Federal Register / Vol. 65, No. 109 / Tuesday, June 6, 2000 / Notices 35945

IV. Electronic Access

Persons with access to the Internet

may obtain the guidance document and

the Version 1.2.0 Standard at http://

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

Dated: May 25, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–14211 Filed 6–2–00; 11:16 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1277]

Draft Guidance for Industry: Fumonisin

Levels in Human Foods and Animal

Feeds; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Guidance for

Industry: Fumonisin Levels in Human

Foods and Animal Feeds.’’ The purpose

of this draft guidance is to identify for

the industry recommended maximum

fumonisin levels that FDA considers

adequate to protect human and animal

health and that are achievable in human

foods and animal feeds with the use of

good agricultural and good

manufacturing practices. FDA considers

this guidance to be a prudent public

health measure during the development

of a better understanding of the human

health risk associated with fumonisins

and the development of a long-term risk

management policy and program by the

agency for the control of fumonisins in

human foods and animal feeds.

DATES: Submit written comments by

August 7, 2000.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Draft Guidance for Industry:

Fumonisin Levels in Human Foods and

Animal Feeds’’ to Henry Kim, Center for

Food Safety and Applied Nutrition

(CFSAN) (address below), or Randall A.

Lovell, Center for Veterinary Medicine

(CVM) (address below). Send one selfaddressed adhesive label to assist that

office in processing your request. The

draft guidance, CFSAN’s ‘‘Background

Paper in Support of Fumonisin Levels

in Corn and Corn Products Intended for

Human Consumption,’’ and CVM’s

‘‘Background Paper in Support of

Fumonisin Levels in Animal Feed,’’

may also be accessed at the CFSAN or

CVM home page on the Internet at http:/

/www.cfsan.fda.gov and http://

www.fda.gov/cvm, respectively.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

and requests for copies should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Henry Kim, Center for Food Safety

and Applied Nutrition (HFS–306),

Food and Drug Administration, 200

C St. SW., Washington, DC 20204,

202–260–0631, FAX 202–205–4422,

or

Randall A. Lovell, Center for

Veterinary Medicine (HFV–222),

Food and Drug Administration,

7500 Standish Pl., Rockville, MD

20855, 301–827–0176, FAX 301–

827–1484.

SUPPLEMENTARY INFORMATION: FDA has

developed a draft guidance document

regarding the maximum recommended

levels of fumonisins in corn used for

production of human foods and animal

feeds. Fumonisins are naturally

occurring toxins produced by the molds

Fusarium moniliforme (F.

verticillioides), F. proliferatum, and

other Fusarium species that are common

contaminants of corn. Fumonisins have

been linked to a variety of significant

adverse health effects in livestock and

experimental animals. Although human

epidemiological studies are

inconclusive at this time, based on a

wide variety of significant adverse

animal health effects, FDA believes that

an association between fumonisins and

human disease is possible.

The purpose of the draft guidance is

to identify for the industry

recommended maximum fumonisin

levels that FDA considers adequate to

protect human and animal health and

that are achievable in human foods and

animal feeds with the use of good

agricultural and good manufacturing

practices. FDA considers this guidance

to be a prudent public health measure

during the development of a better

understanding of the human health risk

associated with fumonisins and the

development of a long-term risk

management policy and program by the

agency for the control of fumonisins in

human foods and animal feeds. Based

on information obtained from future

national and international workshops

on the risk from exposure to fumonisins,

FDA will consider whether to establish

tolerances, regulatory limits, or action

levels, as appropriate, for fumonisins in

human foods and animal feeds,

respectively, under 21 CFR Part 109—

Unavoidable Contaminants in Food for

Human Consumption and FoodPackaging Material and under 21 CFR

Part 509—Unavoidable Contaminants in

Animal Food and Food-Packaging

Material.

The agency has adopted good

guidance practices (GGP’s) that set forth

the agency’s policies and procedures for

the development, issuance, and use of

guidance documents (62 FR 8961,

February 27, 1997). The draft guidance

document entitled ‘‘Guidance for

Industry: Fumonisin Levels in Human

Foods and Animal Feeds’’ is being

issued as a level 1 draft guidance

consistent with GGP’s. This draft

guidance represents the agency’s current

thinking on the control of fumonisins in

human foods and animal feeds as a

prudent public health measure. 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 and regulations.

Interested persons may submit written

comments to the Dockets Management

Branch (address above) on the draft

guidance by August 7, 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. The draft guidance, CFSAN’s

‘‘Background Paper in Support of

Fumonisin Levels in Corn and Corn

Products Intended for Human

Consumption,’’ CVM’s ‘‘Background

Paper in Support of Fumonisin Levels

in Animal Feed,’’ and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: May 26, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–14106 Filed 6–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–2540–96]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

35946 Federal Register / Vol. 65, No. 109 / Tuesday, June 6, 2000 / Notices

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: Revision of a currently

approved collection; Title of

Information Collection: Skilled Nursing

Facility Cost Report and Supporting

Regulations in 42 CFR 413.20 and

413.24; Form No.: HCFA–2540 (OMB

0938–0463); Use: Form HCFA–2540–96

is the form used by skilled nursing

facilities participating in the Medicare

program. This form reports the health

care costs used to determine the amount

of reimbursable costs for services

rendered to Medicare beneficiaries;

Frequency: Annually; Affected Public:

Businesses or other for-profit; Not-forprofit institutions; Number of

Respondents: 15,700; Total Annual

Responses: 15,706; Total Annual Hours:

2,943,200.

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.

Dated: May 25, 2000.

John P. Burke III,

Reports Clearance Officer, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–13987 Filed 6–5–00; 8:45 am]

BILLING CODE 4120–03–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–0280]

Agency Information Collection

Activities: Submission for OMB

Review; 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 Request:

Extension of a currently approved

collection; Type of Information

Collection: Medigap Compare; HCFA

Form Number: HCFA–R–0280 (OMB

approval #:0938–0767); Use: HCFA

collects plan-specific Medigap data,

including but not limited to premiums

charged and additional benefits offered,

from each insurer offering Medigap

plans. The data collection occurs

electronically. The data are provided on

www.medicare.gov to assist

beneficiaries in obtaining accurate

information on all their health care

coverage options; Frequency: Annually,

and semi-annually if needed; Affected

Public: Business or other for-profit,

Federal Government, State, Local, or

Tribal Government, Not-for-profit

institutions; Number of Respondents:

300; Total annual Responses: 450; Total

Annual Burden Hours: 75.

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: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: May 25, 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. 00–14067 Filed 6–5–00; 8:45 am]

BILLING CODE 4120–03–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10006]

Emergency Clearance: Public

Information Collection Requirements

Submitted to the Office of Management

and Budget (OMB)

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.

We are, however, requesting an

emergency review of the information