Report on the Standardization of Risk Evaluation and Mitigation Strategies; Correction, 69497 [2014-27522]
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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 https://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 https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
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
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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 https://
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
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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.
-----------------------------------------------------------------------
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
