Document ID: FDA-2011-N-0508-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Blood Establishment Registration and Product Listing
Posted Date: 2011-08-08T04:00Z

[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48167-48168]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19955]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 in the Agency's regulations and Form FDA 
2830.

DATES: Submit either electronic or written comments on the collection 
of information by October 7, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651.

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, and must submit, among other

[[Page 48168]]

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 Form FDA 
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 Form FDA 
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 above 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. 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                               Number of                  Average
                                                  Number of    responses      Total      burden per
        21 CFR Section           Form FDA 2830   respondents      per         annual      response   Total hours
                                                               respondent   responses    (in hours)
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607.20(a), 607.21, 607.22,     Initial                    49            1           49         1              49
 607.25, and 607.40.            Registration.
607.21, 607.22, 607.25,        Re-registration.        2,589            1        2,589         0.5         1,294
 607.26, 607.31, and 607.40.
607.21, 607.25, 607.30(a),     Product Listing           180            1          180         0.25           45
 607.31, and 607.40.            Update.
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    Total....................  ................  ...........  ...........  ...........  ...........        1,388
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: July 26, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19955 Filed 8-5-11; 8:45 am]
BILLING CODE 4160-01-P