Nominations for Membership on the Board of Directors of the Reagan-Udall Foundation From Consumer Advocacy Groups, Professional Scientific and Medical Societies, and Industry Trade Organizations, 56362-56363 [07-4882]
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Federal Register / Vol. 72, No. 191 / Wednesday, October 3, 2007 / Notices
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 25, 2007 (72
FR 20555), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0302. The
approval expires on August 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: September 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–19457 Filed 10–2–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Nominations for Membership on the
Board of Directors of the Reagan-Udall
Foundation From Consumer Advocacy
Groups, Professional Scientific and
Medical Societies, and Industry Trade
Organizations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
opportunity for patient and consumer
advocacy groups, professional scientific
and medical societies, and industry
trade organizations to nominate
candidates to serve on the Board of
Directors (the Board) of a new non-profit
foundation, the Reagan-Udall
Foundation for the Food and Drug
Administration (the Foundation). The
Foundation will be dedicated to
modernizing medical, veterinary, food,
food ingredient, and cosmetic product
development, accelerating innovation,
and enhancing product safety.
DATES: Submit written or electronic
nominations on or before October 15,
2007.
ADDRESSES: Submit written nominations
either by fax to Lisa Rovin or Nancy
Stanisic at 301–443–9718 or by e-mail to
Reagan-Udall-Board@FDA.HHS.GOV.
FOR FURTHER INFORMATION CONTACT:
rwilkins on PROD1PC63 with NOTICES
SUMMARY:
VerDate Aug<31>2005
18:31 Oct 02, 2007
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Lisa Rovin, Office of Policy and
Planning (HF–11), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
1443; or
Nancy Stanisic, Office of Critical Path
Programs (HF–18), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
1660.
SUPPLEMENTARY INFORMATION:
I. Background
On September 27, 2007, the President
signed into law the Food and Drug
Administration Amendments Act of
2007 (FDAAA). The law reauthorizes
the Prescription Drug User Fee Act, the
Medical Device User Fee Act, the Best
Pharmaceuticals for Children Act, and
the Pediatric Research Equity Act of
2007, and enacts the Pediatric Medical
Device Safety and Improvement Act of
2007 as well as additional requirements
and authorities for FDA. Title VI of
FDAAA creates the Foundation. The
purpose of the Foundation is to
‘‘advance the mission of the Food and
Drug Administration to modernize
medical, veterinary, food, food
ingredient, and cosmetic product
development, accelerate innovation, and
enhance product safety.’’
The duties of the Foundation include
the identification of unmet needs in the
development, manufacture, and
evaluation (including postmarket
evaluation) of the safety and
effectiveness of FDA-regulated products,
and the establishment of scientific and
other projects and programs to meet
those needs.
II. Criteria for Board Membership
The statute mandates a 14-member
Board of Directors, composed of the
following:
• Four representatives of the general
pharmaceutical, device, food, cosmetic,
and biotechnology industries;
• Three representatives of academic
research organizations;
• Two representatives of patient or
consumer advocacy organizations;
• One representative of health care
providers; and
• Four at-large representatives with
expertise or experience relevant to the
purpose of the Foundation.
The Board must include individuals
with expertise in areas including the
sciences of developing, manufacturing,
and evaluating the safety and
effectiveness of devices, including
diagnostics, biological products, and
drugs, and the safety of food, food
ingredients, and cosmetics.
The Foundation’s Board will be
responsible for governing the
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organization and ensuring that it
succeeds in its mission. To that end, the
Board members will oversee the mission
and operations of the Foundation,
including: Approving programs and
monitoring their effectiveness,
coordinating Foundation activities with
federal research programs, awarding
grants, and ensuring financial solvency
and raising resources.
The initial Board is to be appointed
no later than 30 days after enactment,
September 27, 2007, by the ex officio
board members designated in the
statute: The Commissioner of Food and
Drugs, the Director of the National
Institutes of Health, the Director of the
Centers for Disease Control and
Prevention, and the Director of the
Agency for Healthcare Research and
Quality. Nine Board members are to be
appointed from a list of candidates
provided by the National Academy of
Sciences. Five Board members are to be
appointed from lists of candidates
provided by ‘‘patient and consumer
advocacy groups, professional scientific
and medical societies, and industry
trade organizations.’’
