Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Notices 6627

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0002]

Regulatory Procedures Manual;

Chapter 9: Import Operations/Action,

Subchapter: Secured Storage;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a new subchapter of the

Regulatory Procedures Manual. The new

subchapter is entitled ‘‘Secured

Storage.’’ This subchapter has been

provided to FDA’s field offices to

provide operational procedures for

identifying those importers who should

be referred to the U.S. Customs Service

(U.S. Customs) so that U.S. Customs can

require those importers to place their

imported foods into secured storage

under the control of U.S. Customs

pending a decision by FDA of their

admissibility. The subchapter is located

in Chapter 9 of FDA’s Regulatory

Procedures Manual.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of the subchapter entitled

‘‘Secured Storage’’ to Joseph L.

McCallion, Division of Import

Operations and Policy (HFC–170), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your request.

Submit written comments on the

subchapter to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20857. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the subchapter.

FOR FURTHER INFORMATION CONTACT:

Joseph L. McCallion, Division of Import

Operations and Policy (HFC–170), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

6553.

SUPPLEMENTARY INFORMATION:

I. Background

On July 3, 1999, the President

announced an initiative to ensure the

safety of imported food by directing the

Secretary of the Department of Health

and Human Services (DHHS) and the

Secretary of the Treasury to develop

new operational procedures to protect

the public health. The initiative is

geared to optimize the statutory

authorities and resources available to

the FDA, DHHS, and the U.S. Customs,

Department of the Treasury, to protect

consumers from unsafe imported foods.

The President directed the agencies to

target unscrupulous importers who

violate the import laws and work to

subvert the system by introducing

unsafe foods into U.S. markets. Six

specific objectives were emphasized in

the directive.

On December 11, 1999, the President

announced the plan developed by FDA

and U.S. Customs in response to the

directive of July 3, 1999. One element of

the plan was to prevent distribution of

imported unsafe food by requiring

importers with a history of illegal

distribution, misrepresentation, or

substitution to hold future shipments in

secure storage facilities until

specifically released by FDA. The

subchapter now being made available is

setting out the procedures for

accomplishing this objective.

The subchapter does not create or

confer any rights, privileges, or benefits

for, or on, any person and does not

operate to bind FDA, U.S. Customs, or

the public. The subchapter is being

distributed in accordance the FDA’s

policy for Level 2 guidance documents

as set out in the agency’s good guidance

practices, published in the Federal

Register of September 19, 2000 (65 FR

56468).

II. Comments

Interested persons may, at any time,

submit written comments to the Dockets

Management Branch (address above)

regarding this new subchapter. Two

copies of any comments are to be

submitted, except individuals may

submit one copy. Comments should be

identified with the docket number

found in the brackets in the heading of

this document. A copy of the subchapter

and any 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 a copy of this subchapter at

http://www.fda.gov/ora.

Dated: January 12, 2001.

Dennis E. Baker,

Associate Commissioner for Regulatory

Affairs.

[FR Doc. 01–1700 Filed 1–17–01; 11:07 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0025]

Guidance for Industry on FDA

Recommendations for Sampling and

Testing Yellow Corn and Dry-Milled

Yellow Corn Shipments Intended for

Human Food Use for Cry9C Protein

Residues; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘FDA Recommendations for

Sampling and Testing Yellow Corn and

Dry-Milled Yellow Corn Shipments

Intended for Human Food Use for Cry9C

Protein Residues.’’ Cry9C is a pesticidal

protein that was introduced into the

StarLinkTM variety of yellow corn using

recombinant deoxyribonucleic acid

(DNA) techniques to make the corn

more resistant to certain types of

insects. StarLinkTM corn is lawful only

for use in animal feed, not human food.

However, some Cry9C-containing corn

was commingled with yellow corn

intended for human use. This document

outlines the approach that FDA

recommends to manufacturers of corn

products for human food use for

sampling and testing yellow corn (and

milled yellow corn in certain situations)

in order to minimize the production of

human food products with corn

containing the Cry9C protein.

DATES: Submit written comments

concerning this guidance to the Dockets

Management Branch (address below) by

March 23, 2001. After March 23, 2001,

submit written comments to the contact

person (address below).

ADDRESSES: Submit written comments

concerning this guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Submit written requests for single

copies of the guidance to Lauren M.

Posnick, Center for Food Safety and

Applied Nutrition (HFS–306), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–5321.

