80 FR 28274 - Cooperative Agreement to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 95 (May 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 95 (May 18, 2015)
| Page Range | 28274-28275 | |
| FR Document | 2015-11847 |
[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)] [Notices] [Pages 28274-28275] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11847] ----------------------------------------------------------------------- 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: 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
![28274 Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices
cooperative agreement with the U.S. Dated: May 13, 2015. 93.103
Department of Education, Rehabilitation Kathy Greenlee,
A. Background
Services Administration. The Administrator and Assistant Secretary for
Department of Health and Human Aging. 1. Authority
Services is currently transitioning [FR Doc. 2015–11961 Filed 5–15–15; 8:45 am] FDA activities to increase the
programs under the AT Act to ACL. BILLING CODE 4154–01–P harmonization of regulatory
DATES: Estimated Project Period— requirements to ensure that safe,
September 30, 2015 through September effective, and high quality medicines are
DEPARTMENT OF HEALTH AND developed and registered in the most
30, 2016 HUMAN SERVICES resource-efficient manner are authorized
SUPPLEMENTARY INFORMATION: by 21 U.S.C. 383(c) and 393(b).
Food and Drug Administration
Program Name: Assistive Technology 2. Program Background
[Docket No. FDA–2015–N–0012]
National Activities.
The ICH is a globally unique venue
Award Amount: $640,000 to Cooperative Agreement to with the capability of bringing together
Rehabilitation Engineering and International Council for the regulatory authorities and
Assistive Technology Society of North Harmonization of Technical pharmaceutical industry to discuss
America; $100,000 to University of New Requirements for Pharmaceuticals for scientific and technical aspects of drug
Hampshire Institute on Disability. Human Use registration. ICH is a programmatic
Project Period: 9/30/2015 to 9/30/ AGENCY: Food and Drug Administration, global priority for FDA to achieve its
2016. HHS. identified strategic priority of
ACTION: Notice. globalization. Working through its
Award Type: Cooperative Agreement.
Center for Drug Evaluation and Research
Statutory Authority: This program is SUMMARY: The Food and Drug (CDER) and Center for Biologics
authorized under Section 6 of the Assistive Administration (FDA) is announcing the Evaluation and Research, FDA has
Technology Act of 1998, as amended (29 availability of grant funds for the played a leading role in ICH since its
U.S.C. 3005) support of the International Council for inception in 1990. ICH, founded to
Catalog of Federal Domestic Assistance Harmonization of Technical harmonize drug regulatory standards
(CFDA) Number: 93.464 Discretionary Requirements for Pharmaceuticals for between three regions, the United
Projects Human Use (ICH). The goal of the ICH States, the European Union, and Japan,
is to bring together leading global drug has gradually evolved to respond to the
Program Description regulatory agencies and pharmaceutical increasingly global face of drug
The purpose of the National Activities manufacturer associations to achieve development, so that the benefits of
cooperative agreements with RESNA greater harmonization of technical international harmonization for better
standards to ensure that safe, effective, global health can be realized worldwide.
and the University of New Hampshire is
and high-quality medicines are ICH’s mission is to achieve greater
to continue existing activities designed
developed and registered in the most harmonization to ensure that safe,
to support and improve the resource-efficient manner.
administration of the AT Act. The effective, and high-quality medicines
DATES: The application due date is are developed and registered in the most
grantees will continue to use both
September 30, 2015. The expiration date resource-efficient manner.
