Office of the Director; Notice of Charter Renewal, 13670 [2019-06615]

Download as PDF khammond on DSKBBV9HB2PROD with NOTICES 13670 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Notices 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approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)).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. ANTIVERT (meclizine hydrochloride) chewable tablets, 25 mg, and tablets, 12.5 mg, 25 mg, and 50 mg, are the subject of NDA 010721, currently held by Casper Pharma LLC, and initially approved on February 14, 1957. ANTIVERT is indicated for the treatment of vertigo associated with diseases affecting the vestibular system. ANTIVERT (meclizine hydrochloride) chewable tablets, 25 mg, and tablets, 12.5 mg, 25 mg, and 50 mg, are currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Since 2011, the Agency has received four citizen petitions, submitted under 21 CFR 10.30, requesting that FDA determine whether one or more dosage forms and strengths of ANTIVERT were withdrawn from sale for reasons of safety or effectiveness. • InvaGen Pharmaceuticals submitted a citizen petition dated January 14, 2011, and amendment dated February 24, 2011 (Docket No. FDA–2011–P– VerDate Sep<11>2014 18:46 Apr 04, 2019 Jkt 247001 0047), requesting that the Agency determine whether ANTIVERT (meclizine hydrochloride) chewable tablets, 25 mg, was withdrawn from sale for reasons of safety or effectiveness. • Modavar Pharmaceuticals LLC submitted a citizen petition dated May 4, 2012, (Docket No. FDA–2012–P– 0468) requesting that the Agency determine whether ANTIVERT (meclizine hydrochloride) tablets, 12.5 mg and 25 mg, were withdrawn from sale for reasons of safety or effectiveness. • Lupin Pharmaceuticals, Inc. submitted a citizen petition dated September 18, 2015 (Docket No. FDA– 2015–P–3400), requesting that the Agency determine whether ANTIVERT (meclizine hydrochloride) tablets, 12.5 mg, 25 mg, and 50 mg, were withdrawn from sale for reasons of safety or effectiveness. • Zydus Pharmaceuticals submitted a citizen petition dated June 14, 2016 (Docket No. FDA–2016–P–1667), requesting that the Agency determine whether ANTIVERT (meclizine hydrochloride) tablets, 12.5 mg and 25 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petitions and reviewing Agency records, and based on the information we have at this time, FDA has determined under § 314.161 that ANTIVERT (meclizine hydrochloride) chewable tablets, 25 mg, and tablets, 12.5 mg, 25 mg, and 50 mg, were not withdrawn for reasons of safety or effectiveness. The petitioners have identified no data or other information suggesting that these drug products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ANTIVERT (meclizine hydrochloride) chewable tablets, 25 mg, and tablets, 12.5 mg, 25 mg, and 50 mg, from sale. We have also independently evaluated relevant literature and data for possible post marketing adverse events. We have found no information that would indicate that these drug products were withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list ANTIVERT (meclizine hydrochloride) chewable tablets, 25 mg, and tablets, 12.5 mg, 25 mg, and 50 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 these drug products. Additional PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 ANDAs for these drug 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: April 1, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–06656 Filed 4–4–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director; Notice of Charter Renewal In accordance with Title 41 of the U.S. Code of Federal Regulations, Section 102–3.65(a), notice is hereby given that the Charter for the Center for Scientific Review Advisory Council (CSRAC) was renewed for an additional two-year period on March 31, 2019. It is determined that the CSRAC is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed through the advice and counsel of this group. Inquiries may be directed to Claire Harris, Acting Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail Code 4875), Telephone (301) 496– 2123, or harriscl@mail.nih.gov. Dated: April 1, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–06615 Filed 4–4–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-day Comment Request: A Generic Submission for Formative Research, Pretesting and Customer Satisfaction of NCI’s Communication and Education Resources (NCI) AGENCY: National Institutes of Health, HHS. ACTION: E:\FR\FM\05APN1.SGM Notice. 05APN1

Agencies

[Federal Register Volume 84, Number 66 (Friday, April 5, 2019)]
[Notices]
[Page 13670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06615]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director; Notice of Charter Renewal

    In accordance with Title 41 of the U.S. Code of Federal 
Regulations, Section 102-3.65(a), notice is hereby given that the 
Charter for the Center for Scientific Review Advisory Council (CSRAC) 
was renewed for an additional two-year period on March 31, 2019.
    It is determined that the CSRAC is in the public interest in 
connection with the performance of duties imposed on the National 
Institutes of Health by law, and that these duties can best be 
performed through the advice and counsel of this group.
    Inquiries may be directed to Claire Harris, Acting Director, Office 
of Federal Advisory Committee Policy, Office of the Director, National 
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, 
Maryland 20892 (Mail Code 4875), Telephone (301) 496-2123, or 
[email protected].

    Dated: April 1, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-06615 Filed 4-4-19; 8:45 am]
BILLING CODE 4140-01-P