Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications, 54355-54356 [2018-23528]
Download as PDF
<![CDATA[
54355
Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
Description: This is a new proposed
data collection from the Office of Child
Care (OCC) for the Onsite Monitoring
System.
Section 658I of the Child Care and
Development Block Grant Act and
Subpart J of 45 CFR, part 98 of the Child
Care and Development Fund requires
the monitoring of programs funded
under the CCDF for compliance with:
(1) The Act;
(2) CCDF Regulations; and
(3) The State/Territory CCDF
approved Plan.
The proposed data collection will be
used by the Office of Child Care (OCC)
to monitor State CCDF Lead Agencies to
determine and validate compliance with
CCDF regulations and the approved
State Plan. The data collection is
designed to provide States with the
flexibility to propose an approach that
is feasible and sufficient to demonstrate
compliance based on State
circumstances and processes. State Lead
Agencies will participate in onsite
monitoring based on a 3-year cohort;
submitting data once every three years.
OCC will begin monitoring for
compliance in FY 2019.
The data collection for the first 3years will focus on 11 topical areas: (1)
Disaster Preparedness, Response and
Recovery; (2) Consumer Education:
Dissemination of Information to Parents,
Providers, and General Public
(Monitoring Reports and Annual
Aggregate Data); (3) Twelve-Month
Eligibility; (4) Child: Staff Ratios and
Group Sizes; (5) Health and Safety
Requirements for Providers (11 Health
and Safety Topics); (6) Pre-Service/
Orientation and Ongoing Training
Requirements for Providers; (7)
Inspections for CCDF Licensed
Providers; (8) Inspections for LicenseExempt CCDF Providers; (9) Ratios for
Licensing Inspectors; (10) Child Abuse
and Neglect Reporting; and (11) Program
Integrity.
In developing the Onsite Monitoring
System, OCC convened a workgroup of
states to provide feedback and input on
the design of the Onsite Monitoring
System. As part of the workgroup
discussions, states emphasized the need
for individualized monitoring because
of the complexity of each state’s CCDF
structure and variance in
implementation strategies. As a
response, OCC developed the
Compliance Demonstration Packet that
offers states the opportunity to propose
their approach to demonstrating
compliance based on how their CCDF
program is administered. OCC also
consulted other federal programs and
monitoring experts on the Onsite
Monitoring System’s development and
incorporated their feedback regarding
the efficiency and efficacy of the
proposed process.
During the development of the Onsite
Monitoring System, OCC conducted
pilots in a number of States. Feedback
received from pilot States and the pilot
results were used to enhance the
monitoring process and data collection
method. Burden estimates below are
based on an analysis of data collected
through all of the pilot visits while
accounting for variance in state
documentation.
Respondents: State grantees and the
District of Columbia.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
amozie on DSK3GDR082PROD with NOTICES1
Compliance Demonstration Chart ....................................................................
Document Submission Chart ...........................................................................
Estimated Total Annual Burden
Hours: 1,632 hours.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
VerDate Sep<11>2014
17:48 Oct 26, 2018
Jkt 247001
17
17
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–23536 Filed 10–26–18; 8:45 am]
BILLING CODE 4184–43–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3647]
Endo Pharmaceuticals, Inc., et al.;
Withdrawal of Approval of 10 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden hours
per response
1
1
ACTION:
16
80
Total burden
hours
272
1,360
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 10 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
November 28, 2018.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
SUMMARY:
E:\FR\FM\29OCN1.SGM
29OCN1
54356
Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
Withdrawal of approval of an
application or abbreviated application
Application No.
Drug
Applicant
NDA 009165 ..........
Delatestryl (testosterone enanthate) Injection, 200 milligrams (mg)/milliliter (mL).
Xylocaine (lidocaine hydrochloride (HCl)) 4% Topical Solution/Sterile Injection.
Xylocaine (1.5% lidocaine HCl with dextrose 7.5%) Spinal
Injection, 2 mL ampules.
Norinyl 1+80 (mestranol and norethindrone) 21-Day Tablets,
0.08 mg/1 mg.
Norinyl 1+80 (mestranol and norethindrone) 28-Day Tablets,
0.08 mg/1 mg.
Sodium Chloride 0.9% Injection USP in Plastic Container, 9
mg/mL.
Dextrose 5% Injection USP in Plastic Container, 50 mg/mL
Testosterone Gel, 2.5 mg/1.25 grams (g), 25 mg/2.5 g, 50
mg/5 g.
Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, 7.5 mg/325 mg.
Targiniq ER (naloxone HCl and oxycodone HCl) ExtendedRelease Tablets, 5 mg/10 mg, 10 mg/20 mg, and 20 mg/
40 mg.
Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA
19355.
Fresenius Kabi, USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
Do.
NDA 010417 ..........
NDA 016297 ..........
NDA 016724 ..........
NDA 016725 ..........
NDA 019217 ..........
NDA 019222 ..........
NDA 203098 ..........
NDA 204031 ..........
NDA 205777 ..........
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of November 28,
2018. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on November 28,
2018 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23528 Filed 10–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0821]
amozie on DSK3GDR082PROD with NOTICES1
under § 314.150(c) is without prejudice
to refiling.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigation of
Consumer Perceptions of Expressed
Modified Risk Claims
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
GD Searle LLC, a subsidiary of Pfizer Inc., 235 East 42nd
St., New York, NY 10017.
