[Federal Register Volume 73, Number 219 (Wednesday, November 12, 2008)]
[Notices]
[Pages 66901-66906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26863]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0345]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Current Good 
Manufacturing Practices and Related Regulations for Blood and Blood 
Components; and Requirements for Donor Testing, Donor Notification, and 
``Lookback''

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 
December 12, 2008.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0116. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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.

Current Good Manufacturing Practices and Related Regulations for Blood 
and Blood Components; and Requirements for Donor Testing, Donor 
Notification, and ``Lookback'' (OMB Control Number 0910-0116--
Extension)

    All blood and blood components introduced or delivered for 
introduction into interstate commerce are subject to section 351(a) of 
the Public Health Service Act (PHS Act) (42 U.S.C. 262). Section 351(a) 
requires that manufacturers of biological products, which include blood 
and blood components intended for further manufacture into injectable 
products, have a license, issued upon a demonstration that the product 
is safe, pure and potent and that the manufacturing establishment meets 
all applicable standards, including those prescribed in the FDA 
regulations designed to ensure the continued safety, purity, and 
potency of the product. In addition, under section 361 of the PHS Act 
(42 U.S.C. 264), by delegation from the Secretary of Health and Human 
Services, FDA may make and enforce regulations necessary to prevent the 
introduction, transmission, or spread of communicable diseases from 
foreign countries into the States or possessions, or from one State or 
possession into any other State or possession.
    Section 351(j) of the PHS Act states that the Federal Food, Drug, 
and Cosmetic (FD&C) Act also applies to biological products. Blood and 
blood components for transfusion or for further manufacture into 
injectable products are drugs, as that term is

[[Page 66902]]

