Summary of Public Comments and CDC Response

Att 2b_Response to Public Comments on 60 Day FRN.pdf

Pregnancy Risk Assessment Monitoring System (PRAMS)

Summary of Public Comments and CDC Response

OMB: 0920-1273

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Comments in response to the Federal Register Notice
A 60-Day Notice was published in the Federal Register on August 31, 2018, Vol. 83, No. 170, pp. 44630-44631, with the title “Pregnancy Risk Assessment
Monitoring System (PRAMS)” (Attachment 2a). CDC received four comments related to this notice. CDC did not provide a response to two comments
because it fell outside of the scope of this information collection. Two other comments were sent to CDC by individuals outside of CDC, both of which
were supportive. These two individuals commented on the importance of protecting the data provided by the women and provided suggestions as to
further improve partnerships among agencies at global, federal, state, and local levels in regards to perinatal data collection and subsequent action

Standard Area/Topic

Comments

Evaluate whether the
proposed collection of
information is necessary for
the proper performance of
the functions of the agency,
including whether the
information will have
practical utility

Comment #1:
Anonymous supportively
commented that the
information collection is a good
idea as long as the information
provided by women is not selfincriminating.

Comment #2:
Julie Babyar, RN, MPH
supportively commented that
she is grateful for CDC’s
surveillance and offered
suggestions of collaboration at
federal, state, and local levels to
standardize data and further
enact action from the data
collection, as well as developing
partnerships globally.
Comment #3:

Date Received
by CDC
9/17/18

10/26/18

10/26/18

CDC’s Response
Thank you for your comment. Additional information addressing
confidentiality of the data collected has been added to Supporting
Statement A. A Certificate of Confidentiality provides additional
protections to respondents for sensitive questions such as substance
use. Section 301(d) of the Public Health Service Act (PHS) Act, which
authorizes the use of Certificates, was amended by The 21st Century
Cures Act amends Section 301(d) of the Public Health Service Act (PHS)
Act and automatically issues Certificates to biomedical, behavioral,
clinical, or other research activities in which identifiable, sensitive
information is collected such as PRAMS. Individuals participating in the
PRAMS are informed that they do not have to participate and that they
may refuse to answer any question. It also describes the protections
and limitations of the Certificate of Confidentiality.
Thank you for your comment. We actively collaborate with federal,
state and local health agencies to ensure quality and timely data
collection that can be used to inform and evaluate programs and policy.

Non-substantive comment (outside of scope of project).

An Anonymous comment stating
that the information collection is
a waste of taxpayer money and
instead the importance of
RhoGAM shot and the impact on
newborns from Rh-negative
mothers should be examined.
Comment #4:
An Anonymous comment stating
his/her opinion on the current
administration.

10/30/18

Non-substantive comment (outside of scope of project).

Document Metadata:CDC-2018-0077-0002

Document Details
Docket ID:

CDC-2018-0077

Docket Title:

þÿThe Pregnancy Risk Assessment Monitoring System (PRAMS)
0920-16JO

Document File:
Docket Phase:

Notice

Phase Sequence:

1

Original Document ID:

CDC-2018-0077-DRAFT-0002

Current Document ID:

CDC-2018-0077-0002

Title:

Comment from (Anonymous Anonymous)

Number of Attachments:

0

Document Type:

PUBLIC SUBMISSIONS

Document Subtype:
Comment on Document ID:

CDC-2018-0077-0001

Comment on Document Title: þÿThe Pregnancy Risk Assessment Monitoring System (PRAMS)
0920-16JO 2018-19014
Status:

Posted

Received Date:

09/17/2018

Date Posted:

09/20/2018

Posting Restriction:

No restrictions

Submission Type:

Web

Number of Submissions:

1

Document Optional Details
Status Set Date:

09/20/2018

Current Assignee:

NA

Status Set By:

Burroughs-Stokes, Kennya LaTrice (CDC)

Tracking Number:

1k2-95hb-i5e2

Page Count:

1

Total Page Count
Including Attachments:

1

Submitter Info

Comment:

See attached file(s)

First Name:

Anonymous

Last Name:

Anonymous

ZIP/Postal Code:
Email Address:
Organization Name:
Cover Page:

Submitter Info
Comment:

As long as this information the women provide is not at all
self-incriminating, I think this is a good idea.

First Name:

Anonymous

Last Name:

Anonymous

ZIP/Postal Code:
Email Address:
Organization Name:
Cover Page:

Document Optional Details
Status Set Date:

09/20/2018

Current Assignee:

NCCDPHP2018FluorideControlRange

Status Set By:

Public

Tracking Number:

1k2-95wk-xukf

Page Count:

1

Total Page Count
Including Attachments:

1

Submitter Info
Comment:

See attached file(s)

First Name:

Anonymous

Last Name:

Anonymous

ZIP/Postal Code:
Email Address:
Organization Name:

Cover Page:

Submitter Info
Comment:

As long as this information the women provide is not at all
self-incriminating, I think this is a good idea.

