Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications, 107146-107147 [2024-31360]
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107146
Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
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. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: On May 31, 2024, OCSS
published an NPRM (89 Federal
Register (FR) 47109; Regulation
Identification Number (RIN) 0970–
AD00) proposing to allow Federal
financial participation (FFP) for certain
optional and nonduplicative
employment and training services for
eligible noncustodial parents in the
child support program. The proposed
rule will permit states, at their
discretion, to use FFP to provide any or
all the following services: Job search
assistance; job readiness training; job
development and job placement
services; skills assessments; job
retention services; work supports; and
ADDRESSES:
Submission for Office of Management
and Budget Review; State Plan for
Child Support Collection and
Establishment of Paternity Title IV–D of
the Social Security Act
Office of Child Support
Services, Administration for Children
and Families, Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Child Support
Services (OCSS) is requesting review by
the Office of Management and Budget
(OMB) of revisions to the State Plan for
Child Support Collection and
Establishment of Paternity Under Title
IV–D of the Social Security Act (State
Plan; OMB # 0970–0017). These
revisions are necessary to align this
collection with updates resulting from a
final rule: Employment and Training
Services for Noncustodial Parents in the
Child Support Program which will
require states to amend State Plans if
they elect to participate in employment
and training services for non-custodial
parents in the child support program.
DATES: Comments due January 30, 2025.
OMB must decide about the collection
of information between 30 and 60 days
after publication of this document in the
SUMMARY:
Total number
of respondents
Instrument
Annual Burden Estimates
We estimate states will take 3 hours
to draft the required information to
amend their State Plan. We estimate
about 33 states will submit
amendments.
Average
burden hours
per response
Total burden
hours
Annual
burden hours
State Plan and State Plan Cover Page (OCSS–100) .........
State Plan Transmittal .........................................................
(OCSS–21–U4) ....................................................................
Amendments Specific to the Employment and Training
Services for Non-Custodial Parents in the Child Support
Program ............................................................................
54
36
.5
972
324
54
36
.25
486
162
33
1
3
99
33
Estimated Total Annual Burden Hours .........................
........................
........................
........................
........................
519
Authority: 42 U.S.C 652, 654, and 666.
Mary C. Jones,
ACF/OPRE Certifying Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2024–31185 Filed 12–30–24; 8:45 am]
BILLING CODE 4184–41–P
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Total number
of responses
per
respondent
occupational training and other skills
training directly related to employment.
On December 13, 2024, OCSS
published the Employment and
Training Services for Noncustodial
Parents in the Child Support Program
final rule (89 FR 100789; RIN 0970–
AD00). This rule results in revisions to
this information collection, as states that
elect to participate in Employment and
Training Services for Non-Custodial
Parents in the Child Support Program
must submit a state plan amendment to
OCSS. To account for states potentially
submitting revisions to their State Plans
and as required by the Paperwork
Reduction Act (PRA) of 1995, we are
submitting the revised data collection to
OMB for review and approval. States
can elect to participate in these services
on page 2.12–15 of the State Plan. OCSS
is updating the burden estimates to
account for potential additional
amendments as a result of this rule.
Additionally, the full State Plan has
not historically been submitted under
this OMB number and this request adds
the full document to the materials for
review and approval.
Respondents: State IV–D Agencies.
[Docket No. FDA–2024–N–3271]
Flamingo Pharmaceuticals Ltd.;
Withdrawal of Approval of Two
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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18:31 Dec 30, 2024
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withdrawing approval of two
abbreviated new drug applications
(ANDAs) from the holder of those
ANDAs. The basis for the withdrawal is
that the ANDA holder has repeatedly
failed to file required annual reports for
those ANDAs.
Approval is withdrawn as of
December 31, 2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
E:\FR\FM\31DEN1.SGM
31DEN1
Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices
Silver Spring, MD 20993–0002, 301–
796–3471, Martha.Nguyen@fda.hhs.gov.
The
holder of an approved application to
market a new drug for human use is
required to submit annual reports to
FDA concerning its approved
application in accordance with
§§ 314.81 and 314.98 (21 CFR 314.81
and 314.98).
SUPPLEMENTARY INFORMATION:
In the Federal Register of August 8,
2024 (89 FR 64936), FDA published a
notice offering an opportunity for a
hearing (NOOH) on a proposal to
withdraw approval of two ANDAs
because the holder of these ANDAs had
repeatedly failed to submit the required
annual reports for these ANDAs. The
holder of these ANDAs did not respond
to the NOOH. Failure to file a written
notice of participation and request for
107147
hearing as required by § 314.200 (21
CFR 314.200) constitutes a waiver of the
opportunity for hearing by the holder of
the ANDAs concerning the proposal to
withdraw approval of the ANDAs and a
waiver of any contentions concerning
the legal status of the drug products.
