Document ID: FDA-2011-D-0239-0015
Agency: fda
Document Type: Notice
Title: Assessing the Center of Drug Evaluation and Research’s Safety-
Related Regulatory Science Needs and Identifying Priorities; Report;
Availability; Request for Comments
Posted Date: 2015-03-19T04:00Z

[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Notices]
[Pages 14389-14390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06288]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0239]

Assessing the Center of Drug Evaluation and Research's Safety-
Related Regulatory Science Needs and Identifying Priorities; Report; 
Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a report entitled ``Assessing CDER's Drug Safety-
Related Regulatory Science Needs and Identifying Priorities.'' This 
report identifies drug safety-related regulatory science needs and 
priorities related to the mission of FDA's Center for Drug Evaluation 
and Research (CDER) that would benefit from external collaborations and 
resources. FDA hopes to foster collaborations with external partners 
and stakeholders to help address these needs and priorities. This 
notice asks stakeholders conducting research related to these needs to 
describe that research and indicate their interest in collaborating 
with FDA to address safety-related research priorities.

DATES: Although you can comment on the report at any time, to ensure 
that FDA considers your comments on this report, submit either 
electronic or written comments on the report by May 18, 2015.

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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the report.
    Submit electronic comments on the report to http://www.regulations.gov.

[[Page 14390]]

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

    Since publication of the 2011 ``Identifying CDER's Science and 
Research Needs'' report, FDA has been engaged in efforts to further 
assess and prioritize the needs articulated therein. As part of these 
efforts, CDER's Safety Research Interest Group (SRIG), a subcommittee 
of the Science Prioritization and Review Committee, assessed CDER's 
overall drug safety-related regulatory science needs in view of FDA's 
ongoing research efforts and highlighted areas that would benefit from 
additional resources and collaboration.
    The SRIG identified the following seven overall needs for drug 
safety-related regulatory science:
    1. Improve access to postmarket data sources and explore the 
feasibility of their use in safety signal analyses
    2. Improve risk assessment and management strategies to reinforce 
the safe use of drugs
    3. Evaluate the effectiveness of risk communications of drug safety 
information to health care providers and the public
    4. Improve product quality and design, manufacturing processes, and 
product performance relating to safety
    5. Develop and improve predictive models of safety in humans, 
including nonclinical biomarkers
    6. Improve clinical trial statistical analyses for safety, 
including benefit-risk assessment
    7. Investigate clinical biomarkers of safety, including standards 
for qualification.
    Particular priorities within the seven overall needs requiring 
further resources and outside participation were also identified. FDA 
seeks to stimulate collaborations with external partners and 
stakeholders to address these needs by asking them to: (1) Submit 
descriptions of their ongoing research and initiatives related to the 
seven overall needs, especially the identified priorities, and (2) 
indicate their interest in working with FDA to address these needs. 
Outside parties are being asked to submit comments to the docket and 
email address CDER_Science_Needs@fda.hhs.gov.

II. Comments

    Interested persons may submit either electronic comments regarding 
the report to http://www.regulations.gov and email address 
CDER_Science_Needs@fda.hhs.gov, or written comments to the Division of 
Dockets Management (see ADDRESSES). It is only necessary to send one 
set of 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, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the report at http://www.regulations.gov.

    Dated: March 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06288 Filed 3-18-15; 8:45 am]
 BILLING CODE 4164-01-P