defined in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). 
Because blood and blood components are drugs under the act, blood and 
plasma establishments must comply with the substantive provisions and 
related regulatory scheme of the FD&C Act. For example, under section 
501 of the FD&C Act (21 U.S.C. 351(a)), drugs are deemed 
``adulterated'' if the methods used in their manufacturing, processing, 
packing, or holding do not conform to current good manufacturing 
practice (CGMP) and related regulations.
    The CGMP regulations (part 606) (21 CFR part 606) and related 
regulations implement FDA's statutory authority to ensure the safety, 
purity, and potency of blood and blood components. The public health 
objective in testing human blood donors for evidence of infection due 
to communicable disease agents and in notifying donors is to prevent 
the transmission of communicable disease. For example, the ``lookback'' 
requirements are intended to help ensure the continued safety of the 
blood supply by providing necessary information to users of blood and 
blood components and appropriate notification of recipients of 
transfusion who are at increased risk for transmitting human 
immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
    The information collection requirements in the CGMP, donor testing, 
donor notification, and ``Lookback'' regulations provide FDA with the 
necessary information to perform its duty to ensure the safety, purity, 
and potency of blood and blood components. These requirements establish 
accountability and traceability in the processing and handling of blood 
and blood components and enable FDA to perform meaningful inspections. 
The recordkeeping requirements serve preventive and remedial purposes. 
The disclosure requirements identify the various blood and blood 
components and important properties of the product, demonstrate that 
the CGMP requirements have been met, and facilitate the tracing of a 
product back to its original source. The reporting requirements inform 
FDA of any deviations that occur and that may require immediate 
corrective action.
    Under the reporting requirements, Sec.  606.170(b), in brief, 
requires that facilities notify FDA's Center for Biologics Evaluation 
and Research (CBER), as soon as possible after confirming a 
complication of blood collection or transfusion to be fatal. The 
collecting facility is to report donor fatalities, and the 
compatibility testing facility is to report recipient fatalities. The 
regulation also requires the reporting facility to submit a written 
report of the investigation within 7 days after the fatality. In fiscal 
years 2006 and 2007, FDA received, on average, 100 of these reports.
    Section 610.40(c)(1)(ii) (21 CFR 610.40(c)(1)(ii)), in brief, 
requires that each donation dedicated to a single identified recipient 
be labeled as required under Sec.  606.121 and with a label entitled 
``INTENDED RECIPIENT INFORMATION LABEL'' containing the name and 
identifying information of the recipient.
    Section 610.40(g)(2) (21 CFR 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 for evidence of infection due to certain communicable 
disease agents.
    Section 610.40(h)(2)(ii)(A) (21 CFR 610.40(h)(2)(ii)(A)), in brief, 
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 certain communicable disease agent(s) or 
collected from a donor with a record of a reactive screening test. 
Furthermore, Sec.  610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) (21 CFR 
610.40(h)(2)(ii)(C) and (h)(2)(ii)(D)), in brief, requires an 
establishment to label certain reactive human blood and blood 
components with the appropriate screening test results, and, if they 
are intended for further manufacturing use into injectable products, 
include a statement on the label indicating the exempted use 
specifically approved by FDA. Finally, Sec.  610.40(h)(2)(vi) (21 CFR 
610.40(h)(2)(vi)) requires each donation of human blood or blood 
components, excluding Source Plasma, that tests reactive by a screening 
test for syphilis and is determined to be a biological false positive 
to be labeled with both test results.
    Section 610.42(a) (21 CFR 610.42(a)) requires a warning statement 
``indicating that the product was manufactured from a donation found to 
be reactive by a screening test for evidence of infection due to the 
identified communicable disease agent(s)'' in the labeling for medical 
devices containing human blood or a blood component found to be 
reactive by a screening test for evidence of infection due to a 
communicable disease agent(s) or syphilis.
    In brief, Sec. Sec.  610.46 and 610.47 (21 CFR 610.46 and 610.47) 
require blood collecting establishments to establish, maintain, and 
follow an appropriate system for performing HIV and HCV prospective 
``lookback'' when: (1) A donor tests reactive for evidence of HIV or 
HCV infection or (2) the collecting establishment becomes aware of 
other reliable test results or information indicating evidence of HIV 
or HCV infection (``prospective lookback''). (See Sec. Sec.  
610.46(a)(1) and 610.47(a)(1).) The requirement for ``an appropriate 
system'' requires the collecting establishment to design standard 
operating procedures (SOPs) to identify and quarantine all blood and 
blood components previously collected from a donor who later tests 
reactive for evidence of HIV or HCV infection, or when the collecting 
establishment is made aware of other reliable test results or 
information indicating evidence of HIV or HCV infection. Within 3 
calendar days of the donor testing reactive by an HIV or HCV screening 
test or the collecting establishment becoming aware of other reliable 
test results or information, the collecting establishment must, among 
other things, notify consignees to quarantine all identified previously 
collected in-date blood and blood components (Sec. Sec.  
610.46(a)(1)(ii)(B) and 610.47(a)(1)(ii)(B)) and, within 45 days, 
notify the consignees of supplemental test results, or the results of a 
reactive screening test if there is no available supplemental test that 
is approved for such use by FDA (Sec. Sec.  610.46(a)(3) and 
610.47(a)(3)).
    Consignees also must establish, maintain, and follow an appropriate 
system for performing HIV and HCV ``lookback'' when notified by the 
collecting establishment that they have received blood and blood 
components previously collected from donors who later tested reactive 
for evidence of HIV or HCV infection, or when the collecting 
establishment is made aware of other reliable test results or 
information indicating evidence of HIV or HCV infection in a donor 
(Sec. Sec.  610.46(b) and 610.47(b)). This provision for a system 
requires the consignee to establish SOPs for, among other things, 
notifying transfusion recipients of blood and blood components, or the 
recipient's physician of record or legal representative, when such 
action is indicated by the results of the supplemental (additional, 
more specific) tests or a reactive screening test if there is no 
available supplemental test that is approved for such use by FDA, or if 
under an investigational new drug application (IND) or an 
investigational device exemption (IDE), is exempted for such use by 
FDA. The consignee must make reasonable attempts to perform the 
notification within 12 weeks of receipt

