Proposed Information Collection Activity; Comment Request, 6126-6127 [2012-2656]
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Federal Register / Vol. 77, No. 25 / Tuesday, February 7, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Impact Studies of the Health
Professions Opportunity Grants.
OMB No.: New Collection.
Description
The Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS) is
proposing data collection activities as
part of the Impact Studies of the Health
Professions Opportunity Grants (HPOGImpact). The goal of HPOG-Impact is to
evaluate the effectiveness of approaches
HPOG grantees use to provide
Temporary Assistance for Needy
Families (TANF) recipients and other
low-income individuals with
opportunities for education, training
and advancement within the health care
field. HPOG-Impact also is intended to
evaluate variation in participant impact
that may be attributable to different
HPOG program components and
models. The impact study design is a
classic experiment in which eligible
applicants for HPOG program services
will be randomly assigned to a
treatment group offered participation in
HPOG and a control group not offered
the opportunity to enroll in HPOG.
To achieve these goals, it is necessary
to collect data about both treatment
group and control group sample
members. It also is necessary to collect
data about implementation from
program operators (site managers and
staff) and from employers involved in
programs. This 60-day notice describes
the universe of data collection efforts for
this study. However, this information
request is limited to the baseline
surveys and the program
implementation data collection
activities, which are described under 1,
2, 3, and 4 below. As part of this
submission, we are also requesting
permission to waive 60-day notices
necessary for the follow-up surveys
(described under 5 and 6 below).
The universe of information
collection proposed for HPOG-Impact
includes:
1. Brief baseline survey of eligible
applicants to HPOG programs. This
survey will augment data already
collected about eligible program
applicants through the Performance
Reporting System (PRS) that currently is
being used in the Implementation,
Systems and Outcome Evaluation of the
Tribal and Low-Income Health
Profession Opportunity Grants (OMB
Control No. 0970–0394). To reduce
burden to the extent possible, HPOGImpact will use data from the PRS. The
15-minute ‘‘supplemental survey’’ will
collect any additional information
necessary for HPOG-Impact and will be
administered prior to random
assignment.
2. In-person interviews with HPOG
site managers. The site manager
protocol will collect data about program
design and content and will provide
information about the grantees’ rationale
for applying for HPOG funding, about
administrative challenges and about
challenges implementing programs as
planned.
3. In-person interviews with HPOG
site staff. The protocol for site staff will
include questions about staff roles and
responsibilities and perceptions of the
program.
4. In-person interviews with
partnering employer(s). The protocol for
employers will include questions about
employers’ rationale for participating in
the effort, their perceptions of program
strengths and challenges, and their role
in program design and implementation.
At each site, evaluators will conduct
one meeting with an average of two
employers.
5. A follow-up survey of both
treatment and control group members.
This survey will be administered
approximately 12 months after baseline.
It will be administered by phone with
field back-up. It will collect data about
program experiences and outcomes of
interest, including certifications and
educational achievements, job
placement, wages, and benefits. It also
will collect some information about
participants’ tenure and experience in
HPOG programming.
6. A second follow-up survey of both
treatment and control group members.
This survey will be administered
approximately 30 months after baseline
and will be administered by phone with
field back-up. It will collect updated
information about outcomes of interest,
including certifications and educational
achievements, job placement, wages,
and benefits.
Respondents
Individuals enrolled in HPOG
interventions; control group members;
HPOG program managers; HPOG
program staff, including program
designers, instructors, case managers;
employers.
ANNUAL RESPONSE BURDEN ESTIMATES
[These data collection activities will occur over a two-year period]
Annual
number of
respondents
Instrument
tkelley on DSK3SPTVN1PROD with NOTICES
1.
2.
3.
4.
Brief baseline survey of eligible applicants to HPOG programs ...............
In-person interviews with HPOG site managers .......................................
In-person interviews with HPOG site staff ................................................
In-person interviews with partnering employer(s) .....................................
Estimated Annual Response Burden
Hours: 1,375.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families (ACF), Department of Health
and Human Services, is soliciting public
comment on the specific aspects of the
information collection described above.
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17:34 Feb 06, 2012
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4000
50
200
25
Copies of the proposed collection of
information can be obtained and
comments may be forwarded in writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. Email address:
OPREinfocollection@acf.hhs.gov. All
PO 00000
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Number of
responses per
respondent
Average burden
hours per
response
Annual burden
hours
.25
1000
150
200
25
1
1
1
1
3
1
1
requests should be identified by the title
of the information collection.
The Department specifically requests
comments 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
E:\FR\FM\07FEN1.SGM
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Federal Register / Vol. 77, No. 25 / Tuesday, February 7, 2012 / Notices
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: January 30, 2012.
