80 FR 30468 - Molecular Characterization of Multiple Myeloma Black/African Ancestry Disparity

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 102 (May 28, 2015)

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 (CDER). FDA is announcing its intent to accept and consider a single-source application for the award of a grant to the Multiple Myeloma Service of Memorial Sloan Kettering Cancer Institute. The goal of the cooperative agreement between CDER and the Multiple Myeloma Service of Memorial Sloan Kettering Cancer Institute is to support the development of appropriate methodologies to conduct clinical trial design evaluation and determine extrapolation of findings from the general population to the U.S. Black population.

[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30468-30469]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12742]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0012]


Molecular Characterization of Multiple Myeloma Black/African 
Ancestry Disparity

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 (CDER). FDA is announcing its 
intent to accept and consider a single-source application for the award 
of a grant to the Multiple Myeloma Service of Memorial Sloan Kettering 
Cancer Institute. The goal of the cooperative agreement between CDER 
and the Multiple Myeloma Service of Memorial Sloan Kettering Cancer 
Institute is to support the development of appropriate methodologies to 
conduct clinical trial design evaluation and determine extrapolation of 
findings from the general population to the U.S. Black population.

DATES: Important dates are as follows:
    1. The application due date is July 20, 2015.
    2. The anticipated start date is August 2015.
    3. The opening date is May 18, 2015.
    4. The expiration date is July 21, 2015.

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

FOR FURTHER INFORMATION CONTACT: Dickran Kazandjian, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2320, Silver Spring, MD 20993-0002, 240-
402-5272; or Vieda Hubbard, Division of Acquisition Support and Grants 
(HFA-500), Food and Drug

[[Page 30469]]

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. Search by Funding Opportunity 
Number: RFA-FD-15-029.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

    RFA-FD-15-029
    93.103

A. Background

    Multiple Myeloma (MM) is mainly a disease of older adults with a 
median diagnosis age of 65 years and patients younger than 40 represent 
only 2 percent of diagnoses. In the United States, 20,000 new cases are 
diagnosed annually. Although the etiology of MM remains elusive, 
clinical features, observed racial disparity patterns of incidence, 
reported familial clustering, and younger incidence in patients of 
Black/African ancestry suggests a role for susceptibility genes. Novel 
therapies have revolutionized treatment of MM and much of current 
research is focused on identifying not only efficacious drugs but also 
on the most efficacious time to initiate treatment. MM is a spectrum of 
disease which is first manifested by its precursor state Monoclonal 
gammopathy of undetermined significance (MGUS) which then evolves into 
smoldering myeloma and then finally symptomatic myeloma and therefore 
some paradigms of treatment initiation are evolving. Much of this work 
involves identifying the molecular aberrations, which classify 
patients' risks. However, this work has mostly been done on the 
population as a whole. Despite that MM in patients of Black ancestry 
clearly has a biologically different natural history; clinically Blacks 
are assessed using the same genetic approaches as the whole population. 
The proposed project will afford us the opportunity to identify and 
characterize MM in the Black population with much higher genetic and 
molecular resolution. It will answer questions such as whether Blacks 
have, in general, better survival because of the presence of more low 
risk genetic aberrations and whether these changes alter the effect of 
treatment drug. Our conclusions may have immense regulatory impact. For 
example, certain MM therapies may be indicated sooner in the treatment 
course in Blacks. Alternatively, some therapies may be found to have 
minimal efficacy and indication in Blacks with certain molecular 
subtypes. This proposal will be the first study to characterize the 
molecular subtypes of MM in Blacks in a systematic fashion, investigate 
the effect of these on novel therapy outcomes, and potentially have 
major impact on regulatory approvals of future therapies. Therefore, it 
is imperative to focus on this under-represented population and at 
least begin to understand the differences in MM pathophysiology, which 
may ultimately lead to improved outcomes.
    The Memorial Sloan Kettering Cancer Institute has established a 
cohort of Black/African ancestry patients diagnosed with MM. These 
patients have been previously enrolled onto clinical trials and bone 
marrow biopsy tissue samples are available along with peripheral blood 
samples all banked. Furthermore, there has been close monitoring of 
these patients and detailed clinical data already exist. This is 
crucial to the project. Memorial Sloan Kettering is uniquely positioned 
to provide FDA much required data both by their novel technical 
platform and also by their available unique patient cohort and biopsy 
samples. Finally, organized involvement among a number of Sloan 
Kettering/National Cancer Institute (NCI)/FDA working groups on issues 
related to endpoints in MM which provides the unique ability to 
collaboratively engage FDA, patients, academics, government and 
industry so that any important findings may distributed to the 
community will be required.

B. Research Objectives

    The research objective is to characterize the molecular subtypes of 
MM in patients of Black/African ancestry and investigate the effect of 
these on prognosis and novel therapy outcomes.

C. Eligibility Information

    The following organization is eligible to apply: The Multiple 
Myeloma Service of the Memorial Sloan Kettering Cancer Institute. This 
is a sole source request for application because the Multiple Myeloma 
Service of the Memorial Sloan Kettering Cancer Institute is uniquely 
situated to support FDA's scientific mission of protecting and 
promoting the public health by initiating and facilitating research 
into demographic subpopulations of the United States. It has both the 
required patient population and the proprietary technical assays 
required to perform the proposed work.

II. Award Information/Funds Available

A. Award Amount

    It is anticipated that FDA/CDER will fund this Cooperative 
Agreement up to $172,000 in Fiscal Year (FY) 2015 and $106,000 in FY 
2016 in support of this program project. It is anticipated that only 
one award will be made, not to exceed $278,000 (direct plus indirect) 
for total costs. Awards are contingent upon the availability of funds.

B. Length of Support

    Two-year period of performance beginning on August 2015 or 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. 
Search by Funding Opportunity Number: RFA-FD-15-029. (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 on http://www.Grants.gov
     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: May 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12742 Filed 5-27-15; 8:45 am]
 BILLING CODE 4164-01-P