4954 Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 

3As set forth in the EUAs for these products, FDA 

has concluded that: (1) SARS-CoV–2 can cause a 

serious or life-threatening disease or condition, 

including severe respiratory illness, to humans 

infected by this virus; (2) based on the totality of 

scientific evidence available to FDA, it is reasonable 

to believe that the products may be effective in 

diagnosing COVID–19, and that the known and 

potential benefits of the products, when used for 

diagnosing COVID–19, outweigh the known and 

potential risks of such products; and (3) there is no 

adequate, approved, and available alternative to the 

emergency use of the products. 

4As set forth in the EUA for this product, FDA 

has concluded that: (1) SARS–CoV–2 can cause a 

serious or life-threatening disease or condition, 

including severe respiratory illness, to humans 

infected by this virus; (2) based on the totality of 

scientific evidence available to FDA, it is reasonable 

to believe that the product may be effective in 

diagnosing COVID–19 through the simultaneous 

detection and differentiation of SARS–CoV–2, 

influenza A virus and/or influenza B virus 

nucleocapsid protein antigens, and that the known 

and potential benefits of the product when used for 

diagnosing COVID–19, outweigh the known and 

potential risks of such product; and (3) there is no 

adequate, approved, and available alternative to the 

emergency use of the product. 

5As set forth in the EUA for this product, FDA 

has concluded that: (1) SARS–CoV–2 can cause a 

serious or life-threatening disease or condition, 

including severe respiratory illness, to humans 

infected by this virus; (2) based on the totality of 

scientific evidence available to FDA, it is reasonable 

to believe that the product may be effective in 

diagnosing COVID–19 through the simultaneous 

qualitative detection and differentiation of SARS– 

CoV–2, influenza A virus and/or influenza B virus 

RNA, and that the known and potential benefits of 

the product when used for diagnosing COVID–19, 

outweigh the known and potential risks of such 

product; and (3) there is no adequate, approved, 

and available alternative to the emergency use of 

the product. 

diagnostic and antigen tests for COVID– 

19, excluding multianalyte tests: 3

• Azure Biotech, Inc.’s Azure Fatep 

COVID–19 Antigen Pen Home Test, 

issued April 14, 2023; 

• MedArbor, LLC dba MedArbor 

Diagnostics’ MedArbor Diagnostics 

SARS–CoV–2 Assay, issued April 19, 

2023; 

• Princeton BioMeditech Corp’s 

Status COVID–19 Antigen Rapid Test 

for Home Use, issued April 24, 2023; 

• University of Massachusetts’ ICTC 

SARS–CoV–2 RT–PCR Assay, issued 

April 26, 2023; 

• Drexel University College of 

Medicine’s SARS–CoV–2 DUCoM–PDL 

Modified Tetracore Assay, issued on 

April 28, 2023; 

• Access Medical Laboratories, Inc.’s 

Global Direct RT–PCR Test, issued on 

May 3, 2023; 

• Nano-Ditech Corporation’s NanoCheck COVID–19 Antigen At-Home 

Test, issued on May 12, 2023; 

• BioTeke USA, LLC’s Bio-Self 

COVID–19 Antigen Home Test, issued 

on May 22, 2023; 

• Acutis Diagnostics’ SARS–CoV–2 

Acutis Multiplex Assay, issued on June 

06, 2023; 

• Michigan State University 

laboratories, Department of Medicine 

Olin Student Health Center’s In-Dx 

SARS–CoV–2 RT–LAMP Assay, issued 

on June 08, 2023; 

• Discover Labs’ Discover Labs 

COVID–19 Assay, issued on June 30, 

2023; 

• Immunostics Inc.’s Swab-N-Go 

Home Test COVID–19 Ag, issued on 

July 17, 2023; 

• Alphadera Labs, LLC’s ALPHADx 

SARS–COV–2RT–PCR Test, issued on 

July 20, 2023; 

• Laboratory Corporation of 

America’s Clear Dx SARS–CoV–2 WGS 

v3.0 Test, issued on August 1, 2023; and 

• 3EO Health, Inc.’s 3EO Health 

COVID–19 Test, issued on September 

19, 2023. 

