OMB INFORMATION COLLECTION

SUPPORTING STATEMENT

Current Good Manufacturing Practices and Related Regulations for Blood
and Blood Components; and Requirements for Donor Testing, Donor
Notification, and "Lookback"

0910-0116

# JUSTIFICATION

## Need and Legal Basis

The Food and Drug Administration (FDA) is requesting an extension of
Office of Management and Budget (OMB) Control No. 0910-0116 and OMB
approval of the information collection requirements (Tab A) as listed
below:

  --------------------- ---------------------- -----------------------------------------
  21 CFR 606.100(b)     Recordkeeping          Requires that written standard operating
                                               procedures (SOPs) be maintained for the
                                               collection, processing, compatibility
                                               testing, storage and distribution of
                                               blood and blood components used for
                                               transfusion and manufacturing purposes.

  21 CFR 606.100(c)     Recordkeeping          Requires the review of all pertinent
                                               records to a lot or unit of blood prior
                                               to release. Any unexplained discrepancy
                                               or 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.

  21 CFR 606.110(a)     Recordkeeping          Requires a physician to certify in
                                               writing that the donor's health permits
                                               plateletpheresis or leukapheresis if a
                                               variance from additional regulatory
                                               standards for a specific product is used
                                               when obtaining the product from a
                                               specific donor for a specific recipient.

  21 CFR 606.121        Disclosure             Requires container label for blood and
                                               blood components by all blood
                                               establishments.

  21 CFR 606.122        Disclosure             Requires an instruction circular,
                                               containing adequate directions for use,
                                               be available for distribution if the
                                               product is intended for transfusion.

  21 CFR 606.151(e)     Recordkeeping          Requires that records of expedited
                                               transfusions in life-threatening
                                               emergencies be maintained.

  21 CFR 606.160        Recordkeeping          Requires that legible and indelible
                                               contemporaneous records of each
                                               significant step be made and maintained
                                               for no less than 5 years.

  21 CFR                Recordkeeping          Requires a facility to maintain records
  606.160(b)(1)(ix)                            of notification of donors deferred or
                                               determined not to be eligible for
                                               donation, including appropriate follow-up
                                               if the initial notification attempt
                                               fails.

  21 CFR                Recordkeeping          Requires an establishment to maintain
  606.160(b)(1)(xi)                            records of notification of the referring
                                               physician of a deferred autologous donor,
                                               including appropriate follow-up if the
                                               initial notification attempt fails.

  21 CFR 606.165        Recordkeeping          Requires that distribution and receipt
                                               records be maintained to facilitate
                                               recalls, if necessary.

  21 CFR 606.170(a)     Recordkeeping          Requires records to be maintained of any
                                               reports of complaints of adverse
                                               reactions 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.

  21 CFR 606.170(b)     Reporting              Requires that fatal complications of
                                               blood collection and transfusions be
                                               reported to FDA as soon as possible and
                                               that a written report shall be submitted
                                               within 7 days.

  21 CFR                Reporting              Requires each dedicated donation be
  610.40(c)(1)(ii)                             labeled, as required under § 606.121, and
                                               with a label entitled "INTENDED RECIPIENT
                                               INFORMATION LABEL" containing the name
                                               and identifying information of the
                                               recipient.

  21 CFR 610.40(g)(1)   Recordkeeping          Requires an establishment to
                                               appropriately document a medical
                                               emergency for the release of human blood
                                               or blood components prior to completion
                                               of required testing.

  21 CFR 610.40(g)(2)   Reporting              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.

  21 CFR                Reporting              Requires an establishment to obtain
  610.40(h)(2)(ii)(A)                          written approval from FDA to use or ship
                                               human blood or blood components found to
                                               be reactive by a screening test for
                                               evidence of a communicable disease
                                               agent(s) or collect from a donor with a
                                               record of a reactive screening test.

