[Federal Register Volume 62, Number 107 (Wednesday, June 4, 1997)]
[Notices]
[Pages 30591-30592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14601]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0180]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Reinstatement
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
(the PRA), Federal agencies are required to publish a notice in the
Federal Register concerning each proposed collection of information,
including each proposed reinstatement of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requirements relating to the
preapproved or emergency shipment of a blood product for manufacturing
prior to completion of hepatitis B surface antigen (HBsAg) testing and
shipment of a blood product for manufacturing when the donor is known
to be reactive for HBsAg.
DATES: Submit written comments on the collection of information by
August 4, 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: Margaret R. Wolff, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600
[[Page 30592]]
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: Under 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. 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 reinstatement 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.
Shipment of a Blood Product Prior to Completion of Testing for
Hepatitis B Surface Antigen (HbsAg)--21 CFR 610.40(b); and Shipment
of Blood Products Known Reactive for HbsAg--21 CFR 610.40(d)--(OMB
Control Number 0910-0168)--Reinstatement
Under Sections 351 and 361 of the Public Health Service Act (42
U.S.C. 262 and 264), FDA prescribes standards designed to ensure the
safety, purity, potency, and effectiveness of biological products
including blood and blood components and to prevent the transmission of
communicable diseases. To accomplish this, FDA requires, among other
things, that each unit of Whole Blood or Source Plasma be tested by a
licensed serologic test for HbsAg. Section 610.40(b)(4) (21 CFR
610.40(b)(4)) permits preapproved or emergency shipments of blood
products for further manufacturing before the test for HBsAg is
completed. To obtain approval for such shipments, the collection
facility must submit a description of the control procedures to be used
by the collection facility and manufacturer. Proper control procedures
are essential to ensure the safe shipment, handling, quarantine of
untested or incompletely tested blood products, communication of test
results, and appropriate use or disposal of the blood products based on
the test results. Section 610.40(d)(1) and (d)(2) requires that a
collection facility notify FDA of each shipment of HBsAg reactive
source blood, plasma, or serum for manufacturing into hepatitis B
vaccine and licensed or unlicensed in vitro diagnostic biological
products, including clinical chemistry control reagents. The reporting
requirements inform FDA of the shipment of potentially infectious
biological products that may be capable of transmitting disease. The
respondents for this information collection are the blood collection
facilities that are shipping hepatitis B reactive products. FDA's
monitoring of such activity is essential in the event that any
deviations occur that may require immediate corrective action to
protect public safety. The labeling helps ensure that product is safely
and appropriately handled and used by the collection facility, shipper,
and manufacturer.
Only a few firms are actually engaged in shipping hepatitis B
reactive products and making the reports required by Sec. 610.40.
Further, there are very few to no emergency shipments per year related
to further manufacturing and the only product currently shipped prior
to completion of hepatitis B testing is a licensed product, Source
Leukocytes. Shipments of Source Leukocytes are preapproved under the
product license applications and do not require notification for each
shipment. Currently, there have been no respondents reporting emergency
or preapproved shipments (Sec. 610.40(b)). However, FDA is currently
listing one report per year for emergency or preapproved shipments to
account for the possibility of future emergency shipments.
FDA estimates the burden of this collection of information as
follows:
Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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610.40(b)\1\ 1 1 1 0.5 0.5
610.40(d)\2\ 6 8.5 51 0.5 25.5
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There are no capital costs or operating and maintenance costs associated with this information collection.
\1\ This notice involves a brief letter and an enclosure. The letter identifies who is making the shipment, to
whom the product was shipped, the nature of the emergency, the kind and quantity shipped, and the date of
shipment. The enclosure is a copy of the shippers written standard operating procedures for handling, labeling
storage, and shipment of contaminated (contagious) product. The burden for development and maintenance of
standard operating procedures is approved under OMB No. 0910-0116. Preparation of the notice and duplication
of standard operating procedure documents is estimated at one half hour per notice.
\2\ The notice of reactive product shipment is limited to information on: the identity of the kind and amount of
source material shipped; the name and address of the consignee; the date of shipment; and the manner in which
the source material is labeled.
FDA has calculated no additional burden in this information
collection package for the labeling requirements in Sec. 610.40(d)
because the information and statements on the label necessary for
public disclosure and safety are provided by FDA in these regulations.
Under 5 CFR 1320.3(c)(2), the public disclosure of information
originally supplied by the Federal government to the recipient for the
purpose of disclosure to the public is not a collection of information.
Dated: May 28, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-14601 Filed 6-3-97; 8:45 am]
BILLING CODE 4160-01-F
