Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle; Public Workshop; Request for Comments, 73029-73030 [E7-24960]
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Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Notices
accommodations should notify Chris
Moser or Lori Benner (see Contact
Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop,
cosponsored with IDSA, regarding
antimicrobial drug development. This
public workshop will focus on scientific
considerations in designing clinical
trials for community-acquired
pneumonia. The topics for discussion
include approaches to the diagnosis of
community-acquired pneumonia, the
effect of antimicrobial treatment for
community-acquired pneumonia,
various endpoints that might be
considered as endpoints for trials of
community-acquired pneumonia, and
statistical issues in analysis of results
from trials in community-acquired
pneumonia. The input from this public
workshop will help in developing topics
for further discussion.
The agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 20 working days after the
public workshop, at a cost of 10 cents
per page.
Dated: December 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–24927 Filed 12–21–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0480]
Maximizing the Public Health Benefit of
Adverse Event Collection Throughout
a Product’s Marketed Life Cycle;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
pwalker on PROD1PC71 with NOTICES
ACTION:
SUMMARY: The Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER) at the Food and Drug
Administration (FDA) are announcing a
public workshop entitled ‘‘Maximizing
the Public Health Benefit of Adverse
VerDate Aug<31>2005
17:33 Dec 21, 2007
Jkt 214001
Event Collection Throughout a
Product’s Marketed Life Cycle.’’ The
purpose of the public workshop is to
solicit information and views from
interested persons on research
approaches and methods associated
with the best ways to assess the public
health benefit of collecting and
reporting all adverse events (AEs). The
input from this workshop will be used
to publish a request for information to
determine the types of outside
organizations that would be interested
in, and have the capability to conduct,
the research described in this paragraph,
followed by a request for proposal
(RFP).
DATES: The public workshop will be
held on January 29, 2008, from 8:30 a.m.
to 5 p.m. Individuals who wish to speak
during the public workshop must
register on or before January 15, 2008.
See section III of this document for
information on how to attend or present
at the meeting.
We are opening a docket to receive
your written or electronic comments.
Written or electronic comments must be
submitted to the docket by February 29,
2008.
ADDRESSES: The public workshop will
be held at The Conference Facility
(terrace level) located at 5635 Fishers
Lane, Rockville, MD 20857 (Metro:
Twinbrook Station on the Red Line).
Submit written or electronic
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified 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.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
publish a Federal Register notice
announcing that date.
FOR FURTHER INFORMATION CONTACT:
Lana Pauls, Center for Drug Evaluation
and Research (HFD–006), Food and
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
73029
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–796–
0518, FAX: 301–827–1069, e-mail:
lana.pauls@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The collection of information relating
to AEs is an integral part of
understanding the safety of a product
throughout its marketed life cycle. FDA
is committed to maximizing the public
health benefit of collecting and
reporting serious and non-serious AEs.
Central to addressing this question is
determining the number and type of
safety concerns discovered by AE
collection, the age of products at the
time safety concerns are detected by AE
collection, and the types of actions that
are subsequently taken to protect patient
safety.
The workshop objectives are as
follows: (1) Initiate constructive
dialogue and information-sharing
among regulators, researchers, the
pharmaceutical industry, health
organizations, and individuals affected
by postmarketing AE collection,
reporting, and evaluation; (2) share
current FDA practices regarding
postmarketing AE collection and
reporting; and (3) obtain input on the
questions and methods that will be used
to conduct research on this topic.
Two panel discussions will focus on
how FDA currently uses spontaneous
reports and other methods of signal
detection, the key research questions
that should be addressed by the RFP,
and appropriate research approaches
and methods including, but not limited
to, hypothesis, study design, data
sources, outcome measures, and
analytic methods. Panel one will focus
on the key research questions; panel two
will discuss research approaches and
methods.
Some of the key questions to be
addressed in the RFP include the
following:
(1) What is the value to patient safety
of collecting AEs through a passive
surveillance system over the marketed
life cycle of a product? How are these
data best used in regulatory decisionmaking?
(2) How can safety issue identification
and subsequent regulatory action be
characterized in relation to time elapsed
following product approval? Is this
influenced by the type of regulatory
action and/or the nature of the safety
signal?
(3) What are the roles of serious and
non-serious outcome reports in safety
issue identification and subsequent
regulatory action? How do the roles of
E:\FR\FM\26DEN1.SGM
26DEN1
73030
Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Notices
these report types change over the
product’s marketed life cycle?
(4) What are the roles of reports by
health care professionals and consumers
in safety signal detection?
(5) Are there any types of AE reports
that are not helpful to safety signal
detection?
(6) What do we know about nonreported AEs or characteristics
associated with non-reporting?
FDA is working to refine the
workshop agenda and to invite panel
members. We are seeking broad
participation by safety researchers,
health system officials, the
pharmaceutical industry, and others.
We anticipate issuing a summary of the
workshop findings, including a
discussion of implications and next
steps for further development.