  21 CFR                Reporting              Require an establishment to label
  610.40(h)(2)(ii)(C)                          reactive human blood and blood components
  and (h)(2)(ii)(D)                            with the appropriate screening test
                                               results, and, if they are intended for
                                               further manufacturing use into injectable
                                               products, with a statement indicating the
                                               exempted use specifically approved by
                                               FDA.

  21 CFR                Reporting              Requires each donation of human blood or
  610.40(h)(2)(vi)                             blood component that tests reactive by a
                                               screening test for syphilis and is
                                               determined to be a biological false
                                               positive be labeled with both test
                                               results.

  21 CFR 610.42(a)      Reporting              Requires a warning statement, including
                                               the identity of the communicable disease
                                               agent, on medical devices containing
                                               human blood or blood components found to
                                               be reactive by a screening test for
                                               evidence of infection due to a
                                               communicable disease agent(s) or
                                               syphilis.

  21 CFR 610.46(a)      Reporting Disclosure   Requires blood establishments to notify
                                               consignees, within 72 hours, of
                                               repeatedly reactive tests results so that
                                               previously collected blood and blood
                                               components are appropriately quarantined.

  21 CFR 610.46(b)      Reporting-Disclosure   Requires blood establishments to notify
                                               consignees of licensed, more specific
                                               test results for HIV within 30 calendar
                                               days after the donor's repeatedly
                                               reactive test.

  21 CFR 610.47(b)      Reporting-Disclosure   Requires transfusion services not subject
                                               to Centers for Medicare and Medicaid
                                               Services regulations to notify physicians
                                               of prior donation recipients or to notify
                                               recipients themselves of the need for HIV
                                               testing and counseling.

  21 CFR 630.6(a)       Reporting              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.

  21 CFR 630.6(d)(1)    Reporting              Requires 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.
  --------------------- ---------------------- -----------------------------------------

In addition to the Current Good Manufacturing Practices (CGMP's) in part
606 (21 CFR part 606), there are regulations in part 640 (21 CFR part
640) that require additional standards for certain blood and blood
components as follows: §§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 section 12, below.

Under the statutory requirements contained in section 351 of the Public
Health Service Act (42 U.S.C. 262, Tab B), no blood, blood component, or
derivative may move in interstate commerce unless: (1) It is propagated
or manufactured and prepared at an establishment holding an unsuspended
and unrevoked license; (2) the product complies with regulatory
standards designed to ensure safety, purity, and potency; and (3) it
bears a label plainly marked with the product's proper name,
manufacturer, and expiration date. In addition, under sections 351 and
361 of the Public Health Service Act (42 U.S.C. 262 and 264, Tab C) and
the provisions of the Federal Food, Drug, and Cosmetic Act (the act)
that apply to drugs (21 U.S.C. 321 et seq.) (Tab D), FDA may issue and
enforce regulations necessary to prevent the introduction, transmission,
or spread of communicable diseases between States or Possessions or from
foreign countries into the States or Possessions. The CGMPs and related
regulations implement FDA's statutory authority to ensure the safety,
purity, and potency of blood and blood components. 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) infection. The public health objective in
testing human blood donors for evidence of infection due to communicable
disease agents and in donor notification is to prevent the transmission
of communicable disease.

## Information Users

The information collection requirements in the CGMP regulations, donor
testing, donor notification, and "lookback" requirements 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 preventative and
remedial purposes*,* and ensure that industry has the necessary
information to perform the "lookback" procedures. The disclosure
requirements identify the various blood and blood components and
important properties of the product, demonstrate that the CGMP
requirements have been met, and facilitate the tracing of a product back
to its original source. Consignee notification ensures that the prior
collections of blood and blood components are appropriately quarantined.
Recipient notification provides an opportunity for counseling,
appropriate testing, early treatment and precautions necessary to
prevent further spread of the virus. The reporting requirements inform
FDA of any deviations that occur and that may require immediate
corrective action.

