Federal Register / Vol. 89, No. 203 / Monday, October 21, 2024 / Notices 84161 

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, VYNDAQEL 

(tafamidis meglumine) indicated for the 

treatment of the cardiomyopathy of wild 

type or hereditary transthyretinmediated amyloidosis in adults to 

reduce cardiovascular mortality and 

cardiovascular-related hospitalization. 

Subsequent to this approval, the USPTO 

received a patent term restoration 

application for VYNDAQEL (U.S. Patent 

No. 7,214,696) from The Scripps 

Research Institute and the USPTO 

requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

February 8, 2024, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

VYNDAQEL 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 

VYNDAQEL is 4,978 days. Of this time, 

4,794 days occurred during the testing 

phase of the regulatory review period, 

while 184 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: September 18, 

2005. The applicant claims September 

19, 2005, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

September 18, 2005, which was 30 days 

after FDA receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: November 2, 2018. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

VYNDAQEL (NDA 211996) was initially 

submitted on November 2, 2018. 

3. The date the application was 

approved: May 3, 2019, 6:13 p.m. FDA 

has verified the applicant’s claim that 

NDA 211996 was approved on May 3, 

2019, 6:13 p.m. 

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 applications for patent extension, 

this applicant seeks 1,827 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 

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: October 10, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24188 Filed 10–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–3123] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Vyndamax 

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 VYNDAMAX and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications 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 must submit either electronic 

or written comments and ask for a 

redetermination by December 20, 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 

April 21, 2025. 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 

December 20, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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’’). 


lotter on DSK11XQN23PROD with NOTICES1
84162 Federal Register / Vol. 89, No. 203 / Monday, October 21, 2024 / Notices 

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–3123 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; VYNDAMAX.’’ 

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. 6200, 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 biological 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, VYNDAMAX 

(tafamidis) indicated for the treatment of 

the cardiomyopathy of wild type or 

hereditary transthyretin-mediated 

amyloidosis in adults to reduce 

cardiovascular mortality and 

cardiovascular-related hospitalization. 

Subsequent to this approval, the USPTO 

received a patent term restoration 

application for VYNDAMAX (U.S. 

Patent No. 7,214,695) from The Scripps 

Research Institute, and the USPTO 

requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

February 8, 2024, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

VYNDAMAX 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 

VYNDAMAX is 4,978 days. Of this time, 

4,794 days occurred during the testing 

phase of the regulatory review period, 

while 184 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: September 18, 

2005. The applicant claims September 

19, 2005, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

September 18, 2005, which was 30 days 

after FDA receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: November 2, 2018. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

VYNDAMAX (NDA 212161) was 

initially submitted on November 2, 

2018. 

3. The date the application was 

approved: May 3, 2019, 6:13 p.m. FDA 

has verified the applicant’s claim that 

NDA 212161 was approved on May 3, 

2019, 6:13 p.m. 

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 applications for patent extension, 

this applicant seeks 1,826 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 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 203 / Monday, October 21, 2024 / Notices 84163 

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: October 10, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24187 Filed 10–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Cardiovascular and Hematological 

Studies. 

Date: November 13, 2024. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Dmitri V. Gnatenko, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 867–5309, gnatenkod2@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; AREA/ 

REAP: Musculoskeletal, Skin and Oral 

Sciences. 

Date: November 14, 2024. 

Time: 9:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Richard Ingraham, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4116, 

MSC 7814, Bethesda, MD 20892, (301) 496– 

8551, ingrahamrh@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Health Services and Systems. 

Date: November 14–15, 2024. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Michael J. McQuestion, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3114, 

Bethesda, MD 20892, 301–480–1276, 

mike.mcquestion@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Neuro 

Informatics, Computational and Data 

Analysis. 

Date: November 14, 2024. 

Time: 9:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Joseph G. Rudolph, Ph.D., 

Chief and Scientific Review Officer, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5186, 

MSC 7844, Bethesda, MD 20892, 301–408– 

9098, josephru@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Drug Discovery for Aging, 

Neurodegenerative and Neurological 

Disorders. 

Date: November 14–15, 2024. 

Time: 9:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Kathryn Partlow, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1016D, 

Bethesda, MD 20892, (301) 594–2138, 

partlowkc@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Clinical Care and Health 

Interventions. 

Date: November 14–15, 2024. 

Time: 9:30 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: In-Person and Virtual 

Meeting. 

Contact Person: Trina Colleen Salm Ward, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 594–5254, salmwardtc@

csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Brain Disorders and Related 

Neurosciences. 

Date: November 14–15, 2024. 

Time: 9:30 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Vilen A Movsesyan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040M, 

MSC 7806, Bethesda, MD 20892, 301–402– 

7278, movsesyanv@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: October 15, 2024. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–24236 Filed 10–18–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review and 

National Institute of Allergy and 

Infectious Diseases; Amended Notice 

of Closed Meeting 

Notice is hereby given of changes 

pertaining to the meeting of the Center 

for Scientific Review Special Emphasis 

Panel, Fellowship: NIH Medical 

Scientist Partnership Program (FM1), 

October 31, 2024, 9:00 a.m. to November 

1, 2024, 06:00 p.m., National Institutes 

of Health, Rockledge II, 6701 Rockledge 

Drive, Bethesda, MD 20892, which was 

published in the Federal Register on 


lotter on DSK11XQN23PROD with NOTICES1