Increasing the Quality and Efficiency of Clinical Trials, 29780-29781 [2014-11924]

Download as PDF 29780 Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 700 Allegation reporting respondent 1 700 2.25 175 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 15 minutes. Dated: May 16, 2014. Leslie Kux, Assistant Commissioner for Policy. refer to the full FOA located at https:// www.grants.gov. Search by Funding Opportunity Number: RFA–FD–14–017. SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2014–N–0610] Increasing the Quality and Efficiency of Clinical Trials Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the efforts of the Center for Drug Evaluation and Research/Office of Medical Policy to increase the quality and efficiency of clinical trials. The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy is announcing its intent to accept and consider a single-source application for the award of a grant to the Duke University’s Duke Translational Medicine Institute (DTMI). DATES: The application due date is June 30, 2014, by 11:59 p.m. Eastern Time. The expiration date is July 1, 2014. ADDRESSES: Submit electronic applications to: https://www.grants.gov. For more information, see section III of the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: Mark Lauda, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10990 New Hampshire Ave., Bldg. 51, Rm. 2212, Silver Spring, MD 20993, 301–796–0381, email: Mark.Lauda@fda.hhs.gov; or Lisa Ko, Office of Acquisition & Grants Services, Food and Drug Administration, 5630 Fishers Lane, Rockville, MD, 240–402– 7592, email: Lisa.Ko@fda.hhs.gov. For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:44 May 22, 2014 Jkt 232001 The goals of this program are to develop and maintain an administrative and scientific infrastructure to support the creation and execution of a series of projects under the auspices of CTTI that will increase the quality and efficiency of clinical trials. The following are examples of activities that could be supported by this grant: • Maintaining an adequate administrative and scientific infrastructure to implement all related projects under this collaborative effort. • Identifying and/or hiring a sufficient number of qualified personnel to conduct activities, including project management, such as review of project milestones for degree of completion, preparation/reporting of project findings, periodic and final reports, and for subsequent distribution in the public domain. • Developing plans for the conduct of identified projects. • Identifying, securing, and/or building, and effectively leveraging other resources for the conduct of identified projects. • Upon completion of a given project, generating project results and recommendations and proposing related studies/projects, if needed, to build on the findings of the project and continuing to leverage established resources and personnel. A. Background Food and Drug Administration AGENCY: B. Research Objectives RFA–FD–14–017 93.103 [FR Doc. 2014–11922 Filed 5–22–14; 8:45 am] investigational new drug (IND) safety reporting, clinical trial monitoring, use of central investigational review boards, and antibacterial drug development. It has long been recognized that the clinical trial enterprise will need to evolve in order to meet the demand to provide data to support evidence-based decisionmaking. A memorandum of understanding (MOU) between FDA and Duke University published in the Federal Register on November 23, 2007, served as the basis for the establishment of the Clinical Trials Transformation Initiative (CTTI). CTTI is a publicprivate partnership whose mission is to identify and promote practices that will increase the quality and efficiency of clinical trials. This award will be made to DTMI within Duke University to identify and implement projects and disseminate resulting findings that will increase the quality and efficiency of clinical trials, CTTI’s mission. CTTI membership is broad and includes stakeholders from government, industry, patient advocacy and consumer groups, professional societies, clinical research organizations, and academia. CTTI helps to effect change through the conduct of projects that identify existing inefficiencies, elucidate superior practices, and/or provide innovative approaches to evidence generation and medical product development. CTTI conducts projects that are either: (1) Proposed by its member organizations, including FDA, developed during review by its Steering Committee, and endorsed by its Executive Committee or (2) responsive to urgent needs of FDA. The opportunity for meaningful interaction with a broad set of stakeholders committed to improving the clinical trial enterprise and also the ability to rapidly gather data to address emerging issues offer significant value to the clinical trial enterprise. Since its inception, CTTI has undertaken many projects that have direct relevance to FDA’s mission, including PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 C. Eligibility Information The following organization is eligible to apply: DTMI located within Duke University. II. Award Information/Funds Available A. Award Amount This is a multiyear grant. FDA/CDER intends to fund up to $7,500,000 in total costs (direct and indirect) in Fiscal Year 2014. Awards are contingent upon the availability of funds. Subject to the availability of Federal funds and successful performance of the FOA’s stated goals and objectives, four additional years of support may be E:\FR\FM\23MYN1.SGM 23MYN1 Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices available. Funding beyond the first year will be noncompetitive and will depend on: (1) Satisfactory performance during the preceding year and (2) the availability of Federal fiscal year funds. Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect): Year 01: $7,500,000 Year 02: $7,500,000 Year 03: $7,500,000 Year 04: $7,500,000 Year 05: $7,500,000 Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board; Availability ACTION: Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.’’ The guidance announced in this document discusses regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA’s jurisdiction is transferred from one IRB to another IRB. The guidance also addresses questions that have been previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred. 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 (1–888– 463–6332 or 301–796–3400); or 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 (1–800–835–4709 or 301–827–1800); or the 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. 4622, Silver Spring, MD 20993 (1–800–638– 2041 or 301–796–7100). Send one selfaddressed adhesive label to assist the 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. SUMMARY: III. Electronic Application, Registration, and Submission Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full announcement located at https:// www.grants.gov. Search by Funding Opportunity Number: RFA–FD–14–017. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) For all electronically submitted applications, the following steps are required. • Step 1: Obtain a Dun and Bradstreet (DUNS) Number • Step 2: Register With System for Award Management (SAM) • Step 3: Obtain Username & Password • Step 4: Authorized Organization Representative (AOR) Authorization • Step 5: Track AOR Status • Step 6: Register With Electronic Research Administration (eRA) Commons mstockstill on DSK4VPTVN1PROD with NOTICES [Docket No. FDA–2011–D–0835] HHS. The scope of the proposed project should determine the project period. The maximum project period is 5 years. Steps 1 through 5, in detail, can be found at https://www07.grants.gov/ applicants/organization_ registration.jsp. Step 6, in detail, can be found at https://commons.era.nih.gov/ commons/registration/ registrationInstructions.jsp. After you have followed these steps, submit electronic applications to: https:// www.grants.gov. Dated: May 15, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–11924 Filed 5–22–14; 8:45 am] BILLING CODE 4160–01–P 18:44 May 22, 2014 Food and Drug Administration AGENCY: B. Length of Support VerDate Mar<15>2010 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 232001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 29781 Submit written comments to the Division of Dockets Managements (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Bridget Foltz, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5174, Silver Spring, MD 20993, 301–796–8340. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance entitled, ‘‘Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.’’ The guidance discusses the regulatory responsibilities of IRBs, clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA’s jurisdiction is transferred from one IRB to another IRB. In particular, the guidance discusses eight steps to be considered when transferring oversight of a previously approved clinical investigation from one IRB to another IRB. These include identifying those studies for which IRB oversight is being transferred; ensuring availability and retention of pertinent records; establishing an effective date for the transfer of oversight; conducting a review of the study(ies) by the receiving IRB, where appropriate; confirming or establishing the date for the next continuing review; determining whether the consent form needs to be revised; notifying the key parties; and updating IRB registration information. The IRB transfer process is expected to vary depending on the reasons for the transfer, the parties involved, and the number and risk of the studies being transferred. To enhance human subject protections and reduce regulatory burden, FDA and the Office for Human Research Protections (OHRP) have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subjects research. This guidance document was developed as a part of these efforts and in consultation with OHRP. In the Federal Register of June 12, 2012 (77 FR 34958), FDA announced the availability of the draft guidance of the same title. FDA received several comments on the draft guidance and considered them in preparing the final guidance. In response to the comments, FDA added a recommendation that the receiving IRB notify the sponsor if it decides to suspend or terminate study E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29780-29781]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11924]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0610]


