[Federal Register Volume 64, Number 216 (Tuesday, November 9, 1999)]
[Proposed Rules]
[Pages 61045-61046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29224]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 600, 606, 607, 610, 630, 640, and 660
[Docket Nos. 98N-0581, 98N-0607, and 98N-0815]
Blood Safety Initiative: Extension of Comment Period on Proposed
Rules and Announcement of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; announcement of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and is extending to December 22, 1999, the comment period on
two proposed rules entitled ``Requirements for Testing Human Blood
Donors for Evidence of Infection Due to Communicable Disease Agents,''
and ``General Requirements for Blood, Blood Components, and Blood
Derivatives; Notification of Deferred Donors.'' FDA is also extending
to December 22, 1999, the comment period on the advance notice of
proposed rulemaking (ANPRM) entitled ``Plasma Derivatives and other
Blood-Derived Products; Requirements for Tracking and Notification.''
The purpose of the meeting is to provide a public forum for gathering
information and views regarding the proposed rules and the ANPRM. The
comment periods are being extended to provide time for the submission
of comments that may result from the issues discussed at the public
meeting.
DATES: The public meeting will be held on Monday, November 22, 1999,
from 8:30 a.m. to 12 noon. Submit written comments for ``Requirements
for Testing Human Blood Donors for Evidence of Infection Due to
Communicable Disease Agents,'' ``General Requirements for Blood, Blood
Components, and Blood Derivatives; Notification of Deferred Donors,''
and ``Plasma Derivatives and other Blood-Derived Products; Requirements
for Tracking and Notification'' by December 22, 1999.
ADDRESSES: The public meeting will be held at the National Institutes
of Health
[[Page 61046]]
(NIH), NIH Clinical Center, Bldg. 10, Jack Masur Auditorium, 9000
Rockville Pike, Bethesda, MD.
Submit written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Comments should be identified with the appropriate docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
For registration and meeting information: Kathy Eberhart, Center
for Biologics Evaluation and Research (HFM-49), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-1317, FAX 301-827-3079, e-mail: eberhart@cber.fda.gov.
For information about this document: Nathaniel L. Geary, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 19, 1999 (64 FR 45340 and 45355),
FDA published two proposed rules that were intended to help protect the
safety and ensure the quality of the nation's blood supply and to
promote consistency in the industry. The document entitled
``Requirements for Testing Human Blood Donors for Evidence of Infection
Due to Communicable Disease Agents'' (64 FR 45340) [Docket No. 98N-
0581] proposed to revise the general biological product standards by
updating the hepatitis B virus (HBV) and human immunodeficiency virus
(HIV) testing requirements, by adding testing requirements for
hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), and by
adding requirements for licensed supplemental (i.e., additional, more
specific) testing when a donation is found to be repeatedly reactive
for any of the required screening tests for evidence of infection due
to communicable disease agents.
The document entitled ``General Requirements for Blood, Blood
Components, and Blood Derivatives; Notification of Deferred Donors''
(64 FR 45355) [Docket No. 98N-0607] proposed to require blood and
plasma establishments to notify donors of their deferral due to test
results for communicable disease agents or failure to satisfy
suitability requirements with the intent of reducing the risk of
transmission of communicable disease through the use of blood, blood
components, and blood derivatives. Blood and plasma establishments
would notify donors that they have been deferred and the reason for the
deferral; provide information concerning appropriate medical follow up
and counseling; describe the types of donations the donors should not
make in the future; and discuss the possibility that the donor may be
found suitable in the future, where appropriate. FDA provided until
November 17, 1999, to submit comments on these proposed rules.
The ANPRM entitled ``Plasma Derivatives and other Blood-Derived
Products; Requirements for Tracking and Notification'' (64 FR 45383,
August 19, 1999) [Docket No. 98N-0815] announced FDA's intention to
propose regulations to require certain blood-derived products,
including certain plasma derivatives, be tracked from a U.S. licensed
manufacturer, through the distribution network, to any patient having
custody of the product. FDA also announced its intention to propose to
require notification of consignees and patients having custody of a
blood-derived product or an analogous recombinant product in the event
the product is associated with a potential increased risk of
transmitting a communicable disease, as determined by FDA or by a U.S.
licensed manufacturer. FDA provided until November 17, 1999, to submit
comments on the ANPRM.
II. Comments
Interested persons may submit written comments on these proposed
rules and the ANPRM to the Dockets Management Branch (address above) by
the date listed above. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the appropriate docket number found in brackets in the
heading of this document. If time permits, comments may be taken from
the floor. FDA is requesting that those persons making oral
presentations at the public meeting also submit their statements in
writing by December 22, 1999, as described above, to ensure their
adequate consideration. Received comments may be seen in the office
above between 9 a.m. and 4 p.m., Monday through Friday.
III. Registration and Requests for Oral Presentations
Mail or fax registration information (including name, title, firm
name, address, telephone, and fax number), and written material and
requests to make oral presentations, to Kathy Eberhart (address above)
by Monday, November 15, 1999. If you do not intend to make a
presentation, registration is not required. However, all interested
persons are encouraged to pre-register.
If you need special accommodations due to a disability, please
contact Kathy Eberhart at least 7 days in advance.
IV. Transcripts
Transcripts of the meeting may be requested in writing from the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15
working days after the meeting at a cost of 10 cents per page. The
transcript will also be available on CBER's website at http://
www.fda.gov/cber/minutes/workshop-min.htm.
Dated: November 2, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-29224 Filed 11-8-99; 8:45 am]
BILLING CODE 4160-01-F
