Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49377 

statutes and regulations. This guidance 

is not subject to Executive Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

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

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

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

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Deciding When to Submit a 510(k) 

for a Change to an Existing Device’’ may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1500054 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This 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 part 820 are approved under 

OMB control number 0910–0073; the 

collections of information in 21 CFR 

part 807, subpart E are approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 803 have been approved under 

OMB control number 0910–0437; and 

the collections of information in 21 CFR 

parts 801 and 809 are approved under 

OMB control number 0910–0485. 

V. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the Web site addresses, as of the date 

this document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. ‘‘The Least Burdensome Provisions of the 

FDA Modernization Act of 1997: 

Concept and Principles,’’ dated October 

4, 2002, available at: https://

www.fda.gov/downloads/Medical

Devices/DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm085999.pdf. 

2. ‘‘Suggested Format for Developing and 

Responding to Deficiencies in 

Accordance with the Least Burdensome 

Provisions of FDAMA,’’ dated November 

2, 2000, available at: https://

www.fda.gov/downloads/Medical

Devices/DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm073680.pdf. 

Dated: October 20, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23197 Filed 10–24–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0655] 

Animal Generic Drug User Fee Act; 

Recommendations; Request for 

Comments; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; request 

for comments; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of the 

Animal Generic Drug User Fee Act 

(AGDUFA) reauthorization draft 

recommendations and extending the 

comment period to allow interested 

persons 30 days to submit comments on 

these draft recommendations. 

DATES: FDA is extending the comment 

period on the AGDUFA reauthorization 

and draft recommendations. Submit 

either electronic or written comments 

on the draft recommendations by 

November 24, 2017. 

ADDRESSES: 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 24, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 24, 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; Recommendations; 

Request for Comments; Extension of 

Comment Period’’ 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 


sradovich on DSK3GMQ082PROD with NOTICES
49378 Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 

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. 

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 the availability of 

the proposed recommendations for the 

reauthorization of AGDUFA, which 

authorizes FDA to collect user fees and 

use them for the process of reviewing 

generic new animal 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 

generic new animal 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 recommendation to 

Congress for the reauthorized program 

(AGDUFA III), we do the following: (1) 

Present the recommendations 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. In the 

Federal Register of October 5, 2017 (82 

FR 46506), we announced a public 

meeting to be held on November 2, 

2017. In that notice we stated that we 

intended 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/For

Industry/UserFees/AnimalGenericDrug

UserFeeActAGDUFA/ucm270232.htm, 

before the public meeting and would 

provide for a period of 30 days for the 

public to provide written comments. 

This notice announces the availability 

of these draft recommendations and 

extends the comment period to 

November 24, 2017 to provide for a 

period of 30 days for the public to 

comment on these draft 

recommendations. After the public 

meeting and closing of the comment 

period, we will revise the draft 

recommendations as necessary. In 

addition, the Agency will present the 

draft recommendations to the 

Congressional committees. 

II. Proposed AGDUFA III 

Recommendations 

A. Enhancing the Process for Premarket 

Review 

We are proposing the following 

changes to the performance 

commitments previously established to 

further enhance the process for review 

of generic new animal drug 

applications. 

Beginning October 1, 2018, all 

applications and submissions under 

section 512(b) of the FD&C Act (21 

U.S.C. 360b(b)) must be submitted to the 

Agency electronically using the 

eSubmitter tool. 

The Agency will review and act on 90 

percent of original abbreviated new 

animal drug applications (ANADAs) 

within 240 days (180-day review plus 

60-day administrative review) after the 

submission date. An application is 

incomplete if it would require 

additional data or information to enable 

the Agency to complete a 

comprehensive review of the 

application and reach a decision on the 

issue(s) presented in the application. If 

the Agency determines that the 

deficiencies are not substantial, the 

Agency will review and act on 90 

percent of reactivated applications 

within 120 days (60-day review plus 60- 

day administrative review) after the 

reactivated ANADA submission date. 

This shorter review time for reactivated 

ANADAs for which the deficiencies are 

determined not to be substantial is not 

intended to prevent the use of minor 

amendments during Agency review of 

an application. If the Agency determines 

that the deficiencies are substantial or 

new substantial information is 

provided, the Agency will review and 

act on 90 percent of reactivated 

applications within 240 days (180-day 

review plus 60-day administrative 

review) after the reactivated ANADA 

submission date. 

