Proposed Data Collection Submitted for Public Comment and Recommendations, 27601-27602 [2018-12637]
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Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
Respondents/Affected Entities: Private
sector.
Respondent’s Obligation to Respond:
Mandatory per 48 CFR 1552.211.
Estimated Number of Respondents:
337 (total).
Frequency of Response: Monthly.
Total Estimated Burden: 97,056 hours
(per year). Burden is defined at 5 CFR
1320.03(b).
Total Estimated Cost: $9,074,736 (per
year), includes $0 annualized capital or
operation & maintenance costs.
Changes in Estimates: There is an
increase of 19,650 hours
(97,056¥77,406) in the total estimated
respondent burden compared with the
ICR currently approved by OMB
because there are approximately 337
contracts and orders requiring response
in 2018 instead of only 266 in 2014.
This figure has increased to 337 due in
part to shorter-value and shorter-length
contracts being awarded due to budget
uncertainty; e.g., continuing funding
resolutions, sequestration budget cuts.
Dated: May 24, 2018.
Pamela D. Legare,
Deputy Director, Office of Acquisition
Management.
[FR Doc. 2018–12712 Filed 6–12–18; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–0728; Docket No. CDC–2018–
0047]
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 the National Notifiable Diseases
Surveillance System (NNDSS). The
NNDSS is the nation’s public health
surveillance system that monitors the
occurrence and spread of diseases and
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:01 Jun 12, 2018
Jkt 244001
conditions that are nationally notifiable
or under standard surveillance.
DATES: CDC must receive written
comments on or before August 13, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0047 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
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.
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 Leroy A.
Richardson, 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 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;
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27601
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.
Proposed Project
National Notifiable Diseases
Surveillance System—Revision—Center
for Surveillance, Epidemiology and
Laboratory Services (CSELS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Public Health Services Act (42
U.S.C. 241) authorizes CDC to
disseminate nationally notifiable
condition information. The National
Notifiable Diseases Surveillance System
(NNDSS) is based on data collected at
the state, territorial and local levels as
a result of legislation and regulations in
those jurisdictions that require health
care providers, medical laboratories,
and other entities to submit healthrelated data on reportable conditions to
public health departments. These
reportable conditions, which include
infectious and non-infectious diseases,
vary by jurisdiction depending upon
each jurisdiction’s health priorities and
needs. Each year, the Council of State
and Territorial Disease Epidemiologists
(CSTE), supported by CDC, determines
which reportable conditions should be
designated nationally notifiable or
under standardized surveillance.
CDC requests a three-year approval for
a Revision for the NNDSS, OMB Control
No. 0920–0728, Expiration Date 02/28/
2021. This Revision includes requests
for approval to: (1) Receive case
notification data for Salmonella enterica
serotype Paratyphi (S. Paratyphi) A, B,
or C Infections should they become
nationally notifiable or be placed under
standardized surveillance; (2) receive
case notification data for
Carbapenemase-Producing CarbapenemResistant Enterobacteriaceae (CP–CRE)
which is now nationally notifiable; (3)
receive case notification data for
Candida auris (C. auris) which is now
under standardized surveillance; and (4)
receive disease-specific data elements
for CP–CRE.
The NNDSS currently facilitates the
submission and aggregation of case
notification data voluntarily submitted
to CDC from 60 jurisdictions: Public
health departments in every U.S. state,
E:\FR\FM\13JNN1.SGM
13JNN1
27602
Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
New York City, Washington DC, 5 U.S.
territories (American Samoa, the
Commonwealth of Northern Mariana
Islands, Guam, Puerto Rico, and the U.S.
Virgin Islands), and 3 freely associated
states (Federated States of Micronesia,
the Republic of the Marshall Islands,
and the Republic of Palau). This
information is shared across
jurisdictional boundaries and both
surveillance and prevention and control
activities are coordinated at regional
and national levels.
Approximately 90% of case
notifications are encrypted and
submitted to NNDSS electronically from
already existing databases by automated
electronic messages. When automated
transmission is not possible, case
notifications are faxed, emailed,
uploaded to a secure network or entered
into a secure website. All case
notifications that are faxed, emailed,
and uploaded are done so in the form
of an aggregate weekly or annual report,
not individual cases. These different
mechanisms used to send case
notifications to CDC vary by the
jurisdiction and the disease or
condition. Private personally
identifiable information (PII) is
collected from automated electronic
messages and information can be
retrieved by PII. In addition, some
combinations of submitted data
elements could potentially be used to
identify individuals. Private information
is not be disclosed unless otherwise
compelled by law. All data are treated
in a secure manner consistent with the
technical, administrative, and
operational controls required by the
Federal Information Security
Management Act of 2002 (FISMA) and
the 2010 National Institute of Standards
and Technology (NIST) Recommended
Security Controls for Federal
Information Systems and Organizations.
