Opportunity ID: 231024

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-13-030
Funding Opportunity Title: In vitro-In vivo Correlations of Parenteral Microsphere Drug Products
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Business and Commerce
Education
Category Explanation:
Expected Number of Awards: 1
Assistance Listings: 93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 4
Posted Date: Apr 18, 2013
Last Updated Date: Jun 03, 2013
Original Closing Date for Applications: Jun 01, 2013
Current Closing Date for Applications: Jun 04, 2013
Archive Date:
Estimated Total Program Funding: $500,000
Award Ceiling: $500,000
Award Floor: $5,000

Eligibility

Eligible Applicants: Native American tribal governments (Federally recognized)
State governments
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Independent school districts
Private institutions of higher education
For profit organizations other than small businesses
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Public and State controlled institutions of higher education
Small businesses
County governments
Additional Information on Eligibility: Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)
Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession
Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Additional Information

Agency Name: Food and Drug Administration
Description: The purpose of this study is to investigate in vitro-in vivo correlations of parenteral microspheres. The encapsulated agent may be a small molecule or peptide, and the dosage form should be an injectable. An in vitro dissolution test which correlates with in vivo absorption should be investigated. In vivo studies should be conducted in a suitable animal model.The results from this project will help to understand the release mechanisms of microspheres and how in vitro studies could be used to predict in vivo bioavailability.
Link to Additional Information: NIH Guide for Grants and Contracts
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Jennerfer Torres-Hernandez

Grants Management Specialist

Phone 301-827-9607
Email:Jennerfer.Torres-Hernandez@fda.hhs.gov

Version History

Version Modification Description Updated Date
update closing date Jun 03, 2013
update closing date to 6/3/2013 until 11:59pm ET. Jun 03, 2013
update URL. Jun 03, 2013
Apr 18, 2013

DISPLAYING: Synopsis 4

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-13-030
Funding Opportunity Title: In vitro-In vivo Correlations of Parenteral Microsphere Drug Products
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Business and Commerce
Education
Category Explanation:
Expected Number of Awards: 1
Assistance Listings: 93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 4
Posted Date: Apr 18, 2013
Last Updated Date: Jun 03, 2013
Original Closing Date for Applications: Jun 01, 2013
Current Closing Date for Applications: Jun 04, 2013
Archive Date:
Estimated Total Program Funding: $500,000
Award Ceiling: $500,000
Award Floor: $5,000

Eligibility

Eligible Applicants: Native American tribal governments (Federally recognized)
State governments
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Independent school districts
Private institutions of higher education
For profit organizations other than small businesses
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Public and State controlled institutions of higher education
Small businesses
County governments
Additional Information on Eligibility: Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)
Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession
Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Additional Information

Agency Name: Food and Drug Administration
Description: The purpose of this study is to investigate in vitro-in vivo correlations of parenteral microspheres. The encapsulated agent may be a small molecule or peptide, and the dosage form should be an injectable. An in vitro dissolution test which correlates with in vivo absorption should be investigated. In vivo studies should be conducted in a suitable animal model.The results from this project will help to understand the release mechanisms of microspheres and how in vitro studies could be used to predict in vivo bioavailability.
Link to Additional Information: NIH Guide for Grants and Contracts
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Jennerfer Torres-Hernandez

Grants Management Specialist

Phone 301-827-9607
Email:Jennerfer.Torres-Hernandez@fda.hhs.gov

DISPLAYING: Synopsis 3

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-13-030
Funding Opportunity Title: In vitro-In vivo Correlations of Parenteral Microsphere Drug Products
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Business and Commerce
Education
Category Explanation:
Expected Number of Awards: 1
Assistance Listings: 93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 3
Posted Date: Jun 03, 2013
Last Updated Date:
Original Closing Date for Applications:
Current Closing Date for Applications: Jun 03, 2013
Archive Date:
Estimated Total Program Funding: $500,000
Award Ceiling: $500,000
Award Floor: $5,000

Eligibility

Eligible Applicants: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Small businesses
State governments
County governments
Native American tribal governments (Federally recognized)
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
City or township governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)
Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession
Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Additional Information

