Pia

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Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

TBD

2a Name:

01/08/20

Distribution of Traceable Opioid Material Kits across U.S. Labora
General Support System (GSS)
Major Application

3

The subject of this PIA is which of the following?

Minor Application (stand-alone)
Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Operations and Maintenance
Yes

3b Is this a FISMA-Reportable system?

4

Does the system include a Website or online
application available to and for the use of the general
public?

5

Identify the operator.

6

Point of Contact (POC):

7

Is this a new or existing system?

8

Does the system have Security Authorization (SA)?

No
Yes
No
Agency
Contractor
POC Title

Senior Service Fellow

POC Name

Melissa Carter

POC Organization DHHS/CDC/DDNID/NCEH/DLS/ER
POC Email

[email protected]

POC Phone

770-488-7263
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

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8c

Briefly explain why security authorization is not
required

10

Describe in further detail any changes to the system
that have occurred since the last PIA.

11 Describe the purpose of the system.

Vendor will be collecting information.

The purpose of this information collection (IC) is to respond to
the US opioid epidemic and ensure that labs have the test
materials they need to detect various opioids. CDC, through a
vendor, will assure that the Traceable Opioid Material Kits
(TOM Kits) are being distributed to different types of
laboratories in public, private, and non-profit sectors.
The types of information the study will collect and maintain
will be:
Lab Contact Information (address, phone number, email);
lab contact information would be for the lab itself and not
specific to any individual working for that lab.
Lab Survey (capacity, analysis techniques, size, testing type,
DEA number, monthly sample volume)

Describe the type of information the system will
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask
about the specific data elements.)
The information collected will be used to determine which
laboratories will receive kits and the number of kits needed.
This information will not be shared outside of CDC.
Laboratories will not be authenticated when submitting
information. The vendor will authenticate all of its internal
users.
Manufacturers of the TOM Kits will use their established client
relationship management systems to manage laboratory
requests for kits and their responses to study questions. The
types of information the study will collect and maintain will be:

Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

Lab Contact Information (address, phone number, email);
lab contact information would be for the lab itself and not
specific to any individual working for that lab.
Lab Survey (capacity, analysis techniques, size, testing type,
DEA number, monthly sample volume)
The information collected will allow CDC to prioritize the
distribution of TOM Kits by (1) the recipient DEA number, (2)
which laboratories requested kits and the number of kits
requested, and (3) then mail kits to the selected laboratories.
Information in the study will be submitted by various
academic, public, private, and commercial laboratories. This
information will not be shared outside of CDC. Laboratories
will not be authenticated when submitting information. The
vendor will authenticate all of its internal users.

14 Does the system collect, maintain, use or share PII?

Yes
No

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Reviewer Questions

Answer

REVIEWER QUESTIONS: The following section contains Reviewer Questions which are not to be filled out unless the user is an OPDIV
Senior Officer for Privacy.

Reviewer Questions
1

Are the questions on the PIA answered correctly, accurately, and completely?

Answer
Yes
No

Reviewer
Notes
2

Does the PIA appropriately communicate the purpose of PII in the system and is the purpose
justified by appropriate legal authorities?

Yes

Do system owners demonstrate appropriate understanding of the impact of the PII in the
system and provide sufficient oversight to employees and contractors?

Yes

No

Reviewer
Notes
3

No

Reviewer
Notes
4

Does the PIA appropriately describe the PII quality and integrity of the data?

Yes
No

Reviewer
Notes
5

Is this a candidate for PII minimization?

Yes
No

Reviewer
Notes
6

Does the PIA accurately identify data retention procedures and records retention schedules?

Yes
No

Reviewer
Notes
7

Are the individuals whose PII is in the system provided appropriate participation?

Yes
No

Reviewer
Notes
8

Does the PIA raise any concerns about the security of the PII?

Yes
No

Reviewer
Notes
9

Is applicability of the Privacy Act captured correctly and is a SORN published or does it need
to be?

Yes
No

Reviewer
Notes
10

Is the PII appropriately limited for use internally and with third parties?

Yes
No

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Reviewer Questions

Answer

Reviewer
Notes
11

Does the PIA demonstrate compliance with all Web privacy requirements?

Yes
No

Reviewer
Notes
12

Were any changes made to the system because of the completion of this PIA?

Yes
No

Reviewer
Notes

General Comments

OPDIV Senior Official
for Privacy Signature

Beverly E.
Walker -S

Digitally signed by
Beverly E. Walker -S
Date: 2020.02.04
14:23:35 -05'00'

HHS Senior
Agency Official
for Privacy

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