Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 64959

1This date was extended to November 7, 2004.

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

http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: November 1, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24879 Filed 11–8–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0554]

Compliance Policy Guide Regarding 

Prior Notice of Imported Food Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised Compliance 

Policy Guide (CPG) entitled ‘‘Prior 

Notice of Imported Food Under the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 

2002.’’ The CPG provides written 

guidance to FDA’s and Customs and 

Border Protection’s (CBP’s) staff on 

enforcement of section 307 of the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(the Bioterrorism Act) and the agency’s 

implementing regulations, which 

require prior notice for food imported or 

offered for import into the United 

States. The CPG has been revised to 

provide additional guidance to FDA and 

CBP staff regarding prior notice 

submissions that do not provide 

information about the identity of the 

manufacturing facility of food no longer 

in its natural state, articles of food 

imported or offered for import by 

express courier, prior notice submission 

time frames, and lastly, gift packs 

purchased or otherwise acquired by an 

individual and imported or offered for 

import for nonbusiness purposes.

DATES: This guidance is final and 

effective on November 8, 2004. 

However, you may submit written or 

electronic comments at any time.

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Compliance Policy (HFC–

230), Office of Enforcement, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

guidance may be sent.

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http://

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document.

FOR FURTHER INFORMATION CONTACT:

Domenic Veneziano, Office of 

Regulatory Affairs (HFC–100), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 703–621–

7809.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

revised CPG section 110.310 entitled 

‘‘Prior Notice of Imported Food Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002.’’ This revised 

guidance is issued with CBP 

concurrence and explains to FDA and 

CBP staff the new FDA and CBP policies 

on enforcement of section 307 of the 

Bioterrorism Act and its implementing 

regulations, which require prior notice 

to FDA of all food imported or offered 

for import into the United States (68 FR 

58974, October 10, 2003 (codified at 21 

CFR part 1, subpart I, 1.276 through 

1.285)). The original CPG was published 

December 2003, and was revised June 

2004 to include additional guidance 

regarding food imported or offered for 

import for noncommercial purposes 

with a noncommercial shipper. In 

August 2004, the CPG was revised to 

provide additional guidance regarding 

food imported or offered for import for 

quality assurance, research or analysis 

purposes only, not for human or animal 

consumption and not for resale. We 

(FDA) also revised the CPG in August to 

extend until November 1, 2004,1 our 

enforcement discretion policy 

concerning certain violations related to 

the registration number of the 

manufacturing facility and the shipper, 

the airway bill number or bill of lading 

number, and the name and address of 

the ultimate consignee.

A. Identity of the Manufacturer

FDA is revising the CPG to provide 

additional guidance regarding prior 

notice submissions that do not provide 

information to identify the 

manufacturing facility of an article of 

food (i.e., the specific facility that 

manufactured the food). This 

information is required for food that is 

no longer in its natural state. FDA and 

CBP intend to exercise broad 

enforcement discretion when this 

information is required but is not 

provided, under the following 

circumstances:

(1) If, after a good faith effort, the 

person submitting prior notice does not 

know the registration number of the 

facility that manufactured the food and 

the facility is required to be registered, 

that person instead provides the name 

and full address of the facility that 

manufactured the food.

(2) If, after a good faith effort, the 

person submitting prior notice does not 

know either the registration number or 

the name and full address of the facility 

that manufactured the food, that person 

instead provides the name and full 

address of the headquarters of the 

facility that manufactured the food.

(3) If, after a good faith effort, the 

person submitting prior notice does not 

know either the information described 

in (1) about the facility that 

manufactured the food, or in (2) about 

the headquarters of the facility that 

manufactured the food, that person 

instead provides the name and full 

address of the invoicing firm.

