83_FR_30879 83 FR 30753 - Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications; Correction

83 FR 30753 - Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

Page Range30753-30754
FR Document2018-14050

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 14, 2018. The notice announced the voluntary withdrawal of approval of four abbreviated new drug applications (ANDAs) from two applicants, effective April 13, 2018. In particular, the notice indicated that FDA was withdrawing approval of the following ANDA after receiving a withdrawal request from Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical), 2 Independence Way, Princeton, NJ 08540: ANDA 076045, Lorazepam Tablets USP, 0.5 milligram (mg), 1 mg, and 2 mg. Before withdrawal of this ANDA became effective, however, Sun Pharmaceutical informed FDA that it did not want approval of the ANDA withdrawn. Because Sun Pharmaceutical timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 076045 is still in effect.

Federal Register, Volume 83 Issue 126 (Friday, June 29, 2018) 
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30753-30754]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0793]


Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; 
Withdrawal of Approval of Four Abbreviated New Drug Applications; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register on March 14, 2018. The notice 
announced the voluntary withdrawal of approval of four abbreviated new 
drug applications (ANDAs) from two applicants, effective April 13, 
2018. In particular, the notice indicated that FDA was withdrawing 
approval of the following ANDA after receiving a withdrawal request 
from Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical 
Industries, Inc. (Sun Pharmaceutical), 2 Independence Way, Princeton, 
NJ 08540: ANDA 076045, Lorazepam Tablets USP, 0.5 milligram (mg), 1 mg, 
and 2 mg. Before withdrawal of this ANDA became effective, however, Sun 
Pharmaceutical informed FDA that it did not want approval of the ANDA 
withdrawn. Because Sun Pharmaceutical timely requested that approval of 
this ANDA not be withdrawn, the approval of ANDA 076045 is still in 
effect.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire

[[Page 30754]]

Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945.

SUPPLEMENTARY INFORMATION: In the Federal Register of Wednesday, March 
14, 2018 (83 FR 11208), appearing on page 11208 in FR Doc. 2018-05120, 
the following correction is made:
    1. On page 11208, the entry for ANDA 076045 in the table is 
removed.

