83 FR 34588 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 83, Issue 140 (July 20, 2018)

Page Range		34588-34589
FR Document		2018-15524

Federal Register, Volume 83 Issue 140 (Friday, July 20, 2018)

[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34588-34589]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15524]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-18TH]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled ``Assessment of a Preventive Service Program 
in the Context of a Zika Virus Outbreak in Puerto Rico'' to the Office 
of Management and Budget (OMB) for review and approval. CDC previously 
published a ``Proposed Data Collection Submitted for Public Comment and 
Recommendations'' notice on March 30, 2018 to obtain comments from the 
public and affected agencies. CDC received one non-substantive comment 
to the previous notice. This notice serves to allow an additional 30 
days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) 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;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) 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 submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to omb@cdc.gov. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Assessment of a Preventive Service Program in the Context of a Zika 
Virus Outbreak in Puerto Rico--New--National Center for Chronic Disease 
Prevention and Health Promotion (NCCDPHP), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    Puerto Rico has reported the highest number of Zika virus 
infections in the United States, including infections in pregnant 
women. Zika virus infection during pregnancy has been identified as a 
cause of microcephaly and other severe brain abnormalities, and has 
been linked to other problems such as miscarriage, stillbirth, defects 
of the eye, hearing deficits, limb abnormalities, and impaired growth. 
One strategy to prevent these devastating outcomes is to prevent 
unintended pregnancy among women at risk of Zika virus infection. To 
this end, an initiative was launched in April 2016 to train physicians 
at clinics across Puerto Rico to provide patient-centered services to 
women who chose to delay or avoid pregnancy during the Zika virus 
outbreak.
    As part of the public health response to the Zika virus outbreak, 
CDC seeks to assess approaches to mitigating the effects of Zika virus 
infection and determine which approaches have utility. Previous 
assessment of the prevention program indicated high satisfaction of 
patients with program services. The specific objectives of this data 
collection are to assess (1) prevention strategy adherence among 
patients at approximately 18 months after receipt of program services; 
and (2) prevention strategy adherence, patient satisfaction, and unmet 
need for services among participants at approximately 30 months after 
receipt of program services. The practical utility of the information 
to be collected as part of this project is to assess services delivered 
to women in Puerto Rico, monitor outcomes of interest, and determine 
potential for replication/adaptation in other jurisdictions similarly 
affected by the Zika virus or during other emergency responses. For the 
information collection, CDC plans to conduct online surveys with 1,920 
patients approximately 18 months after receiving program services and 
1,760 patients approximately 30 months after receiving program 
services. The number of patients surveyed is based on an initial sample 
of 3,200 patients invited to participate, anticipating a 60% response 
rate at 18 months and a 55% response rate at 30 months.
    Participation in all data collection activities will be completely 
voluntary. OMB approval is requested for two years. Total Annualized 
Burden Hours are estimated to be 259, and there are no costs to 
respondents other than their time.

[[Page 34589]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Patients aged 18 years or older.......  Online surveys (18-month             960               1            7/60
                                         follow-up).
Patients aged 18 years or older who     Online surveys (30-month             660               1           10/60
 completed 18 mo survey.                 follow-up).
Patients aged 18 years or older who     Online surveys (30-month             220               1           10/60
 did not complete 18 mo survey.          follow-up).
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
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. 2018-15524 Filed 7-19-18; 8:45 am]
 BILLING CODE 4163-18-P

34588 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices

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

Vector control tools questionnaire ....................... 600 1 25/60 250
Specimen collection ............................................. 2,996 1 5/60 250

Total ........................ .............................................................................. ........................ ........................ ........................ 2,416