Agency Name: Food and Drug Administration
Description: The purpose of this study is to investigate in vitro-in vivo correlations of parenteral microspheres. The encapsulated agent may be a small molecule or peptide, and the dosage form should be an injectable. An in vitro dissolution test which correlates with in vivo absorption should be investigated. In vivo studies should be conducted in a suitable animal model.The results from this project will help to understand the release mechanisms of microspheres and how in vitro studies could be used to predict in vivo bioavailability.
Link to Additional Information: NIH Guide for Grants and Contracts
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Jennerfer Torres-Hernandez

Grants Management Specialist

Phone 301-827-9607
Email:Jennerfer.Torres-Hernandez@fda.hhs.gov

DISPLAYING: Synopsis 2

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-13-030
Funding Opportunity Title: In vitro-In vivo Correlations of Parenteral Microsphere Drug Products
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Business and Commerce
Education
Category Explanation:
Expected Number of Awards: 1
Assistance Listings: 93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Jun 03, 2013
Last Updated Date:
Original Closing Date for Applications:
Current Closing Date for Applications: Jun 01, 2013
Archive Date:
Estimated Total Program Funding: $500,000
Award Ceiling: $500,000
Award Floor: $5,000

Eligibility

Eligible Applicants: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Small businesses
County governments
State governments
Native American tribal governments (Federally recognized)
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
City or township governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)
Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession
Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Additional Information

Agency Name: Food and Drug Administration
Description: The purpose of this study is to investigate in vitro-in vivo correlations of parenteral microspheres. The encapsulated agent may be a small molecule or peptide, and the dosage form should be an injectable. An in vitro dissolution test which correlates with in vivo absorption should be investigated. In vivo studies should be conducted in a suitable animal model.The results from this project will help to understand the release mechanisms of microspheres and how in vitro studies could be used to predict in vivo bioavailability.
Link to Additional Information: NIH Guide for Grants and Contracts
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Jennerfer Torres-Hernandez

Grants Management Specialist

Phone 301-827-9607
Email:Jennerfer.Torres-Hernandez@fda.hhs.gov

DISPLAYING: Synopsis 1

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-13-030
Funding Opportunity Title: In vitro-In vivo Correlations of Parenteral Microsphere Drug Products
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Business and Commerce
Education
Category Explanation:
Expected Number of Awards: 1
Assistance Listings: 93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Apr 18, 2013
Last Updated Date:
Original Closing Date for Applications:
Current Closing Date for Applications: Jun 01, 2013
Archive Date:
Estimated Total Program Funding: $500,000
Award Ceiling: $500,000
Award Floor: $5,000

Eligibility

Eligible Applicants: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Small businesses
State governments
County governments
Native American tribal governments (Federally recognized)
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
City or township governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)
Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession
Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Additional Information

Agency Name: Food and Drug Administration
Description: The purpose of this study is to investigate in vitro-in vivo correlations of parenteral microspheres. The encapsulated agent may be a small molecule or peptide, and the dosage form should be an injectable. An in vitro dissolution test which correlates with in vivo absorption should be investigated. In vivo studies should be conducted in a suitable animal model.

The results from this project will help to understand the release mechanisms of microspheres and how in vitro studies could be used to predict in vivo bioavailability.

Link to Additional Information: NIH Guide for Grants and Contracts
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Jennerfer Torres-Hernandez

Grants Management Specialist

Phone 301-827-9607
Email:Jennerfer.Torres-Hernandez@fda.hhs.gov

Related Documents

Packages

Agency Contact Information: Jennerfer Torres-Hernandez
Grants Management Specialist
Phone 301-827-9607
Email: Jennerfer.Torres-Hernandez@fda.hhs.gov
Who Can Apply: Organization Applicants

Assistance Listing Number Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions
93.103 PKG00174250 May 01, 2013 Jun 04, 2013 View

Package 1

Mandatory forms

231024 RR_SF424_1_2-1.2.pdf

231024 PerformanceSite_1_4-1.4.pdf

231024 RR_OtherProjectInfo_1_3-1.3.pdf

231024 RR_KeyPersonExpanded_1_2-1.2.pdf

231024 RR_Budget-1.1.pdf

231024 PHS398_CoverPageSupplement_1_4-1.4.pdf

231024 PHS398_ResearchPlan_1_3-1.3.pdf

231024 PHS398_Checklist_1_3-1.3.pdf

Optional forms

231024 RR_SubawardBudget30-1.2.pdf

231024 PHS_CoverLetter_1_2-1.2.pdf

2025-07-11T17:08:03-05:00

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