[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: [email protected].
    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