Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”, 62629-62634 [2014-24797]
Download as PDF
<![CDATA[
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices
frequency is yearly, once, and
occasionally; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 56; Total Responses:
1,540 (3-year total); Total Hours: 86,240
(3-year total). (For policy questions
regarding this collection contact
Annette Pearson at 410–786–6858).
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Quarterly
Medicaid and CHIP Budget and
Expenditure Reporting for the Medical
Assistance Program, Administration and
CHIP; Use: At the request of OMB, this
action would consolidate the following
three OMB control numbers for forms
CMS–21 and –21B (OMB control
number: 0938–0731), CMS–37 (OMB
control number: 0938–0101), and CMS–
64 (OMB control number: 0938–0067)
into a single control number that will be
assigned upon OMB approval. It is
important to emphasize that the
consolidation of the control numbers
does not consolidate any of the forms
required for Medicaid and CHIP Budget
and Expenditure Reporting.
While the overall package has been
assigned a new CMS identification
number (CMS–10529), the individual
forms will retain their respective CMSspecific identification numbers, namely
CMS–21, CMS–21B, CMS–37, and
CMS–64. Supporting materials (see
ADDRESSES) can be found under parent
identification number, namely CMS–
10529.
This action also revises CMS–37 and
–64 while CMS–21 and –21B remain
unchanged. Forms CMS–21 and –21B
provide CMS with the information
necessary to issue quarterly grant
awards, monitor current year
expenditure levels, determine the
allowability of state claims for
reimbursement, develop Children’s
Health Insurance Program (CHIP)
financial management information,
provide for state reporting of waiver
expenditures, and ensure that the
federally established allotment is not
exceeded. They are also necessary in the
redistribution and reallocation of
unspent funds over the federally
mandated timeframes.
Form CMS–37 due dates are
November 15, February 15, May 15 and
August 15 of each fiscal year. While all
submissions represent equally
important components of the grant
award cycle, the May and November
submissions are particularly significant
for budget formulation. The November
submission introduces a new fiscal year
to the budget cycle and serves as the
basis for the formulation of the
Medicaid portion of the President’s
VerDate Sep<11>2014
18:41 Oct 17, 2014
Jkt 235001
Budget, which is presented to Congress
in January. The February and August
submissions are used primarily for
budget execution in providing interim
updates to our Office of Financial
Management, the Department of Health
and Human Services, the Office of
Management and Budget and Congress
depending on the scheduling of the
national budget review process in a
given fiscal year. The submissions
provide us with base information
necessary to track current year
obligations and expenditures in relation
to the current year appropriation and to
notify senior managers of any
impending surpluses or deficits.
Form CMS–64 is used to issue
quarterly grant awards, monitor current
year expenditure levels, determine the
allowability of state claims for
reimbursement, develop Medicaid
financial management information
provide for state reporting of waiver
expenditures, ensure that the federallyestablished limit is not exceeded for
HCBS waivers, and to allow for the
implementation of the Assignment of
Rights and Part A and Part B Premium
(i.e., accounting for overdue Part A and
Part B Premiums under state buy-in
agreements)—Billing Offsets.
Form Number: CMS–10529 (OMB
control number: 0938—New);
Frequency: Quarterly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 56; Total
Annual Responses: 672; Total Annual
Hours: 17,920. (For policy questions
regarding this collection contact
Abraham John at 410–786–4519).
Dated: October 15, 2014.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2014–24862 Filed 10–17–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–N–0161]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practices and Related
Regulations for Blood and Blood
Components; and Requirements for
Donor Testing, Donor Notification, and
‘‘Lookback’’
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00037
Fmt 4703
Sfmt 4703
62629
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information
requirements relating to FDA’s
regulation of current good
manufacturing practice (CGMP) and
related regulations for blood and blood
components; and requirements for
donor testing, donor notification, and
‘‘lookback.’’
SUMMARY:
Submit either electronic or
written comments on the collection of
information by December 19, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in the brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
DATES:
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20OCN1.SGM
20OCN1
62630
Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Current Good Manufacturing Practices
and Related Regulations for Blood and
Blood Components; and Requirements
for Donor Testing, Donor Notification,
and ‘‘Lookback’’—(OMB Control
Number 0910–0116)—Extension
All blood and blood components
introduced or delivered for introduction
into interstate commerce are subject to
section 351(a) of the Public Health
Service Act (PHS Act) (42 U.S.C.
262(a)). Section 351(a) 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 (FD&C) Act also applies to
biological products. Blood and blood
components for transfusion or for
further manufacture into injectable
products are drugs, as that term is
defined in section 201(g)(1) of the FD&C
Act (21 U.S.C. 321(g)(1)). Because blood
and blood components are drugs under
the FD&C Act, blood and plasma
establishments must comply with the
substantive provisions and related
regulatory scheme of the FD&C Act. For
VerDate Sep<11>2014
16:28 Oct 17, 2014
Jkt 235001
example, under section 501 of the FD&C
Act (21 U.S.C. 351(a)), drugs are deemed
‘‘adulterated’’ if the methods used in
their manufacturing, processing,
packing, or holding do not conform to
CGMP and related regulations.
