[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Notices]
[Pages 26231-26234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10113]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-16-16AFR; Docket No. CDC-2016-0040]
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 an information
collection request proposal entitled ``Continuing International and
Domestic Information Collections from the 2016 Zika Virus Emergency
Response.'' These collections will allow CDC to continue its ongoing
response to the Zika virus outbreak.
DATES: Written comments must be received on or before July 1, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0040 by any of the following methods:
[[Page 26232]]
Federal eRulemaking Portal: Regulation.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. 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
Continuing International and Domestic Information Collections from
the 2016 Zika Virus Emergency Response--New--National Center for
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
In May 2015, the Pan American Health Organization (PAHO) issued an
alert regarding the first confirmed Zika virus infections in Brazil.
Since then, CDC has been responding to increased reports of Zika and
has assisted in investigations with PAHO and the Brazil Ministry of
Health. The first regional travel notices for Zika in South America and
Mexico were posted in December 2015. In December 2015, the Commonwealth
of Puerto Rico, a United States territory, reported its first confirmed
locally transmitted Zika virus case. Cases of local transmission have
recently been confirmed in two other US territories, the United States
Virgin Islands and American Samoa. As of April 6, 2016, US territories
had reported 351 locally acquired Zika cases and 3 travel-associated
Zika cases to CDC. Of the 354 cases reported, 37 were in pregnant
women. Zika has not been spread by mosquitoes in the continental United
States. However, lab tests have confirmed Zika virus in travelers
returning to the United States. These travelers have gotten the virus
from mosquito bites and a few non-travelers got Zika through sex. With
the recent outbreaks in the Americas, the number of Zika cases among
travelers visiting or returning to the United States is increasing. CDC
monitors and reports to the public cases of Zika, which will help
improve our understanding of how and where Zika is spreading.
Zika virus is spread to people primarily through the bite of an
infected Aedes species mosquito (A. aegypti and A. albopictus).
Mosquitoes that spread Zika virus are aggressive daytime biters, but
they can also bite at night. A pregnant woman can pass Zika virus to
her fetus during pregnancy. CDC is studying how Zika affects
pregnancies. Zika is linked to microcephaly, a severe birth defect that
is a sign of incomplete brain development. Microcephaly is a condition
where a baby's head is much smaller than expected. During pregnancy, a
baby's head grows because the baby's brain grows. Microcephaly can
occur because a baby's brain has not developed properly during
pregnancy or has stopped growing after birth.
In February and March 2016, CDC used OMB emergency clearance
procedures to initiate and expedite multiple urgently needed
information collections in American Samoa, Puerto Rico, Brazil, and
domestically within state, tribal, local, and territorial (STLT)
jurisdictions. These procedures have allowed the agency to target and
refine public health interventions to arrest ongoing spread of
infection.
With this notice, the CDC is announcing its intention to seek OMB
clearances to continue four Zika-related information collections beyond
their current emergency expiration dates. These four projects will be
submitted to OMB as standalone ICRs:
1. A call center in CDC's Emergency Operations Center (EOC) to
respond to inquiries on clinical care of persons potentially of
interest for Zika virus infection [OMB Control No. 0920-1101,
expiration date 8/31/16]. Respondents to this information collection
include the general public, clinicians, and employees at STLT health
departments. The purpose of this information collection is to document
and track clinical inquiries made to the CDC EOC call center and to
systematically collect standardized clinical/demographic/
epidemiological information about suspected cases. The emergency
clearance for this information collection dealt specifically with Zika-
related clinical inquiries. However, the new ICR will cover this
project for any EOC activation. Regardless of the disease or hazard
being responded to, the EOC operates this call center to answer and
respond to clinical inquiries. This information collection is a
necessary part of operating this call center and responding to
emergency situations.
2. A study, in Puerto Rico, on the persistence of Zika virus in
bodily fluids [OMB Control No. 0920-1106, expiration date 9/30/16].
