80 FR 40067 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 80, Issue 133 (July 13, 2015)

Page Range		40067-40069
FR Document		2015-17017

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.

Federal Register, Volume 80 Issue 133 (Monday, July 13, 2015)

[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Notices]
[Pages 40067-40069]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-17017]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

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

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 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 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: omb@cdc.gov.

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

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

[[Page 40068]]

from HIV diagnosis, to AIDS, the end-stage 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
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 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 de-identified 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.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total annual
respondents respondent (in hours) burden hours)
----------------------------------------------------------------------------------------------------------------
Health Departments............ Adult HIV Case 59 1,061 20/60 20,866
Report.
Health Departments............ Pediatric HIV 59 5 20/60 98
Case Report.
Health Departments............ Case Report 59 107 20/60 2,104
Evaluations.
Health Departments............ Case Report 59 1,576 5/60 7,749
Updates.
Health Departments............ Laboratory 59 6,303 1/60 6,198
Updates.
Health Departments............ HIV Incidence 25 2,288 10/60 9,533
Surveillance.
Health Departments............ Molecular HIV 53 829 5/60 3,661
Surveillance
(MHS).
Health Departments............ Perinatal HIV 35 114 30/60 1,995
Exposure
Reporting
(PHER).
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 52,204
----------------------------------------------------------------------------------------------------------------

[[Page 40069]]

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]
BILLING CODE 4163-18-P

40068 Federal Register / Vol. 80, No. 133 / Monday, July 13, 2015 / Notices

from HIV diagnosis, to AIDS, the end- Surveillance definition were approved health departments on a subset of case
stage disease caused by infection with in the last renewal of this information reports (e.g. re-abstraction, validation,
HIV, and death. In addition, this collection. The updates requested in de-duplication). CDC estimates that on
national system provides essential data this revision request include average approximately 107 evaluations
to estimate HIV incidence and monitor modifications to currently collected data of case reports, 1,576 updates to case
patterns in HIV drug resistance and elements and forms to accommodate reports and 6,303 updates of laboratory
genetic diversity, as well as provide new testing technologies as well as test data will be processed by each of
information on perinatal exposures in clinical practice guidelines. the 59 health departments annually.
the United States. Specifically, the HIV Testing and Case report information compiled over
The CDC surveillance case definition Antiretroviral Use History section will time by health departments is then de-
has been modified periodically to be revised on the adult/adolescent and identified and forwarded to CDC on a
accurately monitor disease in adults, pediatric case report forms to include monthly basis to become part of the
adolescents and children and reflect use new laboratory tests, additional national HIV surveillance database.
of new testing technologies and changes information on use of antiretrioviral Supplemental surveillance data are
in HIV treatment. Information is then (ARV) medications for pre-exposure collected in a subset of areas to provide
updated in the case report forms and prophylaxis (PrEP), post-exposure additional information necessary to
reporting software as needed. prophylaxis (PEP), prevention of estimate HIV incidence, the extent of
In 2014, following extensive mother-to-child-transmission among HIV drug resistance and HIV genetic
consultation and peer review, CDC and HIV infected women during pregnancy, diversity among persons infected with
the Council of State and Territorial and hepatitis B virus (HBV) treatment. HIV and to monitor and evaluate
Epidemiologists (CSTE) revised and Other changes include addition of dates perinatal HIV prevention efforts. Health
combined the surveillance case to the address and patient identification departments funded for these
definitions for human fields to better track residence supplemental data collections obtain
immunodeficiency virus (HIV) infection information and minor formatting this information from laboratories,
into a single case definition for persons changes to the form used for Perinatal
of all ages. Laboratory criteria for health providers, and medical records.
HIV Exposure Reporting (PHER). CDC estimates that on average 2,288
defining a confirmed case now
accommodate new multitest algorithms, CDC provides funding for 59 reports containing incidence data
including criteria for differentiating jurisdictions to provide adult and elements will be processed annually by
between HIV–1 and HIV–2 infection and pediatric HIV case reports. Health each of the 25 health departments
for recognizing early HIV infection. department staff compile information funded to collect incidence data; 829
Clinical (nonlaboratory) criteria for from laboratories, physicians, hospitals, reports containing additional data
defining a case for surveillance clinics and other health care providers elements on HIV nucleotide sequences
purposes have been made more to complete the HIV and pediatric case from genotype test results will be
practical by eliminating the requirement reports. CDC estimates that, annually, processed on average by each of the 53
for information about laboratory tests. approximately 1,061 adult HIV case health departments conducting
The surveillance case definition is reports and 5 pediatric case reports are Molecular HIV Surveillance (MHS) and
intended primarily for monitoring the processed by each health department. an estimated 114 reports containing
HIV infection burden and planning for These data are recorded using perinatal exposure data elements will be
prevention and care on a population standard case report forms either on processed on average annually by each
level, not as a basis for clinical paper or electronically and entered into of the 35 health departments reporting
decisions for individual patients. CDC the electronic reporting system. Updates data collected as part of Perinatal HIV
and CSTE recommend that all states and to case reports are also entered into the Exposure Reporting (PHER). These
territories conduct case surveillance of reporting system by health departments supplemental data are also reported
HIV infection using this revised as additional information may be monthly to CDC.
surveillance case definition. received from laboratories, vital The total estimated time burden is
Modifications to data elements to statistics, or additional providers. 52,204 hours. There is no cost to
accommodate the 2014 HIV Case Evaluations are also conducted by respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average bur-
Number of re-
Number of re- den per re- Total annual
Type of respondent Form name sponses per
spondents sponse (in burden hours)
respondent hours)

