Document ID: FDA-2008-N-0439-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
Posted Date: 2008-12-17T05:00Z

[Federal Register: December 17, 2008 (Volume 73, Number 243)]
[Notices]               
[Page 76654-76655]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de08-88]                         

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0439]

 
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.

-----------------------------------------------------------------------

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.

DATES: Fax written comments on the collection of information by January 
16, 2009.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0052. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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, and must 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), in brief, requires owners or operators of 
certain establishments that engage in the manufacture of blood products 
to register and to submit a list of every blood product in commercial 
distribution. Section 607.21, in brief, requires the owners or 
operators of establishments entering into the manufacturing of blood 
products to register within 5 days after beginning such operation and 
to submit a list of every blood product in commercial distribution at 
the time. If the owner or operator of the establishment has not 
previously entered into such operation for which a license is required, 
registration must follow within 5 days after the submission of a 
biologics license application. 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, in brief, requires certain changes to 
be submitted on FDA Form 2830 as amendments to the establishment 
registration within 5 days of such changes. Section 607.30(a), in 
brief, indicates the information required for owners or operators of 
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, in brief, requires certain foreign blood product establishments 
to register and submit the blood product listing information, and to 
provide the name and address of the establishment and the name of the 
individual responsible for submitting blood product listing

[[Page 76655]]

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.
    FDA estimates the burden of this collection of information based 
upon information obtained from FDA's Center for Biologics Evaluation 
and Research's database and FDA experience with the blood establishment 
registration and product listing requirements. The time needed for 
industry to complete the Form FDA 2830 is estimated to be 1 hour for 
new firms. The blood establishments for the most part are familiar with 
the regulations and registration requirements to fill out this form for 
the first time. Approximately 111 new Form FDA 2830s are received 
annually. With annual re-registration of blood establishments, the time 
needed for industry to complete the Form FDA 2830 is estimated to be 
0.5 hours. The blood establishments need only to refer to their files 
or written instructions for a small portion of the information 
required. Approximately 2,621 Form FDA 2830s are received annually for 
re-registration. Approximately 180 Form FDA 2830s are received annually 
for the product listing update with an estimated average of 0.25 hours 
to complete the form.
    In the Federal Register of August 12, 2008 (73 FR 46909), 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\
----------------------------------------------------------------------------------------------------------------
                  Form FDA        No. of       Annual Frequency    Total Annual      Hours per
21 CFR Section      2830        Respondents      per Response        Responses       Response       Total Hours
----------------------------------------------------------------------------------------------------------------
607.20(a),      Initial                  111                   1             111               1             111
 607.21,         Registratio
 607.22,         n
 607.25, and
 607.40
----------------------------------------------------------------------------------------------------------------
607.21,         Re-                    2,621                   1           2,621             0.5           1,311
 607.22,         registratio
 607.25,         n
 607.26,
 607.31, and
 607.40
----------------------------------------------------------------------------------------------------------------
607.21,         Product                  180                   1             180            0.25              45
 607.25,         Listing
 607.30(a),      Update
 607.31, and
 607.40
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      1,467
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: December 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29898 Filed 12-16-08; 8:45 am]

BILLING CODE 4160-01-S