Federal Register / Vol. 87, No. 118 / Tuesday, June 21, 2022 / Notices 36861 

OMB under the PRA. The collections of 

information in the following FDA 

regulation and guidance have been 

approved by OMB as listed in the 

following table: 

21 CFR part or guidance Topic OMB control 

No. 

807, subpart E .............................................................................................................. Premarket notification ............................... 0910–0120 

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program’’.Q-submissions .......................................... 0910–0756 

Dated: June 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13212 Filed 6–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0799] 

Improving 510(k) Submission 

Preparation and Review: Center for 

Biologics Evaluation and Research; 

Voluntary Electronic Submission 

Template and Resource Pilot Program; 

Request for Comments 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Biologics Evaluation and 

Research (CBER) is announcing a pilot 

program for sponsors of CBER 

premarket notification (510(k)) 

submissions that wish to use the 

voluntary Electronic Submission 

Template and Resource (eSTAR) Pilot 

Program. CBER’s voluntary eSTAR Pilot 

Program is intended to improve 

consistency and efficiency in both 

industry’s preparation and FDA’s 

review of premarket notification (510(k)) 

submissions. During CBER’s voluntary 

eSTAR Pilot Program, participants will 

have the opportunity to provide input to 

FDA on the eSTAR Pilot Program for 

submissions to CBER. 

DATES: FDA is seeking participation in 

CBER’s voluntary eSTAR Pilot Program 

beginning June 21, 2022. See section 

I.A. for instructions on how to submit a 

request to participate. The CBER 

voluntary eSTAR Pilot Program will 

select up to nine participants who best 

match the selection criteria. This pilot 

program will begin June 21, 2022. 

Submit either electronic or written 

comments on the notice by August 22, 

2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

August 22, 2022. 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– 

2022–N–0799 for ‘‘Improving 510(k) 

Submission Preparation and Review: 

Center for Biologics Evaluation and 

Research; Voluntary Electronic 

Submission Template and Resource 

Pilot Program.’’ 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, 240–402–7500. 

• 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.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 


jspears on DSK121TN23PROD with NOTICES1
36862 Federal Register / Vol. 87, No. 118 / Tuesday, June 21, 2022 / Notices 

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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, 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 Medical Device User Fee 

Amendments of 2012 (MDUFA III) 

Commitment Letter from the Secretary 

of Health and Human Services to 

Congress, FDA committed to 

streamlining review processes by 

moving beyond paper-based review 

(Ref. 1). Under section 745A(b) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 379k–1), added 

by section 1136 of the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144), an electronic 

copy (eCopy) is required for certain 

premarket submission types, including 

510(k) submissions. FDA provided 

additional information about the 

submissions subject to the eCopy 

requirements in section 745A(b) of the 

FD&C Act and recommendations about 

the use of eCopy generally in a guidance 

initially issued in 2013 (Ref. 2). FDA 

subsequently published a final rule in 

the Federal Register of December 16, 

2019 (84 FR 68334), amending FDA’s 

regulations, where appropriate, to 

reflect the requirement of a single 

submission in electronic format, 

including the use of eCopy 

requirements. 

In the Medical Device User Fee 

Amendments of 2017 (MDUFA IV) 

Commitment Letter from the Secretary 

of Health and Human Services to 

Congress (Ref. 3), FDA committed to 

developing ‘‘electronic submission 

templates that will serve as guided 

submission preparation tools for 

industry to improve submission 

consistency and enhance efficiency in 

the review process.’’ In addition, section 

745A(b) of the FD&C Act, as amended 

by section 207 of the FDA 

Reauthorization Act of 2017 (Pub. L. 

115–52), requires that certain 

presubmissions and submissions for 

devices, including 510(k) submissions, 

be submitted in such electronic format 

as specified in guidance by FDA. 