[[Page 66903]]

of the supplemental test result or receipt of a reactive screening test 
result when there is no available supplemental test that is approved 
for such use by FDA, or if under an IND or IDE, is exempted for such 
use by FDA (Sec. Sec.  610.46(b)(3) and 610.47(b)(3)).
    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 (21 CFR 610.41), or who has been determined 
not to be eligible as a donor. Section 630.6(d)(1) requires an 
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.
    Under the recordkeeping requirements, Sec.  606.100(b), in brief, 
requires that written SOPs be maintained for all steps to be followed 
in the collection, processing, compatibility testing, storage, and 
distribution of blood and blood components used for transfusion and 
further manufacturing purposes. Section 606.100(c) requires the review 
of all records pertinent to the lot or unit of blood prior to release 
or distribution. Any unexplained discrepancy or the failure of a lot or 
unit of final product to meet any of its specifications must be 
thoroughly investigated, and the investigation, including conclusions 
and followup, must be recorded.
    In brief, Sec.  606.110(a) provides that the use of 
plateletpheresis and leukapheresis procedures to obtain a product for a 
specific recipient may be at variance with the additional standards for 
that specific product if, among other things, the physician certifies 
in writing that the donor's health permits plateletpheresis or 
leukapheresis. Section 606.110(b) requires establishments to request 
prior approval from CBER for plasmapheresis of donors who do not meet 
donor requirements. The information collection requirements for Sec.  
606.110(b) are approved under OMB control number 0910-0338 and, 
therefore, are not reflected in tables 1 and 2 of this document.
    Section 606.151(e) requires that SOPs for compatibility testing 
include procedures to expedite transfusion in life-threatening 
emergencies; records of all such incidents must be maintained, 
including complete documentation justifying the emergency action, which 
must be signed by a physician.
    So that each significant step in the collection, processing, 
compatibility testing, storage, and distribution of each unit of blood 
and blood components can be clearly traced, Sec.  606.160 requires that 
legible and indelible contemporaneous records of each such step be made 
and maintained for no less than 10 years. Section 606.160(b)(1)(viii) 
requires records of the quarantine, notification, testing and 
disposition performed under the HIV and HCV ``lookback'' provisions. 
Furthermore, Sec.  606.160(b)(1)(ix) requires a blood collection 
establishment 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.
    Section 606.165, in brief, requires that distribution and receipt 
records be maintained to facilitate recalls, if necessary.
    Section 606.170(a) requires records to be maintained of any reports 
of complaints of adverse reactions arising as a result of blood 
collection or transfusion. Each such report must be thoroughly 
investigated, and a written report, including conclusions and followup, 
must be prepared and maintained. When an investigation concludes that 
the product caused the transfusion reaction, copies of all such written 
reports must be forwarded to and maintained by the manufacturer or 
collecting facility.
    Section 610.40(g)(1) (21 CFR 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.
    In addition to the CGMP regulations in part 606, there are 
regulations in part 640 (21 CFR part 640) that require additional 
standards for certain blood and blood components as follows: Sections 
640.3(a)(1), (a)(2), and (f); 640.4(a)(1) and (a)(2); 640.25(b)(4) and 
(c)(1); 640.27(b); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 
640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 
640.65(b)(2); 640.66; 640.71(b)(1); 640.72; 640.73; and 640.76(a) and 
(b). The information collection requirements and estimated burdens for 
these regulations are included in the part 606 burden estimates, as 
described in tables 1 and 2 of this document.
    Respondents to this collection of information are licensed and 
unlicensed blood establishments that collect blood and blood 
components, including Source Plasma and Source Leukocytes, inspected by 
FDA, and other transfusion services inspected by Centers for Medicare 
and Medicaid Services (CMS). Based on information received from CBER's 
database systems, there are approximately 81 licensed Source Plasma 
establishments with multiple locations and approximately 2,000 
registered blood collection establishments, for an estimated total of 
2,081 establishments. Of these establishments, approximately 696 
perform plateletpheresis and leukapheresis. These establishments 
annually collect approximately 28 million units of Whole Blood and 
blood components, including Source Plasma and Source Leukocytes, and 
are required to follow FDA ``lookback'' procedures. In addition, there 
are another 4,980 establishments that fall under the Clinical 
Laboratory Improvement Amendments of 1988 (formerly referred to as 
facilities approved for Medicare reimbursement) that transfuse blood 
and blood components.
    The following reporting and recordkeeping estimates are based on 
information provided by industry, CMS, and FDA experience. Based on 
information received from industry, we estimate that there are 
approximately 13 million donations of Source Plasma from approximately 
2 million donors and approximately 15 million donations of Whole Blood, 
including approximately 300,000 (2 percent of 15 million) autologous 
donations, from approximately 8 million donors. Assuming each 
autologous donor makes an average of 2 donations, FDA estimates that 
there are approximately 150,000 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 for evidence of 
certain communicable disease agents is a licensed product, Source 
Leukocytes, used in the manufacture of interferon, which requires rapid 
preparation from blood. Shipments of Source Leukocytes are pre-approved 
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 less than one application per year from 
manufacturers of Source Leukocytes. However, for calculation purposes, 
we are estimating one application annually.
    Under Sec.  610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), FDA estimates 
that each manufacturer would ship an estimated 1 unit of human blood or 
blood components per month (12 per year)

