[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