FDA considers both eCopies and 

eSubmissions to be submissions in 

electronic format. eSubmissions are 

submission packages produced by an 

electronic submission template that 

contains the data of a ‘‘complete’’ (see 

Ref. 4) submission. To support the next 

step in transition to 510(k) submissions 

solely in electronic format, FDA has 

developed eSTAR, an electronic 

submission template built within a 

structured dynamic PDF that guides a 

user through construction of an 

eSubmission. eSTAR includes the 

following benefits: 

• automation (e.g., form construction, 

autofilling); 

• content and structure that is 

complementary to FDA internal review 

templates; 

• integration of multiple resources 

(e.g., guidances, databases); 

• guided construction for each 

submission section; 

• automatic verification (i.e., FDA 

does not intend to conduct a Refuse to 

Accept (RTA) review (Ref. 4)); and 

• it is free to use. 

eSTAR contains the following 

additional benefits: 

• intuitive interface; 

• no special software installation (if 

the user has Adobe Acrobat or similar 

software already installed); 

• support for images and dynamic 

pop-up messages; 

• mobile device and Apple iOS 

support; 

• ability to comment when converted 

to a static PDF; 

• ability to share (e.g., email) an 

eSTAR file that is in the process of 

being constructed; and 

• no packaging process. 

In February 2020, CDRH piloted the 

use of the eSTAR electronic submission 

template (85 FR 11371). FDA then 

issued a draft guidance in September 

2021 describing the technical standards 

associated with preparation of the 

electronic submission template for 

510(k)s (Ref. 5) that, when the guidance 

is finalized, will enable submission of 

510(k) electronic submissions solely in 

electronic format. In the draft guidance, 

FDA noted that CBER also intended to 

pilot eSTAR. FDA is now announcing 

CBER’s voluntary eSTAR Pilot Program 

and soliciting participation from 510(k) 

submitters for this program. This pilot 

will provide an opportunity for CBER 

staff to gain experience with review of 

and internal processes for 510(k) 

submissions using the eSTAR template. 

It will also provide experience with use 

of the FDA Electronic Submissions 

Gateway for 510(k) submissions using 

the eSTAR template. Information 

collected through the pilot program will 

help inform FDA on how to improve 

eSTAR and identify any additional 

considerations specific to submissions 

for CBER-regulated devices. 

A. CBER Voluntary eSTAR Pilot 

Program Participation 

FDA seeks participation from 510(k) 

submitters in CBER’s voluntary eSTAR 

Pilot Program beginning June 21, 2022. 

The CBER voluntary eSTAR Pilot 

Program will select up to nine 

participants whose submissions to 

CBER meet the selection criteria. 

Companies that may be eligible to 

participate in CBER’s voluntary eSTAR 

Pilot Program are limited to those firms 

following the procedures set out in 

section I.B. of this document and that 

also meet all the selection criteria that 

follow: 

1. intent to submit a traditional, 

special, or abbreviated 510(k) for a 

medical device regulated by CBER (Ref. 

6) using eSTAR within 1 month of 

acceptance to the CBER voluntary 

eSTAR Pilot Program; and 

2. willingness to provide feedback on 

eSTAR as outlined in section I.C. of this 

document. 

At its discretion, FDA may withdraw 

a manufacturer from the CBER 

voluntary eSTAR Pilot Program for not 

carrying out any of the commitments 

mentioned previously. 

B. CBER Voluntary eSTAR Pilot 

Program Procedure 

To be considered for CBER’s 

voluntary eSTAR Pilot Program, a 

company should submit a statement of 

interest for participation to 

Industry.biologics@fda.hhs.gov. The 

statement of interest should include 

‘‘CBER Voluntary eSTAR Pilot Program’’ 

in the subject line and agreement to the 

selection criteria listed in section I.A. of 

this document, as well as a description 

of the device in enough detail to allow 

verification that it is a CBER regulated 

device. 

The following captures the process for 

the CBER voluntary eSTAR Pilot 

Program: 

1. FDA will collect statements of 

interest for participation in the pilot 

program beginning June 21, 2022. 

The statement of interest should 

include: 

• agreement to the selection criteria 

listed in section I.A. of this document 

• the device(s) that is/are likely to be 

submitted during the pilot program 

using eSTAR 

2. FDA will select no more than nine 

participants, who best meet the 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 118 / Tuesday, June 21, 2022 / Notices 36863 

selection criteria and who reflect the 

broad spectrum of device 

manufacturers, including companies 

that develop a range of products. 

Enrollment in the pilot program will be 

ongoing throughout the duration of the 

program. FDA will apply lessons 

learned from the initial participants in 

the pilot program to refine eSTAR with 

participants, as appropriate. 

3. FDA intends to notify the 

manufacturer via email if the 

manufacturer is enrolled as a participant 

in the CBER’s voluntary eSTAR Pilot 

Program. 

