Agency Forms Undergoing Paperwork Reduction Act Review, 76692-76693 [2015-31105]
Download as PDF
<![CDATA[
76692
Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Clinic ...............................................................
Laboratory .......................................................
Demographic Clinical Data Form 1 ................
Antimicrobial Susceptibility Testing Form 2 ...
Control Strain Susceptibility Testing Form 3
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. 2015–31104 Filed 12–9–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–0488]
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) 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; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) 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 submission of
responses; and (e) Assess information
collection costs.
VerDate Sep<11>2014
19:33 Dec 09, 2015
Jkt 238001
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Restrictions on Interstate Travel of
Persons (42 CFR part 70) (OMB Control
No. 0920–0488, expiration, 3/31/
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
This revision to an existing
information collection request is
intended to ensure that CDC can
continue collect pertinent information
related to communicable disease or
deaths that occur aboard conveyances
during interstate travel within the
United States, as authorized under 42
Code of Federal Regulations (CFR) part
70. Additionally, CDC is requesting
approval to use the Passenger Locator
Form in the event that travelers on
domestic flights within the United
States need to be contacted for public
health follow-up.
The intended use of the information
is to ensure that CDC can assess and
respond to reports of communicable
disease or death that occur on
conveyances engaged in interstate
travel, and assist state and local health
authorities if an illness or death occurs
that poses a risk to public health.
Generally, the primary source of this
information is aircraft and travelers
moving within the United States.
This revision makes several
modification to this information
collection. They are as follows: In
current practice, CDC does not process
applications for travel permits using the
Restriction On Travel Of Persons
Multipurpose Application Form Under
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
30
5
5
Number of
responses per
respondent
240
1,452
48
Average
burden per
response
(in hours)
11/60
1
12/60
the Provisions of 42 CFR part 70 (aka Ill
Person Travel Permit); therefore the
information collections under 42 CFR
70.3, Application to the State of
destination for a permit, Copy of
material submitted by applicant and
permit issued by State health authority
(Attending physician), and Copy of
material submitted by applicant and
permit issued by State health authority
(State health authority) are being
removed. Similarly, information
collections under 42 CFR 70.5,
Application for a permit to move from
State to State while in the
communicable period (Attending
physician) and Application for a permit
to move from State to State while in the
communicable period (Traveler) are also
being removed. The issuance of travel
restrictions is a collaborative process
between public health partners, e.g.
state health departments, the
Department of Homeland Security, and
CDC. There is no standardized
collection of information involved. This
change results in the removal of the
information collections under 42 CFR
70.3 and 70.5 from the list of
information collections as well as the
removal of the associated burden.
Reports of communicable disease or
death from domestic conveyances are
almost always submitted electronically
to meet requirements of 42 CFF 70.4, so
the current hard copy Master of Vessel
or Conveyance Illness Report, which
was constructed to be used by masters
of vessels to comply with 42 CFR 70.4,
has been rendered obsolete. In addition,
CDC has issued guidance stating that
reports to CDC, instead of local health
authorities, regarding domestic reports
of communicable disease or death on
board conveyances meet the
requirements of the regulation;
therefore, information collections
related to copies of the report sent by
masters of vessels to state health
departments are no longer necessary.
The only remaining information
collection under 42 CFR 70.4 is Report
by the master of a vessel or person in
charge of conveyance of the incidence of
a communicable disease occurring
while in interstate travel.
E:\FR\FM\10DEN1.SGM
10DEN1
76693
Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
CDC is also requesting an adjustment
to the burden associated with reports of
communicable disease or death from
domestic conveyances. CDC is reducing
the burden from 15 minutes per report
to 7 minutes. This is due to the
facilitation of reporting using electronic
means, i.e. Air Traffic Control and the
Domestic Events Network for domestic
flights, rather than the hard copy Master
of Vessel or Conveyance Illness Report.
Finally, CDC is requesting the
addition of the Passenger Locator Form
to this information collection. CDC
currently has approval to collect the
Passenger Locator Form from travelers
aboard international flights under OMB
Control Number 0920–0134. CDC is
requesting approval to collect passenger
contact and locating information for
travelers aboard domestic flights within
the United States.
The resulting change in burden is a
reduction of 3,611 hours.
Estimated Annualized Burden Hours
CDC anticipates this information
collection will result in 90 total burden
hours from 1,000 respondents. There is
no burden to respondents other than the
time required to complete and send the
requested information to CDC. The
estimated annualized burden is 90
hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Master of a vessel or person in charge of a
conveyance.
42 CFR 70.4 Report by the master of a vessel or person in charge of conveyance of
the incidence of a communicable disease
occurring while in interstate travel.
Passenger Locator Form ...............................
Traveler ...........................................................
