60 day FRN

Att 2a - 60-day FRN.pdf

National Notifiable Diseases Surveillance System (NNDSS)

60 day FRN

OMB: 0920-0728

Document [pdf]
Download: pdf | pdf
93939

Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS

Individuals .....................

Cyclosporiasis National Hypothesis Generating
Questionnaire.

1,000

1

45/60

750

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

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

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

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

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

750

[FR Doc. 2016–30778 Filed 12–21–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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 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 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 national surveillance.
DATES: Written comments must be
received on or before February 21, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0119 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and

17:40 Dec 21, 2016

Jkt 241001

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].
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
FOR FURTHER INFORMATION CONTACT:

[60Day–17–0728; Docket No. CDC–2016–
0119]

VerDate Sep<11>2014

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.

Centers for Disease Control and
Prevention

SUMMARY:

Number of
respondents

Avg. burden
per response
(in hrs.)

Form name

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.

sradovich on DSK3GMQ082PROD with NOTICES

Number of
responses
per
respondent

Type of
respondents

PO 00000

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Total burden
(in hrs.)

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 Notifiable Diseases
Surveillance System (OMB Control
Number 0920–0728, expires 1/31/
2019)—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 Nationally
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. Infectious disease agents and
environmental hazards often cross
geographical boundaries. Each year, the

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Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Notices

Council of State and Territorial Disease
Epidemiologists (CSTE), supported by
CDC, determines which reportable
conditions should be designated
nationally notifiable and voluntarily
submitted to CDC so that information
can be shared across jurisdictional
boundaries and both surveillance and
prevention and control activities can be
coordinated at regional and national
levels.
CDC requests a three-year approval for
a Revision for the National Notifiable
Diseases Surveillance System (NNDSS),
OMB Control No. 0920–0728, Expiration
Date 01/31/2019. This Revision includes
requests for approval to receive: (1) Case
notification data from the Federated
States of Micronesia, the Republic of the
Marshall Islands, and the Republic of
Palau (independent nations that operate
under a Compact of Free Association

nationally notifiable or be placed under
standardized surveillance, will not
increase the burden since most case
notifications are submitted from already
existing databases. The burden on the
states and cities is estimated to be 10
hours per response and the burden on
the territories is estimated to be 5 hours
per response. The total burden will
increase because of the request to
receive case notification data from the
freely associated states. The burden on
the freely associated states is estimated
to be the same as the burden for the
territories, 5 hours per response. This is
because the methods and systems that
the freely associated states use to send
case notification data to CDC are nearly
the same as the territories.
There will be no costs to respondents
other than their time. The estimated
annual burden is 29,120 hours.

with the United States of America that
are commonly referred to as ‘‘freely
associated states’’); (2) case notification
data for histoplasmosis which is now
under standardized surveillance; and (3)
case notification data for all enteric
Escherichia coli infections should any
of them become nationally notifiable or
be placed under standardized
surveillance. CDC already has approval
to receive case notification data for
Shiga toxin-producing Escherichia coli
(STEC) which is nationally notifiable.
Although this Revision includes case
notifications that were not part of the
last NNDSS Revision, the estimate of the
average burden per response based on
the burden tables from all of the
consolidated applications for states,
cities, and territories has not changed.
The addition of new diseases and
conditions, should they become

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
States ................................................
Territories ..........................................
Freely Associated States ..................
Cities .................................................
Total ...........................................

Weekly
Weekly
Weekly
Weekly

10
5
5
10

26,000
1,300
780
1,040

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

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

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

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

29,120

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2275]

Lead in Cosmetic Lip Products and
Externally Applied Cosmetics:
Recommended Maximum Level; Draft
Guidance for Industry; Availability
Food and Drug Administration,

HHS.
sradovich on DSK3GMQ082PROD with NOTICES

ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled, ‘‘Lead in
Cosmetic Lip Products and Externally
Applied Cosmetics: Recommended
Maximum Level.’’ This draft guidance
provides a recommended maximum

SUMMARY:

VerDate Sep<11>2014

17:40 Dec 21, 2016

Total burden
(in hours)

52
52
52
52

BILLING CODE 4163–18–P

Jkt 241001

Annual
Annual
Annual
Annual

Avg. burden
per response
(in hours)

50
5
3
2

[FR Doc. 2016–30779 Filed 12–21–16; 8:45 am]

and
and
and
and

Number of
responses per
respondent

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

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.

AGENCY:

Number of
respondents

Form name

level of 10 parts per million (ppm) for
lead as an impurity in cosmetic lip
products (such as lipsticks, lip glosses,
and lip liners) and externally applied
cosmetics (such as eye shadows,
blushes, shampoos, and body lotions)
marketed in the United States. We
consider the recommended maximum
lead level to be achievable with the use
of good manufacturing practices and
consistent with the 10 ppm maximum
lead level for similar products
recommended by other countries, and
we have concluded that the
recommended maximum lead level
would not pose a health risk.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider
your comment on this draft guidance
before we begin work on the final
version of the guidance, submit either
electronic or written comments on the
draft guidance by February 21, 2017.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the

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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): Division of
Dockets Management (HFA–305), Food

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