FDA recognizes that there are rare emergencies, i.e., where a patient's
need for blood is so acute as to preclude any testing of the blood, that
would afford the release for use prior to the completion of testing for
markers of infection due to communicable disease agents. Upon FDA
approval, collection facilities are permitted to ship under quarantine
blood and blood components for further manufacturing before testing is
completed to ensure the continued availability of biological products
such as interferon, which requires rapid preparation from blood.

Blood establishments intending to distribute human blood or blood
components for further manufacture or autologous use that are reactive
for markers of infection with communicable disease agents are required
to apply for approval by FDA. The written application would describe the
intended use of the blood or blood component, including identification
of all consignees and the procedures for collecting, handling, labeling,
and shipping the blood.

The disclosure requirements ensure that personnel handling human blood
or blood components that have tested repeatedly reactive for markers of
infection with communicable disease agents are aware of this fact and
can take appropriate safety precautions.

The donor notification process is intended to prevent further donations
from donors who have been deferred for positive test results for markers
of communicable disease agents(s) as prescribed in § 610.41 or for
failing to satisfy the donor eligibility criteria under §§ 640.3 or
640.63 prior to collection. Deferred donors are informed of: (1) the
reason for the decision, (2) the types of donation that the donor should
not donate in the future, if appropriate, (3) the results of the tests
for evidence of infection due to communicable disease agents that were
the basis for deferral, if applicable, and (4) information concerning
medical follow-up and counseling. By having this information, the
deferred donor may make informed decisions as to his or her medical
welfare. Since autologous donors donate blood or blood components for
their own use per prescription by their physician, reactive test results
for a communicable disease agent on an autologous donor are sent to the
referring physician. Awareness of reactive test results will aid the
referring physician in the treatment and counseling of the autologous
donor.

Without this information, FDA could not monitor industry procedures and
discharge its statutory responsibility for protecting the nation's
health.

## Improved Information Technology

Establishments may use computer tapes, discs, microfiche or microfilm in
lieu of hard copy records for the purpose of maintaining records.
Computers may be used for filing reports to FDA. Notification of
consignees can be accomplished by phone, fax, or mail. FDA is not aware
of any other improved technology to reduce the burden except that
unautomated blood establishments could reduce the time required to
maintain records with respect to input and retrieval by becoming
computerized.

## Duplication of Similar Information

FDA is the only agency that requests this information. There is no
similar kind of information available from any other source.

## Small Businesses

FDA believes that its duty requires the equal application of the
regulations to all enterprises. While FDA does not believe it can apply
different standards with respect to statutory requirements, FDA does
provide special help to small businesses. The Center for Biologics
Evaluation and Research (CBER), Office of Communication, Training and
Manufacturer's Assistance provides assistance to small businesses
subject to FDA's regulatory requirements.

## Less Frequent Collection

Less frequent information collection would not provide the information
necessary for blood establishments to perform the "lookback" procedures,
and for FDA to monitor the establishment procedures and assure the
prevention of communicable disease. Records are reviewed at the time of
inspection for compliance with FDA regulations and for any appropriate
corrective action. Initial preparation of SOPs is a one-time burden.

There are no technical or legal obstacles to reducing the burden.

## Special Circumstances

There are no special circumstances for the collection of the information
requirements.

## *Federal Register* Notice/Outside Consultation

In accordance with 5 CFR 1320.8(d), a 60-day notice for public comment
on the information collection provisions was published in the **Federal
Register** of June 21, 2005 (70 FR 35680, Tab E). No comments were
received from the public.

## Payment/Gift to Respondent

FDA has not provided and has no intention to provide any payment or gift
to respondents.

## Confidentiality

The confidentiality of information received by FDA would be consistent
with the Freedom of Information (FOI) Act and the agency's regulations
under 21 CFR Part 20. After an FDA investigator completes a routine
inspection of a blood or blood component manufacturing establishment,
the completed report with the results of the inspection become public
information, available under the FOI Act. However, certain information,
such as donor and patient names, for example, is deleted from any
information released by FDA under the FOI Act and FDA regulations.
Manufacturers of human blood and blood components are not required to
reveal any proprietary information or trade secrets to achieve
compliance with the provisions.

