Opportunity
Federal Register #0906-0009-Revision
FDA Priority Review for LOARGYS and HRSA Data Collection Revisions
Buyer
Health Resources and Services Administration
Posted
April 07, 2026
Respond By
June 08, 2026
Identifier
0906-0009-Revision
NAICS
541690, 541720, 621511
This summary covers recent federal actions related to health care and pharmaceuticals: - Government Buyers: - Department of Health and Human Services - Food and Drug Administration (FDA), Center for Drug Evaluation and Research - Health Resources and Services Administration (HRSA) - OEMs and Vendors: - Immedica Pharma AB (manufacturer of LOARGYS) - Products/Services Requested: - LOARGYS (pegzilarginase-nbln) injection for treatment of hyperargininemia in patients 2 years and older with Arginase 1 Deficiency - Part number: pegzilarginase-nbln - No quantity specified - Rural Health Care Services Outreach Program Measures - Annual data collection and performance measurement for 58 Outreach award recipients - Includes new maternal health measures for 11 recipients in the Healthy Rural Hometown Initiative Track - Addition of a sustainability question - Unique or Notable Requirements: - LOARGYS is specifically indicated for use with dietary protein restriction - Data collection revisions focus on maternal health and program sustainability - Locations: - Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, Room 5324, Silver Spring, MD 20993-0002 - Health Resources and Services Administration (federal office)
Description
The Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for the Rural Health Care Services Outreach Program Measures. This program aims to improve and expand health care services in rural areas by collecting performance data from award recipients. The proposed revisions include consolidating sub-sections, adding new maternal health measures for specific awardees, and incorporating a sustainability question, with an estimated annual burden of 507.5 hours across 58 respondents. HRSA seeks public comments on the burden estimate and other aspects of the ICR before submission to OMB.