The CGMP regulations (part 606) (21
CFR part 606)) and related regulations
implement FDA’s statutory authority to
ensure the safety, purity, and potency of
blood and blood components. The
public health objective in testing human
blood donors for evidence of infection
due to communicable disease agents
and in notifying donors is to prevent the
transmission of communicable disease.
For example, the ‘‘lookback’’
requirements are intended to help
ensure the continued safety of the blood
supply by providing necessary
information to users of blood and blood
components and appropriate
notification of recipients of transfusion
who are at increased risk for
transmitting human immunodeficiency
virus (HIV) or hepatitis C virus (HCV)
infection.
The information collection
requirements in the CGMP, donor
testing, donor notification, and
‘‘lookback’’ regulations provide FDA
with the necessary information to
perform its duty to ensure the safety,
purity, and potency of blood and blood
components. These requirements
establish accountability and traceability
in the processing and handling of blood
and blood components and enable FDA
to perform meaningful inspections.
The recordkeeping requirements serve
preventive and remedial purposes. The
third-party disclosure requirements
identify the various blood and blood
components and important properties of
the product, demonstrate that the CGMP
requirements have been met, and
facilitate the tracing of a product back
to its original source. The reporting
requirements inform FDA of certain
information that may require immediate
corrective action.
Under the reporting requirements,
§ 606.170(b), in brief, requires that
facilities notify FDAs Center for
Biologics Evaluation and Research
(CBER), as soon as possible after
confirming a complication of blood
collection or transfusion to be fatal. The
collecting facility is to report donor
fatalities, and the compatibility testing
facility is to report recipient fatalities.
The regulation also requires the
reporting facility to submit a written
report of the investigation within 7 days
after the fatality. In fiscal year 2013,
FDA received 72 of these reports.
Section 610.40(g)(2) requires an
establishment to obtain written approval
from FDA to ship human blood or blood
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
components for further manufacturing
use prior to completion of testing for
evidence of infection due to certain
communicable disease agents.
Section 610.40(h)(2)(ii)(A), in brief,
requires an establishment to obtain
written approval from FDA to use or
ship human blood or blood components
found to be reactive by a screening test
for evidence of certain communicable
disease agent(s) or collected from a
donor with a record of a reactive
screening test.
Under the third-party disclosure
requirements, § 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 § 606.121 and with a
label containing the name and
identifying information of the recipient.
The information collection requirements
under § 606.121 are part of usual and
customary business practice.
Sections 610.40(h)(2)(ii)(C) and
(h)(2)(ii)(D), in brief, require an
establishment to label certain reactive
human blood and blood components
with the appropriate screening test
results, and, if they are intended for
further manufacturing use into
injectable products, to include a
statement on the label indicating the
exempted use specifically approved by
FDA. Also, § 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, §§ 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 §§ 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
E:\FR\FM\20OCN1.SGM
20OCN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices
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
(§§ 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 (§§ 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 (§§ 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 (§§ 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
§ 610.41, or who has been determined
not to be eligible as a donor. Section
VerDate Sep<11>2014
16:28 Oct 17, 2014
Jkt 235001
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 § 610.41.
Under the recordkeeping
requirements, § 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, § 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 § 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, § 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,
§ 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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
62631
records of notification of the referring
physician of a deferred autologous
donor, including appropriate followup.
Section 606.165, in brief, requires that
distribution and receipt records be
maintained to facilitate recalls, if
necessary.
Section 606.170(a) requires records to
be maintained of any reports of
complaints of adverse reactions arising
as a result of blood collection or
transfusion. Each such report must be
thoroughly investigated, and a written
report, including conclusions and
followup, must be prepared and
maintained. Section 606.170(a) also
requires that when an investigation
concludes that the product caused the
transfusion reaction, copies of all such
written reports must be forwarded to
and maintained by the manufacturer or
collecting facility.
Section 610.40(g)(1) requires an
establishment to appropriately
document a medical emergency for the
release of human blood or blood
components prior to completion of
required testing.
In addition to the CGMP regulations
in part 606, there are regulations in 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.
Respondents to this collection of
information are licensed and unlicensed
blood establishments that collect blood
and blood components, including
Source Plasma and Source Leukocytes,
inspected by FDA, and other transfusion
services inspected by Centers for
Medicare and Medicaid Services (CMS).
Based on information received from
CBER’s database systems, there are
approximately 416 licensed Source
Plasma establishments with multiple
locations and approximately 1,265
licensed blood collection
establishments, for an estimated total of
1,681 licensed blood collection
establishments. Also, there are an
estimated total of 680 unlicensed,
registered blood collection
establishments for an approximate total
of 2,361 collection establishments (416
+ 1,265 + 680 = 2,361 establishments).
Of these establishments, approximately
990 perform plateletpheresis and
E:\FR\FM\20OCN1.SGM
20OCN1
tkelley on DSK3SPTVN1PROD with NOTICES
62632
Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices
leukopheresis. These establishments
annually collect approximately 40
million units of Whole Blood and blood
components, including Source Plasma
and Source Leukocytes, and are
required to follow FDA ‘‘lookback’’
procedures. In addition, there are
another 4,961 establishments that fall
under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) (Public Law 100–578) (formerly
referred to as facilities approved for
Medicare reimbursement) that transfuse
blood and blood components.
