49382 Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 

Practice Inspection Mutual Recognition 

Agreement. All other commitments 

related to pre-approval inspections will 

remain the same as ADUFA III. 

The Agency will review and act on 90 

percent of qualifying Animal Drug 

Availability Act (ADAA) combination 

medicated feed applications within 60 

days after the submission date when all 

of the following conditions are met: 

• Basic regulatory requirements for an 

ADAA combination medicated feed 

application has been met as outlined in 

21 CFR 514.4(c)(2)(ii). 

• A presubmission conference has 

been conducted and either: 

Æ No data (no tissue residue noninterference study is required) are 

needed and this agreement is 

documented in the memorandum of 

conference for the presubmission 

conference; or 

Æ A justification for not conducting a 

tissue residue non-interference study 

has been submitted, reviewed, and 

found acceptable under an 

investigational new animal drug (INAD), 

prior to the submission of the ADAA 

combination medicated feed 

application; or 

Æ A tissue residue non-interference 

study has been submitted, reviewed, 

and found acceptable under an INAD, 

prior to the submission of the ADAA 

combination medicated feed 

application. 

• No effectiveness or target animal 

safety data are required. 

• No manufacturing data 

requirements—sponsor can address in 

meeting assay non-interference, but data 

submission is not required. 

• All other information is referenced 

to previous drug experience reports. 

• Sponsor makes submission and it 

includes: Representative (Blue Bird) 

labeling, Veterinary Feed Directive (if 

applicable). 

• Includes a request for categorical 

exclusion from the need to prepare an 

environmental assessment (EA); i.e., no 

EA required. 

• Reference to presubmission 

conference. 

• Right of reference (if applicable) to 

NADA(s) not owned by the filing 

sponsor of the ADAA combination 

medicated feed application has been 

received by the Agency. 

The Agency will review and act on 90 

percent of ADAA combination 

medicated feed applications within 100 

days for those applications accepted for 

the 60-day timeframe and there is a 

need for minor amendments. 

If any of the above conditions cannot 

be met, the ADAA combination 

medicated feed application performance 

metric will be placed in the original 

NADA application cohort with a 180- 

day review timeframe. 

The Agency will review and act on 90 

percent of resubmissions of previously 

completed Environmental Impact 

technical sections within 60 days after 

the submission date where: 

• A categorical exclusion was issued; 

• All other technical sections have 

been submitted; and 

• Information contained in the other 

technical sections reveals a change in 

the conditions of use of the previously 

issued categorical exclusion. 

The Agency will conduct 90 percent 

of qualifying presubmission conferences 

within a 60-day timeframe when all of 

the following conditions are met: 

• All background materials, including 

presentations, have been submitted, and 

• A complete agenda has been agreed 

upon by the Agency and the sponsor. 

A sponsor and the Agency can 

mutually agree to exclude a particular 

presubmission conference from this 

performance goal. If a sponsor accepts a 

date beyond the 60-day timeframe for 

their scheduling purposes or is unable 

to meet with the Agency on Agency 

available dates, the submission will be 

excluded from the presubmission 

conference cohort. 

The Agency will commence 90 

percent of tissue residue method 

demonstrations within 120 days of 

completion of the 3-hour meeting 

process or within 200 days from the 

receipt of a submission that supports a 

single laboratory validation tissue 

residue method demonstration. 

B. Inflation Adjuster and Workload 

Adjuster 

The inflation adjuster will remain the 

same as for ADUFA III. 

The workload adjustment will 

continue to be calculated per Center for 

Veterinary Medicine Program Policy 

and Procedures Manual 1243.3022, 

except that, for purposes of calculating 

the workload adjustment, it has been 

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 

over collections provision and making 

any excess collections available to 

enhance the review process in real time. 

The proposal provides authority for the 

Secretary of Health and Human Services 

(the Secretary) 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 FY 2021. Likewise, the proposal 

also provides authority to the Secretary 

to reduce an increase in fees to recover 

a shortfall in collections in a preceding 

year (after 2018) by any remaining prior 

year excess collections not already 

applied for purposes of reducing fee 

increases. 

D. Impact of ADUFA IV Enhancements 

on User Fee Revenue 

The FY 2019 baseline for ADUFA IV 

is $30,331,240, which includes a 

$400,000 one-time cost for information 

technology enhancement. 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 by the inflation 

adjuster, the workload adjuster, if 

applicable, and will include $900,000 

per year for tissue method trials. 

The total 5-year revenue planned for 

ADUFA I was $47,000,000. The total 5- 

year revenue planned for ADUFA II was 

$98,000,000. The total 5-year revenue 

planned for ADUFA III was 

$114,000,000. It is estimated that the 

total 5-year revenue for ADUFA IV will 

be $150,000,000. 

The fee revenue distribution in 

ADUFA IV will remain the same as 

ADUFA III: 20 percent from application 

fees; 27 percent from product fees; 26 

percent from establishment fees; and 27 

percent from sponsor fees. 

