Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 72854 [2024-20052]
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Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Notices
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, YCANTH
(cantharidin). YCANTH is indicated for
topical treatment of molluscum
contagiosum in adult and pediatric
patients 2 years of age and older.
Subsequent to this approval, the USPTO
received a patent term restoration
application for YCANTH (U.S. Patent
No. 11,052,064) from Verrica
Pharmaceuticals, and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
February 7, 2024, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
YCANTH 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
YCANTH is 2,285 days. Of this time,
877 days occurred during the testing
phase of the regulatory review period,
while 1,408 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: April 20, 2017.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on April 20, 2017.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: September 13, 2019.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
YCANTH (NDA 212905) was initially
submitted on September 13, 2019.
3. The date the application was
approved: July 21, 2023. FDA has
verified the applicant’s claim that NDA
212905 was approved on July 21, 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 745 days of patent
term extension.
Dated: September 3, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
III. Petitions
HHS.
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.
[FR Doc. 2024–20115 Filed 9–5–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2024–N–1464 and FDA–
2023–N–2781]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10 a.m.–12 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Title of collection
OMB control No.
lotter on DSK11XQN23PROD with NOTICES1
New Animal Drugs for Investigational Use ..................................................................................................
Data To Support Drug Product Communications ........................................................................................
0910–0117
0910–0695
Dated: August 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–20052 Filed 9–5–24; 8:45 am]
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8/31/2027
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[Federal Register Volume 89, Number 173 (Friday, September 6, 2024)]
[Notices]
[Page 72854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20052]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2024-N-1464 and FDA-2023-N-2781]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
Date approval
Title of collection OMB control No. expires
------------------------------------------------------------------------
New Animal Drugs for 0910-0117 8/31/2027
Investigational Use..............
Data To Support Drug Product 0910-0695 8/31/2027
Communications...................
------------------------------------------------------------------------
Dated: August 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20052 Filed 9-5-24; 8:45 am]
BILLING CODE 4164-01-P