[[Page 66904]]

that would require 2 labels; one as reactive for the appropriate 
screening test under Sec.  610.40(h)(2)(ii)(C), and the other stating 
the exempted use specifically approved by FDA under Sec.  
610.40(h)(2)(ii)(D). According to CBER's database system, there are 
approximately 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: (1) Annually test reactive by a 
screening test for syphilis, (2) are determined to be biological false 
positives by additional testing, and (3) are labeled accordingly (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 warning statement must 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.
    FDA estimates that approximately 3,500 repeat donors will test 
reactive on a screening test for HIV. We also estimate that an average 
of three components was made from each donation. Under Sec.  
610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 10,500 (3,500 
x 3) notifications of the HIV screening test results to consignees by 
collecting establishments for the purpose of quarantining affected 
blood and blood components, and another 10,500 (3,500 x 3) 
notifications to consignees of subsequent test results. We estimate an 
average of 10 minutes per notification of consignees.
    Moreover, we estimate that Sec.  610.46(b)(3) will require 4,980 
consignees to notify transfusion recipients, their legal 
representatives, or physicians of record an average of 0.35 times per 
year resulting in a total number of 1,755 (585 confirmed positive 
repeat donors x 3) notifications. Under Sec.  610.46(b)(3), we also 
estimate 1 hour to accommodate the time to gather test results and 
records for each recipient and to accommodate multiple attempts to 
contact the recipient.
    Furthermore, we estimate that approximately 7,800 repeat donors per 
year would test reactive for antibody to HCV. Under Sec.  
610.47(a)(1)(ii)(B) and (a)(3), collecting establishments would notify 
the consignee 2 times for each of the 23,400 (7,800 x 3 components) 
components prepared from these donations, once for quarantine purposes 
and again with additional HCV test results for a total of 46,800 
notifications as an annual ongoing burden. Under Sec.  610.47(b)(3), we 
estimate that approximately 4,980 consignees would notify approximately 
2,050 recipients or their physicians of record annually. Finally, we 
estimate 1.0 hours to complete notification.
    Industry estimates that approximately 13 percent of 10 million 
potential 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 approximately 2,000 blood collecting 
establishments to notify onsite and to explain why the donor is 
determined not to be suitable for donating. Based on such available 
information, we estimate that two-thirds (1,333) of the 2,000 blood 
collecting establishments provided onsite 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 667, approximately, blood collecting establishments 
would need to provide, under Sec.  630.6(a), additional information and 
onsite counseling to the estimated 430,000 (one-third of approximately 
1.3 million) ineligible donors.
    It is estimated that another 4.5 percent of 10 million potential 
donors (450,000 donors) are deferred annually based on test results. We 
estimate that currently approximately 95 percent of the establishments 
that collect 99 percent of the blood and blood components notify donors 
who have reactive test results for HIV, Hepatitis B Virus (HBV), HCV, 
Human T-Lymphotropic Virus (HTLV), and syphilis as usual and customary 
business practice. Consequently, 5 percent of the 2,081 establishments 
(104) collecting 1 percent (4,500) of the deferred donors (450,000) 
would notify donors under 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 approximately 5 
percent of the 2,000 blood collection establishments (100) may not 
notify the referring physicians of the estimated 2 percent of 150,000 
autologous donors with the initial reactive test results (3,000) as 
their usual and customary business practice.
    The recordkeeping chart reflects the estimate that approximately 95 
percent of the recordkeepers, which collect 99 percent of the blood 
supply, have developed SOPs as part of their customary and usual 
business practice. Establishments may minimize burdens associated with 
CGMP and related regulations by using model standards developed by 
industries' accreditation organizations. These accreditation 
organizations represent almost all registered blood establishments.
    Under Sec.  606.160(b)(1)(ix), we estimate the total annual records 
based on the approximately 1.3 million donors determined not to be 
eligible to donate and each of the estimated 1.75 million (1.3 million 
+ 450,000) donors deferred based on reactive test results for evidence 
of infection because of communicable disease agents. Under Sec.  
606.160(b)(1)(xi), only the 2,000 registered blood establishments 
collect autologous donations and, therefore, are required to notify 
referring physicians. We estimate that 4.5 percent of the 150,000 
autologous donors (6,750) will be deferred under Sec.  610.41, which in 
turn will lead to the notification of their referring physicians.
    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 1 or fewer 
occurrences 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.
    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 June 24, 2008 (73 FR 35694) (June 2008 
document), FDA published a 60-day notice requesting public comment on 
the information collection provisions. We received one public comment 
on the proposed information collection.
    The comment cited numerous problems that it stated were caused by 
the labeling requirement contained in Sec.  610.40(h)(2)(vi), which 
requires each

