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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. 2004G-0381]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of Guidance for Industry and FDA Staff 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.”  The document finalizes the draft guidance entitled “Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.”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 guidance clarifies the circumstances under which FDA may access and copy records under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. (“Bioterrorism Act”), and describes the procedure that FDA intends to follow to exercise its authority to inspect records under the Federal Food, Drug, and Cosmetic Act (the act).

# DATES:

 Submit written or electronic comments on agency guidance documents at any time.

# ADDRESSES:

                        Submit written requests for single copies of the 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 the Division of Compliance Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD  20857.  Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 240-632-6861. Submit written comments on the final 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:

                         Diane Kelley, Office of Regulatory Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD  20857, 240-632-6860, or e-mail                         *Diane.Kelley@fda.hhs.gov*.                    

# SUPPLEMENTARY INFORMATION:

## I.  Background

                    In the                     **Federal Register**                     of December 9, 2004 (69 FR 71657), FDA (we) announced the availability of a draft guidance 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.”   FDA has finalized the guidance.                

FDA received a number of comments in response to the draft guidance.  The agency considered those within the scope of this document carefully and is making two changes to the draft guidance.  First, we have expanded the answer to question III.C, which describes records FDA may not access, to clarify that FDA has authority to access lists of ingredients (sections 414(a) and 704(a) of the act.  Second, we have changed the answer to question III. E, which describes how FDA intends to make a records request, to indicate that FDA intends to use a new form to make such a request.  FDA has decided to create a specific form to document a request to access and copy records under the Bioterrorism Act.  The form FDA 482c “Notice of Inspection—Request for Records” will be presented to the owner, operator, or agent in charge, once FDA determines that the threshold for requesting records has been attained.  This form will assist industry and the agency in distinguishing this type of notice from a routine Notice of Inspection.

This Level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115).  The guidance represents the agency's current thinking on how it will exercise its authority to access records under the Bioterrorism Act (sections 414(a) and 704(a) of the act (21 U.S.C. 350c and 374)).  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, regulations, or both.

## II.  Paperwork Reduction Act of 1995

                    This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork                           ( print page 71859)                        Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 1.337, 1.345, and 1.352 have been approved under OMB Control Number 0910-0560.                

## III.  Comments

                    Interested persons may submit to the Division of Dockets Management (see                     **ADDRESSES**                    ) written or electronic comments regarding this document.  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 final guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.                

## IV.  Electronic Access

                    Persons with access to the Internet may obtain the final guidance at                     *http://www.fda.gov/​oc/​bioterrorism/​bioact.html*                     under “Section 306 (Records Maintenance)”.                

Dated: November 18, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05-23504 Filed 11-29-05; 8:45 am]

BILLING CODE 4160-01-S