[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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