Federal Register / Vol. 62, No. 159 / Monday, August 18, 1997 / Notices 44011

FOR FURTHER INFORMATION CONTACT:

Carole C. Webb, Center for Devices and

Radiological Health (HFZ–520), 1350

Piccard Dr., Rockville, MD 20850, 301–

594–3948, or internet

‘‘CCW@cdrh.fda.gov’’.

SUPPLEMENTARY INFORMATION:

Pulmonary artery catheters (PAC’s), also

known as right heart catheters, provide

data on blood pressure, blood flow, and

oxygen levels that many doctors

consider crucial to the care of critically

ill hospital patients. A study reported in

the September 18, 1996, Journal of the

American Medical Association (JAMA),

however, suggests use of these catheters

may increase risks of morbidity and

mortality (the JAMA article).

PAC’s have been used in the practice

of critical care medicine since 1970. The

initial marketing of these devices

preceded FDA’s authority to regulate

medical devices which began in 1976.

The JAMA article by Connors et al.

examined the survival of patients

monitored with and without this device

in an intensive care setting. The

Connors et al. study does not provide

evidence that the catheter itself is

unsafe; however, it does raise questions

about the benefit to patients of the

device as it is currently being used.

Concerns about the benefits and risks of

using PAC’s are not new. As early as

1987, other scientists found a greater

risk of morbidity and mortality in use of

PAC’s, but those early studies, as in the

Connors et al. study, were not

randomized. Although the Connors et

al. study showed a relationship between

use of PAC’s and a higher risk of death,

it did not show that use of the catheter

caused those additional deaths. The

additional risk might be related to how

information gained from the catheter is

used or the result of medical therapy a

patient receives. It is possible the results

may not apply when the catheter is used

for diseases or in situations other than

those studied by Connors et al. The

device provides important clinical

information relied upon in determining

a course of treatment. However, FDA

and the National Institutes of Health

(NIH) believe rigorous scientific

evaluations of the device may be needed

in evaluating the context of appropriate

clinical care.

The Pulmonary Artery Catheter and

Clinical Outcomes Workshop will be

cosponsored by FDA and NIH. The goals

of the workshop are to summarize the

following:

(1) Clinical indications, benefits, and

major risks of PAC use;

(2) Current standards for clinical

practice in PAC use;

(3) The need and specific clinical

issues for PAC use in specific patient

populations;

(4) To identify suggestions or

opportunities for future research,

regulatory action, or clinical practice

guidelines.

The workshop will commence with

introductions, overviews of goals,

discussion of contemporary clinical

knowledge of PAC use, and catheter

technology issues. Two concurrent

sessions will be convened in the

morning and afternoon. Each session

will cover two major disease and trauma

topics in separate breakout groups. The

first pair of breakout groups will focus

on PAC use in respiratory disease and

trauma/perioperative/postoperative

management. The second pair of

breakout groups will include sepsis/

multiorgan dysfunction syndrome and

cardiovascular disease. The objective of

these sessions will be to debate critical

clinical issues specific to these areas.

Attendees may observe any available

session and may participate in open

discussions. Following these sessions,

cochairs will guide their teams to

identify pragmatic and prioritized

research considerations. On August 26,

1997, each group will present their

report to the entire workshop. Open

discussions and concluding remarks

will follow. Cochairs will only remain

after the formal part of the workshop to

discuss areas of disagreement and to

write the first draft of the final

document. It is expected the final

document will be delivered to Federal

agencies within 2 weeks.

Dated: August 13, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–21835 Filed 8–13–97; 2:56 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4263–N–04]

Office of the Assistant Secretary for

Fair Housing and Equal Opportunity;

Proposed Information Collection for

Public Comment

AGENCY: Office of the Assistant

Secretary for Fair Housing and Equal

Opportunity; HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due: October 17,

1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Josie D. Harrison, Reports Liaison

Officer, Fair Housing and Equal

Opportunity, Department of Housing

and Urban Development, 451–7th

Street, SW, Room 5124, Washington, DC

20410–5000.

FOR FURTHER INFORMATION CONTACT:

Susan Scanlan (202) 708–2740 (this is

not a toll-free number) for copies of the

proposed forms and other available

documents.

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).

The Notice is soliciting comments

from members of the public and

affecting agencies concerning the

proposed collection of information to:

(1) Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions 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; (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

through the use of appropriate

automated collection techniques or

other forms of information technology,

e.g., permitting electronic submission of

responses.

This Notice also lists the following

information:

Title of Proposal: Survey

Questionnaires.

OMB Control Number: 2529–0045.

Description of the need for the

information and proposed use: HUD

will use this information to assess the

adequacy of its customer service and

review comments and suggestions made

by its customers to better enhance its

customer service as required by

Executive Order 12862.

Agency form numbers: None.

Members of affected public:

Complainants, Respondents of

complaints, Public Housing Authorities

(PHAs), Private Property Managers and

Representatives for Complainants,
44012 Federal Register / Vol. 62, No. 159 / Monday, August 18, 1997 / Notices

members of the mortgage lending

industry who have signed voluntary

agreements with HUD.

