Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80117 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–3787] 

Electromagnetic Compatibility of 

Medical Devices; Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Availability; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice of availability that appeared in 

the Federal Register of November 17, 

2020. In the notice of availability, FDA 

requested comments on the draft 

guidance for industry and FDA staff 

entitled ‘‘Electromagnetic Compatibility 

of Medical Devices.’’ The Agency is 

taking this action in response to a 

request for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the document published on 

November 17, 2020 (85 FR 73276). 

Submit either electronic or written 

comments on the draft guidance by 

February 16, 2021, to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

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– 

2015–D–3787 for ‘‘Electromagnetic 

Compatibility (EMC) of Medical 

Devices.’’ 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)). 

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 draft guidance 

document entitled ‘‘Electromagnetic 

Compatibility (EMC) of Medical 

Devices’’ to the Office of Policy, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

5431, Silver Spring, MD 20993–0002; or 

to 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: Seth 

J. Seidman, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 62, Rm. 1108, Silver Spring, 

MD 20993–0002, 301–796–2477; 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 November 

17, 2020, FDA published a notice of 

availability with a 60-day comment 

period to request comments on the draft 

guidance for industry and FDA staff 

entitled ‘‘Electromagnetic Compatibility 

of Medical Devices.’’ 

The Agency has received a request for 

a 30-day extension of the comment 

period. The request conveyed concern 

that the current 60-day comment period 

does not allow sufficient time to 

develop a meaningful or thoughtful 

response. 

FDA has considered the request and 

is extending the comment period for the 


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80118 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

notice of availability for 30 days, until 

February 16, 2021. The Agency believes 

that a 30-day extension allows adequate 

time for interested persons to submit 

comments without significantly 

delaying guidance on these important 

issues. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on the electromagnetic compatibility of 

medical devices. 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. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the draft 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/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products or from the 

Center for Biologics Evaluation and 

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances. This 

guidance document is also available at 

https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Electromagnetic 

Compatibility (EMC) of Medical 

Devices’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please include the complete title and 

the document number 16040 to identify 

the guidance you are requesting. 

Dated: December 8, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27350 Filed 12–10–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2226] 

Cheese Products Deviating from 

Identity Standard; Temporary Permit 

for Market Testing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a temporary permit has 

been issued to Bongards Creameries (the 

applicant) to market test several 

pasteurized standardized cheeses that 

deviate from the U.S. standards of 

identity for cheese products. The 

temporary permit will allow the 

applicant to evaluate commercial 

viability of the products and to collect 

data on consumer acceptance of the 

products. 

DATES: This permit is effective for 15 

months, beginning on the date the 

applicant introduces or causes 

introduction of the test products into 

interstate commerce, but not later than 

March 11, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Marjan Morravej, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

2371. 

SUPPLEMENTARY INFORMATION: We are 

giving notice that we have issued a 

temporary permit to Bongards 

Creameries. We are issuing the 

temporary permit in accordance with 21 

CFR 130.17, which addresses temporary 

permits for interstate shipments of 

experimental packs of food varying from 

the requirements of standards of 

identity issued under section 401 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 341). 

The permit covers interstate 

marketing test of several pasteurized 

standardized cheeses. The test products 

deviate from the standards of identity 

for cheese products under 21 CFR 

133.167, 133.169, 133.170, and 133.173. 

For the purpose of this permit, 

natamycin, which is not permitted 

under the standards of identity for these 

cheese products, would be added as a 

mold inhibitor in the standardized 

cheeses. The inhibitor would be 

incorporated into blended and 

processed cheese just prior to 

pasteurization and further cast into 

slices (or packaging into loaves or other 

final forms as in the case of pasteurized 

process cheese spread). Natamycin, 

which is stable under typical thermal 

processing conditions for pasteurized 

cheeses, would be added directly to 

cheese blends just prior to 

pasteurization, as is done with other 

mold inhibitors such as sorbic acid, 

sodium propionate, and their approved 

variants. The final concentration of 

natamycin would not exceed 20 parts 

per million and would be effective at 

producing process and blended slices 

with a shelf life of up to 150 days before 

seeing mold growth. 

The purpose of the temporary permit 

is to allow the applicant to market test 

the products throughout the United 

States. The permit will allow the 

applicant to evaluate commercial 

viability of the products and to collect 

data on consumer acceptance of the 

products. 

This permit provides for the 

temporary marketing of a maximum of 

100 million pounds (45,359,237 kg) of 

the test products. The test products will 

be manufactured at the Bongards 

Creamery facilities located at 13200 

County Rd. 51, Bongards, MN 55368, 

and 3001 Hwy. 45 Bypass West, 

Humboldt, TN 38343. 

Bongards Creameries will produce, 

market test, and distribute the test 

products throughout the United States. 

The following sliced cheese products 

will be market tested: American 

Pasteurized Process Cheese, Reduced 

Fat and Reduced Sodium American 

Pasteurized Process Cheese, Restricted 

Melt American Pasteurized Process 

Cheese, American Swiss Pasteurized 

Process Cheese, White American 

Pasteurized Process Cheese, American 

with Jalapeno Pasteurized Process 

Cheese, Pasteurized Blended Cheddar 

Cheese, Pasteurized Reduced Fat 

Cheddar Cheese, Pasteurized Blended 

Swiss Cheese, Pasteurized Blended 

Pepper Jack Cheese, Pasteurized 

Blended Low-Moisture Part Skim 

Mozzarella Cheese, and Pasteurized 

Blended Provolone Cheese. 

In addition, the following products 

will be market tested for further 

manufacturing: Yellow Restricted Melt 

Process American Slice, Yellow 

Reduced Fat/Reduced Sodium Process 

American Slice, Yellow Reduced 

Sodium Process American Slice, and 

Yellow Process American Cheese Food 

Slice. 

Each ingredient used in the food must 

be declared on the labels as required by 

the applicable sections of 21 CFR part 

101. This permit is effective for 15 

months, beginning on the date the 

applicant introduces or causes the 

introduction of the test products into 


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