80 FR 24260 - Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 83 (April 30, 2015)

Page Range		24260-24261
FR Document		2015-10000

The Food and Drug Administration (FDA or ``we'') is announcing the availability of a risk assessment entitled ``Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products.'' The risk assessment is a tool to assist with reevaluating which animal drug residues should be included in milk testing programs. We undertook this project in response to a request from the National Conference on Interstate Milk Shipments (NCIMS).

Federal Register, Volume 80 Issue 83 (Thursday, April 30, 2015)

[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24260-24261]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-10000]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1305]

Multicriteria-Based Ranking Model for Risk Management of Animal
Drug Residues in Milk and Milk Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or ``we'') is announcing
the availability of a risk assessment entitled ``Multicriteria-Based
Ranking Model for Risk Management of Animal Drug Residues in Milk and
Milk Products.'' The risk assessment is a tool to assist with
reevaluating which animal drug residues should be included in milk
testing programs. We undertook this project in response to a request
from the National Conference on Interstate Milk Shipments (NCIMS).

DATES: Submit either electronic or written comments on the risk
assessment by July 29, 2015.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments on the risk assessment to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jane Van Doren, Center for Food Safety
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.

SUPPLEMENTARY INFORMATION:

I. Background

The NCIMS is a voluntary coalition that includes representatives
from

[[Page 24261]]

Federal and State governments, the dairy industry, academia, and
consumer groups. FDA collaborates with the NCIMS under a memorandum of
understanding between the two entities. The NCIMS requested that we
conduct an assessment of animal drug residues in the milk supply to
inform potential changes to milk testing program requirements. In
response, we developed a multicriteria-based ranking model of selected
animal drugs used in dairy cows. The risk assessment provides a
science-based, analytical approach to collate and incorporate relevant
available data and information (Ref. 1). It provides a decision-support
tool to assist with reevaluating which animal drug residues should be
included in milk testing programs. The risk assessment also may be used
to identify and prioritize research needs. The risk assessment model
approach has undergone an independent external peer review. FDA's
response to the peer review is available electronically on the FDA Web
site (Ref. 2).
The muticriteria-based ranking model is based on four overarching
criteria that collectively contribute to a drug's score and rank within
the group of drugs evaluated: (1) The likelihood that the drug will be
administered to lactating dairy cows; (2) the likelihood that,
following administration, drug residues would be present in milk (bulk
tank or bulk milk pickup tanker); (3) the relative extent to which
consumers could be exposed to the drug residue via consumption of milk
and milk products; and (4) the potential for a human health hazard
given exposure to the drug residue. The risk assessment describes the
ranking model structure, the scientific data and assumptions used to
inform scoring in the model, and the ranking results. The risk
assessment also identifies data gaps and research needs.
FDA invites comments that can help improve:
The ranking model approach, including the specific
criteria, scoring, and weighting scheme;
the scientific data and assumptions used to inform scoring
used in the model;
the selection of animal drugs evaluated; and
the clarity and the transparency of the risk assessment.

II. Comments

Interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES) regarding the risk assessment. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

III. Electronic Access

Persons with access to the Internet may obtain the risk assessment
at either http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm443549.htm or http://www.regulations.gov.

IV. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m. Monday through Friday, and
are available electronically at http://www.regulations.gov. (We have
verified the Web site addresses in this reference section, but we are
not responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)

1. U.S. Food and Drug Administration (2015). ``Multicriteria-
Based Ranking Model for Risk Management of Animal Drug Residues in
Milk and Milk Products.'' Accessible at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm443549.htm.
2. U.S. Food and Drug Administration (2015). ``Multicriteria-
Based Ranking Model for Risk Management of Animal Drug Residues in
Milk and Milk Products: Peer Review Report.'' Accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/default.htm.

Dated: April 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10000 Filed 4-29-15; 8:45 am]
BILLING CODE 4164-01-P

