60 Day FRN - published

National HIV Surveillance System (NHSS)

Attachment 2.
60 Day Federal Register Notice

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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents

Form name

Neurologist ......................................................

Key Informant Interview .................................

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. 2015–17011 Filed 7–10–15; 8:45 am]
BILLING CODE 4163–18–P

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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[60Day–15–0920–0573; Docket No. CDC–
2015–0054]

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 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 a proposed revisions of the
National HIV Surveillance System
(NHSS) information collection. This
data collection provides the primary
population-based data used to describe
the epidemiology of HIV in the United
States.
DATES: Written comments must be
received on or before September 11,
2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0054 by any of the following methods:
• 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

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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
FOR FURTHER INFORMATION CONTACT:

Centers for Disease Control and
Prevention

SUMMARY:

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.

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Number of respondents

Number of responses per
respondent

16

1

Avg. burden
per response
(in hrs.)
1

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
National HIV Surveillance System
(NHSS) (OMB Control No. 0920–0573,
Expiration 02/29/2016)—Revision—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
CDC is authorized under Sections 304
and 306 of the Public Health Service Act
(42 U.S.C. 242b and 242k) to collect
information on cases of human
immunodeficiency virus (HIV) and
indicators of HIV disease and HIV
disease progression including AIDS.
Data collected as part of the National
HIV Surveillance System (NHSS) are the
primary data used to monitor the extent
and characteristics of the HIV burden in
the United States. HIV surveillance data
are used to describe trends in HIV
incidence and prevalence and
characteristics of infected persons. HIV
surveillance data are used widely at the
federal, state, and local levels for
planning and evaluating prevention
programs and health-care services, and
allocate funding for prevention and
care.
As science, technology, and our
understanding of HIV have evolved, the
NHSS has been updated periodically.
CDC, in collaboration with health
departments in the 50 states, the District
of Columbia, and U.S. dependent areas,
conducts national surveillance for cases
of HIV infection that includes critical
data across the spectrum of HIV disease

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Federal Register / Vol. 80, No. 133 / Monday, July 13, 2015 / Notices

from HIV diagnosis, to AIDS, the endstage disease caused by infection with
HIV, and death. In addition, this
national system provides essential data
to estimate HIV incidence and monitor
patterns in HIV drug resistance and
genetic diversity, as well as provide
information on perinatal exposures in
the United States.
The CDC surveillance case definition
has been modified periodically to
accurately monitor disease in adults,
adolescents and children and reflect use
of new testing technologies and changes
in HIV treatment. Information is then
updated in the case report forms and
reporting software as needed.
In 2014, following extensive
consultation and peer review, CDC and
the Council of State and Territorial
Epidemiologists (CSTE) revised and
combined the surveillance case
definitions for human
immunodeficiency virus (HIV) infection
into a single case definition for persons
of all ages. Laboratory criteria for
defining a confirmed case now
accommodate new multitest algorithms,
including criteria for differentiating
between HIV–1 and HIV–2 infection and
for recognizing early HIV infection.
Clinical (nonlaboratory) criteria for
defining a case for surveillance
purposes have been made more
practical by eliminating the requirement
for information about laboratory tests.
The surveillance case definition is
intended primarily for monitoring the
HIV infection burden and planning for
prevention and care on a population
level, not as a basis for clinical
decisions for individual patients. CDC
and CSTE recommend that all states and
territories conduct case surveillance of
HIV infection using this revised
surveillance case definition.
Modifications to data elements to
accommodate the 2014 HIV Case

health departments on a subset of case
reports (e.g. re-abstraction, validation,
de-duplication). CDC estimates that on
average approximately 107 evaluations
of case reports, 1,576 updates to case
reports and 6,303 updates of laboratory
test data will be processed by each of
the 59 health departments annually.
Case report information compiled over
time by health departments is then deidentified and forwarded to CDC on a
monthly basis to become part of the
national HIV surveillance database.
Supplemental surveillance data are
collected in a subset of areas to provide
additional information necessary to
estimate HIV incidence, the extent of
HIV drug resistance and HIV genetic
diversity among persons infected with
HIV and to monitor and evaluate
perinatal HIV prevention efforts. Health
departments funded for these
supplemental data collections obtain
this information from laboratories,
health providers, and medical records.
CDC estimates that on average 2,288
reports containing incidence data
elements will be processed annually by
each of the 25 health departments
funded to collect incidence data; 829
reports containing additional data
elements on HIV nucleotide sequences
from genotype test results will be
processed on average by each of the 53
health departments conducting
Molecular HIV Surveillance (MHS) and
an estimated 114 reports containing
perinatal exposure data elements will be
processed on average annually by each
of the 35 health departments reporting
data collected as part of Perinatal HIV
Exposure Reporting (PHER). These
supplemental data are also reported
monthly to CDC.
The total estimated time burden is
52,204 hours. There is no cost to
respondents other than their time.

