82 FR 33507 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 138 (July 20, 2017)

Page Range		33507-33509
FR Document		2017-15206

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.

Federal Register, Volume 82 Issue 138 (Thursday, July 20, 2017)

[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33507-33509]
From the Federal Register Online  [www.thefederalregister.org]
[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 [email protected]. 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

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices 33507

https://www.fda.gov/Drugs/NewsEvents/ represent his/her organization. This will reaches maximum capacity, FDA will
UCM559090.htm. Registration requests help ensure that the meeting will have post a notice closing registration for the
for each meeting should be received broad and varied representation, meeting on FDA’s Web site at https://
during the time periods specified in including across the pharmaceutical www.fda.gov/Drugs/NewsEvents/
table 1. FDA is limiting attendance due distribution supply chain. Registrants UCM559090.htm. If you need special
to restricted space. In addition, FDA will receive confirmation of accommodations due to a disability,
may limit the number of participants participation for their chosen meeting please contact Daniel Bellingham (see
from each organization based on space from FDA within 14 days of the date of FOR FURTHER INFORMATION CONTACT) at
limitations. FDA recommends that each each meeting. There is no registration least 7 days in advance of the public
organization determine who should fee for the public meetings. There will meeting.
register for the public meeting to be no onsite registration. If registration

TABLE 1—PUBLIC MEETING INFORMATION
Relevant section of this document or
Public meeting Topics Date/Time electronic address

# 1 .......................... • Supply chain security in 2023 ........... August 23, 2017, 9 a.m. to 4 p.m.
• Enhanced drug distribution security
needs.
Advance registration ............................. by July 31, 2017 ................................... Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registra-
tion.
Comment period closes ........................ September 22, 2017 ............................. See ‘‘Comments’’.
Request special accommodations due by August 16, 2017 .............................. See FOR FURTHER INFORMATION
to a disability. CONTACT.
# 2 .......................... • Electronic interoperability .................. December 5–6, 2017, 9 a.m. to 4 p.m.
• Standards for data exchange ...........
• Data architecture ...............................
• Aggregation and inference.
Advance registration ............................. October 2–27, 2017 .............................. Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registra-
tion.
Comment period closes ........................ January 5, 2018 .................................... See ‘‘Comments’’.
Request special accommodations due by November 28, 2017 ......................... See FOR FURTHER INFORMATION
to a disability. CONTACT.
# 3 .......................... • Further refinement of enhanced drug February 28, 2018, 9 a.m. to 4 p.m.
distribution security needs.
• Building capacity for a unit-level sys-
tem.
Advance registration ............................. January 2–26, 2018 .............................. Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registra-
tion.
Comment period closes ........................ March 30, 2018 ..................................... See ‘‘Comments’’.
Request special accommodations due by February 21, 2018 ........................... See FOR FURTHER INFORMATION
to a disability. CONTACT.

IV. Webcasting of the Public Meeting DEPARTMENT OF HEALTH AND Office of Management and Budget
HUMAN SERVICES (OMB) for review and clearance under
Portions of each public meeting will the Paperwork Reduction Act of 1995.
be recorded and webcast on the day of Food and Drug Administration
the meeting. Information for how to DATES: Fax written comments on the
access the webcast will be available at [Docket No. FDA–2010–N–0597] collection of information by August 21,
https://www.fda.gov/Drugs/NewsEvents/ 2017.
Agency Information Collection
UCM559090.htm within 7 days prior to Activities; Submission for Office of ADDRESSES: To ensure that comments on
each public meeting. The webcast will Management and Budget Review; the information collection are received,
be conducted in listening mode only. Comment Request; Index of Legally OMB recommends that written
Dated: July 14, 2017. Marketed Unapproved New Animal comments be faxed to the Office of
Anna K. Abram, Drugs for Minor Species Information and Regulatory Affairs,
asabaliauskas on DSKBBXCHB2PROD with NOTICES

Deputy Commissioner for Policy, Planning, OMB, Attn: FDA Desk Officer, FAX:
AGENCY: Food and Drug Administration,
Legislation, and Analysis. 202–395–7285, or emailed to oira_
HHS.
[FR Doc. 2017–15204 Filed 7–19–17; 8:45 am] submission@omb.eop.gov. All
ACTION: Notice. comments should be identified with the
BILLING CODE 4164–01–P
SUMMARY: The Food and Drug OMB control number 0910–0620. Also
Administration (FDA) is announcing include the FDA docket number found
that a proposed collection of in brackets in the heading of this
information has been submitted to the document.

