Agency Information Collection Activities; Proposed Collection; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine, 49836-49837 [2017-23445]
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49836
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23450 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–2017–N–6145]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Dispute Resolution
Procedures for Science-Based
Decisions on Products Regulated by
the Center for Veterinary Medicine
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 provisions of the dispute
resolution procedures for science-based
decisions on products regulated by the
Center for Veterinary Medicine (CVM).
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.
VerDate Sep<11>2014
17:54 Oct 26, 2017
Jkt 244001
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–
2017–N–6145 for ‘‘Dispute Resolution
Procedures for Science-Based Decisions
on Products Regulated by the Center for
Veterinary Medicine.’’ 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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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: 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.
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
E:\FR\FM\27OCN1.SGM
27OCN1
49837
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
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.
Dispute Resolution Procedures for
Science-Based Decisions on Products
Regulated by CVM—21 CFR Section
10.75
OMB Control Number 0910–0566—
Extension
CVM’s Guidance for Industry (GIF)
#79, ‘‘Dispute Resolution Procedures for
Science-Based Decisions on Products
Regulated by the Center for Veterinary
Medicine’’ (https://www.fda.gov/
downloads/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/UCM052393.pdf),
describes the process by which CVM
formally resolves disputes relating to
scientific controversies. A scientific
controversy involves issues concerning
a specific product regulated by CVM
related to matters of technical expertise
and requires specialized education,
training, or experience to be understood
and resolved. The guidance details
information on how CVM intends to
apply provisions of existing regulations
regarding internal review of Agency
decisions. In addition, the guidance
outlines the established procedures for
persons who are sponsors, applicants, or
manufacturers of animal drugs or other
products regulated by CVM that wish to
submit a request for review of a
scientific dispute. When a sponsor,
applicant, or manufacturer has a
scientific disagreement with a written
decision by CVM, they may submit a
request for a review of that decision by
following the established procedures
discussed in the guidance.
CVM encourages applicants to begin
the resolution of science-based disputes
with discussions with the review team/
group, including the Team Leader or
Division Director. The Center prefers
that differences of opinion regarding
science or science-based policy be
resolved between the review team/group
and the applicant. If the matter is not
resolved by this preferred method then
CVM recommends that the applicant
follow the procedures in GFI #79.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
10.75, Request for review of a scientific dispute ................
1
4
4
10
40
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
In the next 3 years, CVM anticipates
receiving one or fewer requests for
review of a scientific dispute per year,
on average. We base our estimate on
CVM’s experience over the past 6 years
in handling formal appeals for scientific
disputes. The burden of this collection
has changed. The number of
respondents decreased from two to one
annually, the number of responses per
respondent remained at four annually,
the hours per response remained at 10
annually, and the total number of hours
decreased from 80 to 40. This decrease
in the total hours is the result of a
natural fluctuation in the number of
respondents taking advantage of this
dispute resolution process.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23445 Filed 10–26–17; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:54 Oct 26, 2017
Jkt 244001
Food and Drug Administration
by December 26, 2017 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
[Docket No. FDA–2017–D–5912]
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pediatric Gastroesophageal Reflux
Disease: Developing Drugs for
Treatment; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Pediatric
Gastroesophageal Reflux Disease:
Developing Drugs for Treatment.’’ The
purpose of this draft guidance is to
assist sponsors in the clinical
development of drugs for the treatment
of gastroesophageal reflux disease
(GERD) in the pediatric patient
population, including guidance on
clinical presentation by age and disease,
study populations, endpoints, and
pharmacometric issues affecting dosing.
DATES: Submit either electronic or
written comments on the draft guidance
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
You may submit comments
on any guidance at any time as follows:
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.
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49836-49837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23445]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6145]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Dispute Resolution Procedures for Science-Based
Decisions on Products Regulated by the Center for Veterinary Medicine
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 provisions of
the dispute resolution procedures for science-based decisions on
products regulated by the Center for Veterinary Medicine (CVM).
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-2017-N-6145 for ``Dispute Resolution Procedures for Science-Based
Decisions on Products Regulated by the Center for Veterinary
Medicine.'' 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
[[Page 49837]]
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.
Dispute Resolution Procedures for Science-Based Decisions on Products
Regulated by CVM--21 CFR Section 10.75
OMB Control Number 0910-0566--Extension
CVM's Guidance for Industry (GIF) #79, ``Dispute Resolution
Procedures for Science-Based Decisions on Products Regulated by the
Center for Veterinary Medicine'' (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052393.pdf), describes the process by which CVM formally resolves
disputes relating to scientific controversies. A scientific controversy
involves issues concerning a specific product regulated by CVM related
to matters of technical expertise and requires specialized education,
training, or experience to be understood and resolved. The guidance
details information on how CVM intends to apply provisions of existing
regulations regarding internal review of Agency decisions. In addition,
the guidance outlines the established procedures for persons who are
sponsors, applicants, or manufacturers of animal drugs or other
products regulated by CVM that wish to submit a request for review of a
scientific dispute. When a sponsor, applicant, or manufacturer has a
scientific disagreement with a written decision by CVM, they may submit
a request for a review of that decision by following the established
procedures discussed in the guidance.
CVM encourages applicants to begin the resolution of science-based
disputes with discussions with the review team/group, including the
Team Leader or Division Director. The Center prefers that differences
of opinion regarding science or science-based policy be resolved
between the review team/group and the applicant. If the matter is not
resolved by this preferred method then CVM recommends that the
applicant follow the procedures in GFI #79.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.75, Request for review of a scientific dispute.................. 1 4 4 10 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
In the next 3 years, CVM anticipates receiving one or fewer
requests for review of a scientific dispute per year, on average. We
base our estimate on CVM's experience over the past 6 years in handling
formal appeals for scientific disputes. The burden of this collection
has changed. The number of respondents decreased from two to one
annually, the number of responses per respondent remained at four
annually, the hours per response remained at 10 annually, and the total
number of hours decreased from 80 to 40. This decrease in the total
hours is the result of a natural fluctuation in the number of
respondents taking advantage of this dispute resolution process.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23445 Filed 10-26-17; 8:45 am]
BILLING CODE 4164-01-P
