[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7378-7379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03775]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-1143; Docket No. CDC-2019-0009]


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 US Zika Pregnancy registry, is to 
seek Paperwork Reduction Act (PRA) clearance to monitor the frequency 
and types of adverse birth outcomes for women with laboratory evidence 
of Zika virus infection during pregnancy and their infants and to 
strengthen the public health response to the Zika virus disease 
outbreak.

DATES: CDC must receive written comments on or before May 3, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0009 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Lead, 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 Jeffrey M. Zirger, 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

    US Zika Pregnancy Registry (OMB Control No. 0920-1143, Expiration 
11/30/2019)--Extension--National Center on Birth Defects and 
Developmental Disabilities (NCBDDD), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    In May 2015, the World Health Organization reported the first local 
transmission of Zika virus in the Western Hemisphere, with 
autochthonous cases identified in Brazil. As of March 16, 2016, local 
transmission has been identified in at least 32 countries or 
territories in the Americas. Further spread to other countries in the 
region is likely. Local vector-borne transmission of Zika virus has not 
been documented in the 50 U.S. states or the District of Columbia, but 
has occurred in US territories, including in Puerto Rico, the US Virgin 
Islands, and American Samoa. However, Zika virus infections have been 
reported in travelers returning to the United States from areas with 
active Zika virus transmission. Zika virus infection also has occurred 
through sexual transmission, which may pose an additional risk to non-
travelling pregnant women whose partners may have traveled to areas at 
high risk for Zika virus acquisition. With the ongoing outbreak in the 
Americas, the number of Zika virus disease cases among travelers 
returning to the United States likely will

[[Page 7379]]

increase, and sexual transmission from male travelers to their sex 
partners in the United States will likely continue to occur. In 
addition, mosquito-borne local transmission may occur in states where 
Aedes species mosquitoes are present.
    In some Brazilian states where Zika virus transmission has 
occurred, there has been an increase in cases of infants born with 
microcephaly. Zika virus infections have been confirmed in several 
infants with microcephaly and in fetal losses in women infected during 
pregnancy. In addition to microcephaly, a range of other problems have 
been detected among fetuses and infants infected with Zika virus before 
birth, such as absent or poorly developed brain structures, defects of 
the eye, hearing deficits, and impaired growth. The Ministry of Health 
in Brazil, with support from the Pan American Health Organization 
(PAHO), the U.S. Centers for Disease Control and Prevention (CDC), and 
other partners, is investigating the association between Zika virus 
infection and microcephaly, as well as other adverse pregnancy and 
infant outcomes.
    Zika virus disease and Zika virus congenital infection are 
nationally notifiable conditions for which the Council of State and 
Territorial Epidemiologists (CSTE) has established interim case 
definitions. All 50 states, the District of Columbia, and Puerto Rico, 
the U.S. Virgin Islands, American Samoa, Guam, and the Northern Mariana 
Islands currently participate in reporting of arboviral diseases 
through ArboNET. However, ArboNET does not capture all the information 
needed to provide timely situational awareness in the context of the 
ongoing public health response. In particular, ArboNET collects limited 
data on pregnancy, pregnancy and birth outcomes, and congenital 
infections, all of which are necessary for informing ongoing response 
efforts.
    As part of the public health response to the Zika virus disease 
outbreak, CDC will conduct supplemental surveillance of antenatal 
diagnostic testing and clinical outcomes among pregnant women with 
laboratory evidence of Zika virus or unspecified flavivirus infection 
and their infants through the U.S. Zika Pregnancy Registry. It is 
anticipated that the Registry will provide critical information to 
direct CDC clinical recommendations and public health guidance and 
messages.
    The data to be collected for the Registry includes information 
about Zika infection-related tests and procedures conducted as part of 
the mother's and child's routine clinical care, and in line with 
existing CDC, American College of Obstetricians and Gynecologists and 
Society of Maternal Fetal Medicine, and American Academy of Pediatrics 
recommendations for evaluation, diagnosis, and follow-up of women 
infected with Zika virus during pregnancy and their children. No 
additional tests or procedures will be performed specifically for 
Registry purposes.
    This request is submitted to extend the collection period of 
collection OMB number 0920-1143 for an additional three years. The 
total estimated annual burden hours are 23,833. There are no costs to 
the respondents other than their time.

                                      Estimates of Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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State, Territorial and Local    Maternal Health            1,100              10           30/60           5,500
 Health Departments.             History Form.
                                Supplemental               1,100              10           10/60           1,833
                                 Imaging Form.
                                Laboratory                 1,100              10           15/60           2,750
                                 Results Form.
Clinicians and Other Providers  Assessment at              1,100              10           30/60           5,500
                                 Delivery Form.
                                Infant Health              1,100              30           15/60           8,250
                                 Follow-Up Form.
                                                 ---------------------------------------------------------------
  Total.......................  ................  ..............  ..............  ..............          23,833
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-03775 Filed 3-1-19; 8:45 am]
BILLING CODE 4163-18-P