Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 40851 

Application No. Drug Applicant 

ANDA 072420 .... Amoxapine Tablets, 100 mg .................................................... Do. 

ANDA 072421 .... Amoxapine Tablets, 150 mg .................................................... Do. 

ANDA 072609 .... Prazosin HCl Capsules, EQ 5 mg base .................................. Do. 

ANDA 072751 .... Verapamil HCl Tablets, 40 mg ................................................. PLIVA Inc. 

ANDA 072923 .... Verapamil HCl Tablets, 40 mg ................................................. Watson Laboratories, Inc. 

ANDA 072953 .... Oxazepam Capsules, 15 mg ................................................... Do. 

ANDA 072954 .... Oxazepam Capsules, 30 mg ................................................... Do. 

ANDA 073093 .... Baclofen Tablets, 20 mg .......................................................... Do. 

ANDA 073122 .... Loperamide HCl Capsules, 2 mg ............................................. Teva Pharmaceuticals USA, Inc. 

ANDA 073334 .... Amiloride HCl and Hydrochlorothiazide Tablets, EQ 5 mg anhydrous; 50 mg.Watson Laboratories, Inc. 

ANDA 073352 .... Atenolol Tablets, 50 mg ........................................................... Do. 

ANDA 073353 .... Atenolol Tablets, 100 mg ......................................................... Do. 

ANDA 073637 .... Piroxicam Capsules, 10 mg ..................................................... Teva Pharmaceuticals USA, Inc. 

ANDA 073638 .... Piroxicam Capsules, 20 mg ..................................................... Do. 

ANDA 074026 .... Triamterene and Hydrochlorothiazide Tablets, 25 mg and 

37.5 mg.

PLIVA Inc. 

ANDA 074359 .... Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg, 50 mg, 40 mg, and 30 mg.Watson Laboratories, Inc. 

ANDA 074405 .... Flurbiprofen Tablets, 50 mg and 100 mg ................................ Teva Pharmaceuticals USA, Inc. 

ANDA 074421 .... Cyclobenzaprine HCl Tablets, 10 mg ...................................... PLIVA Inc. 

ANDA 074436 .... Cyclobenzaprine HCl Tablets, 10 mg ...................................... Watson Laboratories, Inc. 

ANDA 074442 .... Gemfibrozil Tablets, 600 mg .................................................... Do. 

ANDA 074479 .... Alprazolam Tablets, 0.25 mg, 0.5 mg, and 1 mg .................... Do. 

ANDA 074647 .... Flurbiprofen Tablets, 50 mg and 100 mg ................................ PLIVA Inc. 

ANDA 074762 .... Guanfacine HCl Tablets, EQ 1 mg base and EQ 2 mg base Watson Laboratories, Inc. 

ANDA 074836 .... Acyclovir Tablets, 400 mg and 800 mg ................................... IVAX Pharmaceuticals, Inc. 

ANDA 074892 .... Etodolac Tablets, 400 mg and 500 mg ................................... Watson Laboratories, Inc. 

ANDA 074955 .... Ketorolac Tromethamine Tablets, 10 mg ................................ Do. 

ANDA 074964 .... Clonazepam Tablets, 0.5 mg, 1 mg, and 2 mg ....................... Do. 

ANDA 075067 .... Cromolyn Sodium Inhalation Solution, 10 mg/mL ................... Actavis Mid Atlantic LLC (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 075069 .... Etodolac Tablets, 400 mg ........................................................ Watson Laboratories, Inc. 

ANDA 075262 .... Albuterol Sulfate Syrup, EQ 2 mg base/5 mL ......................... Actavis Mid Atlantic LLC. 

ANDA 075284 .... Ketorolac Tromethamine Tablets, 10 mg ................................ PLIVA Inc. 

ANDA 081165 .... Hydroxyzine Pamoate Capsules, EQ 25 mg HCl .................... Watson Laboratories, Inc. 

ANDA 084503 .... Hydralazine HCl Tablets, 50 mg .............................................. Do. 

ANDA 085054 .... Hydrochlorothiazide Tablets, 25 mg ........................................ Actavis Mid Atlantic LLC. 

ANDA 085084 .... Prednisone Tablets, 5 mg ........................................................ Watson Laboratories, Inc. 

ANDA 085085 .... Prednisolone Tablets, 5 mg ..................................................... Do. 

ANDA 085208 .... Hydrochlorothiazide Tablets, 50 mg ........................................ Actavis Elizabeth LLC. 

ANDA 086710 .... Aspirin, Butalbital, Caffeine Tablets, 325 mg, 50 mg, and 40 

mg.

Do. 

ANDA 086813 .... Prednisone Tablets, 20 mg ...................................................... Watson Laboratories, Inc. 

