
[Federal Register Volume 76, Number 172 (Tuesday, September 6, 2011)]
[Notices]
[Pages 55067-55068]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0447]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October 
6, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0563. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
Juanmanuel.Vilela@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 current good manufacturing practice (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.
    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 the FDA Form 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 in this document. The written request for formal DR to the 
DR Panel should be

[[Page 55068]]

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 (as listed on 
FDA Form 483);
     Date of inspection (as listed on FDA Form 483);
     Date the FDA Form 483 issued (from FDA Form 483);
     Facility Establishment Identifier (FEI) Number, if 
available (from FDA Form 483);
     FDA employee names and titles that conducted inspection 
(from FDA Form 483);
     Office responsible for the inspection (e.g., district 
office, as listed on the FDA Form 483);
     Application number if the inspection was a preapproval 
inspection;
     Comprehensive statement of each issue to be resolved:
     Identify the observation in dispute:
    [cir] Clearly present the manufacturer's scientific position or 
rationale concerning the issue under dispute with any supporting data.
    [cir] State the steps that have been taken to resolve the dispute, 
including any informal DR that may have occurred before the issuance of 
the FDA Form 483.
    [cir] Identify possible solutions.
    [cir] State expected outcome.
     Name, title, telephone and FAX number, and email 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, the Center for Biologics Evaluation and 
Research, and the Center for Veterinary Medicine. 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 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 previously. 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 DR 
process to promote consistent application and interpretation of drug 
quality-related regulations.
    In the Federal Register of June 20, 2011 (76 FR 35896), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment. The comment was 
not related to the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Requests for Tier-One Dispute                  2               1               2              30              60
 Resolution.....................
Requests for Tier-Two Dispute                  1               1               1               8               8
 Resolution.....................
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    Total.......................  ..............  ..............  ..............  ..............              68
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 dispute resolution 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.

    Dated: August 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22683 Filed 9-2-11; 8:45 am]
BILLING CODE 4160-01-P


