Proposed Data Collection; Comment Request; Survey of Colorectal Cancer Screening Policies, Programs, and Systems in U.S. Health Plans, 17095-17096 [05-6603]
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Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices
Resources and Housing Branch,
Attention: Christopher Martin, New
Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: March 24, 2005.
John P. Burke, III,
CMS Paperwork Reduction Act Reports
Clearance Officer, Office of Strategic
Operations and Regulatory Affairs,
Regulations Development Group.
[FR Doc. 05–6534 Filed 4–1–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0112]
Draft Guidance for Industry on Clinical
Trial Endpoints for the Approval of
Cancer Drugs and Biologics;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Clinical Trial
Endpoints for the Approval of Cancer
Drugs and Biologics.’’
This is the first of a series of
guidances that will provide
recommendations to sponsors on
endpoints for cancer clinical trials
submitted to FDA to support
effectiveness claims in new drug
applications (NDAs), biologics license
applications (BLAs), or supplemental
applications. Sponsors are encouraged
to use this draft guidance to design
cancer clinical trials and to discuss
protocols with the agency. This draft
guidance provides background
information and discusses general
regulatory principles. Each subsequent
guidance will focus on endpoints for
specific cancer types (e.g., lung cancer,
colon cancer) to support drug approval
or labeling claims. These guidances are
expected to speed the development and
improve the quality of protocols
submitted to the agency to support
anticancer effectiveness claims.
DATES: Submit written or electronic
comments on the draft guidance by June
3, 2005. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
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Administration, 5600 Fishers Lane,
Rockville, MD 20857, or the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
The draft guidance may also be obtained
by mail by calling the Center for
Biologics Evaluation and Research
Voice Information System at 1–800–
835–4709 or 301–827–1800. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Grant Williams, Center for Drug
Evaluation and Research (HFD–
150), Food and Drug
Administration, 1451 Rockville
Pike, Rockville, MD 20852, 301–
594–5758;
Patricia Keegan, Center for Drug
Evaluation and Research (HFD–
107), Food and Drug
Administration, 1451 Rockville
Pike, Rockville, MD 20852, 301–
827–5097; or
Steven Hirschfeld, Center for
Biologics Evaluation and Research
(HFM–755), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–
827–6536.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Clinical Trial Endpoints for the
Approval of Cancer Drugs and
Biologics.’’ FDA is developing guidance
on oncology endpoints through a
process that includes public workshops
of oncology experts and discussions
before FDA’s Oncologic Drugs Advisory
Committee. This draft guidance is the
first in a planned series of cancer
endpoint guidances. It provides
background information and general
principles. The endpoints discussed in
this draft guidance are for drugs to treat
patients with an existing cancer. This
draft guidance does not address
endpoints for drugs to prevent or
decrease the incidence of cancer.
This draft guidance is being issued
consistent with FDA’s good guidance
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17095
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on clinical trial endpoints for the
approval of cancer drugs and biologics.
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 draft guidance. Submit
one copy of electronic comments or two
paper copies of any mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. The draft 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 https://
www.fda.gov/cder/guidance/index.htm,
https://www.fda.gov/cber/
guidelines.htm, or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: March 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–6647 Filed 4–1–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Data Collection; Comment
Request; Survey of Colorectal Cancer
Screening Policies, Programs, and
Systems in U.S. Health Plans
SUMMARY: In compliance with the
provisions of section 3507(1)(D) 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) 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 October 29,
2004 (Volume 69, No. 209, pages 63159–
63160) and allowed 60 days for public
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Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices
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 number.
Proposed Collection: Title: Survey of
Colorectal Cancer Screening Policies,
Programs, and Systems in U.S. Health
Plans. Type of Information Collection
Request: New. Need and Use of
Information Collection: This study will
obtain information on policies,
programs, and practices for colorectal
cancer screening among health plans in
the U.S. The purpose of the study is to
assess (1) health plan policies,
programs, and practices for colorectal
cancer screening; (2) health plan
activities in response to the National
Committee on Quality Assurance’s new
Health Employer Data Information Set
measure for colorectal cancer screening;
and (3) characteristics of health plans
and plan policies and activities that may
be associated with higher rates of
colorectal cancer screening. A
questionnaire will be administered by
mail or Internet using a national sample
of health plans. Study participants will
be health plan medical directors or
administrators, and they will select their
preferred response mode. Burden
estimates are as follows:
Type of respondents
Estimated
number
respondents
Estimated
number
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
Health plan medical directors ..........................................................................
