[Federal Register Volume 69, Number 51 (Tuesday, March 16, 2004)]
[Notices]
[Pages 12334-12336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5833]


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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.

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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 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://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\
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  21 CFR                        Annual Frequency        Total Annual
 Section   No. of Respondents     per Response           Responses        Hours per Response      Total Hours
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610.40(c)        942                  13                12,000                     .08              960
 (1)(ii)
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610.40(g)          1                   1                     1                    1                   1
 (2)
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610.40(h)          1                   1                     1                    1                   1
 (2)(ii)(
 A)
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610.40(h)         40                  12                   480                    0.2                96
 (2)(ii)(
 C) and
 (h)(2)(i
 i)(D)
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610.40(h)        942                  19               18,0000                    0.08            1,440
 (2)(vi)
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610.42(a)          1                   1                     1                    1                   1
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630.6(a)\        311               1,393               433,333                    0.08           34,667
 2\
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630.6(a)\         47                 191                 9,000                    1.5            13,500
 3\
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630.6(d)(         43                 140                 6,000                    1               6,000
 1)
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Total      ..................  ..................  .....................  ..................     56,666
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\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\
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  21 CFR         No. of         Annual Frequency
 Section      Recordkeepers     per Recordkeeping   Total Annual Records   Hours per Records      Total Hours
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610.40(g)        858                   1                   858                     .5               429
 (1)
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606.160(b        942               1,858             1,750,000                    0.05           87,500
 )(1)(ix)
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606.160(b        858                  16                13,500                    0.05              675
 )(1)(xi)
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Total      ..................  ..................  .....................  ..................     88,604
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\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