Federal Register / Vol. 65, No. 213 / Thursday, November 2, 2000 / Notices 65859

marketing or licensing approval

requirements; and a list of certain drugs

or biological products containing a

particular ingredient. FDA may also

request, but not require, the submission

of a qualitative listing of the inactive

ingredients for all listed drugs or

biological products, and a quantitative

listing of the active ingredients for all

listed drugs or biological products

subject to an approved application or

license.

Under § 207.30, establishments must

update their product listing information

by using Form FDA 2657 and/or Form

FDA 2658 every June and December or,

at the discretion of the establishment,

when any change occurs. These updates

must include the following information:

(1) A listing of all drug or biological

products introduced for commercial

distribution that have not been included

in any previously submitted list, (2) all

drug or biological products formerly

listed for which commercial distribution

has been discontinued, (3) all drug or

biological products for which a notice of

discontinuance was submitted and for

which commercial distribution has been

resumed, and (4) any material change in

any information previously submitted.

No update is required if no changes

have occurred since the previously

submitted list.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Form 21 CFR

Section

No. of

Respondents

No. of Responses

per Respondent

Total Annual

Responses

Hours per

Response Total Hours

Form FDA 2656—Registration of

Drug Establishment 207.21

207.22

207.25

207.26

207.40

15,802 .34 5,438 0.5 2,719

Form FDA 2656e—Annual Update

of Drug Establishment 207.21

207.22

207.25

207.26

207.40

7,226 1 7,226 0.5 3,613

Form FDA 2657—Drug Product

Listing 207.21

207.22

207.25

207.30

207.31

207.40

14,381 2.80 40,270 0.5 20,135

Form FDA 2658—Registered Establishments’ Report of Private

Label Distributors 207.21

207.22

207.25

207.30

207.31

6,221 2.14 13,289 0.5 6,645

Total 33,112

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: October 25, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28135 Filed 11–01–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–1192]

Troy Corp.; Withdrawal of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 7B4546) proposing that the food

additive regulations be amended to

provide for the safe use of 3-iodo-2-

propynyl butyl carbamate as a

fungicidal additive for resinous and

polymeric coatings intended to contact

food.

FOR FURTHER INFORMATION CONTACT:

Mark A. Hepp, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3098.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

December 24, 1998 (63 FR 71295), FDA

announced that a food additive petition

(FAP 7B4546) had been filed by Troy

Corp. c/o S.L. Graham & Associates,

1801 Peachtree Lane, Bowie, MD 20721.

The petition proposed to amend the

food additive regulations in § 175.300

Resinous and polymeric coatings (21

CFR 175.300) to provide for the safe use

of 3-iodo-2-propynyl butyl carbamate as

a fungicidal additive for resinous and

polymeric coatings intended to contact

food. Troy Corp. has now withdrawn

the petition without prejudice to a

future filing (21 CFR 171.7).

65860 Federal Register / Vol. 65, No. 213 / Thursday, November 2, 2000 / Notices

Dated: October 11, 2000.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 00–28055 Filed 11–1–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10017]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

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: New; Title of Information

Collection: Follow-Up of

Medicare+Choice DisenrolleesReceiving

Fee-for-Service Inpatient Hospital Care;

Form No.: HCFA–10017 (OMB# 0938–

NEW); Use: This study will survey

Medicare beneficiaries who had a feefor-service hospital stay after choosing

to leave a Medicare+Choice health plan.

The purpose is to gather information

about their reasons for disenrolling and

to explore the link between the decision

to disenroll and their subsequent feefor-service care; Frequency: On

occasion; Affected Public: Individuals or

households; Number of Respondents:

600; Total Annual Responses: 600; Total

Annual Hours: 650.

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: Julie Brown, Room N2–14–

26, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Date: October 24, 2000.

John P. Burke, III,

Reports Clearance Officer, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–28170 Filed 11–1–00; 8:45 am]

BILLING CODE 4120–03–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–0209 and

HCFA–R–0245]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

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.

1. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Medicare and

Medicaid Programs: Reporting Outcome

and Assessment Information Set

(OASIS) Data as Part of the Conditions

of Participation for Home Health

Agencies and Supporting Regulations in

42 CFR 484.11 and 484.20; Form No.:

HCFA–R–0209 (OMB# 0938–0761); Use:

The information collection requirements

contained in the regulations state that

HHAs must report data from the OASIS

data set as a condition of participation

for HHAs. Specifically, they provide

guidelines for HHAs for the electronic

transmission of the OASIS data set as

well as responsibilities of the State

agency or OASIS contractor in

collecting and transmitting this

information to HCFA. These

requirements are necessary to establish

a prospective payment system for HHAs

and to achieve broad-based, measurable

improvement in the quality of care

furnished through Federal programs;

Frequency: As determined by HHA and

monthly; Affected Public: Business or

other for profit, Not for profit

institutions, and State, Local, or Tribal

Government; Number of Respondents:

7,500; Total Annual Responses: 7,500;

Total Annual Hours: 911,313.

2. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Medicare and

Medicaid Programs: Use of Outcome

and Assessment Information Set

(OASIS) as Part of the Conditions of

Participation for Home Health Agencies

and Supporting Regulations in 42 CFR

484.55; Form No.: HCFA–R–0245

(OMB# 0938–0760); Use: These

information collection requirements are

part of the existing conditions of

participation that home health agencies

(HHAs) must meet to participate in the

Medicare program. Specifically, each

patient must receive from the HHA a

patient-specific, comprehensive

assessment that identifies the patient’s

need for home care and that meets the

patient’s medical, nursing,

rehabilitative, social and discharge

planning needs. In addition, the

regulation requires that, as part of the

comprehensive assessment, HHAs use a

standard core assessment data set, the

OASIS, when evaluating adult, nonmaternity patients. These changes are an

integral part of the Administration’s

efforts to achieve broad-based

improvements in the quality of care

furnished through Federal programs and

in the measurement of that care;

Frequency: Upon patient assessment;

Affected Public: Business or other for

profit, Not for profit institutions, and

State, Local, or Tribal Government;

Number of Respondents: 7,500; Total

Annual Responses: 7,500; Total Annual

Hours: 885,000.