24260 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices

Biologics Price Competition and This guidance is being issued IV. Electronic Access
Innovation Act of 2009.’’ This guidance consistent with FDA’s good guidance Persons with access to the Internet
provides answers to common questions practices regulation (21 CFR 10.115). may obtain the document at http://
from sponsors interested in developing The guidance represents the Agency’s www.fda.gov/Drugs/Guidance
proposed biosimilar products, BLA current thinking on ‘‘Biosimilars: ComplianceRegulatoryInformation/
holders, and other interested parties Questions and Answers Regarding Guidances/default.htm, http://
regarding FDA’s interpretation of the Implementation of the Biologics Price www.fda.gov/BiologicsBloodVaccines/
BPCI Act. Competition and Innovation Act of GuidanceComplianceRegulatory
The BPCI Act, enacted as part of the 2009.’’ It does not create or confer any Information/default.htm, or http://
Patient Protection and Affordable Care rights for or on any person and does not www.regulations.gov.
Act (Pub. L. 111–148) on March 23, operate to bind FDA or the public. An
2010, created an abbreviated licensure Dated: April 24, 2015.
alternative approach may be used if
pathway under section 351(k) of the such approach satisfies the Peter Lurie,
Public Health Service Act (PHS Act) (42 requirements of the applicable statutes Associate Commissioner for Public Health
U.S.C. 262(k)) for biological products and regulations. Strategy and Analysis.
demonstrated to be biosimilar to, or [FR Doc. 2015–10064 Filed 4–29–15; 8:45 am]
interchangeable with, an FDA-licensed II. Comments BILLING CODE 4164–01–P
reference product. This guidance Interested persons may submit either
describes FDA’s current interpretation electronic comments regarding this
of certain statutory requirements added DEPARTMENT OF HEALTH AND
document to http://www.regulations.gov HUMAN SERVICES
by the BPCI Act and includes Q&As in
or written comments to the Division of
the following categories:
Dockets Management (see ADDRESSES). It Food and Drug Administration
• Biosimilarity or Interchangeability
is only necessary to send one set of
• Provisions Related to Requirement [Docket No. FDA–2015–N–1305]
comments. Identify comments with the
to Submit a BLA for a ‘‘Biological
docket number found in brackets in the
Product’’ Multicriteria-Based Ranking Model for
heading of this document. Received
• Exclusivity Risk Management of Animal Drug
comments may be seen in the Division Residues in Milk and Milk Products;
The Q&A format is intended to promote of Dockets Management between 9 a.m.
transparency and facilitate development Availability
and 4 p.m., Monday through Friday, and
programs for proposed biosimilar will be posted to the docket at http:// AGENCY: Food and Drug Administration,
products by addressing questions that www.regulations.gov. HHS.
may arise in the early stages of
development. In addition, these Q&As III. The Paperwork Reduction Act of ACTION: Notice.
respond to questions the Agency has 1995 SUMMARY: The Food and Drug
received from prospective BLA and new Administration (FDA or ‘‘we’’) is
drug application (NDA) applicants This guidance refers to information
collection provisions that are subject to announcing the availability of a risk
regarding the appropriate statutory assessment entitled ‘‘Multicriteria-Based
authority under which certain products review by the Office of Management and
Budget (OMB) under the Paperwork Ranking Model for Risk Management of
will be regulated. Animal Drug Residues in Milk and Milk
In the Federal Register of February Reduction Act (PRA) of 1995 (44 U.S.C.
3501–3520). The submission of an Products.’’ The risk assessment is a tool
15, 2012 (77 FR 8885), FDA published to assist with reevaluating which animal
a notice announcing the availability of investigational new drug application is
covered under 21 CFR part 312 and drug residues should be included in
a draft guidance entitled ‘‘Biosimilars: milk testing programs. We undertook
Questions and Answers Regarding approved under OMB control number
this project in response to a request
Implementation of the Biologics Price 0910–0014. The submission of an NDA
from the National Conference on
Competition and Innovation Act of is covered under 21 CFR 314.50 and
Interstate Milk Shipments (NCIMS).
2009.’’ Although interested parties can approved under OMB control number
0910–0001. The submission of a BLA DATES: Submit either electronic or
comment on any guidance at any time,
under section 351(a) of the PHS Act is written comments on the risk
to ensure that the Agency considered
covered under part 601 (21 CFR part assessment by July 29, 2015.
comments on the draft guidance before
beginning work on the final version of 601) and approved under OMB control ADDRESSES: Submit electronic
the guidance, FDA requested that number 0910–0338. The submission of comments to http://www.regulations.
interested parties submit comments by a BLA under section 351(k) of the PHS gov. Submit written comments on the
April 16, 2012. FDA’s consideration of Act is covered under part 601 and risk assessment to the Division of
these comments, among other things, is approved under OMB control number Dockets Management (HFA–305), Food
reflected in a revised draft guidance and 0910–0719. In the Federal Register of and Drug Administration, 5630 Fishers
this final guidance. This guidance April 1, 2013 (78 FR 19492), FDA Lane, Rm. 1061, Rockville, MD 20852.
describes the status of the draft published a notice announcing the FOR FURTHER INFORMATION CONTACT: Jane
guidance Q&As provided in Revision 1 availability of a draft guidance for Van Doren, Center for Food Safety and
of the draft guidance entitled industry entitled ‘‘Formal Meetings Applied Nutrition (HFS–005), Food and
Between the FDA and Biosimilar Drug Administration, 5100 Paint Branch
mstockstill on DSK4VPTVN1PROD with NOTICES

