Agency Forms Undergoing Paperwork Reduction Act Review, 7800-7802 [2016-03046]
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Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
the PSO’s listing expires. Section
3.108(d) of the Patient Safety Rule
requires AHRQ to provide public notice
when it removes an organization from
the list of federally approved PSOs.
AHRQ has accepted a notification
from Verge Patient Safety Organization,
a component entity of Verge Solutions,
LLC, PSO number P0118, to voluntarily
relinquish its status as a PSO.
Accordingly, Verge Patient Safety
Organization was delisted effective at
12:00 Midnight ET (2400) on February
2, 2016.
Verge Patient Safety Organization has
patient safety work product (PSWP) in
its possession. The PSO will meet the
requirements of section 3.108(c)(2)(i) of
the Patient Safety Rule regarding
notification to providers that have
reported to the PSO. In addition,
according to sections 3.108(c)(2)(ii) and
3.108(b)(3) of the Patient Safety Rule
regarding disposition of PSWP, the PSO
has 90 days from the effective date of
delisting and revocation to complete the
disposition of PSWP that is currently in
the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.pso.ahrq.gov/.
Sharon B. Arnold,
AHRQ Deputy Director.
[FR Doc. 2016–03034 Filed 2–12–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0049]
Notice of Availability of the Final
Environmental Assessment and a
Finding of No Significant Impact for
HHS/CDC Lawrenceville Campus
Proposed Improvements 2015–2025,
Lawrenceville, Georgia
Centers for Disease Control and
Prevention, Department of Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS), is issuing this notice to
advise the public that HHS/CDC has
prepared and signed on February 9,
2016 a Finding of No Significant Impact
(FONSI) based on the Final
Environmental Assessment (Final EA)
for the HHS/CDC Lawrenceville Campus
Proposed Improvements 2015–2025 on
the HHS/CDC Lawrenceville Campus,
Lawrenceville, Georgia. The Final EA
has been prepared in accordance with
the National Environmental Policy Act
of 1969 (NEPA), as amended (42 U.S.C.
4321 et seq.), the Council on
Environmental Quality (CEQ)
implementing regulations (40 CFR
1500–1508) and the HHS General
Administration Manual (GAM) Part 30
Environmental Procedures, dated
February 25, 2000.
DATES: The FONSI and Final EA are
available as February 16, 2016.
FOR FURTHER INFORMATION CONTACT:
Copies of the FONSI and/or the Final
EA or additional information may be
obtained by contacting Angela Wagner,
Portfolio Manager, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE., MS–K96, Atlanta, GA 30329.
Telephone: (770) 488–8170.
SUPPLEMENTARY INFORMATION: The
Centers for Disease Control and
Prevention (CDC) within the U.S.
Department of Health and Human
Services (HHS), has prepared an
Environmental Assessment (EA), to
assess the potential impacts associated
with the undertaking of proposed
improvements on the HHS/CDC’s
Lawrenceville Campus located at 602
Webb Gin House Road in Lawrenceville,
Georgia. The proposed improvements
include: (1) Building demolition; (2)
new building construction, including an
approximately 12,000 gross square feet
(gsf) Science Support Building, a new
SUMMARY:
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Transshipping and Receiving Area at
approximately 2,500 gsf and two new
small Office Support Buildings at 8,000
gsf and 6,000 gsf; (3) expansion and
relocation of parking on campus; and (4)
the creation of an additional point of
access to the campus. The proposed
improvements would be undertaken
between the time period of 2015 and
2025 and are contingent on receipt of
funding. The proposed improvements
are needed to maintain an appropriate
facilities quality level on the
Lawrenceville Campus.
On August 14, 2015, HHS/CDC
published a notice in the Federal
Register (80 FR 48863) announcing the
availability of a Draft EA and requesting
public comment. The comment period
ended on September 28, 2015. No
substantive comments were received
that raised specific issues or concerns
with the methodology, analysis,
conclusion or accurateness of the EA.
