Determination That PREZISTA (Darunavir) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 18558-18559 [2014-07337]
Download as PDF
<![CDATA[
18558
Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Notices
development efforts provide tailored
resource support to Senior Legal
Helplines (SLH) and Model Approaches
to Statewide Legal Assistance Systems
(Model Approaches) projects across the
country. Model Approaches grants
promote the creation of legal services
delivery systems that incorporate SLHs
(and other low-cost service delivery
mechanisms) into the broader tapestry
of Title III–B legal services, and other
available legal resources. Specifically,
the TA grant directed to SLHs provides
resource support for various aspects of
helpline legal service delivery,
including the development of reporting/
data collection systems, case
management systems, targeting and
outreach strategies, and integration
strategies that incorporate SLHs into the
broader tapestry of legal service delivery
in each Model Approaches state. The
TA grant directed to the systems
enhancement objectives of Model
Approaches Phase I and Phase II
projects provides resource support on
the development of needs and capacity
assessments, reporting/data collection
systems and outcomes measures used to
determine the impact of legal services,
and the development of legal service
delivery standards/guidelines that
promote quality and consistent
statewide legal service delivery.
II. Justification for The Exception to
Competition
As with the grants comprising the
National Legal Resource Center, it is
important to assess the effectiveness of
TA grants in helping states meet
increasing challenges in the
development and maintenance of ‘‘high
capacity’’ statewide legal service
delivery systems. To this end, ACL
would like to accomplish two goals this
year: (1) Obtain stakeholder input on the
resource support needs of legal and
aging/disability service providers across
the country and the ability to meet those
needs through focused TA grants; and
(2) establish how best to direct the
current objectives of the TA grants
towards advancing anticipated ACL FY
15 activities related to elder rights and
elder abuse prevention.
within the approved scope and budget
of the grant. Areas that will be evaluated
include:
A. Project Relevance & Current Need
B. Approach
C. Budget
D. Project Impact
E. Organizational Capacity
V. Application and Submission
Requirements
A. SF 424—Application for Federal
Assistance
B. SF 424A—Budget Information
C. Separate Budget Narrative/
Justification
D. SF 424B—Assurances. Note: Be
sure to complete this form according to
instructions and have it signed and
dated by the authorized representative
(see item 18d of the SF 424).
E. Lobbying Certification
F. Program narrative—no more than
10 pages.
G. Work Plan
H. Incumbent grantees will be
required to access the non-competing
application kit in GrantSolutions.gov to
submit all materials for this application.
VI. Application Review Information
Applications will be objectively
reviewed by Federal staff utilizing the
criteria listed above in Section III.
VII. Agency Contact
For further information or comments
regarding this program expansion
supplement, contact Omar Valverde,
U.S. Department of Health and Human
Services, Administration for
Community Living, Administration on
Aging, Office of Elder Rights, One
Massachusetts Avenue NW.,
Washington, DC 20001; telephone (202)
357–3515; fax (202) 357–3549; email
omar.valverde@acl.hhs.gov.
Dated: March 27, 2014.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2014–07340 Filed 4–1–14; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration
IV. Evaluation Criteria
Information previously provided in
semi-annual reports, as well as
information in the non-competing
extension application will be
considered to determine satisfactory
progress of the grantee project and
ensure that proposed activities are
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Testing Communications on Medical
Devices and Radiation-Emitting
Products
17:01 Apr 01, 2014
Jkt 232001
[Docket No. FDA–2013–N–0796]
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Testing Communications on Medical
Devices and Radiation-Emitting
Products’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
December 20, 2013, the Agency
submitted a proposed collection of
information entitled ‘‘Testing
Communications on Medical Devices
and Radiation-Emitting Products’’ to
OMB for review and clearance under 44
U.S.C. 3507. 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.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0678. The
approval expires on March 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUMMARY:
Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07325 Filed 4–1–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–1379]
Determination That PREZISTA
(Darunavir) Tablets, 400 Milligrams,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
III. Eligible Applicants
Incumbent TA grantees with award
expiration dates of 5/31/14.
VerDate Mar<15>2010
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined that PREZISTA (darunavir)
tablets, 400 milligrams (mg), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for darunavir
tablets, 400 mg, if all other legal and
regulatory requirements are met.
