Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level, 42127-42130 [2018-17860]
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Notice of this meeting is given under
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U.S.C. app. 2).
Dated: August 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17867 Filed 8–17–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0248]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Formal Dispute
Resolution; Appeals Above the
Division Level
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
SUMMARY:
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42127
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 process for
formally resolving scientific and
procedural disputes in the Center for
Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation
and Research (CBER) that cannot be
resolved at the division level.
DATES: Submit either electronic or
written comments on the collection of
information by October 19, 2018.
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 October 19,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 19, 2018.
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’’).
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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–
2012–N–0248 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
for Industry on Formal Dispute
Resolution; Appeals Above the Division
Level.’’ 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/201523389.pdf.
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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.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
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Guidance for Industry on Formal
Dispute Resolution; Appeals Above the
Division Level
OMB Control Number 0910–0430—
Extension
This information collection approval
request is for FDA guidance on the
process for formally resolving scientific
and procedural disputes in FDA’s CDER
and CBER that cannot be resolved at the
division level. The guidance document
describes procedures for formally
appealing such disputes to the office or
center level and for submitting
information to assist center officials in
resolving the issue or issues presented.
The guidance document provides
information on how the Agency will
interpret and apply provisions of the
existing regulations regarding internal
Agency review of decisions (§ 10.75 (21
CFR 10.75)) and dispute resolution
during the investigational new drug
(IND) process (§ 312.48 (21 CFR 312.48))
and the new drug application/
abbreviated new drug application
(NDA/ANDA) process (§ 314.103 (21
CFR 314.103)). In addition, the guidance
document provides information on how
the Agency will interpret and apply the
specific Prescription Drug User Fee Act
(PDUFA) goals for major dispute
resolution associated with the
development and review of PDUFA
products.
Existing regulations, which appear
primarily in parts 10, 312, and 314 (21
CFR parts 10, 312, and 314), establish
procedures for the resolution of
scientific and procedural disputes
between interested persons and the
Agency, CDER, and CBER. All Agency
decisions on such matters are based on
information in the administrative file
(§ 10.75(d)). In general, the information
in an administrative file is collected
under existing regulations in part 312
(OMB control number 0910–0014), part
314 (OMB control number 0910–0001),
and part 601 (21 CFR part 601) (OMB
control number 0910–0338), which
specify the information manufacturers
must submit so that FDA may properly
evaluate the safety and effectiveness of
drugs and biological products. This
information is usually submitted as part
of an IND, NDA, or biologics license
application (BLA), or as a supplement to
an approved application. Although FDA
already possesses in the administrative
file the information that would form the
basis of a decision on a matter in
dispute resolution, the submission of
information regarding the request itself
and the data and information that the
requestor relies on in the appeal would
facilitate timely resolution of the
dispute. The guidance document
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describes the following collections of
information not expressly specified
under existing regulations: The
submission of the request for dispute
resolution as an amendment to the
application for the underlying product,
including the submission of supporting
information with the request for dispute
resolution.
Agency regulations ((§§ 312.23(a)(11)
and (d) (21 CFR 312.23(a)(11) and (d),
314.50 (21 CFR 314.50), 314.94 (21 CFR
314.94), and 601.2 (21 CFR 601.2)) state
that information provided to the Agency
as part of an IND, NDA, ANDA, or BLA
must be submitted in triplicate and with
an appropriate cover form. Form FDA
1571 must accompany submissions
under INDs and Form FDA 356h must
accompany submissions under NDAs,
ANDAs, and BLAs. Both forms have
valid OMB control numbers as follows:
Form FDA 1571 (OMB control number
0910–0014) and Form FDA 356h (OMB
control number 0910–0338).
In the guidance document, CDER and
CBER ask that a request for formal
dispute resolution be submitted as an
amendment to the application for the
underlying product and that it be
submitted to the Agency in triplicate
with the appropriate form attached,
either Form FDA 1571 or Form FDA
356h. The Agency recommends that a
request be submitted as an amendment
in this manner for two reasons: (1) To
ensure that each request is kept in the
administrative file with the entire
underlying application; and (2) to
ensure that pertinent information about
the request is entered into the
appropriate tracking databases. Use of
the information in the Agency’s tracking
databases enables the appropriate
Agency official to monitor progress on
the resolution of the dispute and to
ensure that appropriate steps will be
taken in a timely manner.
