[Federal Register Volume 64, Number 243 (Monday, December 20, 1999)]
[Notices]
[Pages 71144-71145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32788]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2875]


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 listed below 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 
January 19, 2000.

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: 
Wendy Taylor, 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.

 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, 
by 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 
products 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, Blood Establishment 
Registration and Product Listing, 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 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.
     In the Federal Register of September 3, 1999 (64 FR 48408), the 
agency requested comments on the proposed collection of information. No 
significant comments were received.

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
 21 CFR Sections   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, 607.22,    Registration
 and 607.25
607.21, 607.22,    Re-              3,300               1           3,300               0.5         1,650
 607.25, 607.26,    registration
 and 607.31
607.21, 607.25,    Product             75               1              75               0.25           19
 607.30, and        Listing
 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.



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    Dated: December 10, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-32788 Filed 12-17-99; 8:45 am]
BILLING CODE 4160-01-F