[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48173-48174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19004]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0597]


Guidance for Industry on Oversight of Clinical Investigations--A 
Risk-Based Approach to Monitoring; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Oversight of 
Clinical Investigations--A Risk-Based Approach to Monitoring.'' This 
guidance assists sponsors in developing risk-based monitoring 
strategies and plans for clinical investigations of human drugs, 
biologics, medical devices, and combinations thereof. The overarching 
goal of this guidance is to enhance human subject protection and the 
quality of clinical trial data by focusing sponsor oversight on the 
most important aspects of study conduct and reporting. The guidance 
makes clear that sponsors can use a variety of approaches to meet their 
responsibilities for monitoring investigational new drug or 
investigational device exemption studies.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
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; the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448; or the Office of 
Communication and Education, Division of Small Manufacturers, 
International and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4613, 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 guidance document.
    Submit electronic comments on the guidance 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: Ann Meeker-O'Connell, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 5356, Silver Spring, MD 20993-0002, 301-
796-7615; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-6210; or Linda Godfrey, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3446, Silver 
Spring, MD 20993-0002, 301-796-5490.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Oversight of Clinical Investigations--A Risk-Based Approach 
to Monitoring.'' FDA is publishing this guidance to assist sponsors of 
clinical investigations in developing risk-based monitoring strategies 
and plans for clinical investigations of human drug and biological 
products, medical devices, and combinations thereof. This guidance is 
intended to make clear that sponsors can use a variety of approaches to 
meet their responsibilities for monitoring clinical investigations 
under 21 CFR parts 312 and 812.

[[Page 48174]]

    In the Federal Register of August 29, 2011 (76 FR 53683), FDA 
announced the availability of the draft guidance entitled ``Oversight 
of Clinical Investigations: A Risk-Based Approach to Monitoring,'' 
dated August 2011, and the public was provided with an opportunity to 
comment on it until November 28, 2011. FDA carefully considered all of 
the comments received in developing the final guidance. The final 
guidance includes clarifications and additional detail on some topics. 
For example, the final guidance includes additional detail on how to 
perform risk-based monitoring and examples of monitoring techniques.
    The final guidance describes strategies for monitoring activities 
that reflect a modern, risk-based approach that focuses on critical 
study parameters and relies on a combination of monitoring activities 
to oversee a study effectively. The guidance also makes recommendations 
about how to develop monitoring plans and document monitoring 
activities and includes additional strategies to ensure study quality.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on oversight of clinical investigations--a 
risk-based approach to monitoring. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance were approved under OMB 
control numbers 0910-0078, 0910-0014, and 0910-0733.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceREgulatoryInformation/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: August 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19004 Filed 8-6-13; 8:45 am]
BILLING CODE 4160-01-P