[Federal Register Volume 70, Number 229 (Wednesday, November 30, 2005)]
[Notices]
[Pages 71858-71859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23504]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004G-0381]


Guidance for Industry and Food and Drug Administration Staff, 
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 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 The document finalizes the draft guidance entitled ``Draft 
Guidance for Records Access Authority Provided in Title III, Subtitle 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 [email protected].

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

[[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