[Federal Register: March 16, 2004 (Volume 69, Number 51)]
[Notices]
[Page 12334-12336]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr04-74]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0101]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Requirements for Testing Human Blood Donors for
Evidence of Infection Due to Communicable Disease Agents; and
Requirements for Donor Notification
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 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. This notice solicits comments on the information collection
requirements relating to requirements for testing human blood donors
for evidence of infection due to communicable disease agents and for
donor notification.
DATES: Submit written or electronic comments on the collection of
information by May 17, 2004.
ADDRESSES: Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
All comments should be identified with the docket number
found in brackets in the heading of this document. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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 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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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.
Requirements for Testing Human Blood Donors for Evidence of Infection
Due to Communicable Disease Agents; and Requirements for Donor
Notification (OMB Control Number 0910-0472)--Extension
Under sections 351 and 361 of the Public Health Service Act (PHS
Act)(42 U.S.C. 262 and 264) and the provisions of the Federal Food,
Drug, and Cosmetic Act (the act) that apply to drugs (21 U.S.C. 321 et
seq.), FDA may issue and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases between
States or Possessions or from foreign countries into the States or
Possessions. The public health objective in testing human blood donors
for evidence of infection due to communicable disease agents and in
donor notification is to prevent the transmission of communicable
disease. Section 351 of the PHS Act, applies to biological products.
Blood and blood components are considered drugs, as that term is
defined in section 201(g)(1) of the act (21 U.S.C. 321(g)(1)).
Section 610.40(c)(1)(ii) (Sec. 610.40(c)(1)(ii) requires each
dedicated donation be labeled, as required under Sec. 606.121 (21 CFR
606.121), and with a label entitled ``INTENDED RECIPIENT INFORMATION
LABEL'' containing the name and identifying information of the
recipient. (21 CFR 606.121 is approved under OMB control number 0910-
0116.) Section 610.40(g)(2) requires an establishment to obtain written
approval from FDA to ship human blood or blood components for further
manufacturing use prior to completion of testing. Section
610.40(h)(2)(ii)(A) requires an establishment to obtain written
approval from FDA to use or ship human blood or blood components found
to be reactive by a screening test for evidence of a communicable
disease agent(s) or collect from a donor with a record of a reactive
screening test. Sections 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) require
an establishment to label reactive human blood and blood components
with the appropriate screening test results, and, if they are intended
for further manufacturing use into injectable products, with a
statement indicating the exempted use specifically approved by FDA.
Section 610.40(h)(2)(vi) requires each donation of human blood or blood
component that tests reactive by a screening test for syphilis and is
determined to be a
[[Page 12335]]
biological false positive be labeled with both test results. Section
610.42(a) requires a warning statement, including the identity of the
communicable disease agent, on medical devices containing human blood
or blood components found to be reactive by a screening test for
evidence of infection due to a communicable disease agent(s) or
syphilis. Section 630.6(a) (21 CFR 630.6(a)) requires an establishment
to make reasonable attempts to notify any donor who has been deferred
as required by Sec. 610.41, or who has been determined not to be
eligible as a donor. Section 630.6(d)(1) requires establishment to
provide certain information to the referring physician of an autologous
donor who is deferred based on the results of tests as described in
Sec. 610.41.
Section 610.40(g)(1) requires an establishment to appropriately
document a medical emergency for the release of human blood or blood
components prior to completion of required testing. Section
606.160(b)(1)(ix) requires a facility to maintain records of
notification of donors deferred or determined not to be eligible for
donation, including appropriate followup. Section 606.160(b)(1)(xi)
requires an establishment to maintain records of notification of the
referring physician of a deferred autologous donor, including
appropriate followup.
Respondents to this collection of information are Whole Blood and
Source Plasma establishments that collect blood and blood components,
including Source Plasma and Source Leukocytes. Based on information
from FDA's Center for Biologics and Evaluation Research database
system, there are approximately 84 licensed Source Plasma collection
establishments and 858 registered Whole Blood collection establishments
for a total of 942 establishments. Based on information received from
industry, we estimate that these establishments collect annually an
estimated 30 million donations: 15 million donations of Source Plasma
from approximately 2 million donors and 15 million donations of Whole
Blood, including 600,000 autologous, from approximately 8 million
donors.
Assuming each autologous donor makes an average of 2 donations, FDA
estimates that there are approximately 300,000 autologous donors. FDA
estimates that approximately 5 percent (12,000) of the 240,000
donations that are donated specifically for the use of an identified
recipient would be tested under the dedicated donors testing provisions
in Sec. 610.40(c)(1)(ii).
Under Sec. 610.40(g)(2) and (h)(2)(ii)(A), the only product
currently shipped prior to completion of testing is a licensed product,
Source Leukocytes, used in the manufacture of interferon, which
requires rapid preparation from blood. Shipments of Source Leukocytes
are preapproved under a biologics license application and each shipment
does not have to be reported to the agency. Based on information from
CBER's database system, FDA receives an estimated 1 application per
year from manufacturers of Source Leukocytes.
Under Sec. 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), FDA estimates
that each manufacturer would ship an estimated 1 human blood or blood
components per month (12 per year) that would require two labels; one
as reactive for the appropriate screening test under paragraph
(h)(2)(ii)(C), and the other stating the exempted use specifically
approved by FDA under paragraph (h)(2)(ii)(D). According to CBER's
database system, there are an estimated 40 licensed manufacturers that
ship known reactive human blood or blood components.
Based on information we received from industry, we estimate that
approximately 18,000 donations annually test reactive by a screening
test for syphilis, and are determined to be biological false positives
by additional testing (Sec. 610.40(h)(2)(vi)).
