Submission for OMB review; comment request; California Health Interview Survey 2005, 93-94 [04-28687]
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Federal Register / Vol. 70, No. 1 / Monday, January 3, 2005 / Notices
3503, FAX: 301–827–2875.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Submitting Separate Marketing
Applications and Clinical Data for
Purposes of Assessing User Fees.’’ The
guidance document describes FDA’s
thinking on what will be considered
separate marketing applications and
what will constitute clinical data for
purposes of assessing user fees under
sections 735 and 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
379g and 379h).
This guidance was issued in draft on
February 22, 2001 (66 FR 11175) with
comments due by March 26, 2001. No
comments were received. In the
meantime, Congress considered
reauthorization of the user fee program.
As a result, FDA delayed issuance of the
guidance. Now that the program has
been reauthorized without change to the
relevant language, FDA is issuing the
guidance. Other than minor editorial
changes, only two changes of note have
been made to the guidance. We have
reevaluated our policy on pharmacy
bulk packages and products for
prescription compounding and
determined that a separate application
is no longer needed for these products
unless otherwise noted in the guidance
document. Therefore, the subsection
entitled ‘‘Pharmacy Bulk Packages and
Products for Prescription
Compounding’’ has been removed. In
addition, the Medicare Prescription
Drug, Improvement, and Modernization
Act of 2003 (Public Law 108–173) may
require a new application to be
submitted because of a change to the
reference listed drug. Therefore, a new
subsection was added to clarify the user
fee liability.
The guidance represents the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance at any time.
Two copies of mailed comments are to
VerDate jul<14>2003
14:47 Dec 30, 2004
Jkt 205001
be submitted, except that individuals
may submit one copy. Comments are to
be identified with the docket number
found in brackets in the heading of this
document. The guidance and received
comments are available for public
examination in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either http:/
/www.fda.gov/cder/guidance/index.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: December 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04–28654 Filed 12–30–04; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB review; comment
request; California Health Interview
Survey 2005
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute, the National Institutes
of Health has submitted to the Office of
Management and Budget (OMB) a
request to review and approve the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on August 5, 2004, p. 47450
and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: California
Health Interview Survey 2005. Type of
Information Collection Request: New.
Need and Use of Information Collection.
The NCI has sponsored two Cancer
Control Modules to the California
Health Interview Survey (CHIS), and
will be sponsoring a third to be
PO 00000
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Sfmt 4703
93
admitted in 2005. The CHIS is a
telephone survey designed to provide
population-based, standardized healthrelated data to assess California’s
progress in meeting Healthy People
2010 objectives for the nation and the
state. The CHIS sample is designed to
provide statistically reliable estimates
statewide, for California counties, and
for California’s ethnically and racially
diverse population. Initiated by the
UCLA Center for Health Policy
Research, the California Department of
Health Services, and the California
Public Health Institute, the survey is
funded by a number of public and
private sources. It was first administered
in 2001 to 55,428 adults and
subsequently in 2003 to 42,043 adults.
These adults are a representative sample
of California’s non-institutionalized
population living in households. CHIS
2005, the third bi-annual survey, is
planned for administration to 55,000
adult Californians. The cancer control
module, which is similar to that
administered in CHIS 2001 and CHIS
2003, will allow NCI to examine trends
in breast cancer screening and
diagnosis, as well as to study other
cancer-related topics, such as diet,
physical activity and obesity.
