60 day FRN

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:
[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;

PO 00000

Frm 00064

Fmt 4703

Sfmt 4703

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

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

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

[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

Food and Drug Administration
[Docket No. FDA–2016–D–2285]

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is

SUMMARY:

VerDate Sep<11>2014

18:01 Jun 12, 2018

Jkt 244001

PO 00000

Frm 00065

Fmt 4703

Sfmt 4703

Total
burden
(in hours)

52
52
52
1
1

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

AGENCY:

Average
burden per
response
(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

amozie on DSK3GDR082PROD with NOTICES1

Number of
responses per
respondent

Number of
respondents

Form name

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

13JNN1