80 FR 78738 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 242 (December 17, 2015)

Page Range		78738-78740
FR Document		2015-31742

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 ``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.

Federal Register, Volume 80 Issue 242 (Thursday, December 17, 2015)

[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78738-78740]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31742]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0821; Docket No. CDC-2015-0114]


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 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

[[Page 78739]]

``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.


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: [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 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 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

[[Page 78740]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
          Respondent                  Form          respondents    responses per   response  (in       hours
                                                                    respondent       minutes)
----------------------------------------------------------------------------------------------------------------
Traveler......................  Airline Travel             1,800               1            5/60             150
                                 Illness or
                                 Death
                                 Investigation
                                 Form.
Ship Medical Personnel........  Maritime                     750               1            5/60              63
                                 Conveyance
                                 Illness or
                                 Death
                                 Investigation
                                 Form.
Traveler......................  Land Travel                  100               1            5/60               8
                                 Illness or
                                 Death
                                 Investigation
                                 Form.
Traveler......................  Ebola Risk                   100               1           15/60              25
                                 Assessment Form
                                 (Ill traveler
                                 interview:
                                 English,
                                 French, Arabic,
                                 or other as
                                 needed).
Traveler......................  United States              9,000               1           15/60            2250
                                 Traveler Health
                                 Declaration
                                 (English: Hard
                                 Copy, fillable
                                 PDF, electronic
                                 portal).
Traveler......................  United States              8,400               1           15/60            2100
                                 Traveler Health
                                 Declaration
                                 (French
                                 translation
                                 guide).
Traveler......................  United States                100               1           15/60              25
                                 Traveler Health
                                 Declaration
                                 (Arabic
                                 translation
                                 guide).
Traveler......................  Ebola Risk                   810               1           15/60             203
                                 Assessment Form
                                 (English hard
                                 copy).
Traveler......................  Ebola Risk                   252               1           15/60              63
                                 Assessment
                                 French
                                 translation
                                 guide.
Traveler......................  Ebola Risk                     5               1           15/60               1
                                 Assessment
                                 Arabic
                                 translation
                                 guide.
Traveler......................  IVR Active                 9,000              21            4/60          12,600
                                 Monitoring
                                 Survey
                                 (English:
                                 Recorded).
Traveler......................  IVR Active                 8,400              21            4/60          11,760
                                 Monitoring
                                 Survey (French:
                                 Recorded).
Traveler......................  IVR Active                   100              21            4/60             140
                                 Monitoring:
                                 Arabic
                                 translation
                                 assistance (no
                                 script).
                                                 ---------------------------------------------------------------
    Total.....................  ................          38,817  ..............  ..............          29,388
----------------------------------------------------------------------------------------------------------------


