62724 Federal Register / Vol. 65, No. 203 / Thursday, October 19, 2000 / Notices

European Union, Japan, and the United

States, and includes input from both

regulatory and industry representatives.

The VICH Steering Committee is

composed of member representatives

from the: European Commission;

European Medicines Evaluation Agency;

European Federation of Animal Health;

Committee on Veterinary Medicinal

Products; U.S. FDA; U.S. Department of

Agriculture; Animal Health Institute;

Japanese Veterinary Pharmaceutical

Association; Japanese Association of

Veterinary Biologics; and Japanese

Ministry of Agriculture, Forestry, and

Fisheries.

Two observers are eligible to

participate in the VICH Steering

Committee: One representative from the

Government of Australia/New Zealand

and one representative from the

industry in Australia/New Zealand. The

VICH Secretariat, which coordinates the

preparation of documentation, is

provided by the Confederation

Mondiale de L’Industrie de la Sante

Animale (COMISA). A COMISA

representative also participates in the

VICH Steering Committee meetings.

The VICH Steering Committee held a

meeting on November 16 through 19,

1999, and agreed that the three draft

guidances entitled ‘‘Effectiveness of

Anthelmintics: Specific

Recommendations for Equine’’ (VICH

GL15), ‘‘Effectiveness of Anthelmintics:

Specific Recommendations for Porcine’’

(VICH GL16), and ‘‘Effectiveness of

Anthelmintics: Specific

Recommendations for Canine’’ (VICH

GL19) should be made available for

public comment.

The three draft guidances: VICH

GL15, VICH GL16, and VICH GL19,

should be read in conjunction with the

‘‘Efficacy of Anthelmintics: General

Recommendations (EAGR)’’ announced

in the Federal Register of July 16, 1999

(64 FR 38445). The draft guidances for

equine, porcine, and canine are part of

the EAGR, and the aim of these three

draft guidances is to: (1) Be more

specific for certain issues not discussed

in the general guidance, (2) highlight

differences with the EAGR on

effectiveness data recommendations,

and (3) give explanations for disparities

with the EAGR. Comments about the

draft guidances will be considered by

the FDA and the VICH Anthelmintic

Working Group. Ultimately, FDA

intends to adopt the VICH Steering

Committee’s final guidances and

publish them as future guidances.

These draft guidances, developed

under the VICH process, have been

revised to conform to FDA’s good

guidance practices (65 FR 56468,

September 19, 2000). For example, the

documents have been designated

‘‘guidance’’ rather than ‘‘guideline.’’

Because guidance documents are not

binding, unless specifically supported

by statute or regulation, mandatory

words such as ‘‘must,’’ ‘‘shall,’’ and

‘‘will’’ in the original VICH documents

have been substituted with ‘‘should.’’

Similarly, words such as ‘‘requirement’’

or ‘‘acceptable’’ have been replaced by

‘‘recommendation’’ or ‘‘recommended’’

as appropriate to the context.

These draft guidances represent

current FDA thinking on effectiveness

recommendations for certain veterinary

anthelmintic medicinal products. These

draft guidances do not create or confer

any rights for or on any person and will

not operate to bind FDA or the public.

An alternate method may be used as

long as it satisfies the requirements of

applicable statutes and regulations.

II. Comments

These draft guidances are being

distributed for comment purposes only,

and they are not intended for

implementation at this time. Interested

persons may submit to the Dockets

Management Branch (address above)

written comments regarding the draft

guidance documents by December 18,

2000. Two copies of any comments are

to be submitted, 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. A copy of the draft guidances

and received comments may be seen in

the Dockets Management Branch

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

through Friday.

Dated: October 6, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–26897 Filed 10–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–250 through

HCFA–254]

Notice of Emergency Clearance and

Public Meeting: Public Information

Collection Requirements Submitted to

the Office of Management and Budget

(OMB)

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.

We are, however, requesting an

emergency review of the information

collections referenced below. In

compliance with the requirement of

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

Reduction Act of 1995, we have

submitted to the Office of Management

and Budget (OMB) the following

requirements for emergency review. We

are requesting an emergency review

because the collection of this

information is needed before the

expiration of the normal time limits

under OMB’s regulations at 5 CFR, Part

1320. A disruption in this collection

activity may cause public harm. This is

due to the potential and unnecessary

loss to the Medicare Trust Fund as the

result of the non-identification of health

insurance coverage that is primary to

Medicare. Collection of this information

allows HCFA to identify those Medicare

beneficiaries who have other group

health insurance that would pay before

Medicare, resulting in savings to the

Medicare Trust Fund. The annual

savings from the Medicare Secondary

Payer (MSP) program are more than $3

billion per year.

Emergency Clearance

HCFA is requesting OMB review and

approval of this collection by November

24, 2000, with a 180-day approval

period. Written comments and

recommendations will be accepted from

the public if received by the individuals

designated below by November 23,

2000. During this 180-day period, we

will publish a separate Federal Register

notice announcing the initiation of an

extensive 60-day agency review and

public comment period on these

requirements. We will submit the

requirements for OMB review and an

extension of this emergency approval.