• Tangen Biosciences, Inc.’s 

TangenDx SARS–CoV–2 Molecular Test, 

issued September 29, 2023; 

• SD Biosensor, Inc.’s STANDARD Q 

COVID–19 Ag Test 2.0, issued 

September 29, 2023; 

• MAWD Laboratories’ MAWD 

Laboratories SARS–CoV–2 Dual Target 

by RT–PCR, issued on October 13, 2023; 

• RCA Laboratory Services LLC dba 

GENETWORx’s Gx HTIQ SARS–CoV–2 

Test, issued December 08, 2023; and 

• RCA Laboratory Services LLC dba 

GENETWORx’s Gx HTKB SARS–CoV–2 

Test, issued on December 08, 2023. 

FDA is hereby announcing the 

following Authorizations for 

multianalyte tests: 

• Princeton BioMeditech Corp’s 

ViraDx SARS–CoV–2/Flu A+B Rapid 

Antigen Test, issued on September 8, 

2023.4

• Roche Molecular Systems’s cobas 

SARS–CoV–2 & Influenza A/B v2, 

issued on November 16, 2023.5

Dated: January 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01426 Filed 1–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–0449] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CABENUVA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for CABENUVA and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by March 25, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

July 23, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

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 

March 25, 2024. 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 4955 

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–E–0449 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; CABENUVA.’’ 

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 § 10.20 (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. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biologic product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product CABENUVA 

(cabotegravir and rilpivirine). 

CABENUVA is indicated as a complete 

regimen for the treatment of HIV–1 

infection in adults to replace the current 

antiretroviral regimen in those who are 

virologically suppressed (HIV–1 RNA 

less than 50 copies per mL) on a stable 

antiretroviral regimen with no history of 

treatment failure and with no known or 

suspected resistance to either 

cabotegravir or rilpivirine. Subsequent 

to this approval, the USPTO received a 

patent term restoration application for 

CABENUVA (U.S. Patent No. 8,410,103) 

from ViiV Healthcare Company and 

Shionogi & Co., Ltd. and the USPTO 

requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

September 28, 2022, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

CABENUVA represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

CABENUVA is 4,719 days. Of this time, 

4,085 days occurred during the testing 

phase of the regulatory review period, 

while 634 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: February 22, 

2008. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on February 22, 2008. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: April 29, 2019. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

CABENUVA (NDA 212888) was initially 

submitted on April 29, 2019. 

3. The date the application was 

approved: January 21, 2021. FDA has 

verified the applicant’s claim that NDA 

212888 was approved on January 21, 

2021. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,742 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 


khammond on DSKJM1Z7X2PROD with NOTICES
4956 Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: January 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01439 Filed 1–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4761] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; Good 

Manufacturing Practice for Active 

Pharmaceutical Ingredients Used in 

Veterinary Medicinal Products; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry (GFI) #286 (VICH 

GL60) entitled ‘‘Good Manufacturing 

Practice for Active Pharmaceutical 

Ingredients Used in Veterinary 

Medicinal Products.’’ This draft 

guidance has been developed for 

veterinary use by the International 

Cooperation on Harmonisation of 

Technical Requirements for Registration 

of Veterinary Medicinal Products 

(VICH). The objective of this draft 

guidance is to provide 

recommendations regarding good 

manufacturing practice (GMP) for the 

manufacturing of active pharmaceutical 

ingredients (APIs) under an appropriate 

system for managing quality. It is also 

intended to help ensure that APIs meet 

the requirements for quality and purity 

that they purport or are represented to 

possess. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 25, 2024 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– 

2023–D–4761 for ‘‘Good Manufacturing 

Practice for Active Pharmaceutical 

Ingredients Used in Veterinary 

Medicinal Products.’’ 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 guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 


khammond on DSKJM1Z7X2PROD with NOTICES