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

78738 Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices

Proposed Project Trichinosis, Legionellosis, Tularemia, evaluate nationwide surveillance
National Disease Surveillance Lyme Disease (LD), Typhoid Fever, systems. State epidemiologists are
Program–I—Case Reports—Revision— Malaria, Viral Hepatitis, and Plague. responsible for the collection,
National Center for Emerging and Due to change requests and surveillance interpretation, and transmission of
Zoonotic Infectious Disease (NCEZID), systems moving to and receiving medical and epidemiological
Centers for Disease Control and information collection approval under information to CDC.
Prevention (CDC) OMB Control number 0920–0728
The original purpose for reporting
(National Notifiable Diseases
Background and Brief Description Surveillance System (NNDSS)) during communicable diseases was to
the last three years, the following determine the prevalence of diseases
Surveillance of the incidence and
diseases/conditions are now included in dangerous to public health. However,
distribution of disease has been an
important function of the US Public this program: Creutzfeldt-Jakob Disease collecting data also provided the basis
Health Service (PHS) since an 1878 Act (CJD), Reye Syndrome, Kawasaki for planning and evaluating effective
of Congress, which authorized the PHS syndrome, and Acute Flaccid Myelitis. programs for prevention and control of
to collect morbidity reports. After the CDC needs to continue this surveillance infectious diseases. Current information
Malaria Control in War Areas Program package for another three years to on disease incidence is needed to study
had fulfilled its original 1942 objective maintain continuity in these present and emerging disease problems.
of reducing malaria transmission, its surveillance systems. The data CDC coordination of nationwide
basic tenets were carried forward and throughout the years are used to reporting maintains uniformity so that
broadened by the formation of the monitor the occurrence of non-notifiable comparisons can be made from state to
Communicable Disease Center (CDC) in conditions and to plan and conduct state and year to year.
1946. CDC was conceived of as a well- prevention and control programs at the In addition to development of
equipped, broadly staffed agency used state, territorial, local and national prevention and control programs,
to translate facts about analysis of levels. surveillance data serves as statistical
morbidity and mortality statistics on CDC currently collects data for certain
material for those engaged in research or
communicable diseases and through diseases in summary form under OMB
Control number 0920–0004, (National medical practice, aid to health
field investigations.
The surveillance emphasis has shifted Disease Surveillance Program II— education officials and students, and
as certain diseases have declined in Disease Summaries). These disease data for manufacturers of
incidence, national emergencies have summaries are for important, yet pharmaceutical products. Annual
prompted involvement in new areas, different types of infections from those surveillance data are published in the
and other diseases have taken on new covered in this disease case reports MMWR Surveillance Summary. The
aspects. Surveillance for the following request. Maintaining separate OMB total burden requested is 190 hours, a
diseases was approved three years ago: Control number approvals for these two decrease in 11,257 hours since the last
Creutzfeldt-Jakob Disease (CJD), types of data collections assists CDC in submission. This is due to the other
Cyclosporiasis cayetanensis, Q Fever, managing the two surveillance diseases reporting moving to the
Dengue, Reye Syndrome, Hantavirus activities. Notifiable Diseases Surveillance System
pulmonary syndrome (HPS), Tick-borne CDC works with state health (0920–0728). There is no cost to
Rickettsial Disease, Kawasaki syndrome, departments to propose, coordinate, and respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)

Epidemiologist ................................................. CJD ................................................................ 20 2 20/60
Epidemiologist ................................................. Kawasaki Syndrome ...................................... 55 8 15/60
Epidemiologist ................................................. Reye Syndrome ............................................. 50 1 20/60
Epidemiologist ................................................. Acute Flaccid Myelitis .................................... 100 1 30/60

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

Leroy Richardson, DEPARTMENT OF HEALTH AND ACTION: Notice with comment period.
Chief, Information Collection Review Office, HUMAN SERVICES
Office of Scientific Integrity, Office of the SUMMARY: The Centers for Disease
Associate Director for Science, Office of the Centers for Disease Control and Control and Prevention (CDC), as part of
Director, Centers for Disease Control and Prevention its continuing efforts to reduce public
Prevention. burden and maximize the utility of
[60Day–16–0821; Docket No. CDC–2015– government information, invites the
asabaliauskas on DSK5VPTVN1PROD with NOTICES

[FR Doc. 2015–31706 Filed 12–16–15; 8:45 am]
0114] general public and other Federal
BILLING CODE 4163–18–P
Proposed Data Collection Submitted agencies to take this opportunity to
for Public Comment and comment on proposed and/or
Recommendations continuing information collections, as
required by the Paperwork Reduction
AGENCY: Centers for Disease Control and Act of 1995. This notice invites
Prevention (CDC), Department of Health comment on a proposed revision of an
and Human Services (HHS). information collection request entitled

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78740 Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices

assistance (no script), with a decrease of CDC requested a total of 38,817 ship medical personnel. There is no cost
106 burden hours. respondents and 29,388 burden hours to respondents other than the time
These adjustments result in a decrease annually. The respondents to these required to provide the information
of 55,994 burden hours. information collections are travelers and requested.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Respondent Form responses per
respondents response hours
respondent (in minutes)

