Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 20986 [2024-06265]
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20986
Federal Register / Vol. 89, No. 59 / Tuesday, March 26, 2024 / Notices
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the Federal Advisory Committee Act (5
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also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
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under 21 CFR 10.19 are met.
Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06314 Filed 3–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2023–N–3168; FDA–
2023–N–2780; FDA–2023–N–0940; and
FDA–2023–N–3490]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
SUMMARY:
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Extralabel Drug Use in Animals ..............................................................................................................................
Premarket Notification for a New Dietary Ingredient ...............................................................................................
Food and Drug Administration Rapid Response Surveys ......................................................................................
Application for Participation in Food and Drug Administration Fellowship Programs ............................................
Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06265 Filed 3–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1077]
AstraZeneca Pharmaceuticals LP;
Withdrawal of Approval of New Drug
Application for LYNPARZA (Olaparib)
Capsules
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of new drug
application (NDA) for LYNPARZA
(olaparib) Capsules, 50 milligrams (mg)
held by AstraZeneca Pharmaceuticals
LP (AZ), 1800 Concord Pike,
Wilmington, DE 19803. AZ has
voluntarily requested that FDA
withdraw approval of this application
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:10 Mar 25, 2024
Jkt 262001
and has waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of
March 26, 2024.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
December 19, 2014, FDA approved NDA
206162 for LYNPARZA (olaparib)
Capsules, 50 mg, as monotherapy in
patients with deleterious or suspected
deleterious germline BRCA-mutated (as
detected by an FDA-approved test)
advanced ovarian cancer who have been
treated with three or more prior lines of
chemotherapy. On July 14, 2022, FDA
met with AZ to discuss the final overall
survival (OS) results from the clinical
trial entitled ‘‘A Phase III, Open Label,
Randomised, Controlled, Multi-Centre
Study to Assess the Efficacy and Safety
of Olaparib Monotherapy Versus
Physician’s Choice Single Agent
Chemotherapy in the Treatment of
Platinum Sensitive Relapsed Ovarian
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
0910–0325
0910–0330
0910–0500
0910–0780
Date approval
expires
2/28/2027
2/28/2027
2/28/2027
2/28/2027
Cancer in Patients Carrying Germline
BRCA1/2 Mutations’’ (SOLO3).’’ 1 The
results indicated that patients who were
taking olaparib potentially had a shorter
OS than patients not on olaparib,
particularly in the subgroup analysis of
patients who had received three or more
lines of chemotherapy. On July 26,
2022, the Agency asked AZ, in writing,
to voluntarily permit FDA to withdraw
approval of NDA 206162, pursuant to
§ 314.150(d) (21 CFR 314.150(d)) and
waive its opportunity for a hearing for
NDA 206162. On January 19, 2023, AZ
submitted a letter requesting withdrawal
of approval of the application for
LYNPARZA (olaparib) Capsules (NDA
206162) pursuant to § 314.150(d) and
waiving its opportunity for a hearing.
Approval of NDA 206162 for
LYNPARZA (olaparib) Capsules, and all
amendments and supplements thereto,
is also withdrawn under § 314.150(d) as
1 The study, under its abbreviated title ‘‘Olaparib
Treatment in Relapsed Germline Breast Cancer
Susceptibility Gene (BRCA) Mutated Ovarian
Cancer Patients Who Have Progressed at Least 6
Months After Last Platinum Treatment and Have
Received at Least 2 Prior Platinum Treatments
(SOLO3),’’ is available on the NIH National Library
of Medicine’s ClinicalTrials.gov web page at https://
clinicaltrials.gov/ct2/show/NCT02282020.
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]]>Agencies
[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Page 20986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06265]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2023-N-3168; FDA-2023-N-2780; FDA-2023-N-0940; and
FDA-2023-N-3490]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Extralabel Drug Use in Animals.......... 0910-0325 2/28/2027
Premarket Notification for a New Dietary 0910-0330 2/28/2027
Ingredient.............................
Food and Drug Administration Rapid 0910-0500 2/28/2027
Response Surveys.......................
Application for Participation in Food 0910-0780 2/28/2027
and Drug Administration Fellowship
Programs...............................
------------------------------------------------------------------------
Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06265 Filed 3-25-24; 8:45 am]
BILLING CODE 4164-01-P