Because California is the most
populous and the most racially and
ethnically diverse state in the nation,
the CHIS 2005 sample will yield
adequate numbers of respondents in key
ethnic and racial groups, including
African Americans, Latinos, Asians, and
American Indian/Alaska Natives. The
Latino group will include large numbers
of Mexican-origin, Central Americans,
South Americans, and other Latino
subgroups; the Asian group will include
large numbers of respondents in the
Chinese, Filipino, Japanese, Vietnamese,
and Korean subgroups. NCI will
compare the CHIS and National Health
Interview Survey (NHIS) data in order to
conduct comparative analyses and
better estimate cancer risk factors and
screening among racial/ethnic minority
populations. The CHIS sample size also
permits NCI to create estimates for
ethnic subdomains of the population,
for which NHIS has insufficient
numbers for analysis. Frequency of
Response: One-time. Affected Public:
Individuals. Type of Respondents:
Adults (persons 18 years of age and
older). The annual reporting burden is
as follows:
E:\FR\FM\03JAN1.SGM
03JAN1
94
Federal Register / Vol. 70, No. 1 / Monday, January 3, 2005 / Notices
TABLE A.—RESPONDENT AND HOUR BURDEN ESTIMATES FOR CHIS 2005 CANCER CONTROL TOPICAL MODULE
Estimated
number of
respondents
Type of respondents
Estimated
number of
responses
per respondent
Average
burden
hours per
response
Estimated
total annual
burden
hours requested
Adult Individuals—Pilot CCM and Demographics ...........................................................
Adult Individuals—CCM and Demographics ...................................................................
150
55,000
1
1
.17
.17
25.50
9,350.00
Totals ........................................................................................................................
....................
....................
....................
9,375.50
The annualized cost to respondents is
estimated at: $140,632.50. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function 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 the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments To OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
Nancy Breen, Ph.D., Project Officer,
National Cancer Institute, EPN 4005,
6130 Executive Boulevard MSC 7344.
Bethesda, Maryland 20852–7344, or call
non-toll free number (301) 496–8500 or
e-mail your request, including your
address to breenn@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
VerDate jul<14>2003
14:47 Dec 30, 2004
Jkt 205001
Dated: December 21, 2004.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 04–28687 Filed 12–30–04; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, DHHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: (301)
496–7057; fax: (301) 402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Use of Anti-Parafibromin Antibodies to
Diagnose Hyperparathyroidism-Jaw
Tumor Syndrome (HPT–JT) and
Parathyroid Cancer
William Simonds, Jian-hua Zhang, and
Geoffrey Woodard (NIDDK) U.S.
Provisional Application No. 60/
531,875 filed 22 Dec 2003 (DHHS
Reference No. E–032–2004/0–US–01)
Licensing Contact: Brenda Hefti; (301)
435–4632; heftib@mail.nih.gov.
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
This technology relates to methods of
diagnosing cancer using antibodies that
specifically bind to parafibromin.
Parafibromin appears to be a tumor
suppressor. Mutations in the coding
sequence, specifically truncations or
deletions, might be indicative of cancer
or increased susceptibility to cancer.
Antibodies targeting this tumor
suppressor protein might have utility as
a cancer diagnostic or prognostic, either
alone, or as part of a kit.
This technology is described, in part,
in GE Woodard et al., ‘‘Parafibromin,
product of the hyperparathyroidism-jaw
tumor syndrome gene HRPT2, regulates
cyclin D1/PRAD1 expression.’’
Oncogene 2004 Dec 06 (e-pub ahead of
print).
Eosinophil-Derived Neurotoxin, an
Antimicrobial Protein with
Ribonuclease Activity, is an
Immunostimulant
De Yang et al. (NCI)
U.S. Patent Application No. 10/834,733
filed 29 Apr 2004 (DHHS Reference
No. E–191–2003/1–US–01)
Licensing Contact: Brenda Hefti; (301)
435–4632; heftib@mail.nih.gov.
Eosinophil-derived neurotoxin (EDN)
has in vitro anti-viral activity that is
dependent on its ribonuclease activity.
This invention discloses that EDN is a
selective chemoattractant and activator
of dendritic cells, resulting in dendritic
cell migration, maturation, and a
production of a wide variety of
cytokines. Based on these potent
chemotactic and activating effects on
dendritic cells, EDN might be useful as
a clinical immunoadjuvant for the
promotion of immune responses to
specific antigens of tumors or
pathogenic organisms.
Genes Expressed in Prostate Cancer
and Methods of Use
Ira Pastan, Tapan Bera, and Byungkook
Lee (NCI)
U.S. Provisional Patent Application No.
