Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring; Availability, 48173-48174 [2013-19004]

Download as PDF Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices an unsafe and uncontrolled manner may cause injury to the user and/or others within range of the laser beam. This is a particular concern for lasers intended for entertainment purposes, especially when intended to be used as toys by children. Although Federal law requires all laser products sold in the United States to be in compliance with the Federal Performance Standards for Laser Products (21 CFR 1040.10 and 1040.11), at present FDA regulations do not specifically address children’s toy laser products. FDA recently issued a proposed rule (78 FR 37723) that proposes to define children’s toy laser products and require them to be within International Electrotechnical Commission (IEC) Class 1 emission limits. While this rulemaking process is ongoing, CDRH encourages manufacturers to keep children’s toy laser products within IEC Class 1 emission limits in order to minimize the risk they pose to this vulnerable population. mstockstill on DSK4VPTVN1PROD with NOTICES II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance represents the Agency’s proposed approach on children’s toys that are or that contain laser products. 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive ‘‘Minimizing Risk for Children’s Toy Laser Products,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1810 to identify the guidance you are requesting. A search capability for all CDRH guidance documents is available at https://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. IV. Paperwork Reduction Act of 1995 This draft guidance refers to a currently approved collection of information found in FDA regulations. This collection of information is subject to review by the Office of Management and Budget (OMB) under the Paperwork VerDate Mar<15>2010 17:03 Aug 06, 2013 Jkt 229001 Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collection of information in 21 CFR part 1040 is approved under OMB control number 0910–0025. V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments regarding this document 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 https:// www.regulations.gov. Dated: August 1, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–19018 Filed 8–6–13; 8:45 am] BILLING CODE 4160–01–P 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. 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. SUMMARY: Submit either electronic or written comments on Agency guidances at any time. DATES: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 48173 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 https://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: ADDRESSES: 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. E:\FR\FM\07AUN1.SGM 07AUN1 48174 Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices 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. mstockstill on DSK4VPTVN1PROD with NOTICES 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 https://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 https:// www.regulations.gov. VerDate Mar<15>2010 17:03 Aug 06, 2013 Jkt 229001 IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, https://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceREgulatoryInformation/ default.htm, https://www.fda.gov/ MedicalDevices/DeviceRegulation andGuidance/GuidanceDocuments/ default.htm, or https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Anti-Infective Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Anti-Infective Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on October 17, 2013, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center (Rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Diane Goyette, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 796–9001, FAX: 301–847–8533, email: AIDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The purpose of the meeting on October 17, 2013, is to discuss susceptibility interpretive criteria for systemic antibacterial drugs and for dosing recommendations in product labeling. We will seek input on the role of pharmacokinetic data in setting susceptibility interpretive criteria. We will also discuss revising dosing recommendations in product labeling based on pharmacokinetic data and clinical safety and efficacy data. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 2, 2013. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 24, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48173-48174]
From the Federal Register Online via the Government Printing 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 https://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 https://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 https://www.regulations.gov.

IV. Electronic Access

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