Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 83504-83505 [2024-23811]
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Federal Register / Vol. 89, No. 200 / Wednesday, October 16, 2024 / Notices
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Assessing Adoption and
Implementation of the National Institute
of Occupational Safety and Health’s
(NIOSH) Outputs—New—National
Institute of Occupational Safety and
Health’s (NIOSH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Institute for
Occupational Safety and Health
(NIOSH), is requesting approval of a
new Generic information collection for
a period of three years under the project
titled, ‘‘Assessing Adoption and
Implementation of the National Institute
of Occupational Safety and Health’s
(NIOSH) Outputs.’’
With the continuation of the
Government Performance and Results
Act and the more recent passage of the
Foundations of Evidence-Based Policy
Making Act, there is an increased need
for federal agencies to measure and
demonstrate their impact. However,
measuring impact is challenging,
especially for organizations that have a
science-driven mission because of the
time it takes to move from basic to
applied research. Demonstrating
attribution (cause and effect
relationships) is particularly challenging
for research organizations.
NIOSH research is often designed to
collect implementation and adoption
data through document reviews of
NIOSH records, including grantee final
reports, and through interviews with
NIOSH researchers (federal employees).
While commonly recognized metrics,
these data sources are not
comprehensive, representative, or
informative of the adoption and
implementation of NIOSH products and
efforts. Further, the design and
execution of research projects has
hindered research and program leaders
Type of data
collection
instrument
Type of respondent
Subject matter experts ....................................
Former NIOSH funding recipients ..................
Intermediary or end users (e.g., employers,
workers, manufactures, labor/professional
associations, policymakers).
prioritizing information collections to
understand and assess the adoption and
implementation of research efforts and
products.
The proposed generic information
collection package would allow
researchers to expeditiously pursue
efforts to provide NIOSH with critical
information to inform mission-driven
needs. Additionally, the proposed
efforts go beyond simply measuring
customer satisfaction and rather seek to
advance NIOSH’s burden, need, and
impact framework for future research
while also endeavoring to execute the
Office of Management and Budget’s
(OMB) guidance regarding the
Foundations of Evidence-Based
Policymaking Act.
Respondents are expected to consist
of users and potential users of NIOSH
products including subject matter
expects, former NIOSH funding
recipients, and intermediary and end
users. CDC requests OMB approval for
an estimated 17,150 total burden hours
with an estimated annual burden of
6,069 hours. There is no cost to
respondents other than their time to
participate.
Estimated Annualized Burden Hours
Number of
respondents
Survey instrument (single, pre and post, or
poll) including demographics.
Informed consent form ...................................
Interview or focus group guide ......................
Survey instrument (single, pre and post, or
poll) including demographics.
Informed consent form ...................................
Interview or focus group guide ......................
Survey instrument (single, pre and post, or
poll) including demographics.
[FR Doc. 2024–23859 Filed 10–15–24; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2024–P–4163]
Determination That NOXAFIL
(Posaconazole) Delayed-Release
Tablets, 100 Grams Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
BILLING CODE 4163–18–P
lotter on DSK11XQN23PROD with NOTICES1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
1
20/60
250
250
200
1
1
1
5/60
1
20/60
25
25
10,000
1
1
1
5/60
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20/60
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650
1
1
5/60
1
The Food and Drug
Administration (FDA, Agency, or we)
16:43 Oct 15, 2024
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has determined that NOXAFIL
(posaconazole) delayed-release tablets,
100 grams (g), was not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
this drug product, and it will allow FDA
to continue to approve ANDAs that refer
to the product as long as they meet
relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Notice.
SUMMARY:
VerDate Sep<11>2014
Average
burden per
response
(in hours)
5,000
Informed consent form ...................................
Interview or focus group guide ......................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
Number of
responses per
respondent
Sfmt 4703
Archampong-Gray, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
E:\FR\FM\16OCN1.SGM
16OCN1
Awo
Federal Register / Vol. 89, No. 200 / Wednesday, October 16, 2024 / Notices
Hampshire Ave., Bldg. 51, Rm. 6243,
Silver Spring, MD 20993–0002, 301–
796–0110, Awo.Archampong-Gray@
fda.hhs.gov.
Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
NOXAFIL (posaconazole) delayedrelease tablets, 100 g, is the subject of
NDA 205053, held by Merck Sharp &
Dohme Corp., and initially approved on
November 25, 2013. Noxafil delayedrelease tablets are indicated for the
treatment of invasive aspergillosis in
adults and pediatric patients 13 years of
age and older. In addition, NOXAFIL is
indicated for the prophylaxis of invasive
Aspergillus and Candida infections in
patients who are at high risk of
developing these infections due to being
severely immunocompromised, such as
hematopoietic stem cell transplant
recipients with graft-versus-host disease
or those with hematologic malignancies
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:43 Oct 15, 2024
Jkt 265001
with prolonged neutropenia from
chemotherapy as follows; for NOXAFIL
delayed-release tablets: adults and
pediatric patients 2 years of age and
older who weigh greater than 40
kilograms.
NOXAFIL (posaconazole) delayedrelease tablets, 100 g, is currently listed
in the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Aizant Drug Research Solutions
Private Limited, submitted a citizen
petition dated September 2, 2024
(Docket No. FDA–2024–P–4163), and
amended on September 4, 2024, under
21 CFR 10.30, requesting that the
Agency determine whether NOXAFIL
(posaconazole) delayed-release tablets,
NDA 205053 was withdrawn from sale
for reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that NOXAFIL (posaconazole)
delayed-release tablets, 100 g, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that NOXAFIL
(posaconazole) delayed-release tablets,
100 g, was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of NOXAFIL
(posaconazole) delayed-release tablets,
100 g, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NOXAFIL
(posaconazole) delayed-release tablets,
100 g, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–23811 Filed 10–15–24; 8:45 am]
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83505
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0281]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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.
SUMMARY: 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 November 15,
2024.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0281–30D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, or call (202)
795–7714 the Reports Clearance Officer.
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: Prevention
Communication Formative Research.
Type of Collection: Extension.
OMB No: 0990–0281—Office of
Disease Prevention and Health
Promotion.
Abstract: The Office of Disease
Prevention and Health Promotion
(ODPHP) is focused on developing and
disseminating health information to the
public. ODPHP faces an increasingly
urgent interest in finding effective ways
to communicate health information to
SUMMARY:
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 89, Number 200 (Wednesday, October 16, 2024)]
[Notices]
[Pages 83504-83505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23811]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-4163]
Determination That NOXAFIL (Posaconazole) Delayed-Release
Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that NOXAFIL (posaconazole) delayed-release tablets, 100
grams (g), was not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Awo Archampong-Gray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
[[Page 83505]]
Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, [email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
NOXAFIL (posaconazole) delayed-release tablets, 100 g, is the
subject of NDA 205053, held by Merck Sharp & Dohme Corp., and initially
approved on November 25, 2013. Noxafil delayed-release tablets are
indicated for the treatment of invasive aspergillosis in adults and
pediatric patients 13 years of age and older. In addition, NOXAFIL is
indicated for the prophylaxis of invasive Aspergillus and Candida
infections in patients who are at high risk of developing these
infections due to being severely immunocompromised, such as
hematopoietic stem cell transplant recipients with graft-versus-host
disease or those with hematologic malignancies with prolonged
neutropenia from chemotherapy as follows; for NOXAFIL delayed-release
tablets: adults and pediatric patients 2 years of age and older who
weigh greater than 40 kilograms.
NOXAFIL (posaconazole) delayed-release tablets, 100 g, is currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
Aizant Drug Research Solutions Private Limited, submitted a citizen
petition dated September 2, 2024 (Docket No. FDA-2024-P-4163), and
amended on September 4, 2024, under 21 CFR 10.30, requesting that the
Agency determine whether NOXAFIL (posaconazole) delayed-release
tablets, NDA 205053 was withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that NOXAFIL (posaconazole) delayed-release
tablets, 100 g, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that NOXAFIL (posaconazole) delayed-release
tablets, 100 g, was withdrawn for reasons of safety or effectiveness.
We have carefully reviewed our files for records concerning the
withdrawal of NOXAFIL (posaconazole) delayed-release tablets, 100 g,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have found no
information that would indicate that this drug product was withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NOXAFIL
(posaconazole) delayed-release tablets, 100 g, in the ``Discontinued
Drug Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. If FDA determines that labeling for this drug product
should be revised to meet current standards, the Agency will advise
ANDA applicants to submit such labeling.
Dated: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-23811 Filed 10-15-24; 8:45 am]
BILLING CODE 4164-01-P
