0594 GFI Blood Sep SSA 2018 Ext

United States Food & Drug Administration
Guidance for Industry and Food and Drug Administration Staff - Class II Special
Controls Guidance Document: Automated Blood Cell Separator Device Operating by
Centrifugal or Filtration Separation Principle
OMB Control No. 0910-0594
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we)
regulations. Under the Safe Medical Devices Act of 1990 (Public Law 101 – 629), FDA
may establish special controls, including performance standards, postmarket surveillance,
patient registries, guidelines, and other appropriate actions it believes necessary to
provide reasonable assurance of the safety and effectiveness of a device. The special
controls guidance document entitled, “Guidance for Industry and Food and Drug
Administration Staff - Class II Special Controls Guidance Document: Automated Blood
Cell Separator Device Operating by Centrifugal or Filtration Separation Principle,”
serves as the special control for the automated blood cell separator device operating by
centrifugal or filtration separation principle intended for the routine collection of blood
and blood components, as codified under 21 CFR 864.9245.
The guidance provides for annual reporting of a summary of anticipated and
unanticipated adverse events that have occurred, and that are not required to be reported
by manufacturers under Medical Device Reporting (MDR) (21 CFR Part 803)); any
subsequent change to the device requiring the submission of a premarket notification in
accordance with section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act); and any subsequent change to the preamendments class III device requiring a 30day notice in accordance with 21 CFR 814.39(f).
For currently marketed products not approved under the premarket approval (PMA)
process, the manufacturer should file with FDA for 3 consecutive years an annual report
on the anniversary date of the device reclassification from Class III to Class II or, on the
anniversary date of the section 510(k) of the FD&C Act (21 U.S.C. 360(k)) clearance.
Also, a manufacturer of a device determined to be substantially equivalent to the
centrifugal or filtration-based automated blood cell separator device intended for the
routine collection of blood and blood components, should comply with the same general
and special controls. These special controls along the general controls should provide
reasonable assurance of the safety and efficacy of the device.
Accordingly, we are requesting extension of OMB approval for the information
collection provisions found in the special controls guidance discussed in this supporting
statement and codified under 21 CFR § 864.9245.

2. Purpose and Use of the Information Collection
Collecting or transfusing facilities, the intended users of the device, and the device
manufacturers have certain responsibilities under the Federal regulations. For example,
collecting or transfusing facilities are required to maintain records of any reports of
complaints of adverse reactions (21 CFR 606.170), while the device manufacturer is
responsible for conducting an investigation of each event that is reasonably known to the
manufacturer and evaluating the cause of the event (21 CFR 803.50(b)). In addition,
manufacturers of medical devices are required to submit to FDA individual adverse event
reports of death, serious injury, and malfunctions (21 CFR 803.50).
In the special controls guidance document, FDA recommends that manufacturers include
certain information in their three annual reports including, but not limited to, a summary
of anticipated and unanticipated adverse events that have occurred. The reporting of
adverse device events summarized in an annual report will alert FDA to trends or clusters
of events that might be a safety issue otherwise unreported under the MDR regulation.
3. Use of Improved Information Technology and Burden Reduction
The Center for Biologics Evaluation and Research (CBER) currently accepts the
electronic submissions of certain information. There is no change to the currently
available methods of electronic submission of annual reports. We are not aware of any
other improved technology to reduce the burden.
4. Efforts to Identify Duplication and Use of Similar Information
In the special controls guidance document, FDA recommends that manufacturers include
in their three annual reports a summary of adverse events maintained by the collecting or
transfusing facility or similar reports of adverse events collected in addition to those
required under the MDR regulation. The guidance does not request duplicate MDR
reporting in the annual report.
5. Impact on Small Businesses or Other Small Entities
The information collection does not impose undue burden on small entities. Rather,
reclassification of this device from class III to class II relieves manufacturers of the
burden of complying with the premarket approval requirements of section 515 of the
FD&C Act (21 U.S.C. 360e), and may permit small potential competitors to enter the
marketplace by reducing the burden. Although the special controls guidance document
recommends that manufacturers of these devices file with FDA an annual report for three
consecutive years, this would be less burdensome than the current postapproval
requirements under 21 CFR Part 814, subpart E, including the submission of periodic
reports under 21 CFR 814.84.
FDA must apply the regulatory and statutory requirements equally to all establishments
regardless of size, however we do provide special help to small businesses. CBER’s

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Office of Communication, Outreach, and Development, Division of Manufacturer’s
Assistance and Training provides assistance to small businesses concerning FDA’s
regulatory requirements.
6. Consequences of Collecting the Information Less Frequently
There are regulatory compliance consequences if the collection of information is not
conducted or is conducted less frequently. The frequency of collection of three
consecutive years in the annual report is to provide for donor and user safety, and to
reveal trends that may identify safety hazards.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment
in the Federal Register on February 22, 2018 (83 FR 7745). One comment was received
but was not responsive to the four information collection topics solicited and was
therefore not addressed by the agency.
9. Explanation of Any Payment or Gift to Respondent
No payment or gifts are provided to respondents to the information collection.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information received by FDA is consistent with the Freedom of
Information Act (FOIA) (5 U.S.C. 552(b)), and FDA's published regulations of “Public
Information” under 21 CFR Part 20 and 21 CFR 807.95 (Confidentiality of Information).
11. Justification for Sensitive Questions
Questions of a sensitive nature are not applicable to this collection of information.
12. Estimates of Annualized Burden Hours and Costs
The total annual estimated burden for this collection of information is 15 hours.

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12a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Reporting Burden
Activity

No. of
Respondents

No. of Responses
per Response

Total Annual
Responses

Avg. Burden per
Response

Total
Hours

Annual Report

3

1

3

5

15

Based on FDA records, there are approximately 3 manufacturers of automated blood cell
separator devices. The estimated average burden per response is based on the estimate
that the manufacturers will spend approximately 5 hours preparing and submitting the
annual report. The total annual burden of this collection of information is estimated at
approximately 15 hours.
Other burden hours associated with reporting under 21 CFR 864.9245 are already
reported and approved under OMB Control Numbers 0910-0120 (premarket notification
submission 510(k), 21 CFR Part 807, Subpart E), and 0910-0437 (MDR), 21 CFR Part
803).
12b. Annual Cost Burden Estimate
The estimated annual cost to respondents is $840.00.
Activity

Total Burden Hours

Hourly Wage Rate

Reporting

15

$56.00

Total Respondent
Cost
$840.00

The cost estimate is based on a regulatory affairs specialist, at a pay rate of $56.00/hour,
who would be responsible for preparing the submission to FDA. The estimated average
hourly pay rate includes benefits but no overhead costs.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capitol
Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection of information.
14. Annualized Cost to Federal Government
The estimated annualized cost to the Federal Government is $210.00. The estimate
includes the time by FDA to review the additional information requested in the annual
report. The estimated cost is based on an average grade scale of a GS-14 ($70/hour)
reviewer. The salary estimate includes benefits but no overhead costs.

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Activity

Number of
Responses

Hours per
Response

Cost per Hour

Total Cost

Review

3

1

$ 70.00

$ 210.00

15. Explanation for Program Changes or Adjustments
The information collection reflects adjustments. We have decreased our estimated
number of respondents from 4 to 3, which resulted in a corresponding adjustment in
burden hours from 20 to 15. We attribute the decrease to fewer submissions since last
OMB review and approval of the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking approval to exempt the display of the expiration date of the OMB
approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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