Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 83883 

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, EXXUA (gepirone 

hydrochloride) indicated for treatment 

of major depressive disorder in adults. 

Subsequent to this approval, the USPTO 

received a patent term restoration 

application for EXXUA (U.S. Patent No. 

7,538,116) from Fabre-Kramer 

Pharmaceuticals, Inc. and the USPTO 

requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

February 6, 2024, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of EXXUA 

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 

EXXUA is 14,390 days. Of this time, 

6,226 days occurred during the testing 

phase of the regulatory review period, 

while 8,164 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: May 2, 1984. 

Fabre-Kramer Pharmaceuticals, Inc. 

claims that October 1, 1989, is the date 

the investigational new drug application 

(IND) became effective. However, FDA’s 

records indicate that the effective date 

of an earlier IND was May 2, 1984, 

which was 30 days after FDA received 

the earlier IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: May 18, 2001. The 

applicant claims July 19, 1999, as the 

date the new drug application (NDA) for 

EXXUA (NDA 21164) was initially 

submitted. However, FDA records 

indicate that NDA 21164, submitted on 

October 1, 1999, was incomplete. FDA 

refused the application and notified the 

applicant of this fact by letter dated 

November 30, 1999. The complete NDA 

was then submitted on May 18, 2001, 

which is considered to be the initially 

submitted date. 

3. The date the application was 

approved: September 22, 2023 5:47:00 

p.m. FDA has verified the applicant’s 

claim that NDA 21164 was approved on 

September 22, 2023. 

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 5 years 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. 2024–24109 Filed 10–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4560] 

Linde, Inc.; Withdrawal of Approval of 

a New Drug Application and New 

Animal Drug Application for Helium, 

USP 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of the new drug 

application (NDA) 205851 and the new 

animal drug application (NADA) 141– 

389 for the designated medical gas 

Helium, USP held by Linde, Inc., 175 

East Park Dr., Tonawanda, NY 14150– 

7844. Linde, Inc. notified the Agency in 

writing that the drug product was no 

longer marketed and requested that the 

approval of the application be 

withdrawn. 

DATES: Approval is withdrawn as of 

November 18, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov; or Scott Fontana (HFV– 

180), Center for Veterinary Medicine, 

Food and Drug Administration, 7500 

Standish Pl., Rockville, MD 20855, 240– 

402–0656, Scott.Fontana@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On March 

12, 2024, Linde, Inc. informed FDA that 

it is no longer marketing the designated 

medical gas Helium, USP and requested 

that FDA withdraw approval of NDA 

205851 and NADA 141–389 under the 

processes in § 314.150(c) (21 CFR 

314.150(c)) and § 514.115(d) (21 CFR 

514.115(d)). Linde, Inc. has also, by its 

request, waived its opportunity for a 

hearing. Withdrawal of approval of an 

application or abbreviated application 

under § 314.150(c) or an NADA or 

abbreviated new animal drug 

application under § 514.115(d) is 

without prejudice to refiling. 

Therefore, approval of NDA 205851 

and NADA 141–389, and all 

amendments and supplements thereto, 


khammond on DSKJM1Z7X2PROD with NOTICES
83884 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Notices 

are hereby withdrawn as of November 

18, 2024. Introduction or delivery for 

introduction into interstate commerce of 

Helium, USP, without an approved new 

drug application or an approved new 

animal drug application violates 

sections 505(a), 512(a), 301(a), and 

301(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(a), 

360b(a)(1), 331(a), and 331(d)). Any 

Helium, USP manufactured by Linde, 

Inc. pursuant to these applications that 

is in inventory on November 18, 2024 

may continue to be dispensed until the 

inventories have been depleted or the 

drug product has reached its expiration 

date or otherwise become violative, 

whichever occurs first. 

Dated: October 9, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24106 Filed 10–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2303] 

Core Patient-Reported Outcomes in 

Cancer Clinical Trials; 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 final 

guidance for industry entitled ‘‘Core 

Patient-Reported Outcomes in Cancer 

Clinical Trials.’’ This final guidance 

provides recommendations to sponsors 

regarding the collection of a core set of 

patient-reported clinical outcomes 

(herein referred to as core patientreported outcomes) in cancer clinical 

trials and related considerations for 

instrument selection and trial design. 

This final guidance focuses on patientreported outcome (PRO) measures and 

is specific to registration trials for anticancer therapies intended to 

demonstrate an effect on survival, tumor 

response, or delay in the progression of 

a malignancy. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 18, 2024. 

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–2303 for ‘‘Core PatientReported Outcomes in Cancer Clinical 

Trials.’’ 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 this 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Vishal Bhatnagar, Oncology Center of 

Excellence, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2113, Silver Spring, 

MD 20993–0002, 240–402–3696; or 

James Myers, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 240– 

402–7910. 

SUPPLEMENTARY INFORMATION: 


khammond on DSKJM1Z7X2PROD with NOTICES