SUMMARY:
E:\FR\FM\02APN1.SGM
02APN1
Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Notices
FOR FURTHER INFORMATION CONTACT:
Na’Im R. Moses, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 240–
402–3990.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which 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.
PREZISTA (darunavir) tablets, 400
mg, is the subject of NDA 21–976, held
by Janssen Products, LP, and initially
approved on June 23, 2006. PREZISTA
is a human immunodeficiency virus
(HIV–1) protease inhibitor indicated for
the treatment of HIV–1 infection in
adult patients. It is also indicated for the
treatment of HIV–1 infection in
pediatric patients 3 years of age and
older. PREZISTA must be
coadministered with ritonavir
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
17:01 Apr 01, 2014
Jkt 232001
(PREZISTA/ritonavir) and with other
antiretroviral agents.
In an email dated July 30, 2013,
Janssen Products, LP, notified FDA that
PREZISTA (darunavir) tablets, 400 mg,
was being discontinued for the U.S.
market only. The PREZISTA 800-mg
tablet continues to be marketed in the
United States. Lachman Consultant
Services, Inc., submitted a citizen
petition dated October 21, 2013 (Docket
No. FDA–2013–P–1379), under 21 CFR
10.30, requesting that the Agency
determine whether PREZISTA
(darunavir) tablets, 400 mg, was
withdrawn from sale for reasons of
safety or effectiveness. In January 2014,
FDA moved the 400-mg dosage strength
of this drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
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 PREZISTA (darunavir)
tablets, 400 mg, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that PREZISTA
(darunavir) tablets, 400 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
PREZISTA (darunavir) tablets, 400 mg,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that the
product was not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list PREZISTA (darunavir)
tablets, 400 mg, 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.
ANDAs that refer to PREZISTA
(darunavir) tablets, 400 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. 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: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07337 Filed 4–1–14; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
18559
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0267]
Determination That NIMOTOP
(Nimodipine) Capsules, 30 Milligrams,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that NIMOTOP
(Nimodipine) Capsules, 30 milligrams
(mg), was not withdrawn from sale for
reasons of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of the abbreviated new drug
applications (ANDAs) that refer to
nimodipine capsules, 30 mg, and it will
allow FDA to approve ANDAs that refer
to this drug as long as they meet
relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rachel Turow, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6236,
Silver Spring, MD 20993–0002, 301–
796–5094.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which 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
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18558-18559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07337]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-1379]
Determination That PREZISTA (Darunavir) Tablets, 400 Milligrams,
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 or the Agency) has
determined that PREZISTA (darunavir) tablets, 400 milligrams (mg), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for darunavir tablets, 400 mg, if all other legal
and regulatory requirements are met.
[[Page 18559]]
FOR FURTHER INFORMATION CONTACT: Na'Im R. Moses, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 240-
402-3990.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
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.
PREZISTA (darunavir) tablets, 400 mg, is the subject of NDA 21-976,
held by Janssen Products, LP, and initially approved on June 23, 2006.
PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor
indicated for the treatment of HIV-1 infection in adult patients. It is
also indicated for the treatment of HIV-1 infection in pediatric
patients 3 years of age and older. PREZISTA must be coadministered with
ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents.
In an email dated July 30, 2013, Janssen Products, LP, notified FDA
that PREZISTA (darunavir) tablets, 400 mg, was being discontinued for
the U.S. market only. The PREZISTA 800-mg tablet continues to be
marketed in the United States. Lachman Consultant Services, Inc.,
submitted a citizen petition dated October 21, 2013 (Docket No. FDA-
2013-P-1379), under 21 CFR 10.30, requesting that the Agency determine
whether PREZISTA (darunavir) tablets, 400 mg, was withdrawn from sale
for reasons of safety or effectiveness. In January 2014, FDA moved the
400-mg dosage strength of this drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
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 PREZISTA (darunavir) tablets, 400 mg, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that PREZISTA
(darunavir) tablets, 400 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of PREZISTA (darunavir) tablets, 400 mg, from
sale. We have also independently evaluated relevant literature and data
for possible postmarketing adverse events. We have reviewed the
available evidence and determined that the product was not withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list PREZISTA (darunavir)
tablets, 400 mg, 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. ANDAs that
refer to PREZISTA (darunavir) tablets, 400 mg, may be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. 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: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07337 Filed 4-1-14; 8:45 am]
BILLING CODE 4160-01-P
