Document ID: FDA-2011-N-0508-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Blood Establishment Registration and Product Listing
Posted Date: 2011-12-22T05:00Z

[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Pages 79691-79692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32777]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0508]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Blood Establishment 
Registration and Product Listing, Food and Drug Administration Form 
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.

DATES: Fax written comments on the collection of information by January 
23, 2012.

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) 395-7285, or emailed 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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, (301) 796-7726, Ila.Mizrachi@fda.hhs.gov.

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, FDA Form 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, 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, owners or operators of all 
establishments so engaged must register annually between November 15 
and December 31 and must update their blood product listing information 
every June and December. Section 607.22 requires the use of FDA Form 
2830 (Blood Establishment Registration and Product Listing) for initial 
registration, subsequent annual registration, and for blood product 
listing information. Section 607.25 sets forth 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 an amendment to establishment registration within 5 days of 
such changes. Section 607.30(a), in brief, sets forth the information 
required from owners or operators of establishments when updating 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 comply with the establishment 
registration and blood product listing information requirements 
discussed earlier in this document and to provide the name and address 
of the establishment and the name of the individual responsible for 
submitting establishment registration and 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. FDA Form 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.
    In the Federal Register of August 8, 2011 (76 FR 48167), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. 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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                                                                                                        Number of       Total       Average
                 21 CFR Section                             FDA Form 2830               Number of     responses per     annual     burden per    Total
                                                                                       respondents     respondent     responses     response     hours
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607.20(a), 607.21, 607.22, 607.25, and 607.40..  Initial registration..............              49               1           49            1         49
607.21, 607.22, 607.25, 607.26, 607.31, and      Re-registration...................           2,589               1        2,589          0.5      1,295
 607.40.                                                                                                                            (30 min.)

[[Page 79692]]

 
607.21, 607.25, 607.30(a), 607.31, and 607.40..  Product listing update............             180               1          180         0.25         45
                                                                                                                                    (15 min.)
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    Total......................................  ..................................  ..............  ..............  ...........  ...........      1,389
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: December 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32777 Filed 12-21-11; 8:45 am]
BILLING CODE 4160-01-P