60 day FRN

Att. B - 60-day FRN.pdf

One Health Harmful Algal Bloom System (OHHABS)

60 day FRN

OMB: 0920-1105

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Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices

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inappropriate for public disclosure. If
you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be on
public display. CDC will review all
submissions and may choose (but is not
required) to redact, or withhold,
submissions containing private or
proprietary information such as Social
Security numbers, medical information,
inappropriate language, or duplicate/
near-duplicate examples of a mass-mail
campaign. CDC will carefully consider
all comments timely submitted in
preparation of the final guideline
Infection Control in Healthcare
Personnel: Infrastructure and Routine
Practices for Occupational Infection
Prevention and Control Services and
may revise the final document as
appropriate.
Background
The Draft Guideline, located in the
‘‘Supporting & Related Material’’ tab of
the docket, updates two sections from
the 1998 Guideline: C. Infection Control
Objectives for a Personnel Health
Service and D. Elements of a Personnel
Health Service for Infection Control.
Those sections described the
infrastructure and routine practices of
Occupational Health Services for
providing occupational infection
prevention and control services to
healthcare personnel.
Once finalized, the Draft Guideline is
intended for use by the leaders and staff
of Occupational Health Services and the
administrators and leaders of healthcare
organizations in order to facilitate the
provision of occupational infection
prevention and control services to
healthcare personnel.
Since 2015, the Healthcare Infection
Control Practices Advisory Committee
(HICPAC) has worked with national
partners, academicians, public health
professionals, healthcare providers, and
other partners to develop this Draft
Guideline as a recommendation for CDC
to update sections of the 1998
Guideline. HICPAC includes
representatives from public health,
infectious diseases, regulatory and other
federal agencies, professional societies,
and other stakeholders.
The draft recommendations in this
Draft Guideline are informed by a
systematic literature review of articles
published in peer-reviewed journals or
repositories of systematic reviews; and a
review of occupational infection
prevention and control guidelines,
regulations, and standards. This Draft
Guideline is not, and once finalized will
not be, a federal rule or regulation;
instead its purpose, as discussed above,

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will be to facilitate the provision of
occupational prevention and control
services to healthcare personnel.
Dated: October 10, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2018–22377 Filed 10–12–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–1105; Docket No. CDC–2018–
0098]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 One Health Harmful Algal Bloom
System (OHHABS). The OHHABS is a
voluntary reporting system available to
state and territorial public health
departments and their designated
environmental health or animal health
partners. It collects data on individual
human and animal cases of illnesses
from harmful algal bloom (HAB)associated exposures, as well as
environmental data about HABs.
DATES: CDC must receive written
comments on or before December 14,
2018.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2018–
0098 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. CDC will post, without

ADDRESSES:

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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.

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.
FOR FURTHER INFORMATION:

Proposed Project
One Health Harmful Algal Bloom
System (OHHABS)—Extension—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),

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Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Center for
Emerging and Zoonotic Infectious
Diseases requests a three-year extension
for the One Health Harmful Algal Bloom
System (OHHABS) for harmful algal
bloom (HAB) and HAB-associated
illness surveillance.
Algal toxins from Harmful Algal
Blooms (HABs) include some of the
most potent natural chemicals; these
toxins can contaminate surface water
used for recreation and drinking, as well
as food sources. HABs pose a threat to
both humans and animals. Human and
animal illnesses from environmental
exposures to HABs in fresh and marine
waters have been documented in the
United States. Animal illness may be an
indicator of bloom toxicity; thus, it is
necessary to provide a One Health
approach for reporting HAB-associated
illnesses and events. One Health is a
collaborative, multisectoral, and transdisciplinary approach with the goal of
achieving optimal health outcomes
recognizing the interconnection
between people, animals, plants, and
their shared environment.
HABs are an emerging public health
concern. Several outbreaks related to
HABs in freshwater settings have
occurred in the United States. In 2009–
2010, 11 HAB-associated outbreaks in
fresh water settings were reported to the
CDC Waterborne Disease and Outbreak
Surveillance System (WBDOSS). These
11 outbreaks represent 46% of the
outbreaks associated with untreated
recreational water reported in 2009–
2010 and 79% of HAB-associated
outbreaks reported to WBDOSS since
1978. At least 61 persons experienced

