Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon), 16001 [2024-04735]

Download as PDF Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices 16001 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 21 CFR section Number of respondents Number of responses per respondent 54 1.98 107 0.5 (30 minutes) ........... 53.5 314.107(e)—notification of court actions or written consent to approval ...... Total annual responses Average burden per response (in hours) Total hours Subparts G, H, and I 314.420—Drug Master Files—original Form FDA 3938 ................................ DMF Amendments—Technical ...................................................................... DMF Amendments—REMS ........................................................................... DM Amendments—administrative .................................................................. DMFs—Annual reports ................................................................................... 314.550—Promotional material and subpart H applications 2 ....................... CPA Requests for NDA/Biologics License Application Products .................. 491 1,335 2 1,024 1,836 69 1 2.05 18.71 1 9.67 6.04 5.84 1 1,005 24,979 2 6,851 11,097 403 1 61 .................................. 8 .................................... 8 .................................... 6 .................................... 4 .................................... 120 ................................ 5 .................................... 61,305 199,832 16 41,106 44,388 48,360 5 Total ........................................................................................................ .................... ........................ ........................ ....................................... 3,476,650 1 Total burden hours have been rounded. 2 We have included burden attendant to subpart H applications activity in our estimate of burden associated with § 314.50. Our estimated burden for the information collection reflects an overall decrease of 642,293.5 hours. The reporting period for this information collection renewal includes the 3 years of the COVID–19 pandemic. We attribute this adjustment to a decrease in the number of submissions received during the public health emergency. We anticipate that the numbers of submissions to FDA will return to prepandemic levels as economic activity recovers. We also attribute a portion of the burden adjustment to improved operational efficiencies with regard to Agency data systems and digital submission processes. I. Background Dated: February 29, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–04715 Filed 3–5–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–2390] Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon) AGENCY: Food and Drug Administration, HHS. ddrumheller on DSK120RN23PROD with NOTICES1 ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677–004, submitted by Vanda Pharmaceuticals, SUMMARY: VerDate Sep<11>2014 16:57 Mar 05, 2024 Jkt 262001 Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of jet lag disorder. The decision, which also refuses approval of sNDA 205677–004, is available in the docket identified by the number in the heading of this document. DATES: The decision was published in the docket on March 1, 2024. FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240–402–5931. SUPPLEMENTARY INFORMATION: On January 31, 2014, FDA approved new drug application (NDA) 205677 for HETLIOZ (tasimelteon) for treatment of non-24-hour sleep-wake disorder, a circadian-rhythm disorder that disproportionately afflicts individuals who are totally blind. On October 16, 2018, Vanda submitted the supplemental NDA (sNDA) that is the subject at issue here: sNDA 205677–004 for HETLIOZ (tasimelteon) capsules, 20 mg, proposing to add a new indication for the treatment of jet lag disorder. On December 1, 2020, FDA approved NDA 214517 for HETLIOZ (tasimelteon) suspension for the treatment of nighttime sleep disturbances in pediatric patients with Smith-Magenis Syndrome, a rare genetic neurodevelopment disorder. On July 1, 2022, Vanda requested an opportunity for a hearing under 21 CFR 314.110(b)(3) on whether there are grounds under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) for denying approval of sNDA 205677–004 for the treatment of jet lag disorder. On August 29, 2022, CDER notified Vanda by registered mail, providing it with a notice of opportunity for a hearing (NOOH) on a proposal to PO 00000 Frm 00033 Fmt 4703 Sfmt 9990 refuse to approve sNDA 205677–004. The NOOH was subsequently published in the Federal Register of October 11, 2022 (87 FR 61337). On November 10, 2022, Vanda filed a notice of participation and requested a hearing and, on December 12, 2022, submitted information, data, and analyses in support of that request. On June 12, 2023, CDER submitted a proposed order denying Vanda’s request for a hearing and refusing to approve the sNDA. On August 11, 2023, Vanda responded to CDER’s proposed order. On September 8, 2023, CDER submitted a reply, which included a revised proposed order. After considering the parties’ submissions, on March 1, 2024, FDA issued a decision denying Vanda’s request for a hearing on CDER’s proposal to refuse approval and refusing to approve sNDA 205677–004. II. Electronic Access Persons with access to the internet may obtain the final decision at https:// www.regulations.gov/docket/FDA-2022N-2390. The final decision and other documents pertaining to the refusal to approve HETLIOZ (sNDA 205677–004) are available at https:// www.regulations.gov under the docket number found in brackets in the heading of this document. Dated: March 1, 2024. Namandje´ N. Bumpus, Principal Deputy Commissioner. [FR Doc. 2024–04735 Filed 3–5–24; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\06MRN1.SGM 06MRN1