Therefore, FDA is withdrawing approval
of the two applications listed in table 1
of this document.
TABLE 1—APPROVED ANDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED
Application No.
Drug
ANDA 207309 ...
Metronidazole tablet, 250 milligrams (mg) and 500 mg ...........
ANDA 207938 ...
Piroxicam capsule, 10 mg and 20 mg ......................................
FDA finds that the holder of the
ANDAs listed in table 1 has repeatedly
failed to submit reports required by
§§ 314.81 and 314.98. In addition, under
§ 314.200, FDA finds that the holder of
the ANDAs has waived its opportunity
for a hearing and any contentions
concerning the legal status of the drug
products. Therefore, based on these
findings and pursuant to the authority
under section 505(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(e)), approval of the ANDAs listed in
table 1 and all amendments and
supplements thereto, is hereby
withdrawn, as of December 31, 2024.
Dated: December 23, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31360 Filed 12–30–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2980]
Evaluating the Immunogenicity Risk of
Host Cell Proteins in Follow-On
Recombinant Peptide Products;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
khammond on DSK9W7S144PROD with NOTICES
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for the
request for information and comments
notice entitled ‘‘Evaluating the
Immunogenicity Risk of Host Cell
Proteins in Follow-On Recombinant
Peptide Products,’’ published in the
SUMMARY:
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18:31 Dec 30, 2024
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Applicant
Flamingo Pharmaceuticals Ltd., U.S. Agent for Flamingo
Pharmaceuticals Ltd., 1125 Gaither Rd., Rockville, MD
20850.
Do.
Federal Register of July 25, 2024. FDA
is reopening the comment period to
update comments and to receive any
new information.
DATES: FDA is reopening the comment
period on the request for information
and comments notice published July 25,
2024 (89 FR 60436). Either electronic or
written comments must be submitted by
March 3, 2025.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 3, 2025. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
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.
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• 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–
2024–N–2980 for ‘‘Evaluating the
Immunogenicity Risk of Host Cell
Proteins in Follow-On Recombinant
Peptide Products; Request for
Information and Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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
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]]>Agencies
[Federal Register Volume 89, Number 250 (Tuesday, December 31, 2024)]
[Notices]
[Pages 107146-107147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31360]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3271]
Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of two abbreviated new drug applications (ANDAs)
from the holder of those ANDAs. The basis for the withdrawal is that
the ANDA holder has repeatedly failed to file required annual reports
for those ANDAs.
DATES: Approval is withdrawn as of December 31, 2024.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
[[Page 107147]]
Silver Spring, MD 20993-0002, 301-796-3471, [email protected].
SUPPLEMENTARY INFORMATION: The holder of an approved application to
market a new drug for human use is required to submit annual reports to
FDA concerning its approved application in accordance with Sec. Sec.
314.81 and 314.98 (21 CFR 314.81 and 314.98).
In the Federal Register of August 8, 2024 (89 FR 64936), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of two ANDAs because the holder of these
ANDAs had repeatedly failed to submit the required annual reports for
these ANDAs. The holder of these ANDAs did not respond to the NOOH.
Failure to file a written notice of participation and request for
hearing as required by Sec. 314.200 (21 CFR 314.200) constitutes a
waiver of the opportunity for hearing by the holder of the ANDAs
concerning the proposal to withdraw approval of the ANDAs and a waiver
of any contentions concerning the legal status of the drug products.
Therefore, FDA is withdrawing approval of the two applications listed
in table 1 of this document.
Table 1--Approved ANDAs for Which Required Reports Have Not Been
Submitted
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 207309............... Metronidazole tablet, Flamingo
250 milligrams (mg) Pharmaceuticals
and 500 mg. Ltd., U.S. Agent for
Flamingo
Pharmaceuticals
Ltd., 1125 Gaither
Rd., Rockville, MD
20850.
ANDA 207938............... Piroxicam capsule, 10 Do.
mg and 20 mg.
------------------------------------------------------------------------
FDA finds that the holder of the ANDAs listed in table 1 has
repeatedly failed to submit reports required by Sec. Sec. 314.81 and
314.98. In addition, under Sec. 314.200, FDA finds that the holder of
the ANDAs has waived its opportunity for a hearing and any contentions
concerning the legal status of the drug products. Therefore, based on
these findings and pursuant to the authority under section 505(e) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)), approval
of the ANDAs listed in table 1 and all amendments and supplements
thereto, is hereby withdrawn, as of December 31, 2024.
Dated: December 23, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31360 Filed 12-30-24; 8:45 am]
BILLING CODE 4164-01-P