The Agency will review and act on 90 

percent of administrative ANADAs 

(ANADAs submitted after all scientific 

decisions have been made in the generic 

investigational new animal drug 

(JINAD) process, i.e., prior to the 

submission of the ANADA) within 60 

days after the submission date. 

Paragraph IV certification applications 

(section 512(n)(1)(H)(iv) of the FD&C 

Act) submitted as administrative 

ANADAs will be excluded from the 

administrative ANADA cohort. 

The Agency will review and act on 90 

percent of Prior Approval 

manufacturing supplemental ANADAs 

within 180 days after the submission 

date. A Prior Approval manufacturing 

supplemental ANADA includes: One or 

more major manufacturing changes 

according to § 514.8(b)(2)(ii) (21 CFR 

514.8(b)(2)(ii)) and in accordance with 

Guidance for Industry #83, ‘‘Chemistry, 

Manufacturing, and Controls Changes to 

an Approved NADA or ANADA’’; and 

changes submitted as ‘‘SupplementChanges Being Effected in 30 Days’’ that 

require prior approval according to 

§ 514.8(b)(3)(v)(A). If a Prior Approval 

supplement does not clearly identify 

any major manufacturing changes, the 

Prior Approval supplement will be 

designated by the Agency as a 

‘‘Supplement—Changes Being Effected’’ 

with a 270-day review goal (see 

‘‘Supplement—Changes Being Effected 

Manufacturing Supplemental ANADAs 

and Reactivations’’ below). 

A submission is incomplete if it 

requires additional data or information 

to enable the Agency to complete a 

comprehensive review of the 

submission and reach a decision on the 

issue(s) presented in the submission. If 

the Agency determines that the 

deficiencies are not substantial for 

manufacturing supplements requiring 

prior approval, the Agency will allow 

the manufacturing supplements to be 

resubmitted as ‘‘Supplement-Changes 

Being Effected in 30 Days’’ as described 


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Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49379 

in § 514.8(b)(3) and the drug made with 

the change can be distributed 30 days 

after the resubmission according to 

§ 514.8(b)(3)(iv). The Agency will 

review and act on 90 percent of these 

reactivated manufacturing supplements 

within 270 days after the resubmission 

date of a complete submission. If the 

Agency determines that the deficiencies 

remain substantial or new substantial 

information is provided, prior approval 

is required according to 

§ 514.8(b)(3)(v)(A). The Agency will 

review and act on 90 percent of these 

reactivated manufacturing supplements 

within 180 days after the resubmission 

date of a complete submission. 

The Agency will review and act on 90 

percent of ‘‘Supplement-Changes Being 

Effected’’ manufacturing supplemental 

ANADAs and reactivations submitted 

according to § 514.8(b)(3)(vi) and in 

accordance with Guidance for Industry 

#83, ‘‘Chemistry, Manufacturing, and 

Controls Changes to an Approved 

NADA or ANADA,’’ including 

manufacturing changes not requiring 

prior approval according to 

§ 514.8(b)(3)(iv), within 270 days after 

the submission date. 

The Agency will review and act on 90 

percent of JINAD study submissions 

within 180 days after the submission 

date. 

A submission is incomplete if it 

would require additional data or 

information to enable the Agency to 

complete a comprehensive review of the 

study submission and reach a decision 

on the issue(s) presented in the 

submission. If the Agency determines 

that the deficiencies are not substantial, 

the Agency will review and act on 90 

percent of resubmitted JINAD study 

submissions within 60 days after the 

receipt date of a complete study 

submission. This shorter review time for 

resubmitted JINAD study submissions is 

not intended to prevent the use of minor 

amendments during Agency review of a 

study submission. If the Agency 

determines that the deficiencies are 

substantial or new substantial 

information is provided, the Agency 

will review and act on 90 percent of 

resubmitted JINAD study submissions 

within 180 days after the receipt date of 

a complete study submission. 

The Agency will review and act on 90 

percent of JINAD submissions 

consisting of protocols without 

substantial data, that the Agency and 

the sponsor consider to be an essential 

part of the basis for making the decision 

to approve or not approve an ANADA 

or supplemental ANADA, within 75 

days after the submission date. 