    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14050 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30753 in the body of your comments and you (e.g., pain). This draft guidance information in the ‘‘Content and Format must identify this information as discusses the following concepts: (1) of Labeling for Human Prescription ‘‘confidential.’’ Any information marked Evaluation of toxicities from the ligand; Drug and Biological Products; as ‘‘confidential’’ will not be disclosed (2) evaluation of radiation toxicities; Requirements for Pregnancy and except in accordance with 21 CFR 10.20 and (3) information for product labeling Lactation Labeling’’ final rule has been and other applicable disclosure law. For as related to reproductive toxicity, approved under OMB control number more information about FDA’s posting genotoxicity, carcinogenicity, 0910–0624. of comments to public dockets, see 80 contraception, and use in lactating women. III. Electronic Access FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ Currently, no FDA or International Persons with access to the internet fdsys/pkg/FR-2015-09-18/pdf/2015- Council for Harmonisation guidance may obtain the draft guidance at either 23389.pdf. addresses nonclinical studies https://www.fda.gov/Drugs/Guidance Docket: For access to the docket to supporting FIH trials and approval for ComplianceRegulatoryInformation/ read background documents or the radiopharmaceuticals for treatment of Guidances/default.htm or https:// electronic and written/paper comments cancer. The guidance for industry www.regulations.gov. received, go to https:// entitled ‘‘Nonclinical Evaluation of Late Dated: June 26, 2018. www.regulations.gov and insert the Radiation Toxicity of Therapeutic Leslie Kux, docket number, found in brackets in the Radiopharmaceuticals’’ (available at https://www.fda.gov/downloads/Drugs/ Associate Commissioner for Policy. heading of this document, into the GuidanceComplianceRegulatory [FR Doc. 2018–14055 Filed 6–28–18; 8:45 am] ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Information/Guidances/ BILLING CODE 4164–01–P Staff, 5630 Fishers Lane, Rm. 1061, UCM079242.pdf) describes nonclinical Rockville, MD 20852. studies to address late radiation toxicity only. This draft guidance provides DEPARTMENT OF HEALTH AND You may submit comments on any further clarification of recommendations HUMAN SERVICES guidance at any time (see 21 CFR 10.115(g)(5)). made in that guidance for the timing and design of late radiation toxicity Food and Drug Administration Submit written requests for single copies of the draft guidance to the studies. This draft guidance intends to [Docket No. FDA–2018–N–0793] Division of Drug Information, Center for bring consistency in nonclinical safety assessment and in product labeling for Sun Pharmaceutical Industries, Ltd., Drug Evaluation and Research, Food therapeutic radiopharmaceuticals and to and Sun Pharma Global FZE; and Drug Administration, 10001 New reduce the number of nonclinical Withdrawal of Approval of Four Hampshire Ave., Hillandale Building, studies that are not informative for Abbreviated New Drug Applications; 4th Floor, Silver Spring, MD 20993– product use. Correction 0002. Send one self-addressed adhesive label to assist that office in processing This draft guidance is being issued consistent with FDA’s good guidance AGENCY: Food and Drug Administration, your requests. See the SUPPLEMENTARY HHS. INFORMATION section for electronic practices regulation (21 CFR 10.115). The draft guidance, when finalized, will ACTION: Notice; correction. access to the draft guidance document. represent the current thinking of FDA FOR FURTHER INFORMATION CONTACT: SUMMARY: The Food and Drug on nonclinical studies and labeling Haleh Saber, Center for Drug Evaluation Administration (FDA) is correcting a recommendations for oncology and Research, Food and Drug therapeutic radiopharmaceuticals. It notice that appeared in the Federal Administration, 10903 New Hampshire does not establish any rights for any Register on March 14, 2018. The notice Ave., Bldg. 22, Rm. 2117, Silver Spring, person and is not binding on FDA or the announced the voluntary withdrawal of MD 20993–0002, 301–796–7550, or John public. You can use an alternative approval of four abbreviated new drug Leighton, Center for Drug Evaluation approach if it satisfies the requirements applications (ANDAs) from two and Research, Food and Drug of the applicable statutes and applicants, effective April 13, 2018. In Administration, 10903 New Hampshire regulations. This guidance is not subject particular, the notice indicated that FDA Ave., Bldg. 22, Rm. 2204, Silver Spring, to Executive Order 12866. was withdrawing approval of the MD 20993–0002, 301–796–7550. following ANDA after receiving a SUPPLEMENTARY INFORMATION: II. Paperwork Reduction Act of 1995 withdrawal request from Sun This draft guidance refers to Pharmaceutical Industries, Ltd., c/o Sun I. Background previously approved collections of Pharmaceutical Industries, Inc. (Sun FDA is announcing the availability of information found in FDA regulations. Pharmaceutical), 2 Independence Way, a draft guidance for industry entitled These collections of information are Princeton, NJ 08540: ANDA 076045, ‘‘Oncology Therapeutic subject to review by the Office of Lorazepam Tablets USP, 0.5 milligram Radiopharmaceuticals: Nonclinical Management and Budget (OMB) under (mg), 1 mg, and 2 mg. Before withdrawal Studies and Labeling the Paperwork Reduction Act of 1995 of this ANDA became effective, Recommendations.’’ This draft guidance (44 U.S.C. 3501–3520). The collection of however, Sun Pharmaceutical informed presents FDA’s current thinking on information in 21 CFR 312.23(a)(8) for FDA that it did not want approval of the nonclinical studies needed to support submitting pharmacological and ANDA withdrawn. Because Sun FIH studies and for approval for toxicology information has been Pharmaceutical timely requested that sradovich on DSK3GMQ082PROD with NOTICES therapeutic radiopharmaceuticals. In approved under OMB control number approval of this ANDA not be this draft guidance, the term therapeutic 0910–0014; the collection of withdrawn, the approval of ANDA radiopharmaceutical refers to a information in 21 CFR 201.56 and 076045 is still in effect. pharmaceutical that contains a 201.57 for preparing human FOR FURTHER INFORMATION CONTACT: radionuclide and is used in patients prescription drug labeling has been Trang Tran, Center for Drug Evaluation with cancer for the treatment or for approved under OMB control number and Research, Food and Drug palliation of tumor-related symptoms 0910–0572; and the collection of Administration, 10903 New Hampshire VerDate Sep<11>2014 17:58 Jun 28, 2018 Jkt 244001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1

