OMB Information Collection

Requirements for Testing Human Blood Donors for Evidence of Infection
Due to Communicable Disease Agents

Final Rule (OMB No. 0910-0472)

Supporting Statement

A. JUSTIFICATION

1\. [Circumstances Making the Collection of Information
Necessary]{.underline}

The Food and Drug Administration (FDA) is requesting Office of
Management and Budget (OMB) approval of the information collection
requirements contained in the final rule amending 21 CFR Parts 607, 610,
640, and 660 (Attachment A). These requirements are listed below.

§ 610.40(c)(1)(ii) Disclosure Each donation must be labeled as required
under § 606.121 and with a label entitled "INTENDED RECIPIENT
INFORMATION LABEL" containing the name and identifying information of
the recipient. Each donation that is untested in the 30-day period must
be labeled "DONOR TESTED WITHIN THE LAST 30 DAYS."

§ 610.40(g)(2) Reporting A manufacturer must obtain written approval
from FDA when a manufacturer seeks to ship human blood or blood
components for further manufacturing use prior to completion of testing.

§ 610.40(h)(2)(ii)(A) Reporting A manufacturer must obtain written
approval from FDA when a manufacturer seeks to 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.

§ 610.40(h)(2)(ii)(C) and (D) Disclosure The manufacturer must label
reactive blood and blood components with the appropriate screening test
results and with a statement indicating the exempted use specifically
approved by FDA.

§ 610.40(h)(2)(vi) Disclosure Each donation of human blood or blood
component that tests reactive by a screening test for syphilis and is
determined to be a biological false positive must be labeled with both
test results.

§610.42(a) Disclosure 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.

§610.40(g)(1) Recordkeeping Release of blood or blood components due to
a medical emergency prior to completion of required testing must be
appropriately documented.

Because the public health objective in testing human blood donors for
evidence of infection due to communicable disease agents is to prevent
the transmission of communicable disease, FDA issued this final rule
under the legal authority of sections 351 and 361 of the Public Health
Service Act (PHS Act)(42 U.S.C. 262 and 264) (Attachment B) and the
provisions of the Federal Food, Drug, and Cosmetic Act (FDC Act) which
apply to drugs (21 U.S.C. 321 et seq.) (Attachment C). Section 361 of
the PHS Act authorizes the Secretary, Department of Health and Human
Services, to make and enforce such regulations as judged 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 to another State or Possession. Section 351 of
the PHS Act (42 U.S.C. 262(d)), applies to biological products. Blood
and blood components are considered drugs, as that term is defined in
section 201(g)(1) of the FDC Act (21 U.S.C. 321(g)(1)).

2\. [Purpose and Use of the Information]{.underline}

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.

3\. [Use of Information Technology and Burden Reduction]{.underline}

All establishments may use computer tapes or discs, microfiche or
microfilm to record and store data and information rather than hard copy
records if they choose. FDA is not aware of any improved information
technology that could be used 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.

4\. [Efforts to Identify Duplication and Use of Similar
Information]{.underline}

There are no other regulations requiring this information for this
purpose. The required information is not available from any other
source.

5\. [Impact on Small Businesses or Other Small Entities]{.underline}

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, the agency
does provide special help to small businesses. CBER's Office of
Communication, Training and Manufacturers Assistance provides guidance
to small businesses concerning regulatory requirements.

6\. [Consequences of Collecting the Information Less
Frequently]{.underline}

Less frequent collection of information or other methods of reducing the
frequency of information would not provide the information needed to
prevent the transmission of communicable disease by blood and blood
components.

7\. [Special Circumstances Relating to the Guideline of 5 CFR
1320.5]{.underline}

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

8\. [Comments in Response to the Federal Register Notice and Efforts to
Consult Outside the Agency]{.underline}

As required by section 3506(c)(2)(B) of the Paperwork Reduction Act of
1995 (PRA), FDA provided an opportunity for public comment on the
information collection requirements of the proposed rule that published
on August 19, 1999 (64 FR 31146). In accordance with the PRA, OMB
reserved approval of the information collection burden in the proposed
rule stating they will make an assessment in light of public comments
received on the proposed rule. No letters of comment on the information
collection requirements were submitted to OMB or the docket.