The Agency will allow comparability 

protocols as described in § 514.8(b)(2)(v) 

to be submitted as protocols without 

substantial data in a JINAD file. The 

Agency will review and act on 90 

percent of JINAD submissions 

consisting of protocols without 

substantial data within 75 days after the 

submission date of the protocol. For 

potentially more complex comparability 

protocols, for example sterile process 

validation protocols, the sponsor should 

discuss and have Agency concurrence 

regarding the appropriate filing strategy. 

The Agency will continue to allow 

two-phased Chemistry, Manufacturing, 

and Controls technical section 

submissions under the JINAD process. 

The Agency and regulated industry 

are committed to improving the review 

and business processes that will 

facilitate the timely scheduling and 

conducting of pre-approval inspections 

(PAIs). To improve the timeliness and 

predictability of foreign PAIs, sponsors 

may voluntarily submit: (1) At the 

beginning of the calendar year, a list of 

foreign manufacturing facilities that are 

specified in an abbreviated application, 

supplemental abbreviated application, 

or generic investigational file and may 

be subject to foreign PAIs for the 

following fiscal year; and (2) a 

notification 30 days prior to submitting 

an abbreviated application, a 

supplemental abbreviated application, 

or generic investigational file that 

informs the Agency that the application 

includes a foreign manufacturing 

facility. Should any changes to the 

annual list occur after its submission to 

the Agency, the sponsor may provide 

the updated information to the Agency. 

The Agency will keep a record of the 

number of foreign PAIs conducted for 

abbreviated applications, along with the 

average time for completing the PAIs, 

and include this information in its 

annual performance report. The time for 

completing the PAI is understood to 

mean the time from the inspection 

scheduling request through notification 

to the Center for Veterinary Medicine 

(CVM) of inspectional findings. 

The Agency and regulated industry 

agree that the use of both formal 

meetings (e.g., pre-submission 

conferences, workshops) and informal 

communication by both parties is 

critical to ensure high submission 

quality such that the above performance 

goals can be achieved. 

B. Inflation Adjuster and Workload 

Adjuster 

The Agency and regulated industry 

agree to change the current fixed 4 

percent inflation adjuster to a variable 

inflation adjuster calculated using 

payroll cost and benefits and the 

Consumer Price Index less food and 

energy. 

The workload adjustment will 

continue to be calculated per CVM 

Program Policy and Procedures Manual 

1243.3022, except that, for purposes of 

calculating the workload adjustment, it 

is agreed to reset the base years to fiscal 

year (FY) 2014 through FY 2018. There 

will be no workload adjustment for FY 

2019. Workload adjustments are onetime adjustments and are calculated 

annually. 

C. Offset Provision and Excess 

Collections 

The proposal adds financial flexibility 

by eliminating the final year offset of the 

over collections provision and making 

any excess collections available to 

enhance the review process in real time. 

In addition, the proposal provides 

authority for the Secretary of Health and 

Human Services when setting fees to 

reduce a calculated workload 

adjustment up to the amount of excess 

collections in the second preceding 

fiscal year. The first fiscal year this 

provision could be applied while setting 

fees is fiscal year 2021. 

D. Impact of AGDUFA III Changes on 

User Fee Revenue 

The FY 2019 baseline for AGDUFA III 

is $18,336,340. For each year from FY 

2020 through FY 2023, the annual 

statutory revenue amounts established 

in section 741(b) of the FD&C Act (21 

U.S.C. 379j–21(b)) will be further 

adjusted according to the new statutory 

provision for the inflation adjuster and 

may be further adjusted by the workload 

adjuster, if applicable. 

The planned total 5-year revenue for 

AGDUFA I was $27,100,000. The 

planned total 5-year revenue for 

AGDUFA II was $38,100,000, which 

also included one-time information 

technology funding in the amount of 

$850,000 for FY 2014. It is estimated 

that the planned total 5-year revenue for 

AGDUFA III will be $95,000,000. 

The fee revenue distribution in 

AGDUFA III will remain the same as 

AGDUFA II: 25 percent in application 

fees; 37.5 percent in product fees; and 

37.5 percent in sponsor fees. 

Dated: October 20, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23173 Filed 10–24–17; 8:45 am] 

BILLING CODE 4164–01–P 


sradovich on DSK3GMQ082PROD with NOTICES