Since getting OMB approval in March 2016, CDC has
[[Page 26233]]
investigated the persistence of Zika virus in different body fluids
(shedding) and its relation to immune response to provide a basis for
development of non-blood-based diagnostic tools, and target and refine
public health interventions to arrest ongoing spread of infection. CDC
has begun a prospective cohort study of symptomatic individuals with
reverse transcription-polymerase chain reaction (RT-PCR) positive Zika
virus infection and a cross-sectional study of their household
contacts. Information collection is expected to conclude within one
year. Results and analyses will be used to update relevant counseling
messages and recommendations from the CDC. Participants for the
shedding study are patients with laboratory-confirmed Zika virus
infection and their household contacts.
3. A study, carried out in the United States, on the persistence of
Zika virus in the semen and urine of men with laboratory-confirmed Zika
virus infection [OMB Control No. 0920-1109, expiration date 9/30/2016].
Since getting emergency OMB approval in March, 2016, specimens have
been tested for Zika RNA by reverse transcriptase polymerase chain
reaction assay (RT-PCR) at CDC; those testing positive may be further
evaluated by virus isolation techniques. Zika virus disease is a
nationally notifiable condition, and participants are recruited through
contact with CDC personnel. Urine and semen specimens are self-
collected using home collection kits, a short questionnaire is self-
administered, and participants receive a token of appreciation. Results
of testing will be provided to participants at the conclusion of
testing. The results of this study are expected to have immediate
implications for public health recommendations and disease prevention.
The results of this study will be of great relevance to provide
evidence-based information to circumvent Zika virus transmission. They
will inform the development of recommendations used in the current
epidemic setting, as well as in future Zika virus situations. Results
and analysis will be used to update and refine relevant counseling
messages and recommendations.
4. Registry of pregnant women with laboratory-confirmed Zika virus
infections in the U.S. [OMB Control No. 0920-1101, expiration date 8/
31/16]. As part of the public health response to the Zika virus disease
outbreak, CDC has been collecting information from clinicians in the
U.S. about pregnant women they treat who are diagnosed with Zika virus
infection. CDC also plans to collect information from clinicians about
their patients' infants in order to better understand the clinical
consequences of Zika virus infection in pregnancy and its impact on
newborn infants. Information gathered directs public health messages
provided by CDC on reducing the risk of adverse outcomes for pregnant
women and their infants.
These information collections will align with their legislative
authority, Section 301 of the Public Health Service Act (42 U.S.C.
241).
There are no costs to the respondents other than their time. The
total annualized burden requested is 1,146 hours. This number
represents the number of burden hours yet to be imposed. It does not
include the burden hours sustained during the initial six-month
emergency clearance period.
Estimated Annualized Burden Hours
1--Clinical Inquiries Database
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
Local health departments...... Clinical 420 1 15/60 105
inquiries
database.
Clinicians and other providers Clinical 800 1 15/60 200
inquiries
database.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 305
----------------------------------------------------------------------------------------------------------------
2--Persistence of Zika Virus in Bodily Fluids Study, Puerto Rico
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
Public health personnel........ Questionnaire 200 8 10/60 267
(Symptomatics).
Questionnaire 600 1 10/60 100
(Cross-Sectional
household
contacts).
General public................. Eligibility Form. 1,000 1 2/60 33
-------------------------------------------------------------
Total...................... ................. .............. .............. .............. 400
----------------------------------------------------------------------------------------------------------------
3--Persistence of Zika Virus in Bodily Fluids Study, United States
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
General public................. Introductory 175 1 2/60 6
survey.
Follow-Up survey. 175 12 1/60 35
-------------------------------------------------------------
Total...................... ................. .............. .............. .............. 41
----------------------------------------------------------------------------------------------------------------
[[Page 26234]]
4--Pregnancy Registry
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
State and Local Health Maternal Health 100 5 30/60 250
Departments. History Form.
Specimen 100 1 15/60 25
Collection Form.
Clinicians and other providers. Assessment at 100 1 30/60 50
Delivery Form.
Infant Health 100 1 30/60 50
Follow-Up Form.
-------------------------------------------------------------
Total...................... ................. .............. .............. .............. 400
----------------------------------------------------------------------------------------------------------------
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. 2016-10113 Filed 4-29-16; 8:45 am]
BILLING CODE 4163-18-P