First Name:

Anonymous

Last Name:

Anonymous

ZIP/Postal Code:
Email Address:
Organization Name:
Cover Page:

Document Metadata:CDC-2018-0077-0004

Document Details
Docket ID:

CDC-2018-0077

Docket Title:

þÿThe Pregnancy Risk Assessment Monitoring System (PRAMS)
0920-16JO

Document File:
Docket Phase:

Notice

Phase Sequence:

1

Original Document ID:

CDC-2018-0077-DRAFT-0004

Current Document ID:

CDC-2018-0077-0004

Title:

Comment from (Julie Babyar)

Number of Attachments:

0

Document Type:

PUBLIC SUBMISSIONS

Document Subtype:
Comment on Document ID:

CDC-2018-0077-0001

Comment on Document Title: þÿThe Pregnancy Risk Assessment Monitoring System (PRAMS)
0920-16JO 2018-19014
Status:

Posted

Received Date:

10/26/2018

Date Posted:

10/29/2018

Posting Restriction:

No restrictions

Submission Type:

Web

Number of Submissions:

1

Document Optional Details
Submitter Info
Submitter Info
Comment:

CDC-2018-0077 October 26th, 2018 Thank you for the opportunity
to comment on the renewal of PRAMS funding. I am grateful for
the effort and science dedicated to new moms and babies
through CDC surveillance. 1) I would love to see further
action from the data collection, perhaps from state or local
public health and perinatal hospital collaborations, perhaps
from medical associations. It would be of benefit to know that
PRAMS data has been acknowledged on an annual basis at the
state and local level, with process improvement on the agenda.

2) PRAMS data covers live births, and some of the collected
information requires further data from all pregnancies for any
local action to be considered. I believe reconvening with
federal and state epidemiology may maximize how and what data
should be collected. 3) I believe data collection in the
perinatal period can be extremely redundant, especially for
those seeking social services. Standardization of data
collection is important. PRAMS should actively work with other
federal programs and states to identify ways to maximize
efficiency for the patients and the programs. 4) As perinatal
data is utilized comparatively across countries, and perinatal
data drives public health and private philanthropy abroad, I
believe federal epidemiology programs should actively partner
with global health in data collection and tracking standards.
I believe PRAMS would be a wonderful way to forge that
partnership and initiate stronger conversations on data,
epidemiology and cross country collaboration. Thank you for
the consideration, Julie Babyar, RN MPH
First Name:

Julie

Last Name:

Babyar

ZIP/Postal Code:

94591

Email Address:

[email protected]

Organization Name:
Cover Page:

Document Optional Details
Status Set Date:

10/29/2018

Current Assignee:

NA

Status Set By:

Burroughs-Stokes, Kennya LaTrice (CDC)

Tracking Number:

1k2-9679-lur4

Page Count:

1

Total Page Count
Including Attachments:

1

Submitter Info
Submitter Info
Comment:

CDC-2018-0077 October 26th, 2018 Thank you for the opportunity
to comment on the renewal of PRAMS funding. I am grateful for
the effort and science dedicated to new moms and babies
through CDC surveillance. 1) I would love to see further
action from the data collection, perhaps from state or local
public health and perinatal hospital collaborations, perhaps
from medical associations. It would be of benefit to know that
PRAMS data has been acknowledged on an annual basis at the
state and local level, with process improvement on the agenda.
2) PRAMS data covers live births, and some of the collected

information requires further data from all pregnancies for any
local action to be considered. I believe reconvening with
federal and state epidemiology may maximize how and what data
should be collected. 3) I believe data collection in the
perinatal period can be extremely redundant, especially for
those seeking social services. Standardization of data
collection is important. PRAMS should actively work with other
federal programs and states to identify ways to maximize
efficiency for the patients and the programs. 4) As perinatal
data is utilized comparatively across countries, and perinatal
data drives public health and private philanthropy abroad, I
believe federal epidemiology programs should actively partner
with global health in data collection and tracking standards.
I believe PRAMS would be a wonderful way to forge that
partnership and initiate stronger conversations on data,
epidemiology and cross country collaboration. Thank you for
the consideration, Julie Babyar, RN MPH
First Name:

Julie

Last Name:

Babyar

ZIP/Postal Code:

94591

Email Address:

[email protected]

Organization Name:
Cover Page:

