Report on the Standardization of Risk Evaluation and Mitigation Strategies; Correction, 69497 [2014-27522]

Download as PDF Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 601.12 and Form FDA 356h have been approved under OMB control number 0910–0338; the collections of information in 21 CFR 607.26 and Form FDA 2830 have been approved under OMB control number 0910–0052; the collections of information in 21 CFR 606.121, 606.170, and 610.40 have been approved under OMB control number 0910–0116; and the collections of information in 21 CFR 600.14 have been approved under OMB control number 0910–0458. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or http:// www.regulations.gov. Food and Drug Administration [Docket No. FDA–2014–N–0001] Developing and Using Precision Therapies in the ‘‘Omics’’ Era: Generating and Interpreting Evidence for Rare Subsets; Public Workshop DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: ACTION: Report on the Standardization of Risk Evaluation and Mitigation Strategies; Correction Food and Drug Administration, mstockstill on DSK4VPTVN1PROD with NOTICES HHS. Notice; correction. The Food and Drug Administration (FDA) is correcting a notice entitled ‘‘Report on the Standardization of Risk Evaluation and Mitigation Strategies’’ that appeared in the Federal Register of September 23, 2014. The document misstated the name Jkt 235001 Notice of public workshop. The Food and Drug Administration (FDA or the Agency) is announcing a public workshop entitled ‘‘Developing and Using Precision Therapies in the ‘Omics’ Era: Generating and Interpreting Evidence for Rare Subsets.’’ This public workshop is being cosponsored with the Center for Translational and Regulatory Sciences at the University of Virginia (UVA). The goals of this public workshop are to facilitate discussion on current scientific approaches using rare subsets during drug development programs and to further seek input from multiple stakeholders on approaches to obtain evidence that inform the regulatory SUMMARY: [Docket No. FDA–2013–N–0502] 18:00 Nov 20, 2014 Food and Drug Administration, HHS. Food and Drug Administration VerDate Sep<11>2014 Dated: November 17, 2014. Leslie Kux, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4164–01–P SUMMARY: Richard Currey, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6125, Silver Spring, MD 20993–0002, 301– 796–3918, FAX: 301–595–7910, REMS_ Standardization@fda.hhs.gov; or Adam Kroetsch, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993–0002; 301–796–3842, FAX: 301–847–8443, REMS_ Standardization@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of September 23, 2014 (79 FR 56816), in FR Doc. 2014–22513, the following correction is made: 1. On page 56817, in the third column, under ‘‘Draft Report Describing Findings Concerning REMS Standardization and Plans for Projects to Standardize REMS,’’ ‘‘Accreditation Commission for Education in Nursing’’ is corrected to read ‘‘American Nurses Credentialing Center.’’ BILLING CODE 4164–01–P [FR Doc. 2014–27521 Filed 11–20–14; 8:45 am] ACTION: FOR FURTHER INFORMATION CONTACT: [FR Doc. 2014–27522 Filed 11–20–14; 8:45 am] Dated: November 17, 2014. Leslie Kux, Associate Commissioner for Policy. AGENCY: of an organization. This document corrects that error. PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 69497 evaluation of therapeutic products in rare subsets of patients identified through in-vitro diagnostic testing when specific, controlled trials are not feasible. DATES: The public workshop will be held on December 12, 2014, from 9 a.m. to 5 p.m. Individuals who wish to attend the public workshop in person or via a live Webcast must register online by December 1, 2014, at: https:// www.signup4.net/Public/ ap.aspx?OID=130&EID=DEVE96E. Section II of this document provides attendance and registration information. ADDRESSES: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993–0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Padmaja Mummaneni, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2164, Silver Spring, MD 20993–0002, 301– 796–2027, email: padmaja.mummaneni@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Therapeutic products are increasingly targeted to patients who have molecular characteristics that are diagnostic of a particular subtype of disease, prognostic for better or worse outcomes, or predictive of treatment response. The advent of next-generation sequencing and other high throughput technologies has enabled the development of in-vitro diagnostic tests that are able to detect rare molecular variations, specifically in the patient, tumor, or microbial DNA sequence. FDA and UVA are cosponsoring an open public workshop among stakeholders in the pharmaceutical industry, representatives from academia, regulatory scientists, and other interested parties on the development and usage of diagnostic and therapeutic products that respectively have the potential to identify and treat patients with rare molecular characteristics. It is important for regulatory agencies, pharmaceutical and diagnostic industries, and the medical community, including payers, to have a mutual E:\FR\FM\21NON1.SGM 21NON1

Agencies

[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Page 69497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0502]


Report on the Standardization of Risk Evaluation and Mitigation 
Strategies; 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 
entitled ``Report on the Standardization of Risk Evaluation and 
Mitigation Strategies'' that appeared in the Federal Register of 
September 23, 2014. The document misstated the name of an organization. 
This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Richard Currey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6125, Silver Spring, MD 20993-0002, 301-
796-3918, FAX: 301-595-7910, REMS_Standardization@fda.hhs.gov; or Adam 
Kroetsch, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver 
Spring, MD 20993-0002; 301-796-3842, FAX: 301-847-8443, 
REMS_Standardization@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 23, 
2014 (79 FR 56816), in FR Doc. 2014-22513, the following correction is 
made:
    1. On page 56817, in the third column, under ``Draft Report 
Describing Findings Concerning REMS Standardization and Plans for 
Projects to Standardize REMS,'' ``Accreditation Commission for 
Education in Nursing'' is corrected to read ``American Nurses 
Credentialing Center.''

    Dated: November 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27522 Filed 11-20-14; 8:45 am]
BILLING CODE 4164-01-P