CDER and CBER have determined and
the guidance document recommends
that the following information should be
submitted to the appropriate center with
each request for dispute resolution so
that the center may quickly and
efficiently respond to the request: (1) A
brief but comprehensive statement of
each issue to be resolved, including a
description of the issue, the nature of
the issue (i.e., scientific, procedural, or
both), possible solutions based on
information in the administrative file,
whether informal dispute resolution
was sought prior to the formal appeal,
whether advisory committee review is
sought, and the expected outcome; (2) a
statement identifying the review
division/office that issued the original
decision on the matter and, if
applicable, the last Agency official that
attempted to formally resolve the
matter; (3) a list of documents in the
administrative file or additional copies
of such documents that are deemed
necessary for resolution of the issue or
issues; and (4) a statement that the
previous supervisory level has already
had the opportunity to review all of the
material relied on for dispute resolution.
The information the Agency suggests
submitting with a formal request for
dispute resolution consists of: (1)
Statements describing the issue from the
perspective of the person with a
dispute; (2) brief statements describing
the history of the matter; and (3) the
documents previously submitted to FDA
under an OMB approved collection of
information.
Based on FDA’s experience with
dispute resolution, the Agency expects
that most persons seeking formal
dispute resolution will have gathered
the materials listed previously when
identifying the existence of a dispute
with the Agency. Consequently, FDA
anticipates that the collection of
information attributed solely to the
guidance document will be minimal.
Provided in this document is an
estimate of the annual reporting burden
for requests for dispute resolution.
Based on data collected from review
divisions and offices within CDER and
CBER, FDA estimates that
approximately 12 sponsors and
applicants (respondents) will submit
requests for formal dispute resolution to
CDER annually and approximately one
respondent will submit requests for
formal dispute resolution to CBER
annually.
The total annual responses are the
total number of requests submitted to
CDER and CBER in 1 year, including
requests for dispute resolution that a
single respondent submits more than
one time. FDA estimates that CDER
receives approximately 17 requests
annually and CBER receives
approximately 1 request annually. The
hours per response is the estimated
number of hours that a respondent
would spend preparing the information
to be submitted with a request for
formal dispute resolution in accordance
with the guidance document, including
the time it takes to gather and copy brief
statements describing the issue from the
perspective of the person with the
dispute, brief statements describing the
history of the matter, and supporting
information that has already been
submitted to the Agency. Based on
experience, FDA estimates that
approximately 8 hours, on average,
would be needed per response.
Therefore, FDA estimates that 8 hours
will be spent per year by respondents
requesting formal dispute resolution in
accordance with the guidance
document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Requests for formal dispute resolution
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
CDER ...................................................................................
CBER ...................................................................................
12
1
1.42
1
17
1
8
8
136
8
Total ..............................................................................
........................
........................
........................
........................
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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The burden for this information
collection has changed since the last
OMB approval. Our burden estimate
reflects a decrease in burden by 14
records and 112 hours. We attribute this
adjustment to a decrease in the number
of requests received over the last few
years.
Dated: August 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17860 Filed 8–17–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3038]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Request for
Samples and Protocols
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 September
19, 2018.
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 0910–0206. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
Ila
Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
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FOR FURTHER INFORMATION CONTACT:
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:
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Request for Samples and Protocols
OMB Control Number 0910–0206—
Extension
This information collection supports
Agency regulations. Under section 351
of the Public Health Service Act (42
U.S.C. 262), FDA has the responsibility
to issue regulations that prescribe
standards designed to ensure the safety,
purity, and potency of biological
products and to ensure that the
biologics licenses for such products are
only issued when a product meets the
prescribed standards. Under § 610.2 (21
CFR 610.2), the Center for Biologics
Evaluation and Research (CBER) or the
Center for Drug Evaluation and Research
may at any time require manufacturers
of licensed biological products to
submit to FDA samples of any lot along
with the protocols showing the results
of applicable tests prior to distributing
the lot of the product. In addition to
§ 610.2, there are other regulations that
require the submission of samples and
protocols for specific licensed biological
products: 21 CFR 660.6 (Antibody to
Hepatitis B Surface Antigen); 21 CFR
660.36 (Reagent Red Blood Cells); and
21 CFR 660.46 (Hepatitis B Surface
Antigen).
Section 660.6(a) provides
requirements for the frequency of
submission of samples from each lot of
Antibody to Hepatitis B Surface Antigen
product, and § 660.6(b) provides the
requirements for the submission of a
protocol containing specific information
along with each required sample. For
§ 660.6 products subject to official
release by CBER, one sample from each
filling of each lot is required to be
submitted along with a protocol
consisting of a summary of the history
of manufacture of the product,
including all results of each test for
which test results are requested by
CBER. After official release is no longer
required, one sample along with a
protocol is required to be submitted at
90-day intervals. In addition, samples,
which must be accompanied by a
protocol, may at any time be required to
be submitted to CBER if continued
evaluation is deemed necessary.
