Agency Forms Undergoing Paperwork Reduction Act Review, 28881-28882 [2012-11874]
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Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Notices
HIT Policy Committee Advisory
Meeting; Notice of Meeting
Robertson at least seven (7) days in advance
of the meeting.
Notice of this meeting is given under the
Federal Advisory Committee Act (Pub. L. 92–
463, 5 U.S.C., App. 2).
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice of meeting.
Dated: May 7, 2012.
MacKenzie Robertson,
FACA Program Lead, Office of Policy and
Planning, Office of the National Coordinator
for Health Information Technology.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
srobinson on DSK4SPTVN1PROD with NOTICES
This notice announces a forthcoming
meeting of a public advisory committee
of the Office of the National Coordinator
for Health Information Technology
(ONC). The meeting will be open to the
public.
[FR Doc. 2012–11776 Filed 5–15–12; 8:45 am]
Name of Committee: HIT Policy
Committee.
General Function of the Committee: to
provide recommendations to the National
Coordinator on a policy framework for the
development and adoption of a nationwide
health information technology infrastructure
that permits the electronic exchange and use
of health information as is consistent with
the Federal Health IT Strategic Plan and that
includes recommendations on the areas in
which standards, implementation
specifications, and certification criteria are
needed.
Date and Time: The meeting will be held
on May 30, 2012, from 4:00 p.m. to 6:00 p.m./
Eastern Time.
Location: This is a virtual meeting. For upto-date call-in information, go to the ONC
Web site, https://healthit.hhs.gov.
Contact Person: MacKenzie Robertson,
Office of the National Coordinator, HHS, 355
E Street SW., Washington, DC 20201, 202–
205–8089, Fax: 202–260–1276, email:
mackenzie.robertson@hhs.gov. Please call the
contact person for up-to-date information on
this meeting. A notice in the Federal Register
about last minute modifications that impact
a previously announced advisory committee
meeting cannot always be published quickly
enough to provide timely notice.
Agenda: The committee will hear reports
from its workgroups and updates from ONC
and other Federal agencies. ONC intends to
make background material available to the
public prior to the meeting on its Web site,
at https://healthit.hhs.gov.
Procedure: ONC is committed to the
orderly conduct of its advisory committee
meetings. Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
Committee. Written submissions may be
made to the contact person on or before two
days prior to the Committee’s meeting date.
Oral comments from the public will be
scheduled in the agenda. Time allotted for
each presentation will be limited to three
minutes. If the number of speakers requesting
to comment is greater than can be reasonably
accommodated during the scheduled public
comment period, ONC will take written
comments after the meeting until close of
business on that day.
ONC welcomes the attendance of the
public at its advisory committee meetings. If
you require special accommodations due to
a disability, please contact MacKenzie
Centers for Disease Control and
Prevention
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[30Day–12–0814]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC at (404) 639–7570
or send an email to omb@cdc.gov. Send
written comments to CDC Desk Officer,
Office of Management and Budget,
Washington, DC or by fax to (202) 395–
5806. Written comments should be
received within 30 days of this notice.
Proposed Project
CDC Cervical Cancer Study
(CX3)(OMB No. 0920–0814, exp. 6/30/
2012)—Revision—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The National Breast and Cervical
Cancer Early Detection Program
(NBCCEDP) is the only organized
national screening program in the
United States that offers breast and
cervical cancer screening to
underserved women. Current NBCCEDP
screening standards for cervical cancer
include an annual Pap test until a
woman has had three consecutive
normal Pap tests, at which time the Pap
test frequency is reduced to every three
years.
An alternative cervical cancer
screening strategy involves
administration of both the Pap test and
a human papillomavirus (HPV) DNA
test. Because persistent, carcinogenic
HPV is strongly predictive of cervical
cancer, this strategy, called HPV cotesting, can be used to identify women
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28881
who should be screened frequently for
signs of cervical cancer. HPV co-testing
can also be used to extend the screening
interval for women who are low risk,
i.e., both cytology negative and HPV
negative. HPV co-testing is
recommended by national
organizations, but health care providers
have been slow to adopt it or to use the
results of HPV testing to modify the
frequency of cervical cancer screening
with the Pap test.
CDC is currently conducting a pilot
study in 15 clinics in Illinois to examine
the effects of an educational
intervention aimed at improving patient
and provider understanding of HPV cotesting (CDC Cervical Cancer Study
(CX3)). The specific aims of the study
are to: (1) Assess whether provider and
patient education leads to extended
screening intervals for women who have
negative screening results; (2) identify
facilitators and barriers to acceptance
and appropriate use of the HPV test and
longer screening intervals; (3) track
costs associated with HPV testing and
educational interventions; and
(4) identify the HPV genotypes among
this sample of low income women.
