44274 Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 

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– 

2018–D–1041 for ‘‘Development of a 

Shared System Risk Evaluation and 

Mitigation Strategy; Draft Guidance for 

Industry.’’ 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)). 

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: 

Lubna Merchant, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4418, 

Silver Spring, MD 20993–0002, 301– 

796–5162, email: Lubna.Merchant@

fda.hhs.gov; or 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 

In the Federal Register of June 1, 2018 

(83 FR 25468), FDA published a notice 

of availability with a 60-day comment 

period to request comments on the draft 

guidance for industry entitled 

‘‘Development of a Shared System Risk 

Evaluation and Mitigation Strategy.’’ 

The Agency has received a request for 

an extension of the comment period for 

the draft guidance. FDA has considered 

the request and is reopening the 

comment period for the draft guidance 

until September 13, 2018. The Agency 

believes that a 14-day reopening of the 

comment period allows adequate time 

for interested persons to submit 

comments to ensure that the Agency can 

consider the comments on this draft 

guidance before it begins work on the 

final version of the guidance. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: August 23, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18775 Filed 8–29–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0049] 

Complex Innovative Designs Pilot 

Meeting Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The sixth iteration of the 

Prescription Drug User Fee Act (PDUFA 

VI), incorporated as part of the FDA 

Reauthorization Act of 2017 (FDARA), 

highlights the goal of facilitating and 

advancing the use of complex adaptive, 

Bayesian, and other novel clinical trial 

designs. The Food and Drug 

Administration (FDA or Agency) is 

announcing a pilot meeting program 

that affords sponsors who are selected 

the opportunity to meet with Agency 

staff to discuss the use of complex 

innovative trial design (CID) approaches 

in medical product development. 

Meetings under the pilot program will 

be conducted by FDA’s Center for Drug 

Evaluation and Research (CDER) or 

Center for Biologics Evaluation and 

Research (CBER) during fiscal years 

2018 to 2022. This pilot meeting 

program fulfills FDA’s commitment 

under PDUFA VI. For each sponsor 

whose meeting request is granted as part 

of the pilot, FDA will grant two 

meetings between the sponsor and 

CDER or CBER that will provide an 

opportunity for medical product 

developers and FDA to discuss 

regulatory approaches for CID. To 

promote innovation in this area, trial 

designs developed through the pilot 

meeting program may be presented by 

FDA (e.g., in a guidance or public 

workshop) as case studies, including 


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Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 44275 

trial designs for drugs that have not yet 

been approved by FDA. 

DATES: The CID pilot meeting program 

will proceed from the date of this notice 

through September 30, 2022. Sponsors 

may submit meeting requests for the 

pilot program through June 30, 2022. 

Comments about this pilot meeting 

program can be submitted until October 

1, 2018. Please note that late, untimely 

filed comments will not be considered. 

ADDRESSES: You may submit comments 

about the CID pilot meetings program 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– 

2018–N–0049 for ‘‘Complex Innovative 

Designs Pilot Meeting Program.’’ 

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. 

FOR FURTHER INFORMATION CONTACT: 

CDER: Scott Goldie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, Rm 3557, 

Silver Spring, MD 20993–0002, 301– 

796–2055, Scott.Goldie@fda.hhs.gov, 

with the subject line ‘‘CID Pilot Meeting 

Program for CDER.’’ 

CBER: Christopher Egelebo, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm 

1043, Silver Spring, MD 20993–0002, 

240–402–8625, Christopher.Egelebo@

fda.hhs.gov, with the subject line ‘‘CID 

Pilot Meeting Program for CBER.’’ 

SUPPLEMENTARY INFORMATION: 

I. Background 

In connection with the sixth iteration 

of PDUFA, FDA committed to conduct 

a pilot program for highly innovative 

trial designs for which analytically 

derived properties (e.g., Type I error) 

may not be feasible, and simulations are 

necessary to determine trial operating 

characteristics. The Agency also 

committed to issue a Federal Register 

Notice announcing the pilot program, 

clarifying pilot program eligibility, and 

describing the proposal submission and 

selection process (see PDUFA 

Reauthorization Performance Goals and 

Procedures Fiscal Years 2018 Through 

2022, section I.J.4.b. (https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf)). 

