
[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Pages 79692-79697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 January 
23, 2012.

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 oira_submission@omb.eop.gov. 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: Ila S. Mizrachi, Food and Drug 
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, (301) 
796-7726, Ila.Mizrachi@fda.hhs.gov.

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

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

    All blood and blood components introduced or delivered for 
introduction into interstate commerce are subject to section 351(a) of 
the Public Health Service Act (PHS Act) (42 U.S.C. 262). Section 351(a) 
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 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 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 
Federal, Food, Drug, and Cosmetics Act (21 U.S.C. 321(g)(1)). Because 
blood and blood components are drugs under the Federal, Food, Drug, and 
Cosmetics Act, blood and plasma establishments must comply with the 
substantive provisions and related regulatory scheme of the act. For 
example, under section 501 of the Federal, Food, Drug, and Cosmetic 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 in 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

[[Page 79693]]

(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) in part 610 (21 CFR part 610), 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. 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) 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 
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 (standard operating 
procedures) 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 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

[[Page 79694]]

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 (21 CFR 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 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. 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 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 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. Sec.  
610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments

[[Page 79695]]

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, 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 1,675 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.
    In the Federal Register of July 28, 2011 (76 FR 45262), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
606.170(b) \1\..................              76               1              76              20           1,520
610.40(g)(2)....................               1               1               1               1               1
610.40(h)(2)(ii)(A).............               1               1               1               1               1
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,522
----------------------------------------------------------------------------------------------------------------
\1\ 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
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
606.100(b) \1\..................         \4\ 288            1.20             346              24           6,912
606.100(c)......................         \4\ 288              10           2,880               1           2,880
606.110(a) \2\..................          \5\ 52               1              52            0.50              26
                                                                                       (30 min.)
606.151(e)......................         \4\ 288              12           3,456            0.08             276
                                                                                        (5 min.)

[[Page 79696]]

 
606.160 \3\.....................         \4\ 288        1,329.86         383,000            0.75         287,250
                                                                                       (45 min.)
606.160(b)(1)(viii).............  ..............  ..............  ..............  ..............  ..............
HIV consignee notification......           1,675           12.54          21,000             .17           3,570
                                                                                       (10 min.)
                                           4,059            5.17          21,000             .17           3,570
                                                                                       (10 min.)
HCV consignee notification......           1,675           27.94          46,800             .17           7,956
                                                                                       (10 min.)
                                           4,059           11.53          46,800             .17           7,956
                                                                                       (10 min.)
HIV recipient notification......           4,059            0.43           1,755             .17             298
                                                                                       (10 min.)
HCV recipient notification......           4,059            0.51           2,050             .17             349
                                                                                       (10 min.)
606.160(b)(1)(ix)...............           1,706        1,025.79       1,750,000            0.05          87,500
                                                                                        (3 min.)
606.160(b)(1)(xi)...............           1,675            3.51           5,872            0.05             294
                                                                                        (3 min.)
606.165.........................         \5\ 288        1,329.86         383,000            0.08          30,640
                                                                                        (5 min.)
606.170(a)......................         \5\ 288              12           3,456               1           3,456
610.40(g)(1)....................           1,706               1           1,706            0.50             853
                                                                                       (30 min.)
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         443,786
----------------------------------------------------------------------------------------------------------------
\1\ 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).
\2\ 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).
\3\ 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.
\4\ 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).
\5\ Five percent of plateletpheresis and leukopheresis establishments (0.05 x 1,032).


                             Table 3--Estimated Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
         21 CFR section             respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
606.170(a)......................         \1\ 288            1.20             346            0.50             173
                                                                                       (30 min.)
610.40(c)(1)(ii)................           1,706            2.11           3,600            0.08             288
                                                                                        (5 min.)
610.40(h)(2)(ii)(C) and                       40              12             480            0.20              96
 (h)(2)(ii)(D)..................                                                       (12 min.)
610.40(h)(2)(vi)................           1,706           10.55          18,000            0.08           1,440
                                                                                        (5 min.)
610.42(a).......................               1               1               1               1               1
610.46(a)(1)(ii)(B).............           1,675            6.27          10,500            0.17           1,785
                                                                                       (10 min.)
610.46(a)(3)....................           1,675            6.27          10,500            0.17           1,785
                                                                                       (10 min.)
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
                                                                                       (10 min.)
610.47(a)(3)....................           1,675           13.97          23,400            0.17           3,978
                                                                                       (10 min.)
610.47(b)(3)....................           4,059            0.51           2,050               1           2,050
630.6(a) \2\....................             558          755.98         433,000            0.08          34,640
                                                                                        (5 min.)
630.6(a) \3\....................              85           52.94           4,500            1.50           6,750
                                                                                       (90 min.)
630.6(d)(1).....................              84           31.07           2,610               1           2,610
                                 -------------------------------------------------------------------------------

[[Page 79697]]

 
    Total.......................  ..............  ..............  ..............  ..............          61,329
----------------------------------------------------------------------------------------------------------------
\1\ 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).
\2\ Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility
  criteria.
\3\ Notification of donors deferred based on reactive test results for evidence of infection due to communicable
  disease agents.


    Dated: December 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32778 Filed 12-21-11; 8:45 am]
BILLING CODE 4160-01-P


