Determination That MEVACOR (Lovastatin) Tablets, 20 Milligrams and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 3435-3436 [2016-01096]
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3435
Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
FDA
Form No.
Pre-notification Consultation or Master File
(concerning a food contact substance).8
Amendment to an existing notification
(170.101), amendment to a Pre-notification Consultation, or amendment to a
Master File (concerning a food contact
substance).9
171.1 Indirect Food Additive Petitions ........
Use of Recycled Plastics in Food Packaging:
Chemistry Considerations.
FDA 3480
190
1
190
0.5
95
FDA
3480A.
100
1
100
0.5
50
N/A .........
N/A .........
1
10
1
1
1
10
................
........................
........................
........................
Total ........................................................
Number of
respondents
Average
burden per
response
21 CFR Section or other category
Total annual
responses
Total hours
10,995
25
..........................
10,995
250
31,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479
(‘‘Notification for a Food Contact Substance Formulation’’) only.
3 Duplicate notifications for uses of food contact substances.
4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
5 Notifications for uses that are the subject of moderately complex food additive petitions.
6 Notifications for uses that are the subject of very complex food additive petitions.
7 These notifications require the submission of Form FDA 3480.
8 These notifications recommend the submission of Form FDA 3480.
9 These notifications recommend the submission of Form FDA 3480A.
asabaliauskas on DSK9F6TC42PROD with NOTICES
2 Notifications
The estimates in table 1 are based on
our current experience with the food
contact substance notification program
and informal communication with
industry.
Beginning in row 1 we estimate 10
respondents will submit two
notifications annually for food contact
substance formulations (Form FDA
3479), for a total of 20 responses. We
calculate a reporting burden of 2 hours
per response, for a total of 40 hours. In
row 2 we estimate six respondents. We
believe the hourly burden for preparing
these notifications will primarily consist
of the manufacturer or supplier
completing Form FDA 3480, verifying
that a previous notification is effective
and preparing necessary documentation.
We estimate one submission for each
respondent, for a total of six responses.
We calculate a reporting burden of 25
hours per response, for a total of 150
hours.
In rows 3, 4, and 5 we identify three
tiers of FCNs that reflect different levels
of burden applicable to the respective
information collection items (denoted as
Categories C, D, and E). We estimate 6
respondents will submit 2 Category C
submissions annually, for a total of 12
responses. We calculate a reporting
burden of 120 hours per response, for a
total burden of 1,440 hours. We estimate
42 respondents will submit 2 Category
D submissions annually, for a total of 84
responses. We calculate a reporting
burden of 150 hours per response, for a
total burden of 12,600 hours. We
estimate 38 respondents will submit
1Category E submission annually, for a
total of 38 responses. We calculate a
VerDate Sep<11>2014
18:26 Jan 20, 2016
Jkt 238001
reporting burden of 150 hours per
response, for a total burden of 5,700
hours.
In row 6 we estimate 190 respondents
will submit information to a prenotification consultation or a master file
in support of FCN submission using
Form FDA 3480. We calculate a
reporting burden of 0.5 hours per
response, for a total burden of 95 hours.
In row 7 we estimate 100 respondents
will submit an amendment (Form FDA
3480A) to a substantive or nonsubstantive request of additional
information to an incomplete FCN
submission, an amendment to a prenotification consultation, or an
amendment to a master file in support
of an FCN. We calculate a reporting
burden of 0.5 hours per response, for a
total burden of 50 hours.
In row 8 we estimate one respondent
will submit one indirect food additive
petition under § 171.1, for a total of one
response. We calculate a reporting
burden of 10,995 hours per response, for
a total burden of 10,995 hours.
Finally, in row 9 we estimate ten
respondents will utilize the
recommendations in the guidance
document entitled, ‘‘Use of Recycled
Plastics in Food Packaging: Chemistry
Considerations,’’ to develop the
additional information for one such
submission annually, for a total of 10
responses. We calculate a reporting
burden of 25 hours per response, for a
total burden of 250 hours.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–01102 Filed 1–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–P–3319]
Determination That MEVACOR
(Lovastatin) Tablets, 20 Milligrams and
40 Milligrams, 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 MEVACOR (lovastatin)
tablets, 20 milligrams (mg) and 40 mg,
were not withdrawn from sale for
reasons of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to these drug
products, and it will allow FDA to
continue to approve ANDAs that refer to
the products as long as they meet
relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT: Kate
Greenwood, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
SUMMARY:
E:\FR\FM\21JAN1.SGM
21JAN1
asabaliauskas on DSK9F6TC42PROD with NOTICES
3436
Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
Ave., Bldg. 51, Rm. 6286, Silver Spring,
MD 20993–0002, 240–402–1748.
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)).
FDA may not approve an ANDA that
does not refer to a listed drug.
MEVACOR (lovastatin) tablets, 20 mg
and 40 mg, are the subject of NDA 19–
643, held by Merck & Co. Inc., and
initially approved on August 31, 1987.
