Determination That LEVOTHROID (Levothyroxine Sodium) Tablets, 0.025 Milligram, 0.05 Milligram, 0.075 Milligram, 0.088 Milligram, 0.112 Milligram, 0.125 Milligram, 0.137 Milligram, 0.15 Milligram, 0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 34347-34348 [2016-12655]
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34347
Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1—Continued
E6(R2) Good Clinical Practice; International Council for
Harmonisation; Draft Guidance for Industry
Number of
recordkeepers
Number of
records per
recordkeeper
Average burden per recordkeeping
Total annual
records
Total hours
Developing a Quality Management System.
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
E6(R2) Good Clinical Practice; International Council for
Harmonisation; Draft Guidance for Industry
Number of respondents
Number of responses per
respondent
Total annual
responses
Average burden per response
Total hours
Section 5.0.7—Risk Reporting .............................................
Describing the Quality Management Approach Implemented in a Clinical Trial and Summarizing Important
Deviations From the Predefined Quality Tolerance Limits in a Clinical Study Report.
1,457
4.6
6,702
3
20,107
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1
E6(R2) Good Clinical Practice; International Council for
Harmonisation; Draft Guidance for Industry
Number of
recordkeepers
Number of
records per
recordkeeper
Total records
Average burden per record
Total hours
Section 5.0—Quality Management (including 5.0.1 to
5.0.7) ................................................................................
Developing a Quality Management System.
218
1
218
60
13,080
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1
E6(R2) Good Clinical Practice; International Council for
Harmonisation; Draft Guidance for Industry
Number of responses
Number of responses per
respondent
Total annual
responses
Average burden per response
Total hours
Section 5.0.7—Risk Reporting .............................................
Describing the Quality Management Approach Implemented in a Clinical Trial and Summarizing Important
Deviations From the Predefined Quality Tolerance Limits in a Clinical Study Report.
218
3.69
804
3
2,413
sradovich on DSK3TPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The collections of information
included in the sections marked as
‘‘ADDENDUM’’ in the E6(R2) draft
guidance also refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by OMB under the PRA. The
collections of information found in 21
CFR part 11 have been approved under
OMB control number 0910–0303; the
collections of information found in 21
CFR part 312 have been approved under
OMB control number 0910–0014; and
collections of information found in 21
CFR part 314 have been approved under
OMB control number 0910–0001. The
collections of information found in 21
CFR part 601 have been approved under
OMB control number 0910–0338.
VerDate Sep<11>2014
20:07 May 27, 2016
Jkt 238001
Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12651 Filed 5–27–16; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2015–P–0403]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination That LEVOTHROID
(Levothyroxine Sodium) Tablets, 0.025
Milligram, 0.05 Milligram, 0.075
Milligram, 0.088 Milligram, 0.112
Milligram, 0.125 Milligram, 0.137
Milligram, 0.15 Milligram, 0.175
Milligram, 0.1 Milligram, 0.2 Milligram,
and 0.3 Milligram, Were 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 LEVOTHROID
SUMMARY:
Frm 00039
Fmt 4703
Sfmt 4703
E:\FR\FM\31MYN1.SGM
31MYN1
sradovich on DSK3TPTVN1PROD with NOTICES
34348
Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
(levothyroxine sodium) tablets, 0.025
milligram (mg), 0.05 mg, 0.075 mg,
0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,
0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, were not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for LEVOTHROID
(levothyroxine sodium) tablets, 0.025
mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112
mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175
mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Reena Raman, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6284,
Silver Spring, MD 20993–0002, 301–
796–7577.
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 (§ 314.161 (21 CFR 314.161)).
VerDate Sep<11>2014
20:07 May 27, 2016
Jkt 238001
FDA may not approve an ANDA that
does not refer to a listed drug.
LEVOTHROID (levothyroxine
sodium) tablets, 0.025 mg, 0.05 mg,
0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,
0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2
mg, and 0.3 mg, are the subject of NDA
021116, held by Lloyd Inc., and initially
approved on October 24, 2002.
LEVOTHROID is used for the following
indications:
• Hypothyroidism—As replacement
or supplemental therapy in congenital
or acquired hypothyroidism of any
etiology, except transient
hypothyroidism during the recovery
phase of subacute thyroiditis. Specific
indications include: Primary (thyroidal),
secondary (pituitary), and tertiary
(hypothalamic) hypothyroidism and
subclinical hypothyroidism. Primary
hypothyroidism may result from
functional deficiency, primary atrophy,
partial or total congenital absence of the
thyroid gland, or from the effects of
surgery, radiation, or drugs, with or
without the presence of goiter.
