45672 Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices

premarket clearance for convenience

kits that have intended uses,

components, and processing methods

that are described in the guidance, and

where the assembler/manufacturer is

able to reasonably conclude that any

further processing of the kit and its

components does not significantly affect

the safety or effectiveness of any of its

components. The intent to exercise

enforcement discretion means that FDA

does not intend to take enforcement

action for the failure to submit

premarket notification for convenience

kits described in the guidance. In the

future, FDA intends to propose

rulemaking to formally exempt these

types of kits from the requirement of

premarket notification.

This guidance is effective

immediately.

The ‘‘Convenience Kits Interim

Regulatory Guidance’’ represents the

agency’s current thinking on premarket

notification regulatory strategy for

convenience kits. 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 statute,

regulations, or both.

II. Electronic Access

In order to receive the ‘‘Convenience

Kits Interim Regulatory Guidance’’

document via your fax machine, call the

CDRH Facts-On-Demand (FOD) system

at 800–899–0381 or 301–827–0111 from

a touch-tone telephone. At the first

voice prompt, press 1 to access DSMA

Facts, at the second voice prompt press

2, and then enter the document number

562 followed by the pound sign (#).

Then follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy

of the guidance may do so by using the

World Wide Web (WWW). The Center

for Devices and Radiological Health

(CDRH) maintains an entry on the

WWW for easy access to information

including text, graphics, and files that

may be downloaded to a PC with access

to the Web. The CDRH home page is

updated on a regular basis and includes

the ‘‘Convenience Kits Interim

Regulatory Guidance’’ document, device

safety alerts, Federal Register reprints,

information on premarket submissions

(including lists of approved applications

and manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at ‘‘http://www.fda.gov/cdrh’’. The

‘‘Convenience Kits Interim Regulatory

Guidance’’ is available on the medical

device reporting page at ‘‘http://

www.fda.gov/cdrh/ode/convkit.html’’.

A text only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select MEDICAL

DEVICES AND RADIOLOGICAL

HEALTH. From there select CENTER

FOR DEVICES AND RADIOLOGICAL

HEALTH for general information, or

arrow down for specific topics.

III. Request for Comments

Interested persons may, at any time,

submit to the contact person listed

above written comments regarding this

guidance.

Dated: August 21, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–22855 Filed 8–27–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–R–39]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

1. Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Home Health

Medicare Conditions of Participation

(COP) Information Collection

Requirements (ICR’s) as outlined in

Regulation 42 CFR Part 484; Form No.:

HCFA–R–39 OMB #0938–0365; Use:

The ICR’s contained in 42 CFR part 484

outline Home Health Agencies Medicare

COP’s to ensure Home Health Agencies

meet Federal patient health and safety

requirements. Frequency: Annually;

Affected Public: Business or other forprofit, Not-for-profit institutions and

Federal Government; Number of

Respondents: 10,203; Total Annual

Responses: 10,203; Total Annual Hours:

86,008.

2. Type of Information Collection

Request: Reinstatement without change

of a previously approved collection for

which approval has expired; Title of

Information Collection: Negative Case

Action Review Process (NCA)/Annual

Report and Supporting Regulations 42

CFR 431.800; Form No.: HCFA—6401

OMB #0938–0300; Use: HCFA uses the

NCA reviews conducted by states to

assure that beneficiaries are not being

denied medical assistance that they are

eligible for and that recipients are being

given adequate and timely notice of

termination. The results of NCA reviews

are used by states and the Federal

Government to identify problem areas

and plan corrective action initiatives.

Frequency: Annually; Affected Public:

State, Local or Tribal Government;

Number of Respondents: 51; Total

Annual Responses: 51; Total Annual

Hours: 6,770.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.
Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices 45673

Dated: August 20, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 97–22963 Filed 8–27–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–R–207]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: New Collection; Title of

Information Collection: Evaluation of

Five State Health Care Reform

Demonstrations and the Evaluation of

the Medicaid State Health Reform

Demonstrations; Form No.: HCFA–R–

207; Use: These evaluations will

investigate health care reform in ten

states that will implement or have

implemented demonstration programs

using Medicaid Section 1115 waivers.