Steven M. Hanmer,
Reports Clearance, Officer.
[FR Doc. 2012–2656 Filed 2–6–12; 8:45 am]
BILLING CODE 4184–09–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0084]
Submission of Extended Digital
Electrocardiogram Waveform Data;
Notice of Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting to consider changes in
how digital electrocardiogram (ECG)
data gathered to assess a drug’s adverse
effects on heart function should be
submitted for review. At the meeting, an
extension of the Health Level-7 (HL7)
Annotated ECG standard data format—
used by the ECG warehouse—will be
presented. The new data format is
intended to facilitate electronic
submission and sharing of ECG data
from continuous recordings. We
encourage device manufacturers, ECG
laboratories, investigators, industry, and
academic researchers to offer advice on
the proposed format and perspective on
the collection, analysis, submission, and
review of data from long-term
continuous ECG recordings for assessing
the safety of investigational drugs.
Date and Time: The public meeting
will be held on Wednesday, March 14,
2012, from 8 a.m. to 5 p.m.
Location: The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 2,
rm. 2031, Silver Spring, MD 20993.
Contact Person: Devi Kozeli, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4183,
Silver Spring, MD 20993–0002, (301)
796–1128, FAX: (301) 796–9841, email:
Devi.Kozeli@fda.hhs.gov.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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17:34 Feb 06, 2012
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Attendance and Registration: The
FDA Conference Center at the White
Oak location is a Federal facility with
security procedures and limited seating.
Therefore, early arrival is encouraged.
There is no fee to attend the meeting,
and attendees who do not wish to make
an oral presentation do not need to
register. Seating will be on a first-come,
first-served basis.
If you would like to make an oral
presentation during the meeting, you
must register by sending an email to
devi.kozeli@fda.hhs.gov by February 14,
2012. Your email should contain
complete contact information for each
attendee, including name, title,
affiliation, address, email address, and
phone number. We will try to
accommodate all persons who wish to
make a presentation. Registrants will
receive confirmation after they have
been selected. Persons registered to
make an oral presentation should check
in before the meeting. If you need
special accommodations because of a
disability, please contact Devi Kozeli
(see Contact Person) at least 7 days
before the meeting.
Comments: Interested persons may
submit either electronic or written
comments regarding this document.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday. To
ensure consideration, all comments
must be received by March 28, 2012.
SUPPLEMENTARY INFORMATION:
I. Background
Some drugs are known to interfere
with the electrical function of the heart
by delaying cardiac repolarization, and
this delay may be associated with
serious and sometimes fatal adverse
events. Delay in cardiac repolarization
can be assessed with an ECG, a
recording of the cyclical changes in the
heart’s electrical activity. The delay is
quantified as the increase in the Q wave
and T wave (QT) interval, the length of
time corresponding to the start of the Q
wave and the end of the T wave on the
ECG tracing. In 2005, FDA issued a
guidance that was developed within the
Expert Working Group of the
International Conference on
Harmonization of Technical
Requirements (ICH) that made
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Fmt 4703
Sfmt 9990
6127
recommendations for the gathering and
submission of ECG data, the clinical
evaluation of the QT interval, and
reporting of adverse events.
In responding to this guidance (ICH
E–14), investigators of the efficacy and
safety of drugs typically submit
digitized 10-second ECGs taken at key
protocol time points to FDA’s ECG
Warehouse. These ECGs are often
extracted from continuous ECG
recordings collected on Holter,
Telemetry, and other long-term
monitoring devices. ECG information
submitted through the ECG warehouse
should be in a format that was jointly
developed by FDA, sponsors, core
laboratories, and device manufactures
under the auspices of HL7, an
international organization of
information scientists who collaborate
to create standards for the exchange of
electronic healthcare information.
Because effects on heart function that
are only apparent in long-term ECG data
from continuous recordings have been
shown to be important in the evaluation
of drug efficacy and safety, FDA plans
to request these data whenever they are
collected in clinical trials. This will
necessitate changes in the HL7
Annotated ECG.
II. Purpose and Scope of the Meeting
The HL7 Annotated ECG data format
will be discussed, and changes to it for
handling long-term ECG data from
continuous recordings will be proposed.
The revised format is expected to
proceed through the standard approval
processes of HL7. Needed expansions to
the hardware and software resources of
FDA’s ECG Warehouse and
modifications to the upload process for
ECG data are underway. FDA is
interested in the perspective of
manufacturers, ECG laboratories,
investigators, industry, and academic
researchers as it seeks to improve the
collection, analysis, submission, and
review of continuous ECG recordings for
purposes of assessing drug safety.
