[Federal Register: August 24, 2005 (Volume 70, Number 163)]
[Notices]               
[Page 49655-49656]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au05-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0327]

 
Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
requirements relating to the blood establishment registration and 
product listing requirements and Form FDA 2830.

DATES:  Submit written or electronic comments on the collection of 
information by October 24, 2005.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on the 

collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Blood Establishment Registration and Product Listing, Form FDA 2830--21 
CFR Part 607 (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

[[Page 49656]]

independent laboratories that engage in quality control and testing for 
registered blood product establishments.
    FDA estimates the burden of this collection of information based 
upon information obtained from the Center for Biologics Evaluation and 
Research's database and FDA experience with the blood establishment 
registration and product listing requirements.
    FDA estimates the burden of this collection as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                     Annual
                                                        No. of      Frequency  Total Annual   Hours per   Total
       21 CFR Section             Form FDA 2830       Respondents      per       Responses    Response    Hours
                                                                    Response
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607.20(a), 607.21, 607.22,    Initial registration            100           1           100        1         100
 607.25, and 607.40
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607.21, 607.22, 607.25,       Reregistration                2,775           1         2,775        0.5     1,388
 607.26, 607.31, and 607.40
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607.21, 607.25, 607.30,       Product listing                 180           1           180        0.25       45
 607.31, and 607.40            update
-----------------------------
Total                                                                                                      1,533
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\1\ There are no capital costs of operating and maintenance costs associated with this collection of
  information.


    Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16847 Filed 8-23-05; 8:45 am]

BILLING CODE 4160-01-S