[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44593-44594]
From the Federal Register Online via the Government Publishing 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]
BILLING CODE 4160-01-P