Surveillance definition were approved
in the last renewal of this information
collection. The updates requested in
this revision request include
modifications to currently collected data
elements and forms to accommodate
new testing technologies as well as
clinical practice guidelines.
Specifically, the HIV Testing and
Antiretroviral Use History section will
be revised on the adult/adolescent and
pediatric case report forms to include
new laboratory tests, additional
information on use of antiretrioviral
(ARV) medications for pre-exposure
prophylaxis (PrEP), post-exposure
prophylaxis (PEP), prevention of
mother-to-child-transmission among
HIV infected women during pregnancy,
and hepatitis B virus (HBV) treatment.
Other changes include addition of dates
to the address and patient identification
fields to better track residence
information and minor formatting
changes to the form used for Perinatal
HIV Exposure Reporting (PHER).
CDC provides funding for 59
jurisdictions to provide adult and
pediatric HIV case reports. Health
department staff compile information
from laboratories, physicians, hospitals,
clinics and other health care providers
to complete the HIV and pediatric case
reports. CDC estimates that, annually,
approximately 1,061 adult HIV case
reports and 5 pediatric case reports are
processed by each health department.
These data are recorded using
standard case report forms either on
paper or electronically and entered into
the electronic reporting system. Updates
to case reports are also entered into the
reporting system by health departments
as additional information may be
received from laboratories, vital
statistics, or additional providers.
Evaluations are also conducted by

ESTIMATED ANNUALIZED BURDEN HOURS

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Type of respondent

Health
Health
Health
Health
Health
Health
Health
Health

Departments
Departments
Departments
Departments
Departments
Departments
Departments
Departments

Form name

Number of respondents

Number of responses per
respondent

Average burden per response (in
hours)

Total annual
burden hours)

..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................

Adult HIV Case Report ....................
Pediatric HIV Case Report ...............
Case Report Evaluations .................
Case Report Updates ......................
Laboratory Updates ..........................
HIV Incidence Surveillance ..............
Molecular HIV Surveillance (MHS) ..
Perinatal HIV Exposure Reporting
(PHER).

59
59
59
59
59
25
53
35

1,061
5
107
1,576
6,303
2,288
829
114

20/60
20/60
20/60
5/60
1/60
10/60
5/60
30/60

20,866
98
2,104
7,749
6,198
9,533
3,661
1,995

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

...........................................................

........................

........................

........................

52,204

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Federal Register / Vol. 80, No. 133 / Monday, July 13, 2015 / Notices
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. 2015–17017 Filed 7–10–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10464]

Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:

Notice.

The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by August 12, 2015.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 or Email:
[email protected].

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To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
http://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
[email protected].
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
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. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved information collection; Title
of Information Collection: Agent/Broker
Data Collection in Federally-Facilitated
Health Insurance Exchanges; Use: The
CMS collects personally identifiable
information from agents/brokers to
register them with the FFM and permit
them to assist individuals and
employers in enrolling in the FFM. We
use this collection of information to
ensure agents/brokers possess the basic
knowledge required to enroll
individuals and SHOP employers/
employees through the Marketplaces.
Agents/brokers will use CMS or thirdparty systems to enter identifying
information and register with the FFM.
As a component of registration, agents/
brokers are required to complete online
training courses through a CMS or thirdparty Learning Management System

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40069

(LMS). Upon completion of their
applications and training requirements,
agents/brokers will be required to attest
to their agreement to adhere to FFM
standards and requirements through a
CMS or third-party LMS. Form Number:
CMS–10464 (OMB control number:
0938–1204); Frequency: Annually;
Affected Public: Private sector (Business
or other for-profits and Not-for-profit
institutions); Number of Respondents:
19,474; Total Annual Responses:
32,929,239; Total Annual Hours:
2,786,198. (For policy questions
regarding this collection contact Daniel
Brown at 301–492–5146.)
Dated: July 8, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–17037 Filed 7–10–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: LIHEAP Quarterly Allocation
Estimates, Form ACF–535.
OMB No.: 0970–0037.
Description: The LIHEAP Quarterly
Allocation Estimates, ACF Form-535 is
a one-page form that is sent to 50 State
grantees and to the District of Columbia.
It is also sent to Tribal Government
grantees that receive over $1 million
annually for the Low Income Home
Energy Assistance Program (LIHEAP).
Grantees are asked to complete and
submit the form in the 4th quarter of
each year. The data collected on the
form are grantees’ estimates of
obligations they expect to make each
quarter for the upcoming fiscal year for
the LIHEAP program. This is the only
method used to request anticipated
distributions of the grantees’ LIHEAP
funds. The information is used to
develop apportionment requests to OMB
and to make grant awards based on
grantees’ anticipated needs. Information
collected on this form is not available
through any other Federal source.
Submission of the form is voluntary.
Respondents: State Governments, and
Tribal Governments that receive over $1
million annually, and the District of
Columbia.

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