II. Comments
The agency is interested in hearing
comments at the public workshop or
receiving written comments (see
ADDRESSES) on the issues described
previously. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Attendance and Registration
The Conference Facility (terrace level)
located at 5635 Fishers Lane is a Federal
facility with limited seating and security
procedures for entrance. Workshop
attendees will be required to show
proper identification and are asked to
allow time for security procedures.
Seating will be made available on a firstcome basis. Individuals who wish to
speak during the public workshop must
register on or before January 15, 2008.
You should identify the subject matter
you wish to address during the public
workshop. Please specify either panel
one or panel two (see section I of this
document). To register to speak, please
contact Lana Pauls (see FOR FORTHER
INFORMATION CONTACT).
Ample time will be allowed during
the scheduled agenda for attendees to
ask questions of panelists. In addition,
we strongly encourage written
comments to the docket.
If you need special accommodations
because of disability, please contact
Lana Pauls (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the workshop.
IV. Workshop Transcripts
The workshop will be transcribed.
The transcript will be available for
review at the Division of Dockets
Management (see ADDRESSES) and on
the Internet at https://www.fda.gov/
ohrms/dockets, approximately 30 days
after the workshop.
Dated: December 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–24960 Filed 12–21–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Division of Loan Repayment; Proposed
Collection; Comment Request;
National Institutes of Health Loan
Repayment Programs
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995
for opportunity for public comment on
proposed data collection projects, the
Division of Loan Repayment, National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: National
Institutes of Health Loan Repayment
Programs. Type of Information
Collection Request: Revision of
currently approved collection (OMB No.
0925–0361, expiration date 6/30/08).
Form Numbers: NIH 2674–1, NIH 2674–
2, NIH 2674–3, NIH 2674–4, NIH 2674–
5, NIH 2674–6, NIH 2674–7, NIH 2674–
8, NIH 2674–9, NIH 2674–10, NIH
2674–11, NIH 2674–12, NIH 2674–13,
NIH 2674–14, NIH 2674–15, NIH 2674–
16, NIH 2674–17, NIH 2674–18, and
NIH 2674–19. Need and Use of
Information Collection: The NIH makes
available financial assistance, in the
form of educational loan repayment, to
M.D., Ph.D., Pharm.D., D.D.S., D.M.D.,
pwalker on PROD1PC71 with NOTICES
Type of
respondents
Number of
respondents
Intramural LRPs
Initial Applicants ........................................................................................
Advisors/Supervisors ................................................................................
Recommenders ........................................................................................
Financial Institutions .................................................................................
VerDate Aug<31>2005
17:33 Dec 21, 2007
Jkt 214001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
D.P.M., D.C., and N.D. degree holders,
or the equivalent, who perform
biomedical or behavioral research in
NIH intramural laboratories or as
extramural grantees for a minimum of 2
years (3 years for the General Research
Loan Repayment Program (LRP)) in
research areas supporting the mission
and priorities of the NIH.
The AIDS Research Loan Repayment
Program (AIDS–LRP) is authorized by
Section 487A of the Public Health
Service Act (42 U.S.C. 288–1); the
Clinical Research Loan Repayment
Program for Individuals from
Disadvantaged Backgrounds (CR–LRP)
is authorized by Section 487E (42 U.S.C.
288–5); the General Research Loan
Repayment Program (GR–LRP) is
authorized by Section 487C (42 U.S.C.
288–3); the Loan Repayment Program
Regarding Clinical Researchers (LRP–
CR) is authorized by Section 487F (42
U.S.C. 288–5a); the Pediatric Research
Loan Repayment Program (PR–LRP) is
authorized by Section 487F (42 U.S.C.
288–6); the Extramural Clinical
Research LRP for Individuals from
Disadvantaged Backgrounds (ECR-LRP)
is authorized by an amendment to
Section 487E (42 U.S.C. 288–5); the
Contraception and Infertility Research
LRP (CIR–LRP) is authorized by Section
487B (42 U.S.C. 288–2); and the Health
Disparities Research Loan Repayment
Program (HD–LRP) is authorized by
Section 485G (42 U.S.C. 287c-33).
The Loan Repayment Programs
provide for the repayment of up to
$35,000 a year of the principal and
interest of the educational loan debt of
qualified health professionals who agree
to conduct qualifying research for each
year of obligated service. The
information proposed for collection will
be used to determine an applicant’s
eligibility for participation in the
program. Frequency of Response: Initial
application and annual or biennial
renewal application. Affected Public:
Applicants, financial institutions,
research institutions, recommenders.
Type of Respondents: Physicians, other
scientific or medical personnel, and
organizational officials. The annual
reporting burden is as follows:
Estimated
number of
responses per
respondent
30
30
90
10
E:\FR\FM\26DEN1.SGM
1
1
1
1
26DEN1
Average
burden hours
per response
10.11
.5
.33
1.25
Annual burden
hours
requested
303.30
15.00
29.70
12.50
]]>Agencies
[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Notices]
[Pages 73029-73030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24960]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0480]
Maximizing the Public Health Benefit of Adverse Event Collection
Throughout a Product's Marketed Life Cycle; Public Workshop; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) at the Food and
Drug Administration (FDA) are announcing a public workshop entitled
``Maximizing the Public Health Benefit of Adverse Event Collection
Throughout a Product's Marketed Life Cycle.'' The purpose of the public
workshop is to solicit information and views from interested persons on
research approaches and methods associated with the best ways to assess
the public health benefit of collecting and reporting all adverse
events (AEs). The input from this workshop will be used to publish a
request for information to determine the types of outside organizations
that would be interested in, and have the capability to conduct, the
research described in this paragraph, followed by a request for
proposal (RFP).
