83 FR 13752 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 83, Issue 62 (March 30, 2018)

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Assessment of a Preventive Service Program in the Context of a Zika Virus Outbreak in Puerto Rico''. Data collected will be used to assess implementation of a patient-centered prevention program and associated outcomes.

[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Notices]
[Pages 13752-13754]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06487]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-18TH; Docket No. CDC-2018-0027]


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.

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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 the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``Assessment of a Preventive 
Service Program in the Context of a Zika

[[Page 13753]]

Virus Outbreak in Puerto Rico''. Data collected will be used to assess 
implementation of a patient-centered prevention program and associated 
outcomes.

DATES: CDC must receive written comments on or before May 29, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0027 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

    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 Z-
CAN patients with program services. The specific objectives of this 
data collection are to assess: (1) Prevention strategy adherence among 
Z-CAN patients at approximately 18 months after receipt of program 
services; and (2) prevention strategy adherence, patient satisfaction, 
and unmet need for services among Z-CAN patients at approximately 30 
months after receipt of program services. The practical utility of the 
collected information 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 project, CDC plans to conduct online 
surveys with 1,600 patients approximately 18 and 30 months after 
receiving program services.
    Participation in all data collection activities will be completely 
voluntary. CDC intends to request a two-year OMB approval to collect 
information. Total Annualized Burden Hours are estimated to be 259, and 
there are no costs to respondents other than their time.

                                                            Estimated Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total  burden
              Type of respondents                               Form name                   respondents    responses per   response  (in    (in hours)
                                                                                                            respondent        hours)
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Patients aged 18 years or older................  Online surveys (18-month follow-up)....             960               1            7/60             112
Patients aged 18 years or older who completed    Online surveys (30-month follow-up)....             660               1           10/60             110
 18-month survey.
Patients aged 18 years or older who did not      Online surveys (30-month follow-up)....             220               1           10/60              37
 complete 18-month survey.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             259
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[[Page 13754]]

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. 2018-06487 Filed 3-29-18; 8:45 am]
 BILLING CODE 4163-18-P