Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction, 77866 [2024-21841]
Download as PDF
<![CDATA[
77866
Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Notices
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Comments on the collection(s) of
information must be received by the
OMB desk officer by October 24, 2024.
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.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
DATES:
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Program
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:07 Sep 23, 2024
Jkt 262001
Integrity: Exchange, Premium
Stabilization Programs, and Market
Standards; Amendments to the HHS
Notice of Benefit and Payment
Parameters for 2014; Final Rule II; Use:
On March 23, 2010, the Patient
Protection and Affordable Care Act
(PPACA; Pub. L. 111–148) was signed
into law and on March 30, 2010, the
Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152) was signed into law. The two laws
implement various health insurance
policies. On June 19, 2013, the
Department of Health and Human
Services (HHS) published proposed rule
CMS–9957–P: Program Integrity:
Exchanges, SHOP, Premium
Stabilization Programs, and Market
Standards (78 FR 37302) (Program
Integrity Proposed Rule) which, among
other things, contained third party
disclosure requirements and data
collections that supported the oversight
of premium stabilization programs,
State Exchanges, and qualified health
plan (QHP) issuers in Federallyfacilitated Exchanges (FFEs). Parts of the
proposed rule were finalized as Patient
Protection and Affordable Care Act;
Program Integrity: Exchange, Premium
Stabilization Programs, and Market
Standards; Amendments to the HHS
Notice of Benefit and Payment
Parameters for 2014; Final Rule
(Program Integrity Final Rule II), 78 FR
25326 (October 24, 2013). This ICR
relates to a portion of the information
collection request (ICR) requirements set
forth in the final rule. Form Number:
CMS–10516 (OMB control number:
0938–1277); Frequency: Annually;
Affected Public: Private Sector, State,
Local, or Tribal Governments; Business
or other for-profits, and Not-for-Profits;
Number of Respondents: 457; Number
of Responses: 457; Total Annual Hours:
42,771. (For questions regarding this
collection, contact Andrea Honig at
(301) 492–4147.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–21732 Filed 9–23–24; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–E–2079]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BRAVECTO; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA or the Agency)
published a notice in the Federal
Register of February 12, 2018, for the
determination of the regulatory review
period for the animal drug BRAVECTO.
In accordance with the Court’s order in
Nissan Chemical Corp., et al. v. FDA, et
al., No. 22–01598 (D.D.C), this
document revises the SUPPLEMENTARY
INFORMATION section of that notice by
adjusting the start date of the testing
phase for BRAVECTO. This notice
supersedes the June 11, 2021, Federal
Register document revising the
February 12, 2018, notice.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION: In the
Federal Register of February 12, 2018
(83 FR 6033), in FR Doc. 2018–02761, in
the first column, the first two
paragraphs under the section ‘‘II.
Determination of Regulatory Review
Period,’’ the following revision is made
on page 6034:
FDA has determined that the
applicable regulatory review period for
BRAVECTO is 1,548 days. Of this time,
1,510 days occurred during the testing
phase of the regulatory review period,
while 38 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 512(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360b(j)) became effective: February 19,
2010. Pursuant to the Court’s order in
Nissan Chemical Corp., et al. v. FDA, et
al., No. 22–01598 (D.D.C), the start date
of the testing phase for BRAVECTO was
February 19, 2010.
SUMMARY:
Dated: September 19, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21841 Filed 9–23–24; 8:45 am]
BILLING CODE 4164–01–P
Frm 00056
Fmt 4703
Sfmt 9990
E:\FR\FM\24SEN1.SGM
24SEN1
]]>Agencies
[Federal Register Volume 89, Number 185 (Tuesday, September 24, 2024)]
[Notices]
[Page 77866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21841]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-E-2079]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BRAVECTO; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) published
a notice in the Federal Register of February 12, 2018, for the
determination of the regulatory review period for the animal drug
BRAVECTO. In accordance with the Court's order in Nissan Chemical
Corp., et al. v. FDA, et al., No. 22-01598 (D.D.C), this document
revises the SUPPLEMENTARY INFORMATION section of that notice by
adjusting the start date of the testing phase for BRAVECTO. This notice
supersedes the June 11, 2021, Federal Register document revising the
February 12, 2018, notice.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 12, 2018
(83 FR 6033), in FR Doc. 2018-02761, in the first column, the first two
paragraphs under the section ``II. Determination of Regulatory Review
Period,'' the following revision is made on page 6034:
FDA has determined that the applicable regulatory review period for
BRAVECTO is 1,548 days. Of this time, 1,510 days occurred during the
testing phase of the regulatory review period, while 38 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(j)) became effective:
February 19, 2010. Pursuant to the Court's order in Nissan Chemical
Corp., et al. v. FDA, et al., No. 22-01598 (D.D.C), the start date of
the testing phase for BRAVECTO was February 19, 2010.
Dated: September 19, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21841 Filed 9-23-24; 8:45 am]
BILLING CODE 4164-01-P