Section 660.36(a) requires, after each
routine establishment inspection by
FDA, the submission of samples from a
lot of final Reagent Red Blood Cell
product along with a protocol
containing specific information. Section
660.36(a)(2) requires that a protocol
contain information including, but not
limited to, manufacturing records,
certain test records, and identity test
results. Section 660.36(b) requires a
copy of the antigenic constitution
matrix specifying the antigens present
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or absent to be submitted to the CBER
Director at the time of initial
distribution of each lot.
Section 660.46(a) contains
requirements as to the frequency of
submission of samples from each lot of
Hepatitis B Surface Antigen product,
and § 660.46(b) contains the
requirements as to the submission of a
protocol containing specific information
along with each required sample. For
§ 660.46 products subject to official
release by CBER, one sample from each
filling of each lot is required to be
submitted along with a protocol
consisting of a summary of the history
or manufacture of the product,
including all results of each test for
which test results are requested by
CBER. After notification of official
release is received, one sample along
with a protocol is required to be
submitted at 90-day intervals. In
addition, samples, which must be
accompanied by a protocol, may at any
time be required to be submitted to
CBER if continued evaluation is deemed
necessary.
Samples and protocols are required by
FDA to help ensure the safety, purity, or
potency of the product because of the
potential lot-to-lot variability of a
product produced from living
organisms. In cases of certain biological
products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological
products) that are known to have lot-tolot consistency, official lot release is not
normally required. However,
submissions of samples and protocols of
these products may still be required for
surveillance, licensing, and export
purposes, or in the event that FDA
obtains information that the
manufacturing process may not result in
consistent quality of the product.
The following burden estimate is for
the protocols required to be submitted
with each sample. The collection of
samples is not a collection of
information under 5 CFR 1320.3(h)(2).
Respondents to the collection of
information under § 610.2 are
manufacturers of licensed biological
products. Respondents to the collection
of information under §§ 660.6(b),
660.36(a)(2) and (b), and 660.46(b) are
manufacturers of the specific products
referenced previously in this document.
The estimated number of respondents
for each regulation is based on the
annual number of manufacturers that
submitted samples and protocols for
biological products including
submissions for lot release, surveillance,
licensing, or export. Based on
information obtained from FDA’s
database system, approximately 79
manufacturers submitted samples and
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]]>Agencies
[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Notices]
[Pages 42127-42130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17860]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0248]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Formal Dispute Resolution;
Appeals Above the Division Level
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 process for formally resolving
scientific and procedural disputes in the Center for Drug Evaluation
and Research (CDER) and the Center for Biologics Evaluation and
Research (CBER) that cannot be resolved at the division level.
DATES: Submit either electronic or written comments on the collection
of information by October 19, 2018.
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 October 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 19, 2018. 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'').
[[Page 42128]]
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-2012-N-0248 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry on Formal
Dispute Resolution; Appeals Above the Division Level.'' 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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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; Appeals Above the
Division Level
OMB Control Number 0910-0430--Extension
This information collection approval request is for FDA guidance on
the process for formally resolving scientific and procedural disputes
in FDA's CDER and CBER that cannot be resolved at the division level.
The guidance document describes procedures for formally appealing such
disputes to the office or center level and for submitting information
to assist center officials in resolving the issue or issues presented.
The guidance document provides information on how the Agency will
interpret and apply provisions of the existing regulations regarding
internal Agency review of decisions (Sec. 10.75 (21 CFR 10.75)) and
dispute resolution during the investigational new drug (IND) process
(Sec. 312.48 (21 CFR 312.48)) and the new drug application/abbreviated
new drug application (NDA/ANDA) process (Sec. 314.103 (21 CFR
314.103)). In addition, the guidance document provides information on
how the Agency will interpret and apply the specific Prescription Drug
User Fee Act (PDUFA) goals for major dispute resolution associated with
the development and review of PDUFA products.
Existing regulations, which appear primarily in parts 10, 312, and
314 (21 CFR parts 10, 312, and 314), establish procedures for the
resolution of scientific and procedural disputes between interested
persons and the Agency, CDER, and CBER. All Agency decisions on such
matters are based on information in the administrative file (Sec.
10.75(d)). In general, the information in an administrative file is
collected under existing regulations in part 312 (OMB control number
0910-0014), part 314 (OMB control number 0910-0001), and part 601 (21
CFR part 601) (OMB control number 0910-0338), which specify the
information manufacturers must submit so that FDA may properly evaluate
the safety and effectiveness of drugs and biological products. This
information is usually submitted as part of an IND, NDA, or biologics
license application (BLA), or as a supplement to an approved
application. Although FDA already possesses in the administrative file
the information that would form the basis of a decision on a matter in
dispute resolution, the submission of information regarding the request
itself and the data and information that the requestor relies on in the
appeal would facilitate timely resolution of the dispute. The guidance
document
[[Page 42129]]
describes the following collections of information not expressly
specified under existing regulations: The submission of the request for
dispute resolution as an amendment to the application for the
underlying product, including the submission of supporting information
with the request for dispute resolution.
