Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets; Public Workshop; Request for Comments, 21963-21964 [E8-8772]
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Federal Register / Vol. 73, No. 79 / Wednesday, April 23, 2008 / Notices
Administration, 10903 New Hampshire
Ave. Bldg. 51, rm. 6196, Silver Spring,
MD 20903, 301–796–0518, FAX: 301–
847–8753, e-mail:
lana.pauls@fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0234]
Developing Guidance on Conducting
Scientifically Sound
Pharmacoepidemiologic Safety
Studies Using Large Electronic
Healthcare Data Sets; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
mstockstill on PROD1PC66 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 ‘‘Developing
Guidance on Conducting Scientifically
Sound Pharmacoepidemiologic Safety
Studies Using Large Electronic
Healthcare Data Sets.’’ The purpose of
the public workshop is to solicit
information and views from interested
persons on best practices and principles
for the design and evaluation of
pharmacoepidemiologic safety studies
using large electronic healthcare data
sets. The input from this workshop will
be used to develop a draft Guidance to
Industry, and to provide consistent
review criteria for FDA to use in
evaluating protocols and study reports
submitted to the agency.
DATES: The public workshop will be
held on Wednesday, May 7, 2008, from
8:30 a.m. to 5 p.m. See section III of this
document for information on the
deadline and on how to attend or
present at the meeting. Written or
electronic comments must be submitted
to the docket by June 7, 2008.
ADDRESSES: The public workshop will
be held in the Ballroom at the Crowne
Plaza Hotel Washington DC-Silver
Spring, MD at 8777 Georgia Ave., Silver
Spring, MD 20910.
Regardless of attendance at the public
workshop, interested persons may
submit written 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 https://
www.regulations.gov. Comments are to
be identified with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Lana Pauls, Center for Drug Evaluation
and Research, Food and Drug
VerDate Aug<31>2005
16:58 Apr 22, 2008
Jkt 214001
SUPPLEMENTARY INFORMATION:
I. Background
As part of the reauthorization of the
Prescription Drug User Fee Act (PDUFA
IV), FDA committed to certain
performance goals (see https://
www.fda.gov/oc/pdufa4/
pdufa4goals.html). In one of these goals,
FDA agreed to identify, with input from
academia, industry, and others from the
general public, epidemiology best
practices and to develop guidance(s)
describing these practices. In addition,
in the Food and Drug Administration
Amendments Act of 2007 (FDAAA,
Public Law 110–85, 121 Stat. 823 et
seq.), Congress directed FDA to develop
and implement a postmarket risk
identification and analysis system that
would include, among other things,
advanced analysis of drug safety data
(FDAAA, section 905, 121 Stat. 944).
This workshop represents the first step
in meeting the PDUFA goal and will
provide valuable information as we
build our active postmarket surveillance
system.
New technologies and the ability to
assemble large data sets for use in
epidemiologic research of drug safety
issues have precipitated a great deal of
discussion over the appropriate use of
these data in conducting
pharmacoepidemiologic studies. FDA is
committed to developing guidance to
identify and encourage the use of best
practices in the conduct of
epidemiologic studies of drug safety
issues by industry, FDA, and academic
researchers. Experts from industry,
academia, and the general public are
invited to contribute ideas and concepts
for consideration.
The workshop objectives are as
follows: (1) Initiate constructive
dialogue and information-sharing
among regulators, researchers, the
pharmaceutical industry, health
organizations, and individuals about the
design, conduct and interpretation of
pharmacoepidemiologic safety studies
using electronic healthcare data sets; (2)
share current FDA experiences
regarding the evaluation of protocols
and study reports submitted to the
agency; and (3) obtain input on
developing consistent review criteria for
FDA to use in evaluating protocols and
study reports submitted to the agency.
Two panel discussions will focus on
areas in which the agency requests
input.
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
21963
Panel 1 will focus on characteristics
of electronic data used to conduct
pharmacoepidemiologic studies for use
in regulatory assessment of product
safety. Topics include: differences in
health care coverage, determinants of
enrollment, country or region of data
collection, characteristics of various
healthcare systems and how these might
impact on the interpretation and the
generalizability of the results to the U.S.
patient population. Specific questions
include:
1. What information and what level of
detail are needed for FDA to ensure the
appropriateness of the data source to
address the product safety questions
being asked? How does this differ by
type of data source (electronic medical
records (EMR) vs. claims)?
2. What are the challenges of using
enrollment data for defining study
populations in claims databases?
Describe effective strategies for
addressing the absence of formal
enrollment data in some EMR systems.
3. Under what circumstances should
FDA consider studies using non-U.S.
electronic data sources in its assessment
of product safety questions?