Jeffrey M. Zirger, including the validity of the prevent unintended pregnancy among
Acting Chief, Information Collection Review methodology and assumptions used; women at risk of Zika virus infection.
Office, Office of Scientific Integrity, Office (c) Enhance the quality, utility, and To this end, an initiative was launched
of the Associate Director for Science, Office clarity of the information to be in April 2016 to train physicians at
of the Director, Centers for Disease Control collected; clinics across Puerto Rico to provide
and Prevention.
(d) Minimize the burden of the patient-centered services to women who
[FR Doc. 2018–15529 Filed 7–19–18; 8:45 am] chose to delay or avoid pregnancy
collection of information on those who
BILLING CODE 4163–18–P
are to respond, including, through the during the Zika virus outbreak.
use of appropriate automated, As part of the public health response
electronic, mechanical, or other to the Zika virus outbreak, CDC seeks to
DEPARTMENT OF HEALTH AND
technological collection techniques or assess approaches to mitigating the
HUMAN SERVICES
other forms of information technology, effects of Zika virus infection and
Centers for Disease Control and e.g., permitting electronic submission of determine which approaches have
Prevention responses; and utility. Previous assessment of the
(e) Assess information collection prevention program indicated high
[30Day–18–18TH] costs. satisfaction of patients with program
To request additional information on services. The specific objectives of this
Agency Forms Undergoing Paperwork data collection are to assess (1)
Reduction Act Review the proposed project or to obtain a copy
of the information collection plan and prevention strategy adherence among
In accordance with the Paperwork instruments, call (404) 639–7570 or patients at approximately 18 months
Reduction Act of 1995, the Centers for send an email to omb@cdc.gov. Direct after receipt of program services; and (2)
Disease Control and Prevention (CDC) written comments and/or suggestions prevention strategy adherence, patient
has submitted the information regarding the items contained in this satisfaction, and unmet need for
collection request titled ‘‘Assessment of notice to the Attention: CDC Desk services among participants at
a Preventive Service Program in the Officer, Office of Management and approximately 30 months after receipt
Context of a Zika Virus Outbreak in Budget, 725 17th Street NW, of program services. The practical utility
Puerto Rico’’ to the Office of Washington, DC 20503 or by fax to (202) of the information to be collected as part
Management and Budget (OMB) for 395–5806. Provide written comments of this project is to assess services
review and approval. CDC previously within 30 days of notice publication. delivered to women in Puerto Rico,
published a ‘‘Proposed Data Collection monitor outcomes of interest, and
Proposed Project determine potential for replication/
Submitted for Public Comment and
Recommendations’’ notice on March 30, Assessment of a Preventive Service adaptation in other jurisdictions
2018 to obtain comments from the Program in the Context of a Zika Virus similarly affected by the Zika virus or
public and affected agencies. CDC Outbreak in Puerto Rico—New— during other emergency responses. For
received one non-substantive comment National Center for Chronic Disease the information collection, CDC plans to
to the previous notice. This notice Prevention and Health Promotion conduct online surveys with 1,920
serves to allow an additional 30 days for (NCCDPHP), Centers for Disease Control patients approximately 18 months after
public and affected agency comments. and Prevention (CDC). receiving program services and 1,760
CDC will accept all comments for this patients approximately 30 months after
Background and Brief Description receiving program services. The number
proposed information collection project.
The Office of Management and Budget Puerto Rico has reported the highest of patients surveyed is based on an
is particularly interested in comments number of Zika virus infections in the initial sample of 3,200 patients invited
that: United States, including infections in to participate, anticipating a 60%
(a) Evaluate whether the proposed pregnant women. Zika virus infection response rate at 18 months and a 55%
collection of information is necessary during pregnancy has been identified as response rate at 30 months.
for the proper performance of the a cause of microcephaly and other Participation in all data collection
functions of the agency, including severe brain abnormalities, and has been activities will be completely voluntary.
whether the information will have linked to other problems such as OMB approval is requested for two
daltland on DSKBBV9HB2PROD with NOTICES

practical utility; miscarriage, stillbirth, defects of the eye, years. Total Annualized Burden Hours
(b) Evaluate the accuracy of the hearing deficits, limb abnormalities, and are estimated to be 259, and there are no
agencies estimate of the burden of the impaired growth. One strategy to costs to respondents other than their
proposed collection of information, prevent these devastating outcomes is to time.

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Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 34589

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

Patients aged 18 years or older ..................... Online surveys (18-month follow-up) ............. 960 1 7/60
Patients aged 18 years or older who com- Online surveys (30-month follow-up) ............. 660 1 10/60
pleted 18 mo survey.
Patients aged 18 years or older who did not Online surveys (30-month follow-up) ............. 220 1 10/60
complete 18 mo survey.

