[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
