[Federal Register Volume 71, Number 8 (Thursday, January 12, 2006)]
[Notices]
[Pages 2057-2058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0386 (formerly Docket No. 03D-0386)]


Guidance for Industry on Formal Dispute Resolution: Scientific 
and Technical Issues Related to Pharmaceutical Current Good 
Manufacturing Practice; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Formal Dispute 
Resolution: Scientific and Technical Issues Related to Pharmaceutical 
CGMP.'' The guidance describes a formal, two-tiered dispute resolution 
process intended to resolve disputes of scientific and technical issues 
relating to current good manufacturing practice (CGMP) that arise 
during FDA inspections of pharmaceutical manufacturers.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857; Office of Communication, Training, and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research, 1401 Rockville Pike, Rockville, MD 20852-1448; or 
Communications Staff (HFV-12), Center for Veterinary Medicine, 7519 
Standish Pl., Rockville, MD 20855.
    The guidance may also be obtained by mail by calling the Center for 
Biologics Evaluation and Research at 1-800-835-4709 or 301-827-1800. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit written comments on the guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 28052. 
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: Edward M. Sherwood, Center for Drug 
Evaluation and Research (HFD-3), Food and Drug Administration, White 
Oak 21, rm. 3528, 10903 New Hampshire Ave., Silver Spring, MD 20993, 
301-796-1605.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Formal Dispute Resolution: Scientific and Technical Issues 
Related to Pharmaceutical CGMP.'' The guidance was developed as part of 
the FDA initiative ``Pharmaceutical CGMPs for the 21st Century: A Risk-
Based Approach,'' which was announced in August 2002. The initiative 
focuses on FDA's current CGMP program and covers the manufacture of 
veterinary and human drugs, including human biological drug products.
    The agency formed the Dispute Resolution Working Group comprising 
representatives from the Office of Regulatory Affairs (ORA), the Center 
for Drug Evaluation and Research (CDER), the Center for Biologics 
Evaluation and Research (CBER), and the Center for Veterinary Medicine 
(CVM). The working group met weekly on issues related to the dispute 
resolution process

[[Page 2058]]

and met with stakeholders in December 2002 to seek their input.
    The guidance was initiated in response to industry's request for a 
formal dispute resolution process to resolve differences related to 
scientific and technical issues that arise between investigators and 
pharmaceutical manufacturers during FDA inspections. In addition to 
encouraging manufacturers to use currently available dispute resolution 
processes, the guidance describes a formal two-tiered dispute 
resolution process that provides a mechanism for requesting review and 
decision on issues that arise during inspections.
    On September 5, 2003 (68 FR 52777), the FDA announced the 
availability of the draft version of this guidance. The public comment 
period closed on March 5, 2004. A number of comments were received, 
which the agency considered carefully as it finalized the guidance and 
made appropriate changes. The agency conducted a pilot program with 
industry for a 12-month period. During that time, the agency received 
one Tier 1 request for dispute resolution and it was resolved. In 
addition, FDA met with representatives from industry trade associations 
in September 2004, near the end of the pilot period, to discuss the 
draft guidance and receive input.
    Most of the changes to the guidance were made to clarify statements 
in the draft guidance. The following changes in the final guidance are 
noteworthy: (1) The time period for manufacturers to ask for 
clarification of a disputed scientific or technical issue was extended 
from 10 to 30 days; (2) if a request for formal dispute resolution 
reaches the agency's Dispute Resolution Panel and is considered 
appropriate for review, the panel will schedule a meeting to discuss 
the issue within 90 days of the request instead of the indefinite time 
period indicated in the draft guidance; (3) the guidance directs 
manufacturers to the Center for Devices and Radiological Health for 
disputes involving combination products when medical device components 
are the focus of the dispute, but clarifies that disputes solely 
involving medical devices are outside the scope of this guidance; and 
(4) the guidance clarifies that, during the dispute resolution process, 
a manufacturer may include relevant information that was not presented 
during the inspection, if FDA determines that a reasonable explanation 
was given on why the information was not presented during the 
inspection.
    This 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 formal dispute resolution: scientific and 
technical issues related to pharmaceutical CGMP. 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 statutes and regulations.

II. 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. The Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0563.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at the following http://www.fda.gov/cder/guidance/index.htm or 
http://www.fda.gov/ohrms/dockets/default.htm or http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/cvm/guidance/guidance.html.

    Dated: January 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-233 Filed 1-11-06; 8:45 am]
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