80 FR 26589 - Request for Scientific Advisory Committee Nominations

REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

Federal Register Volume 80, Issue 89 (May 8, 2015)

Page Range		26589-26590
FR Document		2015-11077

The Reagan-Udall Foundation for the Food and Drug Administration (FDA), which was created by Title VI of the Food and Drug Amendments of 2007, is requesting nominations for its Innovation in Medical Evidence Development and Surveillance (IMEDS) Scientific Advisory Committee. The IMEDS Scientific Advisory Committee will provide scientific oversight and guidance of the IMEDS Program, and will report to the Reagan-Udall Foundation for the FDA's Board of Directors. Instructions on submitting nominations are listed in the ``Background'' section.

Federal Register, Volume 80 Issue 89 (Friday, May 8, 2015)

[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Notices]
[Pages 26589-26590]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11077]


=======================================================================
-----------------------------------------------------------------------

REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

[BAC 416404]


Request for Scientific Advisory Committee Nominations

ACTION: Request for nominations to the Scientific Advisory Committee 
for the Foundation's Innovation in Medical Evidence Development and 
Surveillance (IMEDS) program.

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

SUMMARY: The Reagan-Udall Foundation for the Food and Drug 
Administration (FDA), which was created by Title VI of the Food and 
Drug Amendments of 2007, is requesting nominations for its Innovation 
in Medical Evidence Development and Surveillance (IMEDS) Scientific 
Advisory Committee. The IMEDS Scientific Advisory Committee will 
provide scientific oversight and guidance of the IMEDS Program, and 
will report to the Reagan-Udall Foundation for the FDA's Board of 
Directors. Instructions on submitting nominations are listed in the 
``Background'' section.

DATES: All nominations must be submitted to the Reagan-Udall Foundation 
for the FDA by May 24, 2015. IMEDS Scientific Advisory Committee 
members will be selected by the IMEDS Steering Committee before July 
15, 2015; those selected will be notified by July 30, 2015 regarding 
the Steering Committee's decision.
    Location: The Reagan-Udall Foundation for the FDA is located at 
1025 Connecticut Ave. NW., Suite 1000, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: Nicole Spear, Reagan-Udall Foundation 
for the FDA, 202-828-1210. Nominations should be sent to 
[email protected]. Email subject line: SAC Nomination.

SUPPLEMENTARY INFORMATION:

I. Background

    The Reagan-Udall Foundation for the FDA (the Foundation) is an 
independent 501(c)(3) not-for-profit, organization created by Congress 
to advance the mission of FDA to modernize medical, veterinary, food, 
food ingredient, and cosmetic product development; accelerate 
innovation, and enhance product safety. With the ultimate goal of 
improving public health, the Foundation provides a unique opportunity 
for different sectors (FDA, patient groups, academia, other government 
entities, and industry) to work together in a transparent way to create 
exciting new research projects to advance regulatory science.
    The Foundation acts as a neutral third party to establish novel, 
scientific collaborations. Much like any other independently developed 
information, FDA evaluates the scientific information from these 
collaborations to determine how Reagan-Udall Foundation projects can 
help the agency to fulfill its mission.
    The Innovation in Medical Evidence Development and Surveillance 
(IMEDS) program is offered by the Foundation. IMEDS is a public-private 
partnership created to build upon the significant progress made on 
research methodology by the Sentinel Initiative and the Observational 
Medical Outcomes Partnership (OMOP).
    IMEDS's primary objective is to advance the science and tools 
necessary to support post-market evidence generation on regulated 
products, including safety surveillance and

[[Page 26590]]

evaluations, and to facilitate utilization of a robust electronic 
healthcare data platform for generating better evidence on regulated 
products in the post-market settings. To accomplish this objective, the 
IMEDS program includes three projects:
    1. IMEDS-Methods: Supports the development of a methods research 
agenda and coordination of methods research in support of using 
electronic health data for safety surveillance conducted by FDA as well 
as the broader community of researchers.
    2. IMEDS-Education: Offers educational opportunities in areas 
related to medical product safety surveillance, and methods research 
and application for scientific professionals.
    3. IMEDS-Evaluation: Applies Methods and Education lessons learned 
for medical product assessments to facilitate leveraging Sentinel tools 
and capabilities toward a national resource for evidence generation.
    The IMEDS Scientific Advisory Committee has oversight of all IMEDS 
projects.