60/461,399 filed 08 Apr 2003 (DHHS
Reference No. E–148–2003/0–US–01)
PCT Application No. PCT/US04/10588
filed 05 Apr 2004, which published as
WO 2004/092213 on 28 Oct 2004
E:\FR\FM\03JAN1.SGM
03JAN1
]]>Agencies
[Federal Register Volume 70, Number 1 (Monday, January 3, 2005)]
[Notices]
[Pages 93-94]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-28687]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB review; comment request; California Health
Interview Survey 2005
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Cancer Institute, the National
Institutes of Health has submitted to the Office of Management and
Budget (OMB) a request to review and approve the information collection
listed below. This proposed information collection was previously
published in the Federal Register on August 5, 2004, p. 47450 and
allowed 60 days for public comment. No public comments were received.
The purpose of this notice is to allow an additional 30 days for public
comment. The National Institutes of Health may not conduct or sponsor,
and the respondent is not required to respond to, an information
collection that has been extended, revised, or implemented on or after
October 1, 1995, unless it displays a currently valid OMB control
number.
Proposed Collection: Title: California Health Interview Survey
2005. Type of Information Collection Request: New. Need and Use of
Information Collection. The NCI has sponsored two Cancer Control
Modules to the California Health Interview Survey (CHIS), and will be
sponsoring a third to be admitted in 2005. The CHIS is a telephone
survey designed to provide population-based, standardized health-
related data to assess California's progress in meeting Healthy People
2010 objectives for the nation and the state. The CHIS sample is
designed to provide statistically reliable estimates statewide, for
California counties, and for California's ethnically and racially
diverse population. Initiated by the UCLA Center for Health Policy
Research, the California Department of Health Services, and the
California Public Health Institute, the survey is funded by a number of
public and private sources. It was first administered in 2001 to 55,428
adults and subsequently in 2003 to 42,043 adults. These adults are a
representative sample of California's non-institutionalized population
living in households. CHIS 2005, the third bi-annual survey, is planned
for administration to 55,000 adult Californians. The cancer control
module, which is similar to that administered in CHIS 2001 and CHIS
2003, will allow NCI to examine trends in breast cancer screening and
diagnosis, as well as to study other cancer-related topics, such as
diet, physical activity and obesity.
Because California is the most populous and the most racially and
ethnically diverse state in the nation, the CHIS 2005 sample will yield
adequate numbers of respondents in key ethnic and racial groups,
including African Americans, Latinos, Asians, and American Indian/
Alaska Natives. The Latino group will include large numbers of Mexican-
origin, Central Americans, South Americans, and other Latino subgroups;
the Asian group will include large numbers of respondents in the
Chinese, Filipino, Japanese, Vietnamese, and Korean subgroups. NCI will
compare the CHIS and National Health Interview Survey (NHIS) data in
order to conduct comparative analyses and better estimate cancer risk
factors and screening among racial/ethnic minority populations. The
CHIS sample size also permits NCI to create estimates for ethnic
subdomains of the population, for which NHIS has insufficient numbers
for analysis. Frequency of Response: One-time. Affected Public:
Individuals. Type of Respondents: Adults (persons 18 years of age and
older). The annual reporting burden is as follows:
[[Page 94]]
Table A.--Respondent and Hour Burden Estimates for CHIS 2005 Cancer Control Topical Module
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated Average total
Estimated number of burden annual
Type of respondents number of responses hours per burden
respondents per response hours
respondent requested
----------------------------------------------------------------------------------------------------------------
Adult Individuals--Pilot CCM and Demographics............... 150 1 .17 25.50
Adult Individuals--CCM and Demographics..................... 55,000 1 .17 9,350.00
--------------
Totals.................................................. ........... ........... ........... 9,375.50
----------------------------------------------------------------------------------------------------------------
The annualized cost to respondents is estimated at: $140,632.50.
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
Request For Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function 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 the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments To OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact: Dr. Nancy Breen, Ph.D., Project Officer,
National Cancer Institute, EPN 4005, 6130 Executive Boulevard MSC 7344.
Bethesda, Maryland 20852-7344, or call non-toll free number (301) 496-
8500 or e-mail your request, including your address to
breenn@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: December 21, 2004.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 04-28687 Filed 12-30-04; 8:45 am]
BILLING CODE 4140-01-M