[[Page 66905]]

donation of human blood or blood components, excluding Source Plasma, 
that tests reactive by a screening test for syphilis and is determined 
to be a biological false positive to be labeled with both test results. 
For example, the comment stated that the labeling requirement ``causes 
unnecessary work and interrupts routine operations, thereby introducing 
risk of error, with no increase in safety.'' The comment also stated 
that the requirement ``generates inappropriate concerns on the part of 
healthcare personnel, transfusion recipients and their families.'' The 
comment asked that this requirement be deleted. These concerns pertain 
to matters that are outside the scope of the proposed information 
collection. Consequently, we decline to adopt the comment's 
recommendations.
    The comment also questioned FDA's estimate of 5 minutes in 
connection with Sec.  610.40(h)(2)(vi). We had estimated that the time 
associated with the labeling requirement contained in this rule was 5 
(4.8) minutes. The comment stated, ``Any non-routine activity that 
interrupts normal labeling operations, [sic] causes delays that take 
more than 4.8 minutes.'' The comment later went on to acknowledge that 
the application of a label to a unit, which is only one step in the 
labeling process, may take only five minutes. We wish to clarify that 
we only are referring to the application of a label to a unit in this 
proposed information collection. Therefore, consistent with the 
comment, our estimate remains the same.
    Moreover, the comment referred to page 35697 and table 1 of the 
June 2008 document, and stated that ``FDA estimated that labeling 
directed and reactive or untested units for shipment would take five 
minutes. If labeling refers only to the application of the label to the 
unit, which is only one step in the labeling process, then 5 minutes 
may be adequate.'' We are unclear what the comment is referring to on 
page 35697 of the June 2008 document and note that table 1 refers to an 
estimate of 0.08 (4.8 minutes) with respect to Sec. Sec.  
610.40(c)(1)(ii), 610.40(h)(2)(vi), and 630.6(a). We are assuming that 
the comment is referring to the first two regulations, as the third 
goes to donor notification. We wish to clarify that in this information 
collection, we are only referring to the application of the label to 
the unit. Therefore, consistent with the comment, our estimate remains 
the same.
    Finally, the comment pointed out an error in calculation of total 
hours associated with Sec.  606.160(b)(1)(ix) in table 2 of the June 
2008 document. The total hours calculated was listed as 875,000, 
instead of 87,500 (0.05 x 1,750,000). Therefore, the total estimated 
recordkeeping burden is 362,426. We have corrected this error 
accordingly.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                        No. of         Annual Frequency       Total Annual       Hours per
 21 CFR Section      Respondents         per Response          Responses          Response        Total Hours
----------------------------------------------------------------------------------------------------------------
606.170(a)                   353\5\                  1.20                424              0.5                212
----------------------------------------------------------------------------------------------------------------
606.170(b)\2\                   100                     1                100               20              2,000
----------------------------------------------------------------------------------------------------------------
610.40(c)(1)(ii)              2,081                  5.77             12,000             0.08                960
----------------------------------------------------------------------------------------------------------------
610.40(g)(2)                      1                     1                  1                1                  1
----------------------------------------------------------------------------------------------------------------
610.40(h)(2)(ii)                  1                     1                  1                1                  1
 (A)
----------------------------------------------------------------------------------------------------------------
610.40(h)(2)(ii)                 40                    12                480              0.2                 96
 (C) and
 (h)(2)(ii)(D)
----------------------------------------------------------------------------------------------------------------
610.40(h)(2)(vi)              2,081                  8.65             18,000             0.08              1,440
----------------------------------------------------------------------------------------------------------------
610.42(a)                         1                     1                  1                1                  1
----------------------------------------------------------------------------------------------------------------
610.46(a)(1)(ii)              2,000                  5.25             10,500             0.17              1,785
 (B)
----------------------------------------------------------------------------------------------------------------
610.46(a)(3)                  2,000                  5.25             10,500             0.17              1,785
----------------------------------------------------------------------------------------------------------------
610.47(b)(3)                  4,980                  0.41              2,050              1.0              2,050
----------------------------------------------------------------------------------------------------------------
610.47(a)(1)(ii)              2,000                 11.70             23,400             0.17              3,978
 (B)
----------------------------------------------------------------------------------------------------------------
610.47(a)(3)                  2,000                 11.70             23,400             0.17              3,978
----------------------------------------------------------------------------------------------------------------
610.47(b)(3)                  4,980                  0.41              2,050              1.0              2,050
----------------------------------------------------------------------------------------------------------------
630.6(a)\3\                     667                644.68            430,000             0.08             34,400
----------------------------------------------------------------------------------------------------------------
630.6(a)\4\                     104                 43.27              4,500              1.5              6,750
----------------------------------------------------------------------------------------------------------------
630.6(d)(1)                     100                    30              3,000                1              3,000
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     64,487
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\The reporting requirement in Sec.   640.73, which addresses the reporting of fatal donor reactions, is
  included in the estimate for Sec.   606.170(b).
\3\Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility
  criteria.
\4\Notification of donors deferred based on reactive test results for evidence of infection due to communicable
  disease agents.
\5\Five percent of establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 that
  transfuse blood and components and FDA-registered blood establishments (0.05 x 4,980 + 2,081).


