Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20235 

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. 

Dated: April 9, 2015. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[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. 

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: http://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: http:// 

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 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 http://

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 


tkelley on DSK3SPTVN1PROD with NOTICES
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 http://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: http://

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–0990–0382- 

30–D] 

Agency Information Collection 

Activities; Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: 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. 

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

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Oklahoma Institute for Child Advocacy (OICA) ............................................... 294 2 42/60 412 

Ohio Health ...................................................................................................... 148 3 42/60 310 

Children’s Hospital Los Angeles ...................................................................... 254 2 36/60 305 

EngenderHealth ............................................................................................... 240 2 36/60 288 

Princeton Center for Leadership Training ....................................................... 548 2 36/60 658 

Total .......................................................................................................... ........................ ........................ ........................ 1,973 

Terry S. Clark, 

Assistant Information Collection Clearance 

Officer. 

[FR Doc. 2015–08541 Filed 4–14–15; 8:45 am] 

BILLING CODE 4150–30–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

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 

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. 


tkelley on DSK3SPTVN1PROD with NOTICES