4. The enrolled manufacturer should 

navigate to the FDA ‘‘Voluntary eSTAR 

Program’’ web page at: https://

www.fda.gov/medical-devices/howstudy-and-market-your-device/ 

premarket-submissions and download 

eSTAR from the ‘‘Voluntary eSTAR 

Program’’ web page (Ref. 7). Note: 

eSTAR should not be submitted to 

CBER unless the sponsor is a pilot 

participant. 

5. Directions for preparing and 

submitting a 510(k) using eSTAR to 

FDA are in the final section of the 

eSTAR pdf. We recommend that all 

eSTAR elements including the cover 

letter be submitted through the FDA 

Electronic Submissions Gateway (refer 

to ‘‘Electronic Submissions Gateway’’) 

(Ref. 8) or on physical media through 

CBER’s Document Control Center in 

accordance with the ‘‘Regulatory 

Submissions in Electronic and Paper 

Format for CBER-Regulated Products’’ 

web page (Ref. 9). We recommend that 

you use Adobe Acrobat Pro with 

eSTAR. Be aware that eSTARs should 

not be submitted to CDRH via the 

Electronic Submission Gateway, as 

CDRH does not use the Electronic 

Submission Gateway to receive 

submissions. 

6. If eligible and enrolled as a 

participant, the manufacturer should 

submit a 510(k) submission prepared 

and verified using eSTAR within the 

timeframe identified in the selection 

criteria in section I.A. of this document. 

7. Once the eSTAR prepared 510(k) is 

received by FDA, FDA does not intend 

to conduct the RTA process. However, 

FDA intends to employ a technical 

screening process for the eSTAR like the 

one described in FDA draft guidance 

‘‘Electronic Submission Template for 

Medical Device 510(k) Submissions’’ 

(Ref. 5). The technical screening process 

is a process for verifying that eSTAR 

responses accurately describe the 

device(s) (e.g., there are, in fact, no 

tissue contacting components if 

indicated as such) and that there is at 

least one relevant attachment per each 

applicable attachment-type question 

(e.g., a Software Description attachment 

is included in response to the Software 

Description question if software is 

applicable to the submission). The 

technical screening process is 

anticipated to occur within 15 calendar 

days of FDA receiving the 510(k) 

eSTAR. FDA intends to only begin the 

technical screening for 510(k) electronic 

submissions where the appropriate user 

fee has been paid. If the eSTAR is not 

complete when submitted, FDA intends 

to notify the submitter via email and 

identify the missing information, and 

the 510(k) may be placed on hold until 

a complete replacement eSTAR is 

submitted to FDA. The remainder of the 

review will be conducted according to 

the FDA guidance ‘‘The 510(k) Program: 

Evaluating Substantial Equivalence in 

Premarket Notifications’’ (Ref. 10), and 

the procedures identified in part 807, 

subpart E (21 CFR part 807, subpart E). 

8. Following completion of the review 

of 510(k)s in the CBER voluntary eSTAR 

Pilot Program, participating 

manufacturers will have the opportunity 

to provide individual feedback on the 

CBER voluntary eSTAR Pilot Program 

through the procedures outlined on the 

‘‘Voluntary eSTAR Program’’ web page 

(Ref. 7). Non-pilot participants are 

welcome to submit feedback to the 

Docket (see ADDRESSES). 

During the CBER voluntary eSTAR 

Pilot Program, CBER staff intends to be 

available to answer questions from or 

concerns of pilot participants that may 

arise. 

C. Targeted Questions for the CBER 

Voluntary eSTAR Pilot Program 

FDA requests responses to the 

following questions about eSTAR from 

pilot program participants and 

stakeholders outside the pilot who want 

to submit comments to the docket. 

(1) Is eSTAR able to integrate into 

your organization’s business process? 

(2) Are you able to open eSTAR, and 

are you able to add values to the 

structured data fields, as well as add 

attachments? Once entered and added, 

are the data retained after closing and 

reopening eSTAR? 

(3) If you use Assistive Technology, 

are you able to navigate through and 

complete eSTAR? 

(4) If eSTAR is not intuitive to use, 

why? 

(5) Is the organization and content in 

eSTAR as expected? 

(6) If applicable, did you experience 

any difficulties using the Electronic 

Submission Gateway to submit eSTAR? 

(7) Is eSTAR able to accommodate 

PDF attachments that are of the size you 

typically would provide in a 

submission? 

(8) If all the required questions 

(indicated by red or green indicators) 

are provided values, and all the required 

attachments are added, does eSTAR 

properly indicate it is complete on the 

first page, and are all the sections listed 

in the ‘‘Completed’’ column in the final 

section? 

