Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional

Key Facts

Status: Forecasted

Posted date: July 20, 2026

Archive date: September 19, 2026

Close date: August 20, 2026

Opportunity ID: 363255

Opportunity number: RFA-FD-26-012

Opportunity category: Discretionary

Agency name: Food and Drug Administration

Agency code: HHS-FDA

Award floor: $0

Award ceiling: $1,100,000

Cost sharing required: No

Funding Instrument Types
  • Cooperative Agreement
Category of Funding Activity
  • Agriculture
  • Consumer Protection
  • Food and Nutrition
Eligible Applicants
  • City or township governments
  • County governments
  • For-profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Small businesses
  • Special district governments
  • State governments
Tools
Categories (use these for quoted searches)
  • agency_code:hhs_fda
  • category_of_funding_activity:agriculture
  • category_of_funding_activity:consumer_protection
  • category_of_funding_activity:food_and_nutrition
  • cost_sharing_or_matching_requirement:false
  • eligible_applicants:city_or_township_governments
  • eligible_applicants:county_governments
  • eligible_applicants:for_profit_organizations_other_than_small_businesses
  • eligible_applicants:independent_school_districts
  • eligible_applicants:native_american_tribal_governments_federally_recognized
  • eligible_applicants:native_american_tribal_organizations_other_than_federally_recognized_tribal_governments
  • eligible_applicants:nonprofits_having_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:nonprofits_that_do_not_have_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:private_institutions_of_higher_education
  • eligible_applicants:public_and_state_controlled_institutions_of_higher_education
  • eligible_applicants:public_housing_authoritiesindian_housing_authorities
  • eligible_applicants:small_businesses
  • eligible_applicants:special_district_governments
  • eligible_applicants:state_governments
  • funding_instrument_type:cooperative_agreement
  • opportunity_category:discretionary
  • status:forecasted
Description

The purpose of this Notice of Funding Opportunity (NOFO) is to address topics related to the use of digital health technologies (DHTs) for remote data acquisition in clinical investigations to support drug development.

Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional
The purpose of this Notice of Funding Opportunity (NOFO) is to address topics related to the use of digital health technologies (DHTs) for remote data acquisition in clinical investigations to support drug development.
[Forecasted] Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional
Forecasted
Food and Drug Administration
Agriculture
Consumer Protection
Food and Nutrition
Cooperative Agreement
State governments
County governments
City or township governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For-profit organizations other than small businesses
Small businesses
2026-07-20