[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46836-46837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18943]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1076]


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 October 10, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002; [email protected].

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

[[Page 46837]]

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 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 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 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 Form FDA 483);
     date Form FDA 483 issued (from Form FDA 483);
     facility Establishment Identifier 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, as listed on Form FDA 483);
     application number if the inspection was a preapproval 
inspection;
     comprehensive statement of each issue to be resolved:
    [cir] 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 
Form FDA 483;
    [cir] identify possible solutions; and
    [cir] state expected outcome.
     Name, title, telephone and FAX number, and email address 
(as available) of manufacturer contact.
    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.
    Description of Respondents: Pharmaceutical manufacturers of 
veterinary and human drug products and human biological drug products.
    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 provides an estimate of the annual reporting burden for 
requests for tier-one and tier-two DRs.

                                 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 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: August 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18943 Filed 8-8-14; 8:45 am]
BILLING CODE 4164-01-P