III. Process and Criteria for
Nominations
To facilitate nomination of candidates
from patient and consumer advocacy
groups, professional scientific and
medical societies, and industry trade
organizations, FDA is publishing this
notice and accepting nominations by fax
or e-mail submission (see ADDRESSES).
We welcome nominations from any
such organization, and are not limiting
the number of nominations each
organization may submit. We will
accept joint nominations from multiple
organizations.
Each nomination should include the
following information:
(1) Name, affiliation, and contact
information for each nominating
organization, and a statement indicating
to which of the following categories the
nominating organization belongs:
Patient and consumer advocacy groups,
professional scientific and medical
societies, and industry trade
organizations.
(2) Name, title, affiliation (if any),
resume or curriculum vitae, and contact
information for each nominee. In
addition, please include no more than
one paragraph describing the
individual’s qualifications in relation to
the mission of the Foundation and the
statutory criteria for Board membership,
described in section II of this document.
A nominee may qualify in more than
one of the statutory categories for Board
membership; please list all categories
for which each nominee qualifies.
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Federal Register / Vol. 72, No. 191 / Wednesday, October 3, 2007 / Notices
IV. Electronic Access
SUPPLEMENTARY INFORMATION:
Persons with access to the Internet
may obtain the FDAAA statute at:
https://www.fda.gov/oc/initiatives/
advance/fdaaa.html.
I. Background
FDA is announcing an opportunity to
participate in a 3-year pilot project in a
regulatory setting being conducted by
CDER involving the ongoing testing of
SEND, a nonclinical data model
developed by the Clinical Data
Interchange Standards Consortium
(CDISC) . The ultimate goal of the pilot
is to replace the existing paper/PDFbased listings of nonclinical study data.
CDISC is an open, multidisciplinary,
nonprofit organization that has
established worldwide industry
standards to support the electronic
acquisition, exchange, submission, and
archiving of clinical trial data and
metadata for medical and
biopharmaceutical product
development (https://www.cdisc.org).
CDISC is currently facilitating the
extension of the same standard for
nonclinical data, termed SEND, through
the efforts of the SEND Consortium.
Where possible, the standards
developed for clinical datasets and
metadata, as described in the overall
Study Data Tabulation Model (SDTM),
are being used to develop a
standardized dataset format for
nonclinical studies.
Under current regulations, applicants
must provide tabulated nonclinical data
from animal toxicity studies as part of
NDA (21 CFR 314.50) and IND (21 CFR
312.23) applications. In a guidance for
industry titled ‘‘Providing Regulatory
Submissions in Electronic Format—
Human Pharmaceutical Product
Application and Related Submissions
Using the eCTD Specifications,’’ FDA
makes recommendations about how to
submit documents in electronic format
to INDs, BLAs, and NDAs using the
electronic common technical document
(eCTD) specifications. CDER currently
receives nonclinical study data either on
paper or as electronic PDF files. These
formats do not support the agency’s
ability to easily receive, validate,
display, or evaluate the data using
modern, computer-based review and
analysis tools. As part of FDA’s effort to
modernize its information technology
systems and improve efficiency, the
agency is planning to transition from the
traditional paper/PDF formats to a true
electronic data format for submission of
nonclinical data for regulatory review.
Recently, CDER has adopted a
standard for clinical study data based on
the CDISC SDTM standard. In addition,
CDER entered into a CRADA
(cooperative research and development
agreement) with PharmQuest
Corporation, Inc., for the development
of data validation, viewing, and analysis
Dated: September 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–4882 Filed 9–28–07; 1:26 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0343]
Electronic Nonclinical Study Data
Submission; Notice of Pilot Project
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Center for Drug
Evaluation and Research (CDER) is
seeking sponsors interested in
participating in a pilot project to test, in
a regulatory setting, the electronic
submission of nonclinical study data
using the Standard for Exchange of
Nonclinical Data (SEND). The purpose
of this pilot is to test the ability of a new
electronic data format to support
nonclinical review activity. The pilot
also will involve a collaboration of FDA,
available pilot participants, and the
SEND Consortium to update and create
a new draft SEND implementation
guide. FDA anticipates that a successful
pilot will enable CDER to routinely
accept nonclinical study data
electronically in SEND format, instead
of paper or portable document format
(PDF), in investigational new drug
applications (INDs), new drug
applications (NDAs), and biologics
licensing applications (BLAs).