Dated: February 2, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–2756 Filed 2–6–12; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 77, Number 25 (Tuesday, February 7, 2012)]
[Notices]
[Pages 6126-6127]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2656]
[[Page 6126]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Impact Studies of the Health Professions Opportunity Grants.
OMB No.: New Collection.
Description
The Administration for Children and Families (ACF), U.S. Department
of Health and Human Services (HHS) is proposing data collection
activities as part of the Impact Studies of the Health Professions
Opportunity Grants (HPOG-Impact). The goal of HPOG-Impact is to
evaluate the effectiveness of approaches HPOG grantees use to provide
Temporary Assistance for Needy Families (TANF) recipients and other
low-income individuals with opportunities for education, training and
advancement within the health care field. HPOG-Impact also is intended
to evaluate variation in participant impact that may be attributable to
different HPOG program components and models. The impact study design
is a classic experiment in which eligible applicants for HPOG program
services will be randomly assigned to a treatment group offered
participation in HPOG and a control group not offered the opportunity
to enroll in HPOG.
To achieve these goals, it is necessary to collect data about both
treatment group and control group sample members. It also is necessary
to collect data about implementation from program operators (site
managers and staff) and from employers involved in programs. This 60-
day notice describes the universe of data collection efforts for this
study. However, this information request is limited to the baseline
surveys and the program implementation data collection activities,
which are described under 1, 2, 3, and 4 below. As part of this
submission, we are also requesting permission to waive 60-day notices
necessary for the follow-up surveys (described under 5 and 6 below).
The universe of information collection proposed for HPOG-Impact
includes:
1. Brief baseline survey of eligible applicants to HPOG programs.
This survey will augment data already collected about eligible program
applicants through the Performance Reporting System (PRS) that
currently is being used in the Implementation, Systems and Outcome
Evaluation of the Tribal and Low-Income Health Profession Opportunity
Grants (OMB Control No. 0970-0394). To reduce burden to the extent
possible, HPOG-Impact will use data from the PRS. The 15-minute
``supplemental survey'' will collect any additional information
necessary for HPOG-Impact and will be administered prior to random
assignment.
2. In-person interviews with HPOG site managers. The site manager
protocol will collect data about program design and content and will
provide information about the grantees' rationale for applying for HPOG
funding, about administrative challenges and about challenges
implementing programs as planned.
3. In-person interviews with HPOG site staff. The protocol for site
staff will include questions about staff roles and responsibilities and
perceptions of the program.
4. In-person interviews with partnering employer(s). The protocol
for employers will include questions about employers' rationale for
participating in the effort, their perceptions of program strengths and
challenges, and their role in program design and implementation. At
each site, evaluators will conduct one meeting with an average of two
employers.
5. A follow-up survey of both treatment and control group members.
This survey will be administered approximately 12 months after
baseline. It will be administered by phone with field back-up. It will
collect data about program experiences and outcomes of interest,
including certifications and educational achievements, job placement,
wages, and benefits. It also will collect some information about
participants' tenure and experience in HPOG programming.
6. A second follow-up survey of both treatment and control group
members. This survey will be administered approximately 30 months after
baseline and will be administered by phone with field back-up. It will
collect updated information about outcomes of interest, including
certifications and educational achievements, job placement, wages, and
benefits.
Respondents
Individuals enrolled in HPOG interventions; control group members;
HPOG program managers; HPOG program staff, including program designers,
instructors, case managers; employers.
Annual Response Burden Estimates
[These data collection activities will occur over a two-year period]
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average burden
Instrument of responses per hours per Annual burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
1. Brief baseline survey of eligible applicants 4000 1 .25 1000
to HPOG programs...............................
2. In-person interviews with HPOG site managers. 50 1 3 150
3. In-person interviews with HPOG site staff.... 200 1 1 200
4. In-person interviews with partnering 25 1 1 25
employer(s)....................................
----------------------------------------------------------------------------------------------------------------
Estimated Annual Response Burden Hours: 1,375.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families (ACF), Department of Health and Human Services, is soliciting
public comment on the specific aspects of the information collection
described above. Copies of the proposed collection of information can
be obtained and comments may be forwarded in writing to the
Administration for Children and Families, Office of Planning, Research
and Evaluation, 370 L'Enfant Promenade, SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer. Email address:
OPREinfocollection@acf.hhs.gov. All requests should be identified by
the title of the information collection.
The Department specifically requests comments 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
[[Page 6127]]
proposed collection of information; (c) the quality, utility, and
clarity of the information to be collected; and (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. Consideration will be given to comments and
suggestions submitted within 60 days of this publication.
Dated: January 30, 2012.
Steven M. Hanmer,
Reports Clearance, Officer.
[FR Doc. 2012-2656 Filed 2-6-12; 8:45 am]
BILLING CODE 4184-09-M
