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pdfFrom: Jean Public
Sent: Friday, November 17, 2017 2:13 PM
To:
OMB-Comments (CDC); [email protected]; [email protected];
[email protected]
Subject:
Re: public comment on federal register
Follow Up Flag:
Flag Status:
Follow up
Flagged
I am not in favor of spending these American tax dollars for special help
for special privileged classes.
this is not available to all so it should not beavailble for specially
picked out favored people by this
agency. I is not equitable and farir to all us citizens. in fact some of
these people don't even belong in this
country and are illegal sneaky lawbraking Mexicans, ec.
it is time to be fair to all americans and not to pick out some to pay
for the benefits given only to favored
classes to get special highly expensive treatement. straight white
amerians seem to not get any help at all
from their govt these days. they seem to be cut off from everything. why
is our govt acting so
discriminatory to straight white americans who also need health coverage.
I am definitely against this
special treatment only for some favored by this highly discriminatory
agency and govt. this comemtn is for
the public record please receipt. jean publiee [email protected]
[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Notices]
[Pages 52302-52304]
From the Federal Register Online via the Government Publishing Office
[www.gpo.gov]
[FR Doc No: 2017-24473]
----------------------------------------------------------------------DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-17-17AUZ; Docket No. CDC-2017-0065]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on ``Project NICE:
Navigating Insurance Coverage Expansion''. Project NICE will evaluate
the efficacy of an in-person health insurance enrollment assistance
intervention among Black and Hispanic men who have sex with
[[Page 52303]]
men (MSM) and Transgender persons living in the Chicago, Illinois
metropolitan area.
DATES: CDC must receive written comments on or before January 12, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-20170065 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Leroy A. Richardson, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE., MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Leroy A. Richardson, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses.
5. Assess information collection costs.
Proposed Project
Project NICE: Navigating Insurance Coverage Expansion--New-National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
CDC seeks to request a three-year OMB approval to evaluate the
efficacy of an in-person health insurance enrollment assistance
intervention among 1,000 Black and Hispanic MSM and Transgender persons
ages >=18 years living in the Chicago, Illinois metropolitan area. CDC
will invite individuals attending HIV testing outreach events, or
seeking care in select clinics in Chicago to participate in the study
after an HIV testing session. Researchers will collect study
participants' sociodemographic, risk behavior, and insurance coverage
information as part of study enrollment. Each quarter, researchers will
abstract outcome evaluation data (linkage to and retention in HIVrelated care, referrals for mental health or substance use, and other
health outcomes) from study participant's electronic medical records
(EMRs). Researchers will also assess intervention cost-effectiveness.
CDC funded this study through a cooperative agreement with the
University of Chicago Medicine (UCM). Three partner agencies will
conduct the intervention: (1) University of Chicago Medicine (UCM) (the
lead partner agency), (2) Howard Brown Health, and (3) Chicago House
and Social Service Agency (Chicago House). The three partner agencies
each have a history of providing clinical care, HIV testing outreach,
and in-person health insurance enrollment assistance for Chicago's MSM
and Transgender communities.
As part of this study, CDC will evaluate the in-person health
insurance enrollment assistance. Specifically, researchers will
evaluate whether moving the delivery of in-person health insurance
enrollment assistance, from the first clinic visit after receipt of an
HIV test result, to earlier in the care continuum, during the HIV
testing event, will impact health outcomes. Therefore, this study does
not introduce new intervention activities or burden on the participants
or the agency staff; it reorders the sequence of delivery of standard
practice. Only the addition of data collection forms and procedures
will be new, and the additional burden will be to partner agency staff
workload and participant experience.
In 2013, MSM accounted for 81% of new HIV infections among males
and 65% of all new HIV infections. In 2010, health officials reported
10,600 new HIV infections for African-American (Black) MSM, 11,200 for
White MSM, and 6,700 for Hispanic MSM. Through a 2008 systematic
review, researchers found HIV rates among Black and Hispanic
Transgender women to be 56% and 16%, respectively.
Black and Hispanic MSM and Transgender persons face obstacles in
seeking medical care and following through with referrals or
appointments, including lack of health insurance.
This study will implement a structural intervention. The goal of
this study is to test whether providing in-person assistance for firsttime private health insurance or Medicaid enrollment, changing to a
different insurance plan, or understanding how to use current insurance
policies following HIV testing will: (1) Increase the proportion of
participants who obtain health insurance; (2) result in better health
outcomes among participants (e.g., achieving viral suppression,
remaining HIV negative); (3) improve the linkage and retention rates
for HIV care (i.e., HIV treatment, Pre-exposure Prophylaxis (PrEP)) and
other HIV-associated health services (e.g., mental health counseling,
substance use treatment) of participants, especially those diagnosed
with HIV; and (4) increase HIV care linkage and retention rates
sufficiently to justify the cost of implementing the intervention
(cost-benefit analysis) among Black and Hispanic MSM and Transgender
persons age 18 or older in the Chicago, Illinois metropolitan area.