Based on the analysis of
environmental impacts in the EA and in
accordance with NEPA, HHS/CDC has
determined that the proposed action
will not significantly affect the human
or natural environment and therefore
does not require the preparation of an
environmental impact statement.
Dated: February 10, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2016–03059 Filed 2–12–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–0573]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
E:\FR\FM\16FEN1.SGM
16FEN1
Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) 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 submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
mstockstill on DSK4VPTVN1PROD with NOTICES
Proposed Project
National HIV Surveillance System
(NHSS) (OMB Control No. 0920–0573,
Expires 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
Data collected as part of the National
HIV Surveillance System (NHSS) are the
primary data used to monitor the impact
of HIV infection in the United States.
The NHSS provides critical data that are
used to describe the incidence and
prevalence of HIV disease and the
characteristics of infected persons. HIV
surveillance data are used widely at the
local, state and national levels for
planning, evaluation and allocation of
funding for HIV prevention and care
programs.
The NHSS has been updated
periodically as science, technology, and
our understanding of HIV has evolved.
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
from HIV diagnosis, to stage 3 (AIDS),
the end-stage disease caused by
VerDate Sep<11>2014
22:15 Feb 12, 2016
Jkt 238001
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 multi-test
algorithms, including criteria for
differentiating between HIV–1 and HIV–
2 infection and for recognizing early
HIV infection. Clinical (non-laboratory)
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 OMB Control No.
0920–0573. The revisions requested in
this extension 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 ID fields to
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7801
better track residence information and
minor formatting changes to the form
used for Perinatal HIV Exposure
Reporting (PHER).
The revisions to this request also
include the addition of burden hours for
annual reporting by health departments
for the Standards Evaluation Report
(SER) and Annual Performance Report
(APR). Findings from these reports are
used to improve data quality and ensure
the accuracy, timeliness, and
completeness of the national HIV
surveillance, as well as to monitor
performance and progress in achieving
both state and national HIV surveillance
program objectives. Fifty-nine health
departments funded for HIV
surveillance will report a Standards
Evaluation Report (SER) and APR
annually.
CDC provides funding for 59 health
departments to conduct adult and
pediatric HIV case surveillance and
report information to CDC. Health
department staff compile information
from laboratories, physicians, hospitals,
clinics and other health care providers
to complete adult and adolescent and
pediatric HIV confidential case reports.
Updates to case reports are also entered
into an electronic database by health
departments, as additional information
may be received from laboratories, vital
statistics offices, or additional
providers. Evaluations are also
conducted by health departments on a
subset of case reports (e.g., reabstraction/validation activities and
routine interstate de-duplication) in all
jurisdictions.
Supplemental surveillance data are
collected in a subset of areas to provide
additional information necessary to
estimate HIV incidence, to better
describe the extent of HIV viral
resistance and quantify HIV subtypes
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 care providers, and
medical records. CDC estimates that 25
health departments will be reporting
data elements containing HIV Incidence
Surveillance (HIS) data, 53 health
departments will report additional data
elements on HIV nucleotide sequences
as part of Molecular HIV Surveillance
(MHS), and 35 areas will be reporting
data as part of 35 health departments
will be reporting data collected as part
of Perinatal HIV Exposure Reporting
(PHER) annually. The total estimated
annual burden hours are 50,504.
E:\FR\FM\16FEN1.SGM
16FEN1
7802
Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Health
Health
Health
Health
Health
Health
Health
Health
Health
Departments
Departments
Departments
Departments
Departments
Departments
Departments
Departments
Departments
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
Health Departments ......................................
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. 2016–03046 Filed 2–12–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Food and Drug Administration Clinical
Trial Requirements, Regulations,
Compliance, and Good Clinical
Practices; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Educational Conference Co-Sponsored
With the Society of Clinical Research
Associates (SOCRA).’’ The public
workshop on FDA’s clinical trial
requirements is designed to aid the
Clinical Research Professional’s
understanding of the mission,
responsibilities, and authority of FDA
and to facilitate interaction with FDA
representatives. The program will focus
on the relationships among FDA,
clinical trial staff, investigators, and
institutional review boards (IRBs).
