Agency Information Collection Activities: Proposed Collection; Comment Request, 53695-53696 [06-7585]
Download as PDF
<![CDATA[
Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Notices
requests for proposals, bid solicitations,
and other documents describing projects
or programs funded in whole or in part
with Federal money, the issuance shall
clearly state the percentage and dollar
amount of the total costs of the program
or project to be financed with Federal
money and the percentage and dollar
amount of the total costs of the project
or program to be financed by nongovernmental sources.
Dated: September 6, 2006.
W. Craig Vanderwagen,
Assistant Secretary for Public Health
Emergency Preparedness, Department of
Health and Human Services.
[FR Doc. E6–15018 Filed 9–11–06; 8:45 am]
3. Reporting Requirements
The applicant must provide HHS with
an original, plus two hard copies, as
well as an electronic copy of the
following reports in English:
1. A quarterly progress report, due no
less than 30 days after the end of each
quarter of the budget period. The
quarterly progress report must contain
the following elements:
a. Activities and Objectives for the
Current Budget Period;
b. Financial Progress for the Current
Budget Period;
c. Proposed Activity Objectives for the
New Budget Period;
d. Budget;
e. Measures of Effectiveness; and
f. Additional Requested Information.
2. A progress report, due 90 days after
the end of the budget period, which
must contain a detailed summary of the
elements required in the quarterly
progress report;
3. A final performance report, due no
more than 90 days after the end of the
project period; and
4. A Financial Status Report (FSR)
SF–269 is due 90 days after the close of
the 12-month budget period.
Recipients must mail the reports to
the Grants Management Specialist listed
in the ‘‘Agency Contacts’’ section of this
announcement.
Agency for Healthcare Research and
Quality
sroberts on PROD1PC70 with NOTICES
VII. Agency Contacts
For program technical assistance,
contact: Craig Carlson, MPH, Office of
Public Health Emergency Preparedness,
Department of Health and Human
Services, Telephone: 202–205–5228, Email: craig.carlson@hhs.gov.
For financial, grants management, or
budget assistance, contact: DeWayne
Wynn, Grants Management Specialist,
Office of Grants Management, Office of
Public Health and Science, Department
of Health and Human Services, 1101
Wootten Parkway, Suite 550, Rockville,
MD 20857, Telephone: (240) 453–8822,
E-Mail Address:
DeWayne.Wynn.os@hhs.gov.
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, Department of Health and
Human Services.
AGENCY:
ACTION:
Notice.
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) allow the proposed
information collection project:
‘‘Eisenberg Center Voluntary Customer
Survey Generic Clearance for the
Agency for Healthcare Research and
Quality.’’ In accordance with the
Paperwork Reduction Act of 1995,
Public Law 104–13 (44 U.S.C.
3506(c)(2)(A)), AHRQ invites the public
to comment on this proposed
information collection.
This proposed information collection
was previously published in the Federal
Register on July 5, 2006 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.
Comments on this notice must be
received by October 12, 2006.
DATES:
Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, 540
Gaither Road, Room #5036, Rockville,
MD 20850. Copies of the proposed
collection plans, data collection
instruments, and specific details on the
estimated burden can be obtained from
AHRQ’s Reports Clearance Officer.
ADDRESSES:
Proposed Project
‘‘Eisenberg Center Voluntary
Customer Survey Generic Clearance for
the Agency for Healthcare Research and
Quality’’.
AHRQ’s newly-established Eisenberg
Center is an innovative effort aimed at
improving communication of findings to
a variety of audiences (‘‘customers’’),
including consumers, clinicians, payers,
and health care policy makers. The
Eisenberg Center, one of three
components of AHRQ’s Effective Health
Care Program announced in September
2005, is directed through a contract by
the Oregon Health and Science
University, Department of Medicine,
located in Portland, Oregon. The
Eisenberg Center intends to employ the
latest survey research techniques to (1)
determine how well its products and
services are meeting customers’ current
and anticipated needs; (2) identify
problem areas with existing products
and services and determine what
improvements should be made to
improve these products and services;
and (3) identify and develop new
products and services.
To address customer requirements
and to evaluate current and future
AHRQ products and services, the
Eisenberg Center must periodically
determine how well the Eisenberg
Center products and services are
meeting customers’ current and
anticipated needs. Work conducted
under this clearance will improve the
products and services the Center
develops for AHRQ for a three year
period. The health care environment
changes rapidly and requires a quick
response from AHRQ to provide
appropriately refined products and
services. A generic clearance for this
work will facilitate AHRQ’s timely
response to customers’ needs.