• Pituitary Thyrotropine-Stimulating
Hormone Suppression—In the treatment
or prevention of various types of
euthyroid goiters, including thyroid
nodules, subacute or chronic
lymphocytic thyroiditis (Hashimoto’s
thyroiditis), multinodular goiter, and as
an adjunct to surgery and radioiodine
therapy in the management of
thyrotropin-dependent welldifferentiated thyroid cancer.
LEVOTHROID (levothyroxine
sodium) tablets, 0.025 mg, 0.05 mg,
0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,
0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2
mg, and 0.3 mg are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated
February 4, 2015 (Docket No. FDA–
2015–P–0403), under 21 CFR 10.30,
requesting that the Agency determine
whether LEVOTHROID (levothyroxine
sodium) tablets, 0.025 mg, 0.05 mg,
0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,
0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2
mg, and 0.3 mg, were 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 LEVOTHROID
(levothyroxine sodium) tablets, 0.025
mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112
mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175
mg, 0.1 mg, 0.2 mg, and 0.3 mg, were
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
suggesting that this drug product was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
LEVOTHROID (levothyroxine sodium)
tablets, 0.025 mg, 0.05 mg, 0.075 mg,
0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,
0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, 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 LEVOTHROID
(levothyroxine sodium) tablets, 0.025
mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112
mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175
mg, 0.1 mg, 0.2 mg, and 0.3 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 this drug product 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: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12655 Filed 5–27–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Clinical Trial Design Considerations
for Malaria Drug Development; Notice
of Public Workshop; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Tuesday, May 10, 2016 (81
FR 28876). The document announced a
public workshop entitled ‘‘Clinical Trial
Design Considerations for Malaria Drug
Development.’’ The document was
SUMMARY:
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34347-34348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12655]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-P-0403]
Determination That LEVOTHROID (Levothyroxine Sodium) Tablets,
0.025 Milligram, 0.05 Milligram, 0.075 Milligram, 0.088 Milligram,
0.112 Milligram, 0.125 Milligram, 0.137 Milligram, 0.15 Milligram,
0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, Were
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 Agency) has
determined that LEVOTHROID
[[Page 34348]]
(levothyroxine sodium) tablets, 0.025 milligram (mg), 0.05 mg, 0.075
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg,
0.2 mg, and 0.3 mg, were not withdrawn from sale for reasons of safety
or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for LEVOTHROID (levothyroxine
sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125
mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Reena Raman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993-0002, 301-
796-7577.
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.
LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg,
0.2 mg, and 0.3 mg, are the subject of NDA 021116, held by Lloyd Inc.,
and initially approved on October 24, 2002. LEVOTHROID is used for the
following indications:
Hypothyroidism--As replacement or supplemental therapy in
congenital or acquired hypothyroidism of any etiology, except transient
hypothyroidism during the recovery phase of subacute thyroiditis.
Specific indications include: Primary (thyroidal), secondary
(pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical
hypothyroidism. Primary hypothyroidism may result from functional
deficiency, primary atrophy, partial or total congenital absence of the
thyroid gland, or from the effects of surgery, radiation, or drugs,
with or without the presence of goiter.
Pituitary Thyrotropine-Stimulating Hormone Suppression--In
the treatment or prevention of various types of euthyroid goiters,
including thyroid nodules, subacute or chronic lymphocytic thyroiditis
(Hashimoto's thyroiditis), multinodular goiter, and as an adjunct to
surgery and radioiodine therapy in the management of thyrotropin-
dependent well-differentiated thyroid cancer.
LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg,
0.2 mg, and 0.3 mg are currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book.
Lachman Consultant Services, Inc., submitted a citizen petition
dated February 4, 2015 (Docket No. FDA-2015-P-0403), under 21 CFR
10.30, requesting that the Agency determine whether LEVOTHROID
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg,
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, were 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 LEVOTHROID (levothyroxine sodium) tablets,
0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,
0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that this drug product was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of LEVOTHROID
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg,
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 mg, 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 LEVOTHROID
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg,
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
0.3 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 this
drug product 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: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12655 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P