The following reporting and
recordkeeping estimates are based on
information provided by industry, CMS,
and FDA experience. Based on
information received from industry, we
estimate that there are approximately 25
million donations of Source Plasma
from approximately 2 million donors
and approximately 15 million donations
of Whole Blood, including
approximately 225,000 (approximately
1.5 percent of 15 million) autologous
donations, from approximately 10.9
million donors. Assuming each
autologous donor makes an average of 2
donations, FDA estimates that there are
approximately 112,500 autologous
donors.
FDA estimates that approximately 5
percent (3,600 of the 72,000 donations
that are donated specifically for the use
of an identified recipient would be
tested under the dedicated donors’
testing provisions in § 610.40(c)(1)(ii).
Under §§ 610.40(g)(2) and
(h)(2)(ii)(A), Source Leukocytes, a
licensed product that is used in the
manufacture of interferon, which
requires rapid preparation from blood,
is currently shipped prior to completion
of testing for evidence of certain
communicable disease agents.
Shipments of Source Leukocytes are
preapproved under a biologics license
application (BLA) and each shipment
does not have to be reported to the
Agency. Based on information from
CBER’s database system, FDA receives
less than one application per year from
manufacturers of Source Leukocytes.
However, for calculation purposes, we
are estimating one application annually.
Under §§ 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 § 610.40(h)(2)(ii)(C), and the
other stating the exempted use
specifically approved by FDA under
§ 610.40(h)(2)(ii)(D). According to
CBER’s database system, there are
approximately 40 licensed
VerDate Sep<11>2014
16:28 Oct 17, 2014
Jkt 235001
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
(§ 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 § 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 §§ 610.46(a)(1)(ii)(B)
and (a)(3), this estimate results in 10,500
(3,500 × 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 × 3) notifications to
consignees of subsequent test results.
We estimate that § 610.46(b)(3) will
require 4,961 consignees to notify
transfusion recipients, their legal
representatives, or physicians of record
an average of 0.35 times per year
resulting in a total number of 1,755 (585
confirmed positive repeat donors × 3)
notifications. Also under § 610.46(b)(3),
we estimate and include the time to
gather test results and records for each
recipient and to accommodate multiple
attempts to contact the recipient.
Furthermore, we estimate that
approximately 7,800 repeat donors per
year would test reactive for antibody to
HCV. Under §§ 610.47(a)(1)(ii)(B) and
610.47(a)(3), collecting establishments
would notify the consignee 2 times for
each of the 23,400 (7,800 × 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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
burden. Under § 610.47(b)(3), we
estimate that approximately 4,961
consignees would notify approximately
2,050 recipients or their physicians of
record annually.
Based on industry estimates,
approximately 13 percent of
approximately 10 million potential
donors (1.3 million donors) who come
to donate annually are determined not
to be eligible for donation prior to
collection because of failure to satisfy
eligibility criteria. It is the usual and
customary business practice of
approximately 1,945 (1,265 + 680) blood
collecting establishments to notify
onsite and to explain why the donor is
determined not to be suitable for
donating. Based on such available
information, we estimate that two-thirds
(1,297) of the 1,945 blood collecting
establishments provided onsite
additional information and counseling
to a donor determined not to be eligible
for donation as usual and customary
business practice. Consequently, we
estimate that only one-third, or 648,
approximately, blood collecting
establishments would need to provide,
under § 630.6(a), additional information
and onsite counseling to the estimated
433,333 (one-third of approximately 1.3
million) ineligible donors.
It is estimated that another 4.5 percent
of 10 million potential donors (450,000
donors) are deferred annually based on
test results. We estimate that
approximately 95 percent of the
establishments that collect 99 percent of
the blood and blood components notify
donors who have reactive test results for
HIV, Hepatitis B Virus (HBV), HCV,
Human T-Lymphotropic Virus (HTLV),
and syphilis as usual and customary
business practice. Consequently, 5
percent of the 1,681 establishments (84)
collecting 1 percent (4,500) of the
deferred donors (450,000) would notify
donors under § 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 § 630.6(d)(1).
However, we estimate that
approximately 5 percent of the 1,265
blood collection establishments (63)
may not notify the referring physicians
of the estimated 2 percent of 112,500
autologous donors with the initial
reactive test results (2,250) as their
usual and customary business practice.
The recordkeeping chart reflects the
estimate that approximately 95 percent
of the recordkeepers, which collect 99
percent of the blood supply, have
developed SOPs as part of their
customary and usual business practice.
E:\FR\FM\20OCN1.SGM
20OCN1
62633
Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices
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 § 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
§ 606.160(b)(1)(xi), only the 1,945
registered blood establishments collect
autologous donations and, therefore, are
required to notify referring physicians.
We estimate that 4.5 percent of the
112,500 autologous donors (5,063) will
be deferred under § 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
§ 610.40(g)(1) to be minimal with one or
fewer occurrences per year. The
reporting of test results to the consignee
in § 610.40(g) is part of the usual and
customary business practice or
procedure to finish the testing and
provide the results to the manufacturer
responsible for labeling the blood
products.
The average burden per response
(hours) and average burden per
recordkeeping (hours) are based on
estimates received from industry or FDA
experience with similar reporting or
recordkeeping requirements.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
606.170(b) 2 ..........................................................................