Methods of Collection
Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427–1477.
Participation in survey testing will be
fully voluntary and non-participation
will have no affect on eligibility for, or
receipt of, future AHRQ health services
research support, on future
opportunities to participate in research
or to obtain informative research results.
Specific estimation procedures, when
used, will be described when we notify
OMB as to actual studies conducted
under the clearance.
SUPPLEMENTARY INFORMATION:
Estimated Annual Respondent Burden
FOR FURTHER INFORMATION CONTACT:
Number of respondents
Type of survey
Average hours
per response
30
50
1
.75
Focus groups for needs assessment ......................................................................................
Individual interviews for needs assessment ............................................................................
VerDate Aug<31>2005
16:16 Sep 11, 2006
Jkt 208001
53695
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
E:\FR\FM\12SEN1.SGM
12SEN1
Total hours
30
37.5
53696
Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Notices
Number of respondents
Average hours
per response
Total hours
Formative focus groups for information tools ..........................................................................
Cognitive testing of information tools ......................................................................................
Clinician interviews for information tools .................................................................................
Decision aid laboratory testing ................................................................................................
Formative focus groups for decision aids ...............................................................................
Automated/web-based surveys for product evaluation ...........................................................
Telephone interviews for product evaluation ...........................................................................
Focus groups for product evaluation .......................................................................................
120
500
160
100
60
600
100
20
1
1
.75
1
1
.163
1
1
120
500
120
100
60
98
100
20
Totals ................................................................................................................................
1,740
Type of survey
Estimated Costs to the Federal
Government
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The maximum cost to the Federal
Government is $750,000 annually for FY
2007, FY 2008, and FY 2009. Most of
the work will be carried out through
contracts. The costs were estimated at
$200 for each face-to-face interview,
$100 for each telephone interview,
$5,000 for each focus group, $10,000 for
Web-based surveys, and $20,000 for
each laboratory testing module. Any
deviation from these limits will be
noted in reports made to OMB with
respect to a particular study or studies
conducted under the clearance.
Food and Drug Administration
Request for Comments
sroberts on PROD1PC70 with NOTICES
In accordance with the above-cited
legislation, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of health care information
dissemination functions of AHRQ,
including whether the information will
have practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) 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 upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the request for OMB
approval of the proposed information
collection. All comments will become a
matter of public record.
Dated: August 31, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06–7585 Filed 9–11–06; 8:45 am]
BILLING CODE 4160–90–M
VerDate Aug<31>2005
16:16 Sep 11, 2006
Jkt 208001
[Docket No. 2006D–0344]
Draft Guidance for Industry on Drug
Interaction Studies—Study Design,
Data Analysis, and Implications for
Dosing and Labeling; 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 ‘‘Drug Interaction
Studies—Study Design, Data Analysis,
and Implications for Dosing and
Labeling.’’ This document is intended to
provide recommendations to sponsors
of new drug applications (NDAs), and
biologic license applications (BLAs) for
therapeutic biologics (drugs) on carrying
out in vitro or in vivo drug-drug
interaction studies. The draft guidance
reflects the current view that the
metabolism and transport of a new drug
should be defined during drug
development and that its interactions
with other drugs should be explored as
part of an adequate assessment of the
safety and effectiveness of the drug.
DATES: Submit written or electronic
comments on the draft guidance by
November 13, 2006. General comments
on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of this draft guidance to
the Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
NA
1,186
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:
Shiew-Mei Huang, Center for Drug
Evaluation and Research (HFD–
850), Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 4550,
Silver Spring, MD 20993–0002,
301–796–1541, or
Toni Stifano, Center for Biologics
Evaluation and Research (HFM–
600), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–
827–6190.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Drug Interaction Studies—Study
Design, Data Analysis, and Implications
for Dosing and Labeling.’’ FDA
previously published two guidance
documents on the use of in vitro and in
vivo approaches to study metabolism
and metabolic drug-drug interactions
entitled ‘‘Drug Metabolism/Drug
Interaction Studies in the Drug
Development Process: Studies in Vitro’’
and ‘‘In Vivo Drug Metabolism/Drug
Interaction Studies—Study Design, Data
Analysis, and Recommendations for
Dosing and Labeling.’’ The draft
guidance, when finalized, will replace
these guidance documents. This draft
guidance discusses study design, choice
of interacting drugs, data analysis, and
provides recommendations for dosing
and labeling.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
E:\FR\FM\12SEN1.SGM
12SEN1
]]>Agencies
[Federal Register Volume 71, Number 176 (Tuesday, September 12, 2006)]
[Notices]
[Pages 53695-53696]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7585]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, Department of
Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) allow the proposed information collection
project: ``Eisenberg Center Voluntary Customer Survey Generic Clearance
for the Agency for Healthcare Research and Quality.'' In accordance
with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C.
