Cooperative Agreement to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, 28274-28275 [2015-11847]

Download as PDF 28274 Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices Estimated Project Period— September 30, 2015 through September 30, 2016 Dated: May 13, 2015. Kathy Greenlee, Administrator and Assistant Secretary for Aging. 93.103 [FR Doc. 2015–11961 Filed 5–15–15; 8:45 am] Food and Drug Administration cooperative agreement with the U.S. Department of Education, Rehabilitation Services Administration. The Department of Health and Human Services is currently transitioning programs under the AT Act to ACL. 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). [Docket No. FDA–2015–N–0012] 2. Program Background BILLING CODE 4154–01–P DATES: SUPPLEMENTARY INFORMATION: Program Name: Assistive Technology National Activities. Award Amount: $640,000 to Rehabilitation Engineering and Assistive Technology Society of North America; $100,000 to University of New Hampshire Institute on Disability. Project Period: 9/30/2015 to 9/30/ 2016. Award Type: Cooperative Agreement. Statutory Authority: This program is authorized under Section 6 of the Assistive Technology Act of 1998, as amended (29 U.S.C. 3005) Catalog of Federal Domestic Assistance (CFDA) Number: 93.464 Discretionary Projects The purpose of the National Activities cooperative agreements with RESNA and the University of New Hampshire is to continue existing activities designed to support and improve the administration of the AT Act. The grantees will continue to use both traditional and innovative approaches that will assist individuals and entities through information dissemination and provide state-specific, regional and national training and technical assistance concerning assistive technology. Justification: ACL is currently working on transitioning the Assistive Technology National Activities program to ACL. To ensure uninterrupted continuation of the grant goals and objectives, ACL plans to issue a one year non-competing award to both RESNA and the University of New Hampshire. For further information or comments regarding this action, contact Lori Gerhard, U.S. Department of Health and Human Services, Administration for Community Living, Center for Consumer Access and SelfDetermination, Office of Integrated Programs, One Massachusetts Avenue NW., Washington, DC 20001; telephone (202) 357–3443; fax (202) 357–3469; email Lori.Gerhard@acl.hhs.gov. asabaliauskas on DSK5VPTVN1PROD with NOTICES VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 Cooperative Agreement to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use 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 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: https://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, Tracy.Porter@fda.hhs.gov; or Lisa Ko, Office of Acquisitions and Grants Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 2037, Rockville, MD 20857, 240–402– 7592, Lisa.Ko@fda.hhs.gov. 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. Search by Funding Opportunity Number: RFA–FD–15–014. SUPPLEMENTARY INFORMATION: SUMMARY: Program Description FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES I. Funding Opportunity Description RFA–FD–15–014 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 A. Background 1. Authority 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 E:\FR\FM\18MYN1.SGM 18MYN1 Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices CDER anticipates providing four additional years of support up to the following amounts: 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 28275 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration FY 2017: $500,000 FY 2018: $500,000 FY 2019: $500,000 FY 2020: $500,000 [Docket No. FDA–2015–N–1377] Electronic Study Data Submission; Data Standards; Study Data Standardization Plan Recommendations 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. AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA) is announcing the availability of draft recommendations for preparing a Study Data Standardization Plan (Standardization Plan). The Standardization Plan is III. Electronic Application, referenced in the Study Data Technical Registration, and Submission Conformance Guide (Guide). The Guide supplements the guidance for industry Only electronic applications will be ‘‘Providing Regulatory Submissions in accepted. To submit an electronic Electronic Format—Standardized Study application in response to this FOA, Data’’ and provides specifications, applicants should first review the full recommendations, and general announcement located at https:// considerations on submitting www.grants.gov. (FDA has verified the standardized study data using FDAWeb site addresses throughout this supported data standards. The Guide document, but FDA is not responsible recommends that, for clinical and for any subsequent changes to the Web nonclinical studies, sponsors include a sites after this document publishes in plan that describes the submission of the Federal Register.) Search by standardized study data to FDA. The Funding Opportunity Number: RFA– proposed recommendations describe the FD–15–014. information that should be included in For all electronically submitted the Standardization Plan. The proposed applications, the following steps are recommendations for creating a required. Standardization Plan are posted on FDA’s Study Data Standards Resources • Step 1: Obtain a Dun and Bradstreet Web page at https://www.fda.gov/ (DUNS) Number forindustry/datastandards/ • Step 2: Register With System for studydatastandards/default.htm. Award Management (SAM) DATES: Although you can comment on • Step 3: Obtain Username & Password these recommendations at any time, to • Step 4: Authorized Organization ensure that the Agency considers your Representative (AOR) Authorization comments, please submit either electronic or written comments by July • Step 5: Track AOR Status 2, 2015. • Step 6: Register With Electronic ADDRESSES: Submit written requests for Research Administration (eRA) single copies of the recommendations to Commons the Division of Drug Information, Center for Drug Evaluation and Research, Food Steps 1 through 5, in detail, can be and Drug Administration, 10903 New found at https://www07.grants.gov/ applicants/organization_registration.jsp. Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– Step 6, in detail, can be found at https://commons.era.nih.gov/commons/ 0002; or the Office of Communication, registration/registrationInstructions.jsp. Outreach, and Development, Center for Biologics Evaluation and Research, After you have followed these steps, Food and Drug Administration, 10903 submit electronic applications to: New Hampshire Ave., Bldg. 71, Rm. https://www.grants.gov. 3128, Silver Spring, MD 20993–0002. Dated: May 11, 2015. Send one self-addressed adhesive label Leslie Kux, to assist that office in processing your Associate Commissioner for Policy. requests. [FR Doc. 2015–11847 Filed 5–15–15; 8:45 am] Submit electronic comments to https://www.regulations.gov. Submit BILLING CODE 4164–01–P PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 SUMMARY: E:\FR\FM\18MYN1.SGM 18MYN1

Agencies

[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.

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

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: https://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, 
Tracy.Porter@fda.hhs.gov; or Lisa Ko, Office of Acquisitions and Grants 
Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 2037, 
Rockville, MD 20857, 240-402-7592, Lisa.Ko@fda.hhs.gov.
    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. 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 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.) 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 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 electronic applications to: https://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
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