610.40(g)(2) .........................................................................
610.40(h)(2)(ii)(A) .................................................................
72
1
1
1
1
1
72
1
1
20
1
1
1,440
1
1
Total ..............................................................................
........................
........................
........................
........................
1,442
1 There
2 The
are no capital costs or operating and maintenance costs associated with this collection of information.
reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b).
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
606.100(b) 2 ..............................................................
606.100(c) ................................................................
606.110(a) 3 ..............................................................
606.151(e) ................................................................
606.160 4 ..................................................................
606.160(b)(1)(viii) .....................................................
HIV consignee notification .......................................
606.160(b)(1)(viii) .....................................................
HCV consignee notification ......................................
HIV recipient notification ..........................................
HCV recipient notification ........................................
606.160(b)(1)(ix) ......................................................
606.160(b)(1)(xi) ......................................................
606.165 ....................................................................
606.170(a) ................................................................
610.40(g)(1) .............................................................
Total ..................................................................
Number of
records per
recordkeeper
5 366
Total annual
records
Average
burden per
recordkeeping
Total hours
5 366
1,945
4,961
1,945
4,961
4,961
4,961
2,361
1,945
5 366
5 366
2,361
1
10
1
12
1,046.45
10.80
4.23
24.06
9.43
0.35
0.41
741.21
2.60
1,046.45
12
1
366
3,660
50
4,392
383,000
21,000
21,000
46,800
46,800
1,755
2,050
1,750,000
5,063
383,000
4,392
2,361
24 ..............................
1 ................................
0.5 (30 minutes) ........
0.08 (5 minutes) ........
0.75 (45 minutes) ......
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.17 (10 minutes) ......
0.05 (3 minutes) ........
0.05 (3 minutes) ........
0.08 (5 minutes) ........
1 ................................
0.5 (30 minutes) ........
8,784
3,660
25
351
287,250
3,570
3,570
7,956
7,956
298
349
87,500
253
30,640
4,392
1,180
........................
........................
........................
....................................
447,734
5 366
6 50
5 366
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the estimate for § 606.100(b).
3 The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included
in the estimate for § 606.110(a).
4 The recordkeeping requirements in §§ 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 § 606.160.
5 Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 ×
4,961 + 2,361 = 366).
6 Five percent of plateletpheresis and leukopheresis establishments (0.05 × 990 = 50).
tkelley on DSK3SPTVN1PROD with NOTICES
2 The
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
No. of
respondents
21 CFR section
2 366
606.170(a) ................................................................
VerDate Sep<11>2014
16:28 Oct 17, 2014
Jkt 235001
PO 00000
No. of
responses per
respondent
Frm 00041
Fmt 4703
12
Sfmt 4703
Total annual
responses
4,392
E:\FR\FM\20OCN1.SGM
Average
burden per
response
0.5 (30 minutes) ........
20OCN1
Total hours
2,196
62634
Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
No. of
respondents
21 CFR section
No. of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
610.40(c)(1)(ii) ..........................................................
610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) ..........................
610.40(h)(2)(vi) ........................................................
610.42(a) ..................................................................
610.46(a)(1)(ii)(B) .....................................................
610.46(a)(3) .............................................................
610.46(b)(3) .............................................................
610.47(a)(1)(ii)(B) .....................................................
610.47(a)(3) .............................................................
610.47(b)(3) .............................................................
630.6(a) 3 ..................................................................
630.6(a) 4 ..................................................................
630.6(d)(1) ...............................................................
2,361
40
2,361
1
1,945
1,945
4,961
1,945
1,945
4,961
648
84
63
1.52
12
7.62
1
5.40
5.40
0.35
12.03
12.03
0.41
668.72
53.57
35.71
3,600
480
18,000
1
10,500
10,500
1,755
23,400
23,400
2,050
433,333
4,500
2,250
0.08 (5 minutes) ........
0.20 (12 minutes) ......
0.08 (5 minutes) ........
1 ................................
0.17 (10 minutes) ......
0.17 (10 minutes) ......
1 ................................
0.17 (10 minutes) ......
0.17 (10 minutes) ......
1 ................................
0.08 (5 minutes) ........
1.5 (90 minutes) ........
1 ................................
288
96
1,440
1
1,785
1,785
1,755
3,978
3,978
2,050
34,667
6,750
2,250
Total ..................................................................
........................
........................
........................
....................................
63,019
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 ×
4,961 + 2,361 = 366).
3 Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria.
4 Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents.
2 Five
Dated: October 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24797 Filed 10–17–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0960]
Kelvin Soto: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
SUPPLEMENTARY INFORMATION:
Notice.
I. Background
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Kelvin Soto from providing services in
any capacity to a person that has an
approved or pending drug product
application for a period of 6 years. We
base this order on a finding that Mr.
Soto was convicted of four felony
counts under Federal law for conduct
involving health care fraud and
conspiracy to commit health care fraud
and that this pattern of conduct is
sufficient to find that there is reason to
believe he may violate requirements
under the FD&C Act relating to drug
products. Mr. Soto was given notice of
the proposed debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Mr. Soto failed to request a hearing. Mr.
Soto’s failure to request a hearing
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is effective October
20, 2014.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Element Bldg., Rm.
4144, Rockville, MD 20857, 301–796–
4640.