The surveys will gather information to

answer questions regarding access to

health care, quality of care delivered,

satisfaction with health services, and

the use and cost of health services. The

surveys will be administered to

Medicaid eligible and newly covered

enrollees and eligible and near-eligible

non-enrollees. A subsample of survey

respondents will be SSI recipients and

other disabled people who have

participated in demonstrations for at

least a year. Quality of care surveys will

be administered to Medicaid enrollees

who have diabetes and to parents of

children in the Medicaid program who

have pediatric asthma. Frequency:

(Other) one time for most respondents;

Affected Public: Individuals or

Households; Number of Respondents:

33,693; Total Annual Responses:

34,035; Total Annual Hours: 10,279.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Dated: August 11, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 97–22964 Filed 8–27–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Receipt of Applications for

Permit

The following applicants have

applied for a permit to conduct certain

activities with endangered species. This

notice is provided pursuant to Section

10(c) of the Endangered Species Act of

1973, as amended (16 U.S.C. 1531, et

seq.):

Applicant: Life Fellowship Bird

Sanctuary, Seffner, FL, PRT–832609.

The applicant requests a permit

authorizing import of 36 Galapagos

tortoises (Geochelone elephantopus)

from the Bermuda Aquarium, Natural

History Museum and Zoo, Flatts,

Bermuda for the purpose of

enhancement of the species through

captive propagation.

Applicant: University of Wisconsin,

Dept. of Zoology, Madison, WI, PRT–

831689.

The applicant request a permit to

import blood and feather samples taken

from captive-held Andean condors

(Vultur gryphus) in Ecuador, Bolivia,

Colombia, and Argentina for the

purpose of scientific research.

Applicant: Cohanzick Zoo, Bridgeton,

NJ, PRT–833281.

The applicant request a permit to

import a male and female Bengal tigers

(Panthera tigris tigris) born in captivity

from Parken Zoo, Eskilstuna, Sweden,

for the purpose of enhancement of the

species through conservation education.

Applicant: University of Puerto Rico,

Rio Piedras, PR, PRT–833581.

The applicant requests a permit to

export and re-import non-living

museum specimens of endangered and

threatened species of plants and animals

previously accessioned into the

permittee’s collection for scientific

research. This notification covers

activities conducted by the applicant for

a five year period.

Applicant: Stephen Fullmer, Salt Lake

City, UT, PRT–833360.

The applicant requests a permit to

import the sport-hunted trophy of one

male bontebok (Damaliscus pygargus

dorcas) culled from a captive herd

maintained under the management

program of the Republic of South Africa,

for the purpose of enhancement of the

survival of the species.

Written data or comments should be

submitted to the Director, U.S. Fish and

Wildlife Service, Office of Management

Authority, 4401 North Fairfax Drive,

Room 430, Arlington, Virginia 22203

and must be received by the Director

within 30 days of the date of this

publication.

The public is invited to comment on

the following application(s) for permits

to conduct certain activities with marine

mammals. The application(s) was/were

submitted to satisfy requirements of the

Marine Mammal Protection Act of 1972,

as amended (16 U.S.C. 1361 et seq.) and

the regulations governing marine

mammals (50 CFR 18).

Applicant: Richard Nelson, Sarasota,

FL, PRT–833155.

The applicant requests a permit to

import a polar bear (Ursus maritimus)

sport-hunted prior to April 30, 1994

from the Foxe Basin polar bear

population, Northwest Territories,

Canada for personal use.

Applicant: Arlo Spiess, El Macero,

CA, PRT–833156.

The applicant requests a permit to

import a polar bear (Ursus maritimus)

sport-hunted prior to April 30, 1994,

from the Lancaster Sound polar bear

population, Northwest Territories,

Canada for personal use.

Applicant: John Richardson, New

Middletown, OH, PRT–832321.

The applicant requests a permit to

import a polar bear (Ursus maritimus)

sport-hunted from the McClintock

Channel polar bear population,