Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46503 

1This date corrects the comment closing date of 

December 1, 2017, stated in the Federal Register 

notice announcing the initial ADUFA 

reauthorization public meeting held on May 16, 

2016 (81 FR 23313, April 20, 2016). 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product TECFIDERA 

(dimethyl fumarate). TECFIDERA is 

indicated for treatment of patients with 

relapsing forms of multiple sclerosis. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for TECFIDERA (U.S. 

Patent Nos. 6,509,376; 7,320,999; 

7,619,001; and 7,803,840) from Biogen 

Idec International GmbH, and the 

USPTO requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

November 4, 2015, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

TECFIDERA represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

TECFIDERA is 2,480 days. Of this time, 

2,085 days occurred during the testing 

phase and 395 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355(i)) became effective: June 14, 

2006. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application (IND) became 

effective was on June 14, 2006. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: February 27, 

2012. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for TECFIDERA (NDA 204063) 

was initially submitted on February 27, 

2012. 

3. The date the application was 

approved: March 27, 2013. FDA has 

verified the applicant’s claims that NDA 

204063 was approved on March 27, 

2013. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 1,438 days, 1,144 

days, 811 days, or 654 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: September 29, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21435 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–2011–N–0656] 

Animal 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 a forthcoming public 

meeting entitled ‘‘Animal Drug User Fee 

Act.’’ The topic to be discussed is 

proposed recommendations for the 

reauthorization of the Animal Drug User 

Fee Act (ADUFA IV). The meeting will 

be open to the public. 

DATES: The public meeting will be held 

on November 2, 2017, from 9 a.m. to 12 

noon. Submit either electronic or 

written comments on this public 

meeting to the docket 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., Room 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 


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46504 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 

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–0656 for ‘‘Animal 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/User

Fees/AnimalDrugUserFeeActADUFA/ 

ucm042891.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 ADUFA, 

which authorizes FDA to collect user 

fees and use them for the process of 

reviewing new animal drug applications 

and associated submissions. The 

authority for ADUFA expires September 

30, 2018. Without new legislation, FDA 

will no longer have the authority to 

collect user fees to fund the new animal 

drug review process for future fiscal 

years. Section 740A(d)(4) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 379j–13(d)(4)) 

requires that, after holding negotiations 

with regulated industry and periodic 

consultations with stakeholder, and 

before transmitting the Agency’s final 

recommendation to Congress for the 

reauthorized program (ADUFA IV), 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 

the safety and effectiveness of new 

animal drug applications (NADAs) to be 

central to the Agency’s mission to 

protect and promote human and animal 

health. Prior to 2004, the timeliness and 

predictability of the new animal drug 

review program was a concern. The 

Animal Drug User Fee Act enacted in 

2003 (Pub. L. 108–130; hereinafter 

referred to as ‘‘ADUFA I’’) authorized 

FDA to collect user fees dedicated to the 

timely review of new animal drug 

applications in accordance with certain 

performance goals and to expand and 

modernize the new animal drug review 

program. The Agency agreed, under 

ADUFA I, to meet a comprehensive set 

of performance goals established to 

show significant improvement in the 

timeliness and predictability of the new 

animal drug review process. The 

implementation of ADUFA I provided a 

significant funding increase that 

enabled FDA to increase the number of 

staff dedicated to the new animal drug 

application review process by 30 

percent in ADUFA I. 

In 2008, before ADUFA I expired, 

Congress passed the Animal Drug User 

Fee Amendments of 2008 (Pub. L. 110– 

316; hereinafter referred to as ‘‘ADUFA 

II’’) which included an extension of 

ADUFA for an additional 5 years (fiscal 

year (FY) 2009 through FY 2013). 

ADUFA II performance goals were 

established based on ADUFA I FY 2008 

review time frames. In addition, FDA 

provided program enhancements to 

reduce review cycles and improve 

communications during reviews. The 

ADUFA programs have enabled FDA to 

meet performance timeframes for 

application review for new animal drugs 

without compromising the quality of the 

Agency’s review. 