DATES: Submit written or electronic
requests to participate in the pilot
project by January 2, 2008. General
comments on the pilot project are
welcome at any time.
ADDRESSES: Submit written requests to
participate and comments regarding this
pilot project 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Bobbie Witczak, Food and Drug
Administration, 5600 Fishers Lane
HFD–070, Rockville, MD 20857, 301–
827–3938.
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56363
tools to evaluate standardized
nonclinical datasets based on SEND.
The FDA believes the use of
standardized SEND datasets, together
with new and better analysis tools, will
increase the efficiency of agency review
and evaluation of nonclinical data.
CDER recently completed a related
pilot project (phase 1) that asked for
volunteers from industry to submit
sample nonclinical datasets in the SEND
format outside of a regulatory setting (68
FR 3885; January 27, 2003). The phase
1 pilot also evaluated data validation
and analysis tools specifically designed
to validate datasets according to the
current SEND standard and to enable a
reviewer to efficiently display and
evaluate data from animal toxicity
studies submitted in the SEND format.
The phase 1 pilot resulted in
development of a SEND Implementation
Guide (Version 2.3; November 2005),
which is available on the CDISC Web
site (https://www.cdisc.org/models/send/
v2.3/SENDV2.3Implementation
Guide.pdf). The SEND Implementation
Guide describes the process for
formatting nonclinical data from singleand repeat-dose animal toxicity and
carcinogenicity studies for submission
purposes. The pilot also resulted in the
development of specialized software
tools for validating, displaying, and
analyzing SEND-formatted nonclinical
data.
As a continuation of this testing
process, this new pilot (phase 2) will
enable FDA to evaluate animal toxicity
data submitted in SEND format in a
regulatory setting by comparing SENDformatted data provided electronically
as SAS transport file (XPT version 5)
datasets with data provided in PDF.
In addition, in the intervening time
period between the publication of the
SEND implementation guide version 2.3
(November 2005) and now, some
changes have been made to the SDTM
for clinical data, making it desirable to
update the SEND implementation guide
to ensure harmonized implementation
of the CDISC study data standard across
both clinical and nonclinical data.
There is also a plan to expand the SEND
implementation guide to include a
pharmacokinetics domain, more
detailed implementation examples, and,
eventually, other nonclinical study
types. As a result, FDA will not conduct
the pilot using the existing SEND
implementation guide version 2.3.
Instead, phase 2 will include an initial
collaboration among FDA, available
pilot participants, and the SEND
Consortium to update and create a new
draft SEND implementation guide
before FDA receives any datasets for
regulatory review. The current status of
E:\FR\FM\03OCN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 191 (Wednesday, October 3, 2007)]
[Notices]
[Pages 56362-56363]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-4882]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Nominations for Membership on the Board of Directors of the
Reagan-Udall Foundation From Consumer Advocacy Groups, Professional
Scientific and Medical Societies, and Industry Trade Organizations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
opportunity for patient and consumer advocacy groups, professional
scientific and medical societies, and industry trade organizations to
nominate candidates to serve on the Board of Directors (the Board) of a
new non-profit foundation, the Reagan-Udall Foundation for the Food and
Drug Administration (the Foundation). The Foundation will be dedicated
to modernizing medical, veterinary, food, food ingredient, and cosmetic
product development, accelerating innovation, and enhancing product
safety.
DATES: Submit written or electronic nominations on or before October
15, 2007.
ADDRESSES: Submit written nominations either by fax to Lisa Rovin or
Nancy Stanisic at 301-443-9718 or by e-mail to Reagan-Udall-
Board@FDA.HHS.GOV.
