[Federal Register Volume 61, Number 227 (Friday, November 22, 1996)]
[Notices]
[Pages 59444-59445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29832]


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


Agency Information Collection Activities: Proposed Collection

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, 
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. The agency 
is also announcing that it intends to send blood banks, blood 
collection facilities, and blood component manufacturing facilities the 
annual request to complete Blood Establishment Registration and Product 
Listing, Form FDA 2830. This notice solicits comments on blood 
establishment registration and product listing requirements using form 
FDA 2830.


[[Page 59445]]


DATES: Submit written comments on the collection of information by 
January 21, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Geraldine M. Hogan, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1481.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. FDA submitted a 
copy of this notice to OMB for its review of this information 
collection, and requested emergency processing. OMB approved the 
information collection through February 28, 1997, and assigned OMB 
control number 0910-0052. 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)

    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. Pursuant to 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 \1/2\ 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 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.                  

    Persons are not required to respond to a collection of information 
unless it displays a currently valid OMB control number.

    Dated: November 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-29832 Filed 11-21-96; 8:45 am]
BILLING CODE 4160-01-F