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. 2015–31105 Filed 12–9–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
[Docket Nos. FDA–2014–E–0308 and FDA–
2014–E–0309]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; FULYZAQ
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
FULYZAQ and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by February 8, 2016.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:33 Dec 09, 2015
Jkt 238001
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
June 7, 2016. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows:
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’’).
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
200
1
7/60
800
1
5/60
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 Nos. FDA–
2014–E–0308 and FDA–2014–E–0309
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; FULYZAQ.’’ Received
comments will be placed in the dockets
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management 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’’. The
Agency will review this copy, including
the claimed confidential information, in
E:\FR\FM\10DEN1.SGM
10DEN1
]]>Agencies
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76692-76693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31105]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-0488]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
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; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
Restrictions on Interstate Travel of Persons (42 CFR part 70) (OMB
Control No. 0920-0488, expiration, 3/31/2016)-- 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
This revision to an existing information collection request is
intended to ensure that CDC can continue collect pertinent information
related to communicable disease or deaths that occur aboard conveyances
during interstate travel within the United States, as authorized under
42 Code of Federal Regulations (CFR) part 70. Additionally, CDC is
requesting approval to use the Passenger Locator Form in the event that
travelers on domestic flights within the United States need to be
contacted for public health follow-up.
The intended use of the information is to ensure that CDC can
assess and respond to reports of communicable disease or death that
occur on conveyances engaged in interstate travel, and assist state and
local health authorities if an illness or death occurs that poses a
risk to public health. Generally, the primary source of this
information is aircraft and travelers moving within the United States.
This revision makes several modification to this information
collection. They are as follows: In current practice, CDC does not
process applications for travel permits using the Restriction On Travel
Of Persons Multipurpose Application Form Under the Provisions of 42 CFR
part 70 (aka Ill Person Travel Permit); therefore the information
collections under 42 CFR 70.3, Application to the State of destination
for a permit, Copy of material submitted by applicant and permit issued
by State health authority (Attending physician), and Copy of material
submitted by applicant and permit issued by State health authority
(State health authority) are being removed. Similarly, information
collections under 42 CFR 70.5, Application for a permit to move from
State to State while in the communicable period (Attending physician)
and Application for a permit to move from State to State while in the
communicable period (Traveler) are also being removed. The issuance of
travel restrictions is a collaborative process between public health
partners, e.g. state health departments, the Department of Homeland
Security, and CDC. There is no standardized collection of information
involved. This change results in the removal of the information
collections under 42 CFR 70.3 and 70.5 from the list of information
collections as well as the removal of the associated burden. Reports of
communicable disease or death from domestic conveyances are almost
always submitted electronically to meet requirements of 42 CFF 70.4, so
the current hard copy Master of Vessel or Conveyance Illness Report,
which was constructed to be used by masters of vessels to comply with
42 CFR 70.4, has been rendered obsolete. In addition, CDC has issued
guidance stating that reports to CDC, instead of local health
authorities, regarding domestic reports of communicable disease or
death on board conveyances meet the requirements of the regulation;
therefore, information collections related to copies of the report sent
by masters of vessels to state health departments are no longer
necessary. The only remaining information collection under 42 CFR 70.4
is Report by the master of a vessel or person in charge of conveyance
of the incidence of a communicable disease occurring while in
interstate travel.
[[Page 76693]]
CDC is also requesting an adjustment to the burden associated with
reports of communicable disease or death from domestic conveyances. CDC
is reducing the burden from 15 minutes per report to 7 minutes. This is
due to the facilitation of reporting using electronic means, i.e. Air
Traffic Control and the Domestic Events Network for domestic flights,
rather than the hard copy Master of Vessel or Conveyance Illness
Report.
Finally, CDC is requesting the addition of the Passenger Locator
Form to this information collection. CDC currently has approval to
collect the Passenger Locator Form from travelers aboard international
flights under OMB Control Number 0920-0134. CDC is requesting approval
to collect passenger contact and locating information for travelers
aboard domestic flights within the United States.
The resulting change in burden is a reduction of 3,611 hours.
Estimated Annualized Burden Hours
CDC anticipates this information collection will result in 90 total
burden hours from 1,000 respondents. There is no burden to respondents
other than the time required to complete and send the requested
information to CDC. The estimated annualized burden is 90 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Master of a vessel or person in charge 42 CFR 70.4 Report by 200 1 7/60
of a conveyance. the master of a vessel
or person in charge of
conveyance of the
incidence of a
communicable disease
occurring while in
interstate travel.
Traveler.............................. Passenger Locator Form.. 800 1 5/60
----------------------------------------------------------------------------------------------------------------
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. 2015-31105 Filed 12-9-15; 8:45 am]
BILLING CODE 4163-18-P