Send one self-adhesive address label to

assist that office in processing your

request. Comments and requests for

copies should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

guidance and comments received by

March 23, 2001, are available for public

6628 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Notices

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Lauren M. Posnick, Center for Food

Safety and Applied Nutrition (HFS–

306), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5321, FAX 202–205–4422, e–

mail: lposnick@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is issuing guidance for industry

on sampling and testing for the presence

of Cry9C protein residues in yellow corn

(and milled yellow corn in certain

situations) intended for human food

use. Cry9C is a pesticidal protein that

was introduced into the StarLinkTM

variety of yellow corn to make the corn

more resistant to certain types of

insects. The Environmental Protection

Agency (EPA) authorized StarLinkTM

corn only for use in animal feed, not

human food. EPA has not authorized the

use of StarLinkTM corn in human food

because there is an unresolved question

about the allergenic potential of the

Cry9C protein.

Although restricted to animal food

use, some StarLinkTM corn was

commingled with yellow corn intended

for human use. In addition, in certain

limited cases, the Cry9C protein has also

been detected in corn seeds of a nonStarLinkTM variety of corn or in corn

from such seeds. Aventis S.A., the

developer of StarLinkTM, in cooperation

with the U.S. Department of

Agriculture, has been buying back

harvested StarLinkTM corn from the year

2000 crop to prevent its introduction

into the human food supply. Because

some Cry9C-containing corn may have

been missed in the buy-back program

and because some StarLinkTM corn from

the 1999 crop may still be in some grain

elevators, FDA is urging corn drymilling and masa operations to screen

yellow corn (and milled yellow corn in

certain situations) to minimize the

production of human food products

with corn containing the Cry9C protein.

Because corn containing the Cry9C

pesticide is adulterated if intended for

human food use (21 U.S.C. 342(a)(2)(B)),

manufacturers who detect Cry9Ccontaining corn in any lot should divert

the lot to animal feed or industrial use.

The guidance document contains

FDA’s recommendations to dry milling

and masa operations for sampling and

testing yellow corn shipments; the

guidance recommends appropriate tests,

representative sampling procedures,

appropriate analytical procedures, and

appropriate personnel training. FDA

believes these recommendations will

help manufacturers to identify those lots

of corn that contain the StarLinkTM

variety commingled with other yellow

corn and avoid the use of such corn in

human food products.

This Level 1 guidance is being issued

consistent with FDA’s good guidance

practices regulation (65 FR 56468,

September 19, 2000). The guidance

represents the agency’s current thinking

on sampling and testing yellow corn for

residues of the Cry9C protein. 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 statutes and regulations. To

the extent that use of this guidance

helps millers and food manufacturers

avoid the production of human food

containing Cry9C residues, the guidance

will help prevent human exposure to a

potential food allergen and will

otherwise help prevent adulteration of

the food supply. Due to the urgent need

to convey the sampling and testing

recommendations to members of the

food industry to help prevent the further

introduction of Cry9C-containing corn

into the human food supply, FDA

conveyed the substance of this guidance

to affected millers and food

manufacturers in a letter dated

December 27, 2000 (Ref. 1). Similarly,

FDA is making this guidance document

effective immediately because public

participation prior to its implementation

is not appropriate in these

circumstances (21 CFR 10.115(g)(2); 65

FR 56478). However, in its letter of

December 27, 2000, FDA recognized

that some dry milling and masa

operations may have inventories of

stored grain or meal that have not been

tested or have not been tested as

described in the guidance document.

Consistent with that advice, the agency

is recommending that manufacturers

that choose to follow this sampling

guidance phase it in over a period of no

more than 30 days dating from

December 27, 2000.

Although the guidance document

announced in this notice is being

implemented immediately, FDA is

requesting comments on the guidance.

FDA will review all comments received,

revise the guidance in response to the

comments as appropriate, and publish a

notice of availability of the revised

guidance, if it is revised.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

immediately-in-effect guidance by

March 23, 2001. After March 23, 2001,

submit written comments regarding this

guidance to the contact person (address

above). FDA will consider such

comments when determining whether to

revise the current guidance. 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 guidance

document and comments received by

March 23, 2001, may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday. An electronic version of this

guidance is available on the Internet at

www.cfsan.fda.gov.

III. References

The following references have been

placed on display at the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday

1. Letter and recommendations, dated

December 27, 2000.

2. ‘‘Sampling and testing plan,

scientific basis,’’ January, 2000.

Dated: January 12, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–1609 Filed 1–19–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10027]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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,