[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Pages 11444-11449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-04381]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0161]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
2, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0116. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

    All blood and blood components introduced or delivered for 
introduction into interstate commerce are subject to section 351(a) of 
the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). Section 
351(a) requires that manufacturers of biological products, which 
include blood and blood components intended for further

[[Page 11445]]

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 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 current good manufacturing practice (CGMP) 
and related regulations.
    The CGMP regulations for blood and blood components (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 third-party 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 2013, FDA received 72 of these reports.
    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), 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.
    Under the third-party disclosure requirements, Sec.  
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. The information collection requirements under Sec.  606.121 
are part of usual and customary business practice.
    Sections 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. Also, 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) 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 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

[[Page 11446]]

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, or who has been determined not to be eligible 
as a donor. Section 630.6(d)(1) requires an establishment to provide 
certain information to the referring physician of an autologous donor 
who is deferred based on the results of tests as described in Sec.  
610.41.
    Under the recordkeeping requirements, Sec.  606.100(b), in brief, 
requires that written SOPs be maintained for all steps to be followed 
in the collection, processing, compatibility testing, storage, and 
distribution of blood and blood components used for transfusion and 
further manufacturing purposes. Section 606.100(c) requires the review 
of all records pertinent to the lot or unit of blood prior to release 
or distribution. Any unexplained discrepancy or the failure of a lot or 
unit of final product to meet any of its specifications must be 
thoroughly investigated, and the investigation, including conclusions 
and followup, must be recorded.
    In brief, Sec.  606.110(a) provides that the use of 
plateletpheresis and leukapheresis procedures to obtain a product for a 
specific recipient may be at variance with the additional standards for 
that specific product if, among other things, the physician certifies 
in writing that the donor's health permits plateletpheresis or 
leukapheresis. Section 606.110(b) requires establishments to request 
prior approval from CBER for plasmapheresis of donors who do not meet 
donor requirements. The information collection requirements for Sec.  
606.110(b) are approved under OMB control number 0910-0338 and, 
therefore, are not reflected in tables 1 and 2.
    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. Section 606.170(a) also requires that 
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 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.
    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 416 licensed Source Plasma 
establishments with multiple locations and approximately 1,265 licensed 
blood collection establishments, for an estimated total of 1,681 
licensed blood collection establishments. Also, there are an estimated 
total of 680 unlicensed, registered blood collection establishments for 
an approximate total of 2,361 collection establishments (416 + 1,265 + 
680 = 2,361 establishments). Of these establishments, approximately 990 
perform plateletpheresis and leukapheresis. These establishments 
annually collect approximately 40 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 4,961 establishments that fall under the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578) 
(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 25 million donations of Source Plasma from approximately 
2 million donors and approximately 15 million donations of Whole Blood, 
including approximately 225,000 (approximately 1.5 percent of 15 
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 112,500 autologous donors.
    FDA estimates that approximately 5 percent (3,600) of the 72,000 
donations

[[Page 11447]]

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. 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 preapproved under a 
biologics license application (BLA) and each shipment does not have to 
be reported to the Agency. Based on information from CBER's database 
system, FDA receives less than one application per year from 
manufacturers of Source Leukocytes. However, for calculation purposes, 
we are estimating one application annually.
    Under Sec. 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 two 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 (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 that Sec.  610.46(b)(3) will require 4,961 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. Also under Sec.  610.46(b)(3), we estimate and include 
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 4,961 consignees would 
notify approximately 2,050 recipients or their physicians of record 
annually.
    Based on industry estimates, approximately 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 1,945 (1,265 
+ 680) 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 (1,297) of the 
1,945 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 648, approximately, blood collecting 
establishments would need to provide, under Sec.  630.6(a), additional 
information and onsite counseling to the estimated 433,333 (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, HCV, Human T-
Lymphotropic Virus, and syphilis as usual and customary business 
practice. Consequently, 5 percent of the 1,681 establishments (84) 
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 1,265 blood collection establishments (63) may not 
notify the referring physicians of the estimated 2 percent of 112,500 
autologous donors with the initial reactive test results (2,250) 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 1,945 registered blood establishments 
collect autologous donations and, therefore, are required to notify 
referring physicians. We estimate that 4.5 percent of the 112,500 
autologous donors (5,063) 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

[[Page 11448]]

in Sec.  610.40(g) is part of 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 average burden per response (hours) and average burden per 
recordkeeping (hours) are based on estimates received from industry or 
FDA experience with similar reporting or recordkeeping requirements.
    In the Federal Register of October 20, 2014 (79 FR 62629), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received five comments; however, the 
comments were not responsive to the comment request on the four 
specified aspects of the collection of information and did not provide 
any data or explanation that would support a change regarding the 
information collection estimates.
    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(b) \2\..................              72               1              72              20           1,440
610.40(g)(2)....................               1               1               1               1               1
610.40(h)(2)(ii)(A).............               1               1               1               1               1
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,442
----------------------------------------------------------------------------------------------------------------
\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).