(9) Do you have any suggestions to 

improve the effectiveness of eSTAR in 

its purpose, or suggestions to improve 

the usability? 

II. Paperwork Reduction Act of 1995 

This notice refers to previously 

approved FDA collections of 

information. 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. 3501–3521). The 

collections of information in part 807, 

subpart E have been approved under 

OMB control number 0910–0120. 

III. References 

The following references are on 

display at 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 website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. MDUFA III Commitment Letter, available 

at: https://www.fda.gov/media/83244/ 

download. 

2. ‘‘eCopy Program for Medical Device 

Submissions: Guidance for Industry and 

Food and Drug Administration Staff,’’ 

dated April 27, 2020; available at: 

https://www.fda.gov/media/83522/ 

download. 

3. MDUFA IV Commitment Letter, available 

at: https://www.fda.gov/media/102699/ 

download. 

4. ‘‘Refuse to Accept Policy for 510(k)s: 

Guidance for Industry and Food and 

Drug Administration Staff,’’ dated 

September 13, 2019; available at: https:// 

www.fda.gov/media/83888/download. 

5. ‘‘Electronic Submission Template for 

Medical Device 510(k) Submissions: 

Draft Guidance for Industry and Food 

and Drug Administration Staff,’’ dated 

September 29, 2021; available at: https:// 

www.fda.gov/media/152429/download. 

6. Premarket Notification 510(k) Process for 

CBER-Regulated Products at: https://

www.fda.gov/vaccines-blood-biologics/ 

development-approval-process-cber/ 

premarket-notification-510k-processcber-regulated-products. 

7. Voluntary eSTAR Program, available at: 

https://www.fda.gov/medical-devices/ 

how-study-and-market-your-device/ 

voluntary-estar-program. 

8. Electronic Submission Gateway, available 


jspears on DSK121TN23PROD with NOTICES1
36864 Federal Register / Vol. 87, No. 118 / Tuesday, June 21, 2022 / Notices 

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

electronic-submissions-gateway. 

9. Regulatory Submissions in Electronic and 

Paper Format for CBER-Regulated 

Products; available at: https://

www.fda.gov/about-fda/center-biologicsevaluation-and-research-cber/regulatorysubmissions-electronic-and-paperformat-cber-regulated-products. 

10. ‘‘The 510(k) Program: Evaluating 

Substantial Equivalence in Premarket 

Notifications [510(k)]: Guidance for 

Industry and Food and Drug 

Administration Staff,’’ dated July 28, 

2014; available at: https://www.fda.gov/ 

media/82395/download. 

Dated: June 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13210 Filed 6–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–1997] 

Food and Drug Administration 

Oversight of Food Covered by 

Systems Recognition Arrangements; 

Guidance for Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for FDA staff entitled ‘‘FDA 

Oversight of Food Covered by Systems 

Recognition Arrangements.’’ This 

guidance provides recommendations 

related to FDA’s regulatory oversight 

activities for food covered by a Systems 

Recognition Arrangement (SRA) and 

imported from countries whose food 

safety systems FDA has recognized in 

SRAs. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 21, 2022. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2019–D–1997 for ‘‘FDA Oversight of 

Food Covered by Systems Recognition 

Arrangements; Guidance for FDA Staff.’’ 

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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). Submit written requests 

for a single hard copy of the guidance 

entitled ‘‘FDA Oversight of Food 

Covered by Systems Recognition 

Arrangements’’ to the Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Building, Rm. 4148, Rockville, 

MD 20857. Send one self-addressed 

adhesive label to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Marla Hallacy, Office of Regulatory 

Affairs, Division of Operational Policy, 

Food and Drug Administration, 12420 

Parklawn Dr., Rockville, MD 20857, 

240–402–6674. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for FDA staff entitled ‘‘FDA 

Oversight of Food Covered by Systems 

Recognition Arrangements; Guidance 

for FDA Staff.’’ The guidance is part of 

FDA’s larger effort to take a risk-based 

approach to food safety to include 

ensuring the safety of imported food, 

consistent with the FDA Food Safety 

Modernization Act. The guidance covers 

FDA’s regulatory oversight activities for 

food covered by SRAs between FDA and 

its foreign regulatory counterparts. 

Currently, FDA has signed SRAs with 

food safety agencies in Australia, 

Canada, and New Zealand. 


jspears on DSK121TN23PROD with NOTICES1