Proposed Data Collection; Comment Request; Public Health Service; The National Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) (NCI), 44751 [E8-17505]
Download as PDF
<![CDATA[
44751
Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices
manufacturer, explain the reasons for
the delay, and discuss the time frame for
completing the review.
Third, the comment asked whether
‘‘the manufacturing facility is
approvable or to be re-inspected’’ if the
dispute is not resolved at the end of the
tier-two DR stage.
FDA Response—As described in the
guidance, it is FDA’s intention to
resolve through the DR process all
issues raised by the manufacturer. If
FDA agrees with the manufacturer, the
Form FDA 483 that prompted the
request for formal dispute resolution
would be revised or rescinded. If FDA
disagrees with the manufacturer’s
request, the issues raised in the Form
FDA 483 stand and FDA would expect
compliance with the applicable CGMP
requirements, which FDA may verify by
re-inspection.
Dated: July 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17577 Filed 7–30–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Data Collection; Comment
Request; Public Health Service; The
National Survey of Physician Attitudes
Regarding the Care of Cancer
Survivors (SPARCCS) (NCI)
SUMMARY: In compliance with the
provisions of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comments on
proposed data collection projects, the
National Institutes of Health (NIH),
National Cancer Institute (NCI) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: The
National Survey of Physician Attitudes
Regarding the Care of Cancer Survivors
(SPARCCS); Type of Information
Collection Request: NEW; Need and Use
of Information Collection: The purpose
of SPARCCS is to identify the beliefs,
knowledge, attitudes, and practices of
primary care physicians and cancer
specialists regarding the components
described by the Institute of Medicine’s
(IOM) 2005 report that described the
essential components of cancer
survivorship care within a health care
delivery system. These data will inform
the process of standardization of
survivorship care practices; augment the
data collected in other cancer
survivorship studies such as the Cancer
Care Outcomes Research and
Surveillance Consortium (CanCORS),
and the Cancer Research Network; and
monitor the progress made toward
achieving NCI strategic goals of
improving the quality of cancer care
across the cancer control continuum.
Two questionnaires, one sent to primary
care physicians and one sent to medical
oncologists, will be administered by
mail to a randomly selected national
sample of 2,200 physicians. Study
participants will be 1,100 practicing
physicians who are family practitioners,
general internists, and obstetrician/
gynecologists and 1,100 medical
oncologists. Frequency of Response:
Once. Affected Public: Individuals and
Businesses. Type of Respondents:
Primary care and medical oncology
physicians practicing in a non-federal
facility. The annual reporting burden is
estimated at 903 hours as shown in
Table 1. The total burden hours is
estimated at 1,808 hours over the two
year field period of the study. There are
no capital, operating or maintenance
costs to report.
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
Survey
Receptionists .....................................
Family Practice .................................
General Internists ..............................
OB/GYNs ..........................................
Oncologists .......................................
Receptionists & Administrators .........
Screener ...........................................
PCP Instrument ................................
PCP Instrument ................................
PCP Instrument ................................
Oncology Instrument ........................
Follow-Up Phone Calls ....................
...........................................................
4,236
Average time
per response
(minutes/hour)
Annual burden
hours
1
1
1
1
1
4
5/60
20/60
20/60
20/60
20/60
5/60
169
83
83
17
183
368
........................
........................
903
Frequency of
response
2,033
250
250
50
550
1,103
Total ...........................................
jlentini on PROD1PC65 with NOTICES
Type of respondents
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(a) Whether the proposed collection of
information is necessary for the
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
VerDate Aug<31>2005
15:53 Jul 30, 2008
Jkt 214001
of automated collection techniques or
other forms of information technology.
FOR FURTHER INFORMATION CONTACT:
Send comments to Arnold Potosky,
PhD, Health Services and Economics,
Branch Applied Research Program,
Division of Cancer Control and
Population Sciences, National Cancer
Institute, 6130 Executive Blvd., EPN
Room 4005, Bethesda, MD 20892–7344
Telephone: (301) 496–5662; e-mail:
potoskya@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Dated: July 21, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office,
National Institutes of Health.
[FR Doc. E8–17505 Filed 7–30–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request
Evaluation of Risk Factors Associated
With Viral Infections in Chinese Donors:
a. Risk factors associated with HIV
E:\FR\FM\31JYN1.SGM
31JYN1
]]>Agencies
[Federal Register Volume 73, Number 148 (Thursday, July 31, 2008)]
[Notices]
[Page 44751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17505]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Data Collection; Comment Request; Public Health Service;
The National Survey of Physician Attitudes Regarding the Care of Cancer
Survivors (SPARCCS) (NCI)
SUMMARY: In compliance with the provisions of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public
comments on proposed data collection projects, the National Institutes
of Health (NIH), National Cancer Institute (NCI) will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Proposed Collection: Title: The National Survey of Physician
Attitudes Regarding the Care of Cancer Survivors (SPARCCS); Type of
Information Collection Request: NEW; Need and Use of Information
Collection: The purpose of SPARCCS is to identify the beliefs,
knowledge, attitudes, and practices of primary care physicians and
cancer specialists regarding the components described by the Institute
of Medicine's (IOM) 2005 report that described the essential components
of cancer survivorship care within a health care delivery system. These
data will inform the process of standardization of survivorship care
practices; augment the data collected in other cancer survivorship
studies such as the Cancer Care Outcomes Research and Surveillance
Consortium (CanCORS), and the Cancer Research Network; and monitor the
progress made toward achieving NCI strategic goals of improving the
quality of cancer care across the cancer control continuum. Two
questionnaires, one sent to primary care physicians and one sent to
medical oncologists, will be administered by mail to a randomly
selected national sample of 2,200 physicians. Study participants will
be 1,100 practicing physicians who are family practitioners, general
internists, and obstetrician/gynecologists and 1,100 medical
oncologists. Frequency of Response: Once. Affected Public: Individuals
and Businesses. Type of Respondents: Primary care and medical oncology
physicians practicing in a non-federal facility. The annual reporting
burden is estimated at 903 hours as shown in Table 1. The total burden
hours is estimated at 1,808 hours over the two year field period of the
study. There are no capital, operating or maintenance costs to report.
Table 1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Survey Number of Frequency of per response Annual burden
respondents response (minutes/hour) hours
----------------------------------------------------------------------------------------------------------------
Receptionists................. Screener........ 2,033 1 5/60 169
Family Practice............... PCP Instrument.. 250 1 20/60 83
General Internists............ PCP Instrument.. 250 1 20/60 83
OB/GYNs....................... PCP Instrument.. 50 1 20/60 17
Oncologists................... Oncology 550 1 20/60 183
Instrument.
Receptionists & Administrators Follow-Up Phone 1,103 4 5/60 368
Calls.
=================================================================================
Total..................... ................ 4,236 .............. .............. 903
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (a) Whether the proposed collection of information is
necessary for the 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.
FOR FURTHER INFORMATION CONTACT: Send comments to Arnold Potosky, PhD,
Health Services and Economics, Branch Applied Research Program,
Division of Cancer Control and Population Sciences, National Cancer
Institute, 6130 Executive Blvd., EPN Room 4005, Bethesda, MD 20892-7344
Telephone: (301) 496-5662; e-mail: potoskya@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: July 21, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office, National Institutes of Health.
[FR Doc. E8-17505 Filed 7-30-08; 8:45 am]
BILLING CODE 4140-01-P
