Agency Information Collection Activities: Proposed Collection; Comment Request, 53018-53019 [05-17617]
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Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Notices
information provided in each table,
chart, attachment, etc., is consistent
with the proposal narrative and
information in other tables.
Be organized and logical. Many
applications fail to receive a high score
because the reviewers cannot follow the
thought process of the applicant or
because parts of the application do not
fit together.
Be careful in the use of appendices.
Do not use the appendices for
information that is required in the body
of the application. Be sure to crossreference all tables and attachments
located in the appendices to the
appropriate text in the application.
Carefully proofread the application.
Misspellings and grammatical errors
will impede reviewers in understanding
the application. Be sure pages are
numbered (including appendices) and
that page limits are followed. Limit the
use of abbreviations and acronyms, and
define each one at its first use and
periodically throughout application.
This reinstatement of the previous
clearance approval coves the second
wave of the same survey. The
respondents will be queried as to their
progress in achieving the preparedness
goals reported in the first wave.
DATES: Comments on this notice must be
received by November 7, 2005.
ADDRESSES: Written comments for the
proposed information collection should
be submitted to: Cynthia D. McMichael,
Reports Clearance Officer, AHRQ, 540
Gaither Road, Room #5022, Rockville,
MD 20850.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Cynthia D. McMichael, AHRQ Reports
Clearance Officer, (301) 427–1651.
SUPPLEMENTARY INFORMATION:
Dated: August 26, 2005.
Mary Lou Valdez,
Deputy Director for Policy, Office of Global
Health Affairs.
Cristina V. Beato,
Acting Assistant Secretary for Health, Office
of Public Health and Science.
[FR Doc. 05–17590 Filed 9–2–05; 8:45 am]
‘‘AHRQ–HRSA Chemical, Biological,
Radiological, Nuclear and Explosive
(All Hazards) Preparedness
Questionnaire for Healthcare Facilities
for 2004 (CBRNE)’’
The Preparedness Questionnaire is an
inventory of the U.S. hospitals which
received support for preparedness
activities under the HRSA National
Bioterrorism Hospital Preparedness
Program. This survey instrument is
being designed for use by preparedness
planners to measure local or regional
hospital levels of preparedness for a
chemical, biological, radiological,
nuclear and explosive (CBRNE) event.
One point of contact is designated in
each hospital to provide information on
a range of topics that have been deemed
essential by a panel of nationallyrecognized experts on issues related to
hospital preparedness for a CBRNE, i.e.,
an all hazards event.
These topics include facility planning
and administration; training and
education; communication and
notification; patient capacity; staffing
and support; isolation and
decontaminations; supplies,
pharmaceuticals and laboratory support;
and surveillance.
The inventory, which was
administered in 2004/2005 and will be
again in 2006, will provide national,
state, and regional levels of
preparedness by type of hospital, as
well as estimates of bed capacity and
emergency increase (surge) capacity.
This information will be used to
ascertain the progress of the previously
queried hospitals in attaining their
preparedness goals.
BILLING CODE 4150–38–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
the Office of Management and Budget
(OMB) to reinstate the information
collection project: ‘‘AHRQ–HRSA
Chemical, Biological, Radiological,
Nuclear and Explosive (All Hazards)
Preparedness Questionnaire for
Healthcare Facilities for 2004 (CBRNE)’’.
In accordance with the Paperwork
Reduction Act of 1995, 44 U.S.C.
3506(C)(2)(A), AHRQ invites the public
to comment on this proposed
information collection.
AHRQ obtained a six-month
emergency collection approval for the
first wave of this information collection.
VerDate Aug<18>2005
13:21 Sep 02, 2005
Jkt 205001
Proposed Project
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
In addition to determination the
capacity of the survey instrument to
actually collect information needed for
local and regional planning, it should
also be useful for national planning,
program planning, setting priority areas
in addressing current and future needs,
as well as ensuring that scarce resources
are being used in a way that achieves
the most impact in preparedness.
Data Confidentiality Provisions
The data will be collected by an
independent consulting firm under
terms of its contract. The identifiable
information about institutions will be
kept confidential in accordance with 42
USC 299c–3(c). AHRQ and HRSA will
receive only state-level summary data,
and not individual hospital responses.
Method of Collection
The preparedness questionnaire will
be administered electronically to each
hospital via electronic mail. The
estimated burden is as follows:
Estimated Annual Respondent Burden
Number of
questionnaire
recipients
Estimated burden/respondent
Total hours
of burden
1479 ..............
60 minutes ....