FDA is announcing this pilot meeting 

program to satisfy the above-mentioned 

commitments. The goal of the early 

meeting discussions granted under this 

pilot program is to provide advice on 

how a proposed CID approach can be 

used in a specific drug development 

program and to promote innovation by 

allowing FDA to publicly present the 

trial designs considered through the 

pilot program, including trial designs 

for drugs that have not yet been 

approved by FDA. FDA has committed 

to accepting up to two meeting requests 

quarterly each fiscal year. 

Meeting requests may be submitted on 

a rolling basis; however, only those 

requests received by the quarterly 

closing date, which will be the last day 

of each quarter of the fiscal year (i.e., 

December 31, March 31, June 30, 

September 30), will be considered for 

selection in the following quarter. 

Within 45 days after the quarterly 

closing date, FDA will review the 

submissions, select up to four meeting 

requests each quarter, two primary and 

two alternates to proceed to disclosure 

discussions, and notify sponsors of their 

status. If FDA and the sponsor of a 

meeting request selected as primary are 

unable to reach an agreement on the 

elements for public disclosure, the 

Agency will proceed with an alternate 

submission. When disclosure 

discussions are complete, FDA will 

grant up to two meetings per quarter 

under the pilot. 

The meetings granted will include an 

initial and followup meeting on the 

same CID and medical product within 

the span of approximately 120 days. 

Being granted a meeting as part of the 

pilot meeting program does not mean 

that the proposed CID is appropriate for 


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44276 Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 

regulatory decision making. Likewise, 

being denied a meeting as part of the 

pilot meeting program does not mean 

that the proposed CID is unacceptable 

for regulatory decision making. 

Sponsors who do not participate in the 

pilot program may seek Agency 

interaction on their clinical 

development plan through existing 

channels (e.g., Type C meeting requests, 

Critical Path Innovation Meetings). 

The listed eligibility factors and 

procedures outlined in this Federal 

Register notice reflect the current 

thinking at the time of publication. 

Processes may be revised as this pilot 

program evolves and will be 

communicated on the CID Pilot Meeting 

Program website: https://www.fda.gov/ 

Drugs/DevelopmentApprovalProcess/ 

DevelopmentResources/ 

UCM617212.htm. 

II. Eligibility and Selection for 

Participation in the CID Pilot Meeting 

Program 

To be eligible for the CID Pilot 

Meeting Program: 

• The sponsor must have a pre-IND or 

IND number for the medical product(s) 

included in the CID proposal with the 

intent of implementing the CID in the 

pilot program application. 

• The proposed CID is intended to 

provide substantial evidence of 

effectiveness to support regulatory 

approval of the medical product. 

• The trial is not a first in human 

study, and there is sufficient clinical 

information available to inform the 

proposed CID. 

• The sponsor and FDA are able to 

reach agreement on the trial design 

information to be publicly disclosed. 

Recognizing that the FDA will learn 

both from the number and types of 

submissions received, FDA welcomes 

submissions related to any eligible CID. 

However, given that the Agency expects 

to grant up to two meeting requests per 

quarter as part of the pilot program, the 

Agency currently intends to select 

requests based on the following: 

• Innovative features of the trial 

design, particularly if the innovation 

may provide advantages over alternative 

approaches. Initial priority will be given 

to trial designs for which analytically 

derived properties (e.g., type I error) 

may not be feasible and simulations are 

necessary to determine operating 

characteristics. 

• Therapeutic need (i.e., therapies 

being developed for use in disease areas 

where there are no or limited 

treatments). 

III. Procedures and Submission 

Information 

A. General Information 

The CID pilot meeting program will 

be jointly administered by the following 

centers: 

• CDER: CDER’s Office of 

Biostatistics, in the Office of 

Translational Sciences, which is the 

point of contact for all communications 

for CDER products. 

• CBER: CBER’s Office of Biostatistics 

and Epidemiology, which is the point of 

contact for all communications for 

CBER products. 

B. How To Submit a Meeting Request 

and Meeting Package 

Meeting requests should be submitted 

electronically to the relevant application 

(i.e., pre-IND, IND) with ‘‘CID Pilot 

Program Meeting Request for CDER’’ 

(CDER applications) or ‘‘CID Pilot 

Program Meeting Request for CBER’’ 

(CBER applications) in the subject line. 

Information about providing regulatory 

submissions in electronic format is 

available at: https://www.fda.gov/Drugs/ 

DevelopmentApprovalProcess/Forms

SubmissionRequirements/%20

ElectronicSubmissions/ucm153574.htm. 