Health Departments .......................... Adult HIV Case Report .................... 59 1,061 20/60 20,866
Health Departments .......................... Pediatric HIV Case Report ............... 59 5 20/60 98
Health Departments .......................... Case Report Evaluations ................. 59 107 20/60 2,104
Health Departments .......................... Case Report Updates ...................... 59 1,576 5/60 7,749
Health Departments .......................... Laboratory Updates .......................... 59 6,303 1/60 6,198
Health Departments .......................... HIV Incidence Surveillance .............. 25 2,288 10/60 9,533
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Health Departments .......................... Molecular HIV Surveillance (MHS) .. 53 829 5/60 3,661
Health Departments .......................... Perinatal HIV Exposure Reporting 35 114 30/60 1,995
(PHER).

Total ........................................... ........................................................... ........................ ........................ ........................ 52,204

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Federal Register / Vol. 80, No. 133 / Monday, July 13, 2015 / Notices 40069

Leroy A. Richardson, To obtain copies of a supporting (LMS). Upon completion of their
Chief, Information Collection Review Office, statement and any related forms for the applications and training requirements,
Office of Scientific Integrity, Office of the proposed collection(s) summarized in agents/brokers will be required to attest
Associate Director for Science, Office of the this notice, you may make your request to their agreement to adhere to FFM
Director, Centers for Disease Control and using one of following: standards and requirements through a
Prevention. 1. Access CMS’ Web site address at CMS or third-party LMS. Form Number:
[FR Doc. 2015–17017 Filed 7–10–15; 8:45 am] http://www.cms.hhs.gov/ CMS–10464 (OMB control number:
BILLING CODE 4163–18–P PaperworkReductionActof1995. 0938–1204); Frequency: Annually;
2. Email your request, including your Affected Public: Private sector (Business
address, phone number, OMB number, or other for-profits and Not-for-profit
DEPARTMENT OF HEALTH AND and CMS document identifier, to institutions); Number of Respondents:
HUMAN SERVICES Paperwork@cms.hhs.gov. 19,474; Total Annual Responses:
3. Call the Reports Clearance Office at 32,929,239; Total Annual Hours:
Centers for Medicare & Medicaid (410) 786–1326.
Services 2,786,198. (For policy questions
FOR FURTHER INFORMATION CONTACT: regarding this collection contact Daniel
[Document Identifier: CMS–10464] Reports Clearance Office at (410) 786– Brown at 301–492–5146.)
1326.
Agency Information Collection Dated: July 8, 2015.
SUPPLEMENTARY INFORMATION: Under the
Activities: Submission for OMB William N. Parham, III,
Review; Comment Request Paperwork Reduction Act of 1995 (PRA)
Director, Paperwork Reduction Staff, Office
(44 U.S.C. 3501–3520), federal agencies of Strategic Operations and Regulatory
ACTION: Notice. must obtain approval from the Office of Affairs.
Management and Budget (OMB) for each [FR Doc. 2015–17037 Filed 7–10–15; 8:45 am]
SUMMARY: The Centers for Medicare & collection of information they conduct
Medicaid Services (CMS) is announcing or sponsor. The term ‘‘collection of BILLING CODE 4120–01–P