Type of Information Request: Revision

of a currently approved collection; Title

of Information Collection: Medicare

Secondary Payer Information Collection

Federal Register / Vol. 65, No. 203 / Thursday, October 19, 2000 / Notices 62725

and Supporting Regulations in 42 CFR

411.25, 489.2, and 489.20; Form

Number: HCFA–250 through HCFA–254

(OMB approval #: 0938–0214); Use:

Medicare Secondary Payer (MSP) refers

to those situations where Medicare does

not have primary responsibility for

paying the medical expenses of a

Medicare beneficiary. Medicare

intermediaries and carriers must collect

information to perform various tasks to

detect MSP cases, develop and

disseminate tools to enable them to

better perform their tasks, and monitor

their performance in achievement of

their assigned MSP functions. These

information collection requirements

describe the MSP requirements and

consist of the following:

1. Initial enrollment questionnaire

2. MSP claims investigation, which

consists of first claim development,

trauma code development, self-reporting

MSP liability development, notice to

responsible third party development

(411.25 notice), secondary claims

development, and ‘‘08’’ development

(involving claims where information

cannot be obtained from the beneficiary)

3. Provider MSP development, which

requires the provider to request

information from the beneficiary or

representative during admission and

other encounters; Frequency: On

occasion; Affected Public: Individuals or

households, Business or other for-profit,

and Not-for-profit institutions; Number

of Respondents: 14,204,000; Total

Annual Responses: 116,394,528; Total

Annual Hours Requested: 3,305,814.

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.

Public Meeting

HCFA will be holding a public

meeting to permit interested parties an

opportunity to give their views on how

the content and use of the MSP

collection requirements may need to be

revised. Representatives of the hospital

industry, health care consumer

advocacy groups, and provider groups

who wish to participate in the public

meeting are asked to notify the Agency

in advance of their interest in attending.

At this meeting, the Health Care

Financing Administration will solicit

comments on the topics listed in the

first paragraph of this notice and as

referenced in the supporting statement,

which may be obtained as described

above.

The public meeting will be held on

Friday, November 3, 2000, from 1:00–

4:00 p.m., in the Multipurpose Room

(Capacity: 100 persons) of the Health

Care Financing Administration, 7500

Security Boulevard, Baltimore,

Maryland 21244. Interested parties

should provide notification of their

planned attendance to Tom Bouchat or

Joan Fowler, either via telephone (410)

786–4621 or (410) 786–0922, fax (410)

786–9963, or e-mail: Tbouchat@hcfa.gov

or Jfowler@hcfa.gov by no later than 3

p.m., Monday, October 30, 2000.

Interested persons are invited to send

comments regarding the burden or any

other aspect of these collections of

information requirements. However, as

noted above, comments on these

information collection requirements

must be mailed and/or faxed to the

designees referenced below by

November 23, 2000:

Health Care Financing Administration,

Office of Information Services,

Division of HCFA Enterprise

Standards, Room N2–14–26, 7500

Security Boulevard, Baltimore, MD

21244–1850, Fax Number: (410) 786–

0262, Attn: Julie Brown HCFA–250

through HCFA–254 and,

Office of Information and Regulatory

Affairs, Office of Management and

Budget, Room 10235, New Executive

Office Building, Washington, DC

20503, Fax Number: (202) 395–6974

or (202) 395–5167, Attn: Wendy

Taylor, HCFA Desk Officer.

Dated: October 17, 2000.

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. 00–27028 Filed 10–17–00; 3:06 pm]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–8007–N]

RIN 0938–AK27

Medicare Program; Inpatient Hospital

Deductible and Hospital and Extended

Care Services Coinsurance Amounts

for 2001

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

inpatient hospital deductible and the

hospital and extended care services

coinsurance amounts for services

furnished in calendar year 2001 under

Medicare’s hospital insurance program

(Medicare Part A). The Medicare statute

specifies the formulae used to determine

these amounts.

The inpatient hospital deductible will

be $792. The daily coinsurance amounts

will be: (a) $198 for the 61st through

90th day of hospitalization in a benefit

period; (b) $396 for lifetime reserve

days; and (c) $99 for the 21st through

100th day of extended care services in

a skilled nursing facility in a benefit

period.

EFFECTIVE DATE: This notice is effective

on January 1, 2001.

FOR FURTHER INFORMATION CONTACT:

Clare McFarland, (410) 786–6390. For

case-mix analysis only: Gregory J.

Savord, (410) 786–1521.

SUPPLEMENTARY INFORMATION:

I. Background

Section 1813 of the Social Security

Act (the Act) provides for an inpatient

hospital deductible to be subtracted

from the amount payable by Medicare

for inpatient hospital services furnished

to a beneficiary. It also provides for

certain coinsurance amounts to be

subtracted from the amounts payable by

Medicare for inpatient hospital and

extended care services. Section

1813(b)(2) of the Act requires us to

determine and publish, between

September 1 and September 15 of each

year, the amount of the inpatient

hospital deductible and the hospital and

extended care services coinsurance

amounts applicable for services

furnished in the following calendar

year.

II. Computing the Inpatient Hospital

Deductible for 2001

Section 1813(b) of the Act prescribes

the method for computing the amount of

the inpatient hospital deductible. The

inpatient hospital deductible is an

amount equal to the inpatient hospital

deductible for the preceding calendar

year, changed by our best estimate of the

payment-weighted average of the

applicable percentage increases (as

defined in section 1886(b)(3)(B) of the

Act) used for updating the payment

rates to hospitals for discharges in the

fiscal year that begins on October 1 of

the same preceding calendar year, and

adjusted to reflect real case mix. The

adjustment to reflect real case mix is

determined on the basis of the most

recent case mix data available. The

amount determined under this formula

is rounded to the nearest multiple of $4