C. Content and Format of the Meeting 

Request 

Include the following information in 

the meeting request (25 pages or less): 

1. Product name. 

2. Application number. 

3. Proposed indication(s) or context of 

product development. 

4. A background section that includes 

a brief history of the development 

program and the status of product 

development. 

5. Trial objectives. 

6. Brief rationale for the choice of the 

proposed CID. 

7. Description of study design, 

including study schema with treatment 

arms, randomization strategy, and 

endpoints. 

8. Key features of the statistical 

analysis plan including, but not limited 

to, the analyses, models, analysis 

population, approach to handle missing 

data, and decision criteria. These should 

include aspects of the design that may 

be modified and the corresponding rules 

for decisions, if adaptive. 

9. Simulation plan, including the set 

of parameter configurations that will be 

used for the scenarios to be simulated 

and preliminary evaluation and 

discussion of design operating 

characteristics. Preliminary simulation 

results of the operating characteristics 

(e.g., type 1 error, power, etc.) should 

include several hypothetical, plausible 

scenarios. 

10. Elements of the study design that 

the sponsor considers non-disclosable, 

along with a rationale for exclusion. 

11. A list of issues for discussion with 

the Agency about the specific CID 

proposed approach for the applicable 

drug development program and a 

summarized list of next steps in the 

regulatory decision making process 

along with any supporting data relevant 

to the discussion. 

D. Content and Format of the Meeting 

Information Package 

Sponsors whose meeting requests are 

granted as part of the pilot program 

should submit a meeting information 

package electronically with ‘‘CID Pilot 

Program Meeting Package for CDER’’ 

(CDER applications) or ‘‘CID Pilot 

Program Meeting Package for CBER’’ 

(CBER applications) in the subject line 

no later than 30 days before the initial 

meeting and no later than 90 days before 

the followup meeting. 

The initial meeting package should 

include the following information: 

1. Product name. 

2. Application number. 

3. Proposed agenda, including 

estimated times needed for discussion 

of each agenda item. 

4. List of questions for discussion 

along with a brief summary of each 

question that explains the need or 

context for the question. 

5. Detailed description of the 

statistical methodology including, but 

not limited to, the analyses, models, 

analysis population, approach to handle 

missing data, and decision criteria. 

6. Detailed simulation report that 

includes the following: 

a. Example trials in which a small 

number of hypothetical trials are 

described with different conclusions. 

b. Description of the set of parameter 

configurations used for the simulation 

scenarios, including a justification of 

the adequacy of the choices. 

c. Simulation results detailing the 

simulated type I error probability and 

power under various scenarios. 

d. Simulation code that is readable, 

adequately commented on, and includes 

the random seeds. The code should 

preferably be written in widely-used 

programming languages such as R or 

SAS to facilitate the simulation review. 

7. Overall conclusions including a 

brief summary of the simulated 

operating characteristics based on 

design features and analyses and a 

discussion of the utility of the CID given 

the simulation results. 

The followup meeting package should 

include the following information: 

1. Product name. 

2. Application number. 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 44277 

1For the reasons explained in the third-party 

certification final rule (80 FR 74570 at 74578– 

74579, November 27, 2015), and for consistency 

with the implementing regulations for the thirdparty certification program in 21 CFR parts 1, 11, 

and 16, this notice uses the term ‘‘third-party 

certification body’’ rather than the term ‘‘third-party 

auditor’’ used in section 808(a)(3) of the FD&C Act. 

3. Updated background section that 

includes a brief history of the 

development program and the status of 

product development and clinical data 

to date, if applicable. 

4. Proposed agenda, including 

estimated times needed for discussion 

of each agenda item. 

5. List of questions for discussion 

with a brief summary of each question 

that explains the need or context for the 

question. 

6. Updated programs/shells for 

simulations, if applicable. 

7. Summary of new information that 

is available to support discussions. 

E. Meeting Summaries 

A meeting summary will be sent to 

the sponsor within 60 days of each 

meeting. 

