Federal Register Notice 60-Day

2007 Registry Pilot 60-day notice.pdf

Registry of Unexplained Fatiguing Illnesses and Chronic Fatigue Syndrome (CFS): A Pilot Study

Federal Register Notice 60-Day

OMB: 0920-0788

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41758

Federal Register / Vol. 72, No. 146 / Tuesday, July 31, 2007 / Notices

are members of tribes, and have a good
sense of cultural health beliefs.
The healthcare provider group will
consist of nomination by the Indian
Health Service Chief Medical Officer
(IHSCMO), who will nominate 3 MD/
NP’s or PA’s and 3 nurses in each
region. The participating emergency
care providers will each be asked to
nominate 2 providers from a cardiology
clinic (cardiologists or cardiac nurses)
and/or a pre-hospital (EMT/Paramedic)
provider. The 6 original from each
region will subtotal to 18 emergency
care providers plus the 2 individuals
they each nominate will subtotal to 36
from each region, a total of 54 prehospital and cardiology providers

participate in the key informant
interviews will equal a minimum of
approximately 27 health providers, 15
community members or 42 key
informant interview, each contacts 2
individuals, a minimum of 168
respondents to the survey.
After the key informant interviews
have been completed and analyzed
there will be two community focus
groups each comprised of 8 to 10
participants from all three regions held.
The first involving patients who have
had an MI and the second focus group
will involve community members at risk
for MIs.
There are no costs to the respondent
except their time to participate in the
survey.

(medical providers) key informant
interviews covering all three regions.
The community key informants will
consist of 3 tribal health directors who
will nominate 3 community key
informants from each region, who will
then each nominate 2 additional
community members to be interviewed
for a sample of 30 community key
informants.
The individual key informant
interviews of the group of patients who
have had an MI or have a high risk of
MI, nominated by the physicians, nurses
and community members will be asked
to nominate individuals whom they
know have had or are at risk for a heart
attack. The medical providers and
community members asked to

ESTIMATED ANNUALIZED BURDEN HOURS
Respondents

Number of
respondents

No. of
responses per
respondent

Average
burden per
response (in
hrs.)

Healthcare providers ........................................................................................
Community leaders ..........................................................................................
Community members interviews ......................................................................
(2) Community member focus group retreats .................................................
Total ..........................................................................................................

54
30
168
20
........................

1
1
1
1
........................

1
1
1
8
........................

Dated: July 25, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–14703 Filed 7–30–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–07–06BN]

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Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an e-mail to:
[email protected].

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15:11 Jul 30, 2007

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Comments are invited 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
proposed collection of information; (c)
ways to enhance 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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Conduct a Chronic Fatigue Syndrome
Registry Pilot Test (Bibb County,
Georgia)—New—National Center for
Infectious Diseases (NCID) Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC is tasked with establishing a
registry of chronic fatigue syndrome
(CFS) and other fatiguing illnesses. The
objective of the registry is to identify
persons with unexplained fatiguing
illnesses, including CFS, who access the
healthcare system because of their
symptoms. Patients will be between the
ages of 12 and 59, inclusive.

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Total burden
(in hours)
54
30
168
160
412

Specific aims of the registry are; (1)
Identify and enroll patients with CFS
and other unexplained fatiguing
illnesses who are receiving medical and
ancillary medical care and describe
their epidemiologic and clinical
characteristics; (2) follow CFS patients
and patients with other fatiguing
illnesses over time to characterize the
natural history of CFS and other
unexplained fatiguing illnesses; (3)
assess and monitor health care
providers’ knowledge, attitudes, and
beliefs concerning CFS; (4) and to
identify well-characterized CFS patients
for clinical studies and intervention
trials. These specific aims require
inclusion of subjects in early stages of
CFS (i.e., ill less than one year duration)
who can be followed longitudinally to
assess changes in their CFS symptoms.
Data on persons with CFS in the general
population has been collected in a
separate study and is not an objective of
this Registry.
In order to determine the most
effective and cost-efficient design for
achieving the objective and specific
aims, CDC will conduct a pilot test of
the Registry of CFS and other fatiguing
illnesses in Bibb County, Georgia. The
CFS Registry Pilot Test will assess two
Registry designs for efficacy and
efficiency in identifying adult and
adolescent subjects with CFS who are

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Federal Register / Vol. 72, No. 146 / Tuesday, July 31, 2007 / Notices
receiving medical and ancillary medical
care. Specifically, the CFS Registry Pilot
Test will evaluate surveillance of
patients with CFS identified through
physician practices and a surveillance
of CFS patients identified by physicians
and other health care providers.
The proposed study will begin when
a provider refers a patient to the

registry. Patients who consent to be
contacted for the registry will be asked
to complete a detailed telephone
interview that screens for medical and
psychiatric eligibility. Eligible subjects
will be invited to have a clinical
evaluation that comprises a physical
examination; collection of blood, urine,

and saliva specimens; a mental health
interview; and self-administered
questionnaires.
There is no cost to respondents other
than their time. Patients who are
clinically evaluated will be reimbursed
for their time and effort. The total
annualized burden hours are 2,557.

ESTIMATE OF ANNUALIZED BURDEN HOURS
Average
burden per
response
(hours)

Total burden
(hours)

Referring Providers ..........................................................................................
Patient Consent to be Contacted ....................................................................
Patient Telephone Interview ............................................................................
Patient Clinical Evaluation ...............................................................................

400
677
541
234

2
1
1
1

5/60
10/60
30/60
540/60

67
113
271
2,106

Total Burden .............................................................................................

........................

........................

........................

2,557

Dated: July 24, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–14704 Filed 7–30–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44

U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Bureau of Primary
Health Care (BPHC) Uniform Data
System (OMB No. 0915–0193) Revision
The Uniform Data System (UDS)
contains the annual reporting
requirements for the cluster of primary
care grantees funded by the HRSA. The
UDS includes reporting requirements
for grantees of the following primary
care programs: Community Health
Centers, Migrant Health Centers, Health
Care for the Homeless, Public Housing
Primary Care, and other grantees under
section 330. The authorizing statute is
section 330 of the Public Health Service
Act, as amended.
Number of
respondents

Type of report

rmajette on PROD1PC64 with NOTICES

Number of
responses per
respondent

Number of
respondents

Respondent

Responses
per
respondent

HRSA collects data in the UDS which
is used to ensure compliance with
legislative mandates and to report to
Congress and policy makers on program
accomplishments. To meet these
objectives, BPHC requires a core set of
data collected annually that is
appropriate for monitoring and
evaluating performance and reporting
on annual trends.
The 2008 calendar year UDS will be
revised in several ways. Certain UDS
tables are being proposed for
elimination or modification to
streamline data collection and reporting.
A limited number of clinical measures
will be added for reporting quality of
care, health outcomes, and disparities
data. In addition, the tool used to report
calendar year UDS data will be changed
to a Web based tool.
Estimates of annualized reporting
burden are as follows:
Total
responses

Hours per
response

Total burden
hours

Universal report ....................................................................
Grant report ..........................................................................

1,076
150

1
1

1,076
150

54
18

32,280
2,700

Total ..............................................................................

1,076

........................

1,076

........................

34,980

Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to: [email protected]
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’

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Dated: July 20, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review
and Coordination.
[FR Doc. E7–14680 Filed 7–30–07; 8:45 am]
BILLING CODE 4165–15–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as

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File Typeapplication/pdf
File TitleDocument
SubjectExtracted Pages
AuthorU.S. Government Printing Office
File Modified2007-09-17
File Created2007-09-13

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