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through the front of the building where 

routine security check procedures will 

be performed. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Comments must be submitted on or 

before November 17, 2017.1 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 

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– 

2011–N–0655 for ‘‘Animal Generic Drug 

User Fee Act; Public Meeting; Request 

for Comments.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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.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. 

In addition to being publicly viewable 

at https://www.regulations.gov, 

comments will also be published on 

https://www.fda.gov/ForIndustry/ 

UserFees/AnimalGenericDrug

UserFeeActAGDUFA/ucm270232.htm. 

FOR FURTHER INFORMATION CONTACT: 

Cassie Ravo, Center for Veterinary 

Medicine (HFV–10), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–6866, 

cassie.ravo@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing a public meeting 

to discuss proposed recommendations 

for the reauthorization of AGDUFA, 

which authorizes FDA to collect user 

fees and use them for the process of 

reviewing new animal generic drug 

applications and associated 

submissions. The authority for 

AGDUFA expires September 30, 2018. 

Without new legislation, FDA will no 

longer have the authority to collect user 

fees to fund the new animal generic 

drug review process for future fiscal 

years. Section 742(d)(4) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 379j–22(d)(4)) 

requires that, after holding negotiations 

with regulated industry and periodic 

consultations with stakeholders, and 

before transmitting the Agency’s final 


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Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46507 

recommendation to Congress for the 

reauthorized program (AGDUFA III), we 

do the following: (1) Present the 

recommendation to the relevant 

Congressional committees, (2) publish 

such recommendations in the Federal 

Register, (3) provide for a period of 30 

days for the public to provide written 

comments on such recommendations, 

(4) hold a meeting at which the public 

may present its views on such 

recommendations, and (5) consider such 

public views and comments and revise 

such recommendations as necessary. 

This notice, the 30-day comment period, 

and the public meeting will satisfy 

certain of these requirements. After the 

public meeting, we will revise the draft 

recommendations as necessary. In 

addition, the Agency will present the 

draft recommendations to the 

Congressional committees. 

FDA considers the timely review of 

abbreviated new animal drug 

applications (ANADAs) to be central to 

the Agency’s mission to protect and 

promote human and animal health. 

Prior to 2009, the timeliness and 

predictability of the generic new animal 

drug review program was a concern. 

The Animal Generic Drug User Fee Act 

enacted in 2008 (Pub. L. 110–316; 

hereinafter referred to as ‘‘AGDUFA I’’) 

amended the FD&C Act to authorize the 

FDA’s first-ever generic animal drug 

user fee program. AGDUFA I provided 

FDA with additional funds to enhance 

the performance and predictability of 

the generic new animal drug review 

process. Furthermore, the authorization 

of AGDUFA I enabled FDA’s continued 

assurance that generic new animal drug 

products are safe and effective. 

Under AGDUFA I, FDA agreed to 

meet review performance goals for 

certain submissions over 5 years from 

fiscal year (FY) 2009 through FY 2013. 

The purpose of establishing these 

review performance goals was to ensure 

the timely review of ANADAs and 

reactivations, supplemental ANADAs, 

and generic investigational new animal 

drug (JINAD) submissions, and as a 

result FDA has been able to reduce the 

time for the application review process 

for generic new animal drugs without 

compromising the quality of the 

Agency’s review. 

AGDUFA I established increasingly 

stringent review performance goals over 

a 5-year period from FY 2009 through 

FY 2013. Based on those performance 

goals, in the final year of AGDUFA I (FY 

2013) FDA agreed to review and act on 

90 percent of the following submission 

types within the specified time frames: 

• Original ANADAs and reactivations 

within 270 days after the submission 

date. 

• Administrative ANADAs within 

100 days after the submission date. 

• Manufacturing supplemental 

ANADAs and reactivations within 270 

days after the submission date. 

• JINAD study submissions within 

270 days after the submission date. 

• JINAD protocol submissions within 

100 days after submission date. 

With the reauthorization of AGDUFA 

for an additional 5 years under 

AGDUFA II (FY 2014 to FY 2018), FDA 

agreed to further enhance and improve 

the review process. 

The AGDUFA II reauthorization 

enhancements included developing 

Question Based Review Process for 

Bioequivalence Submissions and 

shortening review time for key 

submission types. Additionally, there 

were chemistry, manufacturing, and 

controls (CMC) enhancements, 

including: Permitting manufacturing 

supplements to be resubmitted as 

‘‘Supplement-Changes Being Effected in 

30 Days’’ if deficiencies are not 

substantial for manufacturing 

supplements requiring prior approval 

according to 21 CFR 514.8(b); permitting 

comparability protocols as described in 

21 CFR 514.8(b)(2)(v) to be submitted as 

protocols without substantial data in a 

JINAD file; and developing guidance for 

a two-phased CMC technical section 

submission and review process under 

the JINAD file. Finally, the proportion of 

revenue collected from user fees was 

redistributed as follows: Application 

fees from 30 percent to 25 percent; 

product fees from 35 percent to 37.5 

percent; and sponsor fees from 35 

percent to 37.5 percent. 

FDA has published a number of 

reports that provide useful background 

on AGDUFA I and AGDUFA II. 

AGDUFA-related Federal Register 

notices, guidances, legislation, 

performance reports, and financial 

reports can be found at: https://

www.fda.gov/ForIndustry/UserFees/ 

AnimalGenericDrugUserFeeAct

AGDUFA/default.htm. 

