Determination That JADELLE (Levonorgestrel) Implant, 75 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 51575-51576 [2014-20634]
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Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices
wreier-aviles on DSK5TPTVN1PROD with NOTICES
It is ACF’s policy to integrate both use
of existing evidence and opportunities
for further learning into all of our
activities. Where an evidence base is
lacking, we will build evidence through
strong evaluations. Where evidence
exists, we will use it. Discretionary
funding opportunity announcements
will require that successful applicants
cooperate with any Federal evaluations
if selected to participate. As legally
allowed, programs with waiver
authorities should require rigorous
evaluations as a condition of waivers.
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incentivize, or require grantees to use
existing evidence of effective strategies
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is meant to support, not inhibit,
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through posting on the web information
about the contractor or grantee
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into contracts to prepare data sets for
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objectivity are core principles of
evaluation.1 Agency and program
leadership, program staff, service
providers, and others should participate
actively in setting evaluation priorities,
identifying evaluation questions, and
assessing the implications of findings.
However, it is important to insulate
1American Evaluation Association, ‘‘An
Evaluation Roadmap for a More Effective
Government’’, November 2013, https://
www.eval.org/d/do/472, accessed 16 December
2013, and Government Accountability Office,
‘‘Employment and Training Administration:
Increased Authority and Accountability Could
Improve Research Program’’, GAO–10- 243, January
2010, https://www.gao.gov/products/GAO-10-243,
accessed 18 June 2012.
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15:25 Aug 28, 2014
Jkt 232001
evaluation functions from undue
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and the reality of bias. To promote
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in the design, conduct, and analysis of
evaluations. To this end:
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Mark H. Greenberg,
Acting Assistant Secretary for Children and
Families.
[FR Doc. 2014–20616 Filed 8–28–14; 8:45 am]
BILLING CODE 4184–79–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0886]
Determination That JADELLE
(Levonorgestrel) Implant, 75
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 we) has
determined that JADELLE
(levonorgestrel) implant, 75 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 JADELLE
(levonorgestrel) implant, 75 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6222, Silver Spring,
MD 20993–0002, 301–796–4455.
SUMMARY:
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51575
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 (§ 314.162 (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.
JADELLE (levonorgestrel) implant, 75
mg, is the subject of NDA 20–544, held
by Population Council, and initially
approved on November 1, 1996.
JADELLE (levonorgestrel) implants, 75
mg, are indicated for the prevention of
pregnancy and are a long-term (up to 5
years) reversible method of
contraception.
Population Council has never
marketed JADELLE (levonorgestrel)
implant, 75 mg. Therefore, as in
previous instances (see e.g., 72 FR 9763,
61 FR 25497), the Agency has
determined, for purposes of §§ 314.161
and 314.162, never marketing an
approved drug product is equivalent to
withdrawing the drug from sale.
Arnall Golden Gregory, LLP
submitted a citizen petition dated July
SUPPLEMENTARY INFORMATION:
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51576
Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices
17, 2013 (Docket No. FDA–2013–P–
0886), under 21 CFR 10.30, requesting
that the Agency determine whether
JADELLE (levonorgestrel) implant, 75
mg, 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 JADELLE (levonorgestrel)
implant, 75 mg, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that JADELLE
(levonorgestrel) implant, 75 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of JADELLE
(levonorgestrel) implant, 75 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 this drug
product was not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list JADELLE
(levonorgestrel) implant, 75 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 JADELLE (levonorgestrel) implant, 75
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: August 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–20634 Filed 8–28–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2014–S–0009]
Draft Guidance for Industry: Electronic
Submission of Lot Distribution
Reports; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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15:25 Aug 28, 2014
Jkt 232001
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Electronic
Submission of Lot Distribution Reports’’
dated August 2014. The draft guidance
document provides information and
recommendations pertaining to the
electronic submission of lot distribution
reports for applicants with approved
biologics license applications (BLAs).
FDA recently published in the Federal
Register a final rule requiring that,
among other things, lot distribution
reports be submitted to FDA in an
electronic format that the Agency can
process, review, and archive. The draft
guidance, when finalized, is intended to
help licensed manufacturers of products
distributed under approved BLAs
(henceforth referred to as applicants)
comply with the final rule.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 28,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002 or
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800 or
CDER at 301–796–3400. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori
J. Churchyard, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911 or Jared Lantzy, Center for
Drug Evaluation and Research (CDER),
SUMMARY:
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Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm.
1116, Silver Spring, MD 20993–0002,
email: esub@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Electronic Submission of Lot
Distribution Reports’’ dated August
2014. The draft guidance provides
information and recommendations
pertaining to the electronic submission
of lot distribution reports. The draft
guidance provides information on how
to electronically submit lot distribution
reports for biological products under
approved BLAs for which CBER or
CDER has regulatory responsibility.
When finalized, this guidance will not
apply to any other biological product.
FDA recently published in the
Federal Register of June 10, 2014 (79 FR
33072), a final rule requiring electronic
submission of certain postmarketing
submissions. Among other things, under
this rule applicants are required to
submit biological lot distribution reports
to FDA in an electronic format that the
Agency can process, review, and
archive. The draft guidance, when
finalized, is intended to help applicants
subject to lot distribution reporting
comply with the final rule. Along with
other information, the draft guidance
provides updated information about the
following: (1) Structured Product
Labeling standard and vocabulary for
electronic submission of lot distribution
reporting; (2) additional resources such
as implementation guide, validation
procedures; and links with further
information; and (3) procedures for
requesting temporary waivers from the
electronic submission requirement.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 600.81 and
E:\FR\FM\29AUN1.SGM
29AUN1
]]>Agencies
[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Notices]
[Pages 51575-51576]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20634]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0886]
Determination That JADELLE (Levonorgestrel) Implant, 75
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 we) has determined
that JADELLE (levonorgestrel) implant, 75 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 JADELLE (levonorgestrel) implant, 75 mg, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455.
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
(Sec. 314.162 (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.
JADELLE (levonorgestrel) implant, 75 mg, is the subject of NDA 20-
544, held by Population Council, and initially approved on November 1,
1996. JADELLE (levonorgestrel) implants, 75 mg, are indicated for the
prevention of pregnancy and are a long-term (up to 5 years) reversible
method of contraception.
Population Council has never marketed JADELLE (levonorgestrel)
implant, 75 mg. Therefore, as in previous instances (see e.g., 72 FR
9763, 61 FR 25497), the Agency has determined, for purposes of
Sec. Sec. 314.161 and 314.162, never marketing an approved drug
product is equivalent to withdrawing the drug from sale.
Arnall Golden Gregory, LLP submitted a citizen petition dated July
[[Page 51576]]
17, 2013 (Docket No. FDA-2013-P-0886), under 21 CFR 10.30, requesting
that the Agency determine whether JADELLE (levonorgestrel) implant, 75
mg, 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 JADELLE (levonorgestrel) implant, 75 mg, was
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that JADELLE
(levonorgestrel) implant, 75 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of JADELLE (levonorgestrel) implant, 75 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 this drug product was not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list JADELLE
(levonorgestrel) implant, 75 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 JADELLE (levonorgestrel) implant, 75
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: August 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-20634 Filed 8-28-14; 8:45 am]
BILLING CODE 4164-01-P
