[Federal Register Volume 65, Number 245 (Wednesday, December 20, 2000)]
[Notices]
[Pages 79866-79867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32377]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D 1618]


Draft ``Guidance for Industry: Variances for Blood Collection 
from Individuals with Hereditary Hemochromatosis;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance document entitled ``Guidance for 
Industry: Variances for Blood Collection from Individuals with 
Hereditary Hemochromatosis'' dated December 2000. The draft guidance 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 than 
every 8 weeks without a physical examination and certification of the 
donor's health by a physician on the day of donation. This draft 
guidance document identifies the conditions under which FDA will 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.

DATES: Submit written comments on the draft guidance to ensure their 
adequate consideration in preparation of the final document by March 
20, 2001.

ADDRESSES: Submit written requests for single copies of ``Guidance for 
Industry: Variances for Blood Collection from Individuals with 
Hereditary Hemochromatosis'' dated December 2000, to the Office of 
Communication, Training, and Manufacturers Assistance (HFM 40), Center 
for Biological 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 draft guidance document.
    Submit written comments on the document to the Dockets Management 
Branch (HFA 305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

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 draft guidance document 
entitled ``Guidance for Industry: Variances for Blood Collection from 
Individuals with Hereditary Hemochromatosis'' dated December 2000. This 
document identifies the 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 hemochromatosis 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). The statutory 
authority and scope of jurisdiction of HCFA limits its ability to 
reduce or eliminate costs of treatment for HH patients, many of whom 
are covered by private insurers, or do not have health insurance. Thus, 
for the foreseeable future, if blood centers wish to distribute blood 
collected from donors with HH without disease labeling, they will have 
the responsibility of removing financial incentives for these donors. 
Each blood center will have to evaluate the advantages of entering 
these donors into their donor pool.
    The draft guidance document is being issued consistent with the 
final rule on good guidance practices (21 CFR 10.15; 65 FR 56468, 
September 19, 2000). The draft guidance document represents the 
agency's current thinking on blood collection from individuals with 
hereditary hemochromatosis. It 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 
requirements of the applicable statute, regulations, or both. As with 
other guidance documents, FDA does not intend this document to be all-
inclusive and cautions that not all information may be applicable to 
all situations. The document is intended to provide information and 
does not set forth requirements.

II. References

    The following have been placed on display in the Dockets Management 
Branch 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/partner/bloodsafety/04 99sum.html
    2. Henney, J. E., Memorandum Blood Donations by Individuals with 
Hemo chromatosis, August 10, 1999. http://www.hhs.gov/partner/bloodsafety/JEH8 10jpg
    3. Blood Products Advisory Committee, 64th Meeting, September 
16, 1999. http://www.fda.gov/ohrms/dockets/ac/cber99.htm-Blood 
Products Advisory Committee

III. Comments

    The draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit to the Dockets Management Branch (address 
above) written comments regarding this draft guidance

[[Page 79867]]

document. Submit written comments to ensure adequate consideration in 
preparation of the final document by March 20, 2001. Two copies of any 
comments are to be submitted, except individuals may submit one copy. 
Comments are to 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 
http://www.fda.gov/cber/guidelines.htm.

    Dated: November 28, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32377 Filed 12-19-00; 8:45 am]
BILLING CODE 4160-01-F