81_FR_53021 81 FR 52867 - Proposed Data Collection Submitted for Public Comment and Recommendations

81 FR 52867 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 154 (August 10, 2016)

Page Range52867-52868
FR Document2016-18938

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts 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 a proposed study to examine the facilitators and barriers to receiving clinical preventive services among newly insured medically underserved women who had previously been served by the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). The purpose of this survey is to assess if newly insured women receive appropriate clinical preventive health services, what barriers and facilitators these women experience, and if they are able to maintain consistent health insurance coverage.

Federal Register, Volume 81 Issue 154 (Wednesday, August 10, 2016)
[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52867-52868]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18938]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16AWP; Docket No. CDC-2016-0075]


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 efforts 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 a proposed study 
to examine the facilitators and barriers to receiving clinical 
preventive services among newly insured medically underserved women who 
had previously been served by the National Breast and Cervical Cancer 
Early Detection Program (NBCCEDP). The purpose of this survey is to 
assess if newly insured women receive appropriate clinical preventive 
health services, what barriers and facilitators these women experience, 
and if they are able to maintain consistent health insurance coverage.

DATES: Written comments must be received on or before October 11, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0075 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted 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 the 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Women's Preventive Health Services Study--New--National Center for 
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The National Breast and Cervical Cancer Early Detection Program 
(NBCCEDP) provides free or low-cost breast and cervical cancer 
screening and diagnostic services to low-income, uninsured, and 
underserved women. The NBCCEDP is an organized screening program with a 
full complement of services including outreach and patient education, 
patient navigation, case management, professional development, and 
tracking and follow-up that contribute to the program's success. 
Compared to when the NBCCEDP was established, more women are eligible 
for insurance coverage but there are still many women who are not 
insured and many insured women not obtaining preventive services that 
they are eligible to receive. Currently, the NBCCEDP not only provides 
screening services to uninsured and underinsured, but has expanded its 
services to include population-based activities that prevent missed 
opportunities and ensure that all women receive appropriate breast and 
cervical cancer screening.
    Previous research suggests that access to health care through 
insurance alone does not ensure adherence to cancer screening, as many 
individual, cultural, and community factors serve as barriers to 
preventive service use. With recent increases in the numbers of women 
who are insured, there is a need to understand the experiences of women 
who had been served by the NBCCEDP and become newly insured. This 
project will inform the development of future activities of the NBCCEDP 
so that all women receive the information and support services needed 
for obtaining clinical preventive services.

[[Page 52868]]

    The purpose of this project is to examine the facilitators and 
barriers to receiving clinical preventive services among newly insured 
medically underserved women who had previously been served by the 
NBCCEDP. The Women's Preventive Services Study aims to survey newly 
insured women about what clinical preventive health services they 
receive, what barriers and facilitators they experience, and their 
ability to maintain consistent health insurance coverage.
    While having newly acquired health insurance will improve access to 
preventive services, insurance coverage alone would not result in 
improved clinical preventive services utilization for all women, 
especially among underserved populations. This project proposes to 
follow a group of women previously served by the NBCCEDP over 3 years 
by administering a yearly questionnaire.
    This study will focus on the following research questions:
    1. What are the insurance coverage patterns (e.g., public or 
private insurance) for a sample of medically underserved women 
previously screened through the NBCCEDP?
    2. What barriers and facilitators do these women face in enrolling 
in new insurance coverage?
    3. What preventive health services, including cancer screening, do 
these women receive?
    4. What barriers and facilitators do these women face in accessing 
preventive health services through their new coverage?
    5. What are the non-financial and financial costs to these women?
    The respondents will be uninsured or underinsured women who 
previously had been screened through the NBCCEDP but now have health 
insurance coverage. To be potentially eligible for the study, women 
must be between the ages of 30-62 years, a U.S. Citizen or U.S. 
permanent resident, resident of the state where they received NBCCEDP 
services, and English or Spanish speaking. Additionally, women must 
meet one of the prior screening criteria: (1) Having received a Pap 
test through a NBCCEDP state program not less than 1 year but not more 
than 4 years from the time of study implementation OR (2) received a 
Pap/HPV co-test through a NBCCEDP grantee not less than 3 years but not 
more than 5 years from the time of study implementation OR (3) received 
a mammogram through a NBCCEDP grantee not less than 1 year but not more 
than 3 years from the time of study implementation.
    NBCCEDP state programs will identify potentially eligible women and 
consent the women to have their contact information shared for the 
study. The women who agree will receive an invitation letter to 
participate in the study through an on-line survey. The first step of 
the on-line survey will be a set of screener questions to determine 
whether they have insurance coverage. Only those who currently have 
insurance will be eligible to continue with the main survey instrument. 
Women who complete the survey will be asked to repeat the survey 
annually the next 2 years.
    The sample design proposes that 14,240 women be identified as 
eligible. We estimate that 80% will be contacted and agree to 
participate. Of that, we expect 9,683 completed on-line screenings to 
occur during year one, representing an annualized 3,288 respondents. 
With an 85% expected completion rate and annual attrition, we estimate 
that 3,292 surveys will be completed in Year 1; 2,222 completed surveys 
in Year 2; and 1,500 completed surveys in Year 3. This represents an 
annualized 2,338 respondents for the survey.
    OMB approval is requested for three years. Participation is 
voluntary and there are no costs to respondents other than their time. 
The estimated annualized burden hours for this data collection are 
1,243 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Women aged 30-62 who            Screener........           3,228               1            5/60             269
 previously received services
 in the NBCCEDP.
                                Survey..........           2,338               1           25/60             974
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,243
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Health Scientist, Acting 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. 2016-18938 Filed 8-9-16; 8:45 am]
 BILLING CODE 4163-18-P