Secondary goals of the study are to:
(1) Assess follow-up of women with
positive test results and (2) determine
provider knowledge and acceptability of
the HPV vaccine.
During the first three years of the
study, each participating clinic was
assigned to one of two study arms.
Clinics in the intervention group
administered the HPV DNA tests to
eligible patients, along with a multicomponent educational intervention
involving both providers and patients.
Clinics in the comparison group
administered the HPV tests, but patients
and providers have not received the
educational intervention. A total of
2,246 women between the ages of 30
and 60 have been recruited into the
study. Baseline information collection
has been completed for an initial clinic
survey, a 12-month follow-up clinic
survey, a baseline provider survey,
patient recruitment and enrollment, and
a baseline patient survey. Information
collection was initiated for a 36-month
follow-up provider survey and an
18-month follow-up patient survey.
These activities were described in the
original Information Collection Request.
In order to complete the study as
planned, CDC requests one additional
year of approval from OMB. Information
collection will include completion of
the 18-month follow-up survey for
approximately 150 patients and
completion of the 36-month follow-up
survey for 70 providers. The final year
of the study will also include focus
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16MYN1
28882
Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Notices
groups with approximately 75
providers.
Information collected through followup surveys of patients and providers
will be used to assess changes in
knowledge, attitudes, beliefs and
behavior regarding cervical cancer
screening. Qualitative information
collected during the focus groups with
providers will be used to identify
facilitators and barriers to acceptance
and appropriate use of the HPV test and
longer screening intervals. Findings
from the CX3 study will help inform
NBCCEDP standards for primary
cervical cancer screening, including
reimbursement guidelines for the HPV
DNA test.
Participation in the CX3 study is
voluntary and there are no costs to
respondents other than their time. OMB
approval is requested for one year.
Because the majority of information
collection activities were completed in
the first three years of the study, the
estimated burden to respondents will
decrease in the final year of OMB
approval. The total estimated
annualized burden hours are 135.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Patients ...................................................
Providers .................................................
Follow-up Patient Survey .......................................
Follow-up Provider Survey .....................................
Focus Group Moderator Guide ..............................
Kimberly S. Lane,
Deputy Director, Office of Science Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
Health (NIOSH), Centers for Disease
Control and Prevention (CDC).
[FR Doc. 2012–11874 Filed 5–15–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–12–0566]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC at (404) 639–7570
or send an email to omb@cdc.gov. Send
written comments to 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
srobinson on DSK4SPTVN1PROD with NOTICES
Evaluation of Worker Notification
Program (0920–0566, Expiration 2/28/
2011)—Reinstatement—National
Institute for Occupational Safety and
Background and Brief Description
The National Institute for
Occupational Safety and Health
(NIOSH), under Section 20(a)(1), (a)(4),
(a)(7)(c), and Section 22(d), (e)(5)(7) of
the Occupational Safety and Health Act
(29 U.S.C. 669), ‘‘has the responsibility
to conduct research relating to
occupational safety and health relating
to innovative methods, techniques, and
approaches for dealing with
occupational safety and health
problems.’’ Although the research
studies continued, the notification
activities were discontinued after the
extension ICR was not submitted to
OMB before the original expiration date.
Since the Right to Know movement in
the late 1970s, NIOSH has been
developing methods and materials to
notify subjects of its epidemiological
studies. Within NIOSH, notifying
workers of past exposures is done to
inform surviving cohort members of
findings from NIOSH studies. Current
NIOSH policy dictates how and when
worker notification should occur. The
extent of the notification effort depends
upon the level of excess mortality or the
extent of the disease or illness found in
the study population. Current
notification efforts range from posting
results at the facilities studied to
mailing individual letters to surviving
members of the study population and
other stakeholders. Each year, the
Number of
responses
per
respondent
150
70
75
Average
burden per
response
(in hours)
1
1
1
10/60
30/60
1
NIOSH Industrywide Studies Branch
(IWSB), Division of Surveillance,
Hazard Evaluation, and Field Studies
(DSHEFS) typically prepares materials
for two to three completed studies. This
often requires individual letters be
mailed to study populations ranging in
size from 200–20,000 workers each. An
evaluation instrument would gauge the
effectiveness of notification materials
and improve future communication of
risk information.
The purpose of the proposed Reader
Response Postcard is to obtain feedback
from workers that would improve the
quality and usefulness of the Institute’s
worker notification activities. The actual
number of notifications required in a
given year cannot be known in advance.