Jeffrey M. Zirger, (c) Enhance the quality, utility, and The purposes for each data collection
Acting Chief, Information Collection Review clarity of the information to be study supported under this extended
Office, Office of Scientific Integrity, Office collected; Generic ICR will be to understand
of the Associate Director for Science, Office (d) Minimize the burden of the specific barriers and facilitators to local
of the Director, Centers for Disease Control collection of information on those who HIV prevention, care and treatment in
and Prevention. are to respond, including, through the the United States and territories. For
[FR Doc. 2018–15524 Filed 7–19–18; 8:45 am] use of appropriate automated, example, each study will seek to
BILLING CODE 4163–18–P electronic, mechanical, or other identify ways to improve programmatic
technological collection techniques or activities along the continuum of HIV
other forms of information technology, prevention, treatment and care for
DEPARTMENT OF HEALTH AND e.g., permitting electronic submission of different populations residing in
HUMAN SERVICES responses; and different geographic settings with
(e) Assess information collection greatest burden of HIV.
Centers for Disease Control and costs.
Prevention The target populations for studies
To request additional information on included in this extended Generic ICR
[30Day–18–1091] the proposed project or to obtain a copy include, but are not limited to: Persons
of the information collection plan and living with HIV who are in treatment;
Agency Forms Undergoing Paperwork instruments, call (404) 639–7570 or persons living with HIV who are out of
Reduction Act Review send an email to omb@cdc.gov. Direct treatment and who may or may not be
written comments and/or suggestions
In accordance with the Paperwork seeking treatment at healthcare
regarding the items contained in this
Reduction Act of 1995, the Centers for facilities; persons at high risk for HIV
notice to the Attention: CDC Desk
Disease Control and Prevention (CDC) acquisition (HIV negative) and HIV
Officer, Office of Management and
has submitted the information transmission (HIV positive); persons
Budget, 725 17th Street NW,
collection request titled ‘‘Using from groups at high risk for HIV
Washington, DC 20503 or by fax to (202)
Qualitative Methods to Understand including gay, bisexual and other MSM,
395–5806. Provide written comments
Issues in HIV Prevention, Care and transgender persons, and injection and
within 30 days of notice publication.
Treatment in the United States’’ to the non-injection drug users; persons from
Office of Management and Budget Proposed Project racial and ethnic minorities; and
(OMB) for review and approval. CDC Using Qualitative Methods to healthcare providers or other
previously published a ‘‘Proposed Data Understand Issues in HIV Prevention, professionals who provide HIV
Collection Submitted for Public Care and Treatment in the United States prevention, care and treatment services.
Comment and Recommendations’’ (OMB No. 0920–1091; expires December Other populations may include
notice on March 13, 2018 to obtain 31, 2018)—Extension—National Center individuals who provide non-HIV
comments from the public and affected for HIV/AIDS, Viral Hepatitis, STD, and services or otherwise interact with
agencies. CDC received four comments TB Prevention, Centers for Disease persons living with HIV or persons at
related to the previous notice. This Control and Prevention (CDC). risk for HIV acquisition.
notice serves to allow an additional 30 Studies will only provide local
days for public and affected agency Background and Brief Description contextual information about the
comments. The CDC’s National Center on HIV/ barriers and facilitators to HIV
CDC will accept all comments for this AIDS, Viral Hepatitis, STD and TB prevention, care, and treatment
proposed information collection project. Prevention (NCHHSTP), Division of experienced by specific communities at
The Office of Management and Budget HIV/AIDS Prevention (DHAP) seeks a risk for acquiring HIV infection, by HIV-
is particularly interested in comments three year extension for an existing positive persons across the HIV care
that: Generic information collection request continuum, and by organizations or
(a) Evaluate whether the proposed (Generic ICR) entitled, ‘‘Using individuals providing HIV prevention,
collection of information is necessary Qualitative Methods to Understand care, treatment, and related support
for the proper performance of the Issues in HIV Prevention, Care and services.
functions of the agency, including Treatment in the United States’’ (OMB Data collection methods used in any
daltland on DSKBBV9HB2PROD with NOTICES

whether the information will have Number: 0920–1091). Specific studies of the specific studies primarily will
practical utility; conducted under this extended Generic consist of rapid qualitative assessment
(b) Evaluate the accuracy of the ICR will be consistent with the national methodologies, such as semi-structured
agencies estimate of the burden of the HIV prevention goals, the CDC Division and in-depth qualitative interviews,
proposed collection of information, of HIV/AIDS Prevention (DHAP) focus groups; direct observations;
including the validity of the Strategic Plan, and DHAP’s High-impact document reviews; and short structured
methodology and assumptions used; HIV Prevention approach. surveys. Data will be analyzed using

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Document Created: 2018-07-20 01:18:19
Document Modified: 2018-07-20 01:18:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		83 FR 34588

83 FR 34588 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 83, Issue 140 (July 20, 2018)

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