Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, 33507-33509 [2017-15206]
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Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices
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UCM559090.htm. Registration requests
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during the time periods specified in
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33507
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please contact Daniel Bellingham (see
FOR FURTHER INFORMATION CONTACT) at
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meeting.
TABLE 1—PUBLIC MEETING INFORMATION
Public meeting
Topics
# 1 ..........................
• Supply chain security in 2023 ...........
• Enhanced drug distribution security
needs.
Advance registration .............................
# 2 ..........................
# 3 ..........................
Comment period closes ........................
Request special accommodations due
to a disability.
• Electronic interoperability ..................
• Standards for data exchange ...........
• Data architecture ...............................
• Aggregation and inference.
Advance registration .............................
Comment period closes ........................
Request special accommodations due
to a disability.
• Further refinement of enhanced drug
distribution security needs.
• Building capacity for a unit-level system.
Advance registration .............................
Comment period closes ........................
Request special accommodations due
to a disability.
IV. Webcasting of the Public Meeting
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Portions of each public meeting will
be recorded and webcast on the day of
the meeting. Information for how to
access the webcast will be available at
https://www.fda.gov/Drugs/NewsEvents/
UCM559090.htm within 7 days prior to
each public meeting. The webcast will
be conducted in listening mode only.
Dated: July 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15204 Filed 7–19–17; 8:45 am]
August 23, 2017, 9 a.m. to 4 p.m.
by July 31, 2017 ...................................
September 22, 2017 .............................
by August 16, 2017 ..............................
October 2–27, 2017 ..............................
January 5, 2018 ....................................
by November 28, 2017 .........................
January 2–26, 2018 ..............................
March 30, 2018 .....................................
by February 21, 2018 ...........................
Food and Drug Administration
[Docket No. FDA–2010–N–0597]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species
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
SUMMARY:
18:50 Jul 19, 2017
Jkt 241001
PO 00000
Frm 00032
Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registration.
See ‘‘Comments’’.
See FOR FURTHER INFORMATION
CONTACT.
February 28, 2018, 9 a.m. to 4 p.m.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registration.
See ‘‘Comments’’.
See FOR FURTHER INFORMATION
CONTACT.
December 5–6, 2017, 9 a.m. to 4 p.m.
BILLING CODE 4164–01–P
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electronic address
Date/Time
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Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registration.
See ‘‘Comments’’.
See FOR FURTHER INFORMATION
CONTACT.
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by August 21,
2017.
DATES:
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 0910–0620. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
E:\FR\FM\20JYN1.SGM
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33508
Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726.
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. Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species—21 CFR part
516 OMB Control Number 0910–0620—
Extension
The Minor Use and Minor Species
Animal Health Act of 2004 (the MUMS
Act) (Pub. L. 108–282) added section
572 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360ccc-1), which authorizes FDA to
establish new regulatory procedures
intended to make more medications
legally available to veterinarians and
animal owners for the treatment of
minor animal species (species other
than cattle, horses, swine, chickens,
turkeys, dogs, and cats). In enacting the
MUMS Act, Congress sought to
encourage the development of these
SUPPLEMENTARY INFORMATION:
new animal drugs. Congress recognized
that the markets for drugs intended to
treat these species, diseases, or
conditions are so small that there are
often insufficient economic incentives
to motivate drug companies to develop
data to support approvals. Further,
Congress recognized that some minor
species populations are too small or
their management systems too diverse to
make it practical to conduct traditional
studies to demonstrate safety and
effectiveness of animal drugs for such
uses. As a result of these limitations,
drug companies have generally not been
willing or able to collect data to support
legal marketing of drugs for these
species, diseases, or conditions.
Consequently, Congress enacted the
MUMS Act to provide incentives to
develop new animal drugs for minor
species, while still ensuring appropriate
safeguards for animal and human
health. Section 572 of the FD&C Act
provides for a public index listing of
legally marketed unapproved new
animal drugs for minor species. FDA
regulations in part 516 (21 CFR part
516) specify, among other things, the
criteria and procedures for requesting
eligibility for indexing and for
requesting addition to the index, as well
as the annual reporting requirements for
index holders. The administrative
procedures and criteria for indexing a
new animal drug for use in a minor
species are set forth in 21 CFR 516.111
through 516.171. Section 516.165 sets
forth the annual reporting requirements
for index holders. FDA needs the
information to determine: (1) The
eligibility of a new animal drug for
indexing; (2) that a qualified expert
panel proposed to review certain
information regarding the new animal
drug meets the selection criteria listed
in the regulations; (3) whether the
Agency agrees with the
recommendation of a qualified expert
panel that a drug be added to the index;
and (4) whether there may be grounds
for removing a drug from the index.
In the Federal Register of December
21, 2016 (81 FR 93689), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment, which was outside the scope
of the comment requests in the notice.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
516.119—requires a foreign drug company to submit
and update the name and address of a permanent
U.S. resident agent ....................................................
516.121—written request for a meeting with FDA to
discuss the requirements for indexing a new animal
drug ............................................................................
516.123—written request for an informal conference
and a requestor’s written response to an FDA initial
decision denying a request ........................................
