[Federal Register: December 20, 2000 (Volume 65, Number 245)]
[Notices]
[Page 79866-79867]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de00-83]
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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availability of a draft guidance document entitled ``Guidance for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 The draft guidance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 This draft
guidance document identifies the conditions under which FDA will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DATES: Submit written comments on the draft guidance to ensure their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