VerDate Sep<11>2014
17:58 Oct 17, 2014
Jkt 235001
Section 306(b)(2)(B)(ii)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(ii)(I))
permits debarment of an individual if
FDA finds that the individual has been
convicted of a felony under Federal law
for conduct that involves bribery;
payment of illegal gratuities; fraud;
perjury; false statement; racketeering;
blackmail; extortion; falsification or
destruction of records; interference
with, obstruction of an investigation
into, or prosecution of any criminal
offense; and FDA finds, on the basis of
the conviction and other information,
that such individual has demonstrated a
pattern of conduct sufficient to find that
there is reason to believe the individual
may violate requirements under the
FD&C Act relating to drug products.
On November 6, 2012, the U.S.
District Court for the Southern District
of Florida entered judgment against Mr.
Soto after a jury found him guilty of four
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
counts of health care fraud in violation
of 18 U.S.C. 1347 and one count of
conspiracy to commit health care fraud
in violation of 18 U.S.C. 1349.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein. The
factual basis for these convictions is as
follows: Mr. Soto was a registered nurse
working for Ideal Home Health Inc.
(Ideal), which was a business in MiamiDade County, FL. Ideal purportedly
provided skilled nursing services to
Medicare beneficiaries who required
home health services. As a registered
nurse in the home health field, it was
Mr. Soto’s duty to provide skilled
nursing services to patients and
maintain proper documentation of all
treatments provided to patients.
Mr. Soto conspired with others to
defraud Medicare. Mr. Soto and his
coconspirators, among other things,
submitted and caused the submission of
false and fraudulent claims to Medicare
and concealed the submission of these
false and fraudulent claims.
Mr. Soto and his co-conspirators
falsified and caused Medicare
beneficiaries to falsify weekly visit/time
record sheets, falsified skilled nursing
progress notes representing that Mr.
Soto had administered insulin
injections and provided various other
medical services to Medicare
beneficiaries, and caused Ideal to
submit false and fraudulent claims to
Medicare for home health benefits by
falsely representing that they had
provided these home health services. As
a result of these fraudulent claims, Mr.
Soto caused Medicare to make payments
E:\FR\FM\20OCN1.SGM
20OCN1
]]>Agencies
[Federal Register Volume 79, Number 202 (Monday, October 20, 2014)]
[Notices]
[Pages 62629-62634]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24797]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-N-0161]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practices and Related
Regulations for Blood and Blood Components; and Requirements for Donor
Testing, Donor Notification, and ``Lookback''
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
requirements relating to FDA's regulation of current good manufacturing
practice (CGMP) and related regulations for blood and blood components;
and requirements for donor testing, donor notification, and
``lookback.''
DATES: Submit either electronic or written comments on the collection
of information by December 19, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in the brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
[[Page 62630]]
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Current Good Manufacturing Practices and Related Regulations for Blood
and Blood Components; and Requirements for Donor Testing, Donor
Notification, and ``Lookback''--(OMB Control Number 0910-0116)--
Extension
All blood and blood components introduced or delivered for
introduction into interstate commerce are subject to section 351(a) of
the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). Section
351(a) 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 (FD&C) Act also applies to biological products. Blood and
blood components for transfusion or for further manufacture into
injectable products are drugs, as that term is defined in section
201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). Because blood and
blood components are drugs under the FD&C Act, blood and plasma
establishments must comply with the substantive provisions and related
regulatory scheme of the FD&C Act. For example, under section 501 of
the FD&C Act (21 U.S.C. 351(a)), drugs are deemed ``adulterated'' if
the methods used in their manufacturing, processing, packing, or
holding do not conform to CGMP and related regulations.
The CGMP regulations (part 606) (21 CFR part 606)) and related
regulations implement FDA's statutory authority to ensure the safety,
purity, and potency of blood and blood components. The public health
objective in testing human blood donors for evidence of infection due
to communicable disease agents and in notifying donors is to prevent
the transmission of communicable disease. For example, the ``lookback''
requirements are intended to help ensure the continued safety of the
blood supply by providing necessary information to users of blood and
blood components and appropriate notification of recipients of
transfusion who are at increased risk for transmitting human
immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
The information collection requirements in the CGMP, donor testing,
donor notification, and ``lookback'' regulations provide FDA with the
necessary information to perform its duty to ensure the safety, purity,
and potency of blood and blood components. These requirements establish
accountability and traceability in the processing and handling of blood
and blood components and enable FDA to perform meaningful inspections.
The recordkeeping requirements serve preventive and remedial
purposes. The third-party disclosure requirements identify the various
blood and blood components and important properties of the product,
demonstrate that the CGMP requirements have been met, and facilitate
the tracing of a product back to its original source. The reporting
requirements inform FDA of certain information that may require
immediate corrective action.
Under the reporting requirements, Sec. 606.170(b), in brief,
requires that facilities notify FDAs Center for Biologics Evaluation
and Research (CBER), as soon as possible after confirming a
complication of blood collection or transfusion to be fatal. The
collecting facility is to report donor fatalities, and the
compatibility testing facility is to report recipient fatalities. The
regulation also requires the reporting facility to submit a written
report of the investigation within 7 days after the fatality. In fiscal
year 2013, FDA received 72 of these reports.
