Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Notices 72851 

1Transaction is defined in section 581(24) of the 

FD&C Act. 

FD&C Act include: (1) providing the 

transaction information, the transaction 

history (when applicable), and 

transaction statement (T3) to the 

subsequent purchaser, providing 

relevant transaction information, 

transaction history, and transaction 

statement upon a request for 

information from FDA or other 

appropriate Federal or State officials if 

a recall or investigation of suspect or 

illegitimate product occurs, and, after 

the Statutory Date, facilitating the 

gathering of information necessary to 

produce the transaction information for 

each transaction 1 going back to the 

manufacturer at an authorized trading 

partner’s request, or at the request of 

FDA or other appropriate Federal or 

State officials; and (2) capturing and 

maintaining transaction information, 

transaction history, and transaction 

statements for each transaction for not 

less than 6 years after the transaction. 

Product identification activities include 

the requirement that manufacturers and 

repackagers affix or imprint a product 

identifier to each package and 

homogeneous case of products that they 

intend to be introduced in a transaction 

into commerce and that they maintain 

product identifier information for each 

package and homogeneous case of 

product for not less than 6 years. 

Verification Activities 

Verification activities include: (1) 

coordinating with other trading partners 

during an investigation of a suspect 

product to determine whether the 

product is illegitimate; (2) for 

manufacturers and repackagers, 

responding to trading partners’ requests 

for verification of product identifiers; (3) 

maintaining records of suspect product 

investigations and disposition of 

illegitimate product for not less than 6 

years; (4) identifying suspect product; 

(5) quarantining suspect and illegitimate 

product; (6) investigating suspect 

product; (7) notifying FDA of suspect 

product that is determined not to be 

illegitimate product (when applicable); 

(8) processing saleable returns; and (9) 

establishing systems and processes to 

comply with all of these requirements. 

We assume manufacturers, 

repackagers and wholesale distributors 

will already have systems and processes 

to comply with many of these 

requirements. Such systems will 

therefore only need to be updated to 

ensure full compliance with the DSCSA. 

We also anticipate that a chain 

pharmacy will develop the required 

systems and processes centrally at its 

headquarters or at its distribution 

centers and then distribute to each 

pharmacy. 

Our estimated burden for the 

information collection as revised 

reflects a significant decrease in the 

burden estimates for annual responses 

and hours. We have excluded from our 

estimated burden the time, effort, and 

financial resources attributable to those 

activities we consider usual and 

customary by respondents, consistent 

with 5 CFR 1320.3(b)(2). We invite 

comment on our assumption. 

Dated: August 29, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20064 Filed 9–5–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–E–1150] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; STEGLATRO 

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 STEGLATRO 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 must submit either electronic 

or written comments and ask for a 

redetermination by November 5, 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 

March 5, 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 

November 5, 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’’). 

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– 

2019–E–1150 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; STEGLATRO.’’ 

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. 


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72852 Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Notices 

• 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, STEGLATRO 

(ertugliflozin) indicated as an adjunct to 

diet and exercise to improve glycemic 

control in adults with type 2 diabetes 

mellitus. Subsequent to this approval, 

the USPTO received a patent term 

restoration application for STEGLATRO 

(U.S. Patent No. 8,080,580) from Pfizer 

Inc. and the USPTO requested FDA’s 

assistance in determining the patent’s 

eligibility for patent term restoration. In 

a letter dated June 12, 2019, FDA 

advised the USPTO that this human 

drug product had undergone a 

regulatory review period and that the 

approval of STEGLATRO 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 

STEGLATRO is 2,976 days. Of this time, 

2,610 days occurred during the testing 

phase of the regulatory review period, 

while 366 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: October 28, 

2009. The applicant claims October 29, 

2009, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was October 28, 2009, 

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: December 19, 2016. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

STEGLATRO (NDA 209803) was 

initially submitted on December 19, 

2016. 

3. The date the application was 

approved: December 19, 2017. FDA has 

verified the applicant’s claim that NDA 

209803 was approved on December 19, 

2017. 

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 524 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: September 3, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20149 Filed 9–5–24; 8:45 am] 

BILLING CODE 4164–01–P 


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