[Federal Register Volume 62, Number 49 (Thursday, March 13, 1997)]
[Notices]
[Pages 11898-11899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0402]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 
April 14, 1997.

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

FOR FURTHER INFORMATION CONTACT: Linda L. Brna, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-3158.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (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)

    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 21 CFR part 607, FDA has issued regulations 
implementing these requirements for manufacturers of human blood and 
blood products. Under these regulations, the agency seeks the 
information required by the act, including the location of the 
facility, name of the reporting official, type of ownership, type of 
establishment, and identification of blood and blood products being 
manufactured. 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 as 
follows: 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 with new blood 
banks, the time needed for industry to complete the FDA 2830 is 
estimated to be 1 hour. For annual re-registration of blood banks, the 
time needed for industry to complete the FDA 2830 form is estimated to 
be one-half hour because re-registrants only need to refer to their 
files or written instructions for a small portion of the information 
required. Blood banks should be familiar with the regulations and 
registration requirements to fill out this form.

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
 Form No. FDA 2830 (21 CFR Part       No. of       Frequency per   Total Annual      Hours per      Total Hours 
              607)                  Respondents      Response        Responses       Response                   
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Initial registration                  300               1             300               1             300       
Re-registration                     3,000               1           3,000               0.5         1,500       
Total                               3,300                           3,300                           1,800       
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There are no capital costs or operating and maintenance costs associated with this collection.                  



[[Page 11899]]

Dated: March 5, 1997

William K. Hubbard,
Associate Commissioner for Policy Coordination
[FR Doc. 97-6356 Filed 3-12-97; 8:45 am]
BILLING CODE 4160-01-F