[Federal Register Volume 66, Number 164 (Thursday, August 23, 2001)]
[Notices]
[Pages 44357-44358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21247]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1618]


``Guidance for Industry: Variances for Blood Collection From 
Individuals With Hereditary Hemochromatosis;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: Variances 
for Blood Collection From Individuals With Hereditary Hemochromatosis'' 
dated August 2001. The guidance document provides recommendations to 
blood establishments that wish to distribute blood and blood components 
collected from individuals with diagnosed hereditary hemochromatosis 
without indicating the donor's disease on the container label, or 
collect blood more frequently from such individuals than every 8 weeks 
without a physical examination and certification of the donor's health 
by a physician on the day of donation. This guidance document 
identifies conditions under which FDA will consider approving the above 
as alternative procedures, or variances, to the current regulations, 
and provides guidance on what to submit when requesting these 
variances. These recommendations apply to all blood establishments, 
whether or not they hold a U.S. license for the manufacture of blood 
and blood components. The guidance document announced in this notice 
finalizes the draft guidance document entitled ``Guidance for Industry: 
Variances for Blood Collection From Individuals With Hereditary 
Hemochromatosis'' dated December 2000.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send one self-addressed adhesive label to assist the office in 
processing your requests. The document may also be obtained by mail by 
calling the CBER Voice Information System at 1-800-835-4709 or 301-827-
1800, or by fax by calling the FAX Information System at 1-888-CBER-FAX 
or 301-827-3844. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Variances for Blood Collection From 
Individuals With Hereditary Hemochromatosis'' dated August 2001. This 
guidance document identifies conditions under which FDA will consider 
approving the above as alternative procedures, or variances, to the 
current regulations, under the provisions of 21 CFR 640.120 and 
provides guidance on what to submit when requesting these variances.
    On April 29, 1999, the Public Health Service Advisory Committee on 
Blood Safety and Availability (ACBSA) recommended that the Department 
of Health and Human Services (DHHS) ``create policies that eliminate 
incentives to seek [blood] donation for purposes of phlebotomy'' from 
patients with diagnosed hemochromatosis who require phlebotomy as 
therapy for their disease. Further, as undue incentives to donate blood 
for transfusion (rather than being therapeutically phlebotomized) are 
removed, DHHS ``should create policies that eliminate barriers to using 
this resource'' to augment the country's blood supply (Ref. 1).
    On August 10, 1999, the Commissioner of Food and Drugs made a 
commitment to consider case-by-case exemptions to existing blood 
labeling and donor suitability regulations for blood establishments 
that can verify that therapeutic phlebotomy for hemachromatosis is 
performed at no expense to the patient (Ref. 2). FDA additionally 
committed itself to work with the Health Care Financing Administration 
in ensuring that the financial incentives for persons with hereditary 
hemochromatosis (HH) to donate blood for transfusion are removed. This 
issue was further discussed at the FDA Blood Products Advisory 
Committee meeting on September 16, 1999 (Ref. 3). For the foreseeable 
future, if blood establishments wish to distribute blood collected from 
donors with HH without disease labeling, they would be responsible for 
removing financial incentives for these donors. Each blood center 
should evaluate the advantages of entering these donors into their 
donor pool.
    The guidance document announced in this notice finalizes the draft 
guidance document entitled ``Guidance for Industry: Variances for Blood 
Collection from Individuals with Hereditary Hemochromatosis'' dated 
December 2000. This guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). This guidance document represents the agency's current 
thinking on blood collection from individuals with hereditary 
hemochromatosis. It

[[Page 44358]]

does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirement of the applicable statutes 
and regulations.

II. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Nightingale, S. D., Summary of Advisory Committee Meeting of 
April 29 and 30, 1999, May 13, 1999 (http://www.hhs.gov/bloodsafety).
    2. Henney, J. E., Memorandum Blood Donations by Individuals with 
Hemochromatosis, August 1999.
    3. Blood Products Advisory Committee, 64th Meeting, September 
16, 1999 (http://www.fda.gov/ohrms/dockets/ac/acmenu.htm).

III. Comments

    Interested persons may, at any time, submit written or electronic 
comments to the Dockets Management Branch (address above) regarding 
this guidance document. Two copies of any comments are to be submitted, 
except individuals may submit one copy. Comments should be identified 
with the docket number found in the brackets in the heading of this 
document. A copy of the document and received comments are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 13, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-21247 Filed 8-22-01; 8:45 am]
BILLING CODE 4160-01-S