[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]
[[Page 71144]]
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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.
[[Page 71145]]
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