Section 610.40(g)(2) requires an establishment to obtain written
approval from FDA to ship human blood or blood components for further
manufacturing use prior to completion of testing for evidence of
infection due to certain communicable disease agents.
Section 610.40(h)(2)(ii)(A), in brief, requires an establishment to
obtain written approval from FDA to use or ship human blood or blood
components found to be reactive by a screening test for evidence of
certain communicable disease agent(s) or collected from a donor with a
record of a reactive screening test.
Under the third-party disclosure requirements, Sec.
610.40(c)(1)(ii) in 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. The information collection
requirements under Sec. 606.121 are part of usual and customary
business practice.
Sections 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), in brief, require
an establishment to label certain reactive human blood and blood
components with the appropriate screening test results, and, if they
are intended for further manufacturing use into injectable products, to
include a statement on the label indicating the exempted use
specifically approved by FDA. Also, Sec. 610.40(h)(2)(vi) requires
each donation of human blood or blood components, excluding Source
Plasma, that tests reactive by a screening test for syphilis and is
determined to be a biological false positive to be labeled with both
test results.
Section 610.42(a) requires a warning statement ``indicating that
the product was manufactured from a donation found to be reactive by a
screening test for evidence of infection due to the identified
communicable disease agent(s)'' in the labeling for medical devices
containing human blood or a blood component found to be reactive by a
screening test for evidence of infection due to a communicable disease
agent(s) or syphilis.
In brief, Sec. Sec. 610.46 and 610.47 require blood collecting
establishments to establish, maintain, and follow an appropriate system
for performing HIV and HCV prospective ``lookback'' when: (1) A donor
tests reactive for evidence of HIV or HCV infection or (2) the
collecting establishment becomes aware of other reliable test results
or information indicating evidence of HIV or HCV infection
(``prospective lookback'') (see Sec. Sec. 610.46(a)(1) and
610.47(a)(1)). The requirement for ``an appropriate system'' requires
the collecting establishment to design standard operating procedures
(SOPs) to
[[Page 62631]]
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 630.6(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 records of the quarantine, notification, testing and
disposition performed under the HIV and HCV ``lookback'' provisions.
Furthermore, Sec. 606.160(b)(1)(ix) requires a blood collection
establishment to maintain records of notification of donors deferred or
determined not to be eligible for donation, including appropriate
followup. Section 606.160(b)(1)(xi) requires an establishment to
maintain records of notification of the referring physician of a
deferred autologous donor, including appropriate followup.
Section 606.165, in brief, requires that distribution and receipt
records be maintained to facilitate recalls, if necessary.
Section 606.170(a) requires records to be maintained of any reports
of complaints of adverse reactions arising as a result of blood
collection or transfusion. Each such report must be thoroughly
investigated, and a written report, including conclusions and followup,
must be prepared and maintained. Section 606.170(a) also requires that
when an investigation concludes that the product caused the transfusion
reaction, copies of all such written reports must be forwarded to and
maintained by the manufacturer or collecting facility.
Section 610.40(g)(1) requires an establishment to appropriately
document a medical emergency for the release of human blood or blood
components prior to completion of required testing.
In addition to the CGMP regulations in part 606, there are
regulations in 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.
Respondents to this collection of information are licensed and
unlicensed blood establishments that collect blood and blood
components, including Source Plasma and Source Leukocytes, inspected by
FDA, and other transfusion services inspected by Centers for Medicare
and Medicaid Services (CMS). Based on information received from CBER's
database systems, there are approximately 416 licensed Source Plasma
establishments with multiple locations and approximately 1,265 licensed
blood collection establishments, for an estimated total of 1,681
licensed blood collection establishments. Also, there are an estimated
total of 680 unlicensed, registered blood collection establishments for
an approximate total of 2,361 collection establishments (416 + 1,265 +
680 = 2,361 establishments). Of these establishments, approximately 990
perform plateletpheresis and
[[Page 62632]]
leukopheresis. These establishments annually collect approximately 40
million units of Whole Blood and blood components, including Source
Plasma and Source Leukocytes, and are required to follow FDA
``lookback'' procedures. In addition, there are another 4,961
establishments that fall under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) (Public Law 100-578) (formerly referred to as
facilities approved for Medicare reimbursement) that transfuse blood
and blood components.
The following reporting and recordkeeping estimates are based on
information provided by industry, CMS, and FDA experience. Based on
information received from industry, we estimate that there are
approximately 25 million donations of Source Plasma from approximately
2 million donors and approximately 15 million donations of Whole Blood,
including approximately 225,000 (approximately 1.5 percent of 15
million) autologous donations, from approximately 10.9 million donors.
Assuming each autologous donor makes an average of 2 donations, FDA
estimates that there are approximately 112,500 autologous donors.
FDA estimates that approximately 5 percent (3,600 of the 72,000
donations that are donated specifically for the use of an identified
recipient would be tested under the dedicated donors' testing
provisions in Sec. 610.40(c)(1)(ii).
