Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Notices 36453

Questioning Regarding Possible

Exposure to Malaria’’ dated May 2000 to

the Office of Communication, Training,

and Manufacturers Assistance (HFM–

40), Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your requests.

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by fax by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance

document.

Submit written comments on the

document to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance document entitled

‘‘Guidance for Industry:

Recommendations for Donor

Questioning Regarding Possible

Exposure to Malaria’’ dated May 2000.

The draft guidance document

recommends questions to be asked of

donors to determine possible exposure

to malaria. The draft guidance

document also provides

recommendations for deferral of donors

for malarial risk. The recommendations

apply only to donations containing

intact Red Blood Cells or platelets.

Donations used for preparing plasma or

plasma derivatives devoid of intact Red

Blood Cells or platelets are excluded.

The draft guidance document currently

being announced, when finalized, will

replace the recommendations in the

guidance entitled ‘‘Recommendations

for Deferral of Donors for Malaria Risk’’

dated July 26, 1994.

The draft guidance document

represents the agency’s current thinking

on malarial risks for prospective donors.

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

such approach satisfies the

requirements of the applicable statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this document to be all-inclusive

and cautions that not all information

may be applicable to all situations. The

document is intended to provide

information and does not set forth

requirements.

II. Comments

The draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding this draft guidance

document. Submit written comments to

ensure adequate consideration in

preparation of the final document by

September 6, 2000. Two copies of any

comments are to be submitted, except

individuals may submit one copy.

Comments are to be identified with the

docket number found in the brackets in

the heading of this document. A copy of

the document and received comments

are available for public examination in

the Dockets Management Branch

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

through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cber/guidelines.htm.

Dated: May 18, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–14371 Filed 6–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10003]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

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 Collection.

Title of Information Collection:

Medicare + Choice Beneficiary Appeal

Notices, ‘‘Notices of Denial of Medical

Services,’’ ‘‘Notice of Denial of Request

for Payment’’ and Supporting

Regulations in 42 CFR 422.568.

Form No.: HCFA–10003 (OMB# 0938–

NEW).

Use: This collection includes two

Medicare + Choice appeal notices,

Denial of Service and Denial of

Payment. Pursuant to the Social

Security Act Section 1852(g)(1)(B), M+C

organizations are required to issue

notices to Medicare managed care

beneficiaries when a request for either

medical service or payment is denied.

Additionally, the notices inform

beneficiaries of their right to file an

appeal.

All M+C organizations will be

required to use these forms. Neither the

Health Care Financing Administration

(HCFA) nor the M+C organizations will

use such notices to collect and analyze

data on M+C beneficiary appeals. They

are for information purposes only.

Frequency: On occasion.

Affected Public: Business or other forprofit and Individuals or Households.

Number of Respondents: 29,892.

Total Annual Responses: 29,892.

Total Annual Hours: 2,994.

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: Dawn Willinghan, Room N2–

14–26, 7500 Security Boulevard,

Baltimore, Maryland 21244–1850.

36454 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Notices

Dated: May 30, 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. 00–14451 Filed 6–07–00; 8:45 am]

BILLING CODE 4120–03–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–2384]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

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: Extension of a currently

approved collection;

Title of Information Collection: Third

Party Premium Billing Request and

Supporting Regulations in 42 CFR

408.6;

Form No.: HCFA–2384 (OMB 0938–

0041);

Use: The Third Party Premium Billing

Request is used as an authorization form

to designate that a family member or

other interested party receive the

Medicare premium bill and pay it on

behalf of a Medicare beneficiary.

Frequency: On occasion;

Affected Public: Individuals or

Households;

Number of Respondents: 15,000;

Total Annual Responses: 15,000;

Total Annual Hours: 6,250.

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: Dawn Willinghan, Room N2–

14–26, 7500 Security Boulevard,

Baltimore, Maryland 21244–1850.

Dated: May 30, 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. 00–14452 Filed 6–7–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–216]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

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: Extension of a currently

approved collection;

Title of Information Collection: Organ

Procurement Organization/

Histocompatibility Laboratory

Statement of Reimbursable Costs,

Manual Instructions and Supporting

Regulations Contained in 42 CFR 413.20

and 413.24;

Form No.: HCFA–216 (OMB No.

0938–0102);

Use: This form is required by statute

for participation in the Medicare

program. The information is used to

determine reasonable costs incurred to

furnish treatment to End Stage Renal

Disease (ESRD) patients by Organ

Procurement Organizations and

Histocompatibility Laboratories.

Frequency: Annually;

Affected Public: Business or other forprofit, Not-for-profit institutions, and

State, Local or Tribal Government;

Number of Respondents: 108;

Total Annual Responses: 108;

Hours: 4,860.

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: Dawn Willinghan, Room N2–

14–26, 7500 Security Boulevard,

Baltimore, Maryland 21244–1850.

Dated: May 30, 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. 00–14453 Filed 6–7–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Receipt of Applications for

Permit

The following applicants have

applied for a permit to conduct certain