[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28274-28275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11847]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Cooperative Agreement to International Council for Harmonization 
of Technical Requirements for Pharmaceuticals for Human Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of the International 
Council for Harmonization of Technical Requirements for Pharmaceuticals 
for Human Use (ICH). The goal of the ICH is to bring together leading 
global drug regulatory agencies and pharmaceutical manufacturer 
associations to achieve greater harmonization of technical standards to 
ensure that safe, effective, and high-quality medicines are developed 
and registered in the most resource-efficient manner.

DATES: The application due date is September 30, 2015. The expiration 
date is October 1, 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: Tracy Porter, Office of Strategic 
Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 1173, Silver Spring, MD 20993, 301-796-7789, 
[email protected]; or Lisa Ko, Office of Acquisitions and Grants 
Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 2037, 
Rockville, MD 20857, 240-402-7592, [email protected].
    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-15-014.

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description

RFA-FD-15-014
93.103

A. Background

1. Authority
    FDA activities to increase the harmonization of regulatory 
requirements to ensure that safe, effective, and high quality medicines 
are developed and registered in the most resource-efficient manner are 
authorized by 21 U.S.C. 383(c) and 393(b).
2. Program Background
    The ICH is a globally unique venue with the capability of bringing 
together the regulatory authorities and pharmaceutical industry to 
discuss scientific and technical aspects of drug registration. ICH is a 
programmatic global priority for FDA to achieve its identified 
strategic priority of globalization. Working through its Center for 
Drug Evaluation and Research (CDER) and Center for Biologics Evaluation 
and Research, FDA has played a leading role in ICH since its inception 
in 1990. ICH, founded to harmonize drug regulatory standards between 
three regions, the United States, the European Union, and Japan, has 
gradually evolved to respond to the increasingly global face of drug 
development, so that the benefits of international harmonization for 
better global health can be realized worldwide. ICH's mission is to 
achieve greater harmonization to ensure that safe, effective, and high-
quality medicines are developed and registered in the most resource-
efficient manner.
    Over the past 2 years, FDA played a leadership role in transforming 
ICH to meet the challenges of 21st century standards development while 
firmly positioning ICH future work to continue the focus on technical 
standards harmonization informed by relevant expertise from regulatory 
agencies and regulated industry. This effort has included: (1) 
Establishing ICH as a formal legal entity in the form of a nonprofit 
association under Swiss law; (2) expanding the opportunities for formal 
participation of other drug regulatory authorities beyond the three 
founding regions via the ICH Assembly; and (3) ensuring adequate and 
predictable funding for the ICH harmonization work (which is also 
critical to FDA's mission).
    FDA remains an ICH founding member and completely committed to ICH 
success as a science-based standards development venue to ensure 
harmonization globally for safe, effective, and high-quality medicines. 
As exemplified in the past 25 years, FDA leadership and participation 
is an

[[Page 28275]]

absolutely essential element for ICH success.

B. Research Objectives

    The program's grant funds will support the ICH to develop a series 
of international guidelines for implementation according to each 
region's requirements aimed at achieving the following: (1) Develop and 
register safe, effective, and high quality medicines in the most 
efficient and cost effective manner; (2) prevent unnecessary 
duplication of clinical trials and minimize the use of animal testing 
without compromising safety and effectiveness, and (3) provide public 
assurance that the rights, safety, and well-being of subjects are 
protected during clinical trials.
    The ICH aims to make information readily available on ICH, ICH 
activities, and ICH guidelines to any country or company that requests 
the information. Additionally, the organization promotes a mutual 
understanding of regional initiatives in order to facilitate 
harmonization processes related to ICH guidelines regionally and 
globally, and to strengthen the capacity of drug regulatory authorities 
and industry to utilize the guidelines. These objectives will be 
accomplished by bringing together representatives from both regulatory 
agencies and pharmaceutic industries from the three founding regions to 
establish guidelines.

C. Eligibility Information

    The following organization is eligible to apply: ICH. Within the 
ICH, the mission is to make recommendations towards achieving greater 
harmonization in the interpretation and application of technical 
guidelines and requirements for pharmaceutical product registration, 
thereby reducing or obviating duplication of testing carried out during 
the research and development of new human medicines. Leveraging its 
status as a neutral nonprofit entity focused on technical standards 
harmonization, the ICH aims to promote international harmonization of 
drug regulatory standards by bringing together representatives from 
both regulatory agencies and pharmaceutic industry to discuss and 
establish common guidelines.

II. Award Information/Funds Available

A. Award Amount

    FDA intends to fund one award, corresponding to a total of up to 
$500,000, for fiscal year (FY) 2016. Future year amounts will depend on 
annual appropriations, availability of funding, and awardee 
performance. CDER anticipates providing four additional years of 
support up to the following amounts:

FY 2017: $500,000
FY 2018: $500,000
FY 2019: $500,000
FY 2020: $500,000

B. Length of Support

    The support will be 1 year with the possibility of an additional 4 
years of noncompetitive support. Continuation beyond the first year 
will be based on satisfactory performance during the preceding year, 
receipt of a noncompeting continuation application and available 
Federal FY appropriations.

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 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.) Search by Funding 
Opportunity Number: RFA-FD-15-014.
    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 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 electronic applications to: http://www.grants.gov.

    Dated: May 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11847 Filed 5-15-15; 8:45 am]
 BILLING CODE 4164-01-P