Third Annual Food and Drug Administration Health Professional Organizations Conference, 44574-44575 [2013-17769]
Download as PDF
<![CDATA[
44574
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
update report 5; or a periodic benefit–
risk evaluation report.6
Non-expedited ICSRs can be
submitted on paper or electronically.
When submitted electronically, the nonexpedited ICSRs should be submitted in
XML format. This is because FDA is
currently able to process electronic
submissions of non-expedited ICSRs
only in XML, prepared according to
International Conference on
Harmonisation (ICH) standards for
database-to-database transmission of
information.7 When submitted in this
compatible electronic format, nonexpedited ICSRs can be downloaded
into the FDA Adverse Event Reporting
System (FAERS) database through the
Electronic Submission Gateway.
We have become aware that some
firms have submitted non-expedited
ICSRs to the electronic Common
Technical Document (eCTD) in a
portable document file (pdf) format
together with the descriptive portion of
the periodic safety report.
FDA does not have a systematic
method to identify non-expedited ICSRs
that are submitted to the eCTD in pdf
format together with the descriptive
portion of the periodic safety report. In
addition, non-expedited ICSRs
submitted to the eCTD in pdf format
cannot be downloaded into the FAERS
database. Lack of access to nonexpedited ICSRs in FAERS hinders
FDA’s ability to monitor product safety
and public health. Furthermore,
submission in pdf format prevents
public access to the non-expedited
ICSRs through FAERS.8
FDA is issuing this guidance as level
2 guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The guidance represents the
Agency’s current thinking on the
submission of non-expedited ICSRs in
an electronic format supported by FDA.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
5 FDA allows firms with approved waivers (under
21 CFR 314.90 and 600.90) to use the ICH E2C
Periodic Safety Update Report format when
submitting the descriptive portion of periodic safety
reports.
6 FDA allows firms with approved waivers (under
21 CFR 314.90 and 600.90) to use the ICH E2C(R2)
Periodic Benefit-Risk Evaluation Report format
when submitting the descriptive portion of periodic
safety reports.
7 See FAERS Electronic Submissions at https://
www.fda.gov/Drugs/GuidanceCompliance
RegulatoryInformation/Surveillance/AdverseDrug
Effects/ucm115894.htm.
8 FAERS data are available to the public as
quarterly data files or by written Freedom of
Information request to FDA. See https://
www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/
Surveillance/AdverseDrugEffects/ucm082193.htm.
VerDate Mar<15>2010
16:35 Jul 23, 2013
Jkt 229001
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
Dated: July 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
representatives of Health Professional
Organizations. Topics on the agenda
include FDA Updates, an overview of
FDA’s Network of Experts (public/
private partnerships), and a FDA Town
Hall. The FDA Town Hall will feature
FDA senior executives including Jeffrey
Shuren, M.D., J.D., Director of the
Center for Devices and Radiological
Health; Douglas C. Throckmorton, M.D.,
Deputy Director for Regulatory Programs
of the Center for Drug Evaluation and
Research; and Michael R. Taylor,
Deputy Commissioner for Foods and
Veterinary Medicine.
Date and Time: The conference will
be held on October 24, 2013, from 8 a.m.
to 12 noon.
Location: The conference will be held
at the White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31 Conference
Center, the Great Room (Rm. 1503),
Silver Spring, MD 20993–0002.
Entrance for the public meeting
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.
Contact: Brenda Rose, Office of
Special Health Issues, 10903 New
Hampshire Ave., Silver Spring, MD
20993, Brenda.Rose@fda.hhs.gov, 301–
796–8460.
Registration: Register at https://
www.cvent.com/d/hcqym9/1Q. Please
include the name and title of the person
attending, the name of the organization,
and email address. There is no
registration fee for this conference. Early
registration is suggested because space
is limited.
[FR Doc. 2013–17747 Filed 7–23–13; 8:45 am]
SUPPLEMENTARY INFORMATION:
II. 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.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations 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 § 314.80 have been
approved under OMB control number
0910–0230. The collections of
information in § 600.80 have been
approved under OMB control number
0910–0308.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov.
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Third Annual Food and Drug
Administration Health Professional
Organizations Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of conference.
The Food and Drug Administration
(FDA) is announcing a conference for
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
The aim of
the conference is to further the public
health mission of the FDA through
training, collaboration, and structured
discussion between health professional
organizations and FDA staff. The Office
of Health and Constituent Affairs serves
as a liaison between the FDA Centers
and the public on matters that involve
medical product safety.
Please indicate during your
registration a question of greatest
interest to you for the FDA Town Hall.
If you need special accommodations
due to a disability, please contact
Brenda Rose at
Brenda.Rose@fda.hhs.gov at least 7 days
in advance of the conference.
E:\FR\FM\24JYN1.SGM
24JYN1
44575
Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Notices
Dated: July 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–17769 Filed 7–23–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Sickle Cell Disease Treatment
Demonstration Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for Class Deviation for
Non-Competitive Extension: Sickle Cell
Disease Treatment Demonstration
Program (U1E) Awards to Three
Currently Funded Grantees.
AGENCY:
HRSA currently has nine
programs that are funded through
competitive grant awards under the
Sickle Cell Disease Treatment
Demonstration Program. Three of these
SUMMARY:
awards will end on August 31, 2013,
prior to the end of the other six awards.
HRSA intends to implement a noncompetitive extension of the project
period for the three grants that will end
in 2013. This will allow improved data
gathering from each of the grantees in
the program, which will be used in a
report for Congress that is mandated by
the legislation authorizing the grant. In
addition, the program will benefit from
cost savings realized from having the
program completed in a consolidated
funding cycle.