based reporting system, is nationally
available for state and territorial health
departments to voluntarily report
information about HAB-associated
human and animal cases and HAB
events.
States and territories lacking a
database to collect information on HAB
events and HAB-associated illnesses
may use OHHABS as a repository to
track and review HAB events and HABassociated illnesses within their state or
territory. OHHABS data may help states
and territories characterize the baseline
frequency of HAB events and HABassociated illnesses. Data from states
and territories will be assessed by CDC
to determine and characterize HAB
events and HAB-associated illnesses
nationally.
As with all routine public health
surveillance conducted by CDC,
participation by states and territorial
health departments with OHHABS is
voluntary. Participating states and
territories will remain responsible for
the collection and interpretation of
these data elements at the state level
and will voluntarily submit them to
CDC. HAB event and HAB-associated
human and animal case definitions,
which were created for OHHABS with
input from state and federal partners,
are available online to assist states and
territories. States and territories that
lack state-specific case and event
definitions may use the HAB-associated
human and animal case and HAB event
definitions to identify suspect, probable,
and confirmed HAB-associated cases
and HAB events, respectively, to report
to OHHABS.
There is no cost to respondents other
than the time to participate. Authorizing
legislation comes from Section 301 of
the Public Health Service Act (42 U.S.C.
241).

health effects such as dermatologic,
gastrointestinal, respiratory, or
neurologic symptoms. In August 2014,
detectable levels of microcystin, a
potent HAB toxin, were detected in the
drinking water supply in Toledo, Ohio,
resulting in a ‘‘do not drink’’ water
advisory and an extensive emergency
response.
Known adverse health effects from
HABs in marine waters include
respiratory illness and seafood
poisoning. In 2007, 15 persons were
affected with respiratory illness from
exposures to brevetoxins, an algal toxin,
during a Florida red tide. From 2007–
2011, HAB-associated foodborne
exposures were identified for 273 case
reports of human illness through a
separate five year data collection effort
with a subset of states. Of these reports,
248 reported ciguatera fish poisoning or
poisoning by other toxins in seafood,
including saxitoxin and brevetoxin. A
review of national outbreak data
reported to CDC for the time period
1998–2015 identified outbreaks of
ciguatera fish poisoning as the second
most common cause of fish-associated
foodborne disease outbreaks in the
United States.
The purpose of OHHABS is (1) to
provide a database for routine data
collection at the state/territorial and
national level to identify and
characterize HAB events, HABassociated illnesses, and HAB exposures
in the United States, and (2) to better
inform and improve our understanding
of HAB-associated illnesses and
exposures through routine surveillance
to inform public health policy and
illness prevention efforts. OHHABS
(electronic, year-round collection)
includes questions about HAB events
and HAB-associated-illness for human
and animal cases. OHHABS, a web-

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Type of respondents

Form name

State/territorial epidemiologists .........

One Health Harmful Algal Bloom
System (OHHABS).

57

3

20/60

57

Total ...........................................

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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.

