Privacy Impact Assessment

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Privacy Impact Assessment Form
v 1.47.4
Status Draft

Form Number

F-37731

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

P-8700785-433756

2a Name:

5/23/2017 8:44:10 AM

Birth Defects Study to Evaluate Pregnancy Exposures (BDSTEPS)
General Support System (GSS)
Major Application

3

Minor Application (stand-alone)

The subject of this PIA is which of the following?

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)?

8b Planned Date of Security Authorization

No
Yes
No
Agency
Contractor
POC Title

ISSO

POC Name

Cindy Allen

POC Organization NCCDPHP
POC Email

[email protected]

POC Phone

770-488-5388
New
Existing
Yes
No
June 14, 2017
Not Applicable

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11 Describe the purpose of the system.

The Birth Defects Study To Evaluate Pregnancy exposureS (BDSTEPS) system has been developed to identify modifiable
maternal exposures in early pregnancy that may increase the
risk for having a pregnancy affected by certain major,
structural birth defects. The BD-STEPS interview will focus on
the key areas of: (1) diabetes, obesity, and physical activity; (2)
other chronic maternal medical conditions; (3) infertility; and
(4) medication use.
The system will contain health care research data such as
chronic conditions, medications used during pregnancy,
interview responses and mothers' experiences during
pregnancy and exposures to possible risk factors.
The system will also contain contact information for mothers of
infants with a date of birth, or pregnancy terminations, on or
after September 1, 2015 in each of the defined study regions.

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 During the study, the participants will also provide the
following information:
about the specific data elements.)

• baby’s estimated date of delivery;
• baby’s date of birth;
• father’s date of birth;
• mother’s email and mailing addresses; and
• name and contact information (mailing address, phone
number) of an additional contact in the event we have
difficulty contacting the mother in the future.

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In January 2014, the Centers for Birth Defects Research and
Prevention (CBDRP) began collaboration on a case-control
study called the Birth Defects Study To Evaluate Pregnancy
exposureS (BD-STEPS). The purpose of BD-STEPS is to identify
modifiable maternal exposures in early pregnancy that may
increase the risk for having a pregnancy affected by certain
major, structural birth defects. Mothers of the case infants and
mothers of randomly selected live born control infants will be
contacted and invited to participate in a maternal interview
covering multiple topics. BD-STEPS will start data collection for
infants with a date of birth, or pregnancy terminations, on or
after September 1, 2015 in each of the defined study regions.

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

Data that is contained and processed by the system will be
used to • Contact sampled study subjects to conduct interviews. These
interviews will focus on the subject’s experiences during her
pregnancy and exposures to possible risk factors.
• Conduct follow-up stillbirth interviews with a subsample of
participants, as well as an additional sample of mothers who
experienced a stillbirth that was not affected by a birth defect.
• Conduct reminder calls with a subsample of participants to
obtain consent for Centers to access their newborn bloodspots
(collected by some states at birth) and reminder calls to
complete an online questionnaire hosted by CDC.
• Conduct all mailings associated with study activities for
Atlanta CBDRP subjects only, including introductory packets
that contain informed consent information and follow-up
letters.
In order to conduct the study activities, the system will
maintain contact information for the purpose of mailing study
related materials and calling study subjects for interviews, and
also for mothers that had pregnancy terminations that
occurred or for mothers of infants born on or after September
1, 2015 in each of the defined study regions.

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

Yes
No

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15

Indicate the type of PII that the system will collect or
maintain.

Social Security Number

Date of Birth

Name

Photographic Identifiers

Driver's License Number

Biometric Identifiers

Mother's Maiden Name

Vehicle Identifiers

E-Mail Address

Mailing Address

Phone Numbers

Medical Records Number

Medical Notes

Financial Account Info

Certificates

Legal Documents

Education Records

Device Identifiers

Military Status

Employment Status

Foreign Activities

Passport Number

Taxpayer ID

Employees
Public Citizens
Indicate the categories of individuals about whom PII
16
is collected, maintained or shared.

