Agency Information Collection Request; 30-Day Public Comment Request, 83505-83506 [2024-23795]
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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the listed drug was withdrawn from sale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a listed drug was withdrawn from sale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time after the drug has been withdrawn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
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SUPPLEMENTARY INFORMATION:
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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:
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Federal Register / Vol. 89, No. 200 / Wednesday, October 16, 2024 / Notices
America’s diverse population. ODPHP
strives to be responsive to the needs of
America’s diverse audiences while
simultaneously serving all Americans
across a range of channels, from print to
new communication technologies. To
carry out prevention information efforts,
ODPHP is committed to conducting
formative and usability research to
provide guidance on the development
and implementation of their
communication and education efforts.
The information collected will be used
to improve communication, products,
and services that support key office
activities including: Healthy People,
Dietary Guidelines for Americans, Food
Is Medicine, Physical Activity
Guidelines for Americans,
MyHealthfinder, the Move Your Way®
Campaign, the President’s Council on
Sports, Fitness & Nutrition, health
literacy and healthy aging. ODPHP
communicates through its website
(www.health.gov) and through other
channels including social media, print
materials, interactive training modules,
and reports. This request builds on
previous formative research approaches
to place more emphasis on Web-based
data collection to allow greater
geographical diversity among
respondents, to decrease respondent
burden, and to save government costs.
Data collection will be qualitative and
quantitative and may include in-depth
interviews, focus groups, web-based
surveys, omnibus surveys, card sorting,
and various forms of usability testing of
materials and interactive tools to assess
the public’s understanding of disease
prevention and health promotion
content, responses to prototype
materials, and barriers to effective use.
The program is requesting a 3-year
extension of its clearance.
ANNUALIZED BURDEN HOUR TABLE
Forms
(if necessary)
Number of
responses per
respondents
Average
burden per
response
Total burden
hours
In-depth interviews—Screener ............................................................................
In-depth interviews—Instrument ..........................................................................
Focus groups—Screener .....................................................................................
Focus groups—Instrument ..................................................................................
Intercept interviews ..............................................................................................
Cognitive testing of instruments—Screener ........................................................
Cognitive testing of instruments—Cognitive test .................................................
Web-based surveys—Screener ...........................................................................
Web-based surveys—Survey ..............................................................................
Omnibus surveys .................................................................................................
Gatekeeper reviews .............................................................................................
Card sorting—Screener .......................................................................................
Card sorting—Card sort .......................................................................................
Usability and prototype testing of materials (print and web)—Screener .............
Usability and prototype testing of materials (print and web)—usability tests .....
500
167
975
325
1750
50
17
10,000
3,333
700
109
200
67
600
208
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
10/60
1.00
10/60
1.50
5/60
10/60
2.00
5/60
15/60
10/60
30/60
10/60
1.00
10/60
1.00
83
167
162.5
487.5
146
8
34
833
833
117
54
33
67
100
208
Total ..............................................................................................................
......................
..........................
....................
3,333
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2024–23795 Filed 10–15–24; 8:45 am]
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Basic
Biology of Blood, Heart, and Vasculature.
Date: November 7, 2024.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Aisha Lanette Walker,
Ph.D., Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, 301–594–3527,
aisha.walker@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Oncology.
Date: November 7–8, 2024.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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Number of
respondents
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
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Contact Person: Reigh-Yi Lin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 4152,
MSC 7846, Bethesda, MD 20892, (301) 827–
6009, lin.reigh-yi@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; S10
Instrumentation: Flow Cytometry.
Date: November 7, 2024.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Jessica Smith, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 402–3717, jessica.smith6@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Pathogenic Eukaryotes.
Date: November 7, 2024.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 89, Number 200 (Wednesday, October 16, 2024)]
[Notices]
[Pages 83505-83506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23795]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0281]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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.
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 [email protected] 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:
[email protected], 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
[[Page 83506]]
America's diverse population. ODPHP strives to be responsive to the
needs of America's diverse audiences while simultaneously serving all
Americans across a range of channels, from print to new communication
technologies. To carry out prevention information efforts, ODPHP is
committed to conducting formative and usability research to provide
guidance on the development and implementation of their communication
and education efforts. The information collected will be used to
improve communication, products, and services that support key office
activities including: Healthy People, Dietary Guidelines for Americans,
Food Is Medicine, Physical Activity Guidelines for Americans,
MyHealthfinder, the Move Your Way[supreg] Campaign, the President's
Council on Sports, Fitness & Nutrition, health literacy and healthy
aging. ODPHP communicates through its website (www.health.gov) and
through other channels including social media, print materials,
interactive training modules, and reports. This request builds on
previous formative research approaches to place more emphasis on Web-
based data collection to allow greater geographical diversity among
respondents, to decrease respondent burden, and to save government
costs. Data collection will be qualitative and quantitative and may
include in-depth interviews, focus groups, web-based surveys, omnibus
surveys, card sorting, and various forms of usability testing of
materials and interactive tools to assess the public's understanding of
disease prevention and health promotion content, responses to prototype
materials, and barriers to effective use.
The program is requesting a 3-year extension of its clearance.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of Average
Forms (if necessary) Number of responses per burden per Total burden
respondents respondents response hours
----------------------------------------------------------------------------------------------------------------
In-depth interviews--Screener....................... 500 1 10/60 83
In-depth interviews--Instrument..................... 167 1 1.00 167
Focus groups--Screener.............................. 975 1 10/60 162.5
Focus groups--Instrument............................ 325 1 1.50 487.5
Intercept interviews................................ 1750 1 5/60 146
Cognitive testing of instruments--Screener.......... 50 1 10/60 8
Cognitive testing of instruments--Cognitive test.... 17 1 2.00 34
Web-based surveys--Screener......................... 10,000 1 5/60 833
Web-based surveys--Survey........................... 3,333 1 15/60 833
Omnibus surveys..................................... 700 1 10/60 117
Gatekeeper reviews.................................. 109 1 30/60 54
Card sorting--Screener.............................. 200 1 10/60 33
Card sorting--Card sort............................. 67 1 1.00 67
Usability and prototype testing of materials (print 600 1 10/60 100
and web)--Screener.................................
Usability and prototype testing of materials (print 208 1 1.00 208
and web)--usability tests..........................
-----------------------------------------------------------
Total........................................... ............ ............... ........... 3,333
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-23795 Filed 10-15-24; 8:45 am]
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