                                                                             Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices                                           52867

                                                  automated collection techniques or                      Disease Control and Prevention, 1600                  generate, maintain, retain, disclose or
                                                  other forms of information technology.                  Clifton Road NE., MS–D74, Atlanta,                    provide information to or for a Federal
                                                    Comments submitted in response to                     Georgia 30329.                                        agency. This includes the time needed
                                                  this notice will be summarized and                         Instructions: All submissions received             to review instructions; to develop,
                                                  included in the Agency’s subsequent                     must include the agency name and                      acquire, install and utilize technology
                                                  request for OMB approval of the                         Docket Number. All relevant comments                  and systems for the purpose of
                                                  proposed information collection. All                    received will be posted without change                collecting, validating and verifying
                                                  comments will become a matter of                        to Regulations.gov, including any                     information, processing and
                                                  public record.                                          personal information provided. For                    maintaining information, and disclosing
                                                                                                          access to the docket to read background               and providing information; to train
                                                  Sharon B. Arnold,
                                                                                                          documents or comments received, go to                 personnel and to be able to respond to
                                                  Deputy Director.                                        Regulations.gov.                                      a collection of information, to search
                                                  [FR Doc. 2016–18995 Filed 8–9–16; 8:45 am]                 Please note: All public comment                    data sources, to complete and review
                                                  BILLING CODE 4160–90–P                                  should be submitted through the                       the collection of information; and to
                                                                                                          Federal eRulemaking portal                            transmit or otherwise disclose the
                                                                                                          (Regulations.gov) or by U.S. mail to the              information.
                                                  DEPARTMENT OF HEALTH AND                                address listed above.
                                                  HUMAN SERVICES                                                                                                Proposed Project
                                                                                                          FOR FURTHER INFORMATION CONTACT: To
                                                  Centers for Disease Control and                         request more information on the                         Women’s Preventive Health Services
                                                  Prevention                                              proposed project or to obtain a copy of               Study—New—National Center for
                                                                                                          the information collection plan and                   Chronic Disease Prevention and Health
                                                  [60Day–16–16AWP; Docket No. CDC–2016–                   instruments, contact the Information                  Promotion (NCCDPHP), Centers for
                                                  0075]                                                   Collection Review Office, Centers for                 Disease Control and Prevention (CDC).
                                                                                                          Disease Control and Prevention, 1600
                                                  Proposed Data Collection Submitted                                                                            Background and Brief Description
                                                                                                          Clifton Road NE., MS–D74, Atlanta,
                                                  for Public Comment and
                                                                                                          Georgia 30329; phone: 404–639–7570;                      The National Breast and Cervical
                                                  Recommendations
                                                                                                          Email: omb@cdc.gov.                                   Cancer Early Detection Program
                                                  AGENCY: Centers for Disease Control and                 SUPPLEMENTARY INFORMATION: Under the                  (NBCCEDP) provides free or low-cost
                                                  Prevention (CDC), Department of Health                  Paperwork Reduction Act of 1995 (PRA)                 breast and cervical cancer screening and
                                                  and Human Services (HHS).                               (44 U.S.C. 3501–3520), Federal agencies               diagnostic services to low-income,
                                                  ACTION: Notice with comment period.                     must obtain approval from the Office of               uninsured, and underserved women.
                                                                                                          Management and Budget (OMB) for each                  The NBCCEDP is an organized screening
                                                  SUMMARY:   The Centers for Disease                      collection of information they conduct                program with a full complement of
                                                  Control and Prevention (CDC), as part of                or sponsor. In addition, the PRA also                 services including outreach and patient
                                                  its continuing efforts to reduce public                 requires Federal agencies to provide a                education, patient navigation, case
                                                  burden and maximize the utility of                      60-day notice in the Federal Register                 management, professional development,
                                                  government information, invites the                     concerning each proposed collection of                and tracking and follow-up that
                                                  general public and other Federal                        information, including each new                       contribute to the program’s success.
                                                  agencies to take this opportunity to                    proposed collection, each proposed                    Compared to when the NBCCEDP was
                                                  comment on proposed and/or                              extension of existing collection of                   established, more women are eligible for
                                                  continuing information collections, as                  information, and each reinstatement of                insurance coverage but there are still
                                                  required by the Paperwork Reduction                     previously approved information                       many women who are not insured and
                                                  Act of 1995. This notice invites                        collection before submitting the                      many insured women not obtaining
                                                  comment on a proposed study to                          collection to OMB for approval. To                    preventive services that they are eligible
                                                  examine the facilitators and barriers to                comply with this requirement, we are                  to receive. Currently, the NBCCEDP not
                                                  receiving clinical preventive services                  publishing this notice of a proposed                  only provides screening services to
                                                  among newly insured medically                           data collection as described below.                   uninsured and underinsured, but has
                                                  underserved women who had                                  Comments are invited on: (a) Whether               expanded its services to include
                                                  previously been served by the National                  the proposed collection of information                population-based activities that prevent
                                                  Breast and Cervical Cancer Early                        is necessary for the proper performance               missed opportunities and ensure that all
                                                  Detection Program (NBCCEDP). The                        of the functions of the agency, including             women receive appropriate breast and
                                                  purpose of this survey is to assess if                  whether the information shall have                    cervical cancer screening.
                                                  newly insured women receive                             practical utility; (b) the accuracy of the               Previous research suggests that access
                                                  appropriate clinical preventive health                  agency’s estimate of the burden of the                to health care through insurance alone
                                                  services, what barriers and facilitators                proposed collection of information; (c)               does not ensure adherence to cancer
                                                  these women experience, and if they are                 ways to enhance the quality, utility, and             screening, as many individual, cultural,
                                                  able to maintain consistent health                      clarity of the information to be                      and community factors serve as barriers
                                                  insurance coverage.                                     collected; (d) ways to minimize the                   to preventive service use. With recent
                                                  DATES: Written comments must be                         burden of the collection of information               increases in the numbers of women who
                                                  received on or before October 11, 2016.                 on respondents, including through the                 are insured, there is a need to
                                                  ADDRESSES: You may submit comments,                     use of automated collection techniques                understand the experiences of women
mstockstill on DSK3G9T082PROD with NOTICES