FOR FURTHER INFORMATION CONTACT:
Lisa Rovin, Office of Policy and Planning (HF-11), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1443;
or
Nancy Stanisic, Office of Critical Path Programs (HF-18), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
1660.
SUPPLEMENTARY INFORMATION:
I. Background
On September 27, 2007, the President signed into law the Food and
Drug Administration Amendments Act of 2007 (FDAAA). The law
reauthorizes the Prescription Drug User Fee Act, the Medical Device
User Fee Act, the Best Pharmaceuticals for Children Act, and the
Pediatric Research Equity Act of 2007, and enacts the Pediatric Medical
Device Safety and Improvement Act of 2007 as well as additional
requirements and authorities for FDA. Title VI of FDAAA creates the
Foundation. The purpose of the Foundation is to ``advance the mission
of the Food and Drug Administration to modernize medical, veterinary,
food, food ingredient, and cosmetic product development, accelerate
innovation, and enhance product safety.''
The duties of the Foundation include the identification of unmet
needs in the development, manufacture, and evaluation (including
postmarket evaluation) of the safety and effectiveness of FDA-regulated
products, and the establishment of scientific and other projects and
programs to meet those needs.
II. Criteria for Board Membership
The statute mandates a 14-member Board of Directors, composed of
the following:
Four representatives of the general pharmaceutical,
device, food, cosmetic, and biotechnology industries;
Three representatives of academic research organizations;
Two representatives of patient or consumer advocacy
organizations;
One representative of health care providers; and
Four at-large representatives with expertise or experience
relevant to the purpose of the Foundation.
The Board must include individuals with expertise in areas
including the sciences of developing, manufacturing, and evaluating the
safety and effectiveness of devices, including diagnostics, biological
products, and drugs, and the safety of food, food ingredients, and
cosmetics.
The Foundation's Board will be responsible for governing the
organization and ensuring that it succeeds in its mission. To that end,
the Board members will oversee the mission and operations of the
Foundation, including: Approving programs and monitoring their
effectiveness, coordinating Foundation activities with federal research
programs, awarding grants, and ensuring financial solvency and raising
resources.
The initial Board is to be appointed no later than 30 days after
enactment, September 27, 2007, by the ex officio board members
designated in the statute: The Commissioner of Food and Drugs, the
Director of the National Institutes of Health, the Director of the
Centers for Disease Control and Prevention, and the Director of the
Agency for Healthcare Research and Quality. Nine Board members are to
be appointed from a list of candidates provided by the National Academy
of Sciences. Five Board members are to be appointed from lists of
candidates provided by ``patient and consumer advocacy groups,
professional scientific and medical societies, and industry trade
organizations.''
III. Process and Criteria for Nominations
To facilitate nomination of candidates from patient and consumer
advocacy groups, professional scientific and medical societies, and
industry trade organizations, FDA is publishing this notice and
accepting nominations by fax or e-mail submission (see ADDRESSES). We
welcome nominations from any such organization, and are not limiting
the number of nominations each organization may submit. We will accept
joint nominations from multiple organizations.
Each nomination should include the following information:
(1) Name, affiliation, and contact information for each nominating
organization, and a statement indicating to which of the following
categories the nominating organization belongs: Patient and consumer
advocacy groups, professional scientific and medical societies, and
industry trade organizations.
(2) Name, title, affiliation (if any), resume or curriculum vitae,
and contact information for each nominee. In addition, please include
no more than one paragraph describing the individual's qualifications
in relation to the mission of the Foundation and the statutory criteria
for Board membership, described in section II of this document. A
nominee may qualify in more than one of the statutory categories for
Board membership; please list all categories for which each nominee
qualifies.
[[Page 56363]]
IV. Electronic Access
Persons with access to the Internet may obtain the FDAAA statute
at: https://www.fda.gov/oc/initiatives/advance/fdaaa.html.
Dated: September 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-4882 Filed 9-28-07; 1:26 pm]
BILLING CODE 4160-01-S
