[Federal Register Volume 60, Number 233 (Tuesday, December 5, 1995)]
[Notices]
[Pages 62253-62254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29479]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0358]


Revised FDA Form 2830 Blood Establishment Registration and 
Product Listing (8/95); 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 the revised FDA Form 2830 Blood Establishment 
Registration and Product Listing (8/95). This form replaces the 
previous edition of FDA Form 2830 (7/93). FDA Form 2830 is used for 
blood establishment registration and product listing, in accordance 
with the agency's regulations. FDA has made minor changes to the blood 
establishment registration and product listing which are intended to 
update the form, simplify processing, provide for efficient and 
effective use of the data base, and decrease expenditure of resources 
for both FDA and industry.

DATES: FDA will continue to accept submissions using the previous FDA 
Form 2830 (7/93) until June 5, 1996.

FOR FURTHER INFORMATION CONTACT: Valerie A. Windsor, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

ADDRESSES: Submit written requests for single copies of the revised FDA 
Form 2830 Blood Establishment Registration and Product Listing (8/95) 
to the Congressional and Consumer Affairs Branch (HFM-12), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, or 
call FDA's automated information system at 800-835-4709. Send two self-
addressed adhesive labels to assist that office in processing your 
requests. The revised FDA Form 2830 Blood Establishment Registration 
and Product Listing (8/95) may also be obtained by calling the CBER FAX 
Information System (FAX--ON--DEMAND) at 301-594-1939 from a touch tone 
phone. Submit written comments on the revised FDA Form 2830 Blood 
Establishment Registration and Product Listing (8/95) to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. Two copies of any comments are 
to be submitted, except that individuals may submit one copy. Requests 
and comments should be identified with the docket number found in 
brackets in the heading of this document. The revised FDA Form 2830 
Blood Establishment Registration and Product Listing (8/95) and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION: FDA is making available revised FDA Form 
2830 Blood Establishment Registration and Product Listing (8/95), used 
in accordance with part 607 (21 CFR part 607), by owners or operators 
of establishments that engage in the manufacturing of blood products. 
Minor revisions have been made to the format of the form and the 
information solicited which include, but are not limited to, the 
following: (1) Revised FDA Form 2830 was reformatted into a single copy 
form, which replaces the previous four-copy form; (2) item 15, 
products, was revised by: (a) Adding Red Blood Cells Rejuvenated Frozen 
and Red Blood Cells Rejuvenated Deglycerolized and (b) adding a column 
to identify irradiated blood products; (3) item 13, type establishment, 
was revised by adding product testing laboratory, with the subheadings: 
Independent and associated with community or hospital blood bank; and 
(4) instructions for completing blood registration FDA Form 2830, were 
revised and included on a separate page.
    In addition, the revised form continues to solicit the following 
information: (1) Registration number; (2) legal name and location; (3) 
reporting official; (4) type of ownership; (5) type establishment; (6) 
listing of products collected, processed, prepared, tested, and stored 
for distribution; and (7) human immunodeficiency virus (HIV) and 
hepatitis B surface antigen (HBsAg) proficiency test program name.
     In accordance with Sec. 607.20, owners or operators of all 
establishments that engage in the manufacture of blood products are 
required to register and to submit a list of every blood product in 
commercial distribution, whether or not the output of such blood 
product establishment or any particular blood product so listed enters 
interstate commerce.
    Owners or operators of establishments that engage in the 
manufacturing of blood products that are currently registered with FDA 
need not request the revised form. In accordance with Sec. 607.22, FDA 
Form 2830 will be distributed by FDA before November 15 of each year to 
establishments whose product registration for that year was validated, 
pursuant to Sec. 607.35. In addition, these establishments are required 
to update their blood product listing information every June and 
December. New owners or operators of establishments that engage in the 
manufacturing of blood products may request the revised form as 
instructed under the Addresses caption (see above).
     Owners or operators of establishments that engage in the 
manufacturing of blood products that are preparing to submit 
applications for blood establishment registration and product listing 
should now utilize the revised FDA Form 2830 (8/95). FDA will continue 
to accept submissions using the previous FDA Form 2830 (7/93) until 
June 5, 1996.
     Under the Paperwork Reduction Act of 1995 (Pub. L. 104-13), all 
forms requesting a collection of information on identical items from 10 
or more public respondents must be approved by the Office of Management 
and Budget (OMB) and must display a valid OMB control number and 
expiration date. OMB approval for FDA Form 2830 was obtained on 
February 9, 1993, and given OMB approval number 0910-0052; expiration 
date February 28, 1996, however, the expiration date has been extended 
by OMB to May 31, 1996. Since these minor revisions to FDA Form 2830 
did not increase burden to the public, OMB approval was not required.


[[Page 62254]]

    Dated: November 28, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-29479 Filed 12-4-95; 8:45 am]
BILLING CODE 4160-01-F