Under Sec. Sec. 610.40(g)(2) and (h)(2)(ii)(A), Source Leukocytes,
a licensed product that is used in the manufacture of interferon, which
requires rapid preparation from blood, is currently shipped prior to
completion of testing for evidence of certain communicable disease
agents. Shipments of Source Leukocytes are preapproved under a
biologics license application (BLA) and each shipment does not have to
be reported to the Agency. Based on information from CBER's database
system, FDA receives less than one application per year from
manufacturers of Source Leukocytes. However, for calculation purposes,
we are estimating one application annually.
Under Sec. Sec. 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), FDA
estimates that each manufacturer would ship an estimated 1 unit of
human blood or blood components per month (12 per year) that would
require two labels; one as reactive for the appropriate screening test
under Sec. 610.40(h)(2)(ii)(C), and the other stating the exempted use
specifically approved by FDA under Sec. 610.40(h)(2)(ii)(D). According
to CBER's database system, there are approximately 40 licensed
manufacturers that ship known reactive human blood or blood components.
Based on information we received from industry, we estimate that
approximately 18,000 donations: (1) Annually test reactive by a
screening test for syphilis; (2) are determined to be biological false
positives by additional testing; and (3) are labeled accordingly (Sec.
610.40(h)(2)(vi)).
Human blood or a blood component with a reactive screening test, as
a component of a medical device, is an integral part of the medical
device, e.g., a positive control for an in vitro diagnostic testing
kit. It is usual and customary business practice for manufacturers to
include on the container label a warning statement that identifies the
communicable disease agent. In addition, on the rare occasion when a
human blood or blood component with a reactive screening test is the
only component available for a medical device that does not require a
reactive component, then a warning statement must be affixed to the
medical device. To account for this rare occasion under Sec.
610.42(a), we estimate that the warning statement would be necessary no
more than once a year.
FDA estimates that approximately 3,500 repeat donors will test
reactive on a screening test for HIV. We also estimate that an average
of three components was made from each donation. Under Sec. Sec.
610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 10,500 (3,500
x 3) notifications of the HIV screening test results to consignees by
collecting establishments for the purpose of quarantining affected
blood and blood components, and another 10,500 (3,500 x 3)
notifications to consignees of subsequent test results.
We estimate that Sec. 610.46(b)(3) will require 4,961 consignees
to notify transfusion recipients, their legal representatives, or
physicians of record an average of 0.35 times per year resulting in a
total number of 1,755 (585 confirmed positive repeat donors x 3)
notifications. Also under Sec. 610.46(b)(3), we estimate and include
the time to gather test results and records for each recipient and to
accommodate multiple attempts to contact the recipient.
Furthermore, we estimate that approximately 7,800 repeat donors per
year would test reactive for antibody to HCV. Under Sec. Sec.
610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments would
notify the consignee 2 times for each of the 23,400 (7,800 x 3
components) components prepared from these donations, once for
quarantine purposes and again with additional HCV test results for a
total of 46,800 notifications as an annual ongoing burden. Under Sec.
610.47(b)(3), we estimate that approximately 4,961 consignees would
notify approximately 2,050 recipients or their physicians of record
annually.
Based on industry estimates, approximately 13 percent of
approximately 10 million potential donors (1.3 million donors) who come
to donate annually are determined not to be eligible for donation prior
to collection because of failure to satisfy eligibility criteria. It is
the usual and customary business practice of approximately 1,945 (1,265
+ 680) blood collecting establishments to notify onsite and to explain
why the donor is determined not to be suitable for donating. Based on
such available information, we estimate that two-thirds (1,297) of the
1,945 blood collecting establishments provided onsite additional
information and counseling to a donor determined not to be eligible for
donation as usual and customary business practice. Consequently, we
estimate that only one-third, or 648, approximately, blood collecting
establishments would need to provide, under Sec. 630.6(a), additional
information and onsite counseling to the estimated 433,333 (one-third
of approximately 1.3 million) ineligible donors.
It is estimated that another 4.5 percent of 10 million potential
donors (450,000 donors) are deferred annually based on test results. We
estimate that approximately 95 percent of the establishments that
collect 99 percent of the blood and blood components notify donors who
have reactive test results for HIV, Hepatitis B Virus (HBV), HCV, Human
T-Lymphotropic Virus (HTLV), and syphilis as usual and customary
business practice. Consequently, 5 percent of the 1,681 establishments
(84) collecting 1 percent (4,500) of the deferred donors (450,000)
would notify donors under Sec. 630.6(a).
As part of usual and customary business practice, collecting
establishments notify an autologous donor's referring physician of
reactive test results obtained during the donation process required
under Sec. 630.6(d)(1). However, we estimate that approximately 5
percent of the 1,265 blood collection establishments (63) may not
notify the referring physicians of the estimated 2 percent of 112,500
autologous donors with the initial reactive test results (2,250) as
their usual and customary business practice.
The recordkeeping chart reflects the estimate that approximately 95
percent of the recordkeepers, which collect 99 percent of the blood
supply, have developed SOPs as part of their customary and usual
business practice.
[[Page 62633]]
Establishments may minimize burdens associated with CGMP and related
regulations by using model standards developed by industries'
accreditation organizations. These accreditation organizations
represent almost all registered blood establishments.
Under Sec. 606.160(b)(1)(ix), we estimate the total annual records
based on the approximately 1.3 million donors determined not to be
eligible to donate and each of the estimated 1.75 million (1.3 million
+ 450,000) donors deferred based on reactive test results for evidence
of infection because of communicable disease agents. Under Sec.
