[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44593-44594]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18880]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0239]
Identifying the Center for Drug Evaluation and Research's Science
and Research Needs; Availability of a Draft Report; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft report entitled ``Identifying CDER's Science
and Research Needs.'' This document identifies current priorities in
regulatory science related to the mission of the Center for Drug
Evaluation and Research (CDER), and will guide strategic planning of
internal research efforts. Through external communication of the
science and research needs outlined in the report, CDER hopes to
stimulate research and foster collaborations with external partners and
stakeholders to address these priorities.
DATES: Although you can comment on the report at any time, to ensure
that the Agency considers your comment on this report before it begins
work on the final version of the report, submit either electronic or
written comments on the report by September 26, 2011.
ADDRESSES: Submit written requests for single copies of this report to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft report.
Submit electronic comments on the draft report to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Ruth Barratt, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 4540,
Silver Spring, MD 20993-0002, 301-796-2600.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft report entitled
``Identifying CDER's Science and Research Needs.'' This report is the
result of an effort to identify regulatory science needs that, if
addressed, would enhance CDER's ability to fulfill its regulatory
mission. A publication entitled ``FDA Critical Path Opportunities
Report and Critical Path Opportunities List'' was published in March
2006. That report focused on the scientific challenges underlying
medical product development and served as a catalyst for CDER to launch
an effort to identify specific areas that would benefit from additional
regulatory science efforts. More recently, FDA released, ``Advancing
Regulatory Science for Public Health'', which incorporates the Critical
Path objectives into a broad framework for advancing regulatory
science. In support of these initiatives, this report delineates major
areas of scientific need that can contribute to the development of a
strategic science and research agenda.
To begin an assessment of these needs, more than 200
representatives from CDER's offices were asked to identify: (1)
Scientific challenges currently addressed on a case-by-case basis that
might benefit from the development of a systematized approach; (2)
recurrent science issues across teams, divisions, or offices; and (3)
emerging scientific challenges. A comprehensive set of science and
research needs was compiled from these discussions. Senior management
from CDER offices reviewed and prioritized topics from their offices.
These science and research needs were ultimately grouped into seven
categories that were reviewed and endorsed by the CDER Science
Prioritization and Review Committee and CDER senior management.
Seven major categories that crossed multiple disciplines were
identified: (1) Improve access to postmarket data sources and explore
feasibility of their use in different types of analyses; (2) improve
risk assessment and management strategies to reinforce the safe use of
drugs; (3) evaluate the effectiveness and impact of different types of
regulatory communications to the public and other stakeholders; (4)
evaluate the links among product quality attributes, manufacturing
processes, and product performance; (5) develop and improve predictive
models of safety and efficacy in humans; (6) improve clinical trial
design, analysis, and conduct; and (7) enhance individualization of
patient treatment.
The draft report is not intended to address the need to maintain a
robust scientific readiness to respond rapidly to regulatory crises,
but by communicating CDER's current science and research needs, CDER
hopes to stimulate research and foster collaborations with external
partners and stakeholders. CDER is disseminating this document
externally and soliciting input on: (1) Research and initiatives that
may be ongoing; and (2) opportunities to collaborate with external
partners and stakeholders to maximize resources to address the areas
for development discussed previously. The input will be reviewed and
incorporated as appropriate into plans for collaborations and potential
external partners will be contacted for further discussion.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.regulations.gov.
[[Page 44594]]
Dated: July 21, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-18880 Filed 7-25-11; 8:45 am]
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