Randomized controlled trials (RCTs) of structural interventions are
rare. Nevertheless, CDC will use a RCT design to enhance scientific
validity and the policy impact of the intervention, and help
researchers assess the efficacy of this intervention as an emerging
practice prior to dissemination to HIV prevention service providers
nationwide.
[[Page 52304]]
This project aligns with National HIV/AIDS Strategy 2020 and Health
People 2020 objectives. This structural intervention aligns with the
OMB's emphasis on application of behavioral insights in that it
restructures the context (i.e., after HIV testing) in which healthrelated decision-making (i.e., health insurance enrollment) occurs in
order to promote the selection of beneficial options. The proposed
health insurance enrollment assistance project has the potential for
widespread health improvements for Black and Hispanic MSM and
Transgender persons regardless of their HIV status.
The study will enroll 1,000 participants over 12 months to reach
adequate power calculations (500 into the intervention arm, and 500
into the control arm).
After an HIV testing session at an outreach event or clinic visit,
a partner-agency staff person will invite an individual to participate
in the study. If interested, participants will complete a consent form.
Staff will screen individuals using the Eligibility Form, which will
take approximately five minutes to complete. Researchers would need to
screen approximately 1,500 individuals in order to identify and enroll
1,000 eligible study participants. If eligible and interested in
participating, individuals will complete the Participant Enrollment
Form, which will take approximately 35 minutes to complete. Researchers
then will offer in-person health insurance enrollment to randomized
intervention arm participants. This enrollment will take a maximum of
60 minutes to complete. The study's in-person health insurance
enrollment assistance will take the same amount of time as standard
practice health insurance enrollment assistance.
The total estimated annualized hourly burden anticipated for this
study is 1,458 hours.
Estimated
Annualized Burden Hours
-----------------------------------------------------------------------------------------------------------------------------------------------------Number
of
Average burden
Type of respondent
Number
of
responses per per response
Form name
Total burden
respondents
respondent
(in hours)
hours
-----------------------------------------------------------------------------------------------------------------------------------------------------Study participant.............................. Consent
Form...........................
1,500
1
10/60
250
Study participant.............................. Eligibility
Form.......................
1,500
1
5/60
125
Study participant.............................. Participant Enrollment
Form............
1,000
1
35/60
583
Study participant (Intervention arm ONLY)...... ACTIVITY: In-person
health
insurance
500
1
1
500
enrollment assistance.
-------------------------------------------------------------Total......................................
....................................... .............. ..............
..............
1,458
-----------------------------------------------------------------------------------------------------------------------------------------------------Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-24473 Filed 11-9-17; 8:45 am]
BILLING CODE 4163-18-P
------=_Part_996759_2145826244.1510585544144
Content-Type: text/html; charset=UTF-8
Content-Transfer-Encoding: 7bit
[Federal Register Volume 82,
Number 217 (Monday, November 13, 2017)]
[Notices]
[Pages 52302-52304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24473]
----------------------------------------------------------------------DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-17-17AUZ; Docket No. CDC-2017-0065]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
----------------------------------------------------------------------SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on ``Project NICE:
Navigating Insurance Coverage Expansion''. Project NICE will evaluate
the efficacy of an in-person health insurance enrollment assistance
intervention among Black and Hispanic men who have sex with
[[Page 52303]]
men (MSM) and Transgender persons living in the Chicago, Illinois
metropolitan area.
DATES: CDC must receive written comments on or before January 12, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-20170065 by any of the following methods:
Federal
eRulemaking
Portal: Regulations.gov. Follow
the
instructions for submitting comments.
Mail: Leroy A.
Richardson, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE., MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Leroy A. Richardson, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses.
5. Assess information collection costs.
Proposed Project
Project NICE: Navigating Insurance Coverage Expansion--New-National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
CDC seeks to request a three-year OMB approval to evaluate the
efficacy of an in-person health insurance enrollment assistance
intervention among 1,000 Black and Hispanic MSM and Transgender persons
ages >=18 years living in the Chicago, Illinois metropolitan area. CDC
will invite individuals attending HIV testing outreach events, or
seeking care in select clinics in Chicago to participate in the study
after an HIV testing session. Researchers will collect study
participants' sociodemographic, risk behavior, and insurance coverage
information as part of study enrollment. Each quarter, researchers will
abstract outcome evaluation data (linkage to and retention in HIVrelated care, referrals for mental health or substance use, and other
health outcomes) from study participant's electronic medical records
(EMRs). Researchers will also assess intervention cost-effectiveness.
CDC funded this study through a cooperative agreement with the
University of Chicago Medicine (UCM). Three partner agencies will
conduct the intervention: (1) University of Chicago Medicine (UCM) (the
lead partner agency), (2) Howard Brown Health, and (3) Chicago House
and Social Service Agency (Chicago House). The three partner agencies
each have a history of providing clinical care, HIV testing outreach,
and in-person health insurance enrollment assistance for Chicago's MSM
and Transgender communities.