Human blood or a blood component with a reactive screening test, as
a component of a medical device, is an integral part of the medical
device, e.g., a positive control for an in vitro diagnostic testing
kit. It is usual and customary business practice for manufacturers to
include on the container label a warning statement that identifies the
communicable disease agent. In addition, on the rare occasion when a
human blood or blood component with a reactive screening test is the
only component available for a medical device that does not require a
reactive component, then a statement of warning is required to be
affixed to the medical device. To account for this rare occasion under
Sec. 610.42(a), we estimate that the warning statement would be
necessary no more than once a year.
Industry estimates that approximately 13 percent of 10 million
donors (1.3 million donors) who come to donate annually are determined
not to be eligible for donation prior to collection because of failure
to satisfy eligibility criteria. It is the usual and customary business
practice of virtually all 942 collecting establishments to notify on
site and to explain the reason why the donor is determined not to be
suitable for donating. Based on such information as is available to
FDA, we estimate that two-thirds of the 942 collecting establishments
provided on site additional information and counseling to a donor
determined not to be eligible for donation as usual and customary
business practice. Consequently, we estimate that only one-third or 311
collection establishments would need to provide, under Sec. 630.6(a),
additional information and counseling onsite to 433,333 (one-third of
1.3 millions) ineligible donors.
It is estimated that another 4.5 percent of 10 million donors
(450,000 donors) are deferred annually based on test results. We
estimate that currently 95 percent of the establishments that collect
98 percent of the blood and blood components notify donors who have
reactive test results for human immunodeficiency virus (HIV), hepatitis
B virus (HBV), hepatitis C virus (HCV), human T-Lymphotropic virus
(HTLV), and syphilis as usual and customary business practice.
Consequently, 5 percent (47) of the industry (942) collecting 2 percent
(9,000) of the deferred donors (450,000) would experience burden
related to Sec. 630.6(a). As part of usual and customary business
practice, collecting establishments notify an autologous donor's
referring physician of reactive test results obtained during the
donation process required under Sec. 630.6(d)(1). However, we estimate
that 5 percent of the 858 blood collection establishments (43) do not
notify the referring physicians of the estimated 2 percent of 300,000
autologous donors with reactive test results (6,000).
FDA has concluded that the use of untested or incompletely tested
but appropriately documented human blood or blood components in rare
medical emergencies should not be prohibited. We estimate the
recordkeeping under Sec. 610.40(g)(1) to be minimal with one or less
occurrence per year. The reporting of test results to the consignee in
Sec. 610.40(g) does not create a new burden for respondents because it
is the usual and customary business practice or procedure to finish the
testing and provide the results to the manufacturer responsible for
labeling the blood products.
Section 606.160(b)(1)(ix) requires that establishment to maintain
records of the notification efforts. We estimate the total annual
records based on the 1.3 million donors determined not to be eligible
to donate and each of the 450,000 (1.3 + 450,000 = 1,750,000) donors
deferred based on reactive test results for evidence of infection due
to communicable disease agents. Under
[[Page 12336]]
Sec. 606.160(b)(1)(xi), only the 858 registered blood establishments
collect autologous donations and, therefore, are required to notify
referring physicians. We estimate that 4.5 percent of the 300,000
autologous donors (13,500) will be deferred under Sec. 610.41 and thus
result in the notification of their referring physicians.
The hours per response and hours per record are based on estimates
received from industry or FDA experience with similar recordkeeping or
reporting requirements.
FDA estimates the burden of this information collection as follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR Annual Frequency Total Annual
Section No. of Respondents per Response Responses Hours per Response Total Hours
----------------------------------------------------------------------------------------------------------------
610.40(c) 942 13 12,000 .08 960
(1)(ii)
----------------------------------------------------------------------------------------------------------------
610.40(g) 1 1 1 1 1
(2)
----------------------------------------------------------------------------------------------------------------
610.40(h) 1 1 1 1 1
(2)(ii)(
A)
----------------------------------------------------------------------------------------------------------------
610.40(h) 40 12 480 0.2 96
(2)(ii)(
C) and
(h)(2)(i
i)(D)
----------------------------------------------------------------------------------------------------------------
610.40(h) 942 19 18,0000 0.08 1,440
(2)(vi)
----------------------------------------------------------------------------------------------------------------
610.42(a) 1 1 1 1 1
----------------------------------------------------------------------------------------------------------------
630.6(a)\ 311 1,393 433,333 0.08 34,667
2\
----------------------------------------------------------------------------------------------------------------
630.6(a)\ 47 191 9,000 1.5 13,500
3\
----------------------------------------------------------------------------------------------------------------
630.6(d)( 43 140 6,000 1 6,000
1)
----------------------------------------------------------------------------------------------------------------
Total .................. .................. ..................... .................. 56,666
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility
criteria.
\3\ Notification of donors deferred based on reactive test results for evidence of infection due to communicable
disease agents.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency
Section Recordkeepers per Recordkeeping Total Annual Records Hours per Records Total Hours
----------------------------------------------------------------------------------------------------------------
610.40(g) 858 1 858 .5 429
(1)
----------------------------------------------------------------------------------------------------------------
606.160(b 942 1,858 1,750,000 0.05 87,500
)(1)(ix)
----------------------------------------------------------------------------------------------------------------
606.160(b 858 16 13,500 0.05 675
)(1)(xi)
----------------------------------------------------------------------------------------------------------------
Total .................. .................. ..................... .................. 88,604
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5833 Filed 3-15-04; 8:45 am]
BILLING CODE 4160-01-S