traditional and innovative approaches is October 1, 2015. Over the past 2 years, FDA played a
that will assist individuals and entities
ADDRESSES: Submit electronic leadership role in transforming ICH to
through information dissemination and
applications to: http://www.grants.gov. meet the challenges of 21st century
provide state-specific, regional and
For more information, see section III of standards development while firmly
national training and technical the SUPPLEMENTARY INFORMATION section positioning ICH future work to continue
assistance concerning assistive of this notice. the focus on technical standards
technology. harmonization informed by relevant
FOR FURTHER INFORMATION CONTACT:
Justification: ACL is currently Tracy Porter, Office of Strategic expertise from regulatory agencies and
working on transitioning the Assistive Programs, Food and Drug regulated industry. This effort has
Technology National Activities program Administration, 10903 New Hampshire included: (1) Establishing ICH as a
to ACL. To ensure uninterrupted Ave., Bldg. 51, Rm. 1173, Silver Spring, formal legal entity in the form of a
continuation of the grant goals and MD 20993, 301–796–7789, nonprofit association under Swiss law;
objectives, ACL plans to issue a one year Tracy.Porter@fda.hhs.gov; or Lisa Ko, (2) expanding the opportunities for
non-competing award to both RESNA Office of Acquisitions and Grants formal participation of other drug
and the University of New Hampshire. Services, Food and Drug regulatory authorities beyond the three
Administration, 5630 Fishers Lane, Rm. founding regions via the ICH Assembly;
FOR FURTHER INFORMATION CONTACT: For 2037, Rockville, MD 20857, 240–402– and (3) ensuring adequate and
further information or comments 7592, Lisa.Ko@fda.hhs.gov. predictable funding for the ICH
regarding this action, contact Lori For more information on this funding harmonization work (which is also
Gerhard, U.S. Department of Health and opportunity announcement (FOA) and critical to FDA’s mission).
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Human Services, Administration for to obtain detailed requirements, please FDA remains an ICH founding
Community Living, Center for refer to the full FOA located at http:// member and completely committed to
Consumer Access and Self- www.grants.gov. Search by Funding ICH success as a science-based
Determination, Office of Integrated Opportunity Number: RFA–FD–15–014. standards development venue to ensure
Programs, One Massachusetts Avenue SUPPLEMENTARY INFORMATION: harmonization globally for safe,
NW., Washington, DC 20001; telephone effective, and high-quality medicines.
(202) 357–3443; fax (202) 357–3469; I. Funding Opportunity Description As exemplified in the past 25 years,
email Lori.Gerhard@acl.hhs.gov. RFA–FD–15–014 FDA leadership and participation is an
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![Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices 28275
absolutely essential element for ICH CDER anticipates providing four DEPARTMENT OF HEALTH AND
success. additional years of support up to the HUMAN SERVICES
following amounts:
B. Research Objectives Food and Drug Administration
The program’s grant funds will FY 2017: $500,000
FY 2018: $500,000 [Docket No. FDA–2015–N–1377]
support the ICH to develop a series of
international guidelines for FY 2019: $500,000 Electronic Study Data Submission;
implementation according to each Data Standards; Study Data
region’s requirements aimed at FY 2020: $500,000
Standardization Plan
achieving the following: (1) Develop and B. Length of Support Recommendations
register safe, effective, and high quality
medicines in the most efficient and cost The support will be 1 year with the AGENCY: Food and Drug Administration,
effective manner; (2) prevent possibility of an additional 4 years of HHS.
unnecessary duplication of clinical noncompetitive support. Continuation ACTION: Notice; request for comments.