Dated: October 20, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23172 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–2016–D–2021] 

Deciding When To Submit a 510(k) for 

a Software Change to an Existing 

Device; Guidance for Industry and 

Food and Drug Administration Staff; 

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 the 

guidance entitled ‘‘Deciding When to 

Submit a 510(k) for a Software Change 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49383 

to an Existing Device.’’ FDA is issuing 

this final guidance document to clarify 

when a software change in a legally 

marketed medical device would require 

that a manufacturer submit a premarket 

notification (510(k)) to FDA. FDA is 

correcting an error in the docket number 

assigned to the ‘‘Deciding When to 

Submit a 510(k) for a Software Change 

to an Existing Device’’ notice of 

availability when it published in the 

Federal Register (81 FR 52441, August 

8, 2016). The docket number currently 

is FDA–2011–D–0453. FDA is changing 

the docket number to FDA–2016–D– 

2021. This action is administrative in 

nature and is being taken to avoid any 

potential confusion in the docket. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 25, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2016–D–2021 for ‘‘Deciding When to 

Submit a 510(k) for a Software Change 

to an Existing Device.’’ 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.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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Deciding When to 

Submit a 510(k) for a Software Change 

to an Existing Device’’ to the Office of 

the Center Director, Guidance and 

Policy Development, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002, or the Office of 

Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Linda Ricci, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G634, Silver Spring, 

MD 20993–0002, 301–796–6325, 

linda.ricci@fda.hhs.gov; and Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A 510(k) is required when a legally 

marketed device subject to 510(k) 

requirements is about to be significantly 

changed or modified in design, 

components, method of manufacture, or 

intended use. Significant changes or 

modifications are those that could 

significantly affect the safety or 

effectiveness of the device, or major 

changes or modifications in the 

intended use of the device 

(§ 807.81(a)(3) (21 CFR 807.81(a)(3)). 

This guidance will aid manufacturers of 

medical devices who intend to make a 

software modification to a 510(k)- 

cleared device or other device subject to 

510(k) requirements, such as a 

preamendments device or a device that 

was granted marketing authorization via 

the De Novo classification process 

under section 513(f)(2) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 360c(f)(2)) (also 

referred to together as ‘‘existing 

devices’’), during the process of 

deciding whether the software 

modification exceeds the regulatory 

threshold of § 807.81(a)(3) for 

submission and clearance of a new 

510(k). 


sradovich on DSK3GMQ082PROD with NOTICES
49384 Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 

This guidance specifically addresses 

software design and technology 

modifications, including firmware. This 

guidance does not apply to software for 

which the Agency has stated in 

guidance that it does not intend to 

enforce compliance with applicable 

regulatory controls (e.g., ‘‘Mobile 

Medical Applications: Guidance for 

Industry and FDA Staff,’’ issued 

February 9, 2015, available on the 

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

downloads/medicaldevices/.../ 

ucm263366.pdf) and software that does 

not meet the definition of a medical 

device at section 201(h) of the FD&C Act 

(21 U.S.C. 321(h)). 

In the Federal Register on August 8, 

2016, FDA announced the availability of 

the draft guidance and interested parties 

were requested to comment by 

November 7, 2016. FDA considered 

comments received on the draft 

guidance and revised the guidance as 

appropriate. 

This guidance is not intended to 

implement significant policy changes to 

FDA’s current thinking on when 

submission of a new 510(k) is required 

for a software change to an existing 

device. Rather, the intent of this 

guidance is to enhance the 

predictability, consistency, and 

transparency of the ‘‘when to submit’’ 

decision-making process by providing a 

least burdensome approach, and 

describing in greater detail the 

regulatory framework, policies, and 

practices underlying such a decision, 

specifically as it relates to software 

changes. The recommendations 

discussed in this guidance for 

evaluating when a software change to an 

existing device would trigger the 

requirement that a manufacturer submit 

a new 510(k) to the Agency are 

consistent with the least burdensome 

principles (Refs. 1 and 2). This guidance 

applies the least burdensome principles, 

in part, by reliance on risk management 

and the quality system regulation (21 

CFR part 820) to determine whether 

submission of a new 510(k) is required 

for a software change to an existing 

device. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of the guidance document 

entitled ‘‘Deciding When to Submit a 

510(k) for a Change to an Existing 

Device,’’ to aid manufacturers of 

medical devices who intend to make 

non-software changes to an existing 

device during the process of deciding 

whether the modification exceeds the 

regulatory threshold of § 807.81(a)(3) for 

submission and clearance of a new 

510(k). 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Deciding When to 

Submit a 510(k) for a Software Change 

to an Existing Device.’’ 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. 

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/Guidances/ 

default.htm or https://

www.regulations.gov. Persons unable to 

download an electronic copy of 

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

a Software Change to an Existing 

Device’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 

1500055 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 are approved under OMB 

control number 0910–0437; and the 

collections of information in 21 CFR 

parts 801 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. 2017–23196 Filed 10–24–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Interest Rate on Overdue 

Debts 

Section 30.18 of the Department of 

Health and Human Services’ claims 

collection regulations (45 CFR part 30) 

provides that the Secretary shall charge 

an annual rate of interest, which is 

determined and fixed by the Secretary 

of the Treasury after considering private 

consumer rates of interest on the date 

that the Department of Health and 

Human Services becomes entitled to 

recovery. The rate cannot be lower than 

the Department of Treasury’s current 

value of funds rate or the applicable rate 

determined from the ‘‘Schedule of 

Certified Interest Rates with Range of 

Maturities’’ unless the Secretary waives 

interest in whole or part, or a different 

rate is prescribed by statute, contract, or 

repayment agreement. The Secretary of 

the Treasury may revise this rate 

quarterly. The Department of Health and 

Human Services publishes this rate in 

the Federal Register. 

The current rate of 93⁄4%, as fixed by 

the Secretary of the Treasury, is certified 

for the quarter ended September 30, 

2017. This rate is based on the Interest 

Rates for Specific Legislation, ‘‘National 

Health Services Corps Scholarship 

Program (42 U.S.C. 254o(b)(1)(A))’’ and 

‘‘National Research Service Award 

Program (42 U.S.C. 288(c)(4)(B)).’’ This 

interest rate will be applied to overdue 


sradovich on DSK3GMQ082PROD with NOTICES