Agency Forms Undergoing Paperwork Reduction Act Review, 62907-62908 [2016-21922]
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Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices
recommendations for Congress and the
President for commemorating the
centennial of World War I. The
Commission does not have an
appropriation and operated solely on
donated funds.
Agenda: Friday September 30, 2016
Old Business
• Acceptance of minutes of last meeting
• Public Comment Period
New Business
• Executive Director’s Report—Mr.
Dayton
• Approval of United States Foundation
Relationship Memo
• Approval of Budget Request for
Foundation
• Memorial Report—Mr. Fountain
• Education Report—Dr. O’Connell
• Endorsements—(RFS)—Dr. Seefried
• International Report—Dr. Seefried
• Report on April 6 Event—Drs.
Seefried and Naylor
• Other Business
• Chairman’s Report
• Set Next Meeting
• Motion to Adjourn
BILLING CODE 6820–95–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–16BBS]
Proposed Data Collection Submitted
for Public Comment and
Recommendations—Airline and
Traveler Information Collection:
Domestic Manifests and the Passenger
Locator Form; Correction
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice; Correction.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) published
a document in the Federal Register of
September 2, 2016, concerning request
for comments on Proposed Data
Collection Submitted for Public
Comment and Recommendations—
Airline and Traveler Information
Collection: Domestic Manifests and the
Passenger Locator Form. The document
provided the incorrect docket number
(CDC–2016–0088).
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15:27 Sep 12, 2016
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Correction
In the Federal Register of September
2, 2016, in FR Doc. 2016–21103, on page
60702, in the second column (second
and third paragraphs), correct the
Docket No. to read:
CDC–2016–0086
Dated: September 9, 2016.
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. 2016–21923 Filed 9–12–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Agency Forms Undergoing Paperwork
Reduction Act Review
[FR Doc. 2016–21901 Filed 9–12–16; 8:45 am]
VerDate Sep<11>2014
Leroy Richardson, 1600 Clifton Road,
MS D–74, Atlanta, GA 30333; telephone
(404) 639–4965; email: omb@cdc.gov.
[30Day–16–1005]
Dated: September 7, 2016.
Daniel S. Dayton,
Designated Federal Official, World War I
Centennial Commission.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
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
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62907
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
Older Adult Safe Mobility Assessment
Tool (OMB Control No. 0920–1005,
Expiration Date: 10/31/2016)—
Extension—National Center for Injury
Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) is seeking OMB
approval to extend the previously
approved information collection project
under OMB Control Number 0920–1005
to evaluate the Mobility Planning Tool
(MPT).
Within the Injury Center, preventing
falls and ensuring safe transportation for
older adults are strategic priorities. The
purposes of this information collection
is to evaluate whether the Mobility
Planning Tool is effective for promoting
readiness to adopt mobility-protective
behaviors in older adults and to assess
potential strategies for dissemination of
the MPT.
The study population is communityliving older adults ages 60–74 with no
known mobility limitations.
Effectiveness of the tool will be assessed
using two different comparisons: (1) A
comparison between individuals’
attitudes and behaviors related to
protecting their mobility as they age
before and after receiving the MPT in
the group that received the MPT, and (2)
a comparison of both mobility-related
attitudes and behaviors and changes
between the group that received the
MPT and the group that did not receive
the MPT.
Study findings will be used to
identify areas of the MPT that may need
revision before it is disseminated
publicly.
There are no costs to respondents
other than their time. The total
estimated annual burden hours are 367.
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13SEN1
62908
Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Type of respondents
Form name
Individuals Responding to Initial Phone Call
Who Refuse to be Screened.
Individuals Responding to Initial Phone Call
Responding to Screening Questions.
Study Participants ...........................................
Study Participants ...........................................
Study Participants ...........................................
Screening Interview Guide .............................
1,250
1
1/60
Screening Interview Guide .............................
750
1
5/60
Baseline Interview Guide ...............................
MPT ................................................................
Follow-up Interview Guide .............................
500
250
450
1
1
1
10/60
30/60
10/60
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. 2016–21922 Filed 9–12–16; 8:45 am]
BILLING CODE 4163–18–P
Food and Drug Administration
[Docket No. FDA–2015–D–2244]
Qualification of Biomarker—Plasma
Fibrinogen in Studies Examining
Exacerbations and/or All-Cause
Mortality for Patients With Chronic
Obstructive Pulmonary Disease;
Guidance for Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Qualification of Biomarker—Plasma
Fibrinogen in Studies Examining
Exacerbations and/or All-Cause
Mortality for Patients With Chronic
Obstructive Pulmonary Disease.’’ This
guidance provides a qualified context of
use (COU) for plasma fibrinogen in
interventional clinical trials of chronic
obstructive pulmonary disease (COPD)
subjects at high risk for exacerbations
and/or all-cause mortality. This
guidance also describes the
experimental conditions and constraints
for which this biomarker is qualified
through the Center for Drug Evaluation
and Research (CDER) Biomarker
Qualification Program. This biomarker
can be used by drug developers for the
qualified COU in submissions of
investigational new drug applications
(INDs), new drug applications (NDAs),
and biologics license applications
(BLAs) without the relevant CDER
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SUMMARY:
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Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comment
as follows:
DATES:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
review group reconsidering and
reconfirming the suitability of the
biomarker.
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): 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,
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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–
2015–D–2244 for ‘‘Qualification for the
Use of Plasma Fibrinogen in Studies
Examining Exacerbations and/or AllCause Mortality for Patients with
Chronic Obstructive Pulmonary Disease;
Availability.’’ Received comments will
be placed in the docket 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
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 Division of Dockets
Management. If you do not wish your
name and contact information to 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 this
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.fda.gov/
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]]>Agencies
[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62907-62908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21922]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-1005]
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
Older Adult Safe Mobility Assessment Tool (OMB Control No. 0920-
1005, Expiration Date: 10/31/2016)--Extension--National Center for
Injury Prevention and Control (NCIPC), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC) is seeking OMB
approval to extend the previously approved information collection
project under OMB Control Number 0920-1005 to evaluate the Mobility
Planning Tool (MPT).
Within the Injury Center, preventing falls and ensuring safe
transportation for older adults are strategic priorities. The purposes
of this information collection is to evaluate whether the Mobility
Planning Tool is effective for promoting readiness to adopt mobility-
protective behaviors in older adults and to assess potential strategies
for dissemination of the MPT.
The study population is community-living older adults ages 60-74
with no known mobility limitations. Effectiveness of the tool will be
assessed using two different comparisons: (1) A comparison between
individuals' attitudes and behaviors related to protecting their
mobility as they age before and after receiving the MPT in the group
that received the MPT, and (2) a comparison of both mobility-related
attitudes and behaviors and changes between the group that received the
MPT and the group that did not receive the MPT.
Study findings will be used to identify areas of the MPT that may
need revision before it is disseminated publicly.
There are no costs to respondents other than their time. The total
estimated annual burden hours are 367.
[[Page 62908]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Individuals Responding to Initial Screening Interview 1,250 1 1/60
Phone Call Who Refuse to be Screened. Guide.
Individuals Responding to Initial Screening Interview 750 1 5/60
Phone Call Responding to Screening Guide.
Questions.
Study Participants................... Baseline Interview Guide 500 1 10/60
Study Participants................... MPT..................... 250 1 30/60
Study Participants................... Follow-up Interview 450 1 10/60
Guide.
----------------------------------------------------------------------------------------------------------------
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. 2016-21922 Filed 9-12-16; 8:45 am]
BILLING CODE 4163-18-P
