Determination That MEVACOR (Lovastatin) Tablets, 20 Milligrams and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 3435-3436 [2016-01096]

Download as PDF 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]


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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