[Federal Register: January 22, 2008 (Volume 73, Number 14)]
[Notices]
[Page 3729-3731]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ja08-71]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2008N-0005]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Formal Dispute Resolution:
Scientific and Technical Issues Related to Pharmaceutical Current Good
Manufacturing Practice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
[[Page 3730]]
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed collection of
information resulting from the guidance to manufacturers of veterinary
and human drugs, including human biological drug products, on how to
resolve disputes of scientific and technical issues relating to current
good manufacturing practice (CGMP).
DATES: Submit written or electronic comments on the collection of
information by March 24, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4816.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance for Industry on Formal Dispute Resolution: Scientific and
Technical Issues Related to Pharmaceutical Current Good Manufacturing
Practice--(OMB Control Number 0910-0563)--Extension
The guidance is intended to provide information to manufacturers of
veterinary and human drugs, including human biological drug products,
on how to resolve disputes of scientific and technical issues relating
to CGMP. Disputes related to scientific and technical issues may arise
during FDA inspections of pharmaceutical manufacturers to determine
compliance with CGMP requirements, or during FDA's assessment of
corrective actions undertaken as a result of such inspections. The
guidance provides procedures that encourage open and prompt discussion
of disputes and lead to their resolution. The guidance describes
procedures for raising such disputes to the Office of Regulatory
Affairs (ORA) and center levels and for requesting review by the
dispute resolution (DR) Panel (the DR Panel).
When a scientific or technical issue arises during an FDA
inspection, the manufacturer should initially attempt to reach
agreement on the issue informally with the investigator. Certain
scientific or technical issues may be too complex or time-consuming to
resolve during the inspection. If resolution of a scientific or
technical issue is not accomplished through informal mechanisms prior
to the issuance of Form FDA 483, the manufacturer can formally request
DR and can use the formal two-tiered DR process described in the
guidance.
Tier-one of the formal DR process involves scientific or technical
issues raised by a manufacturer to the ORA and center levels. If a
manufacturer disagrees with the tier-one decision, tier two of the
formal DR process would then be available for appealing that decision
to the DR Panel.
The written request for formal DR to the appropriate ORA unit
should be made within 30 days of the completion of an inspection, and
should include all supporting documentation and arguments for review,
as described below. The written request for formal DR to the DR Panel
should be made within 60 days of receipt of the tier-one decision, and
should include all supporting documentation and arguments, as described
in the following paragraphs.
All requests for formal DR should be in writing and include
adequate information to explain the nature of the dispute and to allow
FDA to act quickly and efficiently. Each request should be sent to the
appropriate address listed in the guidance and include the following:
Cover sheet that clearly identifies the submission as
either a request for tier-one DR or a request for tier-two DR;
Name and address of manufacturer inspected (from Form FDA
483);
Date of inspection (from Form FDA 483);
Date the Form FDA 483 issued (from Form FDA 483);
FEI Number, if available (from Form FDA 483);
FDA employee names and titles that conducted inspection
(from Form FDA 483);
Office responsible for the inspection, e.g., district
office (from Form FDA 483);
Application number if the inspection was a preapproval
inspection;
Comprehensive statement of each issue to be resolved:
Identify the observation in dispute.
[ctrcir] Clearly present the manufacturer's scientific position or
rationale concerning the issue under dispute with any supporting data.
[ctrcir] State the steps that have been taken to resolve the
dispute, including any informal DR that may have occurred before the
issuance of Form FDA 483.
[ctrcir] Identify possible solutions.
[ctrcir] State expected outcome.
Name, title, telephone and fax number, and e-mail address
(as available) of manufacturer contact.
The guidance was 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 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 DR process and met
with stakeholders in December 2002 to seek their input.
The guidance was initiated in response to industry's request for a
formal DR process to resolve differences
[[Page 3731]]
related to scientific and technical issues that arise between
investigators and pharmaceutical manufacturers during FDA inspections
of foreign and domestic manufacturers. In addition to encouraging
manufacturers to use currently available DR processes, the guidance
describes the formal two-tiered DR process explained above. The
guidance also covers the following topics.
The suitability of certain issues for the formal DR
process, including examples of some issues with a discussion of their
appropriateness for the DR process.
Instructions on how to submit requests for formal DR and a
list of the supporting information that should accompany these
requests.
Public availability of decisions reached during the
dispute resolution process to promote consistent application and
interpretation of drug quality-related regulations.
Description of Respondents: Pharmaceutical manufacturers of
veterinary and human drug products and human biological drug products.
Burden Estimate: Based on the number of requests for tier-one and
tier-two DR received by FDA since the guidance published in January
2006, FDA estimates that approximately two manufacturers will submit
approximately two requests annually for a tier-one DR, and that there
will be one appeal of these requests to the DR Panel (request for tier-
two DR). FDA estimates that it will take manufacturers approximately 30
hours to prepare and submit each request for a tier-one DR, and
approximately 8 hours to prepare and submit each request for a tier-two
DR. Table 1 of this document provides an estimate of the annual
reporting burden for requests for tier-one and tier-two DRs.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Requests for Tier- 2 1 2 30 60
One DR
----------------------------------------------------------------------------------------------------------------
Requests for Tier- 1 1 1 8 8
Two DR
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 68
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through the FDMS only.
Dated: January 14, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1004 Filed 1-18-08; 8:45 am]
BILLING CODE 4160-01-S