[Federal Register Volume 59, Number 13 (Thursday, January 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1335]


[[Page Unknown]]

[Federal Register: January 20, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 91P-0176]

 

Citizen Petition Requesting Federal Preemption of Certain State 
and Local Standards Affecting Blood, Blood Components, and Blood 
Derivatives; Request for Information; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the citizen petition filed on behalf of the American 
Blood Resources Association, American National Red Cross, American 
Association of Blood Banks, and Council of Community Blood Centers. The 
petition requests Federal preemption of State and local regulations on 
donor suitability, testing, and labeling of blood, blood components, 
and blood derivatives. FDA is taking this action in response to 
requests to allow additional time for public comment.

DATES: Submit written comments on the petition by March 21, 1994.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Tracey H. Forfa, Center for Biologics 
Evaluation and Research (HFM-635), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 27, 1993 
(58 FR 45341), FDA published a notice requesting public comment from 
interested parties, including the States, on a citizen petition 
requesting that the Commissioner of Food and Drugs issue a regulation 
or order, or take other appropriate action, to preempt State and local 
laws and regulations pertaining to: (1) The determination of donor 
suitability; (2) the testing of blood, blood components, and blood 
derivatives; and (3) the labeling of blood, blood components, and blood 
derivatives. Interested persons were given until November 26, 1993, to 
submit written comments on the petition.
    The agency has received requests for an extension of the comment 
period from the Association of Minority Health Professions Schools, 
several members of the hemophilia community and the general public, the 
Northwest Ohio Hemophilia Foundation, the National Hemophilia 
Foundation, the National Hemophilia Foundation/Northern Ohio Chapter, 
and several State health organizations. Many of those who asked for an 
extension stated that the hemophilia community as a whole was informed 
about the request for comments shortly before the comment period ended. 
In addition, responding groups and individuals cited the need for more 
time to determine the impact such preemptive regulations would have on 
the blood product supply and the pending litigation arising from human 
immunodeficiency virus and hepatitis contamination of the blood product 
supply in the early 1980's. A number of the individuals seeking an 
extension requested at least 30 additional days for comment.
    After careful consideration, the agency has concluded that it is in 
the public interest to allow additional time for interested persons to 
submit comments on the citizen petition. Accordingly, the comment 
period is reopened until March 21, 1994.
    Interested persons may, on or before March 21, 1994, submit to the 
Dockets Management Branch (address above) written comments regarding 
this notice. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. The citizen petition and received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 13, 1994.
 Michael R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-1335 Filed 1-19-94; 8:45 am]
BILLING CODE 4160-01-F