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33508 Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices

FOR FURTHER INFORMATION CONTACT: Ila new animal drugs. Congress recognized requesting addition to the index, as well
S. Mizrachi, Office of Operations, Food that the markets for drugs intended to as the annual reporting requirements for
and Drug Administration, Three White treat these species, diseases, or index holders. The administrative
Flint North, 10A63, 11601 Landsdown conditions are so small that there are procedures and criteria for indexing a
St., North Bethesda, MD 20852, 301– often insufficient economic incentives new animal drug for use in a minor
796–7726. to motivate drug companies to develop species are set forth in 21 CFR 516.111
data to support approvals. Further, through 516.171. Section 516.165 sets
SUPPLEMENTARY INFORMATION: In
Congress recognized that some minor forth the annual reporting requirements
compliance with 44 U.S.C. 3507, FDA species populations are too small or
has submitted the following proposed for index holders. FDA needs the
their management systems too diverse to information to determine: (1) The
collection of information to OMB for make it practical to conduct traditional
review and clearance. Index of Legally eligibility of a new animal drug for
studies to demonstrate safety and indexing; (2) that a qualified expert
Marketed Unapproved New Animal effectiveness of animal drugs for such
Drugs for Minor Species—21 CFR part panel proposed to review certain
uses. As a result of these limitations, information regarding the new animal
516 OMB Control Number 0910–0620— drug companies have generally not been
Extension drug meets the selection criteria listed
willing or able to collect data to support in the regulations; (3) whether the
The Minor Use and Minor Species legal marketing of drugs for these Agency agrees with the
Animal Health Act of 2004 (the MUMS species, diseases, or conditions. recommendation of a qualified expert
Act) (Pub. L. 108–282) added section Consequently, Congress enacted the panel that a drug be added to the index;
572 of the Federal Food, Drug, and MUMS Act to provide incentives to and (4) whether there may be grounds
Cosmetic Act (the FD&C Act) (21 U.S.C. develop new animal drugs for minor for removing a drug from the index.
360ccc-1), which authorizes FDA to species, while still ensuring appropriate
establish new regulatory procedures safeguards for animal and human In the Federal Register of December
intended to make more medications health. Section 572 of the FD&C Act 21, 2016 (81 FR 93689), FDA published
legally available to veterinarians and provides for a public index listing of a 60-day notice requesting public
animal owners for the treatment of legally marketed unapproved new comment on the proposed collection of
minor animal species (species other animal drugs for minor species. FDA information. FDA received one
than cattle, horses, swine, chickens, regulations in part 516 (21 CFR part comment, which was outside the scope
turkeys, dogs, and cats). In enacting the 516) specify, among other things, the of the comment requests in the notice.
MUMS Act, Congress sought to criteria and procedures for requesting FDA estimates the burden of this
encourage the development of these eligibility for indexing and for collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

516.119—requires a foreign drug company to submit
and update the name and address of a permanent
U.S. resident agent .................................................... 2 1 2 1 2
516.121—written request for a meeting with FDA to
discuss the requirements for indexing a new animal
drug ............................................................................ 30 2 60 4 240
516.123—written request for an informal conference
and a requestor’s written response to an FDA initial
decision denying a request ........................................ 3 1 3 8 24
516.125—correspondence and information associated
with investigational use of new animal drugs in-
tended for indexing ..................................................... 2 3 6 20 120
516.129—content and format of a request for deter-
mination of eligibility for indexing ............................... 30 2 60 20 1,200
516.141—information to be submitted to FDA by a re-
questor seeking to establish a qualified expert panel 20 1 20 16 320
516.143—content and format of the written report of
the qualified expert panel ........................................... 20 1 20 120 2,400
516.145—content and format of a request for addition
to the Index ................................................................ 20 1 20 20 400
516.161—content and format of a request for modifica-
tion of an indexed drug .............................................. 1 1 1 4 4
516.163—information to be contained in a request to
FDA to transfer ownership of a drug’s index file to
asabaliauskas on DSKBBXCHB2PROD with NOTICES

another person ........................................................... 1 1 1 2 2
516.165—requires drug experience reports and dis-
tributor statements to be submitted to FDA ............... 10 2 20 8 160

Total ........................................................................ .............................. ........................ ........................ ........................ 4,872
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices 33509

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average bur-
Number of record- Total annual
21 CFR Section records per den per rec- Total hours
keepers records
recordkeeper ordkeeping

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 sub-
mitted to the requestor for 2 years after the report is
submitted .................................................................... 30 2 60 *.5 30
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 for-
eign and domestic sources ........................................ 10 2 20 1 20

Total ........................................................................ .............................. ........................ ........................ ........................ 50
1 Thereare no capital costs or operating and maintenance costs associated with this collection of information.
*30 minutes.