In 2013, Congress passed the Animal 

Drug and Animal Generic Drug User Fee 

Reauthorization Act of 2013, 

reauthorizing ADUFA (Pub. L. 113–14; 

hereinafter referred to as ‘‘ADUFA III’’). 

ADUFA II was set to expire September 

30, 2013, and the new reauthorization 

extends ADUFA until 2018. 

ADUFA III reauthorization 

maintained the FY 2013 review 

timeframes for key submissions in 

addition to enhancements to the 

program. Enhancements included: 

Replacing the End Review Amendment 

with a short, second-round review; 

reducing time for microbial food safety 

hazard characterization submissions to 


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Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46505 

100 days; and adding a variable 

inflation adjuster to account for changes 

in the Center for Veterinary Medicine’s 

costs using the Consumer Price Index as 

a guide. Also, the proportion of revenue 

collected from fees was redistributed as 

follows: Application fees from 25 

percent to 20 percent; product fees from 

25 percent to 27 percent; establishment 

fees from 25 percent to 26 percent; and 

sponsor fees from 25 percent to 27 

percent. 

Additionally, there were chemistry, 

manufacturing, and controls (CMC) 

enhancements, including: Permitting 

the 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 an 

investigational new animal drug (INAD) 

file; and developing guidance for a twophased CMC technical section 

submission and review process under 

the INAD file. The Agency agreed to 

explore the feasibility of pursuing 

expanded conditional approvals and of 

modifying the current requirement that 

the use of multiple new animal drugs in 

the same medicated feed (combination 

medicated feed) be subject to an 

approved application. The 

reauthorization of ADUFA is targeted to 

generate $114,000,000 in user fees over 

5 years (FY 2014 through FY 2018). 

FDA has published a number of 

reports that provide useful background 

on ADUFA I, II, and III. ADUFA-related 

Federal Register notices, guidances, 

legislation, performance reports, and 

financial reports can be found at: 

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

UserFees/AnimalDrugUserFeeAct

ADUFA/default.htm. 

II. Topics for Discussion at the Public 

Meeting 

In preparing the proposed 

recommendations to Congress for 

ADUFA reauthorization (ADUFA IV), 

we have conducted discussions with the 

regulated industry, and we have 

consulted with stakeholders as required 

by the law. We began the ADUFA 

reauthorization process with a public 

meeting held on May 16, 2016 (81 FR 

23313, April 20, 2016). Following the 

May 2016 public meeting, FDA 

conducted negotiations with regulated 

industry and continued regular 

consultations with public stakeholders 

from October 2016 through April 2017. 

As directed by Congress, FDA posted 

minutes of these discussions on its Web 

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

UserFees/AnimalDrugUserFee

ActADUFA/ucm042891.htm. 

The proposed enhancements from 

ADUFA IV 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 ADUFA IV 

Performance Goals and Procedures 

Letter. FDA intends to publish in the 

Federal Register the full text of the 

proposed ADUFA IV Performance Goals 

and Procedures Letter and a summary of 

proposed statutory changes, as well as 

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

ForIndustry/UserFees/AnimalDrug

UserFeeActADUFA/default.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/AnimalDrugUser

FeeActADUFA/default.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 8:30 a.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 

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 the 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: ADUFA IV Public Meeting. 

Event address for attendees: https://

fda.webex.com/fda/onstage/g.php

?MTID=e9adcd215b7dba5d99361

b002663e51fe. Date and time: Thursday, 

November 2, 2017, 9 a.m. Eastern 

Daylight Time (New York, GMT–4). 

Duration: 3 hours. Event number: 812 

395 634. 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: 

812 395 634. 

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/AnimalDrugUser

FeeActADUFA/ucm042891.htm. 

Dated: September 29, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21439 Filed 10–4–17; 8:45 am] 

BILLING CODE 4164–01–P 


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