Proposed Data Collection Submitted for Public Comment and Recommendations, 45246-45247 [2018-19294]
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45246
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
Jeffrey M. Zirger,
Acting 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. 2018–19296 Filed 9–5–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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 a proposed and/or
continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled ‘‘Assessment of
Outcomes Associated with the
Preventive Health and Health Services
Block Grant’’. This assessment will
assess select cross-cutting outputs and
outcomes of the Preventive Health and
Health Services Block Grant and
demonstrates the utility of the grant on
a national level.
DATES: CDC must receive written
comments on or before November 5,
2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0081 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, 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. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
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16:56 Sep 05, 2018
Jkt 244001
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffery M. Zirger,
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.
FOR FURTHER INFORMATION CONTACT:
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.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. 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 submissions
of responses.
5. Assess information collection costs.
SUPPLEMENTARY INFORMATION:
[60Day–18–18AVU; Docket No. CDC–2018–
0081]
SUMMARY:
(regulations.gov) or by U.S. mail to the
address listed above.
Proposed Project
Assessment of Outcomes Associated
with the Preventive Health and Health
Services Block Grant—New—Office for
State, Tribal, Local and Territorial
Support (OSTLTS), Centers for Disease
Control and Prevention (CDC).
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Fmt 4703
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Background and Brief Description
For more than 35 years, the
Preventive Health and Health Services
Block Grant (PHHS Block Grant) has
provided flexible funding for all 50
states, the District of Columbia, two
American Indian tribes, five U.S.
territories, and three freely associated
states to address the unique public
health needs of their jurisdictions in
innovative and locally defined ways.
First authorized by Congress in 1981
through the Public Health Service Act
(Pub. L. 102–531), the fundamental and
enduring purpose of the grant has been
to provide grantees with flexibility and
control to address their priority public
health needs. In 1992, Congress
amended the law to align PHHS Block
Grant funding priorities with the 22
chapters specified in Healthy People
(HP) 2000, a set of national objectives
designed to guide health promotion and
disease prevention efforts. Additional
amendments included set-aside funds
specifically dedicated to sex offense
prevention and victim services, thus
requiring grantees receiving this support
to include related HP objectives and
activities as part of their PHHS Block
Grant-funded local programs.
CDC is establishing a comprehensive,
standardized method to collect data to
describe select outputs and outcomes
and ensure the accountability of the
PHHS Block Grant. The CDC PHHS
Block Grant Measurement Framework is
an innovative approach to assessing
cross-cutting outputs and outcomes
resulting from grantees’ use of flexible
grant funds. The framework defines four
measures that enable CDC to
standardize the collection of data on
grantee achievements. The measures
capture data on public health
infrastructure improved (i.e.,
information systems improved and
quality improved—efficiency and
effectiveness improvements achieved in
programs, services, and operations),
emerging public health needs
addressed, and evidence-based public
health interventions implemented.
The purpose of this information
collection request (ICR) is to collect data
that assess select cross-cutting outputs
and outcomes of the grant (as defined by
the framework measures) and that
demonstrate the utility of the grant on
a national level. This data collection
will describe the outcomes of the PHHS
Block Grant as a whole—not individual
grantee activities or outcomes. Findings
from this data collection will be used to:
(1) Describe the outcomes and
achievements of grantees’ public health
efforts and identify how the use of
PHHS Block Grant funds contributed to
E:\FR\FM\06SEN1.SGM
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45247
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
those results, and (2) help assess how
the PHHS Block Grant advances work of
the public health system and provides
evidence to support future budgetary
requests.
The respondent universe consists of
61 PHHS Block Grant coordinators, or
their designees, across 61 health
departments (50 states, the District of
Columbia, two tribes, five US territories,
and three freely associated states). The
assessment will be administered to
PHHS Block Grant coordinators
electronically via a web-based
questionnaire. A link to the assessment
will be provided by email invitation.
The survey will be completed once
every two years. The total annualized
estimated burden is 46 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total
burden
(in hours)
Form name
PHHS Block Grant Coordinators, or
Designees.
PHHS Block Grant Assessment ......
61
1
45/60
46
Total ...........................................
...........................................................
........................
........................
........................
