Federal Register / Vol. 69, No. 236 / Thursday, December 9, 2004 / Rules and Regulations 71655

§ 1.363 What are the consequences of 

failing to establish or maintain records or 

make them available to FDA as required by 

this subpart?

(a) The failure to establish or maintain 

records as required by section 414(b) of 

the act and this regulation or the refusal 

to permit access to or verification or 

copying of any such required record is 

a prohibited act under section 301 of the 

act.

(b) The failure of a nontransporter 

immediate previous source or a 

nontransporter immediate subsequent 

recipient who enters an agreement 

under § 1.352(c) to establish, maintain, 

or establish and maintain, records 

required under § 1.352(a) or (b), or the 

refusal to permit access to or 

verification or copying of any such 

required record, is a prohibited act 

under section 301 of the act.

(c) The failure of any person to make 

records or other information available to 

FDA as required by section 414 or 

704(a) of the act and this regulation is 

a prohibited act under section 301 of the 

act.

Compliance Dates

§ 1.368 What are the compliance dates for 

this subpart?

The compliance date for the 

requirements in this subpart is 

December 9, 2005. However, the 

compliance dates for small and very 

small businesses are contained in 

paragraphs (a) and (b) of this section. 

The size of the business is determined 

using the total number of full-time 

equivalent employees in the entire 

business, not each individual location 

or establishment. A full-time employee 

counts as one full-time equivalent 

employee. Two part-time employees, 

each working half time, count as one 

full-time equivalent employee.

(a) The compliance date for the 

requirements in this subpart is June 9, 

2004, for small businesses employing 

fewer than 500, but more than 10 fulltime equivalent employees.

(b) The compliance date for the 

requirements in this subpart is 

December 11, 2006, for very small 

businesses that employ 10 or fewer fulltime equivalent employees.

PART 11—ELECTRONIC RECORDS; 

ELECTRONIC SIGNATURES

■ 3. The authority citation for 21 CFR 

part 11 continues to read as follows:

Authority: 21 U.S.C. 321-393; 42 U.S.C. 

262.

■ 4. Section 11.1 is amended by adding 

paragraph (f) to read as follows:

§ 11.1 Scope

* * * * *

(f) This part does not apply to records 

required to be established or maintained 

by §§ 1.326 through 1.368 of this 

chapter. Records that satisfy the 

requirements of part 1, subpart J of this 

chapter, but that also are required under 

other applicable statutory provisions or 

regulations, remain subject to this part.

Dated: November 30, 2004.

Lester M. Crawford,

Acting Commissioner of Food and Drugs.

Dated: December 2, 2004.

Tommy G. Thompson,

Secretary of Health and Human Services.

[FR Doc. 04–26929 Filed 12–6–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2002N–0277]

Final Regulation Implementing the 

Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002—Establishment 

and Maintenance of Records for 

Foods; Notice of Public Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice; public meeting on final 

rule.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

series of domestic public meetings to 

discuss the final regulation 

implementing section 306 (Maintenance 

and Inspection of Records) of the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(Bioterrorism Act), which is publishing 

in this issue of Federal Register. The 

purpose of these public meetings is to 

provide information on the rule to the 

public and to provide the public an 

opportunity to ask questions of 

clarification.

DATES: See table 1 of the SUPPLEMENTARY

INFORMATION section of this document.

ADDRESSES: See table 1 of the 

SUPPLEMENTARY INFORMATION section of 

this document.

FOR FURTHER INFORMATION CONTACT:

Marion V. Allen, Center for Food Safety 

and Applied Nutrition (HFS–32), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1584, FAX: 301–436–2605, email: marion.allen@fda.hhs.gov, for 

general questions only about the 

meeting.

SUPPLEMENTARY INFORMATION:

I. Background

The events of September 11, 2001, 

highlighted the need to enhance the 

security of the U.S. food supply. 

Congress responded by passing the 

Bioterrorism Act (Public Law 107–188), 

which was signed into law on June 12, 

2002.

In this issue of the Federal Register, 

FDA is publishing the final rule 

implementing section 306 of the 

Bioterrorism Act and a draft guidance 

on records access under the 

Bioterrorism Act. During the public 

meetings, FDA will explain this rule 

and the draft guidance and answer 

questions of clarification.

Information about the public 

meetings, contact information, and the 

provisions of the Bioterrorism Act under 

FDA’s jurisdiction can be accessed at 

http://www.fda.gov/oc/bioterrorism/

bioact.html.