Panel 2 will focus on characteristics
related to study design, conduct and
interpretation of
pharmacoepidemiologic safety studies,
specifically those using electronic
healthcare data sources. Topics include
issues pertinent to definition of
exposure, ascertainment of outcome,
analysis of data, and interpretation of
study findings and will address the
following questions:
1. How can FDA assure that the study
design accurately captures the clinical
events, exposures of interest, and
confounding factors needed to answer
the product safety question under
investigation?
2. What are effective strategies to
address confounding by indication and
the effect of measured and unmeasured
confounders?
3. What are other challenges to
internal and external validity in studies
using EMR and claims databases? What
are the best practices for addressing
them?
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, including a discussion of
implications and next steps for further
development.
E:\FR\FM\23APN1.SGM
23APN1
21964
Federal Register / Vol. 73, No. 79 / Wednesday, April 23, 2008 / Notices
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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 on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Attendance and Registration
The Workshop facility, the Ballroom
in the Crowne Plaza Hotel at 8777
Georgia Ave. in Silver Spring, MD is not
a secure facility. Seating will be made
available on a first-come basis.
Individual interested in attending the
workshop need not register.
Individuals who wish to speak during
the public workshop must register on or
before April 7, 2008. You should
identify the subject matter you wish to
address during the public workshop.
Please specify Panel 1, or Panel 2 (see
I. Background). To register to speak,
contact lana.pauls@fda.hhs.gov or call
301–796–0518.
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.
mstockstill on PROD1PC66 with NOTICES
IV. Workshop Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm. It may be
viewed at the Division of Dockets
Management (see ADDRESSES). A
transcript will also be available in either
hardcopy or on CD-ROM, after
submission of a Freedom of Information
request. Written requests are to be sent
to Division of Freedom of Information
(HFI-35), Office of Management
Programs, Food and Drug
VerDate Aug<31>2005
19:55 Apr 22, 2008
Jkt 214001
Administration, 5600 Fishers Lane, rm.
6-30, Rockville, MD 20857.
Dated: April 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–8772 Filed 4–22–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Interagency Autism Coordinating
Committee.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
inform the Contact Person listed below
in advance of the meeting.
Name of Committee: Interagency Autism
Coordinating Committee (IACC).
Date: May 12, 2008.
Time: 9 a.m. to 4 p.m.
Agenda: Agency updates; reports from
Services Subcommittee, town hall meeting;
presentation of Strategic Planning Workgroup
recommendations for IACC strategic plan for
autism spectrum disorder (ASD) research;
review draft of summary of advances in ASD
research.
Place: Ronald Reagan Building and
International Trade Center, Rotunda, North
Tower, 8th Floor, 1300 Pennsylvania
Avenue, NW., Washington, DC 20004, Phone:
202–312–1300.
Contact Person: Tanya Pryor, Interagency
Autism Coordinating Committee, National
Institute of Mental Health, NIH, 6001
Executive Boulevard, Room 6187, MSC 9669,
Bethesda, MD 20892–9669, (301) 443–7153,
pryort@mail.nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
telephone number and when applicable, the
business or professional affiliation of the
interested person.
In the interest of security, all guests and
vehicles are screened upon entry into the
underground parking garage at the Ronald
Reagan Building. Please allow extra time for
this process.
A registration link and information about
the meeting will be available on the IACC
Web site: https://www.nimh.nih.gov/researchfunding/scientific-meetings/recurringmeetings/iacc/events/index.shtml.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS).
Dated: April 16, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–8724 Filed 4–22–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
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 following
meetings.
The meetings 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: National Cancer
Institute Initial Review Group; Subcommittee
I—Career Development.
Date: May 19–20, 2008.
Time: 8 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Alexandria Old Town, 1767
King Street, Alexandria, VA 22314.
Contact Person: Robert Bird, PhD,
Scientific Review Officer, Resources and
Training Review Branch, National Cancer
Institute, National Institutes of Health, 6116
Executive Blvd., Room 8113, MSC 8328,
Bethesda, MD 20892–8328, 301–496–7978,
birdr@mail.nih.gov.
E:\FR\FM\23APN1.SGM
23APN1
]]>Agencies
[Federal Register Volume 73, Number 79 (Wednesday, April 23, 2008)]
[Notices]
[Pages 21963-21964]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-8772]
[[Page 21963]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0234]
Developing Guidance on Conducting Scientifically Sound
Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare
Data Sets; 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
``Developing Guidance on Conducting Scientifically Sound
Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare
Data Sets.'' The purpose of the public workshop is to solicit
information and views from interested persons on best practices and
principles for the design and evaluation of pharmacoepidemiologic
safety studies using large electronic healthcare data sets. The input
from this workshop will be used to develop a draft Guidance to
Industry, and to provide consistent review criteria for FDA to use in
evaluating protocols and study reports submitted to the agency.
