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This draft guidance is being issued 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The draft guidance, when finalized, will 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of the draft guidance may do so by 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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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80119 

interstate commerce, but not later than 

March 11, 2021. 

Dated: December 7, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27197 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–2197] 

VistaPharm, Inc., et al.; Withdrawal of 

Approval of 10 Abbreviated New Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 10 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The applicants 

notified the Agency in writing that the 

drug products were no longer marketed 

and requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

January 11, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 040323 ................................. Prednisolone Syrup, 15 milligrams (mg)/5 milliliters (mL) ..................... VistaPharm, Inc., 7265 Ulmerton 

Rd., Largo, FL 33771 

ANDA 075782 ................................. Valproic Acid Syrup, 250 mg/5 mL ........................................................ Do. 

ANDA 076188 ................................. Fosinopril Sodium Tablets, 10 mg, 20 mg, and 40 mg ......................... Upsher-Smith Laboratories, LLC, 

6701 Evenstad Dr., Maple 

Grove, MN 55369 

ANDA 076189 ................................. Mirtazapine Tablets, 15 mg, 30 mg, and 45 mg ................................... Do. 

ANDA 077537 ................................. Glyburide Tablets, 1.25 mg, 2.5 mg, and 5 mg .................................... Aurobindo Pharma USA, Inc., 279 

Princeton-Hightstown Rd., East 

Windsor, NJ 08520 

ANDA 077672 ................................. Stavudine Capsules, 15 mg, 20 mg, 30 mg, and 40 mg ...................... Do. 

ANDA 085055 ................................. Tylenol W/Codeine No. 1 (acetaminophen and codeine phosphate) 

Tablets, 300 mg; 7.5 mg.

Tylenol W/Codeine No. 2 (acetaminophen and codeine phosphate) 

Tablets, 300 mg; 15 mg.

Tylenol W/Codeine No. 3 (acetaminophen and codeine phosphate) 

Tablets, 300 mg; 30 mg.

Tylenol W/Codeine No. 4 (acetaminophen and codeine phosphate) 

Tablets, 300 mg; 60 mg.

Janssen Pharmaceuticals, Inc., 

1000 U.S. Route 202, P.O. Box 

300, Raritan NJ 08869 

ANDA 087266 ................................. Lindane Shampoo, 1% .......................................................................... Olta Pharmaceuticals Corp. (an 

Akorn Company), 1925 West 

Field Ct., Suite 300, Lake Forest, IL 60045 

ANDA 087313 ................................. Lindane Lotion, 1% ................................................................................ Do. 

ANDA 089003 ................................. Phenytoin Sodium Injection, 50 mg/mL ................................................. Fresenius Kabi USA, LLC, Three 

Corporate Dr., Lake Zurich, IL 

60047 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of January 11, 

2021. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in the table 

that are in inventory on January 11, 

2021 may continue to be dispensed 

until the inventories have been depleted 

or the drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: December 8, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27303 Filed 12–10–20; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0529] 

Qualification Process for Drug 

Development Tools; Guidance for 

Industry; Availability; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Qualification Process 


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