[Federal Register Volume 71, Number 16 (Wednesday, January 25, 2006)]
[Notices]
[Pages 4145-4147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-844]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0327]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Blood Establishment 
Registration and Product Listing, Form FDA 2830

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

[[Page 4146]]


DATES: Fax written comments on the collection of information by 
February 24, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Blood Establishment Registration and Product Listing, Form FDA 2830--
(OMB Control Number 0910-0052)--Extension

    Under section 510 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360), any person owning or operating an establishment that 
manufactures, prepares, propagates, compounds, or processes a drug or 
device must register with the Secretary of Health and Human Services, 
on or before December 31 of each year, his or her name, place of 
business, and all such establishments submit, among other information, 
a listing of all drug or device products manufactured, prepared, 
propagated, compounded, or processed by him or her for commercial 
distribution. In part 607 (21 CFR part 607), FDA has issued regulations 
implementing these requirements for manufacturers of human blood and 
blood products.
    Section 607.20(a) requires certain establishments that engage in 
the manufacture of blood products to register and to submit a list of 
blood products in commercial distribution. Section 607.21 requires the 
establishments entering into the manufacturing of blood products to 
register within 5 days after beginning such operation and to submit a 
blood product listing at that time. In addition, establishments are 
required to register annually between November 15 and December 31 and 
update their blood product listing every June and December of each 
year. Section 607.22 requires the use of Form FDA 2830, Blood 
Establishment Registration and Product Listing, for initial 
registration, for annual registration, and for blood product listing. 
Section 607.25 indicates the information required for establishment 
registration and blood product listing. Section 607.26 requires certain 
changes to be submitted as amendments to the establishment registration 
within 5 days of such changes. Section 607.30 requires establishments 
to update their blood product listing information every June and 
December, or at the discretion of the registrant at the time the change 
occurs. Section 607.31 requires that additional blood product listing 
information be provided upon FDA request. Section 607.40 requires 
foreign blood product establishments to register and submit the blood 
product listing information, the name and address of the establishment, 
and the name of the individual responsible for submitting blood product 
listing information as well as the name, address, and phone number of 
its U.S. agent.
    Among other uses, this information assists FDA in its inspections 
of facilities, and its collection is essential to the overall 
regulatory scheme designed to ensure the safety of the Nation's blood 
supply. Form FDA 2830 is used to collect this information.
    Respondents to this collection of information are human blood and 
plasma donor centers, blood banks, certain transfusion services, other 
blood product manufacturers, and independent laboratories that engage 
in quality control and testing for registered blood product 
establishments.
    In the Federal Register of August 24, 2005 (70 FR 49655), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                             Annual
   21 CFR      Form FDA      No. of       frequency per     Total annual        Hours per         Total hours
   Section       2830      respondents      response         responses           response
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607.20(a),    Initial            100               1                100                  1                100
 607.21,       registra
 607.22,       tion
 607.25, and
 607.40
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607.21,       Reregistr        2,775               1              2,775                  0.5            1,388
 607.22,       ation
 607.25,
 607.26,
 607.31, and
 607.40
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607.21,       Product            180               1                180                  0.25              45
 607.25,       listing
 607.30,       update
 607.31, and
 607.40
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Total                                                                                                   1,533
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 4147]]

    Dated: January 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-844 Filed 1-24-06; 8:45 am]
BILLING CODE 4160-01-S