Document ID: FDA-2017-N-6931-0003
Agency: fda
Document Type: Notice
Title: 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 Donation Testing, Donor Notification, and ‘‘Lookback’’
Posted Date: 2018-04-17T04:00Z

[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16870-16875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07972]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6931]

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 Donation Testing, Donor Notification, 
and ``Lookback''

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) 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 May 17, 
2018.

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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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 Donation 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 manufacturing 
into 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 (FD&C Act) also applies to biological products. Blood 
and blood components for transfusion or for further manufacturing into 
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 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), drugs are 
deemed ``adulterated'' if the methods used in their manufacturing, 
processing, packing, or holding do not conform to current good 
manufacturing practice (CGMP) and related regulations.
    The CGMP regulations (part 606) (21 CFR part 606) and related 
regulations implement FDA's statutory authority to ensure the safety, 
purity, and potency of blood and blood components. The public health 
objective in testing human blood donations for evidence of relevant 
transfusion-transmitted infections and in notifying donors is to 
prevent the transmission of relevant transfusion-transmitted 
infections. For example, the ``lookback'' requirements are intended to 
help ensure the continued safety of the blood supply by providing 
necessary information to consignees of blood and blood components and 
appropriate notification of recipients of blood components that are at 
increased risk for transmitting human immunodeficiency virus (HIV) or 
hepatitis C virus (HCV) infection.
    The information collection requirements in the CGMP, donation 
testing, donor notification, and ``lookback'' regulations provide FDA

[[Page 16871]]

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 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) (21 CFR 
606.170(b)), in brief, requires that facilities notify FDA's Center for 
Biologics Evaluation and Research (CBER), as soon as possible after a 
complication of blood collection or transfusion is confirmed to be 
fatal. The collecting facility is required 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 2016, FDA received 81 fatality 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 relevant transfusion-
transmitted infections.
    Section 610.41(b) (21 CFR 610.41(b)) allows for a previously 
deferred donor to subsequently be found to be an eligible donor of 
blood and blood components by a requalification method or process found 
acceptable for such purposes by FDA.
    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 
infection due to a relevant transfusion-transmitted infection(s) or 
collected from a donor deferred under Sec.  610.41(a).
    In addition, Sec.  630.35(b) (21 CFR 630.35(b)) allows for a 
previously deferred donor, deferred for reasons other than Sec.  
610.41(a), to become requalified for donation by a method or process 
found acceptable for such purpose by FDA.
    Under the third-party disclosure requirements, Sec.  606.145(c) (21 
CFR 606.145(c)) requires transfusion services to notify certain blood 
collection establishments concerning bacterial contamination of 
platelets and other additional information. In table 3, FDA estimates 
that for the approximately 4,961 transfusion services, there would be 
1,400 total notifications per year to blood collection establishments 
(700 notifications that platelets are bacterially contaminated and 700 
notifications per year concerning the identity or non-identity of the 
species of the contaminating organism).
    Section 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 (21 CFR 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.
    Section 610.40(h)(2)(ii)(C) and (D), in brief, require an 
establishment to label certain reactive human blood and blood 
components with the appropriate screening test results for evidence of 
infection due to the identified relevant transfusion-transmitted 
infection(s), and, if they are intended for further manufacturing use 
into 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) (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 relevant transfusion-transmitted infection(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 relevant transfusion-transmitted infection(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 ``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 
(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 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)). The burden for the recordkeeping 
requirements under Sec. Sec.  610.46(a) and (b) and 610.47(a) and

[[Page 16872]]