## Sensitive Questions

Establishments as part of the donor screening process for blood
collection must ask questions of sensitive nature. These questions are
used to evaluate the suitability of a donor. Donors not meeting certain
criteria are deferred from donating. This information is necessary to
help prevent the transmission of communicable diseases and protect
public health. These records are maintained by the establishment and may
be reviewed by FDA during an inspection.

## Burden Estimate (Total Hours and Wages)

The total annual estimated burden imposed by this collection of
information is 564,678 hours.

^Table\ 1.\ --\ Estimated\ Annual\ Reporting\ Burden^

  --------------------- ------------- ------------- ----------- ---------- --------
  21 CFR Section        No. of        Annual        Total       Hours per  Total
                        Respondents   Frequency per Annual      Response   Hours
                                      Response      Responses              

  606.170(b)^1^         82            1             82          20         1,640

  610.40(c)(1)(ii)      1,628         8             12,000      0.08       960

  610.40(g)(2)          1             1             1           1          1

  610.40(h)(2)(ii)(A)   1             1             1           1          1

  610.40(h)(2)(ii)(C)   40            12            480         0.2        96
  and (h)(2)(ii)(D)                                                        

  610.40(h)(2)(vi)      1,628         13            18,000      0.08       1,440

  610.42(a)             1             1             1           1          1

  610.46(a)             1,709         16            26,544      0.17       4,512

  610.46(b)             1,709         16            26,544      0.17       4,512

  610.47(b)             134           1             134         1          134

  630.6(a)^2^           570           760           433,333     0.08       34,667

  630.6(a)^3^           85            106           9,000       1.5        13,500

  630.6(d)(1)           81            37            3,000       1          3,000

  Total                                                                    64,464
  --------------------- ------------- ------------- ----------- ---------- --------

^1^ The reporting requirement in § 640.73, which addresses the reporting
of fatal donor reactions, is included in the estimate for § 606.170(b).

^2^ Notification of donors determined not to be eligible for donation
based on failure to satisfy eligibility criteria.

^3^ Notification of donors deferred based on reactive test results for
evidence of infection due to communicable disease agents.

^TABLE\ 2.\ -Estimated\ Annual\ Recordkeeping\ Burden^

  ------------------- ---------------- ---------------- ----------- --------- ---------
  21 CFR Section      No. of           Annual Frequency Total       Hours per Total
                      Record-keepers   per              Annual      Record    Hours
                                       Recordkeeping    Records               

  606.100(b)^1^       249^4^           1                249         24        5,976

  606.100(c)          249^4^           10               2,490       1         2,490

  606.110(a)^2^       39^5^            1                39          0.5       20

  606.151(e)          249^4^           12               2,988       0.083     248

  606.160^3^          249^4^           1,928            480,000     0.75      360,000

  606.160(b)(1)(ix)   1,709            1,024            1,750,000   0.05      87,500

  606.160(b)(1)(xi)   1,628            4                6,750       0.05      338

  606.165             249^4^           1,928            480,000     0.083     39,840

  606.170(a)          249^4^           12               2,988       1         2,988

  610.40(g)(1)        1,628            1                1,628       0.5       814

  Total                                                                       500,214
  ------------------- ---------------- ---------------- ----------- --------- ---------

^1^ The 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).

^2^ The recordkeeping requirements in § 640.27(b), which address the
maintenance of donor health records for the plateletpheresis, are
included in the estimated for § 606.110(a).

^3^ 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.

^4^ Five percent of CMS transfusion services and FDA-registered blood
establishments (0.05 X 4,980).

