75942 Federal Register / Vol. 65, No. 234 / Tuesday, December 5, 2000 / Notices

information collection and has assigned

OMB control number 0910–0264. The

approval expires on November 30, 2003.

A copy of the supporting statement for

this information collection is available

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: November 28, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–30831 Filed 12–4–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1060]

Agency Information Collection

Activities; Announcement of OMB

Approval; Adoption of FDA Food Code

by Local, State, and Tribal

Jurisdictions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Adoption of FDA Food Code by Local,

State, and Tribal Jurisdictions’’ has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 3, 2000 (65

FR 47736), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–448. The

approval expires on November 30, 2003.

A copy of the supporting statement for

this information collection is available

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: November 28, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–30874 Filed 12–4–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1440]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; User Fee

Cover Sheet

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by January 4,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

User Fee Cover Sheet; Form FDA

3397—(OMB Control Number 0910–

0297)—Extension

Under sections 735 and 736 of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 379g and 379h), the

‘‘Prescription Drug User Fee Act of

1992’’ (PDUFA) (Public Law 102–571),

as amended by the Food and Drug

Administration Modernization Act of

1997 (Public Law 105–115), FDA has

the authority to assess and collect user

fees for certain drug and biologics

license applications and supplements.

Under this authority, pharmaceutical

companies pay a fee for certain new

human drug applications, biologics

license applications or supplements

submitted to the agency for review.

Because the submission of user fees

concurrently with applications and

supplements is required, review of an

application cannot begin until the fee is

submitted. Form FDA 3397 is the user

fee cover sheet, which is designed to

provide the minimum necessary

information to determine whether a fee

is required for review of an application,

to determine the amount of the fee

required, and to account for and track

user fees. The form provides a crossreference of the fee submitted for an

application with the actual application

by using a unique number tracking

system. The information collected is

used by FDA’s Center for Drug

Evaluation and Research (CDER) and

Center for Biologics Evaluation and

Research (CBER) to initiate the

administrative screening of new drug

applications, biologics license

applications, and supplemental

applications.

Respondents to this collection of

information are new drug and biologics

manufacturers. Based on FDA’s data

base system, there are an estimated 208

manufacturers of products subject to

PDUFA. However, not all manufacturers

will have any submissions in a given

year and some may have multiple

submissions. The total number of

annual responses is based on the

number of submissions received by FDA

in fiscal year 1999. CDER estimates

2,478 annual responses that include the

following: 125 new drug applications,

1,458 chemistry supplements, 755

labeling supplements, and 140 efficacy

supplements. CBER estimates 443

annual responses that include the

following: 8 biologics license

applications, 396 manufacturing

(chemistry) supplements, 29 labeling

supplements, and 10 efficacy

supplements. The estimated hours per

response are based on past FDA

experience with the various

submissions, and range from 5 to 30

minutes. The hours per response are

based on the average of these estimates.

In the Federal Register of August 18,

2000 (65 FR 50540), the agency

requested comments on the proposed

collections of information. No

significant comments were received.

FDA estimates the burden of this

collection of information as follows:

Federal Register / Vol. 65, No. 234 / Tuesday, December 5, 2000 / Notices 75943

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Form No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

FDA 3397 208 14.4 2,921 .30 876

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

Dated: November 28, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–30829 Filed 12–4–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–1491, HCFA–

382, and 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.

(1.) Type of Information Collection

Request: Extension of a currently

approved collection;

Title of Information Collection:

Request for Medicare Payment—

Ambulance and Supporting Regulations

in 42 CFR Section 410.40 and 424.124;

Form No.: HCFA–1491 (OMB# 0938–

0042);

Use: This form is used by physicians,

suppliers, and beneficiaries to request

payment of Part B Medicare services. It

is used to apply for reimbursement for

ambulance services.

Frequency: On occasion;

Affected Public: Business or other forprofit, Individuals or households, and

Not-for-profit Institutions;

Number of Respondents: 9,301,183;

Total Annual Responses: 9,301,183;

Total Annual Hours: 390,418.

(2.)Type of Information Collection

Request: Extension of a currently

approved collection;

Title of Information Collection: ESRD

Beneficiary Selection and Supporting

Regulations Contained in 42 CFR

414.330;

Form No.: HCFA–382 (OMB# 0938–

0372);

Use: ESRD facilities have each new

home dialysis patient select one of two

methods to handle Medicare

reimbursement. The intermediaries pay

for the beneficiaries selecting Method I

and the carriers pay for the beneficiaries

selecting Method II. This system was

developed to avoid duplicate billing by

both intermediaries and carriers.

Frequency: Other (One time only);

Affected Public: Individuals or

households, business or other for-profit,

and not-for-profit institutions;

Number of Respondents: 8,600;

Total Annual Responses: 8,600;

Total Annual Hours: 717.

(3.) Type of Information Collection

Request: Revision of a currently

approved collection;

Title of Information Collection:

Evaluation of the State Medicaid Reform

Demonstrations and Evaluation of the

Medicaid Health Reform

Demonstrations;

Form No.: HCFA–R–207 (OMB#

0938–0708);

Use: These evaluations investigate

health care reform in ten states that have

implemented demonstration programs

using Section 1115 waivers. The surveys

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. During the extended

period of authorization, the surveys will

be administered to Medicaid eligibles,

both demonstration participants and

comparison group non-participants.;

Frequency: Other: One-time;

Affected Public: Individuals or

Households;

Number of Respondents: 5,050;

Total Annual Responses: 5,050;

Total Annual Hours: 2,746.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s Web Site Address at http://

www.hcfa.gov/regs/prdact95.htm, or Email 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 OMB Desk 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: November 20, 2000.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–30840 Filed 12–4–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1162–N]

Medicare Program; Establishment of

the Advisory Panel on Ambulatory

Payment Classification Groups and

Request for Nominations for Members

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

establishment of the Advisory Panel on

Ambulatory Payment Classification

(APC) Groups and solicits nominations

for members of the panel. The purpose

of the panel is to review the APC groups

and their associated weights and advise

the Secretary and the Administrator of

the Health Care Financing

Administration (HCFA) concerning the

clinical integrity of these groups and

weights, which are major elements of

the hospital outpatient prospective

payment system (OPPS). This notice

also announces that on November 21,

2000 the Secretary signed the charter

establishing the panel. The charter will