(b) are included under Sec.  606.100 (21 CFR 606.100).
    Section 630.40(a) (21 CFR 630.40(a)) requires an establishment to 
make reasonable attempts to notify any donor who has been deferred as 
required by Sec.  610.41(a), or who has been determined not to be 
eligible as a donor. Section 630.40(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) (21 CFR 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 determines and documents 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 the 
tables of this document.
    Section 606.151(e) (21 CFR 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.
    Section 606.171 (21 CFR 606.171) requires establishments to 
establish and maintain procedures related to product deviations. The 
burden for the recordkeeping requirements under Sec.  606.171 are 
included under Sec.  606.100.
    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 (21 CFR 
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)(x) 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. Section 606.170(a) also requires that 
when an investigation determines 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.
    Under Sec.  630.15(a)(1)(ii)(B) (21 CFR 630.15(a)(1)(ii)(B)), FDA 
requires that for a dedicated donation based on the intended 
recipient's documented exceptional medical need, the responsible 
physician determines and documents that the health of the donor would 
not be adversely affected by donating.
    Under Sec.  630.20(c) (21 CFR 630.20(c)), a collection 
establishment may collect blood and blood components from a donor who 
is determined to be not eligible to donate under any provision of Sec.  
630.10(e) and (f) or Sec.  630.15(a), if the donation is restricted for 
use solely by a specific transfusion recipient based on documented 
exceptional medical need and the responsible physician determines and 
documents that the donor's health permits the collection procedure, and 
that the donation presents no undue medical risk to the transfusion 
recipient.
    In addition to the CGMP regulations in part 606, the regulations in 
21 CFR part 630 that include requirements for blood and blood 
components intended for transfusion or further manufacturing use and in 
21 CFR part 640 that require additional standards for certain blood and 
blood products are as follows: 21 CFR 630.5(b)(1)(i) and(d); 
630.10(c)(1) and (2); 630.10(f)(2) and (4); 630.10(g)(2)(i); 
630.15(a)(1)(ii)(A) and (B); 630.15(b)(2), (b)(7)(i) and (iii); 
630.20(a) and (b); 640.21(e)(4); 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); 
640.65(b)(2)(i); 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 transfusion services inspected by Centers for Medicare and 
Medicaid Services (CMS). Based on information received from CBER's 
database systems, there are approximately 569 licensed Source Plasma 
establishments and approximately 1,054 licensed blood collection 
establishments, for an estimated total of 1,623 (569 + 1,054) licensed 
blood collection establishments. Also, there are an estimated total of 
680 unlicensed, registered blood collection establishments for an 
approximate total of 2,303 collection establishments (569 + 1,054 + 680 
= 2,303 establishments). Of these establishments, approximately 901 
perform plateletpheresis and leukopheresis. These establishments 
annually collect approximately 53.3 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 estimated 4,961 establishments that fall under the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) (formerly referred to 
as facilities approved for Medicare reimbursement) that transfuse blood 
and blood components.
    The following reporting, recordkeeping, and disclosure estimates 
are based on information provided by industry, CMS, and FDA experience. 
Based on information from industry, we estimate that there are 
approximately

[[Page 16873]]