                                                  identified by Docket No. CDC–2016–                      or other forms of information                         who had been served by the NBCCEDP
                                                  0075 by any of the following methods:                   technology; and (e) estimates of capital              and become newly insured. This project
                                                     • Federal eRulemaking Portal:                        or start-up costs and costs of operation,             will inform the development of future
                                                  Regulations.gov. Follow the instructions                maintenance, and purchase of services                 activities of the NBCCEDP so that all
                                                  for submitting comments.                                to provide information. Burden means                  women receive the information and
                                                     • Mail: Jeffrey M. Zirger, Information               the total time, effort, or financial                  support services needed for obtaining
                                                  Collection Review Office, Centers for                   resources expended by persons to                      clinical preventive services.


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                                                  52868                              Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices

                                                     The purpose of this project is to                                        3. What preventive health services,                                       the women to have their contact
                                                  examine the facilitators and barriers to                                 including cancer screening, do these                                         information shared for the study. The
                                                  receiving clinical preventive services                                   women receive?                                                               women who agree will receive an
                                                  among newly insured medically                                               4. What barriers and facilitators do                                      invitation letter to participate in the
                                                  underserved women who had                                                these women face in accessing                                                study through an on-line survey. The
                                                  previously been served by the                                            preventive health services through their                                     first step of the on-line survey will be
                                                  NBCCEDP. The Women’s Preventive                                          new coverage?                                                                a set of screener questions to determine
                                                  Services Study aims to survey newly                                         5. What are the non-financial and                                         whether they have insurance coverage.
                                                  insured women about what clinical                                        financial costs to these women?                                              Only those who currently have
                                                  preventive health services they receive,                                    The respondents will be uninsured or                                      insurance will be eligible to continue
                                                  what barriers and facilitators they                                      underinsured women who previously                                            with the main survey instrument.
                                                  experience, and their ability to maintain                                had been screened through the                                                Women who complete the survey will
                                                                                                                           NBCCEDP but now have health                                                  be asked to repeat the survey annually
                                                  consistent health insurance coverage.
                                                                                                                           insurance coverage. To be potentially                                        the next 2 years.
                                                     While having newly acquired health                                    eligible for the study, women must be
                                                  insurance will improve access to                                         between the ages of 30–62 years, a U.S.                                         The sample design proposes that
                                                  preventive services, insurance coverage                                  Citizen or U.S. permanent resident,                                          14,240 women be identified as eligible.
                                                  alone would not result in improved                                       resident of the state where they received                                    We estimate that 80% will be contacted
                                                  clinical preventive services utilization                                 NBCCEDP services, and English or                                             and agree to participate. Of that, we
                                                  for all women, especially among                                          Spanish speaking. Additionally, women                                        expect 9,683 completed on-line
                                                  underserved populations. This project                                    must meet one of the prior screening                                         screenings to occur during year one,
                                                  proposes to follow a group of women                                      criteria: (1) Having received a Pap test                                     representing an annualized 3,288
                                                  previously served by the NBCCEDP over                                    through a NBCCEDP state program not                                          respondents. With an 85% expected
                                                  3 years by administering a yearly                                        less than 1 year but not more than 4                                         completion rate and annual attrition, we
                                                  questionnaire.                                                           years from the time of study                                                 estimate that 3,292 surveys will be
                                                                                                                           implementation OR (2) received a Pap/                                        completed in Year 1; 2,222 completed
                                                     This study will focus on the following                                                                                                             surveys in Year 2; and 1,500 completed
                                                  research questions:                                                      HPV co-test through a NBCCEDP grantee
                                                                                                                           not less than 3 years but not more than                                      surveys in Year 3. This represents an
                                                     1. What are the insurance coverage                                    5 years from the time of study                                               annualized 2,338 respondents for the
                                                  patterns (e.g., public or private                                        implementation OR (3) received a                                             survey.