^5^ Five percent of plateletpheresis and leukopheresis establishments
(0.05 X 773)

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 CMS. Based on information
received from CBER's database systems, there are approximately 81
licensed Source Plasma collection establishments with multiple locations
and 1,628 registered Whole Blood collection establishments for a total
of 1,709 establishments. There are approximately 2,156 registered blood
establishments inspected by FDA. Of these establishments, approximately
773 perform plateletpheresis and leukopheresis. These establishments
annually collect approximately 28 million units of Whole Blood, blood
components including Source Plasma, and Source Leukocytes and are
required to follow FDA "lookback" procedures, and approximately 134 are
registered transfusion services that are not subject to CMS's "lookback"
regulations. Based on CMS records, there are an estimated 4,980
transfusion services approved for Medicare reimbursement.

The 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 an average of 13
million donations of Source Plasma from approximately 2 million donors
and 15 million donations of Whole Blood, including 300,000 (2% of 15
million) autologous, from approximately 8 million donors. Assuming each
autologous donor makes an average of 2 donations, FDA estimates that
there are approximately 150,000 autologous donors.

FDA estimates that approximately 5 percent (12,000) of the 240,000
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), the only product currently
shipped prior to completion of testing is a licensed product, Source
Leukocytes, used in the manufacture of interferon, which requires rapid
preparation from blood. Shipments of Source Leukocytes are pre-approved
under a biologics license application and each shipment does not have to
be reported to the agency. Based on information from CBER's database
system, FDA receives an estimated 1 application per year from
manufacturers of Source Leukocytes.

Under § 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), FDA estimates that each
manufacturer would ship an estimated 1 human blood or blood component
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 an
estimated 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 annually test reactive by a screening
test for syphilis, and are determined to be biological false positives
by additional testing and 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 statement of warning is required to 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.

Based on information received from industry, we estimate that there are
approximately 4,424 repeat donors that will test reactive on a screening
test for HIV with 159 confirmed positive. We estimate that each repeat
donor has donated two previous times and an average of three components
were made from each donation. Under § 610.46(a) and (b), this estimates
results in 26,544 (4,424 x 2 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 26,544
(4,424 x 2 x 3) notifications to consignees of subsequent test results.

Under 610.47(b), based also on the information received from industry,
we estimate that 80% of the 159 (127) confirmed HIV positive were from
repeat donors of Whole Blood donations.

Industry estimates that approximately 13 percent of 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 1,709 collecting establishments to notify on site and to
explain the reason why the donor is determined not to be suitable for
donating. Based on such available information, we estimate that
two-thirds of the 1,709 collecting establishments provided on site
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 570 collection
establishments would need to provide, under § 630.6(a), additional
information and counseling on-site to the estimated 433,333 (one-third
of 1.3 million) ineligible donors.

It is estimated that another 4.5 percent of 10 million donors (450,000
donors) are deferred annually based on test results. We estimate that
currently 95 percent of the establishments that collect 98 percent of
the blood and blood components notify donors who have reactive test
results for HIV, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human
T-Lymphotropic Virus (HTLV), and syphilis as usual and customary
business practice. Consequently, 5 percent (85) of the industry (1,709)
collecting 2 percent (9,000) of the deferred donors (450,000) would
notify donor 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 5 percent of the 1,628
blood collection establishments (81) may not notify the referring
physicians of the estimated 2 percent of 150,000 autologous donors with
reactive test results (3,000) as their usual and customary business
practice.

The recordkeeping chart reflects the estimate that 95% of the
recordkeepers, which collect 98% of the blood supply, had developed
SOP's as part of their customary and usual business practice.
Establishments may minimize burdens associated with CGMP and related
regulations by using model SOP's 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 1.3 million donors determined not to be eligible to donate and each
of the 450,000 (1,300,000 + 450,000 = 1,750,000) donors deferred based
on reactive test results for evidence of infection due to communicable
disease agents. Under § 606.160(b)(1)(xi), only the 1,628 registered
blood establishments collect autologous donations and, therefore, are
required to notify referring physicians. We estimate that 4.5 percent of
the 150,000 autologous donors (6,750) will be deferred under § 610.41
and thus result in 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 less occurrence per year.
The reporting of test results to the consignee in § 610.40(g) does not
create a new burden for respondents because it is the usual and
customary business practice or procedure to finish the testing and
provide the results to the manufacturer responsible for labeling the
blood products.