II. Topics for Discussion at the Public 

Meeting 

In preparing the proposed 

recommendations to Congress for 

AGDUFA reauthorization (AGDUFA III), 

we have conducted discussions with the 

regulated industry, and we have 

consulted with stakeholders as required 

by the law. We began the AGDUFA 

reauthorization process with a public 

meeting held on May 16, 2016 (81 FR 

23311, April 20, 2016). Following the 

May 2016 public meeting, FDA 

conducted negotiations with regulated 

industry and continued regular 

consultations with public stakeholders 

from August 2016 through January 2017. 

As directed by Congress, FDA posted 

minutes of these discussions on its Web 

site at https://www.fda.gov/ForIndustry/ 

UserFees/AnimalGenericDrugUserFee

ActAGDUFA/ucm270232.htm. The 

proposed enhancements from AGDUFA 

III address many of the top priorities 

identified by public stakeholders, the 

top concerns identified by regulated 

industry, and the most important 

challenges identified within FDA. The 

full descriptions of these proposed 

recommendations can be found in the 

proposed AGDUFA III Performance 

Goals and Procedures Letter. FDA 

intends to publish in the Federal 

Register the full text of the proposed 

AGDUFA III Performance Goals and 

Procedures Letter and a summary of 

proposed statutory changes, as well as 

post them at https://www.fda.gov/ 

ForIndustry/UserFees/AnimalGeneric

DrugUserFeeActAGDUFA/ 

ucm270232.htm, before the public 

meeting, and will provide for a period 

of 30 days for the public to provide 

written comments. 

FDA will post the agenda 

approximately 5 days before the meeting 

at https://www.fda.gov/ForIndustry/ 

UserFees/AnimalGenericDrugUserFee

ActAGDUFA/ucm270232.htm. 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please contact Cassie Ravo (see 

FOR FURTHER INFORMATION CONTACT). 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone. Also, please self-identify 

as a member of one of the following 

stakeholder categories: Scientific or 

academic experts; veterinary 

professionals; patients and consumer 

advocacy groups; or the regulated 

industry, and whether you are 

requesting a scheduled presentation. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting must 

register by October 26, 2017, midnight 

Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. If time and space permit, 

onsite registration on the day of the 

public meeting will be provided 

beginning at 12:30 p.m. We will let 

registrants know if registration closes 

before the day of the public meeting. 

If you need special accommodations 

due to a disability, please contact Cassie 


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46508 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 

Ravo (see FOR FURTHER INFORMATION

CONTACT) no later than October 26, 2017. 

Requests for Oral Presentations: When 

registering, you may indicate if you 

wish to present during a public 

comment session or participate in a 

specific session, and which topic(s) you 

wish to address. We will do our best to 

accommodate requests to make public 

comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the focused sessions. Following the 

close of registration, we will determine 

the amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

October 27, 2017. All requests to make 

oral presentations must be received by 

the close of registration on October 26, 

2017. If selected for presentation, any 

presentation materials must be emailed 

to Cassie Ravo (see FOR FURTHER

INFORMATION CONTACT) no later than 

October 31, 2017. No commercial or 

promotional material will be permitted 

to be presented or distributed at the 

public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. 

Event: AGDUFA III Public Meeting. 

Event address for attendees: https://

fda.webex.com/fda/onstage/ 

g.php?MTID=ec1c356734bcf010b59

e0b885726ccad0. Date and time: 

Thursday, November 2, 2017, 1 p.m. 

Eastern Daylight Time (New York, 

GMT–4). Duration: 3 hours. Event 

number: 817 527 611. Event password: 

110217. Teleconference: Provide your 

number when you join the event to 

receive a call back. (1) Call one of the 

following numbers: Local: 1–301–796– 

7777; toll free: 1–855–828–1770. (2) 

Follow the instructions that you hear on 

the phone. Cisco Unified MeetingPlace 

meeting ID: 817 527 611. 

FDA has verified the Web site 

addresses in this document, as of the 

date this document publishes in the 

Federal Register, but Web sites are 

subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/ 

ForIndustry/UserFees/AnimalGeneric

DrugUserFeeActAGDUFA/ 

ucm270232.htm. 

Dated: September 29, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21438 Filed 10–4–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5017] 

Health Canada and United States Food 

and Drug Administration Joint Public 

Consultation on International Council 

for Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use; Public Meeting and 

Webcast 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting and 

webcast; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a regional public meeting 

entitled ‘‘Health Canada and U.S. Food 

and Drug Administration Joint Public 

Consultation on International Council 

for Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use (ICH).’’ The purpose of this 

public meeting is to provide information 

and solicit public input on the current 

activities of ICH as well as the 

upcoming ICH Assembly Meeting and 

the Expert Working Group Meetings in 

Geneva, Switzerland, scheduled for 

November 11 through 16, 2017. The 

topics to be discussed are the topics for 

discussion at the forthcoming ICH 

Assembly Meeting in Geneva. 

DATES: The public meeting will be held 

on October 19, 2017, from 9 a.m. to 12 

noon Eastern Time. Submit either 

electronic or written comments on this 

public meeting by October 26, 2017. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

Registration to attend the meeting and 

requests for oral presentations must be 

received by October 16, 2017; see the 

SUPPLEMENTARY INFORMATION section for 

information on how to register for the 

meeting. 

ADDRESSES: The public meeting will be 

held at the Sir Frederick G. Banting 

Research Centre, 251 Sir Frederick 

Banting Dr., Ottawa, ON K1Y 0M1, 

Canada. It will also be broadcast on the 

web allowing participants to join in 

person OR via the Web. 

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 October 26, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of October 27, 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 

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–N–5017 for ‘‘Health Canada and 

U.S. Food and Drug Administration 

Joint Public Consultation on 

International Council on Harmonisation 

of Technical Requirements for 

Pharmaceuticals for Human Use; Public 


ethrower on DSK3G9T082PROD with NOTICES