F. Disclosure 

To promote innovation and to provide 

better clarity on the acceptance of 

different types of trial designs, trial 

designs developed through the pilot 

program may be presented by FDA (e.g., 

in a guidance or public workshop) as 

case studies, including while the drug 

studied in the trial has not yet been 

approved by FDA. Accordingly, before 

FDA grants the initial meeting under 

this pilot program, FDA and the sponsor 

must agree on the information that FDA 

may include in these public case 

studies. The specific information to be 

disclosed will depend on the content of 

each application, but FDA intends to 

focus on information that is beneficial to 

advancing the use of CIDs, and those 

elements relevant to the understanding 

of the CID and its potential use in a 

clinical trial intended to support 

regulatory approval. Generally, the 

Agency does not anticipate that the case 

studies will need to include information 

such as molecular structure, the 

sponsor’s name, product name, subjectlevel data, recruitment strategies, 

adverse events, or a complete 

description of study eligibility criteria. 

FDA does anticipate that the following 

information will generally need to be 

disclosed to facilitate discussion of the 

proposed CID: Study endpoints to the 

degree necessary to describe the design 

(e.g., overall survival in the context of 

a time to event analysis), target 

population, sample size and power 

determination, null and alternative 

hypotheses, key operating 

characteristics, assumed rates for 

dichotomous outcomes or mean and 

variance for continuous outcomes, 

simulation objectives, simulation 

scenarios, assumptions (e.g., dropout 

rate, rate of enrollment), modeling 

characteristics, critical study design 

characteristics including any adaptive 

elements (e.g., decision criteria to add/ 

drop a dose, etc.), and, if a Bayesian 

approach, how Bayesian methods are 

being used for design and/or analysis 

purposes. 

It is important that sponsors wishing 

to participate in the pilot program 

identify aspects of the design and 

analysis that they consider nondisclosable and provide a rationale for 

withholding the information. 

Participation in the pilot program, 

including any agreement on information 

disclosure, will be voluntary and at the 

discretion of the sponsor. Sponsors that 

do not wish to make such disclosures 

may seek regulatory input through other 

existing channels. 

IV. Paperwork Reduction Act of 1995 

This notice refers to collections of 

information that 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 

collection of information resulting from 

formal meetings between sponsors or 

applicants and FDA has been approved 

under OMB control number 0910–0429. 

The collection of information in 21 CFR 

part 312 (investigational new drug 

applications) has been approved under 

OMB control number 0910–0014. 

Dated: August 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18801 Filed 8–29–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–4119] 

Food Safety Modernization Act ThirdParty Certification Program User Fee 

Rate for Fiscal Year 2019 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fiscal year (FY) 2019 annual fee rate for 

recognized accreditation bodies and 

accredited certification bodies, and the 

fee rate for accreditation bodies 

applying to be recognized in the thirdparty certification program that is 

authorized by the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the FDA Food Safety 

Modernization Act (FSMA). We are also 

announcing the fee rate for certification 

bodies that are applying to be directly 

accredited by FDA. 

DATES: This fee is effective October 1, 

2018. 

FOR FURTHER INFORMATION CONTACT: 

Donald Prater, Office of Foods and 

Veterinary Medicine, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3234, Silver Spring, 

MD 20993, 301–348–3007. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 307 of FSMA, Accreditation 

of Third-Party Auditors, amended the 

FD&C Act to create a new provision, 

section 808, under the same name. 

Section 808 of the FD&C Act (21 U.S.C. 

384d) directs FDA to establish a 

program for accreditation of third-party 

certification bodies 1 conducting food 

safety audits and issuing food and 

facility certifications to eligible foreign 

entities (including registered foreign 

food facilities) that meet our applicable 

requirements. Under this provision, we 

established a system for FDA to 

recognize accreditation bodies to 

accredit certification bodies, except for 

limited circumstances in which we may 

directly accredit certification bodies to 

participate in the third-party 

certification program. 

Section 808(c)(8) of the FD&C Act 

directs FDA to establish a 

reimbursement (user fee) program by 

which we assess fees and require 

reimbursement for the work FDA 

performs to establish and administer the 

third-party certification program under 

section 808 of the FD&C Act. The user 

fee program for the third-party 

certification program was established by 

a final rule entitled ‘‘Amendments to 

Accreditation of Third-Party 

Certification Bodies To Conduct Food 

Safety Audits and To Issue 

Certifications To Provide for the User 

Fee Program’’ (81 FR 90186, December 

14, 2016). 

The FSMA FY 2019 third-party 

certification program user fee rate 

announced in this notice is effective on 

October 1, 2018, and will remain in 

effect through September 30, 2019. 

II. Estimating the Average Cost of a 

Supported Direct FDA Work Hour for 

FY 2019 

In each year, the costs of salary (or 

personnel compensation) and benefits 


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