516.125—correspondence and information associated
with investigational use of new animal drugs intended for indexing .....................................................
516.129—content and format of a request for determination of eligibility for indexing ...............................
516.141—information to be submitted to FDA by a requestor seeking to establish a qualified expert panel
516.143—content and format of the written report of
the qualified expert panel ...........................................
516.145—content and format of a request for addition
to the Index ................................................................
516.161—content and format of a request for modification of an indexed drug ..............................................
516.163—information to be contained in a request to
FDA to transfer ownership of a drug’s index file to
another person ...........................................................
516.165—requires drug experience reports and distributor statements to be submitted to FDA ...............
Total ........................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
2
1
2
1
2
30
2
60
4
240
3
1
3
8
24
2
3
6
20
120
30
2
60
20
1,200
20
1
20
16
320
20
1
20
120
2,400
20
1
20
20
400
1
1
1
4
4
1
1
1
2
2
10
2
20
8
160
..............................
........................
........................
........................
4,872
are no capital costs or operating and maintenance costs associated with this collection of information.
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33509
Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average burden per recordkeeping
Total hours
516.141—requires the qualified expert panel leader to
maintain a copy of the written report and all notes or
minutes relating to panel deliberations that are submitted to the requestor for 2 years after the report is
submitted ....................................................................
516.165—requires the holder of an indexed drug to
maintain records of all information pertinent to the
safety or effectiveness of the indexed drug, from foreign and domestic sources ........................................
30
2
60
*.5
30
10
2
20
1
20
Total ........................................................................
..............................
........................
........................
........................
50
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
*30 minutes.
We based our estimates in tables 1
and 2 on our experience with the
MUMS indexing program and the
requests for eligibility for indexing and
for addition to the index, as well as the
periodic drug experience reports
submitted during the past 3 years. The
burden has not changed since the last
OMB approval.
Dated: July 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15206 Filed 7–19–17; 8:45 am]
BILLING CODE 4164–01–P
(FEMA) has provided to the affected
communities. The FIRM and FIS report
are the basis of the floodplain
management measures that the
community is required either to adopt
or to show evidence of having in effect
an order to qualify or remain qualified
for participation in the National Flood
Insurance Program (NFIP). In addition,
the FIRM and FIS report, once effective,
will be used by insurance agents and
others to calculate appropriate flood
insurance premium rates for new
buildings and the contents of those
buildings.
Comments are to be submitted
on or before October 18, 2017.
DATES:
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2017–0002; Internal
Agency Docket No. FEMA–B–1724]
Proposed Flood Hazard
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
Comments are requested on
proposed flood hazard determinations,
which may include additions or
modifications of any Base Flood
Elevation (BFE), base flood depth,
Special Flood Hazard Area (SFHA)
boundary or zone designation, or
regulatory floodway on the Flood
Insurance Rate Maps (FIRMs), and
where applicable, in the supporting
Flood Insurance Study (FIS) reports for
the communities listed in the table
below. The purpose of this notice is to
seek general information and comment
regarding the preliminary FIRM, and
where applicable, the FIS report that the
Federal Emergency Management Agency
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:50 Jul 19, 2017
Jkt 241001
The Preliminary FIRM, and
where applicable, the FIS report for
each community are available for
inspection at both the online location
and the respective Community Map
Repository address listed in the tables
below. Additionally, the current
effective FIRM and FIS report for each
community are accessible online
through the FEMA Map Service Center
at www.msc.fema.gov for comparison.
You may submit comments, identified
by Docket No. FEMA–B–1724, to Rick
Sacbibit, Chief, Engineering Services
Branch, Federal Insurance and
Mitigation Administration, FEMA, 400
C Street SW., Washington, DC 20472,
(202) 646–7659, or (email)
patrick.sacbibit@fema.dhs.gov.
ADDRESSES:
Rick
Sacbibit, Chief, Engineering Services
Branch, Federal Insurance and
Mitigation Administration, FEMA, 400
C Street SW., Washington, DC 20472,
(202) 646–7659, or (email)
patrick.sacbibit@fema.dhs.gov; or visit
the FEMA Map Information eXchange
(FMIX) online at
www.floodmaps.fema.gov/fhm/fmx_
main.html.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
FEMA
proposes to make flood hazard
determinations for each community
listed below, in accordance with section
110 of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
These proposed flood hazard
determinations, together with the
floodplain management criteria required
by 44 CFR 60.3, are the minimum that
are required. They should not be
construed to mean that the community
must change any existing ordinances
that are more stringent in their
floodplain management requirements.
The community may at any time enact
stricter requirements of its own or
pursuant to policies established by other
Federal, State, or regional entities.
These flood hazard determinations are
used to meet the floodplain
management requirements of the NFIP
and also are used to calculate the
appropriate flood insurance premium
rates for new buildings built after the
FIRM and FIS report become effective.
The communities affected by the
flood hazard determinations are
provided in the tables below. Any
request for reconsideration of the
revised flood hazard information shown
on the Preliminary FIRM and FIS report
that satisfies the data requirements
outlined in 44 CFR 67.6(b) is considered
an appeal. Comments unrelated to the
flood hazard determinations also will be
considered before the FIRM and FIS
report become effective.