MEVACOR is indicated: (1) To reduce
the risk of myocardial infarction,
unstable angina, and coronary
revascularization procedures in
individuals without symptomatic
cardiovascular disease, average to
moderately elevated total cholesterol
(total-C) and low-density lipoprotein
cholesterol (LDL–C), and below average
high-density lipoprotein cholesterol; (2)
to slow the progression of coronary
atherosclerosis in patients with
coronary heart disease as part of a
treatment strategy to lower total-C and
VerDate Sep<11>2014
18:26 Jan 20, 2016
Jkt 238001
LDL–C to target levels; and (3) as an
adjunct to diet for the reduction of
elevated total-C and LDL–C levels in
patients with primary
hypercholesterolemia (Types IIa and
IIb), when the response to diet restricted
in saturated fat and cholesterol and to
other nonpharmacological measures
alone has been inadequate. MEVACOR
is also indicated as an adjunct to diet to
reduce total-C, LDL–C, and
apolipoprotein B levels in adolescent
boys and girls who are at least 1 year
post-menarche, 10–17 years of age, with
heterozygous familial
hypercholesterolemia if, after an
adequate trial of diet therapy, the
following findings are present: (1) LDL–
C remains >189 mg/deciliter (dL) or (2)
LDL–C remains >160 mg/dL and there is
a positive family history of premature
cardiovascular disease (CVD) or two or
more other CVD risk factors are present
in the adolescent patient.
MEVACOR (lovastatin) tablets, 20 mg
and 40 mg, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Winifred M. Begley submitted a
citizen petition dated September 10,
2015 (Docket No. FDA–2015–P–3319),
under 21 CFR 10.30, requesting that the
Agency determine whether MEVACOR
(lovastatin) tablets, 20 mg and 40 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 MEVACOR (lovastatin)
tablets, 20 mg and 40 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that MEVACOR (lovastatin)
tablets, 20 mg and 40 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
MEVACOR (lovastatin) tablets, 20 mg
and 40 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 product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list MEVACOR (lovastatin)
tablets, 20 mg and 40 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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to
MEVACOR (lovastatin) tablets, 20 mg
and 40 mg. Additional ANDAs that refer
to these products may also 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 these drug
products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–01096 Filed 1–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0611]
Submission and Review of Sterility
Information in Premarket Notification
(510(k)) Submissions for Devices
Labeled as Sterile; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘Submission and
Review of Sterility Information in
Premarket Notification (510(k))
Submissions for Devices Labeled as
Sterile.’’ This guidance updates and
clarifies the information regarding
sterilization processes that FDA
recommends sponsors include in
510(k)s for devices labeled as sterile.
This guidance document also provides
details about the pyrogenicity
information that FDA recommends
sponsors include in a 510(k)
submission.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time. The recommendations in this
guidance will be implemented on March
21, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\21JAN1.SGM
21JAN1
]]>Agencies
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3435-3436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01096]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-P-3319]
Determination That MEVACOR (Lovastatin) Tablets, 20 Milligrams
and 40 Milligrams, 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 MEVACOR (lovastatin) tablets, 20 milligrams (mg) and 40
mg, were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to these drug products, and it will allow FDA to
continue to approve ANDAs that refer to the products as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire
[[Page 3436]]
Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240-402-1748.
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.
MEVACOR (lovastatin) tablets, 20 mg and 40 mg, are the subject of
NDA 19-643, held by Merck & Co. Inc., and initially approved on August
31, 1987. MEVACOR is indicated: (1) To reduce the risk of myocardial
infarction, unstable angina, and coronary revascularization procedures
in individuals without symptomatic cardiovascular disease, average to
moderately elevated total cholesterol (total-C) and low-density
lipoprotein cholesterol (LDL-C), and below average high-density
lipoprotein cholesterol; (2) to slow the progression of coronary
atherosclerosis in patients with coronary heart disease as part of a
treatment strategy to lower total-C and LDL-C to target levels; and (3)
as an adjunct to diet for the reduction of elevated total-C and LDL-C
levels in patients with primary hypercholesterolemia (Types IIa and
IIb), when the response to diet restricted in saturated fat and
cholesterol and to other nonpharmacological measures alone has been
inadequate. MEVACOR is also indicated as an adjunct to diet to reduce
total-C, LDL-C, and apolipoprotein B levels in adolescent boys and
girls who are at least 1 year post-menarche, 10-17 years of age, with
heterozygous familial hypercholesterolemia if, after an adequate trial
of diet therapy, the following findings are present: (1) LDL-C remains
>189 mg/deciliter (dL) or (2) LDL-C remains >160 mg/dL and there is a
positive family history of premature cardiovascular disease (CVD) or
two or more other CVD risk factors are present in the adolescent
patient.
MEVACOR (lovastatin) tablets, 20 mg and 40 mg, are currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
Winifred M. Begley submitted a citizen petition dated September 10,
2015 (Docket No. FDA-2015-P-3319), under 21 CFR 10.30, requesting that
the Agency determine whether MEVACOR (lovastatin) tablets, 20 mg and 40
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 MEVACOR (lovastatin) tablets, 20 mg and 40 mg,
were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
MEVACOR (lovastatin) tablets, 20 mg and 40 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of MEVACOR (lovastatin)
tablets, 20 mg and 40 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 product was withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list MEVACOR (lovastatin)
tablets, 20 mg and 40 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to MEVACOR (lovastatin) tablets, 20 mg and 40
mg. Additional ANDAs that refer to these products may also 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 these drug products should be revised to meet current standards,
the Agency will advise ANDA applicants to submit such labeling.
Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01096 Filed 1-20-16; 8:45 am]
BILLING CODE 4164-01-P