                                                  insurance) for a sample of medically                                     mammogram through a NBCCEDP                                                     OMB approval is requested for three
                                                  underserved women previously                                             grantee not less than 1 year but not more                                    years. Participation is voluntary and
                                                  screened through the NBCCEDP?                                            than 3 years from the time of study                                          there are no costs to respondents other
                                                     2. What barriers and facilitators do                                  implementation.                                                              than their time. The estimated
                                                  these women face in enrolling in new                                        NBCCEDP state programs will identify                                      annualized burden hours for this data
                                                  insurance coverage?                                                      potentially eligible women and consent                                       collection are 1,243 hours.

                                                                                                                          ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                    Average
                                                                                                                                                                                                      Number of
                                                                                                                                                                           Number of                                              burden per              Total burden
                                                                      Type of respondents                                                Form name                                                  responses per
                                                                                                                                                                          respondents                                              response                (in hours)
                                                                                                                                                                                                      respondent                   (in hours)

                                                  Women aged 30–62 who previously received                                     Screener .......................                         3,228                             1                     5/60               269
                                                   services in the NBCCEDP.
                                                                                                                               Survey ..........................                        2,338                             1                   25/60                974

                                                       Total ...............................................................   .......................................   ........................   ........................   ........................          1,243



                                                  Jeffrey M. Zirger,                                                       DEPARTMENT OF HEALTH AND                                                     its continuing efforts to reduce public
                                                  Health Scientist, Acting Chief, Information                              HUMAN SERVICES                                                               burden and maximize the utility of
                                                  Collection Review Office, Office of Scientific                                                                                                        government information, invites the
                                                  Integrity, Office of the Associate Director for                          Centers for Disease Control and                                              general public and other Federal
                                                  Science, Office of the Director, Centers for                             Prevention                                                                   agencies to take this opportunity to
                                                  Disease Control and Prevention.                                                                                                                       comment on proposed and/or
                                                  [FR Doc. 2016–18938 Filed 8–9–16; 8:45 am]                               [60 Day–16–16AWN: Docket No. CDC–2016–                                       continuing information collections, as
                                                  BILLING CODE 4163–18–P
                                                                                                                           0080]                                                                        required by the Paperwork Reduction
                                                                                                                                                                                                        Act of 1995. This notice invites
                                                                                                                           Proposed Data Collection Submitted                                           comment on the National Youth
                                                                                                                           for Public Comment and                                                       Tobacco Survey (NYTS) 2017 Computer
                                                                                                                           Recommendations                                                              Based Pilot. The NYTS is currently
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                           AGENCY: Centers for Disease Control and                                      administered in a paper and pencil
                                                                                                                           Prevention (CDC), Department of Health                                       format. The NYTS Computer Based Pilot
                                                                                                                           and Human Services (HHS).                                                    will assess the feasibility of
                                                                                                                           ACTION: Notice with comment period.
                                                                                                                                                                                                        administering the survey in an
                                                                                                                                                                                                        electronic format.
                                                                                                                           SUMMARY:  The Centers for Disease                                            DATES: Written comments must be
                                                                                                                           Control and Prevention (CDC), as part of                                     received on or before October 11, 2016.


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Document Created: 2016-08-10 01:59:48
Document Modified: 2016-08-10 01:59:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before October 11, 2016.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the 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]
FR Citation81 FR 52867 

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