The hours per response and hours per record are based on estimates
received from industry or FDA experience with similar recordkeeping or
reporting requirements.

[Cost to Respondents]{.underline}

The estimated annual cost to respondents is \$26,539,866.

+-----------------+-----------------+-----------------+-----------------+
| # Activity      | # No. of Hours  | # Cost per Hour | # Total Cost    |
+-----------------+-----------------+-----------------+-----------------+
| Reporting       | 64,464          | \$47            | \$3,029,808     |
+-----------------+-----------------+-----------------+-----------------+
| Recordkeeping   | 500,214         | \$47            | \$23,510,058    |
+-----------------+-----------------+-----------------+-----------------+
| Total           |                 |                 | \$26,539,866    |
+-----------------+-----------------+-----------------+-----------------+

The cost is based on a pay rate of \$31/hour for a medical technologist
(MT), who is responsible for recording donor, quarantine, testing, and
disposition of information, notifying consignees of test results, and
has the training and skills to handle various recordkeeping
requirements. The cost estimate is also based on a supervisor, at a pay
rate of \$42/hour who is responsible for updating SOPs, recording donor
information, and notifying physicians of recipients or recipients of
test results, investigating, writing, and reporting a fatality, and a
Medical Director (MD), at a pay rate of \$69/hour, who is responsible
for updating SOPs, recording donor information, and notifying physicians
of recipients or recipients of test results, investigating, writing, and
reporting a fatality. These salary estimates include recordkeeping and
reporting-disclosure requirements that are performed by the MT,
supervisor, or MD, the cost/hour includes the average salary of the
three (\$47). These salary estimates include benefits but no overhead
costs.

## Capital Costs (Maintenance of Capital Costs)

There are no capital and start-up, or operation, maintenance and
purchase costs associated with the collection of information
requirements.

## Cost to Federal Government

The estimated annualized cost to the Federal Government is \$1,949,520.
This estimate is based on a FDA reviewer or investigator at an average
grade scale of GS-12/5 (\$44/hour), who reviews the requests for
approval submitted under §§ 610.40(g)(2) and 610.40(h)(2)(ii)(A), or
performs biannual on-site inspections. The inspection cost includes
inspection of a facility, review of facility records, and report
preparation. The estimated cost is also based on a GS-13/5 (\$53/hour)
Consumer Safety Officer who compiles, reviews, and analyzes fatality
reports. These salary estimates include benefits but no overhead costs.

  ---------------------- -------------- ---------- ----------- -------------
  Activity               Number of      Number of  Cost per    Total Cost
                         Respondents    Hours      Hour        

  Product Release Review 2              1          \$44        \$88

  Inspection             1,078          40         \$44        \$1,897,280

  Fatality Report Review 82             12         \$53        \$52,152

  Total                                                        \$1,949,520
  ---------------------- -------------- ---------- ----------- -------------

## Program or Burden Changes

FDA is consolidating OMB control number 0910-0472 into 0910-0116. The
previous estimated total annual burden was 335,346 hours for 0910-0116
and 145,270 hours for 0910-0472 (for a total of 480,616 hours). The
current estimated total annual burden is 564,678 hours. The overall
increase in burden (+84,062 hours) is mostly attributed to the revised
estimate for the hours per record under § 606.160.

## Publication and Tabulation Dates

There are no results to publish for this information collection.

## Display of OMB Approval Date

FDA is not seeking approval to exempt display of the expiration date for
OMB approval.

## Exceptions to "Certification for Paperwork Reduction Act Submissions"

There are no exceptions to Item 19 of OMB Form 83-I.