38.3 million donations of Source Plasma from approximately 2 million 
donors and approximately 15 million donations of Whole Blood and 
apheresis Red Blood Cells including approximately 34,500 (approximately 
0.23 percent of 15 million) autologous donations, from approximately 
10.9 million donors. Assuming each autologous donor makes an average of 
1.1 donations, FDA estimates that there are approximately 31,364 
autologous donors (34,500 autologous/1.1 average donations).
    FDA estimates that approximately 0.19 percent (21,000/10,794,000) 
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 relevant transfusion-transmitted 
infections. Shipments of Source Leukocytes are 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.
    According to CBER's database system, there are approximately 15 
licensed manufacturers that ship known reactive human blood or blood 
components under Sec.  610.40(h)(2)(ii)(C) and (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).
    Based on information received from industry, we estimate that 
approximately 7,544 donations will test reactive by a screening test 
for syphilis and be determined to be biological false positives by 
additional testing annually. These units would be labeled according to 
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 indicating that the 
product was manufactured from a donation found to be reactive for the 
identified relevant transfusion-transmitted infection(s). 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 3,021 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 9,063 (3,021 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 9,063 (3,021 x 3) notifications 
to consignees of subsequent test results.
    We estimate that approximately 4,961 consignees will be required 
under Sec.  610.46(b)(3) 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 6,799 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 two times for each of the 20,397 (6,799 x 3 components) 
components prepared from these donations, once for quarantine purposes 
and again with additional HCV test results for a total of 40,794 
(20,397 x 2) 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 14.3 percent of 
approximately 9 million potential donors (1,287,000 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 1,734 (1,054 
+ 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 (1,156) of the 
1,734 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 approximately one-third, or 578 of the 1,734 blood 
collecting establishments would need to provide, under Sec.  630.40(a), 
additional information and onsite counseling to the estimated 429,000 
(one-third of approximately 1,287,000) 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 1,623 licensed establishments 
(81) collecting 1 percent (4,050) of the deferred donors (405,000) 
would notify donors under Sec.  630.40(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.  630.40(d)(1). However, we estimate that approximately 5 
percent of the 1,054 blood collection establishments (53) may not 
notify the referring physicians of the estimated 2 percent of 31,364 
autologous donors with the initial reactive test results (627) 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)(x), we estimate the total annual records 
based on the approximately 1,287,000 donors determined not to be 
eligible to donate and each of the estimated 1,692,000 (1,287,000 + 
405,000) donors deferred based on reactive test results for

[[Page 16874]]

evidence of infection because of relevant transfusion-transmitted 
infections. Under Sec.  606.160(b)(1)(xi), only the 1,734 registered 
blood establishments collect autologous donations and, therefore, are 
required to notify referring physicians. We estimate that 4.5 percent 
of the 31,364 autologous donors (1,411) will be deferred under Sec.  
610.41, which in turn will lead to the notification of their referring 
physicians.
    Under Sec.  610.41(b), FDA estimates that there would be 25 
submissions for requalification of donors. In addition, FDA estimates 
that there would be only three notifications for requalification of 
donors under Sec.  630.35(b). FDA also estimates the average time for 
each submission.
    FDA permits the shipment of untested or incompletely tested human 
blood or blood components in rare medical emergencies and when 
appropriately documented (Sec.  610.40(g)(1)). 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) is part of the usual and customary business practice of 
blood establishments.
    In the Federal Register of January 23, 2018 (83 FR 3165), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited 
and therefore will not be discussed in this document.
    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.
    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\..................              81               1              81              20           1,620
610.40(g)(2)....................               1               1               1               1               1
610.41(b).......................           1,623           0.015              25               7             175
610.40(h)(2)(ii)(A).............               1               1               1               1               1
630.35(b).......................           1,623           0.002               3               7              21
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,818
----------------------------------------------------------------------------------------------------------------
\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/activity       Number of      records per    Total annual   Average burden per    Total hours
                               recordkeepers   recordkeeper       records        recordkeeping
----------------------------------------------------------------------------------------------------------------
606.100(b) \2\..............         \5\ 363               1             363  24................           8,712
606.100(c)..................         \5\ 363              10           3,630  1.................           3,630
606.110(a) \3\..............          \6\ 45               1              45  0.5 (30 min)......              23
606.151(e)..................         \5\ 363              12           4,356  0.08 (5 min.).....             348
606.160 \4\.................         \5\ 363       1,055.096         383,000  0.75 (45 min.)....         287,250
606.160(b)(1)(viii) HIV                1,734         10.4533          18,126  0.17 (10 min.)....           3,081
 consignee notification.      ..............  ..............  ..............  0.17 (10 min.)....  ..............
                                       4,961          3.6537          18,126                               3,081
606.160(b)(1)(viii) HCV                1,734         23.5259          40,794  0.17 (10 min.)....           6,935
 consignee notification.      ..............  ..............  ..............  0.17 (10 min).....  ..............
                                       4,961          8.2229          40,794                               6,935
HIV recipient notification..           4,961          0.3538           1,755  0.17 (10 min.)....             298
HCV recipient notification..           4,961          0.4132           2,050  0.17 (10 min.)....             349
606.160(b)(1)(x)............           2,303        734.6939       1,692,000  0.05 (3 min.).....          84,600
606.160(b)(1)(xi)...........           1,734          0.8137           1,411  0.05 (3 min.).....              71
606.165.....................         \5\ 363       1,055.096         383,000  0.08 (5 min.).....          30,640
606.170(a)..................         \5\ 363              12           4,356  1.................           4,356
610.40(g)(1)................           2,303               1           2,303  0.5 (30 min.).....           1,152
630.15(a)(1)(ii)(B).........           1,734               1           1,734  1.................           1,734
630.20(c)...................           1,734               1           1,734  1.................           1,734
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............  ..............  ..................         444,930
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The recordkeeping requirements in Sec.  Sec.   606.171, 610.46(a) and (b), 610.47(a) and (b), 630.5(d),
  630.10(c)(1) and (2), 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.   606.110(a)(2); 630.5(b)(1)(i); 630.109(f)(2) and (4);
  630.10(g)(2)(i); 630.15(a)(1)(ii)(A) and (B); 630.15(b)(2), (b)(7)(i) and (iii); 630.20(a) and (b);
  640.21(e)(4); 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);
  630.15(b)(2); 640.65(b)(2)(i); 640.71(b)(1); 640.72; 640.73; 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 + 2,303 = 363).
\6\ Five percent of plateletpheresis and leukopheresis establishments (0.05 x 901 = 45).