Weekly tables of nationally notifiable
diseases are available through CDC
WONDER and data.cdc.gov. Annual
summaries of finalized nationally
notifiable disease data are published on
CDC WONDER and data.cdc.gov and
disease-specific data are published by
individual CDC programs.
The burden estimates include the
number of hours that the public health
department uses to process and send
case notification data from their
jurisdiction to CDC. Specifically, the
burden estimates include separate
burden hours incurred for automated
and non-automated transmissions,
separate weekly burden hours incurred
for modernizing surveillance systems as
part of NNDSS Modernization Initiative
(NMI) implementation, separate burden
hours incurred for annual data
reconciliation and submission, and
separate one-time burden hours
incurred for the addition of new
diseases and data elements. The burden
estimates also include the one-time
burden for reporting jurisdictions for the
addition of case notification data for
CP–CRE and C. auris and diseasespecific data elements for CP–CRE. The
estimated annual burden for the 233
respondents is 18,619 hours. The cost of
the information collection is $787,846.
The total burden hours increased from
18,529 to 18,619 since the last revision
because of the addition of diseases and
disease-specific data elements.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
States
States
States
States
States
................................................
................................................
................................................
................................................
................................................
Territories
Territories
Territories
Territories
Territories
..........................................
..........................................
..........................................
..........................................
..........................................
Freely Associated States ..................
Freely Associated States ..................
Number of
responses per
respondent
Number of
respondents
Form name
Weekly (Automated) .........................
Weekly (Non-Automated) .................
Weekly (NMI Implementation) ..........
Annual ..............................................
One-time Addition of Diseases and
Data Elements.
Weekly (Automated) .........................
Weekly, Quarterly (Non-Automated)
Weekly (NMI Implementation) ..........
Annual ..............................................
One-time Addition of Diseases and
Data Elements.
Weekly, Quarterly (Non-Automated)
Annual ..............................................
52
52
52
1
1
20/60
2
4
75
10
867
1,040
10,400
3,750
485
1
5
5
5
1
52
56
52
1
1
20/60
20/60
4
5
10/60
17
93
1,040
25
1
3
3
56
1
20/60
5
56
15
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–12637 Filed 6–12–18; 8:45 am]
Medical Product Communications That
Are Consistent With the Food and
Drug Administration-Required
Labeling—Questions and Answers;
Guidance for Industry; Availability
amozie on DSK3GDR082PROD with NOTICES1
Food and Drug Administration
[Docket No. FDA–2016–D–2285]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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Total
burden
(in hours)
50
10
50
50
50
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.
BILLING CODE 4163–18–P
Average
burden per
response
(in hours)
announcing the availability of a
guidance for industry entitled ‘‘Medical
Product Communications That Are
Consistent With the FDA-Required
Labeling—Questions and Answers.’’
This guidance provides information for
manufacturers, packers, and distributors
and their representatives (collectively
‘‘firms’’) of drugs and medical devices
for humans, including those that are
licensed as biological products, and
animal drugs (collectively ‘‘medical
products’’), about how FDA evaluates
their medical product communications
that present information that is not
contained in the FDA-required labeling
for the product but that may be
E:\FR\FM\13JNN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27601-27602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12637]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-18-0728; Docket No. CDC-2018-0047]
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 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 the National Notifiable Diseases
Surveillance System (NNDSS). The NNDSS is the nation's public health
surveillance system that monitors the occurrence and spread of diseases
and conditions that are nationally notifiable or under standard
surveillance.
DATES: CDC must receive written comments on or before August 13, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0047 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 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.
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 Leroy A. Richardson, 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.
Proposed Project
National Notifiable Diseases Surveillance System--Revision--Center
for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
The Public Health Services Act (42 U.S.C. 241) authorizes CDC to
disseminate nationally notifiable condition information. The National
Notifiable Diseases Surveillance System (NNDSS) is based on data
collected at the state, territorial and local levels as a result of
legislation and regulations in those jurisdictions that require health
care providers, medical laboratories, and other entities to submit
health-related data on reportable conditions to public health
departments. These reportable conditions, which include infectious and
non-infectious diseases, vary by jurisdiction depending upon each
jurisdiction's health priorities and needs. Each year, the Council of
State and Territorial Disease Epidemiologists (CSTE), supported by CDC,
determines which reportable conditions should be designated nationally
notifiable or under standardized surveillance.
