[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48167-48168]
From the Federal Register Online via the Government Publishing 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]
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