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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents

Form

Respondents

Email Verification ....................

Registered nurses, Health educators, and Social and
human service assistants, social and community service
managers.

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–24001 Filed 11–1–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–0728; Docket No. CDC–2019–
0096]

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
conditions that are nationally notifiable
or under standard surveillance.
DATES: CDC must receive written
comments on or before January 3, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0096 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.
SUMMARY:

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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 Jeffrey M. Zirger,
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

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Number of
responses per
respondent

3,600

1

Average
burden per
response
(in hours)
8/60

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 (NNDSS)—
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 to the NNDSS (OMB Control
No. 0920–0728, Expiration Date 04/30/
2022). This Revision includes requests
for approval to: (1) Receive case
notification data for Blastomycosis
which is now under standardized
surveillance; and (2) receive diseasespecific data elements for Carbon
Monoxide (CO) Poisoning, Congenital
Syphilis, and Sexually Transmitted
Disease (STD, not congenital).
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,

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59388

Federal Register / Vol. 84, No. 213 / Monday, November 4, 2019 / Notices

New York City, Washington DC, five
U.S. territories (American Samoa, the
Commonwealth of Northern Mariana
Islands, Guam, Puerto Rico, and the U.S.
Virgin Islands), and three 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

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 for the one-time burden for
reporting jurisdictions for the addition
of case notification data for
Blastomycosis and disease-specific data
elements for CO Poisoning, Congenital
Syphilis, and Sexually Transmitted
Disease (not congenital). The estimated
annual burden for the 257 respondents
is 18,354 hours.

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 to 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.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

States
States
States
States
States

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

Territories
Territories
Territories
Territories
Territories

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

Freely
Freely
Freely
Freely

Associated
Associated
Associated
Associated

States
States
States
States

Cities
Cities
Cities
Cities
Cities

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

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

Average
burden per
response
(in hours)

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 (Automated) ............................................
Weekly, Quarterly (Non-automated) ....................
Annual ..................................................................
One-time Addition of Diseases and Data Elements.
Weekly (Automated) ............................................
Weekly (Non-automated) .....................................
Weekly (NMI Implementation) .............................
Annual ..................................................................
One-time Addition of Diseases and Data Elements.

50
10
50
50
50

52
52
52
1
1

20/60
2
4
75
2

867
1,040
10,400
3,750
100

5
5
5
5
5

52
56
52
1
1

20/60
20/60
4
5
2

87
93
1,040
25
10

3
3
3
3

52
56
1
1

20/60
20/60
5
2

52
56
15
6

2
2
2
2
2

52
52
52
1
1

20/60
2
4
75
2

35
208
416
150
4

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

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

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

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

18,354

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–24003 Filed 11–1–19; 8:45 am]
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Federal Register / Vol. 84, No. 213 / Monday, November 4, 2019 / Notices
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4986]

Cardiovascular and Renal Drugs
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:

Electronic Submissions

Food and Drug Administration,

HHS.
Notice; establishment of a
public docket; request for comments.

ACTION:

The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Cardiovascular and Renal
Drugs Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.

SUMMARY:

The meeting will be held on
December 10, 2019, from 8 a.m. to 5
p.m.

DATES:

FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2019–N–4986.
The docket will close on December 9,
2019. Submit either electronic or
written comments on this public
meeting by December 9, 2019. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before December 9, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
December 9, 2019. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before
November 25, 2019, will be provided to
the committee. Comments received after

ADDRESSES:

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Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–4986 for ‘‘Cardiovascular and
Renal Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential

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59389

Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between
9 a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify the information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:

Yinghua S. Wang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
[email protected], or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute

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