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applications be withdrawn. 

DATES: Approval is withdrawn as of 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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80120 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

for Drug Development Tools; Guidance 

for Industry; Availability’’ that appeared 

in the Federal Register of November 25, 

2020. The document announced the 

availability of a final guidance for 

industry and FDA staff that met the 21st 

Century Cures Act’s requirement to 

issue guidance on this qualification 

process and elaborated on the new 

qualification process and transparency 

requirements and discusses the 

taxonomy for biomarkers and other drug 

development tools. The document was 

published with incorrect information in 

the Paperwork Reduction Act of 1995 

section. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: 

Chris Leptak, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6461, Silver Spring, 

MD 20993–0002, 301–796–0017; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002; 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 25, 2020 

(85 FR 75334), in FR Doc. 2020–26051, 

the following correction is made: 

On page 75336, in the first column, 

under the heading, ‘‘II. Paperwork 

Reduction Act of 1995’’, the paragraph 

is corrected to read: 

‘‘While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information pertaining to submissions 

of investigational new drug applications 

have been approved under OMB control 

number 0910–0014; the collections of 

information pertaining to submissions 

of new drug applications and 

abbreviated new drug applications have 

been approved under OMB control 

number 0910–0001; and the collections 

of information pertaining to 

submissions of biologics license 

applications in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338.’’ 

Dated: December 8, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27288 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–D–0064] 

Pre-Submission Consultation Process 

for Animal Food Additive Petitions or 

Generally Recognized as Safe Notices; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing the availability of a final 

guidance for industry #262 entitled 

‘‘Pre-Submission Consultation Process 

for Animal Food Additive Petitions or 

Generally Recognized as Safe (GRAS) 

Notices.’’ The guidance provides 

uniform, consistent process information 

to industry to facilitate effective and 

efficient review of pre-consultation 

submissions for animal food additives 

or GRAS notices for intended use in 

animal food. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 11, 2020. 

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– 

2020–D–0064 for ‘‘Pre-Submission 

Consultation Process for Animal Food 

Additive Petitions or Generally 

Recognized as Safe (GRAS) Notices.’’ 

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 


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