Agency regulations ((Sec. Sec. 312.23(a)(11) and (d) (21 CFR
312.23(a)(11) and (d), 314.50 (21 CFR 314.50), 314.94 (21 CFR 314.94),
and 601.2 (21 CFR 601.2)) state that information provided to the Agency
as part of an IND, NDA, ANDA, or BLA must be submitted in triplicate
and with an appropriate cover form. Form FDA 1571 must accompany
submissions under INDs and Form FDA 356h must accompany submissions
under NDAs, ANDAs, and BLAs. Both forms have valid OMB control numbers
as follows: Form FDA 1571 (OMB control number 0910-0014) and Form FDA
356h (OMB control number 0910-0338).
In the guidance document, CDER and CBER ask that a request for
formal dispute resolution be submitted as an amendment to the
application for the underlying product and that it be submitted to the
Agency in triplicate with the appropriate form attached, either Form
FDA 1571 or Form FDA 356h. The Agency recommends that a request be
submitted as an amendment in this manner for two reasons: (1) To ensure
that each request is kept in the administrative file with the entire
underlying application; and (2) to ensure that pertinent information
about the request is entered into the appropriate tracking databases.
Use of the information in the Agency's tracking databases enables the
appropriate Agency official to monitor progress on the resolution of
the dispute and to ensure that appropriate steps will be taken in a
timely manner.
CDER and CBER have determined and the guidance document recommends
that the following information should be submitted to the appropriate
center with each request for dispute resolution so that the center may
quickly and efficiently respond to the request: (1) A brief but
comprehensive statement of each issue to be resolved, including a
description of the issue, the nature of the issue (i.e., scientific,
procedural, or both), possible solutions based on information in the
administrative file, whether informal dispute resolution was sought
prior to the formal appeal, whether advisory committee review is
sought, and the expected outcome; (2) a statement identifying the
review division/office that issued the original decision on the matter
and, if applicable, the last Agency official that attempted to formally
resolve the matter; (3) a list of documents in the administrative file
or additional copies of such documents that are deemed necessary for
resolution of the issue or issues; and (4) a statement that the
previous supervisory level has already had the opportunity to review
all of the material relied on for dispute resolution. The information
the Agency suggests submitting with a formal request for dispute
resolution consists of: (1) Statements describing the issue from the
perspective of the person with a dispute; (2) brief statements
describing the history of the matter; and (3) the documents previously
submitted to FDA under an OMB approved collection of information.
Based on FDA's experience with dispute resolution, the Agency
expects that most persons seeking formal dispute resolution will have
gathered the materials listed previously when identifying the existence
of a dispute with the Agency. Consequently, FDA anticipates that the
collection of information attributed solely to the guidance document
will be minimal.
Provided in this document is an estimate of the annual reporting
burden for requests for dispute resolution. Based on data collected
from review divisions and offices within CDER and CBER, FDA estimates
that approximately 12 sponsors and applicants (respondents) will submit
requests for formal dispute resolution to CDER annually and
approximately one respondent will submit requests for formal dispute
resolution to CBER annually.
The total annual responses are the total number of requests
submitted to CDER and CBER in 1 year, including requests for dispute
resolution that a single respondent submits more than one time. FDA
estimates that CDER receives approximately 17 requests annually and
CBER receives approximately 1 request annually. The hours per response
is the estimated number of hours that a respondent would spend
preparing the information to be submitted with a request for formal
dispute resolution in accordance with the guidance document, including
the time it takes to gather and copy brief statements describing the
issue from the perspective of the person with the dispute, brief
statements describing the history of the matter, and supporting
information that has already been submitted to the Agency. Based on
experience, FDA estimates that approximately 8 hours, on average, would
be needed per response. Therefore, FDA estimates that 8 hours will be
spent per year by respondents requesting formal dispute resolution in
accordance with the guidance document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Requests for formal dispute Number of responses per Total annual Average burden Total hours
resolution respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
CDER............................ 12 1.42 17 8 136
CBER............................ 1 1 1 8 8
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 144
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 42130]]
The burden for this information collection has changed since the
last OMB approval. Our burden estimate reflects a decrease in burden by
14 records and 112 hours. We attribute this adjustment to a decrease in
the number of requests received over the last few years.
Dated: August 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17860 Filed 8-17-18; 8:45 am]
BILLING CODE 4164-01-P