As part of this study, CDC will evaluate the in-person health
insurance enrollment assistance. Specifically, researchers will
evaluate whether moving the delivery of in-person health insurance
enrollment assistance, from the first clinic visit after receipt of an
HIV test result, to earlier in the care continuum, during the HIV
testing event, will impact health outcomes. Therefore, this study does
not introduce new intervention activities or burden on the participants
or the agency staff; it reorders the sequence of delivery of standard
practice. Only the addition of data collection forms and procedures
will be new, and the additional burden will be to partner agency staff
workload and participant experience.
In 2013, MSM accounted for 81% of new HIV infections among males
and 65% of all new HIV infections. In 2010, health officials reported
10,600 new HIV infections for African-American (Black) MSM, 11,200 for
White MSM, and 6,700 for Hispanic MSM. Through a 2008 systematic
review, researchers found HIV rates among Black and Hispanic
Transgender women to be 56% and 16%, respectively.
Black and Hispanic MSM and Transgender persons face obstacles in
seeking medical care and following through with referrals or
appointments, including lack of health insurance.
This study will implement a structural intervention. The goal of
this study is to test whether providing in-person assistance for firsttime private health insurance or Medicaid enrollment, changing to a
different insurance plan, or understanding how to use current insurance
policies following HIV testing will: (1) Increase the proportion of
participants who obtain health insurance; (2) result in better health
outcomes among participants (e.g., achieving viral suppression,
remaining HIV negative); (3) improve the linkage and retention rates
for HIV care (i.e., HIV treatment, Pre-exposure Prophylaxis (PrEP)) and
other HIV-associated health services (e.g., mental health counseling,
substance use treatment) of participants, especially those diagnosed
with HIV; and (4) increase HIV care linkage and retention rates
sufficiently to justify the cost of implementing the intervention
(cost-benefit analysis) among Black and Hispanic MSM and Transgender
persons age 18 or older in the Chicago, Illinois metropolitan area.
Randomized controlled trials (RCTs) of structural interventions are
rare. Nevertheless, CDC will use a RCT design to enhance scientific
validity and the policy impact of the intervention, and help
researchers assess the efficacy of this intervention as an emerging
practice prior to dissemination to HIV prevention service providers
nationwide.
[[Page 52304]]
This project aligns with National HIV/AIDS Strategy 2020 and Health
People 2020 objectives. This structural intervention aligns with the
OMB's emphasis on application of behavioral insights in that it
restructures the context (i.e., after HIV testing) in which healthrelated decision-making (i.e., health insurance enrollment) occurs in
order to promote the selection of beneficial options. The proposed
health insurance enrollment assistance project has the potential for
widespread health improvements for Black and Hispanic MSM and
Transgender persons regardless of their HIV status.
The study will enroll 1,000 participants over 12 months to reach
adequate power calculations (500 into the intervention arm, and 500
into the control arm).
After an HIV testing session at an outreach event or clinic visit,
a partner-agency staff person will invite an individual to participate
in the study. If interested, participants will complete a consent form.
Staff will screen individuals using the Eligibility Form, which will
take approximately five minutes to complete. Researchers would need to
screen approximately 1,500 individuals in order to identify and enroll
1,000 eligible study participants. If eligible and interested in
participating, individuals will complete the Participant Enrollment
Form, which will take approximately 35 minutes to complete. Researchers
then will offer in-person health insurance enrollment to randomized
intervention arm participants. This enrollment will take a maximum of
60 minutes to complete. The study's in-person health insurance
enrollment assistance will take the same amount of time as standard
practice health insurance enrollment assistance.
The total estimated annualized hourly burden anticipated for this
study is 1,458 hours.
Estimated
Annualized Burden Hours
------------------------------------------------------------------------------------------------------------------------------------------------------
Number
of
Average burden
Type of respondent
Number
of
responses per per response
Form name
Total burden
respondents
respondent
(in hours)
hours
-----------------------------------------------------------------------------------------------------------------------------------------------------Study participant.............................. Consent
Form...........................
1,500
1
10/60
250
Study participant.............................. Eligibility
Form.......................
1,500
1
5/60
125
Study participant.............................. Participant Enrollment
Form............
1,000
1
35/60
583
Study participant (Intervention arm ONLY)...... ACTIVITY: In-person
health
insurance
500
1
1
500
enrollment assistance.
-------------------------------------------------------------Total......................................
....................................... .............. ..............
..............
1,458
-----------------------------------------------------------------------------------------------------------------------------------------------------Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-24473 Filed 11-9-17; 8:45 am]
BILLING CODE 4163-18-P
| File Type | application/pdf |
| File Modified | 2018-02-16 |
| File Created | 2017-11-30 |