We based our estimates in tables 1 (FEMA) has provided to the affected SUPPLEMENTARY INFORMATION: FEMA
and 2 on our experience with the communities. The FIRM and FIS report proposes to make flood hazard
MUMS indexing program and the are the basis of the floodplain determinations for each community
requests for eligibility for indexing and management measures that the listed below, in accordance with section
for addition to the index, as well as the community is required either to adopt 110 of the Flood Disaster Protection Act
periodic drug experience reports or to show evidence of having in effect of 1973, 42 U.S.C. 4104, and 44 CFR
submitted during the past 3 years. The an order to qualify or remain qualified 67.4(a).
burden has not changed since the last for participation in the National Flood These proposed flood hazard
OMB approval. Insurance Program (NFIP). In addition, determinations, together with the
Dated: July 13, 2017. the FIRM and FIS report, once effective, floodplain management criteria required
Anna K. Abram,
will be used by insurance agents and by 44 CFR 60.3, are the minimum that
others to calculate appropriate flood are required. They should not be
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
insurance premium rates for new construed to mean that the community
buildings and the contents of those must change any existing ordinances
[FR Doc. 2017–15206 Filed 7–19–17; 8:45 am]
buildings. that are more stringent in their
BILLING CODE 4164–01–P
floodplain management requirements.
DATES: Comments are to be submitted The community may at any time enact
on or before October 18, 2017. stricter requirements of its own or
DEPARTMENT OF HOMELAND pursuant to policies established by other
ADDRESSES: The Preliminary FIRM, and
SECURITY Federal, State, or regional entities.
where applicable, the FIS report for
each community are available for These flood hazard determinations are
Federal Emergency Management
inspection at both the online location used to meet the floodplain
Agency
and the respective Community Map management requirements of the NFIP
[Docket ID FEMA–2017–0002; Internal Repository address listed in the tables and also are used to calculate the
Agency Docket No. FEMA–B–1724] below. Additionally, the current appropriate flood insurance premium
effective FIRM and FIS report for each rates for new buildings built after the
Proposed Flood Hazard FIRM and FIS report become effective.
community are accessible online
Determinations The communities affected by the
through the FEMA Map Service Center
AGENCY: Federal Emergency at www.msc.fema.gov for comparison. flood hazard determinations are
Management Agency, DHS. provided in the tables below. Any
You may submit comments, identified
ACTION: Notice. request for reconsideration of the
by Docket No. FEMA–B–1724, to Rick
revised flood hazard information shown
Sacbibit, Chief, Engineering Services
SUMMARY: Comments are requested on on the Preliminary FIRM and FIS report
Branch, Federal Insurance and
proposed flood hazard determinations, that satisfies the data requirements
Mitigation Administration, FEMA, 400
which may include additions or outlined in 44 CFR 67.6(b) is considered
C Street SW., Washington, DC 20472,
modifications of any Base Flood an appeal. Comments unrelated to the
(202) 646–7659, or (email)
Elevation (BFE), base flood depth, flood hazard determinations also will be
patrick.sacbibit@fema.dhs.gov.
Special Flood Hazard Area (SFHA) considered before the FIRM and FIS
boundary or zone designation, or FOR FURTHER INFORMATION CONTACT: Rick report become effective.
regulatory floodway on the Flood Sacbibit, Chief, Engineering Services Use of a Scientific Resolution Panel
asabaliauskas on DSKBBXCHB2PROD with NOTICES

Insurance Rate Maps (FIRMs), and Branch, Federal Insurance and (SRP) is available to communities in
where applicable, in the supporting Mitigation Administration, FEMA, 400 support of the appeal resolution
Flood Insurance Study (FIS) reports for C Street SW., Washington, DC 20472, process. SRPs are independent panels of
the communities listed in the table (202) 646–7659, or (email) experts in hydrology, hydraulics, and
below. The purpose of this notice is to patrick.sacbibit@fema.dhs.gov; or visit other pertinent sciences established to
seek general information and comment the FEMA Map Information eXchange review conflicting scientific and
regarding the preliminary FIRM, and (FMIX) online at technical data and provide
where applicable, the FIS report that the www.floodmaps.fema.gov/fhm/fmx_ recommendations for resolution. Use of
Federal Emergency Management Agency main.html. the SRP only may be exercised after

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Document Created: 2017-07-20 06:57:45
Document Modified: 2017-07-20 06:57:45

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by August 21, 2017.
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.
FR Citation		82 FR 33507

82 FR 33507 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 138 (July 20, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration