53018 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. 

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] 

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: 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 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. 

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) 

Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Notices 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 

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 

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) 

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