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[Federal Register: June 24, 2008 (Volume 73, Number 122)]
[Notices]
[Page 35694-35699]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn08-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0345]
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 information collection
requirements relating to FDA's regulation of current good manufacturing
practice and related regulations for blood and blood components; and
requirements for donor testing, donor notification, and ``lookback.''
DATES: Submit written or electronic comments on the collection of
information by August 25, 2008.
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: Jonna Capezzuto,Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on
[[Page 35695]]
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Current Good Manufacturing Practice 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 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
[[Page 35696]]
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 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) (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 leukopheresis. 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,
[[Page 35697]]
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 1 application per year from
manufacturers of Source Leukocytes. However, for calculation purposes,
we are estimating 1 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. Sec.
610.46(a)(1)(ii)(B) and 610.46(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. Sec.
610.47(a)(1)(ii)(B) and 610.47(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
[[Page 35698]]
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 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.
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).
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
----------------------------------------------------------------------------------------------------------------
[[Page 35699]]
606.160(b)(1)(viii)
----------------------------------------------------------------------------------------------------------------
HIV consignee 2,000 10.50 21,000 .17 3,570
notification
----------------------------------------------------------------------------------------------
4,980 4.21 21,000 .17 3,570
----------------------------------------------------------------------------------------------------------------
HCV consignee 2,000 23.40 46,800 .17 7,956
notification
----------------------------------------------------------------------------------------------
4,980 9.4 46,800 .17 7,956
----------------------------------------------------------------------------------------------------------------
HIV recipient 4,980 0.35 1,755 .17 298
notification
----------------------------------------------------------------------------------------------------------------
HCV recipient 4,980 0.41 2,050 .17 349
notification
----------------------------------------------------------------------------------------------------------------
606.160(b)(1)(ix) 2,081 840.94 1,750,000 0.05 875,000
----------------------------------------------------------------------------------------------------------------
606.160(b)(1)(xi) 2,000 3.375 6,750 0.05 338
----------------------------------------------------------------------------------------------------------------
606.165 353\5\ 793.20 280,000 0.083 23,240
----------------------------------------------------------------------------------------------------------------
606.170(a) 353\5\ 12 4,236 1.00 4,236
----------------------------------------------------------------------------------------------------------------
610.40(g)(1) 2,081 1 2,081 0.50 1,041
----------------------------------------------------------------------------------------------------------------
Total 1,149,926
----------------------------------------------------------------------------------------------------------------
\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); 640.61; 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: June 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14248 Filed 6-23-08; 8:45 am]
BILLING CODE 4160-01-S