and Enrollment Group, Center for
Consumer Information and Insurance
Oversight, CMS, 7501 Wisconsin Ave.
Bethesda, MD 20814, (410) 786–0639, or
by email at [email protected].
SUPPLEMENTARY INFORMATION: The
[FR Doc. 2018–22358 Filed 10–12–18; 8:45 am]
Privacy Act of 1974, as amended (5
BILLING CODE 4163–18–P
U.S.C. 552a) provides certain
protections for individuals applying for
and receiving federal benefits. The law
DEPARTMENT OF HEALTH AND
governs the use of computer matching
HUMAN SERVICES
by federal agencies when records in a
system of records (meaning, federal
Centers for Medicare & Medicaid
agency records about individuals
Services
retrieved by name or other personal
Privacy Act of 1974; Matching Program identifier) are matched with records of
other federal or non-federal agencies.
AGENCY: Centers for Medicare &
The Privacy Act requires agencies
Medicaid Services (CMS), Department
involved in a matching program to:
of Health and Human Services (HHS).
1. Enter into a written agreement,
ACTION: Notice of a new matching
which must be prepared in accordance
program.
with the Privacy Act, approved by the
Data Integrity Board of each source and
SUMMARY: In accordance with subsection
recipient federal agency, provided to
(e)(12) of the Privacy Act of 1974, as
Congress and the Office of Management
amended, the Department of Health and
and Budget (OMB), and made available
Human Services (HHS), Centers for
to the public, as required by 5 U.S.C.
Medicare & Medicaid Services (CMS) is
552a(o), (u)(3)(A), and (u)(4).
providing notice of a re-established
2. Notify the individuals whose
matching program between CMS and
information will be used in the
each State Based Administering Entity
matching program that the information
(AE), titled ‘‘Determining Eligibility for
they provide is subject to verification
Enrollment in Applicable State Health
through matching, as required by 5
Subsidy Programs Under the Patient
U.S.C. 552a(o)(1)(D).
Protection and Affordable Care Act.’’
3. Verify match findings before
DATES: The deadline for comments on
suspending, terminating, reducing, or
this notice is November 14, 2018. The
making a final denial of an individual’s
re-established matching program will
benefits or payments or taking other
commence not sooner than 30 days after adverse action against the individual, as
publication of this notice, provided no
required by 5 U.S.C. 552a(p).
comments are received that warrant a
4. Report the matching program to
change to this notice. The matching
Congress and the OMB, in advance and
program will be conducted for an initial annually, as required by 5 U.S.C.
term of 18 months (from approximately
552a(o)(2)(A)(i), (r), and (u)(3)(D).
October 2018 to April 2020) and within
5. Publish advance notice of the
3 months of expiration may be renewed matching program in the Federal
for one additional year if the parties
Register as required by 5 U.S.C.
make no changes to the matching
552a(e)(12).
program and certify that the program
This matching program meets these
has been conducted in compliance with requirements.
the matching agreement.
Walter Stone,
ADDRESSES: Written comments can be
CMS Privacy Act Officer, Information Security
sent to: CMS Privacy Act Officer,
and Privacy Group, and Office of Information
Division of Security, Privacy Policy &
Technology, Centers for Medicare & Medicaid
Governance, Information Security &
Service.
Privacy Group, Office of Information
Participating Agencies
Technology, CMS, 7500 Security Blvd.,
Baltimore, MD 21244–1870, Mailstop:
Department of Health and Human
N3–15–25, or by email to: walter.stone@ Services (HHS), Centers for Medicare &
cms.hhs.gov. Comments received will be Medicaid Services (CMS), and the AE in
available for review at this location, by
each state. Each is both a source and a
appointment, during regular business
recipient agency as explained in the
hours, Monday through Friday from
Purpose(s) section below.
9:00 a.m. to 3:00 p.m.
AEs administer insurance
affordability programs, and include
FOR FURTHER INFORMATION CONTACT: If
Medicaid/Children’s Health Insurance
you have questions about the matching
Program (CHIP) agencies, state-based
program, you may contact Jack Lavelle,
exchanges (SBEs), and basic health
Senior Advisor, Marketplace Eligibility

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programs (BHPs). In states that operate
a SBE, the AE would include the
Medicaid/CHIP agency. Additionally,
there are two states—Minnesota and
New York—where the AE operates both
a SBE and BHP. In states that have
elected to utilize the federally-facilitated
exchange (FFE), the AE would include
only the Medicaid/CHIP agency.
Authority for Conducting the Matching
Program
The statutory authority for the
matching program is 42 U.S.C. 18001, et
seq.
Purpose(s)
The matching program will enable
CMS to provide information (including
information CMS receives from other
federal agencies under related matching
agreements) to AEs, to assist AEs in
verifying applicant information as
required by the Affordable Care Act to
determine applicants’ eligibility for
enrollment in applicable state health
subsidy programs, including exemption
from the requirement to maintain
minimum essential coverage (MEC) or
from the individual responsibility
payment. In addition, to avoid dual
enrollment, information will be shared
between CMS and AEs, and among AEs,
for the purpose of verifying whether
applicants and enrollees are currently
eligible for or enrolled in a Medicaid/
CHIP program. All information will be
shared through a data services hub
(Hub) established by CMS to support the
federally-facilitated health insurance
exchange (which CMS operates) and
state-based exchanges.
Categories of Individuals
The individuals whose information
will be used in the matching program
are consumers who apply for eligibility
to enroll in applicable state health
subsidy programs through an exchange
established under ACA and other
relevant individuals (such as,
applicants’ household members).
Categories of Records
The categories of records that will be
used in the matching program are
identifying records; minimum essential
coverage period records; return
information (household income and
family size information); citizenship
status records; birth and death
information; disability coverage and
income information; and imprisonment
status records.
The data elements CMS will receive
from AEs may include:
1. Social security number (if
applicable).
2. last name.

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