1479
The estimate burden is based on the
completion of a paper version of the
questionnaire by a pilot hospital. The
more efficient data collection effort
enabled by the electronic format has
been taken into account in this estimate.
The annualized cost to all potential
respondents is estimated at $51,528
Total ($34.84/hr [average staff time] × 1
hr. × 1479 respondents). Percentage of
capital costs, operating costs or
maintenance costs are negligible.
A stratified random sample by state
will be used in this second wave survey.
This second wave (resurvey) is utilizing
statistical methods based on baseline
data in developing a sampling scheme.
Request for Comments
In accordance with the above cited
Paperwork Reduction Act legislation,
comments on the AHRQ’s and HRSA’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 functions of AHRQ and
HRSA, including whether the
information will have practical utility;
(b) the accuracy of the agency’s estimate
of the burden (including hours and
costs) of the proposed collection of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
E:\FR\FM\06SEN1.SGM
06SEN1
Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Notices
ways to minimize the burden of the
collection of information on
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 12, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 05–17617 Filed 9–2–05; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004P–0379]
Determination That Penthrane
(Methoxyflurane) Inhalation Liquid,
99.9 Percent, Was Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that Penthrane (methoxyflurane)
Inhalation Liquid, 99.9 percent, was
withdrawn from sale for reasons of
safety or effectiveness. The agency will
not accept or approve abbreviated new
drug applications (ANDAs) for
methoxyflurane inhalation liquid, 99.9
percent.
FOR FURTHER INFORMATION CONTACT:
Mary Catchings, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
which is a version of the drug that was
previously approved. Sponsors of
ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
VerDate Aug<18>2005
13:21 Sep 02, 2005
Jkt 205001
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (§ 314.162 (21
CFR 314.162)).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
Penthrane (methoxyflurane)
Inhalation Liquid, 99.9 percent, was the
subject of NDA 13–056, held by Abbott
Laboratories (Abbott). Penthrane is a
potent inhalation anesthetic indicated to
provide anesthesia for surgical
procedures in which total duration of
administration is anticipated to be 4
hours or less (not to be used at
concentrations that provide skeletal
muscle relaxation). Penthrane was also
indicated to provide analgesia in
obstetrics and in minor surgical
procedures and for use by selfadministration using hand held
inhalers. In the Federal Register of
August 16, 2001 (66 FR 43017), FDA
withdrew approval of NDA 13–056 for
Penthrane after Abbott notified the
agency that Penthrane was no longer
being marketed under NDA 13–056 and
requested withdrawal of that
application. Penthrane was then moved
to the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
In a citizen petition dated August 25,
2004 (Docket No. 2004P–0379/CP1),
submitted under § 10.30 (21 CFR 10.30),
and in accordance with § 314.161, AAC
Consulting Group requested that the
agency determine whether Penthrane
(methoxyflurane) Inhalation Liquid,
99.9 percent, was withdrawn from sale
for reasons of safety or effectiveness.
We have carefully reviewed our files
for records concerning the withdrawal
of Penthrane (methoxyflurane)
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
53019
Inhalation Liquid, 99.9 percent,
including the NDA file for this drug
product. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
event reports. FDA has determined
under §§ 314.161 and 314.162(a)(2) that
Penthrane (methoxyflurane) Inhalation
Liquid, 99.9 percent, was withdrawn
from sale for reasons of safety. FDA’s
review shows that methoxyflurane, a
volatile anesthetic agent, is associated
with serious, irreversible, and even fatal
nephrotoxicity and hepatotoxicity in
humans. FDA has also reviewed the
latest approved labeling for Penthrane
and has determined that this labeling is
inadequate. FDA believes that the risks
of toxicity outweigh any potential
benefits if methoxyflurane is used
according to the latest approved
labeling. Since the initial approval of
Penthrane in 1962, with a subsequent
finding of efficacy in the Federal
Register of December 11, 1981 (46 FR
60652), alternative safe and effective
anesthetics have been approved by FDA
and entered the market. FDA has
determined that new clinical studies are
necessary before methoxyflurane could
be considered for reintroduction to the
market. The agency has determined,
under § 314.161, that Penthrane
(methoxyflurane) Inhalation Liquid,
99.9 percent was withdrawn from sale
for reasons of safety. Therefore,
Penthrane (methoxyflurane) Inhalation
Liquid, 99.9 percent, will be removed
from the list of drug products published
in the Orange Book. FDA will not accept
or approve ANDAs that refer to this
drug product.