46
Jeffrey M. Zirger,
Acting 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. 2018–19294 Filed 9–5–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3130]
Consideration of Uncertainty in Making
Benefit-Risk Determinations in Medical
Device Premarket Approvals, De Novo
Classifications, and Humanitarian
Device Exemptions; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Consideration of
Uncertainty in Making Benefit-Risk
Determinations in Medical Device
Premarket Approvals, De Novo
Classifications, and Humanitarian
Device Exemptions.’’ This guidance
document describes FDA’s current
approach to considering uncertainty in
making benefit-risk determinations to
support certain FDA premarket
decisions for medical devices—
premarket approval applications
(PMAs), De Novo requests, and
humanitarian device exemption (HDE)
applications. This guidance document
elaborates on the consideration of
uncertainty as part of our overarching
approach to a benefit-risk based
framework that is intended to assure
SUMMARY:
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Number of
responses per
respondent
Number of
respondents
Type of respondents
VerDate Sep<11>2014
16:56 Sep 05, 2018
Jkt 244001
greater predictability, consistency, and
efficiency through the application of
least burdensome principles. This draft
guidance also provides examples of how
the principles for considering
uncertainty could be applied in the
context of clinical evidence and
circumstances where greater uncertainty
could be appropriate in premarket
decisions, balanced by postmarket
controls—PMAs for Breakthrough
Devices and PMAs for devices for small
patient populations. This draft guidance
is not final nor is it in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by December 5, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
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
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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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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 No. FDA–
2018–D–3130 for ‘‘Consideration of
Uncertainty in Making Benefit-Risk
Determinations in Medical Device
Premarket Approvals, De Novo
Classifications, and Humanitarian
Device Exemptions; Draft Guidance for
Industry and Food and Drug
Administration Staff.’’ 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 Dockets Management Staff
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
E:\FR\FM\06SEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45246-45247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19294]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-18-18AVU; Docket No. CDC-2018-0081]
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 a proposed and/
or continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled ``Assessment of Outcomes
Associated with the Preventive Health and Health Services Block
Grant''. This assessment will assess select cross-cutting outputs and
outcomes of the Preventive Health and Health Services Block Grant and
demonstrates the utility of the grant on a national level.
DATES: CDC must receive written comments on or before November 5, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0081 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments 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 Jeffery M. Zirger, 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.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. 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
submissions of responses.
5. Assess information collection costs.
Proposed Project
Assessment of Outcomes Associated with the Preventive Health and
Health Services Block Grant--New--Office for State, Tribal, Local and
Territorial Support (OSTLTS), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
For more than 35 years, the Preventive Health and Health Services
Block Grant (PHHS Block Grant) has provided flexible funding for all 50
states, the District of Columbia, two American Indian tribes, five U.S.
territories, and three freely associated states to address the unique
public health needs of their jurisdictions in innovative and locally
defined ways. First authorized by Congress in 1981 through the Public
Health Service Act (Pub. L. 102-531), the fundamental and enduring
purpose of the grant has been to provide grantees with flexibility and
control to address their priority public health needs. In 1992,
Congress amended the law to align PHHS Block Grant funding priorities
with the 22 chapters specified in Healthy People (HP) 2000, a set of
national objectives designed to guide health promotion and disease
prevention efforts. Additional amendments included set-aside funds
specifically dedicated to sex offense prevention and victim services,
thus requiring grantees receiving this support to include related HP
objectives and activities as part of their PHHS Block Grant-funded
local programs.
CDC is establishing a comprehensive, standardized method to collect
data to describe select outputs and outcomes and ensure the
accountability of the PHHS Block Grant. The CDC PHHS Block Grant
Measurement Framework is an innovative approach to assessing cross-
cutting outputs and outcomes resulting from grantees' use of flexible
grant funds. The framework defines four measures that enable CDC to
standardize the collection of data on grantee achievements. The
measures capture data on public health infrastructure improved (i.e.,
information systems improved and quality improved--efficiency and
effectiveness improvements achieved in programs, services, and
operations), emerging public health needs addressed, and evidence-based
public health interventions implemented.
The purpose of this information collection request (ICR) is to
collect data that assess select cross-cutting outputs and outcomes of
the grant (as defined by the framework measures) and that demonstrate
the utility of the grant on a national level. This data collection will
describe the outcomes of the PHHS Block Grant as a whole--not
individual grantee activities or outcomes. Findings from this data
collection will be used to: (1) Describe the outcomes and achievements
of grantees' public health efforts and identify how the use of PHHS
Block Grant funds contributed to
[[Page 45247]]
those results, and (2) help assess how the PHHS Block Grant advances
work of the public health system and provides evidence to support
future budgetary requests.
The respondent universe consists of 61 PHHS Block Grant
coordinators, or their designees, across 61 health departments (50
states, the District of Columbia, two tribes, five US territories, and
three freely associated states). The assessment will be administered to
PHHS Block Grant coordinators electronically via a web-based
questionnaire. A link to the assessment will be provided by email
invitation. The survey will be completed once every two years. The
total annualized estimated burden is 46 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
PHHS Block Grant Coordinators, PHHS Block Grant 61 1 45/60 46
or Designees. Assessment.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 46
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Acting 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. 2018-19294 Filed 9-5-18; 8:45 am]
BILLING CODE 4163-18-P