trials and minimize the use of animal beyond the first year will be based on
testing without compromising safety satisfactory performance during the The Food and Drug
SUMMARY:
and effectiveness, and (3) provide preceding year, receipt of a Administration (FDA) is announcing the
public assurance that the rights, safety, noncompeting continuation application availability of draft recommendations
and well-being of subjects are protected and available Federal FY for preparing a Study Data
during clinical trials. appropriations. Standardization Plan (Standardization
The ICH aims to make information Plan). The Standardization Plan is
III. Electronic Application,
readily available on ICH, ICH activities, referenced in the Study Data Technical
Registration, and Submission
and ICH guidelines to any country or Conformance Guide (Guide). The Guide
company that requests the information. Only electronic applications will be supplements the guidance for industry
Additionally, the organization promotes accepted. To submit an electronic ‘‘Providing Regulatory Submissions in
a mutual understanding of regional application in response to this FOA, Electronic Format—Standardized Study
initiatives in order to facilitate applicants should first review the full Data’’ and provides specifications,
harmonization processes related to ICH announcement located at http:// recommendations, and general
guidelines regionally and globally, and www.grants.gov. (FDA has verified the considerations on submitting
to strengthen the capacity of drug Web site addresses throughout this standardized study data using FDA-
regulatory authorities and industry to document, but FDA is not responsible supported data standards. The Guide
utilize the guidelines. These objectives for any subsequent changes to the Web recommends that, for clinical and
will be accomplished by bringing sites after this document publishes in nonclinical studies, sponsors include a
together representatives from both the Federal Register.) Search by plan that describes the submission of
regulatory agencies and pharmaceutic Funding Opportunity Number: RFA– standardized study data to FDA. The
industries from the three founding FD–15–014. proposed recommendations describe the
regions to establish guidelines. information that should be included in
For all electronically submitted the Standardization Plan. The proposed
C. Eligibility Information applications, the following steps are recommendations for creating a
The following organization is eligible required. Standardization Plan are posted on
to apply: ICH. Within the ICH, the • Step 1: Obtain a Dun and Bradstreet FDA’s Study Data Standards Resources
mission is to make recommendations (DUNS) Number Web page at http://www.fda.gov/
towards achieving greater • Step 2: Register With System for forindustry/datastandards/
harmonization in the interpretation and Award Management (SAM) studydatastandards/default.htm.
application of technical guidelines and DATES: Although you can comment on
requirements for pharmaceutical • Step 3: Obtain Username & Password
these recommendations at any time, to
product registration, thereby reducing or • Step 4: Authorized Organization ensure that the Agency considers your
obviating duplication of testing carried Representative (AOR) Authorization comments, please submit either
out during the research and • Step 5: Track AOR Status electronic or written comments by July
development of new human medicines. 2, 2015.
Leveraging its status as a neutral • Step 6: Register With Electronic
Research Administration (eRA) ADDRESSES: Submit written requests for
nonprofit entity focused on technical single copies of the recommendations to
standards harmonization, the ICH aims Commons
the Division of Drug Information, Center
to promote international harmonization Steps 1 through 5, in detail, can be for Drug Evaluation and Research, Food
of drug regulatory standards by bringing found at http://www07.grants.gov/ and Drug Administration, 10903 New
together representatives from both applicants/organization_registration.jsp. Hampshire Ave., Hillandale Building,
regulatory agencies and pharmaceutic Step 6, in detail, can be found at 4th Floor, Silver Spring, MD 20993–
industry to discuss and establish https://commons.era.nih.gov/commons/ 0002; or the Office of Communication,
common guidelines. registration/registrationInstructions.jsp. Outreach, and Development, Center for
After you have followed these steps, Biologics Evaluation and Research,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
II. Award Information/Funds Available
submit electronic applications to: Food and Drug Administration, 10903
A. Award Amount http://www.grants.gov. New Hampshire Ave., Bldg. 71, Rm.
FDA intends to fund one award, Dated: May 11, 2015. 3128, Silver Spring, MD 20993–0002.
corresponding to a total of up to Send one self-addressed adhesive label
Leslie Kux,
$500,000, for fiscal year (FY) 2016. to assist that office in processing your
Future year amounts will depend on Associate Commissioner for Policy. requests.
annual appropriations, availability of [FR Doc. 2015–11847 Filed 5–15–15; 8:45 am] Submit electronic comments to
funding, and awardee performance. BILLING CODE 4164–01–P http://www.regulations.gov. Submit
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Document Created: 2015-12-16 07:39:00
Document Modified: 2015-12-16 07:39:00
| 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 | Notice. | |
| Dates | The application due date is September 30, 2015. The expiration date is October 1, 2015. | |
| 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] | |
| FR Citation | 80 FR 28274 |
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