2011-20861. Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors.” The purpose of this public workshop is to discuss blood donor hemoglobin and hematocrit qualification standards in the United States, its impact on donor safety and blood availability, and potential measures to maintain adequate iron stores in blood donors. The public workshop has been planned in partnership with the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Health, the National Heart, Lung and Blood Institute, America's Blood Centers, AABB, and the Plasma Protein Therapeutics Association. This public workshop will include presentations and panel discussions by experts knowledgeable in the field from academic institutions, government agencies, and industry.

Dates and Times: The public workshop will be held on November 8, 2011, from 8 a.m. to 5:30 p.m. and November 9, 2011, from 8 a.m. to 3 p.m.

Location: The public workshop will be held at the Natcher Conference Center, Main Auditorium, Building 45, National Institutes of Health, 45 Center Dr., Bethesda, MD 20892.

Contact Person: Rhonda Dawson, Center for Biologics Evaluation and Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6129, FAX: [phone], e-mail: [e-mail].

Registration: Mail, fax, or email your registration information (including name, title, firm name, address, telephone and fax numbers) to Rhonda Dawson (see Contact Person) by October 14, 2011. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m.

If you need special accommodations due to a disability, please contact Rhonda Dawson (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

Under FDA's current regulations, allogeneic blood donors must have a hemoglobin level of no less than 12.5 grams of hemoglobin per 100 milliliters of blood or a hematocrit value of 38 percent prior to donation (21 CFR 640.3(b)(3) and 640.63(c)(3)). Hemoglobin and hematocrit measurements are typically obtained from a small sample of blood drawn from a finger or vein. New technologies that potentially allow for less invasive, faster, and more convenient methods of measuring blood donor hemoglobin and hematocrit levels are being studied. A low donor hemoglobin and hematocrit level is the most common reason that prospective blood donors, particularly women, are deferred.

Allogeneic donors of a unit of red blood cells generally may not donate more than once in an 8 week period to ensure recovery of their red blood cells and iron stores (21 CFR 640.3). Nonetheless, some donors, especially repeat and premenopausal female donors, can develop iron deficiency, with or without anemia, from blood donation. Improved understanding of iron loss in blood donors may help reduce donor deferrals due to low hemoglobin and hematocrit levels and reduce iron deficiency that can result from blood donation. Different strategies to minimize iron deficiency in blood donors (e.g., testing for iron stores, adjusting the donation interval, or providing iron replacement) have been explored in the past. Changes in qualifying hemoglobin levels have been discussed in various forums for both men and women to bring these levels into closer concordance with population norms. However, the potential risks and benefits of these strategies require further discussion.

This public workshop will serve as a forum for discussion of hemoglobin and hematocrit donation standards, current methods for hemoglobin measurement, iron loss and iron measurement methods in blood donors, and strategies to maintain adequate donor iron stores. The first day of the public workshop will include presentations and panel discussions on the following topics: (1) Hemoglobin standards for blood donors in the United States; (2) studies of hemoglobin distribution and deferral patterns in blood donors; and (3) measurement of hemoglobin and hematocrit and iron levels in blood donors. The second day of the public workshop will include a discussion of the following topics: (1) Iron metabolism, iron stores and iron deficiency in blood donors; and (2) potential methods to maintain adequate iron stores in blood donors, including adjustment of the interdonation interval, iron measurement and iron replacement.

Transcripts: Please be advised that as soon as possible after a transcript of the public workshop is available, it will be accessible on the Internet at: http://www.fda.gov/​BiologicsBloodVaccines/​NewsEvents/​WorkshopsMeetingsConferences/​TranscriptsMinutes/​default.htm. Transcripts of the public workshop may also be requested in writing from the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

Dated: August 10, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.