FDA is taking these steps to provide 

additional flexibility in filing prior 

notice to various kinds of importers 

while the final prior notice rule is under 

development. However, if the facility 

that manufactured the food is a foreign 

facility that is required to be registered 

and either its registration number is not 

provided or the name and address of a 

different facility (i.e., the manufacturing 

facility’s headquarters or the invoicing 

firm) is provided, then it will be more 

difficult and/or may take more time for 

FDA and CBP to verify the identity of 

the manufacturing facility and its 

registration status and to determine 

whether the article of food is subject to 

being held under section 801(l) of the 

Federal Food, Drug, and Cosmetic Act 

(the act). As a result, if an article of food 

is imported or offered for import with 

the manufacturer’s name and full 

address, or the name and address of the 

manufacturing facility’s headquarters or 

the invoicing firm, instead of the 

manufacturer’s name and registration 

number, and if FDA has concerns that 

the food may pose a serious health 

threat, then the food may be delayed at 

the port of arrival until the verification 

is completed. Moreover, as with other 

types of prior notice violations, FDA 

may consider the failure to provide 

required information about the 

manufacturer as a factor in determining 

whether and where to examine the 

article of food. Under all circumstances, 

64960 Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 

FDA and CBP intend to reject prior 

notice submissions unless the prior 

notice includes a valid registration 

number or an appropriate reason code 

selected from among those provided in 

the Prior Notice System Interface (PNSI) 

and the Automated Broker Interface of 

the Automated Commercial System 

(ABI/ACS). Rejected submissions are 

not confirmed for FDA review.

This change to our enforcement 

discretion policy pertains to all prior 

notice submissions, including but not 

limited to the following: (1) Food 

carried by or otherwise accompanying 

an individual that is not for personal 

use; (2) food arriving by international 

mail that is not food imported or offered 

for import for noncommercial purposes 

with a noncommercial shipper; and (3) 

food imported or offered for import for 

quality assurance, research or analysis 

purposes only, not for human or animal 

consumption or resale.

Please note that the enforcement 

discretion policy for identity of 

manufacturer does not apply to the 

requirement to provide the registration 

number assigned to the shipper’s facility 

that is associated with the article of 

food, if applicable (see 21 CFR 

1.281(a)(9) and (b)(8)).

B. Express Courier

FDA also is revising the CPG to 

provide additional guidance regarding 

food imported or offered for import by 

an express courier. The term ‘‘express 

courier’’ is being used as the term 

‘‘express consignment operator or 

carrier’’ is defined by CBP at 19 CFR 

128.1(a) and includes, for example, 

Federal Express and United Parcel 

Service. If prior notice is inadequate 

because it does not include the required 

anticipated arrival information and/or 

planned shipment information, FDA 

and CBP should typically consider not 

taking any regulatory action if the article 

of food is imported or offered for import 

via an express courier, the person 

submitting prior notice is not the 

express courier, prior notice is 

submitted via the PNSI, and the prior 

notice includes the shipment’s tracking 

number instead of the required 

anticipated arrival information and/or 

planned shipment information. CBP and 

the Transportation Security 

Administration have advised express 

couriers to not reveal to the public 

certain arrival information. FDA and 

CBP believe that the tracking number 

instead of the planned shipment 

information may provide a means of 

more accurately determining the arrival 

information and intend to explore this 

option while developing the final rule.

C. Time Frame

FDA is revising the CPG to allow prior 

notice to be submitted more than 5, but 

less than 10 days before the anticipated 

date of arrival of the food at the 

anticipated port of arrival (see 21 CFR 

1.279(b)). FDA will typically consider 

not taking any regulatory action if there 

is a prior notice violation because the 

prior notice was submitted more than 5 

calendar days before the anticipated 

date of arrival, provided that the 

following occurs: (1) The prior notice 

was submitted less than 10 calendar 

days before the anticipated date of 

arrival; and (2) the prior notice was 

submitted through the PNSI.

FDA is taking these steps to provide 

additional flexibility in submitting prior 

notice while the final prior notice rule 

is under development. FDA and CBP 

believe that 10 days before the 

anticipated date of arrival of the food is 

sufficient time for a carrier to assure that 

prior notice has been confirmed for FDA 

review before loading the food. FDA 

also believes that this extended period 

will not impact its ability to receive, 

review, and respond to prior notice 

submissions of food, although a time 

period greater than 10 days may be 

problematic. FDA has limited this 

guidance to prior notice submissions by 

PNSI because of the way the ABI/ACS 

is programmed; when prior notice is 

submitted through ABI/ACS, the prior 

notice confirmation number cannot be 

provided more than 5 calendar days 

before the anticipated date of arrival.

