29822 Federal Register / Vol. 66, No. 106 / Friday, June 1, 2001 / Notices

C. Availability of Funds

Approximately $200,676 is available

in FY 2001 to support this project. It is

expected that the award will begin on or

about September 1, 2001, and will be

made for a 12-month budget period

within a one year project period.

Funding estimates may change.

D. Where To Obtain Additional

Information

To obtain business management

technical assistance contact: Michael

Smiley, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 2920 Brandywine Road, Room

3000, MS–E13, Atlanta, GA 30341–

4146, Telephone: (770) 488–2694, Email

address: znr6@cdc.gov.

For program technical assistance,

contact: Liane Hostler, Air Pollution and

Respiratory Health Branch, Division of

Environmental Hazards and Health

Effects, National Center for

Environmental Health, Centers for

Disease Control and Prevention, 1600

Clifton Road, N.E., MS–E17 Atlanta, GA

30333, Telephone: (404) 639–2503,

Email address: lch2@cdc.gov.

Dated: May 25, 2001.

Henry S. Cassell, III,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–13736 Filed 5–31–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0078]

Agency Information Collection

Activities; Proposed Collections;

Reopening of Comment Period; Directto-Consumer Promotion of

Prescription Drugs

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; Reopening of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening the

comment period to June 5, 2001, the

comment period for the two proposed

collections of certain information by the

agency. This notice reopens the

comment period on surveys of

physicians and patients to examine the

impact of direct-to-consumer (DTC)

promotion of prescription drugs. The

purpose of the proposed information

collection is to followup on the agency’s

1999 patient survey and expand

information collection to include

physicians.

DATES: Submit written or electronic

comments on the collection of

information by June 5, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to: http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments by June 5, 2001, on

the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: FDA

needs information from physicians and

patients about their reactions to, and

behaviors that stem from, DTC

prescription drug advertising in order to

develop policy on appropriate

requirements for regulating drug

product promotional materials. The

agency is reopening the comment period

for the proposed collections due to

technical problems encountered on the

electronic comment submission site

during the previous comment period.

Dated: May 29, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13908 Filed 5–30–01; 11:29 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0232]

Medical Devices Premarket Guidance:

Reprocessing and Reuse of Single-Use

Devices; Draft Guidance for Industry

and FDA Staff; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Premarket Guidance:

Reprocessing and Reuse of Single-Use

Devices.’’This draft guidance document

provides premarket guidance to the

medical device industry, including third

party and hospital reprocessors, and to

Center for Devices and Radiological

Health (CDRH) staff, who are

responsible for the premarket evaluation

of submissions for reprocessed singleuse devices (SUDs) or related

enforcement activities. This draft

guidance is neither final nor is it in

effect at this time.

DATES: Submit written comments on the

draft guidance by August 30, 2001.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

draft guidance document entitled,

‘‘Premarket Guidance: Reprocessing and

Reuse of Single-Use Devices’’ to the

Division of Small Manufacturers

Assistance (HFZ–220), Center for

Devices and Radiological Health, Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance document.

FOR FURTHER INFORMATION CONTACT: Tim

Ulatowski, Center for Devices and

Radiological Health (HFZ–480), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8879.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of August 14,

2000 (65 FR 49583), FDA published a

final guidance entitled ‘‘Enforcement

Priorities for Single-Use Devices

Reprocessed by Third Parties and

Hospitals’’ (‘‘the Enforcement Priorities

document’’). The Enforcement Priorities

document provides guidance to third

parties and hospital reprocessors about

their responsibilities as manufacturers

engaged in reprocessing devices labeled

for SUDs under the Federal Food, Drug,

and Cosmetic Act. This draft guidance

document entitled ‘‘Premarket

Guidance: Reprocessing and Reuse of

Single-Use Devices,’’ expands upon the

summary premarket information in the

Enforcement Priorities document.

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on policies and recommendations

regarding premarket regulatory and

technical issues for reprocessed SUDs. 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

Federal Register / Vol. 66, No. 106 / Friday, June 1, 2001 / Notices 29823

such approach satisfies the applicable

statute and regulations.

The agency has adopted good

guidance practices (GGPs), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (21 CFR 10.115; 65 FR

56468, September 19, 2000). This draft

guidance document is issued as a Level

1 guidance in accordance with the GGP

regulations.

III. Electronic Access

In order to receive ‘‘Premarket

Guidance: Reprocessing and Reuse of

Single-Use Devices’’ via your fax

machine, call the CDRH Facts-OnDemand system at 800–899–0381 or

301–827–0111 from a touch-tone

telephone. Press 1 to enter the system.

At the second voice prompt press 1 to

order a document. Enter the document

number (1331) followed by the pound

sign (#). Follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

using the Internet. CDRH maintains an

entry on the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Internet. Updated on a regular basis, the

CDRH home page includes the civil

money penalty guidance documents

package, 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. Guidance

documents are also available on the

Dockets Management Branch Internet

site at http://www.fda.gov/ohrms/

dockets/default.htm.

IV. Comments

Interested persons may submit to

Dockets Management Branch (address

above) written comments regarding this

draft guidance by August 30, 2001.

Submit two copies of any comments,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. The draft guidance

document and received comments may

be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: May 22, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–13731 Filed 5–31–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–906]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, DHHS.

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 this 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: Revision of a Currently

Approved Collection; Title of

Information Collection: The National

Data Reporting Requirements (NDRR).

We are requesting the name of the

collection be changed to the Fiscal

Soundness Reporting Requirements

(FSRR). and Supporting Regulations in

42 CFR 417., .126.478,. 162; Form No.:

HCFA–906 (OMB# 0938–0469); Use:

HCFA needs this information to

establish an on-going fiscal soundness

of the Managed Care Organizations in

the Medicare+Choice Program;

Frequency: Quarterly; Affected Public:

Business or other for-profit; Number of

Respondents: 300; Total Annual

Responses: 300; Total Annual Hours:

301.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, 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,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Melissa Musotto, Room N2–

14–26, 7500 Security Boulevard,

Baltimore, Maryland 21244–1850.

Dated: May 17, 2001.

John P. Burke, III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–13762 Filed 5–31–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10008]

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: Reinstatement, without change,

of a previously approved collection for

which approval has expired;

Title of Information Collection:

Medical Equipment and Supplies

Consumer Survey;