DATES: The public workshop will be held on Wednesday, May 7, 2008, from
8:30 a.m. to 5 p.m. See section III of this document for information on
the deadline and on how to attend or present at the meeting. Written or
electronic comments must be submitted to the docket by June 7, 2008.
ADDRESSES: The public workshop will be held in the Ballroom at the
Crowne Plaza Hotel Washington DC-Silver Spring, MD at 8777 Georgia
Ave., Silver Spring, MD 20910.
Regardless of attendance at the public workshop, interested persons
may submit written 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 https://
www.regulations.gov. Comments are to be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Lana Pauls, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.
Bldg. 51, rm. 6196, Silver Spring, MD 20903, 301-796-0518, FAX: 301-
847-8753, e-mail: lana.pauls@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
As part of the reauthorization of the Prescription Drug User Fee
Act (PDUFA IV), FDA committed to certain performance goals (see https://
www.fda.gov/oc/pdufa4/pdufa4goals.html). In one of these goals, FDA
agreed to identify, with input from academia, industry, and others from
the general public, epidemiology best practices and to develop
guidance(s) describing these practices. In addition, in the Food and
Drug Administration Amendments Act of 2007 (FDAAA, Public Law 110-85,
121 Stat. 823 et seq.), Congress directed FDA to develop and implement
a postmarket risk identification and analysis system that would
include, among other things, advanced analysis of drug safety data
(FDAAA, section 905, 121 Stat. 944). This workshop represents the first
step in meeting the PDUFA goal and will provide valuable information as
we build our active postmarket surveillance system.
New technologies and the ability to assemble large data sets for
use in epidemiologic research of drug safety issues have precipitated a
great deal of discussion over the appropriate use of these data in
conducting pharmacoepidemiologic studies. FDA is committed to
developing guidance to identify and encourage the use of best practices
in the conduct of epidemiologic studies of drug safety issues by
industry, FDA, and academic researchers. Experts from industry,
academia, and the general public are invited to contribute ideas and
concepts for consideration.
The workshop objectives are as follows: (1) Initiate constructive
dialogue and information-sharing among regulators, researchers, the
pharmaceutical industry, health organizations, and individuals about
the design, conduct and interpretation of pharmacoepidemiologic safety
studies using electronic healthcare data sets; (2) share current FDA
experiences regarding the evaluation of protocols and study reports
submitted to the agency; and (3) obtain input on developing consistent
review criteria for FDA to use in evaluating protocols and study
reports submitted to the agency.
Two panel discussions will focus on areas in which the agency
requests input.
Panel 1 will focus on characteristics of electronic data used to
conduct pharmacoepidemiologic studies for use in regulatory assessment
of product safety. Topics include: differences in health care coverage,
determinants of enrollment, country or region of data collection,
characteristics of various healthcare systems and how these might
impact on the interpretation and the generalizability of the results to
the U.S. patient population. Specific questions include:
1. What information and what level of detail are needed for FDA to
ensure the appropriateness of the data source to address the product
safety questions being asked? How does this differ by type of data
source (electronic medical records (EMR) vs. claims)?
2. What are the challenges of using enrollment data for defining
study populations in claims databases? Describe effective strategies
for addressing the absence of formal enrollment data in some EMR
systems.
3. Under what circumstances should FDA consider studies using non-
U.S. electronic data sources in its assessment of product safety
questions?
Panel 2 will focus on characteristics related to study design,
conduct and interpretation of pharmacoepidemiologic safety studies,
specifically those using electronic healthcare data sources. Topics
include issues pertinent to definition of exposure, ascertainment of
outcome, analysis of data, and interpretation of study findings and
will address the following questions:
1. How can FDA assure that the study design accurately captures the
clinical events, exposures of interest, and confounding factors needed
to answer the product safety question under investigation?
2. What are effective strategies to address confounding by
indication and the effect of measured and unmeasured confounders?
3. What are other challenges to internal and external validity in
studies using EMR and claims databases? What are the best practices for
addressing them?
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, including a discussion of
implications and next steps for further development.
[[Page 21964]]
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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 on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
III. Attendance and Registration
The Workshop facility, the Ballroom in the Crowne Plaza Hotel at
8777 Georgia Ave. in Silver Spring, MD is not a secure facility.
Seating will be made available on a first-come basis. Individual
interested in attending the workshop need not register.
Individuals who wish to speak during the public workshop must
register on or before April 7, 2008. You should identify the subject
matter you wish to address during the public workshop. Please specify
Panel 1, or Panel 2 (see I. Background). To register to speak, contact
lana.pauls@fda.hhs.gov or call 301-796-0518.
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
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
It may be viewed at the Division of Dockets Management (see ADDRESSES).
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.
Dated: April 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8772 Filed 4-22-08; 8:45 am]
BILLING CODE 4160-01-S
