30 Day FRN_2025-16295

41584

Federal Register / Vol. 90, No. 163 / Tuesday, August 26, 2025 / Notices

lotter on DSK11XQN23PROD with NOTICES1

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, VORANIGO
(vorasidenib) indicated for the treatment
of adult and pediatric patients 12 years
and older with Grade 2 astrocytoma or
oligodendroglioma with a susceptible
isocitrate dehydrogenase-1 or isocitrate
dehydrogenase-2 mutation following
surgery including biopsy, sub-total
resection, or gross total resection.
Subsequent to this approval, the USPTO
received a patent term restoration
application for VORANIGO (U.S. Patent
No. 9,579,324) from Servier
Pharmaceuticals LLC and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
March 17, 2025, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
VORANIGO 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
VORANIGO is 3,388 days. Of this time,
3,157 days occurred during the testing
phase of the regulatory review period,
while 231 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 30, 2015.

VerDate Sep<11>2014

17:03 Aug 25, 2025

Jkt 265001

FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on April 30, 2015.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: December 20, 2023.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
VORANIGO (NDA 218784) was initially
submitted on December 20, 2023.
3. The date the application was
approved: August 6, 2024. FDA has
verified the applicant’s claim that NDA
218784 was approved on August 6,
2024.
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(s) for patent extension,
this applicant seeks 1,474 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2025–16271 Filed 8–25–25; 8:45 am]
BILLING CODE 4164–01–P

PO 00000

Frm 00042

Fmt 4703

Sfmt 4703

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New–30D]

Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Assistant
Secretary for Technology Policy/Office
of the National Coordinator for Health
IT, Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:

In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 25,
2025.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain . Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Meghan Gabriel, Meghan.Gabriel@
hhs.gov, or (202) 465–0597, or ASTP_
[email protected]. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: National
Survey of Digital Health Companies.
Type of Collection: New.
Document Identifier 0990–New–30D.
SUMMARY:

Abstract
The 21st Century Cures Act (Cures
Act) aimed to advance the exchange of
electronic health information by
promoting patient access through

E:\FR\FM\26AUN1.SGM

26AUN1

41585

Federal Register / Vol. 90, No. 163 / Tuesday, August 26, 2025 / Notices
standardized application programming
interfaces (APIs). Digital health
companies develop apps and health IT
tools that enable human interaction
with APIs to exchange electronic health
information. Prior studies indicate
widespread adoption of standardized
APIs for interoperability with electronic
health records (EHRs). Ongoing
assessment of these technologies is
crucial to examining the impacts of the
Cures Act’s health IT provisions and is
critical to informing the Assistant

survey digital health companies to
assess ASTP/ONC’s implementation of
statutorily mandated information
blocking (42 U.S.C. 300jj–52) and APIs
‘‘without special effort’’ policies (42
U.S.C. 300jj–11) under the Cures Act.
Information gathered from this effort
will help inform ongoing ASTP/ONC
efforts to help nurture an ecosystem of
innovation and transparency in health
care.
This is a 3-year request for OMB
approval.

Secretary for Technology Policy/Office
of the National Coordinator for Health
IT’s (ASTP/ONC’s) policy efforts. With
ASTP/ONC’s support, the University of
California, San Francisco (UCSF)
conducted a 2022 survey of digital
health companies assessing
implementation of and experiences with
healthcare APIs; findings from this
survey work are published in the
Journal of the American Medical
Informatics Association. ASTP/ONC
finds it essential to continue efforts to

ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents

Type of respondent

Average
burden
per response
(in hours)

Total
burden hours

Digital Health Companies ................................................................................

282

1

.5

141

Total ..........................................................................................................

282

1

.5

141

Catherine Howard,
Paperwork Reduction Act Reports Clearance
Officer (Acting), Office of the Secretary.
[FR Doc. 2025–16295 Filed 8–25–25; 8:45 am]
BILLING CODE 4150–45–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Proposed Information Collection:
Addendum to Declaration for Federal
Employment (OF 306), Indian Health
Service, Child Care and Indian Child
Care Worker Positions
AGENCY:

Indian Health Service, HHS.

Notice and request for
comments. Request for reinstatement
without revision.

ACTION:

In compliance with the
Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) invites the
public to take this opportunity to
comment on the information collection
titled, ‘‘Addendum to Declaration for
Federal Employment (OF 306), Indian
Health Service, Childcare and Indian
Child Care Worker Positions,’’ Office of
Management and Budget (OMB) Control
Number 0917–0028.

SUMMARY:

October 27, 2025. Your
comments regarding this information
collection are best assured of having full
effect if received within 60 days of the
date of this publication.

DATES:
lotter on DSK11XQN23PROD with NOTICES1

Number
responses per
respondent

Submit comments to
Randolph Beasley III by email at
[email protected].

ADDRESSES:

VerDate Sep<11>2014

17:03 Aug 25, 2025

Jkt 265001

Comments submitted in response to
this notice will be made available to the
public by publishing them in the 30-day
Federal Register notice for this
information collection. For this reason,
please do not include information of a
confidential nature, such as sensitive
personal information or proprietary
information. If comments are submitted
via email, the email address will be
automatically captured and included as
part of the comment that is placed in the
public docket and made available on the
internet. Please note that responses to
this public comment request containing
any routine notice about the
confidentiality of the communication
will be treated as public comments that
may be made available to the public
notwithstanding the inclusion of the
routine notice.
FOR FURTHER INFORMATION CONTACT: To
request additional information, please
contact Thomas Hamby at
[email protected] or 240–252–
0331.
SUPPLEMENTARY INFORMATION: This
previously approved information
collection project was last published in
the Federal Register on February 23,
2022 (87 FR 10218) and allowed 30 days
for public comment. No public
comment was received in response to
the notice. This notice announces our
intent to submit this collection to OMB
for approval of reinstatement without
revision, and to solicit comments on
specific aspects for the proposed
information collection.
Title: Addendum to Declaration for
Federal Employment (OF 306), Indian
Health Service, Child Care and Indian
Child Care Worker Positions (OMB No.

PO 00000

Frm 00043

Fmt 4703

Sfmt 4703

0917–0028). Type of Information
Collection Request: Reinstatement
without revision, of previouslyapproved information collection, 0917–
0028, Addendum to Declaration for
Federal Employment (OF 306), Indian
Health Service, Child Care and Indian
Child Care Worker Positions. There are
no program changes or adjustments in
burden hours. Form(s): Addendum to
Declaration for Federal Employment
(OF 306), Indian Health Service, Child
Care and Indian Child Care Worker
Positions. Need and Use of Information
Collection: This is a request for approval
of the collection of information as
required by section 408 of the Indian
Child Protection and Family Violence
Prevention Act, Public Law (Pub. L.)
101–630, 104 Stat. 4544, 4551 codified
as amended at 25 United States Code
(U.S.C.) Section 3207; the Crime Control
Act of 1990, Public Law 101–647, title
II, subtitle E, section 231, 104 Stat. 4789,
4808, codified as amended at 34 U.S.C.
20351 (formerly codified at 42 U.S.C.
13041, which was transferred to 34
U.S.C. 20351); and 42 CFR part 136,
subpart K.
The IHS is required to compile a list
of all authorized positions within the
IHS where the duties and
responsibilities involve regular contact
with, or control over, Indian children;
and to conduct an investigation of the
character of each individual who is
employed, or is being considered for
employment, in a position having
regular contact with, or control over,
Indian children. 25 U.S.C. 3207(a)(1)
and (2). Section 3207(a)(3) of Title 25
requires regulations prescribing the
minimum standards of character for

E:\FR\FM\26AUN1.SGM

26AUN1