[[Page 16875]]

                            Table 3--Estimated Annual Third-Party Disclosure Burden 1
----------------------------------------------------------------------------------------------------------------
                                                 Number of
       21 CFR section            Number of      disclosures    Total annual   Average burden per    Total hours
                                respondents   per respondent    disclosures       disclosure
----------------------------------------------------------------------------------------------------------------
606.145(c)..................           4,961          0.2822           1,400  0.02..............              28
606.170(a)..................         \2\ 363              12           4,356  0.5 (30 min.).....           2,178
610.40(c)(1)(ii)............           2,303          0.0595             137  0.08 (5 min.).....              11
610.40(h)(2)(ii)(C) and                   15              12             180  0.20 (12 min.)....              36
 (h)(2)(ii)(D).
610.40(h)(2)(vi)............           2,303            3.28           7,554  0.08 (5 min.).....             604
610.42(a)...................               1               1               1  1.................               1
610.46(a)(1)(ii)(B).........           1,734          5.2266           9,063  0.17 (10 min.)....           1,541
610.46(a)(3)................           1,734          5.2266           9,063  0.17 (10 min.)....           1,541
610.46(b)(3)................           4,961          0.3538           1,755  1.................           1,755
610.47(a)(1)(ii)(B).........           1,734         11.7630          20,397  0.17 (10 min.)....           3,467
610.47(a)(3)................           1,734         11.7630          20,397  0.17 (10 min.)....           3,467
610.47(b)(3)................           4,961          0.4132           2,050  1.................           2,050
630.40(a) \3\...............             578         742.214         429,000  0.08 (5 min.).....          34,320
630.40(a) \4\...............              81              50           4,050  1.5...............           6,075
630.40(d)(1)................              53           11.83             627  1.................             627
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............  ..............  ..................          57,701
----------------------------------------------------------------------------------------------------------------
\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 + 2,303 = 363).
\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 relevant
  transfusion-transmitted infections.

    The burden for this information collection has changed since the 
last OMB approval. Because of a slight decrease in the number of blood 
establishments during the last 3 years, FDA has decreased our 
recordkeeping and third-party disclosure burden estimates.

    Dated: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07972 Filed 4-16-18; 8:45 am]
 BILLING CODE 4164-01-P