Traveler ............................................. Airline Travel Illness or Death Inves- 1,800 1 5/60 150
tigation Form.
Ship Medical Personnel .................... Maritime Conveyance Illness or 750 1 5/60 63
Death Investigation Form.
Traveler ............................................. Land Travel Illness or Death Inves- 100 1 5/60 8
tigation Form.
Traveler ............................................. Ebola Risk Assessment Form (Ill 100 1 15/60 25
traveler interview: English,
French, Arabic, or other as need-
ed).
Traveler ............................................. United States Traveler Health Dec- 9,000 1 15/60 2250
laration (English: Hard Copy,
fillable PDF, electronic portal).
Traveler ............................................. United States Traveler Health Dec- 8,400 1 15/60 2100
laration (French translation guide).
Traveler ............................................. United States Traveler Health Dec- 100 1 15/60 25
laration (Arabic translation guide).
Traveler ............................................. Ebola Risk Assessment Form 810 1 15/60 203
(English hard copy).
Traveler ............................................. Ebola Risk Assessment French 252 1 15/60 63
translation guide.
Traveler ............................................. Ebola Risk Assessment Arabic 5 1 15/60 1
translation guide.
Traveler ............................................. IVR Active Monitoring Survey 9,000 21 4/60 12,600
(English: Recorded).
Traveler ............................................. IVR Active Monitoring Survey 8,400 21 4/60 11,760
(French: Recorded).
Traveler ............................................. IVR Active Monitoring: Arabic trans- 100 21 4/60 140
lation assistance (no script).

Total ........................................... ........................................................... 38,817 ........................ ........................ 29,388

Leroy A. Richardson, ACTION: Notice. and Drug Administration, 8455
Chief, Information Collection Review Office, Colesville Rd., COLE–14526, Silver
Office of Scientific Integrity, Office of the SUMMARY: The Food and Drug Spring, MD 20993–0002, PRAStaff@
Associate Director for Science, Office of the Administration (FDA) is announcing fda.hhs.gov.
Director, Centers for Disease Control and that a proposed collection of
Prevention. information has been submitted to the SUPPLEMENTARY INFORMATION: In
[FR Doc. 2015–31742 Filed 12–16–15; 8:45 am] Office of Management and Budget compliance with 44 U.S.C. 3507, FDA
(OMB) for review and clearance under has submitted the following proposed
BILLING CODE 4163–18–P
the Paperwork Reduction Act of 1995. collection of information to OMB for
DATES: Fax written comments on the
review and clearance.
DEPARTMENT OF HEALTH AND collection of information by January 19, Guidance for Industry on Safety
HUMAN SERVICES 2016. Labeling Changes—Implementation of
ADDRESSES: To ensure that comments on Section 505(o)(4) of the Federal Food,
Food and Drug Administration the information collection are received, Drug, and Cosmetic Act, OMB Control
OMB recommends that written Number 0910–0734—Extension
[Docket No. FDA–2011–D–0164] comments be faxed to the Office of Section 505(o)(4) of the Federal Food,
Information and Regulatory Affairs, Drug, and Cosmetic Act (the FD&C Act)
Agency Information Collection OMB, Attn: FDA Desk Officer, FAX:
Activities; Submission for Office of (21 U.S.C. 355(o)(4)) authorizes FDA to
202–395–7285, or emailed to oira_ require, and if necessary, order labeling
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Management and Budget Review; submission@omb.eop.gov. All
Comment Request; Guidance for changes if FDA becomes aware of new
comments should be identified with the safety information that FDA believes
Industry on Safety Labeling Changes— OMB control number 0910–0734. Also
Implementation of Section 505(o)(4) of should be included in the labeling of
include the FDA docket number found certain prescription drug and biological
the Federal Food, Drug, and Cosmetic in brackets in the heading of this
Act products approved under section 505 of
document. the FD&C Act or section 351 of the PHS
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: FDA Act (42 U.S.C. 262). Section 505(o)(4) of
HHS. PRA Staff, Office of Operations, Food the FD&C Act applies to prescription

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Document Created: 2018-03-02 09:18:17
Document Modified: 2018-03-02 09:18:17

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before February 16, 2016.
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: [email protected]
FR Citation		80 FR 78738

80 FR 78738 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 242 (December 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention