[Federal Register Volume 64, Number 171 (Friday, September 3, 1999)]
[Notices]
[Pages 48408-48409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23002]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-2875]
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
provisions relating to the blood establishment registration and product
listing requirements in 21 CFR part 607 and relating to Form FDA 2830.
DATES: Submit written comments on the collection of information by
November 2, 1999.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (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: JonnaLynn P. Capezzuto, Office of
Information Resources Management (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 request 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 listed below.
With respect to the following collection of information, FDA
invites comments on: (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 (the
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 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 product 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. Section
607.22 requires the use of Form FDA 2830 for registration and blood
product listing. Section 607.25 indicates the information required for
establishment registration and blood product listing. Section 607.26
requires for certain changes an amendment to the establishment
registration to be made within 5 days of such changes. Section 607.30
requires establishments to update, as needed, their blood product
listing information every June and at the annual registration. Section
607.31 requires that additional blood product listing information be
provided upon FDA request.
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, Blood Establishment Registration and Product
Listing, is used to collect this information. The likely respondents
are blood banks, blood collection facilities, and blood component
manufacturing facilities.
FDA estimates the burden of this collection of information based
upon the past experience of the Center for Biologics Evaluation and
Research, Division of Blood Applications, in regulatory blood
establishment registration and product listing. Most blood banks are
familiar with the regulations and registration requirements to fill out
this form.
[[Page 48409]]
Table 1. -- Estimated Annual Reporting Burden \1\
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Annual
21 CFR Part Form FDA 2830 No. Of Frequency per Total Annual Hours per Total Hours
Respondents Response Response Response
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607.20(a), Initial 300 1 300 1 300
607.21, Registration
607.22, 607.25
607.21,607.22, Re-registration 3,300 1 3,300 0.5 1,650
607.25,
607.26, 607.31
607.21, 607.25, Product Listing 75 1 75 0.25 19
607.30, 607.31 Update
Total 1,969
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: August 27, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-23002 Filed 9-2-99; 8:45 am]
BILLING CODE 4160-01-F
