[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