
[Federal Register Volume 76, Number 118 (Monday, June 20, 2011)]
[Notices]
[Pages 35896-35897]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

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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 
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 either electronic or written comments on the collection 
of information by August 19, 2011.

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: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

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 comment 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.
    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 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

[[Page 35897]]

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 was 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 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, 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 earlier in this document. 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.
    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 DRs 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.
    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 burden
                           Activity                                 Number of       responses per     Total annual      per response       Total hours
                                                                   respondents       respondent         responses        (in hours)
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Requests for Tier One DR......................................                 2                 1                 2                30                60
Requests for Tier Two DR......................................                 1                 1                 1                 8                 8
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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.


    Dated: June 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15141 Filed 6-17-11; 8:45 am]
BILLING CODE 4160-01-P