3506(c)(2)(A)), AHRQ invites the public to comment on this proposed
information collection.
This proposed information collection was previously published in
the Federal Register on July 5, 2006 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.
DATES: Comments on this notice must be received by October 12, 2006.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, 540 Gaither Road, Room 5036,
Rockville, MD 20850. Copies of the proposed collection plans, data
collection instruments, and specific details on the estimated burden
can be obtained from AHRQ's Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427-1477.
SUPPLEMENTARY INFORMATION:
Proposed Project
``Eisenberg Center Voluntary Customer Survey Generic Clearance for
the Agency for Healthcare Research and Quality''.
AHRQ's newly-established Eisenberg Center is an innovative effort
aimed at improving communication of findings to a variety of audiences
(``customers''), including consumers, clinicians, payers, and health
care policy makers. The Eisenberg Center, one of three components of
AHRQ's Effective Health Care Program announced in September 2005, is
directed through a contract by the Oregon Health and Science
University, Department of Medicine, located in Portland, Oregon. The
Eisenberg Center intends to employ the latest survey research
techniques to (1) determine how well its products and services are
meeting customers' current and anticipated needs; (2) identify problem
areas with existing products and services and determine what
improvements should be made to improve these products and services; and
(3) identify and develop new products and services.
To address customer requirements and to evaluate current and future
AHRQ products and services, the Eisenberg Center must periodically
determine how well the Eisenberg Center products and services are
meeting customers' current and anticipated needs. Work conducted under
this clearance will improve the products and services the Center
develops for AHRQ for a three year period. The health care environment
changes rapidly and requires a quick response from AHRQ to provide
appropriately refined products and services. A generic clearance for
this work will facilitate AHRQ's timely response to customers' needs.
Methods of Collection
Participation in survey testing will be fully voluntary and non-
participation will have no affect on eligibility for, or receipt of,
future AHRQ health services research support, on future opportunities
to participate in research or to obtain informative research results.
Specific estimation procedures, when used, will be described when we
notify OMB as to actual studies conducted under the clearance.
Estimated Annual Respondent Burden
----------------------------------------------------------------------------------------------------------------
Number of Average hours
Type of survey respondents per response Total hours
----------------------------------------------------------------------------------------------------------------
Focus groups for needs assessment.............................. 30 1 30
Individual interviews for needs assessment..................... 50 .75 37.5
[[Page 53696]]
Formative focus groups for information tools................... 120 1 120
Cognitive testing of information tools......................... 500 1 500
Clinician interviews for information tools..................... 160 .75 120
Decision aid laboratory testing................................ 100 1 100
Formative focus groups for decision aids....................... 60 1 60
Automated/web-based surveys for product evaluation............. 600 .163 98
Telephone interviews for product evaluation.................... 100 1 100
Focus groups for product evaluation............................ 20 1 20
------------------------------------------------
Totals.................................................... 1,740 NA 1,186
----------------------------------------------------------------------------------------------------------------
Estimated Costs to the Federal Government
The maximum cost to the Federal Government is $750,000 annually for
FY 2007, FY 2008, and FY 2009. Most of the work will be carried out
through contracts. The costs were estimated at $200 for each face-to-
face interview, $100 for each telephone interview, $5,000 for each
focus group, $10,000 for Web-based surveys, and $20,000 for each
laboratory testing module. Any deviation from these limits will be
noted in reports made to OMB with respect to a particular study or
studies conducted under the clearance.
Request for Comments
In accordance with the above-cited legislation, comments on AHRQ's
information collection are requested with regard to any of the
following: (a) Whether the proposed collection of information is
necessary for the proper performance of health care information
dissemination functions of AHRQ, including whether the information will
have practical utility; (b) the accuracy of AHRQ's estimate of burden
(including hours and costs) of the proposed collection(s) 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 upon the respondents, including the use
of automated collection techniques or other forms of information
technology.
Comments submitted in response to this notice will be summarized
and included in the request for OMB approval of the proposed
information collection. All comments will become a matter of public
record.
Dated: August 31, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06-7585 Filed 9-11-06; 8:45 am]
BILLING CODE 4160-90-M
