[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49832-49834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23444]


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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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 information collection in the guidance 
on ``Formal Dispute Resolution: Scientific and Technical Issues Related 
to Pharmaceutical Current Good Manufacturing Practice.''

DATES: Submit either electronic or written comments on the collection 
of information by December 26, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 26, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 26, 2017. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-1076 for ``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.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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

[[Page 49833]]

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

    This information collection supports the guidance for industry on 
``Formal Dispute Resolution: Scientific and Technical Issues Related to 
Pharmaceutical Current Good Manufacturing Practice.'' The guidance is 
available at: https://www.fda.gov/downloads/drugs/guidances/ucm070279.pdf. The guidance informs manufacturers of veterinary and 
human drugs, including human biological drug products, on how to 
resolve disputes about 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 before 
the issuance of Form FDA 483, the manufacturer can formally request DR 
and use the two-tiered DR process described in the guidance.
    Tier one of the formal DR process involves a manufacturer raising 
scientific or technical issues 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 this document.
    All requests for formal DR should be submitted 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 elements:
     Cover sheet that clearly identifies the submission as 
either a tier-one or tier-two DR request.
     Name and address of manufacturer inspected (as listed on 
Form FDA 483).
     Date of inspection (as listed on Form FDA 483).
     Date Form FDA 483 was issued (as listed on Form FDA 483).
     Facility Establishment Identifier number, if available (as 
listed on Form FDA 483).
     Names and titles of FDA employees who conducted inspection 
(as listed on 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.
    [cir] State expected outcome.
     Name, title, telephone and fax numbers, and email address 
(as available) of manufacturer contact.
    The guidance responds 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:
     Suitability of certain issues for the formal DR process, 
including examples, 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 
regulations related to drug quality.
    We estimate the burden for the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
            Activity                 Number of     frequency per   Total annual   Average burden    Total hours
                                    respondents      response        responses     per 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.


[[Page 49834]]

    As reflected in table 1, we estimate two manufacturers will submit 
two requests annually for tier-one DR, and that there will be one 
appeal of these requests to the DR panel (tier-two DR). We estimate 
also 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. Based on our 
experience with this collection we have not changed our estimate since 
our last request for OMB approval.

    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23444 Filed 10-26-17; 8:45 am]
BILLING CODE 4164-01-P


