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.

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.