Federal Register / Vol. 69, No. 236 / Thursday, December 9, 2004 / Notices 71657

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004G–0381]

Draft Guidance for Records Access 

Authority Provided in Title III, Subtitle 

A, of 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 document entitled 

‘‘Draft Guidance for Records Access 

Authority Provided in Title III, Subtitle 

A, of the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002.’’ The draft 

guidance is intended to clarify the 

circumstances under which FDA may 

access and copy records under the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 2003 

(Bioterrorism Act) and establishes 

procedures to exercise its authority.

DATES: Submit written or electronic 

comments on the draft guidance by 

January 24, 2005, to ensure their 

adequate consideration in preparation of 

the final guidance. General comments 

on agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

entitled ‘‘Guidance for Records Access 

Authority Provided in Title III, Subtitle 

A, of the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002’’ to Rudaina 

Alrefai (see FOR FURTHER INFORMATION

CONTACT). Send one self-addressed 

adhesive label to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to this document. 

Submit written comments on the draft 

guidance 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:

Rudaina Alrefai, Division of Compliance 

Information and Quality Assurance 

(HFC–240), Office of Enforcement, Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 240–632–

6815, e-mail: 

rudaina.alrefai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a document entitled ‘‘Draft Guidance for 

Records Access Authority Provided in 

Title III, Subtitle A, of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002.’’ The 

Bioterrorism Act created a new section 

414 (21 U.S.C. 350c) entitled 

‘‘Maintenance and Inspection of 

Records,’’ in the Federal Food, Drug, 

and Cosmetic Act. Under this new 

authority, the Secretary of Health and 

Human Services (the Secretary) may by 

regulation establish requirements for 

persons (excluding farms and 

restaurants) who manufacture, process, 

pack, transport, distribute, receive, hold, 

or import food to establish and maintain 

food records. In addition, sections 

414(a) and 704(a) (21 U.S.C. 374(a)) 

authorize FDA to access and copy all 

records related to an article of food if 

the following occurs: (1) The Secretary 

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 (2) 

the records are necessary to assist FDA 

in making such a determination.

Elsewhere in this issue of the Federal 

Register, FDA is issuing a final rule 

entitled ‘‘Establishment and 

Maintenance of Records Under the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 

2002,’’ in which the agency is 

establishing requirements for persons 

(excluding farms and restaurants) who 

manufacture, process, pack, transport, 

distribute, receive, hold, or import food 

to establish and maintain food records.

The purpose of this draft guidance is 

to describe the procedure that FDA 

intends to follow to exercise its new 

authority, and clarify the circumstances 

under which FDA may access and copy 

records under the Bioterrorism Act.

The agency has adopted good 

guidance practices (GGPs) that set forth 

the agency’s policies and procedures for 

the development, issuance, and use of 

guidance documents (21 CFR 10.115). 

This draft guidance is being issued as a 

level 1 guidance consistent with GGPs. 

The draft guidance represents the 

agency’s current thinking on the topic. 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the draft guidance. 

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. Received 

comments and the draft guidance may 

be seen in the Division of Dockets 

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

Monday through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the draft guidance at http:/

/www.cfsan.fda.gov/guidance.html.

Dated: November 24, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26931 Filed 12–6–04; 8:45 am]

BILLING CODE 4160–01–S