FDA recognizes that if any 

information in the prior notice 

submitted via PNSI changes except the 

anticipated arrival information, the 

estimated quantity, or the planned 

shipment information, after FDA has 

confirmed the prior notice submission 

for review, the prior notice should be 

cancelled and must be resubmitted.

D. Gift Pack Purchased or Otherwise 

Acquired by An Individual and 

Imported or Offered for Import for 

Nonbusiness Purposes

Another change to the CPG relates to 

gift packs purchased or otherwise 

acquired by an individual and imported 

or offered for import for nonbusiness 

purposes. FDA and CBP staff should 

typically consider not taking regulatory 

action if there is a prior notice violation 

because a single prior notice is 

submitted for a gift pack and the 

identity of the facility that packed the 

gift pack is submitted instead of the 

identity of the manufacturer, provided 

that the gift pack is purchased or 

otherwise acquired by an individual and 

imported or offered for import for 

nonbusiness purposes. The policy 

applies irrespective of where the 

individual who purchased or otherwise 

acquired the gift pack lives, irrespective 

of the type of carrier, and irrespective of 

whether it involves a commercial or 

noncommercial shipper. The CPG 

provides information to FDA and CBP 

staff about what constitutes a 

nonbusiness purpose, the identity of a 

gift pack by FDA product code and 

examples of gift packs.

E. Policies Contained in the Previous 

Version of the CPG

Please note that beginning November 

8, 2004, FDA and CBP staff should 

typically consider taking enforcement 

action including refusal and/or 

assessment of Civil Monetary Penalties 

when the prior notice is inadequate, 

except the circumstances described in 

the revised CPG. FDA’s enforcement 

discretion policies in the version of the 

CPG issued in August 2004 concerning 

certain violations related to the 

registration number of the shipper, the 

airway bill number or bill of lading 

number, and the name and address of 

the ultimate consignee will end on 

November 7, 2004, with the exception of 

the airway bill number or bill of lading 

number for prior notice submissions by 

individuals who are not the express 

courier (see section I.B of this 

document). Therefore, beginning 

November 8, 2004, FDA and CBP staff 

should typically consider taking 

enforcement action including refusal 

and/or assessment of Civil Monetary 

Penalties when the prior notice is 

inadequate because the registration 

number for the shipper is required but 

is not provided; the airway bill number 

or bill of lading number is not provided 

or is invalid (except as noted in section 

I.B of this document); or the name and 

address of the ultimate consignee is 

inaccurate because it contains the name 

and address of the express consignment 

operator or consolidator instead of the 

ultimate consignee.

FDA is issuing this document as level 

1 guidance consistent with FDA’s good 

guidance practices regulation § 10.115 

(21 CFR 10.115). The revised CPG 

section 110.310 is being implemented 

on November 8, 2004, without prior 

public comment, under § 10.115(g)(2), 

because the agency has determined that 

prior public participation is not feasible 

or appropriate. This document revises 

policies that are due to take effect on 

November 8, 2004, so it is urgent that 

the agencies explain their new 

enforcement policies before that date.

Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 64961

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the guidance document. 

Submit two copies of written comments, 

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 guidance and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

An electronic version of the revised 

CPG is available on the Internet at http:/

/www.fda.gov/ora under ‘‘Compliance 

References.’’

Dated: October 28, 2004. 

John M. Taylor, 

Associate Commissioner for Regulatory 

Affairs.

[FR Doc. 04–24872 Filed 11–4–04; 8:57 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0562]

Revised Compliance Policy Guide Sec. 

