[Federal Register Volume 67, Number 223 (Tuesday, November 19, 2002)]
[Notices]
[Pages 69747-69748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0319]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
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: Submit written comments on the collection of information by 
December 19, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 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 
and products. Section 607.20(a) requires certain establishments that 
engage in the manufacture of products to register and to submit a list 
of products in commercial distribution. Section 607.21 requires the 
establishments entering into the manufacturing of products to register 
within 5 days after beginning such operation and to submit a product 
listing at that time. In addition, establishments are required to 
register annually between November 15 and December 31 and update their 
product listing every June and December. Section 607.22 requires the 
use of Form FDA 2830 for registration and product listing. Section 
607.25 indicates the information required for establishment 
registration and product listing. Section 607.26 requires certain 
changes to be submitted as an amendment to the establishment 
registration within 5 days of such changes. Section 607.30 requires 
establishments to update, as needed, their product listing information 
every June and at the annual registration. Section 607.31 requires that 
additional product listing information be provided upon FDA request. 
Section 607.40 requires foreign product establishments to register and 
submit the product listing information, the name and address of the 
establishment, and the name of the individual responsible for 
submitting product listing information. 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 supply. Form FDA 2830, Establishment 
Registration and Product Listing, is used to collect this information. 
The likely respondents are banks, collection facilities, and component 
manufacturing facilities. FDA estimates the burden of this collection 
of information based upon the database and past experience of the 
Center for Biologics Evaluation and Research, Division of Applications 
in regulatory establishment registration and product listing. Most 
banks are familiar with the regulations and registration requirements 
to fill out this form.
    In the Federal Register of August 2, 2002 (67 FR 50445), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. One comment was received. The comment agrees 
that the information collection is necessary and the Form FDA 2830 is 
helpful with the registration process.
    The comment stated that we underestimated the hours per response 
regarding the initial registration and product listing update. The 
comment stated that it might take up to 2 hours to complete the initial 
registration and 0.5 hours to complete the product listing update. We 
decline to change the estimates based on our review of the activities 
associated with completing the form. Although it may take some 
establishments longer to complete the form, others may complete the 
form more quickly. Since the reporting burden includes an estimated 
average of the time to complete the various activities associated with 
the form, we believe that the current burden estimates accurately 
reflect the range of time to complete the form.
    The comment also requested that the annual registration process be 
automated so that each facility could electronically submit the form, 
if they desire to do so, and also requested that we continue to send a 
hard copy of the form and instructions as a reminder to registrants to 
re-register. We are currently in the process of setting up a program 
for electronic registration. Use of the electronic system will be 
voluntary. We intend to continue sending a hard copy of the form and 
instructions for the foreseeable future.

[[Page 69748]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                   Form FDA                        Annual Frequency    Total Annual   Hours per
     21 CFR          2830     No. of Respondents     per Response        Responses     Response    Total Hours
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607.20(a),        Initial           300                   1               300                 1        300
                   registrat
                   ion
 607.21, 607.22,  ..........  ..................  ..................  ..............  .........  ...............
607.25, and       ..........  ..................  ..................  ..............  .........  ...............
 607.40
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607.21, 607.22,   Re-             2,867                   1             2,867               0.5      1,434
                   registrat
                   ion
607.25, 607.26,   ..........  ..................  ..................  ..............  .........  ...............
607.31, and       ..........  ..................  ..................  ..............  .........  ...............
 607.40
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607.21, 607.25,   Product            75                   1                75              0.25         19
                   listing
 607.30, 607.31,  update      ..................  ..................  ..............  .........  ...............
and 607.40        ..........  ..................  ..................  ..............  .........  ...............
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Total             ..........  ..................  ..................  ..............  .........      1,753
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 7, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-29295 Filed 11-18-02; 8:45 am]
BILLING CODE 4160-01-S