II. IMEDS Scientific Advisory Committee Positions and Selection 
Criteria

    RUF is seeking nominations for four (4) voting members of the IMEDS 
Scientific Advisory Committee listed below.
    1. At Large (excluding Pharmaceutical representative): 2 members.
    2. Regulated Industry Representative: 2 members.
    The following criteria will be used to evaluate nominees for the 
IMEDS Scientific Advisory Committee.
    1. Required Criteria for Each of 4 Positions.
    a. Currently employed by/volunteering for stakeholder field (e.g., 
academia, patient advocate, provider etc.) with several years of 
relevant experience.
    b. Leading expert in their relevant field (based on position/title, 
publications, or other experience).
    2. Criteria across Scientific Advisory Committee (It is not a 
requirement that all nominees meet all of these criteria, but 
collectively, the Scientific Advisory Committee members should meet 
them.)
    a. Ability to complete Scientific Advisory Committee 
responsibilities (which can be accessed via the IMEDS Web site: http://imeds.reaganudall.org/governance.)
    b. Prior experience serving on a related or similar governance 
body.
    c. Understanding of post-market surveillance landscape and impact 
upon stakeholder group represented by Scientific Advisory Committee 
seat, or understanding of issues around use of electronic health data 
for observational purposes.
    d. Individuals both with and without past experience in Mini-
Sentinel, OMOP, and similar research/regulatory science initiatives to 
ensure a diversity of perspectives.
    e. Individuals from both U.S.- and international-based 
institutions.

III. Terms of Service

     The IMEDS Scientific Advisory Committee meets in-person at 
least twice per year, with bimonthly teleconferences in between 
meetings (or monthly teleconferences as deemed necessary by the Chair).
     Members serve two-year terms, and a maximum of two terms 
(based on IMEDS fiscal calendar).
     Members do not receive compensation from RUF.
     Members can be reimbursed by RUF for actual and reasonable 
expenses incurred in support of IMEDS in accordance with applicable law 
and their specific institutional policies.
     Members are subject to the IMEDS Conflict of Interest 
policies.

IV. Nomination Instructions

     To apply, please submit the nominee's CV and the 
nomination form that can be found on the IMEDS Web site: 
imeds.reaganudall.org, to [email protected] with ``SAC Nomination'' 
in the subject line.
     Individuals may be nominated for one or more of the 4 
voting positions, and those making nominations should specify for which 
of the 4 voting positions the nominee is being nominated.
     Individuals may nominate themselves.

    Dated: May 4, 2015.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2015-11077 Filed 5-7-15; 8:45 am]
 BILLING CODE 4164-04-P

Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Notices 26589

I. Introduction By the Commission. guidance of the IMEDS Program, and
In accordance with 39 U.S.C. 3642 Shoshana M. Grove, will report to the Reagan-Udall
and 39 CFR 3020.30 et seq., the Postal Secretary. Foundation for the FDA’s Board of
Service filed a formal request and [FR Doc. 2015–11079 Filed 5–7–15; 8:45 am] Directors. Instructions on submitting
associated supporting information to BILLING CODE 7710–FW–P
nominations are listed in the
add Priority Mail Express & Priority ‘‘Background’’ section.
Mail Contract 18 to the competitive DATES: All nominations must be
product list.1 POSTAL SERVICE submitted to the Reagan-Udall
The Postal Service Foundation for the FDA by May 24,
contemporaneously filed a redacted Product Change—Priority Mail Express 2015. IMEDS Scientific Advisory
contract related to the proposed new and Priority Mail Negotiated Service Committee members will be selected by
product under 39 U.S.C. 3632(b)(3) and Agreement the IMEDS Steering Committee before
39 CFR 3015.5. Id. Attachment B. July 15, 2015; those selected will be
To support its Request, the Postal AGENCY: Postal ServiceTM. notified by July 30, 2015 regarding the
Service filed a copy of the contract, a ACTION: Notice. Steering Committee’s decision.
copy of the Governors’ Decision Location: The Reagan-Udall
authorizing the product, proposed SUMMARY: The Postal Service gives Foundation for the FDA is located at
changes to the Mail Classification notice of filing a request with the Postal 1025 Connecticut Ave. NW., Suite 1000,
Schedule, a Statement of Supporting Regulatory Commission to add a Washington, DC 20036.
Justification, a certification of domestic shipping services contract to
FOR FURTHER INFORMATION CONTACT:
compliance with 39 U.S.C. 3633(a), and the list of Negotiated Service
Nicole Spear, Reagan-Udall Foundation
an application for non-public treatment Agreements in the Mail Classification
for the FDA, 202–828–1210.
of certain materials. It also filed Schedule’s Competitive Products List.
Nominations should be sent to IMEDS@
supporting financial workpapers. DATES: Effective date: May 8, 2015. ReaganUdall.org. Email subject line:
FOR FURTHER INFORMATION CONTACT: SAC Nomination.
II. Notice of Commission Action
Elizabeth A. Reed, 202–268–3179. SUPPLEMENTARY INFORMATION:
The Commission establishes Docket
SUPPLEMENTARY INFORMATION: The
Nos. MC2015–49 and CP2015–61 to I. Background
United States Postal Service® hereby
consider the Request pertaining to the The Reagan-Udall Foundation for the
gives notice that, pursuant to 39 U.S.C.
proposed Priority Mail Express & FDA (the Foundation) is an independent
3642 and 3632(b)(3), on May 1, 2015, it
Priority Mail Contract 18 product and 501(c)(3) not-for-profit, organization
filed with the Postal Regulatory
the related contract, respectively. created by Congress to advance the
Commission a Request of the United
The Commission invites comments on
States Postal Service to Add Priority mission of FDA to modernize medical,
whether the Postal Service’s filings in
Mail Express & Priority Mail Contract 18 veterinary, food, food ingredient, and
the captioned dockets are consistent
to Competitive Product List. Documents cosmetic product development;
with the policies of 39 U.S.C. 3632,
are available at www.prc.gov, Docket accelerate innovation, and enhance
3633, or 3642, 39 CFR part 3015, and 39
Nos. MC2015–49, CP2015–61. product safety. With the ultimate goal of
CFR part 3020, subpart B. Comments are
improving public health, the
due no later than May 11, 2015. The Stanley F. Mires,
Foundation provides a unique
public portions of these filings can be Attorney, Federal Requirements. opportunity for different sectors (FDA,
accessed via the Commission’s Web site [FR Doc. 2015–11067 Filed 5–7–15; 8:45 am] patient groups, academia, other
(http://www.prc.gov). BILLING CODE 7710–12–P government entities, and industry) to
The Commission appoints Kenneth R.
work together in a transparent way to
Moeller to serve as Public
create exciting new research projects to
Representative in these dockets.
REAGAN-UDALL FOUNDATION FOR advance regulatory science.
III. Ordering Paragraphs THE FOOD AND DRUG The Foundation acts as a neutral third
It is ordered: ADMINISTRATION party to establish novel, scientific
1. The Commission establishes Docket collaborations. Much like any other
[BAC 416404] independently developed information,
Nos. MC2015–49 and CP2015–61 to
consider the matters raised in each Request for Scientific Advisory FDA evaluates the scientific information
docket. Committee Nominations from these collaborations to determine
2. Pursuant to 39 U.S.C. 505, Kenneth how Reagan-Udall Foundation projects
R. Moeller is appointed to serve as an ACTION: Request for nominations to the can help the agency to fulfill its
officer of the Commission to represent Scientific Advisory Committee for the mission.
the interests of the general public in Foundation’s Innovation in Medical The Innovation in Medical Evidence
these proceedings (Public Evidence Development and Surveillance Development and Surveillance (IMEDS)
Representative). (IMEDS) program. program is offered by the Foundation.
3. Comments are due no later than IMEDS is a public-private partnership
May 11, 2015. SUMMARY: The Reagan-Udall Foundation created to build upon the significant
4. The Secretary shall arrange for for the Food and Drug Administration progress made on research methodology
asabaliauskas on DSK5VPTVN1PROD with NOTICES

publication of this order in the Federal (FDA), which was created by Title VI of by the Sentinel Initiative and the
Register. the Food and Drug Amendments of Observational Medical Outcomes
2007, is requesting nominations for its Partnership (OMOP).
1 Request of the United States Postal Service to Innovation in Medical Evidence IMEDS’s primary objective is to
Add Priority Mail Express & Priority Mail Contract Development and Surveillance (IMEDS) advance the science and tools necessary
18 to Competitive Product List and Notice of Filing
(Under Seal) of Unredacted Governors’ Decision,
Scientific Advisory Committee. The to support post-market evidence
Contract, and Supporting Data, May 1, 2015 IMEDS Scientific Advisory Committee generation on regulated products,
(Request). will provide scientific oversight and including safety surveillance and

VerDate Sep<11>2014 16:38 May 07, 2015 Jkt 235001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\08MYN1.SGM 08MYN1

Document Created: 2018-02-21 10:24:18
Document Modified: 2018-02-21 10:24:18

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Request for nominations to the Scientific Advisory Committee for the Foundation's Innovation in Medical Evidence Development and Surveillance (IMEDS) program.
Dates		All nominations must be submitted to the Reagan-Udall Foundation for the FDA by May 24, 2015. IMEDS Scientific Advisory Committee members will be selected by the IMEDS Steering Committee before July 15, 2015; those selected will be notified by July 30, 2015 regarding the Steering Committee's decision.
Contact		Nicole Spear, Reagan-Udall Foundation for the FDA, 202-828-1210. Nominations should be sent to [email protected] Email subject line: SAC Nomination.
FR Citation		80 FR 26589