Innovations in Medical Evidence Development and Surveillance-Methods Research Agenda, 20235-20236 [2015-08613]

Download as PDF Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices document (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: Patrick Archdeacon, Food and Drug Administration, Bldg. 51 Rm.6314, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3952; or Vieda Hubbard, Division of Acquisition Support and Grants (HFA– 500), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 240–402–7588. 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/. SUPPLEMENTARY INFORMATION: Dated: April 9, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. I. Funding Opportunity Description [FR Doc. 2015–08620 Filed 4–14–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–1083] Innovations in Medical Evidence Development and SurveillanceMethods Research Agenda AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of Center for Drug Evaluation and Research (CDER). The goal of the CDER is to support the development of appropriate methodologies to conduct medical product safety surveillance in large electronic databases. Innovations in Medical Evidence Development and Surveillance (IMEDS)-Methods is a program within the Reagan-Udall Foundation that supports FDA’s scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. DATES: 1. The application due date is June 15, 2015. 2. The anticipated start date is July 15, 2015. 3. The opening date is April 13, 2015. 4. The expiration date is June 16, 2015. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: Submit the electronic application to: https://www.grants.gov. For more information, see section III of ADDRESSES: VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 RFA–FD–15–010 93.103 A. Background Section 905 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110–85) mandates FDA to develop an enhanced ability to monitor the safety of drugs after these products reach the market. In response to this mandate, FDA launched its Sentinel Initiative, a long-term program designed to build and implement an electronic system for monitoring the safety of medical products in the post market setting. FDA has already created significant infrastructure on which to operate such a system: Through its Mini-Sentinel pilot, a distributed database with access to more than 150 million patient records has been created (the Sentinel Distributed Database). In order to optimally leverage these data, however, new analytic methodologies will be required. IMEDS-Methods is a program within the Reagan-Udall Foundation that supports FDA’s scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. IMEDS-Methods aims to improve the tools for conducting post-marketing safety surveillance using automated healthcare data and to foster their adoption. B. Research Objectives IMEDS plans to conduct methods research in five core areas: (1) Addressing bias in estimates from observational studies; (2) better understanding uses and limitations of the data; (3) applying lessons learned from earlier IMEDS projects to FDA surveillance activities; (4) expanding the surveillance question to continuous risk/benefit assessment; and (5) continuing to support qualified investigators in industry, government, PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 20235 and academic settings by providing access to de-identified electronic healthcare data and computing resources through the IMEDS Research Laboratory. C. Eligibility Information Eligibility is limited to the ReaganUdall Foundation. The Reagan-Udall Foundation has established the IMEDSMethods program, which is uniquely positioned to develop the new methodologies required for FDA to conduct effective active post market safety surveillance of medical products using large electronic health care data. The IMEDS organization has developed a network of statisticians, epidemiologists, data scientists, and clinicians who have experience operating in both the IMEDS research laboratory and also familiarity with the Sentinel Distributed Database. In addition, through the Reagan-Udall Foundation public-private partnership, the IMEDS-Methods program has a unique ability to convene FDA, patients, academics, government, and industry so that the findings and tools developed through its research agenda will be promulgated and adopted. II. Award Information/Funds Available A. Award Amount FDA/CDER intends to fund up to $1,000,000 in fiscal year 2015 in support of this program project. It is anticipated that only one award will be made, not to exceed $1,000,000 (direct plus indirect) for total costs. B. Length of Support There is a one year period of performance beginning on June 15, 2015 or the date of award. III. Electronic Application, Registration, and Submission Only one electronic application will be accepted. To submit an electronic application in response to this FOA, the applicant should first review the full announcement located at https:// www.grants.gov/. (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 the electronically submitted application, 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 E:\FR\FM\15APN1.SGM 15APN1 20236 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices • 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 the electronic application to: https:// www.grants.gov. Dated: April 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–08613 Filed 4–14–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: HHS–OS–0990–038230–D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request AGENCY: Office of the Secretary, HHS. ACTION: Notice. In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990–0382, scheduled to expire on May 31, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period. DATES: Comments on the ICR must be received on or before May 15, 2015. ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, Information.CollectionClearance@ hhs.gov or (202) 690–6162. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the OMB control number 0990–0382 and document identifier HHS–OS–30D for reference. SUMMARY: Information Collection Request Title: Evaluation of Pregnancy Prevention Approaches—First Follow-up Abstract: The Office of Adolescent Health (OAH), U.S. Department of Health and Human Services (HHS) is requesting an extension without change of a currently approved information collection request by OMB. The purpose of the extension is to complete the ongoing follow-up data collection for the Evaluation of Adolescent Pregnancy Prevention Approaches (PPA), a multisite random assignment evaluation of promising approaches to teen pregnancy prevention. Need and Proposed Use of the Information: The PPA study is being conducted in seven program sites around the country. The proposed extension is necessary to complete ongoing follow-up data collection in five of the seven study sites. The resulting data will be used in a rigorous program impact analysis to assess the effectiveness of each program in reducing rates of teen pregnancy and associated sexual risk behaviors. Likely Respondents: The 1484 youth participants who agreed to participate in the study upon sample enrollment in 5 impact study sites. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Form name Number of responses per respondent Average burden per response (in hours) Total burden hours Oklahoma Institute for Child Advocacy (OICA) ............................................... Ohio Health ...................................................................................................... Children’s Hospital Los Angeles ...................................................................... EngenderHealth ............................................................................................... Princeton Center for Leadership Training ....................................................... 294 148 254 240 548 2 3 2 2 2 42/60 42/60 36/60 36/60 36/60 412 310 305 288 658 Total .......................................................................................................... ........................ ........................ ........................ 1,973 DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–08541 Filed 4–14–15; 8:45 am] National Institutes of Health BILLING CODE 4150–30–P tkelley on DSK3SPTVN1PROD with NOTICES Terry S. Clark, Assistant Information Collection Clearance Officer. Eunice Kennedy Shriver National Institute of Child Health and Human Development Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel PDB–P2C_ Infrastructure/Center Grants. Date: June 29, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\15APN1.SGM 15APN1