[[Page 66906]]


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.100(b)\2\                                                      353\5\                     1                353                 24              8,472
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.100(c)                                                         353\5\                    10              3,530                  1              3,530
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.110(a)\3\                                                       35\6\                     1                 35                0.5                 18
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.151(e)                                                         353\5\                    12              4,236              0.083                352
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.160\4\                                                         353\5\                793.20            280,000               0.75            210,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.160(b)(1)(viii)
--------------------------------------------------------------------------------------------------------------------------------------------------------
  HIV consignee notification                                        2,000                 10.50             21,000                .17              3,570
                                                       -------------------------------------------------------------------------------------------------
                                                                    4,980                  4.21             21,000                .17              3,570
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  HCV consignee notification                                        2,000                 23.40             46,800                .17              7,956
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  HIV recipient notification                                        4,980                  0.35              1,755                .17                298
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Total                                                             362,426
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\The recordkeeping requirements in Sec.  Sec.   640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the
  estimate for Sec.   606.100(b).
\3\The recordkeeping requirements in Sec.   640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in
  the estimate for Sec.   606.110(a).
\4\4 The recordkeeping requirements in Sec.  Sec.   640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b);
  640.53(b) and (c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which
  address the maintenance of various records are included in the estimate for Sec.   606.160.
\5\Five percent of establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 that transfuse blood and components and FDA-
  registered blood establishments (0.05 x 4,980 + 2,081).
\6\Five percent of plateletpheresis and leukopheresis establishments (0.05 x 696).


    Dated: November 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26863 Filed 11-10-08; 8:45 am]
BILLING CODE 4160-01-S