60 Day FRN published

78738

Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices

Proposed Project
National Disease Surveillance
Program–I—Case Reports—Revision—
National Center for Emerging and
Zoonotic Infectious Disease (NCEZID),
Centers for Disease Control and
Prevention (CDC)
Background and Brief Description
Surveillance of the incidence and
distribution of disease has been an
important function of the US Public
Health Service (PHS) since an 1878 Act
of Congress, which authorized the PHS
to collect morbidity reports. After the
Malaria Control in War Areas Program
had fulfilled its original 1942 objective
of reducing malaria transmission, its
basic tenets were carried forward and
broadened by the formation of the
Communicable Disease Center (CDC) in
1946. CDC was conceived of as a wellequipped, broadly staffed agency used
to translate facts about analysis of
morbidity and mortality statistics on
communicable diseases and through
field investigations.
The surveillance emphasis has shifted
as certain diseases have declined in
incidence, national emergencies have
prompted involvement in new areas,
and other diseases have taken on new
aspects. Surveillance for the following
diseases was approved three years ago:
Creutzfeldt-Jakob Disease (CJD),
Cyclosporiasis cayetanensis, Q Fever,
Dengue, Reye Syndrome, Hantavirus
pulmonary syndrome (HPS), Tick-borne
Rickettsial Disease, Kawasaki syndrome,

Trichinosis, Legionellosis, Tularemia,
Lyme Disease (LD), Typhoid Fever,
Malaria, Viral Hepatitis, and Plague.
Due to change requests and surveillance
systems moving to and receiving
information collection approval under
OMB Control number 0920–0728
(National Notifiable Diseases
Surveillance System (NNDSS)) during
the last three years, the following
diseases/conditions are now included in
this program: Creutzfeldt-Jakob Disease
(CJD), Reye Syndrome, Kawasaki
syndrome, and Acute Flaccid Myelitis.
CDC needs to continue this surveillance
package for another three years to
maintain continuity in these
surveillance systems. The data
throughout the years are used to
monitor the occurrence of non-notifiable
conditions and to plan and conduct
prevention and control programs at the
state, territorial, local and national
levels.
CDC currently collects data for certain
diseases in summary form under OMB
Control number 0920–0004, (National
Disease Surveillance Program II—
Disease Summaries). These disease
summaries are for important, yet
different types of infections from those
covered in this disease case reports
request. Maintaining separate OMB
Control number approvals for these two
types of data collections assists CDC in
managing the two surveillance
activities.
CDC works with state health
departments to propose, coordinate, and

evaluate nationwide surveillance
systems. State epidemiologists are
responsible for the collection,
interpretation, and transmission of
medical and epidemiological
information to CDC.
The original purpose for reporting
communicable diseases was to
determine the prevalence of diseases
dangerous to public health. However,
collecting data also provided the basis
for planning and evaluating effective
programs for prevention and control of
infectious diseases. Current information
on disease incidence is needed to study
present and emerging disease problems.
CDC coordination of nationwide
reporting maintains uniformity so that
comparisons can be made from state to
state and year to year.
In addition to development of
prevention and control programs,
surveillance data serves as statistical
material for those engaged in research or
medical practice, aid to health
education officials and students, and
data for manufacturers of
pharmaceutical products. Annual
surveillance data are published in the
MMWR Surveillance Summary. The
total burden requested is 190 hours, a
decrease in 11,257 hours since the last
submission. This is due to the other
diseases reporting moving to the
Notifiable Diseases Surveillance System
(0920–0728). There is no cost to
respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Epidemiologist
Epidemiologist
Epidemiologist
Epidemiologist

Number of
responses per
respondent

Average
burden per
response
(in hrs.)

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

CJD ................................................................
Kawasaki Syndrome ......................................
Reye Syndrome .............................................
Acute Flaccid Myelitis ....................................

20
55
50
100

2
8
1
1

20/60
15/60
20/60
30/60

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

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

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

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

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

Leroy 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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Number of
respondents

Form name

[FR Doc. 2015–31706 Filed 12–16–15; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0821; Docket No. CDC–2015–
0114]

BILLING CODE 4163–18–P

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

Notice with comment period.

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 a proposed revision of an
information collection request entitled

SUMMARY:

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Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
‘‘Quarantine Station Illness Response
Forms: Airline, Maritime, and Land/
Border Crossing’’ which will enable
CDC to collect information concerning
cases of illness or death that occur
during or after travel to the United
States in order to determine if further
public health follow-up is required.
DATES: Written comments must be
received on or before February 16, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0114 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
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. 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.

asabaliauskas on DSK5VPTVN1PROD with NOTICES

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 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: 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 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

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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
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
Quarantine Station Illness Response
Forms: Airline, Maritime, and Land/
Border Crossing (0920–0821, expires 04/
30/2016). Revision. Division of Global
Migration and Quarantine, National
Center for Emerging Zoonotic and
Infectious Diseases, Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
CDC is requesting approval for a
revision to this existing information
collection with the intent of ensuring
that CDC can continue and improve the
collection of pertinent information
related to communicable disease or
deaths that occur aboard conveyances
during travel within the United States
and into the United States from a
foreign country, as authorized under 42
Code of Federal Regulations part 70 and
71, respectively.
Concerning routine operations, CDC is
adjusting its estimates of respondents
and burden associated with the use of
the Air Travel, Maritime Conveyance,
and Land Travel Illness or Death
Investigation forms.
• CDC is requesting an increase in the
number of respondents to the Air Travel
Illness or Death Investigation form, from
1626 respondents to 1800. This results