Business Partners/Contacts (Federal, state, local agencies)
Vendors/Suppliers/Contractors
Patients
Other

17 How many individuals' PII is in the system?
18 For what primary purpose is the PII used?
19

Describe the secondary uses for which the PII will be
used (e.g. testing, training or research)

Live born babies (or pregnancies if not live born) of
study subjects.

10,000-49,999
PII is required to contact sampled respondents for interview.
None

20 Describe the function of the SSN.

SSN is not used, collected or stored.

20a Cite the legal authority to use the SSN.

SSN is not used, collected or stored.

21

Identify legal authorities governing information use Public Health Service Act, Section 301, "Research and
and disclosure specific to the system and program.
Investigation," (42 U.S.C. 241)

22

Are records on the system retrieved by one or more
PII data elements?

Yes
No

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Published:
Identify the number and title of the Privacy Act
System of Records Notice (SORN) that is being used
22a
to cover the system or identify if a SORN is being
developed.

09-20-0136, Epidemiologic Studies and
Surveillance of Disease Problems. HHS/CDC

Published:

Published:
In Progress
Directly from an individual about whom the
information pertains
In-Person
Hard Copy: Mail/Fax
Email
Online
Other
Government Sources
23

Within the OPDIV
Other HHS OPDIV
State/Local/Tribal
Foreign
Other Federal Entities
Other

Identify the sources of PII in the system.

Non-Government Sources
Members of the Public
Commercial Data Broker
Public Media/Internet
Private Sector
Other
23a

Identify the OMB information collection approval
number and expiration date.

24 Is the PII shared with other organizations?

OMB IC# 0920-0010; Expiration date 12/31/2018
Yes
No

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Within HHS
Datafile might be used for further research purposes within
HHS.

24a

Identify with whom the PII is shared or disclosed and
for what purpose.

Other Federal
Agency/Agencies
State or Local
Agency/Agencies
Abt will share PII (i.e., updated contact information) with
State agencies via CDC SAMS, so that the State agencies
have the most up-to-date contact information for their study
mailings and other future contacts with respondents.
Private Sector
PII is shared with Abt via CDC SAMS to conduct research and
analysis.

Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
24b Matching Agreement, Memorandum of
Understanding (MOU), or Information Sharing
Agreement (ISA)).

24c

Describe the procedures for accounting for
disclosures

Describe the process in place to notify individuals
25 that their personal information will be collected. If
no prior notice is given, explain the reason.

26

Is the submission of PII by individuals voluntary or
mandatory?

Data Use Agreements (DUAs) have been signed between Abt
and 6 of the 7 study centers. CDC is the lead for the 7th study
center, therefore no DUA is required. The DUA allows each
Center to share PII with Abt; Abt to contact and collect data
from each Center's study participants; and Abt to share deidentified data with CDC. Lastly, it permits the updated
contact information to go back to the Center.
All requests for disclosure are to be made to the Abt Project
Director and approved by CDC. Approved disclosures are
compiled in an electronic spreadsheet maintained by the
Project Director with the following information:
--name of requester
--purpose of disclosure
--date of disclosure
--address (email or phone) to receive information
--record(s) disclosed
The disclosure information will be retained in an electronic
document by the contractor until the end of the project and
then handed over to the CDC during project close out.
Personal information will be gathered directly from study
participants via phone when the project team reaches out to
conduct telephone interview data collection. A verbal consent
process is conducted before the launch of the telephone
interview.
Voluntary
Mandatory

Initial PII is provided to the contractor (on CDC’s behalf) by the
state health department. The contractor, Abt, contacts
Describe the method for individuals to opt-out of the individuals for participation in the research study, and the
collection or use of their PII. If there is no option to
individuals can then opt out of participation in the study and
27
object to the information collection, provide a
their personal information is then deleted from the
reason.
information collection. However, if they do not opt out of
participation, their personal information is maintained as it is
needed for further contact and use.