Agencies

[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Page 16001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04735]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2390]


Notice of the Denial of a Hearing Request Regarding a Proposal To 
Refuse To Approve a Supplemental New Drug Application for HETLIOZ 
(Tasimelteon)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of the decision to deny a request for a 
hearing regarding the proposal of the Center for Drug Evaluation and 
Research (CDER) to refuse to approve the supplemental new drug 
application (sNDA) 205677-004, submitted by Vanda Pharmaceuticals, Inc. 
(Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for 
the treatment of jet lag disorder. The decision, which also refuses 
approval of sNDA 205677-004, is available in the docket identified by 
the number in the heading of this document.

DATES: The decision was published in the docket on March 1, 2024.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of 
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2014, FDA approved new drug application (NDA) 205677 
for HETLIOZ (tasimelteon) for treatment of non-24-hour sleep-wake 
disorder, a circadian-rhythm disorder that disproportionately afflicts 
individuals who are totally blind. On October 16, 2018, Vanda submitted 
the supplemental NDA (sNDA) that is the subject at issue here: sNDA 
205677-004 for HETLIOZ (tasimelteon) capsules, 20 mg, proposing to add 
a new indication for the treatment of jet lag disorder. On December 1, 
2020, FDA approved NDA 214517 for HETLIOZ (tasimelteon) suspension for 
the treatment of nighttime sleep disturbances in pediatric patients 
with Smith-Magenis Syndrome, a rare genetic neurodevelopment disorder.
    On July 1, 2022, Vanda requested an opportunity for a hearing under 
21 CFR 314.110(b)(3) on whether there are grounds under section 505(d) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) for 
denying approval of sNDA 205677-004 for the treatment of jet lag 
disorder. On August 29, 2022, CDER notified Vanda by registered mail, 
providing it with a notice of opportunity for a hearing (NOOH) on a 
proposal to refuse to approve sNDA 205677-004. The NOOH was 
subsequently published in the Federal Register of October 11, 2022 (87 
FR 61337).
    On November 10, 2022, Vanda filed a notice of participation and 
requested a hearing and, on December 12, 2022, submitted information, 
data, and analyses in support of that request. On June 12, 2023, CDER 
submitted a proposed order denying Vanda's request for a hearing and 
refusing to approve the sNDA. On August 11, 2023, Vanda responded to 
CDER's proposed order. On September 8, 2023, CDER submitted a reply, 
which included a revised proposed order.
    After considering the parties' submissions, on March 1, 2024, FDA 
issued a decision denying Vanda's request for a hearing on CDER's 
proposal to refuse approval and refusing to approve sNDA 205677-004.

II. Electronic Access

    Persons with access to the internet may obtain the final decision 
at https://www.regulations.gov/docket/FDA-2022-N-2390. The final 
decision and other documents pertaining to the refusal to approve 
HETLIOZ (sNDA 205677-004) are available at https://www.regulations.gov 
under the docket number found in brackets in the heading of this 
document.

    Dated: March 1, 2024.
Namandj[eacute] N. Bumpus,
Principal Deputy Commissioner.
[FR Doc. 2024-04735 Filed 3-5-24; 8:45 am]
BILLING CODE 4164-01-P

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