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78739

in an additional 15 hours of burden per
year.
• CDC is requesting fewer
respondents to the Maritime
Conveyance Illness or Death
Investigation Form, from 1873 to 750
reports. This results in a decrease of 94
hours.
• CDC is requesting a decrease in the
number of respondents to the Land
Travel Illness or Death Investigation
form, from 259 respondents to 100. This
results in a decrease of 13 hours.
Also included are adjustments to the
number of respondents and estimated
burden to the public for the use of the
United States Traveler Health
Declaration and Ebola Risk Assessment
forms at U.S. ports of entry. These forms
are currently used to collect contact
information and assess travelers’ risk for
Ebola if they are coming to the United
States from Sierra Leone and Guinea.
The adjustments are as follows:
• CDC is requesting 40,238 fewer
respondents to the United States
Traveler Health Declaration (English:
Hard Copy, fillable PDF, electronic
portal), resulting in a decrease of 10,060
burden hours.
• CDC is requesting an additional
6,814 respondents to the United States
Traveler Health Declaration (French
translation guide), with an increase of
1,703 burden hours.
• CDC is requesting 76 fewer
respondents for the United States
Traveler Health Declaration (Arabic
translation guide), with a decrease of 19
burden hours.
• CDC is requesting 2,637 fewer
respondents to the Ebola Risk
Assessment Form (English hard copy),
and an associated decrease of 659
burden hours.
• CDC is requesting an increase of
141 respondents to the Ebola Risk
Assessment (French translation guide)
and an increase of 35 burden hours.
• CDC is requesting eight fewer
respondents to the Ebola Risk
Assessment (Arabic translation guide)
and two fewer burden hours.
CDC is also requesting an adjustment
to the number of respondents and
burden hours for the use of the
Interactive Voice Response (IVR) system
surveys.
• CDC is requesting 40,238 fewer
respondents to the IVR Active
Monitoring Survey (English: Recorded),
with 56,333 fewer burden hours.
• CDC is requesting an increase of
6,814 respondents to the IVR Active
Monitoring Survey (French: Recorded)
and an additional 9,540 burden hours.
• CDC is requesting 76 fewer
respondents to the IVR Active
Monitoring: Arabic translation

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78740

Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices

assistance (no script), with a decrease of
106 burden hours.
These adjustments result in a decrease
of 55,994 burden hours.

CDC requested a total of 38,817
respondents and 29,388 burden hours
annually. The respondents to these
information collections are travelers and

ship medical personnel. There is no cost
to respondents other than the time
required to provide the information
requested.

ESTIMATED ANNUALIZED BURDEN HOURS
Form

Traveler .............................................

Airline Travel Illness or Death Investigation Form.
Maritime Conveyance Illness or
Death Investigation Form.
Land Travel Illness or Death Investigation Form.
Ebola Risk Assessment Form (Ill
traveler
interview:
English,
French, Arabic, or other as needed).
United States Traveler Health Declaration (English: Hard Copy,
fillable PDF, electronic portal).
United States Traveler Health Declaration (French translation guide).
United States Traveler Health Declaration (Arabic translation guide).
Ebola Risk Assessment Form
(English hard copy).
Ebola Risk Assessment French
translation guide.
Ebola Risk Assessment Arabic
translation guide.
IVR Active Monitoring Survey
(English: Recorded).
IVR Active Monitoring Survey
(French: Recorded).
IVR Active Monitoring: Arabic translation assistance (no script).

Ship Medical Personnel ....................
Traveler .............................................
Traveler .............................................

Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Total ...........................................

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

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. 2015–31742 Filed 12–16–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration

asabaliauskas on DSK5VPTVN1PROD with NOTICES

[Docket No. FDA–2011–D–0164]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Safety Labeling Changes—
Implementation of Section 505(o)(4) of
the Federal Food, Drug, and Cosmetic
Act
AGENCY:

Food and Drug Administration,

HHS.

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ACTION:

Number of
responses per
respondent

Number of
respondents

Respondent

1

5/60

150

750

1

5/60

63

100

1

5/60

8

100

1

15/60

25

9,000

1

15/60

2250

8,400

1

15/60

2100

100

1

15/60

25

810

1

15/60

203

252

1

15/60

63

5

1

15/60

1

9,000

21

4/60

12,600

8,400

21

4/60

11,760

100

21

4/60

140

38,817

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

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

29,388

The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 19,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0734. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food

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Total burden
hours

1,800

Notice.

SUMMARY:

Average
burden per
response
(in minutes)

and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Guidance for Industry on Safety
Labeling Changes—Implementation of
Section 505(o)(4) of the Federal Food,
Drug, and Cosmetic Act, OMB Control
Number 0910–0734—Extension
Section 505(o)(4) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 355(o)(4)) authorizes FDA to
require, and if necessary, order labeling
changes if FDA becomes aware of new
safety information that FDA believes
should be included in the labeling of
certain prescription drug and biological
products approved under section 505 of
the FD&C Act or section 351 of the PHS
Act (42 U.S.C. 262). Section 505(o)(4) of
the FD&C Act applies to prescription

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