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
        21 CFR section             Number of     records per    Total annual     Average burden     Total hours
                                 recordkeepers   recordkeeper      records     per recordkeeping
----------------------------------------------------------------------------------------------------------------
606.100(b) \2\................         \5\ 366           1                366  24...............           8,784
606.100(c)....................         \5\ 366          10              3,660  1................           3,660
606.110(a) \3\................          \6\ 50           1                 50  0.5 (30 minutes).              25
606.151(e)....................         \5\ 366          12              4,392  0.08 (5 minutes).             351
606.160 \4\...................         \5\ 366       1,046.45         383,000  0.75 (45 minutes)         287,250
606.160(b)(1)(viii)...........           1,945          10.80          21,000  0.17 (10 minutes)           3,570
HIV consignee notification....           4,961           4.23          21,000  0.17 (10 minutes)           3,570
606.160(b)(1)(viii)...........           1,945          24.06          46,800  0.17 (10 minutes)           7,956
HCV consignee notification....           4,961           9.43          46,800  0.17 (10 minutes)           7,956
HIV recipient notification....           4,961           0.35           1,755  0.17 (10 minutes)             298
HCV recipient notification....           4,961           0.41           2,050  0.17 (10 minutes)             349
606.160(b)(1)(ix).............           2,361         741.21       1,750,000  0.05 (3 minutes).          87,500
606.160(b)(1)(xi).............           1,945           2.6            5,063  0.05 (3 minutes).             253
606.165.......................         \5\ 366       1,046.45         383,000  0.08 (5 minutes).          30,640
606.170(a)....................         \5\ 366          12              4,392  1................           4,392
610.40(g)(1)..................           2,361           1              2,361  0.5 (30 minutes).           1,180
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  .............  ..............  .................         447,734
----------------------------------------------------------------------------------------------------------------
\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 CLIA that transfuse blood and components and FDA-registered
  blood establishments (0.05 x 4,961 + 2,361 = 366).
\6\ Five percent of plateletpheresis and leukapheresis establishments (0.05 x 990 = 50).


                           Table 3--Estimated Annual Third-Party Disclosure 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)....................         \2\ 366           1.2              439  0.5 (30 minutes).             220
610.40(c)(1)(ii)..............           2,361           1.52           3,600  0.08 (5 minutes).             288
610.40(h)(2)(ii)(C) and                     40          12                480  0.2 (12 minutes).              96
 (h)(2)(ii)(D).
610.40(h)(2)(vi)..............           2,361           7.62          18,000  0.08 (5 minutes).           1,440
610.42(a).....................               1           1                  1  1................               1
610.46(a)(1)(ii)(B)...........           1,945           5.40          10,500  0.17 (10 minutes)           1,785
610.46(a)(3)..................           1,945           5.40          10,500  0.17 (10 minutes)           1,785
610.46(b)(3)..................           4,961           0.35           1,755  1................           1,755
610.47(a)(1)(ii)(B)...........           1,945          12.03          23,400  0.17 (10 minutes)           3,978

[[Page 11449]]

 
610.47(a)(3)..................           1,945          12.03          23,400  0.17 (10 minutes)           3,978
610.47(b)(3)..................           4,961           0.41           2,050  1................           2,050
630.6(a) \3\..................             648         668.72         433,333  0.08 (5 minutes).          34,667
630.6(a) \4\..................              84          53.57           4,500  1.5 (90 minutes).           6,750
630.6(d)(1)...................              63          35.71           2,250  1................           2,250
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  .............  ..............  .................          61,043
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered
  blood establishments (0.05 x 4,961 + 2,361 = 366).
\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.


    Dated: February 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-04381 Filed 3-2-15; 8:45 am]
BILLING CODE 4164-01-P