9\. [Explanation of Any Payment or Gift to Respondents]{.underline}

FDA has no intention to provide any gift or payment to respondents.

10\. [Assurance of Confidentiality Provided to Respondents]{.underline}

The confidentiality of information received by FDA under the rule would
be consistent with the Freedom of Information Act and the agency's
regulations under 21 CFR Part 20. Manufacturers of human blood and blood
components would not be required to reveal any proprietary information
or trade secrets to achieve compliance with the final rule.

11\. [Justification for Sensitive Questions]{.underline}

Questions of a sensitive nature are not applicable to this information
collection.

12\. [Estimate of Hour Burden Including Annualized Hourly
Costs]{.underline}

The estimated annual burden for this information collection is 3,125.5
hours. Based on current information retrieved from FDA\'s registration
database, there are approximately 60 licensed plasma collection
facilities and approximately 981 registered blood collection facilities
for a total of 1,041 establishments. These facilities collect annually
an estimated 24.6 million donations: 12 million donations of Source
Plasma and 12.6 million donations of Whole Blood, including 643,000
autologous. FDA has estimated the following information based on this
information.

Estimated Annual Reporting Burden^1^

+---------------+-----------+------------+----------+---------+-------+
| 21 CFR        | No. of    | Annual     | Total    | Hours   | Total |
| Section       | Re        | Frequency  | Annual   | per     | Hours |
|               | spondents | per        | R        | R       |       |
|               |           | Respondent | esponses | esponse |       |
+---------------+-----------+------------+----------+---------+-------+
| 610           | 1,041     | 9          | 10,250   | .08     | 820   |
| .40(c)(1)(ii) |           |            |          |         |       |
+---------------+-----------+------------+----------+---------+-------+
| 610.40(g)(2)  | 2         | 1          | 2        | 1       | 2     |
+---------------+-----------+------------+----------+---------+-------+
| 610.40        | 2         | 1          | 2        | 1       | 2     |
| (h)(2)(ii)(A) |           |            |          |         |       |
+---------------+-----------+------------+----------+---------+-------+
| 610           | 300       | 10         | 3,000    | 0.2     | 600   |
| .40(h)(2)(ii) |           |            |          |         |       |
|               |           |            |          |         |       |
| \(C\) and (D) |           |            |          |         |       |
+---------------+-----------+------------+----------+---------+-------+
| 610           | 1,041     | 15         | 15,120   | 0.08    | 1,210 |
| .40(h)(2)(vi) |           |            |          |         |       |
+---------------+-----------+------------+----------+---------+-------+
| 610.42(a)     | 1         | 1          | 1        | 1       | 1     |
+---------------+-----------+------------+----------+---------+-------+
| Total         |           |            |          |         | 2,635 |
+---------------+-----------+------------+----------+---------+-------+

^1^There are no capital costs or operationg and maintenance costs
associated with this collection of information.

Estimated Annual Recordkeeping Burden^1^

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

  610.40(g)(1)    981             1               981        0.5        490.5
  --------------- --------------- --------------- ---------- ---------- --------

^1^There are no capital costs or operationg and maintenance costs
associated with this collection of information.

Section 610.40(c)(1)(ii) requires that each dedicated donation be
labeled as required under §606.121 (OMB No. 0910‑0116) and with a label
containing the name and identifying information of the recipient. FDA
estimates that approximately 5 percent (10,250) of the 205,000 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). We estimate that each establishment expends approximately 5
minutes to insert the name of the recipient and identifying information
on each label.

In §610.40(g)(2) and (h)(2)(ii)(A), a manufacturer must obtain written
approval from FDA when a manufacturer seeks to: (1) Ship human blood or
blood components for further manufacturing use prior to completion of
testing; or (2) 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. 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. Shipment of
Source Leukocytes are preapproved under a product license application
and each shipment does not have to be reported to the agency. To obtain
approval from FDA as described in §610.40(g)(2), we expect the
manufacturer(s) to submit specific procedures for collection, shipment,
and quarantine of a product before testing is completed, and the
completion of testing as soon as possible after shipping. In addition,
the manufacturer must promptly communicate the test results to the
consignee. Each year, FDA has received 2 applications from manufacturers
of Source Leukocytes during fiscal year (FY) 95, FY96, and FY 97.
Therefore, we estimate receiving an average of two annually.