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Describe the process to notify and obtain consent
from the individuals whose PII is in the system when
major changes occur to the system (e.g., disclosure
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.

Describe the process in place to resolve an
individual's concerns when they believe their PII has
29 been inappropriately obtained, used, or disclosed, or
that the PII is inaccurate. If no process exists, explain
why not.

If disclosure/data uses change, the Data Use Agreement
between each Center and Abt would be revised to reflect the
changes. Each Center would be responsible for contacting
their IRB to determine if participants needed to be notified of
the change. If necessary, the study newsletter that is available
to each participant would be updated by CDC to reflect the
change and would allow participants to contact study staff to
request additional information and/or withdraw from the
study.
Before Abt contacts any study participants by telephone,
participants are sent an advance packet by each study Center.
The advance packet includes a Rights of Research Subjects
flyer, which directs participants to contact the CDC Human
Research Protection Helpline with any concerns about their
rights as study subjects and their data.
At the start of each interview, Abt staff will advise study
participants to contact their study Center if they have any
concerns about the study and the use of their data. Abt staff
will also direct study participants to either the local study
Center IRB or CDC's IRB (depending on the Center) if they have
any questions about their rights as a study subject and the use
of their data.
Abt will work with CDC and each local Center to resolve any
study participant concerns.

Describe the process in place for periodic reviews of
PII contained in the system to ensure the data's
30
integrity, availability, accuracy and relevancy. If no
processes are in place, explain why not.

31

Identify who will have access to the PII in the system
and the reason why they require access.

Abt staff confirm the accuracy of PII at each contact with the
study subject, including during the interview survey and when
sending follow-up mailings (reminder and thank you letters).
Users

Require access to information to
perform analysis and research.

Administrators

Administrators require access for
troubleshooting.

Developers
Contractors

Require access to perform analysis and
research.

Others
Describe the procedures in place to determine which
Role based access methodologies are employed to determine
32 system users (administrators, developers,
which users may access PII.
contractors, etc.) may access PII.
Describe the methods in place to allow those with
33 access to PII to only access the minimum amount of
information necessary to perform their job.

The Least privilege model is used to ensure that those having
access to PII can access only minimal amount of PII necessary
to perform their job responsibilities.

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Identify training and awareness provided to
personnel (system owners, managers, operators,
contractors and/or program managers) using the
34
system to make them aware of their responsibilities
for protecting the information being collected and
maintained.

Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

Abt provides basic security awareness training to all
information system users (including managers, senior
executives, and contractors) as part of initial training for new
users, when required by system changes, and annually
thereafter.
The training is tracked and provided through Abt's Learning
Management System (LMS). The topics in the training include
safe handling of PII, incident response, phishing, and password
management.
Abt provides role-based training (RBT) at least once a year and
prior to authorizing access to the system. Study-specific
training for interviewers on how to conduct the survey
interviewing is conducted before the project goes live.

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?

Yes
No

Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

Abt retains documents as required by CDC. By default, data is
stored by Abt for 5 years on tape. Data security plans are
developed per project as appropriate and define the data
destruction timelines for the project. CDC will retain the
records for 20 years; or longer if further study is needed.
The specific Records Schedule Number is N1-442-09-1.

Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

The system developed to support this project has been
designed using the National Institute of Standards and
Technology Special Publication 800-53 revision 4. The system
has defined policies and procedures for account creation and
system management. To protect the files, Microsoft Windows
Active Directory controls folder permissions through
discretionary access control. User accounts have strong
password requirements, and all mobile devices that store the
data utilize FIPS 140-2 full device encryption. The data are
physically stored within facilities that have keycard access and
the servers are within another keycard access server room. The
facility has cameras, alarms, and fire suppression systems.

General Comments

OPDIV Senior Official
for Privacy Signature

Beverly E.
Walker -S

Digitally signed by Beverly E. Walker -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=10014403
43, cn=Beverly E. Walker -S
Date: 2017.06.26 12:41:14 -04'00'

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