Individual FDA representatives will
discuss the informed consent process
and informed consent documents;
regulations relating to drugs, devices,
and biologics; as well as inspections of
clinical investigators, of IRBs, and of
research sponsors.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:15 Feb 12, 2016
Number of
respondents
Form name
Jkt 238001
Adult HIV Case Report .................................
Pediatric HIV Case Report ...........................
Case Report Evaluations .............................
Case Report Updates ...................................
Laboratory Updates ......................................
HIV Incidence Surveillance (HIS) .................
Molecular HIV Surveillance (MHS) ..............
Perinatal HIV Exposure Reporting (PHER)
Annual Reporting: Standards Evaluation
Report (SER).
Annual Reporting: Annual Performance Report (APR).
The public workshop will be
held on March 9 and 10, 2016, from 8
a.m. to 5 p.m.
ADDRESSES: The public workshop will
be held at the Holiday Inn San Diego
Bayside, 4875 North Harbor Dr., San
Diego, CA 92106, 619–224–3621.
FOR FURTHER INFORMATION CONTACT: Jane
Kreis, Food and Drug Administration,
1301 Clay St., Suite 1180N, Oakland,
CA 94612, 510–287–2708, FAX: 510–
287–2739, or Society of Clinical
Research Associates (SOCRA), 530 West
Butler Ave., Suite 109, Chalfont, PA
18914, telephone: 800–762–7292 or
215–822–8644, FAX: 215–822–8633,
Office@socra.org, Web site:
www.socra.org. (FDA has verified the
Web site addresses throughout this
document, but we are not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
The public workshop helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
workshop will provide those engaged in
FDA-regulated (human) clinical trials
with information on a number of topics
concerning FDA requirements related to
informed consent, clinical investigation
requirements, IRB inspections,
electronic record requirements, and
investigator initiated research.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The workshop helps to achieve
objectives set forth in section 406 of the
FDA Modernization Act of 1997 (21
U.S.C. 393), which include working
closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
59
59
59
59
59
25
53
35
59
1,061
5
107
1,576
6,303
2,288
829
114
1
20/60
20/60
20/60
2/60
1/60
10/60
5/60
30/60
8
59
1
42
public. The workshop also is consistent
with the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub.
L. 104–121), as outreach activities by
Government Agencies to small
businesses.
II. Topics for Discussion at the Public
Workshop
Topics for discussion include the
following: (1) The Role of the FDA
District Office Relative to the
Bioresearch Monitoring Program
(BIMO); (2) Modernizing FDA’s Clinical
Trials/BIMO; (3) What FDA Expects in
a Pharmaceutical Clinical Trial; (4)
Medical Device Aspects of Clinical
Research; (5) Adverse Event Reporting—
Science, Regulation, Error, and Safety;
(6) Working With FDA’s Center for
Biologics Evaluation and Research; (7)
Ethical Issues in Subject Enrollment; (8)
Keeping Informed and Working
Together; (9) FDA Conduct of Clinical
Investigator Inspections; (10)
Investigator Initiated Research; (11)
Meetings With FDA—Why, When, and
How; (12) Part 11 Compliance—
Electronic Signatures; (13) IRB
Regulations and FDA Inspections; (14)
Informed Consent Regulations; (15) The
Inspection is Over—What Happens
Next? Possible FDA Compliance
Actions; and (16) Question and Answer
Session/Panel Discussion.
Registration: The registration fee will
cover actual expenses including
refreshments, lunch, materials, and
speaker expenses. Seats are limited;
please submit your registration as soon
as possible. Workshop space will be
filled in order of receipt of registration.
