[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Notices]
[Pages 77010-77011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 January 
22, 2015.

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 emailed to <a href="/cdn-cgi/l/email-protection#6b0402190a34181e09060218180204052b040609450e041b450c041d"><span class="__cf_email__" data-cfemail="254a4c57447a565047484c56564c4a4b654a48470b404a550b424a53">[email protected]</span></a>. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#6e3e3c2f3d1a0f08082e080a0f4006061d40090118"><span class="__cf_email__" data-cfemail="0d5d5f4c5e796c6b6b4d6b696c2365657e236a627b">[email protected]</span></a>.

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 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:
    <bullet> Cover sheet that clearly identifies the submission as 
either a request for tier-one DR or a request for tier-two DR;
    <bullet> name and address of manufacturer inspected (as listed on 
FDA Form 483);
    <bullet> date of inspection (as listed on Form FDA 483);
    <bullet> date Form FDA 483 issued (from Form FDA 483);
    <bullet> facility Establishment Identifier Number, if available 
(from Form FDA 483);
    <bullet> FDA employee names and titles that conducted inspection 
(from Form FDA 483);
    <bullet> office responsible for the inspection (e.g., district 
office, as listed on Form FDA 483);
    <bullet> application number if the inspection was a preapproval 
inspection;
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> Instructions on how to submit requests for formal DR and a 
list of the supporting information that should accompany these 
requests.
    <bullet> 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

[[Page 77011]]

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.
    In the Federal Register of August 11, 2014 (79 FR 46836), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

                                 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: December 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29917 Filed 12-22-14; 8:45 am]
BILLING CODE 4164-01-P


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