Dated: August 29, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–17559 Filed 9–2–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005M–0158, 2005M–0159,
2005M–0129, 2005M–0160, 2005M–0130,
2005M–0151, 2005M–0117, 2005M–0118,
2005M–0241, 2005M–0191, 2005M–0192,
2005M–0193, 2005M–0270]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
E:\FR\FM\06SEN1.SGM
06SEN1
]]>Agencies
[Federal Register Volume 70, Number 171 (Tuesday, September 6, 2005)]
[Notices]
[Pages 53018-53019]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17617]
-----------------------------------------------------------------------
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, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request the Office of
Management and Budget (OMB) to reinstate the information collection
project: ``AHRQ-HRSA Chemical, Biological, Radiological, Nuclear and
Explosive (All Hazards) Preparedness Questionnaire for Healthcare
Facilities for 2004 (CBRNE)''. In accordance with the Paperwork
Reduction Act of 1995, 44 U.S.C. 3506(C)(2)(A), AHRQ invites the public
to comment on this proposed information collection.
AHRQ obtained a six-month emergency collection approval for the
first wave of this information collection. This reinstatement of the
previous clearance approval coves the second wave of the same survey.
The respondents will be queried as to their progress in achieving the
preparedness goals reported in the first wave.
DATES: Comments on this notice must be received by November 7, 2005.
ADDRESSES: Written comments for the proposed information collection
should be submitted to: Cynthia D. McMichael, Reports Clearance
Officer, AHRQ, 540 Gaither Road, Room 5022, Rockville, MD
20850.
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can obtained
from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ Reports
Clearance Officer, (301) 427-1651.
SUPPLEMENTARY INFORMATION:
Proposed Project
``AHRQ-HRSA Chemical, Biological, Radiological, Nuclear and
Explosive (All Hazards) Preparedness Questionnaire for Healthcare
Facilities for 2004 (CBRNE)''
The Preparedness Questionnaire is an inventory of the U.S.
hospitals which received support for preparedness activities under the
HRSA National Bioterrorism Hospital Preparedness Program. This survey
instrument is being designed for use by preparedness planners to
measure local or regional hospital levels of preparedness for a
chemical, biological, radiological, nuclear and explosive (CBRNE)
event. One point of contact is designated in each hospital to provide
information on a range of topics that have been deemed essential by a
panel of nationally-recognized experts on issues related to hospital
preparedness for a CBRNE, i.e., an all hazards event.
These topics include facility planning and administration; training
and education; communication and notification; patient capacity;
staffing and support; isolation and decontaminations; supplies,
pharmaceuticals and laboratory support; and surveillance.
The inventory, which was administered in 2004/2005 and will be
again in 2006, will provide national, state, and regional levels of
preparedness by type of hospital, as well as estimates of bed capacity
and emergency increase (surge) capacity. This information will be used
to ascertain the progress of the previously queried hospitals in
attaining their preparedness goals.
In addition to determination the capacity of the survey instrument
to actually collect information needed for local and regional planning,
it should also be useful for national planning, program planning,
setting priority areas in addressing current and future needs, as well
as ensuring that scarce resources are being used in a way that achieves
the most impact in preparedness.
Data Confidentiality Provisions
The data will be collected by an independent consulting firm under
terms of its contract. The identifiable information about institutions
will be kept confidential in accordance with 42 USC 299c-3(c). AHRQ and
HRSA will receive only state-level summary data, and not individual
hospital responses.
Method of Collection
The preparedness questionnaire will be administered electronically
to each hospital via electronic mail. The estimated burden is as
follows:
Estimated Annual Respondent Burden
------------------------------------------------------------------------
Number of questionnaire Total hours
recipients Estimated burden/respondent of burden
------------------------------------------------------------------------
1479.......................... 60 minutes................. 1479
------------------------------------------------------------------------
The estimate burden is based on the completion of a paper version
of the questionnaire by a pilot hospital. The more efficient data
collection effort enabled by the electronic format has been taken into
account in this estimate. The annualized cost to all potential
respondents is estimated at $51,528 Total ($34.84/hr [average staff
time] x 1 hr. x 1479 respondents). Percentage of capital costs,
operating costs or maintenance costs are negligible.
A stratified random sample by state will be used in this second
wave survey. This second wave (resurvey) is utilizing statistical
methods based on baseline data in developing a sampling scheme.
Request for Comments
In accordance with the above cited Paperwork Reduction Act
legislation, comments on the AHRQ's and HRSA'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 functions of AHRQ and HRSA, including whether the
information will have practical utility; (b) the accuracy of the
agency's estimate of the burden (including hours and costs) of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d)
[[Page 53019]]
ways to minimize the burden of the collection of information on
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 12, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 05-17617 Filed 9-2-05; 8:45 am]
BILLING CODE 4160-90-M