606.160(b)(1)(xi), only the 1,945 registered blood establishments
collect autologous donations and, therefore, are required to notify
referring physicians. We estimate that 4.5 percent of the 112,500
autologous donors (5,063) will be deferred under Sec. 610.41, which in
turn will lead to the notification of their referring physicians.
FDA has concluded that the use of untested or incompletely tested
but appropriately documented human blood or blood components in rare
medical emergencies should not be prohibited. We estimate the
recordkeeping under Sec. 610.40(g)(1) to be minimal with one or fewer
occurrences per year. The reporting of test results to the consignee in
Sec. 610.40(g) is part of the usual and customary business practice or
procedure to finish the testing and provide the results to the
manufacturer responsible for labeling the blood products.
The average burden per response (hours) and average burden per
recordkeeping (hours) are based on estimates received from industry or
FDA experience with similar reporting or recordkeeping requirements.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
606.170(b) \2\.................. 72 1 72 20 1,440
610.40(g)(2).................... 1 1 1 1 1
610.40(h)(2)(ii)(A)............. 1 1 1 1 1
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,442
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The reporting requirement in Sec. 640.73, which addresses the reporting of fatal donor reactions, is
included in the estimate for Sec. 606.170(b).
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.100(b) \2\.............................. \5\ 366 1 366 24........................................ 8,784
606.100(c).................................. \5\ 366 10 3,660 1......................................... 3,660
606.110(a) \3\.............................. \6\ 50 1 50 0.5 (30 minutes).......................... 25
606.151(e).................................. \5\ 366 12 4,392 0.08 (5 minutes).......................... 351
606.160 \4\................................. \5\ 366 1,046.45 383,000 0.75 (45 minutes)......................... 287,250
606.160(b)(1)(viii)......................... 1,945 10.80 21,000 0.17 (10 minutes)......................... 3,570
HIV consignee notification.................. 4,961 4.23 21,000 0.17 (10 minutes)......................... 3,570
606.160(b)(1)(viii)......................... 1,945 24.06 46,800 0.17 (10 minutes)......................... 7,956
HCV consignee notification.................. 4,961 9.43 46,800 0.17 (10 minutes)......................... 7,956
HIV recipient notification.................. 4,961 0.35 1,755 0.17 (10 minutes)......................... 298
HCV recipient notification.................. 4,961 0.41 2,050 0.17 (10 minutes)......................... 349
606.160(b)(1)(ix)........................... 2,361 741.21 1,750,000 0.05 (3 minutes).......................... 87,500
606.160(b)(1)(xi)........................... 1,945 2.60 5,063 0.05 (3 minutes).......................... 253
606.165..................................... \5\ 366 1,046.45 383,000 0.08 (5 minutes).......................... 30,640
606.170(a).................................. \5\ 366 12 4,392 1......................................... 4,392
610.40(g)(1)................................ 2,361 1 2,361 0.5 (30 minutes).......................... 1,180
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 447,734
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The recordkeeping requirements in Sec. Sec. 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the
estimate for Sec. 606.100(b).
\3\ The recordkeeping requirements in Sec. 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in
the estimate for Sec. 606.110(a).
\4\ The recordkeeping requirements in Sec. Sec. 640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b)
and (c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which address the
maintenance of various records, are included in the estimate for Sec. 606.160.
\5\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,961 +
2,361 = 366).
\6\ Five percent of plateletpheresis and leukopheresis establishments (0.05 x 990 = 50).
Table 3--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of
21 CFR section No. of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.170(a).................................. \2\ 366 12 4,392 0.5 (30 minutes).......................... 2,196
[[Page 62634]]
610.40(c)(1)(ii)............................ 2,361 1.52 3,600 0.08 (5 minutes).......................... 288
610.40(h)(2)(ii)(C) and (h)(2)(ii)(D)....... 40 12 480 0.20 (12 minutes)......................... 96
610.40(h)(2)(vi)............................ 2,361 7.62 18,000 0.08 (5 minutes).......................... 1,440
610.42(a)................................... 1 1 1 1......................................... 1
610.46(a)(1)(ii)(B)......................... 1,945 5.40 10,500 0.17 (10 minutes)......................... 1,785
610.46(a)(3)................................ 1,945 5.40 10,500 0.17 (10 minutes)......................... 1,785
610.46(b)(3)................................ 4,961 0.35 1,755 1......................................... 1,755
610.47(a)(1)(ii)(B)......................... 1,945 12.03 23,400 0.17 (10 minutes)......................... 3,978
610.47(a)(3)................................ 1,945 12.03 23,400 0.17 (10 minutes)......................... 3,978
610.47(b)(3)................................ 4,961 0.41 2,050 1......................................... 2,050
630.6(a) \3\................................ 648 668.72 433,333 0.08 (5 minutes).......................... 34,667
630.6(a) \4\................................ 84 53.57 4,500 1.5 (90 minutes).......................... 6,750
630.6(d)(1)................................. 63 35.71 2,250 1......................................... 2,250
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 63,019
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,961 +
2,361 = 366).
\3\ Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria.
\4\ Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents.
Dated: October 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24797 Filed 10-17-14; 8:45 am]
BILLING CODE 4164-01-P