Those accepted into the workshop will
receive confirmation. The cost of the
registration is as follows: SOCRA
member—$575, SOCRA nonmember
(includes membership)—$650, Federal
Government member—$450, Federal
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7800-7802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03046]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-0573]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of
[[Page 7801]]
the functions of the agency, including whether the information will
have practical utility; (b) Evaluate the accuracy of the agencies
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (c)
Enhance the quality, utility, and clarity of the information to be
collected; (d) 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 submission of responses; and (e) Assess information
collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
National HIV Surveillance System (NHSS) (OMB Control No. 0920-0573,
Expires 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
Data collected as part of the National HIV Surveillance System
(NHSS) are the primary data used to monitor the impact of HIV infection
in the United States. The NHSS provides critical data that are used to
describe the incidence and prevalence of HIV disease and the
characteristics of infected persons. HIV surveillance data are used
widely at the local, state and national levels for planning, evaluation
and allocation of funding for HIV prevention and care programs.
The NHSS has been updated periodically as science, technology, and
our understanding of HIV has evolved. 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 from HIV diagnosis, to stage 3 (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 multi-test algorithms, including criteria for differentiating
between HIV-1 and HIV-2 infection and for recognizing early HIV
infection. Clinical (non-laboratory) 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 OMB
Control No. 0920-0573. The revisions requested in this extension
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 ID fields to
better track residence information and minor formatting changes to the
form used for Perinatal HIV Exposure Reporting (PHER).
The revisions to this request also include the addition of burden
hours for annual reporting by health departments for the Standards
Evaluation Report (SER) and Annual Performance Report (APR). Findings
from these reports are used to improve data quality and ensure the
accuracy, timeliness, and completeness of the national HIV
surveillance, as well as to monitor performance and progress in
achieving both state and national HIV surveillance program objectives.
Fifty-nine health departments funded for HIV surveillance will report a
Standards Evaluation Report (SER) and APR annually.
CDC provides funding for 59 health departments to conduct adult and
pediatric HIV case surveillance and report information to CDC. Health
department staff compile information from laboratories, physicians,
hospitals, clinics and other health care providers to complete adult
and adolescent and pediatric HIV confidential case reports. Updates to
case reports are also entered into an electronic database by health
departments, as additional information may be received from
laboratories, vital statistics offices, or additional providers.
Evaluations are also conducted by health departments on a subset of
case reports (e.g., re-abstraction/validation activities and routine
interstate de-duplication) in all jurisdictions.
Supplemental surveillance data are collected in a subset of areas
to provide additional information necessary to estimate HIV incidence,
to better describe the extent of HIV viral resistance and quantify HIV
subtypes 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 care providers, and medical records. CDC estimates
that 25 health departments will be reporting data elements containing
HIV Incidence Surveillance (HIS) data, 53 health departments will
report additional data elements on HIV nucleotide sequences as part of
Molecular HIV Surveillance (MHS), and 35 areas will be reporting data
as part of 35 health departments will be reporting data collected as
part of Perinatal HIV Exposure Reporting (PHER) annually. The total
estimated annual burden hours are 50,504.
[[Page 7802]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
---------------------------------------------------------------------------------------------------------------
Health Departments................... Adult HIV Case Report.. 59 1,061 20/60
Health Departments................... Pediatric HIV Case 59 5 20/60
Report.
Health Departments................... Case Report Evaluations 59 107 20/60
Health Departments................... Case Report Updates.... 59 1,576 2/60
Health Departments................... Laboratory Updates..... 59 6,303 1/60
Health Departments................... HIV Incidence 25 2,288 10/60
Surveillance (HIS).
Health Departments................... Molecular HIV 53 829 5/60
Surveillance (MHS).
Health Departments................... Perinatal HIV Exposure 35 114 30/60
Reporting (PHER).
Health Departments................... Annual Reporting: 59 1 8
Standards Evaluation
Report (SER).
Health Departments................... Annual Reporting: 59 1 42
Annual Performance
Report (APR).
----------------------------------------------------------------------------------------------------------------
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. 2016-03046 Filed 2-12-16; 8:45 am]
BILLING CODE 4163-18-P