II. Final Rule and Draft Guidance

Section 306 of the Bioterrorism Act 

directs the Secretary of Health and 

Human Services (the Secretary) to issue 

final regulations that establish 

requirements regarding the 

establishment and maintenance, for not 

longer than 2 years, of records by 

persons (excluding farms and 

restaurants) who manufacture, process, 

pack, transport, distribute, receive, hold, 

or import food. The records that must be 

kept by these regulations are those that 

are needed by the Secretary for 

inspection to allow the Secretary to 

identify the immediate previous sources 

and immediate subsequent recipients of 

food, including its packaging, in order 

to address credible threats of serious 

adverse health consequences or death to 

humans or animals. This regulation 

implements the recordkeeping authority 

in the Bioterrorism Act.

In addition, the Bioterrorism Act 

provides records inspection authority to 

FDA such that if FDA has a reasonable 

belief that an article of food is 

adulterated and presents a threat of 

serious adverse health consequences or 

death to humans or animals, and the 

records are necessary to assist FDA in 

making such a determination, persons 

(excluding farms and restaurants) who 

manufacture, process, pack, transport, 

distribute, receive, hold, or import food 

must provide access to records.

III. Registration for the Public Meetings

Please submit your registration 

information (including name, title, firm 

name, address, telephone number, eVerDate jul<14>2003 16:48 Dec 08, 2004 Jkt 205001 PO 00000 Frm 00095 Fmt 4701 Sfmt 4700 E:\FR\FM\09DER3.SGM 09DER3
71656 Federal Register / Vol. 69, No. 236 / Thursday, December 9, 2004 / Rules and Regulations 

mail address, and fax number) at least 

5 working days before the public 

meeting date. For specific site locations, 

we encourage you to register online at 

http://www.cfsan.fda.gov/~dms/

fsbtac23.html or fax directly to Sharon 

Barcellos at 202–479–4970. We will 

accept registration onsite. Space is 

limited and registration will be closed at 

each site when maximum seating 

capacity for that site is reached 

(between 100 to 200 persons per site). If 

you need special accommodations due 

to a disability, please notify the contact 

person as listed under FOR FURTHER

INFORMATION CONTACT in this document 

at least 7 working days in advance of the 

meeting. All participants must present 

valid photo identification when entering 

a Federal building and parking facility.

IV. Dates, Times, and Addresses of 

Public Meetings

TABLE 1.—PUBLIC MEETING—SECTION 306: ESTABLISHMENT AND MAINTENANCE OF RECORDS FOR FOODS

DATES LOCATION 

Thursday, January 13, 2005 Harvey W. Wiley Federal Bldg. 

5100 Paint Branch Pkwy. 

College Park, MD 20740 

Time: 9 a.m. to 1 p.m. EST

Tuesday, January 25, 2005 Courtyard by Marriott Chicago 

165 E. Ontario St. 

Chicago, IL 60611 

312–573–0800 

Time: 9 a.m. to 1 p.m. CST

Renaissance Seattle Hotel 

515 Madison St. 

Seattle, WA 98104 

800–546–9184 

Time: 9 a.m. to 1 p.m. PST

Thursday, January 27, 2005 San Francisco Downtown Courtyard 

299 Second St. 

San Francisco, CA 94105 

415–947–0700 

Time: 9 a.m. to 1 p.m. PST

Wyndham Orlando Resort 

8001 International Dr. 

Orlando, FL 32819 

407–351–2420 

Time: 9 a.m. to 1 p.m. EST

Tuesday, February 1,2005 Renaissance Philadelphia Airport Hotel 

500 Stevens Dr. 

Philadelphia, PA 19113 

610–521–5900 

Time: 1 p.m. to 5 p.m. 

Hilton Boston Back Bay 

40 Dalton St. 

Boston, MA 02115 

617–236–1100 

Time: 9 a.m. to 1 p.m.

IV. Transcripts

A transcript will be made of the 

proceedings of each meeting. You may 

request a copy of a meeting transcript in 

writing from FDA’s Freedom of 

Information Office (HFI–35), Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 12A–16, Rockville, MD 20857, 

approximately 30 working days after the 

public meetings at a cost of 10 cents per 

page. The transcript of each public 

meeting will be available for public 

examination at the Division of Dockets 

Management, (HFA–305), 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852 

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

through Friday.

Dated: December 2, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26930 Filed 12–6–04; 8:45 am]

BILLING CODE 4160–01–S