[Federal Register Volume 69, Number 132 (Monday, July 12, 2004)]
[Notices]
[Pages 41809-41812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15711]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0101]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
11, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (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.

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) (21 CFR 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. (Section 606.121 is approved under OMB control number 0910-
0116.) Section 610.40(g)(2) requires an

[[Page 41810]]

establishment to obtain written approval from FDA to ship human blood 
or blood components for further manufacturing use before 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. Section 610.40(h)(2)(ii)(C) and 
(h)(2)(ii)(D) requires 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 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 (CBER) 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 two 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 one 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 2 labels; 1 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, 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 before 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

[[Page 41811]]

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 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.
    In the Federal Register of March 16, 2004 (69 FR 12334), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. We received one comment from the industry on the 
proposed information collection. The comment stated that they had no 
reason to believe FDA's burden estimates were not reasonable. Also, the 
comment did not believe the estimated times constituted a burden on 
community blood centers.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                      Annual Frequency per
                21 CFR Section                   No. of Respondents        Respondent       Total Annual Responses   Hours per Response     Total Hours
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610.40(c)(1)(ii)                                              942                    13                  12,000               .08                 960
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610.40(g)(2)                                                    1                     1                       1              1                      1
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610.40(h)(2)(ii)(A)                                             1                     1                       1              1                      1
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610.40(h)(2)(ii)(C) and (h)(2)(ii)(D)                          40                    12                     480              0.2                   96
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610.40(h)(2)(vi)                                              942                    19                  18,000              0.08               1,440
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610.42(a)                                                       1                     1                       1              1                      1
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630.6(a)\2\                                                   311                 1,393                 433,333              0.08              34,667
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630.6(a)\3\                                                    47                   191                   9,000              1.5               13,500
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630.6(d)(1)                                                    43                   140                   6,000              1                  6,000
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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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                                       Annual Frequency     Total Annual
21 CFR Section  No. of Recordkeepers  per Recordkeeping       Records        Hours per Record     Total Hours
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610.40(g)(1)               858                  1                858                  0.5              429
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606.160(b)(1)(             942              1,858          1,750,000                  0.05          87,500
 ix)
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606.160(b)(1)(             858                 16             13,500                  0.05             675
 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.



[[Page 41812]]

    Dated: July 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15711 Filed 7-9-04; 8:45 am]
BILLING CODE 4160-01-S