Each year, the NIOSH IWSB, DSHEFS,
typically prepares materials for two to
three completed studies. This often
requires individual letters be mailed to
study populations ranging in size from
200–20,000 workers each, averaging
8,000/yr. Researchers from NIOSH
propose to routinely include a Reader
Response postcard with notification
materials to assess the value and
usefulness of said materials. The Reader
Response postcard was tested internally
and the average time to complete was 10
minutes. We are requesting approval for
three years. Participation is voluntary
and there is no cost to respondents
except for their time. The total
estimated annual burden hours are
1,333.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Number of
respondents
Number of
responses
Avg. burden
per response
(hours)
Reader Response Card ...............................................................................................................
8,000
1
10/60
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]]>Agencies
[Federal Register Volume 77, Number 95 (Wednesday, May 16, 2012)]
[Notices]
[Pages 28881-28882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11874]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-12-0814]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC at (404) 639-7570 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of Management and Budget,
Washington, DC or by fax to (202) 395-5806. Written comments should be
received within 30 days of this notice.
Proposed Project
CDC Cervical Cancer Study (CX3)(OMB No. 0920-0814, exp. 6/30/
2012)--Revision--National Center for Chronic Disease Prevention and
Health Promotion (NCCDPHP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The National Breast and Cervical Cancer Early Detection Program
(NBCCEDP) is the only organized national screening program in the
United States that offers breast and cervical cancer screening to
underserved women. Current NBCCEDP screening standards for cervical
cancer include an annual Pap test until a woman has had three
consecutive normal Pap tests, at which time the Pap test frequency is
reduced to every three years.
An alternative cervical cancer screening strategy involves
administration of both the Pap test and a human papillomavirus (HPV)
DNA test. Because persistent, carcinogenic HPV is strongly predictive
of cervical cancer, this strategy, called HPV co-testing, can be used
to identify women who should be screened frequently for signs of
cervical cancer. HPV co-testing can also be used to extend the
screening interval for women who are low risk, i.e., both cytology
negative and HPV negative. HPV co-testing is recommended by national
organizations, but health care providers have been slow to adopt it or
to use the results of HPV testing to modify the frequency of cervical
cancer screening with the Pap test.
CDC is currently conducting a pilot study in 15 clinics in Illinois
to examine the effects of an educational intervention aimed at
improving patient and provider understanding of HPV co-testing (CDC
Cervical Cancer Study (CX3)). The specific aims of the study are to:
(1) Assess whether provider and patient education leads to extended
screening intervals for women who have negative screening results; (2)
identify facilitators and barriers to acceptance and appropriate use of
the HPV test and longer screening intervals; (3) track costs associated
with HPV testing and educational interventions; and (4) identify the
HPV genotypes among this sample of low income women. Secondary goals of
the study are to: (1) Assess follow-up of women with positive test
results and (2) determine provider knowledge and acceptability of the
HPV vaccine.
During the first three years of the study, each participating
clinic was assigned to one of two study arms. Clinics in the
intervention group administered the HPV DNA tests to eligible patients,
along with a multi-component educational intervention involving both
providers and patients. Clinics in the comparison group administered
the HPV tests, but patients and providers have not received the
educational intervention. A total of 2,246 women between the ages of 30
and 60 have been recruited into the study. Baseline information
collection has been completed for an initial clinic survey, a 12-month
follow-up clinic survey, a baseline provider survey, patient
recruitment and enrollment, and a baseline patient survey. Information
collection was initiated for a 36-month follow-up provider survey and
an 18-month follow-up patient survey. These activities were described
in the original Information Collection Request.
In order to complete the study as planned, CDC requests one
additional year of approval from OMB. Information collection will
include completion of the 18-month follow-up survey for approximately
150 patients and completion of the 36-month follow-up survey for 70
providers. The final year of the study will also include focus
[[Page 28882]]
groups with approximately 75 providers.
Information collected through follow-up surveys of patients and
providers will be used to assess changes in knowledge, attitudes,
beliefs and behavior regarding cervical cancer screening. Qualitative
information collected during the focus groups with providers will be
used to identify facilitators and barriers to acceptance and
appropriate use of the HPV test and longer screening intervals.
Findings from the CX3 study will help inform NBCCEDP standards for
primary cervical cancer screening, including reimbursement guidelines
for the HPV DNA test.
Participation in the CX3 study is voluntary and there are no costs
to respondents other than their time. OMB approval is requested for one
year. Because the majority of information collection activities were
completed in the first three years of the study, the estimated burden
to respondents will decrease in the final year of OMB approval. The
total estimated annualized burden hours are 135.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Patients........................... Follow-up Patient Survey... 150 1 10/60
Providers.......................... Follow-up Provider Survey.. 70 1 30/60
Focus Group Moderator Guide 75 1 1
----------------------------------------------------------------------------------------------------------------
Kimberly S. Lane,
Deputy Director, Office of Science Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012-11874 Filed 5-15-12; 8:45 am]
BILLING CODE 4163-18-P