ANDA 087773 .... Prednisone Tablets, 10 mg ...................................................... Do. 

ANDA 088348 .... Hydroxyzine HCl Tablets, 10 mg ............................................. Do. 

ANDA 088349 .... Hydroxyzine HCl Tablets, 25 mg ............................................. Do. 

ANDA 088350 .... Hydroxyzine HCl Tablets, 50 mg ............................................. Do. 

ANDA 088497 .... Methylprednisolone Tablets, 4 mg ........................................... Duramed Pharmaceuticals Inc. (an indirect wholly owned 

subsidiary of Teva Pharmaceuticals USA, Inc.), 400 

Interpace Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 089536 .... Acetaminophen, Butalbital, and Caffeine Tablets, 325 mg, 50 

mg, and 40 mg.

Watson Laboratories, Inc. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of August 30, 

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 August 30, 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: July 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16178 Filed 7–28–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0519] 

Rabies: Developing Monoclonal 

Antibody Cocktails for the Passive 

Immunization Component of PostExposure Prophylaxis; Draft Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 


jbell on DSKJLSW7X2PROD with NOTICES
40852 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Rabies: 

Developing Monoclonal Antibody 

Cocktails for the Passive Immunization 

Component of Post-Exposure 

Prophylaxis.’’ The purpose of this draft 

guidance is to help sponsors in the 

development of anti-rabies virus 

monoclonal antibody (mAb) cocktails as 

an alternative to anti-rabies virus 

immunoglobulin (RIG) as the passive 

immunization component of postexposure prophylaxis (PEP) for the 

prevention of rabies when given 

immediately after contact with a rabid 

or possibly rabid animal. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 27, 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– 

2021–D–0519 for ‘‘Rabies: Developing 

Monoclonal Antibody Cocktails for the 

Passive Immunization Component of 

Post-Exposure Prophylaxis.’’ 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 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: 

Stephanie Troy, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6381, 

Silver Spring, MD 20993–0002, 240– 

402–4656. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Rabies: Developing Monoclonal 

Antibody Cocktails for the Passive 

Immunization Component of PostExposure Prophylaxis.’’ The purpose of 

this draft guidance is to help sponsors 

in the development of anti-rabies virus 

mAb cocktails as an alternative to RIG 

as the passive immunization component 

of PEP for the prevention of rabies when 

given immediately after contact with a 

rabid or possibly rabid animal. Because 

of the unique complexities of drug 

development in this area, extensive 

discussion with multiple stakeholders 

has taken place, including a public 

workshop in 2017 and an advisory 

committee meeting in 2019. These 

discussions helped FDA formulate the 

considerations for rabies mAb cocktail 

development that are described in this 

draft guidance. 

The draft guidance addresses the 

following topics: 

• Considerations when selecting the 

mAbs included in the cocktail 

• The nonclinical and clinical data 

needed to support clinical trials of the 

mAb cocktail in potentially rabies virusexposed subjects 

• The clinical data recommended to 

support an initial biologics license 

application submission of the mAb 

cocktail for a second-line indication in 

situations where human-derived RIG is 

not available 

• The clinical data recommended to 

support a first-line indication for the 

mAb cocktail 

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 ‘‘Rabies: Developing Monoclonal 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 40853 

Antibody Cocktails for the Passive 

Immunization Component of PostExposure Prophylaxis.’’ 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. Paperwork Reduction Act of 1995 

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 associated with 

submissions of content and format of 

labeling for drugs and biologics in 21 

CFR 201.56 and 201.57 have been 

approved under OMB control number 

0910–0572; the collections of 

information associated with 

submissions of investigational new drug 

applications in 21 CFR part 312 have 

been approved under OMB control 

numbers 0910–0014; the collections of 

information associated with 

submissions of applications for approval 

to market a new drug in 21 CFR part 314 

have been approved under 0910–0001; 

the collections of information associated 

with the reporting and recordkeeping of 

postmarketing adverse drug experiences 

have been approved under OMB control 

numbers 0910–0001, 0910–0230, 0910– 

0291, and 0910–0645; and the 

collections of information associated 

with general licensing provisions for 

biologics in 21 CFR part 601 have been 

approved under OMB control number 

0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: July 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16175 Filed 7–28–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0584] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Pilot Survey To 

Develop Standardized Reporting 

Forms for Federally Funded Public 

Health Projects 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with a pilot survey 

to develop standardized reporting forms 

for capturing performance data for 

federally funded public health projects. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 27, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 27, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 27, 2021. 

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– 

2021–N–0584 for ‘‘Pilot Survey to 

Develop Standardized Reporting Forms 

for Federally Funded Public Health 

Projects administered by the Office of 

Regulatory Affairs (ORA).’’ 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 


jbell on DSKJLSW7X2PROD with NOTICES