[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3165-3171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01123]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
requirements relating to FDA's regulation of current good manufacturing 
practice (CGMP) and related regulations for blood and blood components; 
and requirements for donation testing, donor notification, and 
``lookback''.

DATES: Submit either electronic or written comments on the collection 
of information by March 26, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of March 26, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-6931 for ``Current Good Manufacturing Practices and Related 
Regulations for Blood and Blood Components; and Requirements for 
Donation Testing, Donor Notification, and `Lookback'.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff

[[Page 3166]]

between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Current Good Manufacturing Practices and Related Regulations for Blood 
and Blood Components; and Requirements for 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(a)), drugs 
are deemed ``adulterated'' if the methods used in their manufacturing, 
processing, packing, or holding do not conform to CGMP and related 
regulations.
    The CGMP regulations (part 606) (21 CFR part 606) and related 
regulations implement FDA's statutory authority to ensure the safety, 
purity, and potency of blood and blood components. The public health 
objective in testing human blood 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 
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), in brief, 
requires that facilities notify FDA's Center for Biologics Evaluation 
and Research

[[Page 3167]]

(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) 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(b) 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) 
requires transfusion services to notify certain blood collection 
establishments concerning bacterial contamination of platelets. 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 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. The information collection 
requirements under Sec.  606.121 are part of usual and customary 
business practice.
    Sections 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) 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 addition, Sec.  630.35(b) allows for a previously deferred 
donor, deferred for reasons other than Sec.  610.41(b) to become 
requalified for donation by a method or process found acceptable for 
such purpose by FDA.
    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 ``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)).
    Section 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

[[Page 3168]]

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 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) 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 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 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, 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), 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), 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, there are 
regulations in part 630 that include requirements for blood and blood 
components intended for transfusion or further manufacturing use, and 
part 640 that require additional standards for certain blood and blood 
products as follows: Sections 630.5(b)(1)(i), 630.5(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); 640.25(b)(4) 
and (c)(1); 640.21(e)(4); 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); 640.66; 
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 and recordkeeping estimates are based on 
information provided by industry, CMS, and FDA experience. Based on 
information from industry, we estimate that there are approximately 
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. 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.

[[Page 3169]]

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. 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 that test reactive by a screening test 
for syphilis and are 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. Sec.  
610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 9,063 (3,012 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. Sec.  
610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments would 
notify the consignee 2 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 (2 x 20,397 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)(ix), 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 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 each requiring 7 hours per 
submission. In addition, FDA estimates that there would be only 3 
notifications for requalification of donors under Sec.  630.35(b) which 
would also require 7 hours 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

[[Page 3170]]

customary business practice of blood establishments.
    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 recordkeeping        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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  .5 (30 min.)............................              23
606.151(e)....................................         \5\ 363              12           4,356  .08 (5 min.)............................             348
606.160 \4\...................................         \5\ 363       1,055.096         383,000  .75 (45 min.)...........................         287,250
606.160(b)(1)(viii) HIV consignee notification           1,734         10.4533          18,126  .17 (10 min.)...........................           3,081
                                                         4,961          3.6537          18,126  .17 (10 min.)...........................           3,081
606.160(b)(1)(viii) HCV consignee notification           1,734         23.5259          40,794  .17 (10 min.)...........................           6,935
                                                         4,961          8.2229          40,794  .17 (10 min.)...........................           6,935
HIV recipient notification....................           4,961          0.3538           1,755  .17 (10 min.)...........................             298
HCV recipient notification....................           4,961          0.4132           2,050  .17 (10 min.)...........................             349
606.160(b)(1)(ix).............................           2,303        734.6939       1,692,000  .05 (3 min.)............................          84,600
606.160(b)(1)(xi).............................           1,734          0.8137           1,411  .05 (3 min.)............................              71
606.165.......................................         \5\ 363       1,055.096         383,000  .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  .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, 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).


                                                Table 3--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
                21 CFR section                     Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.145(c)....................................           4,961          0.2822           1,400  .02.....................................              28
606.170(a)....................................         \2\ 363              12           4,356  .5 (30 min.)............................           2,178
610.40(c)(1)(ii)..............................           2,303          0.0595             137  .08 (5 min.)............................              11
610.40(h)(2)(ii)(C) and (h)(2)(ii)(D).........              15              12             180  .20 (12 min.)...........................              36
610.40(h)(2)(vi)..............................           2,303            3.28           7,554  .08 (5 min.)............................             604
610.42(a).....................................               1               1               1  1.......................................               1
610.46(a)(1)(ii)(B)...........................           1,734          5.2266           9,063  .17 (10 min.)...........................           1,541
610.46(a)(3)..................................           1,734          5.2266           9,063  .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  .17 (10 min.)...........................           3,467

[[Page 3171]]

 
610.47(a)(3)..................................           1,734         11.7630          20,397  .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  .08 (5 min.)............................          34,320
630.40(a) \4\.................................              81           50.00           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: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01123 Filed 1-22-18; 8:45 am]
 BILLING CODE 4164-01-P