CDC requests a three-year approval for a Revision for the NNDSS,
OMB Control No. 0920-0728, Expiration Date 02/28/2021. This Revision
includes requests for approval to: (1) Receive case notification data
for Salmonella enterica serotype Paratyphi (S. Paratyphi) A, B, or C
Infections should they become nationally notifiable or be placed under
standardized surveillance; (2) receive case notification data for
Carbapenemase-Producing Carbapenem-Resistant Enterobacteriaceae (CP-
CRE) which is now nationally notifiable; (3) receive case notification
data for Candida auris (C. auris) which is now under standardized
surveillance; and (4) receive disease-specific data elements for CP-
CRE.
The NNDSS currently facilitates the submission and aggregation of
case notification data voluntarily submitted to CDC from 60
jurisdictions: Public health departments in every U.S. state,
[[Page 27602]]
New York City, Washington DC, 5 U.S. territories (American Samoa, the
Commonwealth of Northern Mariana Islands, Guam, Puerto Rico, and the
U.S. Virgin Islands), and 3 freely associated states (Federated States
of Micronesia, the Republic of the Marshall Islands, and the Republic
of Palau). This information is shared across jurisdictional boundaries
and both surveillance and prevention and control activities are
coordinated at regional and national levels.
Approximately 90% of case notifications are encrypted and submitted
to NNDSS electronically from already existing databases by automated
electronic messages. When automated transmission is not possible, case
notifications are faxed, emailed, uploaded to a secure network or
entered into a secure website. All case notifications that are faxed,
emailed, and uploaded are done so in the form of an aggregate weekly or
annual report, not individual cases. These different mechanisms used to
send case notifications to CDC vary by the jurisdiction and the disease
or condition. Private personally identifiable information (PII) is
collected from automated electronic messages and information can be
retrieved by PII. In addition, some combinations of submitted data
elements could potentially be used to identify individuals. Private
information is not be disclosed unless otherwise compelled by law. All
data are treated in a secure manner consistent with the technical,
administrative, and operational controls required by the Federal
Information Security Management Act of 2002 (FISMA) and the 2010
National Institute of Standards and Technology (NIST) Recommended
Security Controls for Federal Information Systems and Organizations.
Weekly tables of nationally notifiable diseases are available through
CDC WONDER and data.cdc.gov. Annual summaries of finalized nationally
notifiable disease data are published on CDC WONDER and data.cdc.gov
and disease-specific data are published by individual CDC programs.
The burden estimates include the number of hours that the public
health department uses to process and send case notification data from
their jurisdiction to CDC. Specifically, the burden estimates include
separate burden hours incurred for automated and non-automated
transmissions, separate weekly burden hours incurred for modernizing
surveillance systems as part of NNDSS Modernization Initiative (NMI)
implementation, separate burden hours incurred for annual data
reconciliation and submission, and separate one-time burden hours
incurred for the addition of new diseases and data elements. The burden
estimates also include the one-time burden for reporting jurisdictions
for the addition of case notification data for CP-CRE and C. auris and
disease-specific data elements for CP-CRE. The estimated annual burden
for the 233 respondents is 18,619 hours. The cost of the information
collection is $787,846. The total burden hours increased from 18,529 to
18,619 since the last revision because of the addition of diseases and
disease-specific data elements.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
States........................ Weekly 50 52 20/60 867
(Automated).
States........................ Weekly (Non- 10 52 2 1,040
Automated).
States........................ Weekly (NMI 50 52 4 10,400
Implementation).
States........................ Annual.......... 50 1 75 3,750
States........................ One-time 50 1 10 485
Addition of
Diseases and
Data Elements.
Territories................... Weekly 1 52 20/60 17
(Automated).
Territories................... Weekly, 5 56 20/60 93
Quarterly (Non-
Automated).
Territories................... Weekly (NMI 5 52 4 1,040
Implementation).
Territories................... Annual.......... 5 1 5 25
Territories................... One-time 1 1 10/60 1
Addition of
Diseases and
Data Elements.
Freely Associated States...... Weekly, 3 56 20/60 56
Quarterly (Non-
Automated).
Freely Associated States...... Annual.......... 3 1 5 15
----------------------------------------------------------------------------------------------------------------
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.
[FR Doc. 2018-12637 Filed 6-12-18; 8:45 am]
BILLING CODE 4163-18-P