Increasing the Quality and Efficiency of Clinical Trials

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of the efforts of the 
Center for Drug Evaluation and Research/Office of Medical Policy to 
increase the quality and efficiency of clinical trials. The Food and 
Drug Administration (FDA), Center for Drug Evaluation and Research 
(CDER), Office of Medical Policy is announcing its intent to accept and 
consider a single-source application for the award of a grant to the 
Duke University's Duke Translational Medicine Institute (DTMI).

DATES: The application due date is June 30, 2014, by 11:59 p.m. Eastern 
Time. The expiration date is July 1, 2014.

ADDRESSES: Submit electronic applications to: https://www.grants.gov. 
For more information, see section III of the SUPPLEMENTARY INFORMATION 
section of this notice.

FOR FURTHER INFORMATION CONTACT: Mark Lauda, Office of Medical Policy, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10990 New Hampshire Ave., Bldg. 51, Rm. 2212, Silver Spring, MD 20993, 
301-796-0381, email: Mark.Lauda@fda.hhs.gov; or Lisa Ko, Office of 
Acquisition & Grants Services, Food and Drug Administration, 5630 
Fishers Lane, Rockville, MD, 240-402-7592, email: Lisa.Ko@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at https://www.grants.gov. Search by Funding Opportunity Number: 
RFA-FD-14-017.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-14-017
93.103

A. Background

    It has long been recognized that the clinical trial enterprise will 
need to evolve in order to meet the demand to provide data to support 
evidence-based decisionmaking. A memorandum of understanding (MOU) 
between FDA and Duke University published in the Federal Register on 
November 23, 2007, served as the basis for the establishment of the 
Clinical Trials Transformation Initiative (CTTI). CTTI is a public-
private partnership whose mission is to identify and promote practices 
that will increase the quality and efficiency of clinical trials. This 
award will be made to DTMI within Duke University to identify and 
implement projects and disseminate resulting findings that will 
increase the quality and efficiency of clinical trials, CTTI's mission.
    CTTI membership is broad and includes stakeholders from government, 
industry, patient advocacy and consumer groups, professional societies, 
clinical research organizations, and academia. CTTI helps to effect 
change through the conduct of projects that identify existing 
inefficiencies, elucidate superior practices, and/or provide innovative 
approaches to evidence generation and medical product development. CTTI 
conducts projects that are either: (1) Proposed by its member 
organizations, including FDA, developed during review by its Steering 
Committee, and endorsed by its Executive Committee or (2) responsive to 
urgent needs of FDA.
    The opportunity for meaningful interaction with a broad set of 
stakeholders committed to improving the clinical trial enterprise and 
also the ability to rapidly gather data to address emerging issues 
offer significant value to the clinical trial enterprise. Since its 
inception, CTTI has undertaken many projects that have direct relevance 
to FDA's mission, including investigational new drug (IND) safety 
reporting, clinical trial monitoring, use of central investigational 
review boards, and antibacterial drug development.

B. Research Objectives

    The goals of this program are to develop and maintain an 
administrative and scientific infrastructure to support the creation 
and execution of a series of projects under the auspices of CTTI that 
will increase the quality and efficiency of clinical trials. The 
following are examples of activities that could be supported by this 
grant:
     Maintaining an adequate administrative and scientific 
infrastructure to implement all related projects under this 
collaborative effort.
     Identifying and/or hiring a sufficient number of qualified 
personnel to conduct activities, including project management, such as 
review of project milestones for degree of completion, preparation/
reporting of project findings, periodic and final reports, and for 
subsequent distribution in the public domain.
     Developing plans for the conduct of identified projects.
     Identifying, securing, and/or building, and effectively 
leveraging other resources for the conduct of identified projects.
     Upon completion of a given project, generating project 
results and recommendations and proposing related studies/projects, if 
needed, to build on the findings of the project and continuing to 
leverage established resources and personnel.

C. Eligibility Information

    The following organization is eligible to apply: DTMI located 
within Duke University.

II. Award Information/Funds Available

A. Award Amount

    This is a multiyear grant. FDA/CDER intends to fund up to 
$7,500,000 in total costs (direct and indirect) in Fiscal Year 2014. 
Awards are contingent upon the availability of funds.
    Subject to the availability of Federal funds and successful 
performance of the FOA's stated goals and objectives, four additional 
years of support may be

[[Page 29781]]

available. Funding beyond the first year will be noncompetitive and 
will depend on: (1) Satisfactory performance during the preceding year 
and (2) the availability of Federal fiscal year funds.
    Application budgets need to reflect the actual needs of the 
proposed project and should not exceed the following in total costs 
(direct and indirect):

Year 01: $7,500,000
Year 02: $7,500,000
Year 03: $7,500,000
Year 04: $7,500,000
Year 05: $7,500,000

B. Length of Support

    The scope of the proposed project should determine the project 
period. The maximum project period is 5 years.

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an 
electronic application in response to this FOA, applicants should first 
review the full announcement located at https://www.grants.gov. Search 
by Funding Opportunity Number: RFA-FD-14-017. (FDA has verified the Web 
site addresses throughout this document, but FDA is not responsible for 
any subsequent changes to the Web sites after this document publishes 
in the Federal Register.) For all electronically submitted 
applications, the following steps are required.

 Step 1: Obtain a Dun and Bradstreet (DUNS) Number
 Step 2: Register With System for Award Management (SAM)
 Step 3: Obtain Username & Password
 Step 4: Authorized Organization Representative (AOR) 
Authorization
 Step 5: Track AOR Status
 Step 6: Register With Electronic Research Administration 
(eRA) Commons

    Steps 1 through 5, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in 
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed 
these steps, submit electronic applications to: https://www.grants.gov.

    Dated: May 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11924 Filed 5-22-14; 8:45 am]
BILLING CODE 4160-01-P
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