Do.
ICU Medical, Inc., 600 N. Field Dr., Lake Forest, IL 60045.
Do.
Perrigo Co., U.S. Agent for Perrigo Israel Pharmaceuticals
Ltd., 3490 Quebec Ave. North, Minneapolis, MN 55427.
Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO
63042.
Purdue Pharma, LP, One Stamford Forum, Stamford, CT
06901–3431.
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
28, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Investigation of Consumer
Perceptions of Expressed Modified Risk
Claims.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Investigation of Consumer Perceptions
of Expressed Modified Risk Claims
OMB Control Number 0910—NEW
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
VerDate Sep<11>2014
17:48 Oct 26, 2018
Jkt 247001
I. Background
FDA’s Center for Tobacco Products
proposes to conduct a study to develop
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
generalizable scientific knowledge to
help inform its implementation of
section 911 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
387k), wherein FDA will be evaluating
information submitted to the Agency
about how consumers understand and
perceive modified risk tobacco products
(MRTPs). Section 911 of the FD&C Act
authorizes FDA to grant orders to
persons to allow the marketing of
MRTPs. The term ‘‘modified risk
tobacco product’’ means any tobacco
product that is sold or distributed for
use to reduce harm or the risk of
tobacco-related disease associated with
commercially marketed tobacco
products. FDA can issue a risk
modification order under section
911(g)(1) of the FD&C Act authorizing
the marketing of an MRTP only if the
Agency determines that the product, as
it is used by consumers, will
significantly reduce harm and the risk of
tobacco-related disease to individual
tobacco users and benefit the health of
the population as a whole, taking into
account both users of tobacco products
and persons who do not currently use
tobacco products (section 911(g)(1) of
the FD&C Act). Alternatively, with
respect to tobacco products that may not
be commercially marketed under
section 911(g)(1) of the FD&C Act, FDA
may issue an exposure modification
order under section 911(g)(2) of the
FD&C Act authorizing the marketing of
an MRTP if the Agency determines that
the standard in section 911(g)(2) of the
FD&C Act is met, including, among
other requirements, that: Any aspect of
the label, labeling, or advertising that
would cause the product to be an MRTP
E:\FR\FM\29OCN1.SGM
29OCN1
]]>Agencies
[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54355-54356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23528]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3647]
Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10
New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 10 new drug applications (NDAs) from multiple
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of November 28, 2018.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing.
[[Page 54356]]
Withdrawal of approval of an application or abbreviated application
under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 009165.............. Delatestryl Endo Pharmaceuticals,
(testosterone Inc., 1400 Atwater
enanthate) Injection, Dr., Malvern, PA
200 milligrams (mg)/ 19355.
milliliter (mL).
NDA 010417.............. Xylocaine (lidocaine Fresenius Kabi, USA,
hydrochloride (HCl)) LLC, Three Corporate
4% Topical Solution/ Dr., Lake Zurich, IL
Sterile Injection. 60047.
NDA 016297.............. Xylocaine (1.5% Do.
lidocaine HCl with
dextrose 7.5%) Spinal
Injection, 2 mL
ampules.
NDA 016724.............. Norinyl 1+80 GD Searle LLC, a
(mestranol and subsidiary of Pfizer
norethindrone) 21-Day Inc., 235 East 42nd
Tablets, 0.08 mg/1 mg. St., New York, NY
10017.
NDA 016725.............. Norinyl 1+80 Do.
(mestranol and
norethindrone) 28-Day
Tablets, 0.08 mg/1 mg.
NDA 019217.............. Sodium Chloride 0.9% ICU Medical, Inc., 600
Injection USP in N. Field Dr., Lake
Plastic Container, 9 Forest, IL 60045.
mg/mL.
NDA 019222.............. Dextrose 5% Injection Do.
USP in Plastic
Container, 50 mg/mL.
NDA 203098.............. Testosterone Gel, 2.5 Perrigo Co., U.S.
mg/1.25 grams (g), 25 Agent for Perrigo
mg/2.5 g, 50 mg/5 g. Israel
Pharmaceuticals Ltd.,
3490 Quebec Ave.
North, Minneapolis,
MN 55427.
NDA 204031.............. Xartemis XR (oxycodone Mallinckrodt Inc., 675
HCl and McDonnell Blvd.,
acetaminophen) Hazelwood, MO 63042.
Extended-Release
Tablets, 7.5 mg/325
mg.
NDA 205777.............. Targiniq ER (naloxone Purdue Pharma, LP, One
HCl and oxycodone Stamford Forum,
HCl) Extended-Release Stamford, CT 06901-
Tablets, 5 mg/10 mg, 3431.
10 mg/20 mg, and 20
mg/40 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
November 28, 2018. Introduction or delivery for introduction into
interstate commerce of products without approved new drug applications
violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the
table that are in inventory on November 28, 2018 may continue to be
dispensed until the inventories have been depleted or the drug products
have reached their expiration dates or otherwise become violative,
whichever occurs first.
Dated: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23528 Filed 10-26-18; 8:45 am]
BILLING CODE 4164-01-P
