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, 49832-49834 [2017-23444]
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49832
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
[FR Doc. 2017–23447 Filed 10–26–17; 8:45 am]
BILLING CODE 4120–01–C
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.
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.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
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://
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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
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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/201523389.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, PRAStaff@
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
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Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
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
• 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:
Æ Identify the observation in dispute.
Æ Clearly present the manufacturer’s
scientific position or rationale
concerning the issue under dispute with
any supporting data.
Æ 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.
Æ Identify possible solutions.
Æ 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:
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).
asabaliauskas on DSKBBXCHB2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency per
response
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours
Requests for tier-one DR .....................................................
Requests for tier-two DR .....................................................
2
1
1
1
2
1
30
8
60
8
Total ..............................................................................
........................
........................
........................
........................
68
1 There
are no capital costs or operating and maintenance costs associated with this collection.
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Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3710]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Evaluation of the
Food and Drug Administration’s
Education at the Point of Sale
Campaign
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 November
27, 2017.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—NEW and
title ‘‘Evaluation of FDA’s Education at
the Point of Sale Campaign.’’ Also,
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
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White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Evaluation of FDA’s Education at the
Point of Sale Campaign OMB Control
Number 0910—NEW
The 2009 Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) amends
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to grant FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect public health and to
reduce tobacco use by minors. Section
1003(d)(2)(D) of the FD&C Act (21
U.S.C. 393(d)(2)(D)) supports the
development and implementation of
FDA public education campaigns
related to tobacco use. Accordingly,
FDA is currently developing and
implementing a tobacco education
intervention at the point of sale to
reduce the public health burden of
tobacco use. The campaign features
advertisements intended to encourage
future quit attempts among current
smokers in stores that sell tobacco
products.
In support of the provisions of the
Tobacco Control Act that require FDA to
protect the public health, FDA requests
OMB approval to collect information to
evaluate the effectiveness of the point of
sale tobacco education campaign. Data
from this outcome evaluation study will
be used to examine statistical
associations between exposure to the
campaign and specific outcomes of
interest, which include awareness of the
campaign and its messaging, tobaccorelated attitudes, beliefs and risk
perceptions, and motivation to quit
smoking.
Evaluation is an essential
organizational practice in public health
and a systematic way to account for and
improve public health actions.
Comprehensive evaluation of FDA’s
public education campaigns will be
used to document whether the intended
audience is aware of and understands
campaign messages, and whether
campaign exposure influences tobaccorelated attitudes, beliefs and risk
perceptions, intentions to use tobacco,
and motivation to quit smoking.
Participation in the outcome evaluation
study will be voluntary. All of the
information collected is integral to that
evaluation.
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Evaluation of the Point of Sale
Campaign. This outcome evaluation
study will consist of four longitudinal
data collection periods over 24 months
(approximately every 7 months), with
the first survey (Wave 1) occurring
approximately 3 months after campaign
launch. A fourth wave of data collection
has been added to the three proposed in
the 60-day notice because the campaign
has been extended from 18 to 24
months. The additional wave of data
collection is necessary to continue to
assess the impact of the campaign. To
reduce the number of participants
needed to detect the effects of the
campaign on outcomes of interest, the
design of the campaign was changed
from two treatment groups and one
control group to one treatment group
and one control group. The respondent
numbers and burden hours below have
been revised to reflect the four data
collection waves and the change in the
number of treatment groups.
Information will be collected from
adult cigarette smokers, ages 25 to 54,
about awareness of and exposure to
campaign advertisements, tobacco use,
and knowledge, attitudes, and beliefs
related to tobacco use. Information will
be collected on demographic variables
including age, sex, race/ethnicity, and
primary language. Participants will also
be offered the option to download a
smartphone application that will track
their exposure to the campaign, and that
will ask them to respond to a brief
survey about every 6 months over 18
months.
FDA’s media contractor identified 37
potential counties for the campaign.
From this list, FDA’s evaluation
contractor has selected 30 counties to be
included in the evaluation. Of these, 15
counties will receive the intervention
(treatment counties), and 15 counties
will not receive it (control counties).
The number of counties has changed
since the 60-day notice because we
changed the experimental design to
have one treatment group instead of
two, which resulted in needing fewer
counties.
Data will be collected from a
longitudinal cohort that will consist of
an entirely new sample of adult
cigarette smokers. Addresses will be
randomly selected from postal carrier
routes in the 30 selected U.S. counties
to identify households that contain one
or more adult smokers between the ages
of 25 and 54. Pre-paid pre-addressed
paper screening surveys will be mailed
to approximately 104,541 households.
We estimate that 27,651 (9,217
annualized respondents) households
will return the 10-minute screener they
received by mail, and 26,258 (8,753
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[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Annual
Activity Number of frequency per Total annual Average burden Total hours
respondents response responses per response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