Document Metadata:CDC-2018-0077-0003

Document Details
Docket ID:

CDC-2018-0077

Docket Title:

þÿThe Pregnancy Risk Assessment Monitoring System (PRAMS)
0920-16JO

Document File:
Docket Phase:

Notice

Phase Sequence:

1

Original Document ID:

CDC-2018-0077-DRAFT-0003

Current Document ID:

CDC-2018-0077-0003

Title:

Comment from (Anonymous Anonymous)

Number of Attachments:

0

Document Type:

PUBLIC SUBMISSIONS

Document Subtype:
Comment on Document ID:

CDC-2018-0077-0001

Comment on Document Title: þÿThe Pregnancy Risk Assessment Monitoring System (PRAMS)
0920-16JO 2018-19014
Status:

Posted

Received Date:

10/26/2018

Date Posted:

10/29/2018

Posting Restriction:

No restrictions

Submission Type:

Web

Number of Submissions:

1

Document Optional Details
Submitter Info
Submitter Info
Comment:

Absolute terrible idea and waste of taxpayer money. You
already collect massive amounts of data relating to substance
abuse disease. You will not gain in further knowledge, you
will simply be able to put these young women in jail and put
their children in Foster care. However may I suggest that you
actually make a regulation as to the importance of the Rhogam
shot forced upon RH negative mothers. And suggest instead of
collecting more data on substance abuse by mothers, possibly
collect data which you absolutely have none, about newborns,

Whose mothers are RH negative, and the newborn is RH positive
and how many babies have died within the 1st 2 months of their
lives. You seem to have assumed that Rhogam shots are the cure
all. I can assure you it is not, nothing is 100%. This is an
issue that truly needs to be addressed.
First Name:

Anonymous

Last Name:

Anonymous

ZIP/Postal Code:
Email Address:
Organization Name:
Cover Page:

Document Optional Details
Status Set Date:

10/29/2018

Current Assignee:

NA

Status Set By:

Burroughs-Stokes, Kennya LaTrice (CDC)

Tracking Number:

1k2-966z-5x0v

Page Count:

1

Total Page Count
Including Attachments:

1

Submitter Info
Submitter Info
Comment:

Absolute terrible idea and waste of taxpayer money. You
already collect massive amounts of data relating to substance
abuse disease. You will not gain in further knowledge, you
will simply be able to put these young women in jail and put
their children in Foster care. However may I suggest that you
actually make a regulation as to the importance of the Rhogam
shot forced upon RH negative mothers. And suggest instead of
collecting more data on substance abuse by mothers, possibly
collect data which you absolutely have none, about newborns,
Whose mothers are RH negative, and the newborn is RH positive
and how many babies have died within the 1st 2 months of their
lives. You seem to have assumed that Rhogam shots are the cure
all. I can assure you it is not, nothing is 100%. This is an
issue that truly needs to be addressed.

First Name:

Anonymous

Last Name:

Anonymous

ZIP/Postal Code:
Email Address:

Organization Name:
Cover Page:

Document Metadata:CDC-2018-0077-0005

Document Details
Docket ID:

CDC-2018-0077

Docket Title:

þÿThe Pregnancy Risk Assessment Monitoring System (PRAMS)
0920-16JO

Document File:
Docket Phase:

Notice

Phase Sequence:

1

Original Document ID:

CDC-2018-0077-DRAFT-0005

Current Document ID:

CDC-2018-0077-0005

Title:

Comment from (Anonymous Anonymous)

Number of Attachments:

0

Document Type:

PUBLIC SUBMISSIONS

Document Subtype:
Comment on Document ID:

CDC-2018-0077-0001

Comment on Document Title: þÿThe Pregnancy Risk Assessment Monitoring System (PRAMS)
0920-16JO 2018-19014
Status:

Posted

Received Date:

10/30/2018

Date Posted:

11/01/2018

Posting Restriction:

No restrictions

Submission Type:

Web

Number of Submissions:

1

Document Optional Details
Status Set Date:

11/01/2018

Current Assignee:

NA

Status Set By:

Burroughs-Stokes, Kennya LaTrice (CDC)

Tracking Number:

1k2-969o-we8w

Page Count:

1

Total Page Count
Including Attachments:

1

Submitter Info

Comment:

I say let Trump be Trump. If President Tiny Hands wants to act
like a sexist, misogynist patriarchal fool, that's his right.
Anyway Trump's denigration of women is one of the few things
he's honest and consistent about. He was a sexist porker in
the 80's, and he's still one today. #PresidentTinyHands
#OrangeDumbsicle

First Name:

Anonymous

Last Name:

Anonymous

ZIP/Postal Code:
Email Address:
Organization Name:
Cover Page:


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