Use of a Scientific Resolution Panel
(SRP) is available to communities in
support of the appeal resolution
process. SRPs are independent panels of
experts in hydrology, hydraulics, and
other pertinent sciences established to
review conflicting scientific and
technical data and provide
recommendations for resolution. Use of
the SRP only may be exercised after
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20JYN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33507-33509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15206]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0597]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Index of Legally
Marketed Unapproved New Animal Drugs for Minor Species
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
21, 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 0910-0620.
Also include the FDA docket number found in brackets in the heading of
this document.
[[Page 33508]]
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance. Index of Legally Marketed Unapproved New Animal
Drugs for Minor Species--21 CFR part 516 OMB Control Number 0910-0620--
Extension
The Minor Use and Minor Species Animal Health Act of 2004 (the MUMS
Act) (Pub. L. 108-282) added section 572 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360ccc-1), which authorizes FDA
to establish new regulatory procedures intended to make more
medications legally available to veterinarians and animal owners for
the treatment of minor animal species (species other than cattle,
horses, swine, chickens, turkeys, dogs, and cats). In enacting the MUMS
Act, Congress sought to encourage the development of these new animal
drugs. Congress recognized that the markets for drugs intended to treat
these species, diseases, or conditions are so small that there are
often insufficient economic incentives to motivate drug companies to
develop data to support approvals. Further, Congress recognized that
some minor species populations are too small or their management
systems too diverse to make it practical to conduct traditional studies
to demonstrate safety and effectiveness of animal drugs for such uses.
As a result of these limitations, drug companies have generally not
been willing or able to collect data to support legal marketing of
drugs for these species, diseases, or conditions. Consequently,
Congress enacted the MUMS Act to provide incentives to develop new
animal drugs for minor species, while still ensuring appropriate
safeguards for animal and human health. Section 572 of the FD&C Act
provides for a public index listing of legally marketed unapproved new
animal drugs for minor species. FDA regulations in part 516 (21 CFR
part 516) specify, among other things, the criteria and procedures for
requesting eligibility for indexing and for requesting addition to the
index, as well as the annual reporting requirements for index holders.
The administrative procedures and criteria for indexing a new animal
drug for use in a minor species are set forth in 21 CFR 516.111 through
516.171. Section 516.165 sets forth the annual reporting requirements
for index holders. FDA needs the information to determine: (1) The
eligibility of a new animal drug for indexing; (2) that a qualified
expert panel proposed to review certain information regarding the new
animal drug meets the selection criteria listed in the regulations; (3)
whether the Agency agrees with the recommendation of a qualified expert
panel that a drug be added to the index; and (4) whether there may be
grounds for removing a drug from the index.
In the Federal Register of December 21, 2016 (81 FR 93689), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment, which was outside
the scope of the comment requests in the notice.
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
----------------------------------------------------------------------------------------------------------------
516.119--requires a foreign 2 1 2 1 2
drug company to submit and
update the name and address
of a permanent U.S. resident
agent.......................
516.121--written request for 30 2 60 4 240
a meeting with FDA to
discuss the requirements for
indexing a new animal drug..
516.123--written request for 3 1 3 8 24
an informal conference and a
requestor's written response
to an FDA initial decision
denying a request...........
516.125--correspondence and 2 3 6 20 120
information associated with
investigational use of new
animal drugs intended for
indexing....................
516.129--content and format 30 2 60 20 1,200
of a request for
determination of eligibility
for indexing................
516.141--information to be 20 1 20 16 320
submitted to FDA by a
requestor seeking to
establish a qualified expert
panel.......................
516.143--content and format 20 1 20 120 2,400
of the written report of the
qualified expert panel......
516.145--content and format 20 1 20 20 400
of a request for addition to
the Index...................
516.161--content and format 1 1 1 4 4
of a request for
modification of an indexed
drug........................
516.163--information to be 1 1 1 2 2
contained in a request to
FDA to transfer ownership of
a drug's index file to
another person..............
516.165--requires drug 10 2 20 8 160
experience reports and
distributor statements to be
submitted to FDA............
----------------------------------------------------------------------------------
Total.................... ................. .............. .............. .............. 4,872
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 33509]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
516.141--requires the 30 2 60 *.5 30
qualified expert panel
leader to maintain a copy of
the written report and all
notes or minutes relating to
panel deliberations that are
submitted to the requestor
for 2 years after the report
is submitted................
516.165--requires the holder 10 2 20 1 20
of an indexed drug to
maintain records of all
information pertinent to the
safety or effectiveness of
the indexed drug, from
foreign and domestic sources
----------------------------------------------------------------------------------
Total.................... ................. .............. .............. .............. 50
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
*30 minutes.
We based our estimates in tables 1 and 2 on our experience with the
MUMS indexing program and the requests for eligibility for indexing and
for addition to the index, as well as the periodic drug experience
reports submitted during the past 3 years. The burden has not changed
since the last OMB approval.
Dated: July 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15206 Filed 7-19-17; 8:45 am]
BILLING CODE 4164-01-P
