America’s Blood Centers (ABC) has submitted a comments to the U.S. Department of Health and Human Services (HHS) regarding unnecessary regulations. Specifically, the comment letter came in response to a Request for Information (RFI) to identify and eliminate outdated or unnecessary regulations. The comments to HHS regarding unnecessary regulations addressed to HHS Secretary Kennedy outlines and prioritizes 12 recommendations regarding regulations and guidance that ABC urges the agency to modify or repeal. The recommendations from ABC include:
- “[m]inimizing the duplicative data currently required by the U.S. Food and Drug Administration (FDA) and allowing the immediate implementation of all types of apheresis product collections at new fixed site locations” by amending the guidances ‘Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods;’ and ‘Collection of Platelets by Automated Methods;’”
- removing the hepatitis B surface antigen (HBsAg) testing requirement for whole blood and blood components intended for transfusion in the guidance titled: “Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus;”
- revising the guidance titled “‘Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II)‘ to require one-time donor testing for antibodies to HTLV-I/II coupled with effective leukoreduction in donations of whole blood and blood components intended for transfusion;”
- withdrawing the draft guidance titled “‘Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria‘ to ensure there are no requirements for malaria testing of blood donations at this time;”
- promoting innovation and blood product availability by reducing the “platelet content requirement (PCR) from 3 x 1011/unit to 2.5 x 1011/unit to expand platelet supply availability and align with international standards;”
- eliminating the current expiration requirement for recovered plasma to allow blood centers, “to convert plasma collected through apheresis methods from transfusable to recovered plasma for further manufacturing;”
- encouraging FDA to, “reduce undue burdens associated with refrigeration requirements beyond eight hours, and allow for the processing of more platelet products, and more platelets in inventory, [by allowing] blood to be held at room temperature for up to 24 hours prior to processing into components, in line with current evidence and international standards;
- FDA should allow source plasma to be held at room temperature for up to 24 hours prior to freezing, in line with international standards. The 24-hour hold is more flexible for blood centers’ operation, as they can use staff more efficiently in manufacturing plasma (e.g. they can batch plasma and freeze it all at the same time instead of one at a time as it is collected). Additionally, a 24-hour hold is more effective for blood inventory management;
- FDA should quickly move to modify the criteria for use of cold-stored platelets (CSP), based upon the data obtained from the CHIlled Platelet Study (CHIPS) [permitting CSP] for any use, or at the discretion of the transfusing physician;
- FDA should allow a qualified physician’s designee to perform a donor physical assessment and documentation for blood pressure and pulse, when a donor’s measurements fall outside of the required measurements, to determine whether a donor is permitted to donate. Allowing a qualified physician’s designee to perform these functions would maintain the health of the donor, while allowing the physician to perform other essential clinical and medical functions of blood collection and patient safety oversight;”
- FDA is urged in the comments to develop, “a pre-approved framework for commonly requested variances or alternative procedures to expedite innovation and pilot testing;” and
- the comment letter encourages FDA to, “allow the determination of donor eligibility within 24 hours before collection.”
The full letter is available on the ABC website which contains all comments to HHS regarding unnecessary regulations. We thank all members for their input in the development of the comment letter. ABC will continue to provide updates on its advocacy efforts as they become available.
The HHS RFI was part of a broader federal effort to reduce regulatory burdens and increase transparency, in alignment with President Trump’s Executive Order 14192 titled, “Unleashing Prosperity Through Deregulation.” Through the Executive Order, HHS intends to implement:
- “[t]he 10-to-1 rule: For every new regulation introduced, at least ten existing regulations must be eliminated;
- [r]egulatory cost cap: The total cost of all new regulations in fiscal year 2025 must be significantly less than zero;
- [e]xpanded scope: The order applies not only to formal regulations but also to guidance documents, memoranda, policy statements, and similar directives; [and]
- [r]adical transparency: HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset, promoting greater transparency and accountability.”