SUPPLEMENTARY INFORMATION:
Intended Recipients of the Award:
The three incumbent grantees of record
(listed below).
Amount of the Non-Competitive
Awards: Up to $390,000 per grantee.
CFDA Number: 93.365.
Period of Supplemental Funding: 9/1/
2013–8/30/2014.
Authority: Section 712(c) of the American
Jobs Creation Act of 2004, Pub. L. 108–357.
Justification: The Sickle Cell Disease
Treatment Demonstration Program
provides grants to evaluate the use of
strategies in improving sickle cell care.
The extension will allow the Maternal
and Child Health Bureau to fully assess
the impact of the program by allowing
data to be gathered on the health
outcomes and impact of the Sickle Cell
Disease Treatment Demonstration
Program from all grantees on the same
timeline and in a standard format.
Currently, three grantees are scheduled
to end prior to the end of the other
grantees, leaving a period in which data
would not be gathered from these sites.
Data gathered from each of the grantees
in the program will be used in a report
for Congress that is mandated by the
legislation authorizing the grant. In
addition, the program will benefit from
cost savings realized from having the
program completed in a consolidated
funding cycle.
FOR FURTHER INFORMATION CONTACT:
Edward Donnell Ivy, M.D., M.P.H,
Genetic Services Branch, Division of
Services for Children with Special
Health Needs, Maternal and Child
Health Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 18A–19, Rockville, MD
20857; 301.443.9775; eivy@hrsa.gov.
MATERNAL AND CHILD HEALTH BUREAU SELECTED PROGRAMS EXTENSIONS WITH FUNDING
Project end
date
Revised
project end
date
FY 2012
Appropriation
FY 2013
Appropriation
Grant No.
Children’s Hospital & Research
Center.
University of Colorado at Denver.
Newark Beth Israel Medical
Center.
U1EMC16492
CA
9/1/2009
8/31/2013
8/30/2014
$390,000
$390,000
U1EMC16490
CO
9/1/2009
8/31/2013
8/30/2014
390,000
390,000
U1EMC16491
NJ
9/1/2009
8/31/2013
8/30/2014
390,000
390,000
Dated: July 17, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013–17720 Filed 7–23–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sroberts on DSK5SPTVN1PROD with NOTICES
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the meeting of the
Council of Councils.
The meeting will be held via
teleconference and is open to the public
as indicated below. Individuals who
need special assistance, such as sign
language interpretation or other
VerDate Mar<15>2010
16:35 Jul 23, 2013
Jkt 229001
State
Project start
date
Grantee/organization name
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
A portion of the meeting will be
closed to the public in accordance with
the provisions set forth in sections
552b(c)(4), and 552b(c)(6), Title 5
U.S.C., as amended. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Council of Councils.
Open: August 15, 2013, 1:00 p.m. to 1:40
p.m.
Agenda: Establishment of Chimpanzee
Research Use Panel and Discussion. Vote on
Establishment of the Panel. NIH Director’s
Early Independence Awards.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Place: National Institutes of Health,
Building 1, Room 260, 1 Center Drive,
Bethesda, MD 20892.
Dial in number: 1–888–790–1964.
Participant Passcode: 9121608.
Closed: August 15, 2013, 1:45 p.m. to 2:15
p.m.
Agenda: Review of Grant Applications.
Contact Person: Robin Kawazoe, Executive
Secretary, Division of Program Coordination,
Planning, and Strategic Initiatives, Office of
the Director, NIH, Building 1, Room 260,
Bethesda, MD 20892,
kawazoer@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the Council
of Council’s home page at https://
dpcpsi.nih.gov/council/where an agenda and
proposals to be discussed will be posted
before the meeting date.
E:\FR\FM\24JYN1.SGM
24JYN1
]]>Agencies
[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Notices]
[Pages 44574-44575]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17769]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Third Annual Food and Drug Administration Health Professional
Organizations Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of conference.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a conference
for representatives of Health Professional Organizations. Topics on the
agenda include FDA Updates, an overview of FDA's Network of Experts
(public/private partnerships), and a FDA Town Hall. The FDA Town Hall
will feature FDA senior executives including Jeffrey Shuren, M.D.,
J.D., Director of the Center for Devices and Radiological Health;
Douglas C. Throckmorton, M.D., Deputy Director for Regulatory Programs
of the Center for Drug Evaluation and Research; and Michael R. Taylor,
Deputy Commissioner for Foods and Veterinary Medicine.
Date and Time: The conference will be held on October 24, 2013,
from 8 a.m. to 12 noon.
Location: The conference will be held at the White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting 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.
Contact: Brenda Rose, Office of Special Health Issues, 10903 New
Hampshire Ave., Silver Spring, MD 20993, Brenda.Rose@fda.hhs.gov, 301-
796-8460.
Registration: Register at https://www.cvent.com/d/hcqym9/1Q. Please
include the name and title of the person attending, the name of the
organization, and email address. There is no registration fee for this
conference. Early registration is suggested because space is limited.
SUPPLEMENTARY INFORMATION: The aim of the conference is to further the
public health mission of the FDA through training, collaboration, and
structured discussion between health professional organizations and FDA
staff. The Office of Health and Constituent Affairs serves as a liaison
between the FDA Centers and the public on matters that involve medical
product safety.
Please indicate during your registration a question of greatest
interest to you for the FDA Town Hall.
If you need special accommodations due to a disability, please
contact Brenda Rose at Brenda.Rose@fda.hhs.gov at least 7 days in
advance of the conference.
[[Page 44575]]
Dated: July 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17769 Filed 7-23-13; 8:45 am]
BILLING CODE 4160-01-P
