Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications for Pemoline Products; Correction, 52887-52888 [2019-21526]

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Background FDA is announcing the availability of a final guidance for industry entitled ‘‘Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.’’ The nonclinical study requirements for ERT products may be different from products used to treat other diseases because of the rare, seriously debilitating, and lifethreatening nature of the diseases treated by ERT products. Currently, there is no other final guidance that provides recommendations about the substance and scope of nonclinical information needed to support initiation of clinical trials, ongoing clinical development, and marketing approval of ERT products. This guidance provides consistent recommendations for nonclinical studies to expedite developments of ERT products used to treat these rare, life-threatening conditions, especially in pediatric patients. This guidance finalizes the draft guidance of the same title issued May 13, 2015. 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The guidance represents the current thinking of FDA on ‘‘Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 52887 guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014, and the information collection in the regulations on good laboratory practice for nonclinical laboratory studies (21 CFR part 58) is approved under OMB control number 0910–0119. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. Dated: September 27, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–21507 Filed 10–2–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–1707] Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications for Pemoline Products; 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 June 4, 2019. That notice, withdrawing approval of five abbreviated new drug applications for pemoline products, contained an incorrect website address for an archived web page of a Postmarket Drug Safety Information for Healthcare Professionals communication that FDA issued on October 24, 2005, stating its conclusion that the overall liver toxicity risk of CYLERT (new drug applications 016832 and 017703) and generic pemoline products outweighed the benefits of these products. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug SUMMARY: E:\FR\FM\03OCN1.SGM 03OCN1 52888 Federal Register / Vol. 84, No. 192 / Thursday, October 3, 2019 / Notices Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Mental Health (NIMH), National Institutes of Health (NIH), will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993–0002, 301– 796–3137. SUPPLEMENTARY INFORMATION: In the Federal Register of June 4, 2019 (84 FR 25811), appearing on page 25811 in FR Doc. 2019–11519, the following correction is made: On page 25811, in the last paragraph of the third column, the website address, https://wayback.archiveit.org/ 7993/20171114124349/https:// www.fda.gov/DrugsDrugSafety/ PostmarketDrugSafety informationforPatientsandProviders/ ucm126461.htm, is corrected to read https://wayback.archive-it.org/7993/ 20171114124349/https://www.fda.gov/ Drugs/DrugSafety/PostmarketDrug SafetyInformationfor PatientsandProviders/ucm126461.htm. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: The Office of Autism Research Coordination, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9663, Room 6184, Bethesda, Maryland, 20892 or can email your request, including your address to: iaccpublicinquiries@mail.nih.gov or nimhprapubliccomments@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. FOR FURTHER INFORMATION CONTACT: Dated: September 27, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–21526 Filed 10–2–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the SUPPLEMENTARY INFORMATION: National Institutes of Health Proposed Collection; 60-Day Comment Request; Autism Spectrum Disorder (ASD) Research Portfolio Analysis, NIMH AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirement of the Paperwork SUMMARY: methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: Autism Spectrum Disorder (ASD) Research Portfolio Analysis, NIMH, 0925–0682, expiration date 12/31/2019, EXTENSION, National Institute of Mental Health (NIMH, National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the ASD research portfolio analysis is to collect research funding data from U.S. and international ASD research funders, to assist the Interagency Autism Coordinating Committee (IACC) in fulfilling the requirements of the Combating Autism Act, and to inform the committee and interested stakeholders of the funding landscape and current directions for ASD research. Specifically, these analyses will continue to examine the extent to which current funding and research topics align with the IACC Strategic Plan for ASD Research. The findings will help guide future funding priorities by outlining current gaps and opportunities in ASD research as well as serving to highlight annual activities and research progress. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 520. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Number of responses per respondent Average time per response (in hours) Total annual burden hour U.S. Federal ..................................................................................................... U.S. Private ...................................................................................................... International Government ................................................................................ International Private ......................................................................................... 22 8 4 4 63 75 14 9 15/60 15/60 15/60 15/60 347 150 14 9 Total .......................................................................................................... ........................ 2,078 ........................ 520 Dated: September 23, 2019. Melba O. Rojas, Project Clearance Liaison, National Institute of Mental Health, National Institutes of Health. [FR Doc. 2019–21523 Filed 10–2–19; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 17:22 Oct 02, 2019 Jkt 250001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1

Agencies

[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Notices]
[Pages 52887-52888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1707]


Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 
Five Abbreviated New Drug Applications for Pemoline Products; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of June 4, 2019. That notice, 
withdrawing approval of five abbreviated new drug applications for 
pemoline products, contained an incorrect website address for an 
archived web page of a Postmarket Drug Safety Information for 
Healthcare Professionals communication that FDA issued on October 24, 
2005, stating its conclusion that the overall liver toxicity risk of 
CYLERT (new drug applications 016832 and 017703) and generic pemoline 
products outweighed the benefits of these products. This document 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug

[[Page 52888]]

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 4, 2019 (84 
FR 25811), appearing on page 25811 in FR Doc. 2019-11519, the following 
correction is made:
    On page 25811, in the last paragraph of the third column, the 
website address, https://wayback.archiveit.org/7993/20171114124349/https://www.fda.gov/DrugsDrugSafety/PostmarketDrugSafetyinformationforPatientsandProviders/ucm126461.htm, 
is corrected to read https://wayback.archive-it.org/7993/20171114124349/https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126461.htm.

    Dated: September 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21526 Filed 10-2-19; 8:45 am]
BILLING CODE 4164-01-P
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