Estimation of the total number of

hours needed to prepare the information

collection including number of

respondents, frequency of response, and

hours of response: This survey will be

completed on a voluntary basis. The

number of actual respondents can not be

exactly calculated as there are various

programs being surveyed each with

their own unique set of customers. The

attached sample survey instruments

have been pretested. The amount of

time required to complete the

questionnaires is estimated at not more

than 15 minutes for the complainants,

and not more than 30 minutes for all

other recipients.

Status of the proposed information

collection: This is an amended survey

instrument that is being completed to

assess the customer service given by the

Office of Fair Housing and Equal

Opportunity.

Authority: Section 3506 of the Paperwork

Reduction Act of 1995, 44 U.S.C. Chapter 35,

as amended.

Dated: August 8, 1997.

Laurence D. Pearl,

Acting Deputy Assistant Secretary for

Program Operations and Standards.

[FR Doc. 97–21768 Filed 8–15–97; 8:45 am]

BILLING CODE 4210–28–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4263–N–05]

Office of the Assistant Secretary for

Housing, Federal Housing

Commissioner; Proposed Information

Collection for Public Comment

AGENCY: Office of the Assistant

Secretary for Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposals.

DATES: Comments due: October 17,

1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Oliver Walker, Housing, Department of

Housing & Urban Development, 451–7th

Street, SW, Room 9116, Washington, DC

20410.

FOR FURTHER INFORMATION CONTACT:

Michael Diggs, telephone number (202)

708–3944 (this is not a toll-free number)

for copies of the proposed forms and

other available documents.

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).

The Notice is soliciting comments

from members of the public and affected

agencies concerning the proposed

collection of information to: (1) Evaluate

whether the proposed collection of

information is necessary for the proper

performance of the functions 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; (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 through the use of

appropriate automated collection

techniques or other forms of information

technology, e.g., permitting electronic

submission of responses.

This Notice also lists the following

information:

Title of Proposal: Owner/Tenant

Certification for Multifamily Housing

Programs.

OMB Control Number: 2502–0204.

Description of the need for the

information and proposed use: Housing

Programs, subsidies, rental assistance,

eligibility criteria. Information is needed

to determine tenant eligibility and to

compute tenant annual rents for those

occupying HUD subsidized housing

units.

Agency form numbers: HUD 50059,

50059D, 50059F, 50059G.

Members of affected public:

Businesses or other for-profit, Nonprofit institutions, individuals or

households, federal agencies or

employees, small business or

organizations.

Status of the proposed information

collection: Extension without change.

Authority: Section 236 of the Paperwork

Reduction Act of 1995, 44 U.S.C., Chapter 35,

as amended.

Dated: August 8, 1997.

Karen A. Miller,

Deputy Assistant Secretary for Multifamily

Housing.

[FR Doc. 97–21769 Filed 8–15–97; 8:45 am]

BILLING CODE 4210–27–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4211–N–02]

NOFA for Lead-Based Paint Hazard

Control in Privately-Owned Housing,

Fiscal Year 1997; Notice of Extension

of Application Deadline Date Due to

United Parcel Service (UPS) Labor

Strike

AGENCY: Office of the Secretary—Office

of Lead Hazard Control, HUD.

ACTION: Notice of funding availability

for FY 1997; extension of application

deadline date.

SUMMARY: On June 3, 1997 (62 FR

30380), HUD published a notice

announcing the availability of

approximately $50 million for two

categories of lead hazard control

activities in privately-owned housing.

The June 3, 1997 notice of funding

availability (NOFA) provided that

applications had to be received by HUD

no later than 3:00 p.m. (Eastern Time)

on August 5, 1997. Due to the United

Parcel Service (UPS) labor strike, HUD

is retroactively extending the

application deadline date to 5:00 p.m.

(Eastern Time), August 5, 1997. HUD

will also accept late applications which

are either postmarked on or contain a

receipt of delivery to a private express

mail carrier by midnight (Eastern Time)

on August 5, 1997. HUD is extending

the application due date in order to

prevent the unfair rejection of NOFA

applications which, although completed

on a timely basis, could not be delivered

to HUD by the original deadline date

due to the UPS strike.

FOR FURTHER INFORMATION CONTACT: For

Category A applicants: Ellis G.

Goldman, Director, Program

Management Division, Office of Lead

Hazard Control, Room B–133, 451

Seventh Street, SW., Washington, DC

20410, telephone (202) 755–1785,

extension 112 (this is not a toll-free

number). For Category B applicants:

Melissa F. Shapiro, telephone (202)

755–1785, extension 153 (this is not a

toll-free number). For hearing- and

speech-impaired persons, the telephone

number may be accessed via TTY (text

telephone) by calling the toll-free

Federal Information Relay Service at 1–

800–877–8339.

SUPPLEMENTARY INFORMATION:

On June 3, 1997 (62 FR 30380), HUD

published a notice announcing the

competition for two categories of grant

funding: Category A for approximately

$46 million for a grant program for State

and local governments to undertake

lead-based paint hazard control in