[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51041-51042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20861]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


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: 301-827-2843, 
e-mail: rhonda.dawson@fda.hhs.gov.
    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

[[Page 51042]]

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.
[FR Doc. 2011-20861 Filed 8-16-11; 8:45 am]
BILLING CODE 4160-01-P