an opportunity for the public to information’’ is defined in 44 U.S.C.
comment on CMS’ intention to collect 3502(3) and 5 CFR 1320.3(c) and
information from the public. Under the DEPARTMENT OF HEALTH AND
includes agency requests or HUMAN SERVICES
Paperwork Reduction Act of 1995 requirements that members of the public
(PRA), federal agencies are required to submit reports, keep records, or provide Administration for Children and
publish notice in the Federal Register information to a third party. Section Families
concerning each proposed collection of 3506(c)(2)(A) of the PRA (44 U.S.C.
information, including each proposed 3506(c)(2)(A)) requires federal agencies Submission for OMB Review;
extension or reinstatement of an existing to publish a 30-day notice in the Comment Request
collection of information, and to allow Federal Register concerning each
a second opportunity for public proposed collection of information, Title: LIHEAP Quarterly Allocation
comment on the notice. Interested including each proposed extension or Estimates, Form ACF–535.
persons are invited to send comments reinstatement of an existing collection
regarding the burden estimate or any OMB No.: 0970–0037.
of information, before submitting the
other aspect of this collection of collection to OMB for approval. To Description: The LIHEAP Quarterly
information, including any of the comply with this requirement, CMS is Allocation Estimates, ACF Form-535 is
following subjects: (1) The necessity and publishing this notice that summarizes a one-page form that is sent to 50 State
utility of the proposed information the following proposed collection(s) of grantees and to the District of Columbia.
collection for the proper performance of information for public comment: It is also sent to Tribal Government
the agency’s functions; (2) the accuracy 1. Type of Information Collection grantees that receive over $1 million
of the estimated burden; (3) ways to Request: Revision of a currently annually for the Low Income Home
enhance the quality, utility, and clarity approved information collection; Title Energy Assistance Program (LIHEAP).
of the information to be collected; and of Information Collection: Agent/Broker Grantees are asked to complete and
(4) the use of automated collection Data Collection in Federally-Facilitated submit the form in the 4th quarter of
techniques or other forms of information Health Insurance Exchanges; Use: The each year. The data collected on the
technology to minimize the information CMS collects personally identifiable form are grantees’ estimates of
collection burden. information from agents/brokers to obligations they expect to make each
DATES: Comments on the collection(s) of register them with the FFM and permit quarter for the upcoming fiscal year for
information must be received by the them to assist individuals and the LIHEAP program. This is the only
OMB desk officer by August 12, 2015. employers in enrolling in the FFM. We method used to request anticipated
ADDRESSES: When commenting on the use this collection of information to distributions of the grantees’ LIHEAP
proposed information collections, ensure agents/brokers possess the basic funds. The information is used to
please reference the document identifier knowledge required to enroll develop apportionment requests to OMB
or OMB control number. To be assured individuals and SHOP employers/ and to make grant awards based on
consideration, comments and employees through the Marketplaces. grantees’ anticipated needs. Information
recommendations must be received by Agents/brokers will use CMS or third- collected on this form is not available
asabaliauskas on DSK5VPTVN1PROD with NOTICES

the OMB desk officer via one of the party systems to enter identifying through any other Federal source.
following transmissions: OMB, Office of information and register with the FFM. Submission of the form is voluntary.
Information and Regulatory Affairs, As a component of registration, agents/ Respondents: State Governments, and
Attention: CMS Desk Officer, Fax brokers are required to complete online Tribal Governments that receive over $1
Number: (202) 395–5806 or Email: training courses through a CMS or third- million annually, and the District of
OIRA_submission@omb.eop.gov. party Learning Management System Columbia.

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Document Created: 2018-02-23 09:17:33
Document Modified: 2018-02-23 09:17:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before September 11, 2015.
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]
FR Citation		80 FR 40067

80 FR 40067 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 133 (July 13, 2015)

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