[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45262-45267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0511]


Agency Information Collection Activities; Proposed Collection; 
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 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 collection of information 
requirements relating to FDA's regulation of current good manufacturing 
practice (CGMP) and related regulations for blood and blood components; 
and requirements for donor testing, donor notification, and 
``lookback.''

DATES: Submit either electronic or written comments on the collection 
of information by September 26, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
[email protected].

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.

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) 
of the PHS Act 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

[[Page 45263]]

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 Act (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 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 FD&C 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 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 certain information 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 
year 2010, FDA received 76 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 containing 
the name and identifying information of the recipient.
    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 for evidence of 
infection due to certain communicable disease agents.
    Section 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), in brief, require 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, to 
include a statement on the label indicating the exempted use 
specifically approved by FDA. Finally, Sec.  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

[[Page 45264]]

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 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 leukaphesis 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) 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 the Centers for 
Medicare and Medicaid Services (CMS). Based on information received 
from CBER's database systems, there are approximately 31 licensed 
Source Plasma establishments with multiple locations and approximately 
1,675 registered blood collection establishments, for an estimated 
total of 1,706 establishments. Of these establishments, approximately 
1,032 perform plateletpheresis and leukopheresis. These establishments 
annually collect approximately 38.3 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 4,059 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 21 million donations of Source Plasma from approximately 
2 million donors and approximately 17.3 million donations of Whole 
Blood, including approximately 261,000 (approximately 1.5 percent of 
17.3 million) autologous donations, from approximately 10.9 million 
donors. Assuming each autologous donor makes an average of 2 donations, 
FDA estimates that there are approximately 130,500 autologous donors.
    FDA estimates that approximately 5 percent (3,600 of the 72,000 
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), Source Leukocytes, a 
licensed product that is used in the manufacture of interferon, which 
requires rapid preparation from blood, is currently shipped prior to 
completion of testing for evidence of certain communicable disease 
agents. Shipments of Source Leukocytes are pre-approved under a 
biologics license application and each shipment does not have to be 
reported

[[Page 45265]]

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) 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.
    We estimate that Sec.  610.46(b)(3) will require 4,059 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 4,059 consignees would notify approximately 
2,050 recipients or their physicians of record annually. Finally, we 
estimate 1 hour to complete notification.
    Based on industry estimates, roughly 13 percent of approximately 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 1,675 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 (1,117) of the 1,675 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 558, approximately, blood collecting establishments 
would need to provide, under Sec.  630.6(a), additional information and 
onsite counseling to the estimated 433,000 (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 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 1,706 establishments 
(85) 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 1,675 blood collection establishments (84) may not 
notify the referring physicians of the estimated 2 percent of 130,500 
autologous donors with the initial reactive test results (2,610) 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 1,675 registered blood establishments 
collect autologous donations and, therefore, are required to notify 
referring physicians. We estimate that 4.5 percent of the 130,500 
autologous donors (5,872) 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 one 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.

[[Page 45266]]

    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Number of
                          21 CFR section                               Number of      responses per     Total annual     Average burden     Total hours
                                                                      respondents       respondent        responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.170(a)........................................................         \5\ 288               1.20             346               0.5              173
606.170(b) \2\....................................................              76               1                 76              20              1,520
610.40(c)(1)(ii)..................................................           1,706               2.11           3,600               0.08             288
610.40(g)(2)......................................................               1               1                  1               1                  1
610.40(h)(2)(ii)(A)...............................................               1               1                  1               1                  1
610.40(h)(2)(ii)(C) and (h)(2)(ii)(D).............................              40              12                480               0.2               96
610.40(h)(2)(vi)..................................................           1,706              10.55          18,000               0.08           1,440
610.42(a).........................................................               1               1                  1               1                  1
610.46(a)(1)(ii)(B)...............................................           1,675               6.27          10,500               0.17           1,785
610.46(a)(3)......................................................           1,675               6.27          10,500               0.17           1,785
610.46(b)(3)......................................................           4,059               0.43           1,755               1              1,755
610.47(a)(1)(ii)(B)...............................................           1,675              13.97          23,400               0.17           3,978
610.47(a)(3)......................................................           1,675              13.97          23,400               0.17           3,978
610.47(b)(3)......................................................           4,059               0.51           2,050               1              2,050
630.6(a) \3\......................................................             558             775.98         433,000               0.08          34,640
630.6(a) \4\......................................................              85              52.94           4,500               1.5            6,750
630.6(d)(1).......................................................              84              31.07           2,610               1              2,610
                                                                   -------------------------------------------------------------------------------------
    Total.........................................................  ..............  .................  ..............  .................          62,851
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 4,059 + 1,706).


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Number of    Number of records   Total annual     Average burden
                          21 CFR section                             recordkeepers   per recordkeeper      records     per recordkeeping    Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.100(b) \2\....................................................         \5\ 288               1                288              24              6,912
606.100(c)........................................................         \5\ 288              10              2,880               1              2,880
606.110(a) \3\....................................................          \6\ 52               1                 52               0.5               26
606.151(e)........................................................         \5\ 288              12              3,456               0.08             276
606.160 \4\.......................................................         \5\ 288           1,329.86         383,000               0.75         287,250
606.160(b)(1)(viii)
    HIV consignee notification....................................           1,675              12.54          21,000               0.17           3,570
                                                                             4,059               5.17          21,000               0.17           3,570
    HCV consignee notification....................................           1,675              27.94          46,800               0.17           7,956
                                                                             4,059              11.53          46,800               0.17           7,956
    HIV recipient notification....................................           4,059               0.43           1,755               0.17             298
    HCV recipient notification....................................           4,059               0.51           2,050               0.17             349
606.160(b)(1)(ix).................................................           1,706           1,025.79       1,750,000               0.05          87,500
606.160(b)(1)(xi).................................................           1,675               3.51           5,872               0.05             294
606.165...........................................................         \5\ 288           1,329.86         383,000               0.08          30,640
606.170(a)........................................................         \5\ 288              12              3,456               1              3,456
610.40(g)(1)......................................................           1,706               1              1,706               0.50             853
                                                                   -------------------------------------------------------------------------------------
    Total.........................................................  ..............  .................  ..............  .................         443,786
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\ 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 4,059 + 1,706).
\6\ Five percent of plateletpheresis and leukopheresis establishments (0.05 x 1,032).



[[Page 45267]]

    Dated: July 22, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19040 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P