DATES: The public workshop will be held on January 29, 2008, from 8:30
a.m. to 5 p.m. Individuals who wish to speak during the public workshop
must register on or before January 15, 2008. See section III of this
document for information on how to attend or present at the meeting.
We are opening a docket to receive your written or electronic
comments. Written or electronic comments must be submitted to the
docket by February 29, 2008.
ADDRESSES: The public workshop will be held at The Conference Facility
(terrace level) located at 5635 Fishers Lane, Rockville, MD 20857
(Metro: Twinbrook Station on the Red Line).
Submit written or electronic comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to either
https://www.fda.gov/dockets/ecomments or https://www.regulations.gov.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.
Please note that in January 2008, the FDA Web site is expected to
transition to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. After the
transition date, electronic submissions will be accepted by FDA through
the FDMS only. When the exact date of the transition to FDMS is known,
FDA will publish a Federal Register notice announcing that date.
FOR FURTHER INFORMATION CONTACT: Lana Pauls, Center for Drug Evaluation
and Research (HFD-006), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-796-0518, FAX: 301-827-1069, e-mail:
lana.pauls@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The collection of information relating to AEs is an integral part
of understanding the safety of a product throughout its marketed life
cycle. FDA is committed to maximizing the public health benefit of
collecting and reporting serious and non-serious AEs. Central to
addressing this question is determining the number and type of safety
concerns discovered by AE collection, the age of products at the time
safety concerns are detected by AE collection, and the types of actions
that are subsequently taken to protect patient safety.
The workshop objectives are as follows: (1) Initiate constructive
dialogue and information-sharing among regulators, researchers, the
pharmaceutical industry, health organizations, and individuals affected
by postmarketing AE collection, reporting, and evaluation; (2) share
current FDA practices regarding postmarketing AE collection and
reporting; and (3) obtain input on the questions and methods that will
be used to conduct research on this topic.
Two panel discussions will focus on how FDA currently uses
spontaneous reports and other methods of signal detection, the key
research questions that should be addressed by the RFP, and appropriate
research approaches and methods including, but not limited to,
hypothesis, study design, data sources, outcome measures, and analytic
methods. Panel one will focus on the key research questions; panel two
will discuss research approaches and methods.
Some of the key questions to be addressed in the RFP include the
following:
(1) What is the value to patient safety of collecting AEs through a
passive surveillance system over the marketed life cycle of a product?
How are these data best used in regulatory decision-making?
(2) How can safety issue identification and subsequent regulatory
action be characterized in relation to time elapsed following product
approval? Is this influenced by the type of regulatory action and/or
the nature of the safety signal?
(3) What are the roles of serious and non-serious outcome reports
in safety issue identification and subsequent regulatory action? How do
the roles of
[[Page 73030]]
these report types change over the product's marketed life cycle?
(4) What are the roles of reports by health care professionals and
consumers in safety signal detection?
(5) Are there any types of AE reports that are not helpful to
safety signal detection?
(6) What do we know about non-reported AEs or characteristics
associated with non-reporting?
FDA is working to refine the workshop agenda and to invite panel
members. We are seeking broad participation by safety researchers,
health system officials, the pharmaceutical industry, and others. We
anticipate issuing a summary of the workshop findings, including a
discussion of implications and next steps for further development.
II. Comments
The agency is interested in hearing comments at the public workshop
or receiving written comments (see ADDRESSES) on the issues described
previously. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Attendance and Registration
The Conference Facility (terrace level) located at 5635 Fishers
Lane is a Federal facility with limited seating and security procedures
for entrance. Workshop attendees will be required to show proper
identification and are asked to allow time for security procedures.
Seating will be made available on a first-come basis. Individuals who
wish to speak during the public workshop must register on or before
January 15, 2008. You should identify the subject matter you wish to
address during the public workshop. Please specify either panel one or
panel two (see section I of this document). To register to speak,
please contact Lana Pauls (see FOR FORTHER INFORMATION CONTACT).
Ample time will be allowed during the scheduled agenda for
attendees to ask questions of panelists. In addition, we strongly
encourage written comments to the docket.
If you need special accommodations because of disability, please
contact Lana Pauls (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the workshop.
IV. Workshop Transcripts
The workshop will be transcribed. The transcript will be available
for review at the Division of Dockets Management (see ADDRESSES) and on
the Internet at https://www.fda.gov/ohrms/dockets, approximately 30 days
after the workshop.
Dated: December 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24960 Filed 12-21-07; 8:45 am]
BILLING CODE 4160-01-S