30754 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices Ave., Bldg. 75, Rm. 1671, Silver Spring, SUMMARY: In compliance with the and/or economic factors the opportunity MD 20993–0002, 240–402–7945. Paperwork Reduction Act of 1995, to enter into a contract with HHS in HRSA has submitted an Information exchange for the repayment of SUPPLEMENTARY INFORMATION: In the Collection Request (ICR) to the Office of qualifying educational loans for a Federal Register of Wednesday, March Management and Budget (OMB) for minimum of 2 years of service as a full- 14, 2018 (83 FR 11208), appearing on review and approval. Comments time or part-time faculty member at page 11208 in FR Doc. 2018–05120, the submitted during the first public review eligible health professions schools. following correction is made: of this ICR will be provided to OMB. Need and Proposed Use of the 1. On page 11208, the entry for ANDA OMB will accept further comments from Information: The information collected 076045 in the table is removed. the public during the review and will be used to evaluate applicants’ Dated: June 26, 2018. approval period. eligibility to participate in FLRP and to Leslie Kux, DATES: Comments on this ICR should be monitor FLRP-related activities. Associate Commissioner for Policy. received no later than July 30, 2018. Likely Respondents: FLRP applicants [FR Doc. 2018–14050 Filed 6–28–18; 8:45 am] ADDRESSES: Submit your comments and institutions providing employment including the Information Collection to the applicants. BILLING CODE 4164–01–P Request Title, to the desk officer for Burden Statement: Burden in this HRSA, either by email to OIRA_ context means the time expended by DEPARTMENT OF HEALTH AND submission@omb.eop.gov or by fax to persons to generate, maintain, retain, HUMAN SERVICES 202–395–5806. disclose or provide the information FOR FURTHER INFORMATION CONTACT: To requested. This includes the time Health Resources and Services request a copy of the clearance requests needed to review instructions; to Administration submitted to OMB for review, email Lisa develop, acquire, install and utilize Wright-Solomon, the HRSA Information technology and systems for the purpose Agency Information Collection Collection Clearance Officer at of collecting, validating and verifying Activities: Submission to OMB for paperwork@hrsa.gov or call (301) 443– information, processing and Review and Approval; Public Comment 1984. maintaining information, and disclosing Request; Faculty Loan Repayment SUPPLEMENTARY INFORMATION: and providing information; to train Program, OMB No. 0915–0150— Information Collection Request Title: personnel and to be able to respond to Extension Faculty Loan Repayment Program OMB a collection of information; to search No. 0915–0150—Extension. data sources; to complete and review AGENCY: Health Resources and Services Abstract: HRSA administers the the collection of information; and to Administration, (HRSA), Department of Faculty Loan Repayment Program transmit or otherwise disclose the Health and Human Services (HHS). (FLRP). FLRP provides degree-trained information. The total annual burden health professionals from disadvantaged hours estimated for this ICR are ACTION: Notice. backgrounds based on environmental summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Average Number of Number of Total burden per Total burden Form name responses per respondents responses response hours respondent (in hours) Eligible Applications ............................................................. 111 1 111 1.00 111.00 Institution/Loan Repayment Employment Form * ................ 111 1 111 1.00 111.00 Authorization to Release Information Form ......................... 111 1 111 0.25 27.75 Total .............................................................................. 333 ........................ ........................ ........................ 249.75 * Respondent for this form is the institution for the applicant. Amy P. McNulty, The meetings will be closed to the Agenda: To review and evaluate grant Acting Director, Division of the Executive public in accordance with the applications. Secretariat. provisions set forth in sections Place: Residence Inn Bethesda, 7335 [FR Doc. 2018–13955 Filed 6–28–18; 8:45 am] 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Amy Kathleen Wernimont, BILLING CODE 4165–15–P as amended. The grant applications and Ph.D., Scientific Review Officer, Center for the discussions could disclose Scientific Review, National Institutes of confidential trade secrets or commercial Health, 6701 Rockledge Drive, Room 6198, DEPARTMENT OF HEALTH AND property such as patentable material, Bethesda, MD 20892, 301–827–6427, HUMAN SERVICES and personal information concerning amy.wernimont@nih.gov. individuals associated with the grant Name of Committee: Center for Scientific National Institutes of Health applications, the disclosure of which Review Special Emphasis Panel; Member sradovich on DSK3GMQ082PROD with NOTICES Center for Scientific Review; Notice of would constitute a clearly unwarranted Conflict: AIDS and AIDS Related Research. invasion of personal privacy. Date: July 13, 2018. Closed Meetings Time: 10:00 a.m. to 6:00 p.m. Name of Committee: Center for Scientific Agenda: To review and evaluate grant Pursuant to section 10(d) of the Review Special Emphasis Panel; Small applications. Federal Advisory Committee Act, as Business: Cell and Molecular Biology. Place: National Institutes of Health, 6701 amended, notice is hereby given of the Date: July 11–12, 2018. Rockledge Drive, Bethesda, MD 20892 following meetings. Time: 8:00 a.m. to 6:00 p.m. (Virtual Meeting). VerDate Sep<11>2014 17:58 Jun 28, 2018 Jkt 244001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1


Document Created: 2018-06-29 01:13:09
Document Modified: 2018-06-29 01:13:09
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; correction.
ContactTrang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945.
FR Citation83 FR 30753 
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