110.300—Registration of Food 

Facilities Under the Public Health 

Security and Bioterrorism 

Preparedness and Response Act of 

2002; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised compliance 

policy guide (CPG) Sec. 110.300 entitled 

‘‘Registration of Food Facilities Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002’’ (registration 

CPG). The revised CPG provides written 

guidance to FDA’s staff on enforcement 

of section 305 of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002 (the 

Bioterrorism Act) and the agency’s 

implementing regulation, which 

requires, beginning on December 12, 

2003, registration with FDA for all 

domestic and foreign facilities that 

manufacture/process, pack, or hold food 

for human or animal consumption in 

the United States.

DATES: This revised CPG is final upon 

the date of publication. However, you 

may submit written or electronic 

comments at any time.

ADDRESSES: Submit written requests for 

single copies of the revised CPG to the 

Division of Compliance Policy (HFC–

230), Office of Enforcement, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

revised CPG may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revised CPG.

Submit written comments on the 

revised CPG to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Food for human consumption: Judith 

Gushee, Center for Food Safety and 

Applied Nutrition (HFS–605), Food 

and Drug Administration, 301–436–

2417.

Food for animal consumption: Isabel 

Pocurull, Center for Veterinary 

Medicine (HFV–226), Food and 

Drug Administration, 301–827–

0175.

SUPPLEMENTARY INFORMATION: FDA is 

announcing the availability of revised 

CPG Sec. 110.300 entitled ‘‘Registration 

of Food Facilities Under the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 

2002’’ (registration CPG). This revised 

CPG outlines for FDA staff the agency’s 

policy on enforcement of section 305 of 

the Bioterrorism Act and its 

implementing regulation ((68 FR 58894, 

October 10, 2003); (codified at 21 CFR 

part 1, subpart H, 1.225 through 1.243)). 

The Bioterrorism Act and subpart H 

require that, beginning on December 12, 

2003, all domestic and foreign facilities 

that manufacture, process, pack, or hold 

food for human or animal consumption 

in the United States must be registered 

with FDA.

I. Background

On December 19, 2003, FDA issued 

CPG Sec. 110.300 (the December CPG). 

The December CPG states that for 

domestic firms, FDA would initially 

plan to focus the agency’s efforts on 

educating and otherwise informing the 

industry on how to comply with the 

registration of food facilities interim 

final rule, and that thereafter FDA 

would enforce the registration provision 

as appropriate in each situation. We set 

out in the Regulatory Action Guidance 

section our enforcement approach.

For foreign facilities, the December 

CPG referred to the policies set out in 

CPG Sec. 110.310 entitled ‘‘Prior Notice 

of Imported Food Under the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 

2002’’ (the prior notice CPG).

II. Revised CPG Sec. 110.300

FDA is making only one substantive 

change in the registration CPG. 

Specifically, the revised CPG provides 

that, on November 8, 2004, FDA is fully 

implementing the agency’s enforcement 

policy for domestic food facilities, 

which was set out in the Regulatory 

Action Guidance section of the 

December CPG. For foreign facilities, the 

registration CPG continues to state that 

generally, the registration requirement 

for the facilities of foreign 

manufacturers and shippers will be 

enforced in accordance with the policies 

set out in the prior notice CPG. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice of 

availability for the revision to the prior 

notice CPG, which is being issued under 

§ 10.115(g)(2) (21 CFR 10.115(g)(2)) as 

level 1 guidance that is effective 

November 8, 2004.

FDA is also issuing the revised 

registration CPG as level 1 guidance 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). Revised 

CPG Sec. 110.300 is being implemented 

immediately without prior public 

comment, under § 10.115(g)(2), because 

FDA has determined that prior public 

participation is not feasible or 

appropriate. Revision of FDA’s prior 

notice enforcement policy directly 

affects the agency’s enforcement of the 

registration requirement for foreign 

manufacturers and shippers. Given this 

relationship, it is appropriate that FDA 

coordinate announcement and 

implementation of the agency’s revised 

enforcement policy for food facilities 

registration with the agency’s 

comparable actions for the prior notice 

of imported food requirement.

III. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the revised CPG. Submit 

a single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. The guidance and received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.