400
1
0.333
133
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) 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;
(2) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (3) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (4)
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.
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: Carrie
N. Klabunde, Ph.D., Epidemiologist,
National Cancer Institute, EPN 4005,
6130 Executive Boulevard, Bethesda,
Maryland 20892–7344. Telephone: (301)
402–3362; e-mail: ck97b@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.
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Dated: March 21, 2005.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 05–6603 Filed 4–1–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Outcome
Evaluation of the Small Grants
Program for Behavioral Research in
Cancer Control
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 31, 2004, page 53079
and allowed 60 days for public
comment. No public comment was
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: Outcome
Evaluation of the Small Grants Program
for Behavioral Research in Cancer
Control. Type of Information Collection
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Request: New. Need and Use of
Information Collection: The Small
Grants Program support projects that
can be completed in a short period of
time, such as pilot projects,
development and testing of new
methodologies, secondary data analyses,
or innovative studies that provide a
basis for more extended research. This
evaluation is being conducted to
identify progress of this program in
establishing a cohort of scientists with
a high level of research expertise in
behavioral research cancer control. A
primary objective of this study is to
determine if the program’s small grants
R03 funding mechanism is effective in
attracting investigators to the field of
behavioral research and if so, what
impact does the program have on the
career of successful applicants. The
findings will provide valuable
information regarding (1) effectiveness
of the program in attracting investigators
to the field; (2) the impact of the
program on investigators careers; and (3)
the overall benefit provided by the
program through the R03 funding
mechanism and assist the agency in
determining whether changes to the
program are necessary in future.
Frequency of Response: On occasion.
Affected Public: Individuals; teaching
institutions or other non-profit. Type of
Respondents: Grantees funded under
PAR 99–006 (n = 80). Type of
Respondents: Principal Investigator
awarded grants funded by PAR 00–006
(Dec. 1999–Nov. 2001); Estimated
Number of Respondents: 80; Estimated
Number of Response Per Respondent: 1;
Average Burden Hours Per Response:
75; and Estimated Total Annual Burden
Hours Requested: 60.
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[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Pages 17095-17096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Data Collection; Comment Request; Survey of Colorectal
Cancer Screening Policies, Programs, and Systems in U.S. Health Plans
SUMMARY: In compliance with the provisions of section 3507(1)(D) 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) 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 October
29, 2004 (Volume 69, No. 209, pages 63159-63160) and allowed 60 days
for public
[[Page 17096]]
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 number.
Proposed Collection: Title: Survey of Colorectal Cancer Screening
Policies, Programs, and Systems in U.S. Health Plans. Type of
Information Collection Request: New. Need and Use of Information
Collection: This study will obtain information on policies, programs,
and practices for colorectal cancer screening among health plans in the
U.S. The purpose of the study is to assess (1) health plan policies,
programs, and practices for colorectal cancer screening; (2) health
plan activities in response to the National Committee on Quality
Assurance's new Health Employer Data Information Set measure for
colorectal cancer screening; and (3) characteristics of health plans
and plan policies and activities that may be associated with higher
rates of colorectal cancer screening. A questionnaire will be
administered by mail or Internet using a national sample of health
plans. Study participants will be health plan medical directors or
administrators, and they will select their preferred response mode.
Burden estimates are as follows:
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number Average burden Estimated total
Type of respondents number responses per hours per annual burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Health plan medical directors............... 400 1 0.333 133
----------------------------------------------------------------------------------------------------------------
Request For Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) 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; (2) the accuracy
of the agency's estimate of the burden of the proposed collection of
information; (3) ways to enhance the quality, utility, and clarity of
the information to be collected; and (4) 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.
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: Carrie N. Klabunde, Ph.D., Epidemiologist,
National Cancer Institute, EPN 4005, 6130 Executive Boulevard,
Bethesda, Maryland 20892-7344. Telephone: (301) 402-3362; e-mail:
ck97b@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: March 21, 2005.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 05-6603 Filed 4-1-05; 8:45 am]
BILLING CODE 4140-01-M
