Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices 21769

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 0910–0308. The

approval expires on April 31, 2003. A

copy of the supporting statement for this

information collection is available on

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

ohrms/dockets.

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10710 Filed 4–30–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1503]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Orphan

Drug Products

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 May 31,

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.

Orphan Drug Products—21 CFR Part

316 (OMB Number 0910–0167)—

Extension

Sections 525 through 528 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360aa through

360dd) give FDA statutory authority to:

(1) Provide recommendations on

investigations required for approval of

marketing applications for orphan

drugs, (2) designate eligible drugs as

orphan drugs, (3) set forth conditions

under which a sponsor of an approved

orphan drug obtains exclusive approval,

and (4) encourage sponsors to make

orphan drugs available for treatment on

an ‘‘open protocol’’ basis before the drug

has been approved for general

marketing. The implementing

regulations for these statutory

requirements have been codified under

part 316 (21 CFR part 316) and specifies

the content and format of a request for

written recommendations concerning

the nonclinical laboratory studies and

clinical investigations necessary for

approval of marketing applications.

Section 316.12 provides that, before

providing such recommendations, FDA

may require results of studies to be

submitted for review. Section 316.14

contains provisions permitting FDA to

refuse to provide written

recommendations under certain

circumstances. Within 90 days of any

refusal, a sponsor may submit

additional information specified by

FDA. Section 316.20 specifies the

content and format of an orphan drug

application which includes

requirements that an applicant

document that the disease is rare (affects

fewer than 200,000 persons in the

United States annually) or that the

sponsor of the drug has no reasonable

expectation of recovering costs of

research and development of the drug.

Section 316.26 allows an applicant to

amend the application under certain

circumstances. Section 316.30 requires

submission of annual reports, including

progress reports on studies, a

description of the investigational plan,

and a discussion of changes that may

affect orphan status. The information

requested will provide the basis for an

FDA determination that the drug is for

a rare disease or condition and satisfies

the requirements for obtaining orphan

drug status. Secondly, the information

will describe the medical and regulatory

history of the drug. The respondents to

this collection of information are

biotechnology firms, drug companies,

and academic clinical researchers.

In the Federal Register of September

19, 2000 (65 FR 56586), 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:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section No. of Respondents

Annual Frequency perResponse

Total Annual

Responses

Hours per Response Total Hours

316.10, 316.12, and 316.14 0 0 0 0 0

316.20, 316.21, and 316.26 90 1.78 160.20 125 20,025

316.22 5 1 5 2 10

316.27 5 1 5 4 20

316.30 450 1 450 2 900

316.36 .2 3 .6 15 9

Total Burden Hours 20,964

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

The information requested from

respondents represents, for the most

part, an accounting of information

already in possession of the applicant.

It is estimated, based on the frequency

of requests over the past 10 years, that

90 persons or organizations per year

will request orphan drug designation

and that no requests for

recommendations on design of

preclinical or clinical studies will be

received. Based upon FDA experience

over the last decade, FDA estimates that

the effort required to prepare

applications to receive consideration for

sections 525 and 526 of the act

(§§ 316.10, 316.12, 316.20, and 316.21)

is generally similar and is estimated to

21770 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices

require an average of 95 hours of

professional staff time and 30 hours of

support staff time per application.

Estimates of annual activity and burden

for foreign sponsor nomination of a

resident, agent, change in ownership or

designation, and inadequate supplies of

drug in exclusivity, are based on total

experience by FDA with such requests

since 1983.

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10711 Filed 4–30–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–1450]

Agency Information Collection

Activities: Submission for OMB

Review; 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 Request:

Extension of a currently approved

collection; Title of Information

Collection: Medicare Uniform

Institutional Provider Bill and

Supporting Regulations in 42 CFR

424.5; Form Number: HCFA–1450 (OMB

approval #: 0938–0247); Use: This

standardized form is used in the

Medicare/Medicaid program to apply

for reimbursement of covered services

by all providers that accept Medicare/

Medicaid assigned claims; Frequency:

On occasion; Affected Public: Business

or other for-profit, Not-for-profit

institutions; Number of Respondents:

46,708; Total Annual Responses:

147,343,290; Total Annual Hours

Requested: 1,854,070.

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 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Wendy Taylor, New

Executive Office Building, Room 10235,

Washington, DC 20503.

Dated: March 19, 2001.

John P. Burke, III,

HCFA Office of Information Services, Security

and Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–10814 Filed 4–30–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1182–PN]

RIN 0938–AK75

Medicare Program; Revision of

Payment Rates for End-Stage Renal

Disease (ESRD) Patients Enrolled in

Medicare+Choice Plans

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Proposed notice.

SUMMARY: This notice proposes a new

payment methodology, effective January

2002, for beneficiaries with End-Stage

Renal Disease (ESRD) who are enrolled

in Medicare+Choice (M+C) plans. The

proposed methodology would

implement section 605 of the Medicare,

Medicaid, and SCHIP Benefits

Improvement and Protection Act of

2000 (BIPA). Section 605 requires the

Secretary to increase ESRD M+C

payment rates, using appropriate

adjustments, to reflect the

demonstration rates (including the risk

adjustment methodology associated

with those rates) of the social health

maintenance organization ESRD

capitation demonstrations. Briefly, the

approach that we propose follows:

• Base State-level per capita rates on

100 percent of estimated State per capita

ESRD fee-for-service expenditures in a

base year.

• Adjust State per capita rates by age

and sex factors, in order to pay more

accurately, given differences in costs

among ESRD patients.

The effect of the new ESRD M+C

payment methodology would be to

increase Medicare’s Fiscal Year (FY)

2002 ESRD payments by an estimated

$25 million (for 9 months of costs, given

the effective date of January 2002). Total

ESRD M+C payment increases for FY

2003 through FY 2005 are estimated to

be $40 million annually.

The payment methodology proposed

in this notice would govern M+C

payments for enrollees with ESRD in

2002. M+C organizations are required to

submit Adjusted Community Rate (ACR)

proposals setting forth their M+C plan

benefits, premiums, and cost-sharing for

2002 by July 1, 2001. M+C organizations

need information on the payments they

will receive for ESRD enrollees to

prepare their ACR submissions. Section

605(c) of BIPA provided that this notice

had to be published no later than 6

months after the enactment of BIPA or

June 20, 2001. Yet section 605(c) also

requires that the ‘‘final’’ ESRD

methodology be published no later than

July 1, 2001. In light of these deadlines,

and the need of M+C organizations for

final information on ESRD payment

rates to prepare the ACR proposals, we

find that affording the public a full 60-

day comment period would be

‘‘impracticable’’ and ‘‘contrary to the

public interest,’’ and that there is ‘‘good

cause’’ for shortening the 60-day

comment period we normally provide to

30 days.

DATES: We will consider comments if

we receive them at the appropriate

address, as provided below, no later

than 5 p.m. on May 31, 2001.

ADDRESSES: Mail written comments (1

original and 3 copies) to the following

address ONLY: Health Care Financing

Administration, Department of Health

and Human Services, Attention: HCFA–

1182–PN, P.O. Box 8013, Baltimore, MD

21244–8013.

To ensure that mailed comments are

received in time for us to consider them,

please allow for possible delays in

delivering them.

If you prefer, you may deliver your

written comments (1 original and 3

copies) to one of the following

addresses: Room 443–G, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW., Washington, DC 20201, or