Agencies

[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20235-20236]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1083]


Innovations in Medical Evidence Development and Surveillance-
Methods Research Agenda

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 Center for Drug 
Evaluation and Research (CDER). The goal of the CDER is to support the 
development of appropriate methodologies to conduct medical product 
safety surveillance in large electronic databases. Innovations in 
Medical Evidence Development and Surveillance (IMEDS)-Methods is a 
program within the Reagan-Udall Foundation that supports FDA's 
scientific mission of serving public health needs by initiating and 
facilitating research into the methods of safety evaluation in large 
databases.

DATES: 1. The application due date is June 15, 2015.
    2. The anticipated start date is July 15, 2015.
    3. The opening date is April 13, 2015.
    4. The expiration date is June 16, 2015.

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

FOR FURTHER INFORMATION CONTACT: Patrick Archdeacon, Food and Drug 
Administration, Bldg. 51 Rm.6314, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 301-796-3952; or Vieda Hubbard, Division of 
Acquisition Support and Grants (HFA-500), Food and Drug Administration, 
5630 Fishers Lane, Rockville, MD 20857, 240-402-7588.
    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/.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-15-010 93.103

A. Background

    Section 905 of the Food and Drug Administration Amendments Act of 
2007 (Pub. L. 110-85) mandates FDA to develop an enhanced ability to 
monitor the safety of drugs after these products reach the market. In 
response to this mandate, FDA launched its Sentinel Initiative, a long-
term program designed to build and implement an electronic system for 
monitoring the safety of medical products in the post market setting. 
FDA has already created significant infrastructure on which to operate 
such a system: Through its Mini-Sentinel pilot, a distributed database 
with access to more than 150 million patient records has been created 
(the Sentinel Distributed Database). In order to optimally leverage 
these data, however, new analytic methodologies will be required. 
IMEDS-Methods is a program within the Reagan-Udall Foundation that 
supports FDA's scientific mission of serving public health needs by 
initiating and facilitating research into the methods of safety 
evaluation in large databases. IMEDS-Methods aims to improve the tools 
for conducting post-marketing safety surveillance using automated 
healthcare data and to foster their adoption.

B. Research Objectives

    IMEDS plans to conduct methods research in five core areas: (1) 
Addressing bias in estimates from observational studies; (2) better 
understanding uses and limitations of the data; (3) applying lessons 
learned from earlier IMEDS projects to FDA surveillance activities; (4) 
expanding the surveillance question to continuous risk/benefit 
assessment; and (5) continuing to support qualified investigators in 
industry, government, and academic settings by providing access to de-
identified electronic healthcare data and computing resources through 
the IMEDS Research Laboratory.

C. Eligibility Information

    Eligibility is limited to the Reagan-Udall Foundation. The Reagan-
Udall Foundation has established the IMEDS-Methods program, which is 
uniquely positioned to develop the new methodologies required for FDA 
to conduct effective active post market safety surveillance of medical 
products using large electronic health care data. The IMEDS 
organization has developed a network of statisticians, epidemiologists, 
data scientists, and clinicians who have experience operating in both 
the IMEDS research laboratory and also familiarity with the Sentinel 
Distributed Database. In addition, through the Reagan-Udall Foundation 
public-private partnership, the IMEDS-Methods program has a unique 
ability to convene FDA, patients, academics, government, and industry 
so that the findings and tools developed through its research agenda 
will be promulgated and adopted.

II. Award Information/Funds Available

A. Award Amount

    FDA/CDER intends to fund up to $1,000,000 in fiscal year 2015 in 
support of this program project. It is anticipated that only one award 
will be made, not to exceed $1,000,000 (direct plus indirect) for total 
costs.

B. Length of Support

    There is a one year period of performance beginning on June 15, 
2015 or the date of award.

III. Electronic Application, Registration, and Submission

    Only one electronic application will be accepted. To submit an 
electronic application in response to this FOA, the applicant should 
first review the full announcement located at https://www.grants.gov/. 
(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 the electronically submitted application, 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

[[Page 20236]]

     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 the electronic application to: https://www.grants.gov.

    Dated: April 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08613 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P
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