According to information from industry, a license application of this
type would contain safety and effectiveness information and would take
approximately 1,600 hours to prepare. The information that a
manufacturer would need to put together for the request is typically
part of an Biologics License Application (BLA) submission. Therefore, we
estimate that approximately 1 hour of the estimated 1,600 hours would be
used in preparing the request for FDA\'s approval to ship a product
prior to completion of testing.

Under §610.40(h)(2)(ii)(C) and (D), industry estimates that each
manufacturer would ship an estimated 10 blood or blood components per
month that would require two labels; one as reactive for the appropriate
screening test under subparagraph (C), and the other stating the
exempted use specifically approved by FDA under subparagraph (D).
According to FDA\'s database, there are approximately 300 licensed
manufacturers that ship known reactive blood or blood components.
Industry also estimates that it would take approximately 10 minutes per
blood or blood component to affix the labels.

In §610.40(h)(2)(vi), each donation of human blood or blood component
that tests reactive by a screening test for syphilis and is determined
by additional testing to be a biological false positive must be labeled
with both test results. After reviewing information from industry, we
estimate that approximately 15,120 donations annually test reactive by a
screening test for syphilis, and are determined to be biological false
positives by additional testing. We also estimate that the establishment
would expend approximately 5 minutes to label the blood or blood
component with the results of both tests.

Section 610.42(a) 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. 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 we
estimate that the warning statement would be necessary no more than once
a year and we estimate the manufacturer would need to expend an hour to
complete the labeling requirement.

Under §610.40(g)(1), we are permitting in rare emergency circumstances,
the release or shipment of human blood or blood components prior to the
completion of testing for evidence of infection due to communicable
disease agents. Such emergencies include, e.g., where a patient\'s need
for blood is so acute as to preclude any communicable disease testing of
the blood. We have concluded that the use of untested or incompletely
tested blood in such medical emergencies should not be prohibited.
Release of blood or blood components due to a medical emergency prior to
completion of required testing must be appropriately documented. We
estimate the recordkeeping to be minimal with one or less occurrence per
year. Documentation of the medical emergency should take a half‑hour or
less. 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.

[Costs to Respondents]{.underline}

  ----------------- ----------------- ----------------- -----------------
  Activity          No. of Hours      Cost per Hour     Total Cost

  Reporting         2,631             \$25              \$65,775

  Recordkeeping     490.5             \$25              \$12,262.50

  Total                                                 \$78,037.50
  ----------------- ----------------- ----------------- -----------------

The total cost to respondents is \$78,037.50. A medical technologist
responsible for reporting and recordkeeping activities earns an hourly
wage of \$25. This salary estimate includes benefits but no overhead
costs.

13.[Estimate of Other Total Annual Cost Burden to Respondents or
Recordkeepers]{.underline}

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

14\. [Annualized Cost to Federal Government]{.underline}

The total estimated annualized cost to the Federal Government is
\$112.72. This figure is based on a GS-12 Consumer Safety Officer at a
pay rate of \$28.18 per hour, who is responsible for reviewing the
requests for approval submitted under §§610.40(g)(2) and
610.40(h)(2)(ii)(A). The average review time is estimated at 1 hour.

[Cost to the Federal Government]{.underline}

  ----------------- ----------------- ----------------- -----------------
  Activity          No. of Hours      Cost per Hour     Total Cost

  Review            4                 \$28.18           \$112.72
  ----------------- ----------------- ----------------- -----------------

15\. [Explanation of Program Changes or Adjustments]{.underline}

Changes in burden are not applicable because this is the first
submission of this final rule.

16\. [Plans for Tabulation and Publication and Program Time
Schedule]{.underline}

There are no tabulated results to publish for this information
collection.

17\. [Reason(s) Display of Expiration Date is Inappropriate]{.underline}

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

18\. [Exceptions to Certification for Paperwork Reduction Act
Submission]{.underline}

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