‘‘Biosimilars: Additional Questions and
Answers Regarding Implementation of Biological Product Sponsors or Pkwy., College Park, MD 20740, 240–
the Biologics Price Competition and Applicants.’’ The notice contained an 402–2927.
Innovation Act of 2009,’’ and the status analysis of the information collection SUPPLEMENTARY INFORMATION:
of the final guidance Q&As that are burden resulting from the draft
included in this guidance. FDA intends guidance, and will be submitted to OMB I. Background
to update these guidances to include for approval before issuance of the final The NCIMS is a voluntary coalition
additional Q&As as appropriate. guidance. that includes representatives from

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Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices 24261

Federal and State governments, the comments with the docket number (FDA). The meeting will be open to the
dairy industry, academia, and consumer found in brackets in the heading of this public.
groups. FDA collaborates with the document. Received comments may be Name of Committee: Risk
NCIMS under a memorandum of seen in the Division of Dockets Communications Advisory Committee.
understanding between the two entities. Management between 9 a.m. and 4 p.m., General Function of the Committee:
The NCIMS requested that we conduct Monday through Friday, and will be To provide advice and
an assessment of animal drug residues posted to the docket at http:// recommendations to the Agency on
in the milk supply to inform potential www.regulations.gov. FDA’s regulatory issues.
changes to milk testing program Date and Time: The meeting will be
requirements. In response, we III. Electronic Access held on June 8, 2015, from 9 a.m. to 5
developed a multicriteria-based ranking Persons with access to the Internet p.m. and June 9, 2015, from 9 a.m. to 12
model of selected animal drugs used in may obtain the risk assessment at either p.m.
dairy cows. The risk assessment http://www.fda.gov/Food/FoodScience Location: FDA White Oak Campus,
provides a science-based, analytical Research/RiskSafetyAssessment/ 10903 New Hampshire Ave., Bldg. 31
approach to collate and incorporate ucm443549.htm or http:// Conference Center, the Great Room (Rm.
relevant available data and information www.regulations.gov. 1503) Silver Spring, MD 20993–0002.
(Ref. 1). It provides a decision-support Answers to commonly asked questions
IV. References including information regarding special
tool to assist with reevaluating which
animal drug residues should be The following references have been accommodations due to a disability,
included in milk testing programs. The placed on display in the Division of visitor parking, and transportation may
risk assessment also may be used to Dockets Management (see ADDRESSES) be accessed at: http://www.fda.gov/
identify and prioritize research needs. and may be seen by interested persons AdvisoryCommittees/AboutAdvisory
The risk assessment model approach between 9 a.m. and 4 p.m. Monday Committees/ucm408555.htm.
has undergone an independent external through Friday, and are available Contact Person: Luis G. Bravo, Office
peer review. FDA’s response to the peer electronically at http://www.regulations. of Planning, Food and Drug
review is available electronically on the gov. (We have verified the Web site Administration, 10903 New Hampshire
FDA Web site (Ref. 2). addresses in this reference section, but Ave., Bldg. 32, Rm. 3367, 240–402–
The muticriteria-based ranking model we are not responsible for any 5274, FAX: 301–847–3540, RCAC@
is based on four overarching criteria that subsequent changes to the Web sites fda.hhs.gov, or FDA Advisory
collectively contribute to a drug’s score after this document publishes in the Committee Information Line, 1–800–
and rank within the group of drugs Federal Register.) 741–8138 (301–443–0572 in the
evaluated: (1) The likelihood that the Washington, DC area). A notice in the
1. U.S. Food and Drug Administration
drug will be administered to lactating (2015). ‘‘Multicriteria-Based Ranking Model Federal Register about last minute
dairy cows; (2) the likelihood that, for Risk Management of Animal Drug modifications that impact a previously
following administration, drug residues Residues in Milk and Milk Products.’’ announced advisory committee meeting
would be present in milk (bulk tank or Accessible at http://www.fda.gov/Food/ cannot always be published quickly
FoodScienceResearch/RiskSafety enough to provide timely notice.
bulk milk pickup tanker); (3) the relative
Assessment/ucm443549.htm. Therefore, you should always check the
extent to which consumers could be 2. U.S. Food and Drug Administration
exposed to the drug residue via Agency’s Web site at http://
(2015). ‘‘Multicriteria-Based Ranking Model www.fda.gov/AdvisoryCommittees.htm
consumption of milk and milk products; for Risk Management of Animal Drug
and (4) the potential for a human health Residues in Milk and Milk Products: Peer
and scroll down to the appropriate
hazard given exposure to the drug Review Report.’’ Accessible at http:// advisory committee meeting link, or call
residue. The risk assessment describes www.fda.gov/ScienceResearch/ the advisory committee information line
the ranking model structure, the SpecialTopics/PeerReviewof to learn about possible modifications
scientific data and assumptions used to ScientificInformationandAssessments/ before coming to the meeting.
inform scoring in the model, and the
default.htm. If you are unable to join us in person,
ranking results. The risk assessment also Dated: April 20, 2015. we encourage you to watch the free
identifies data gaps and research needs. Leslie Kux, Webcast. Visit the Risk Communication
FDA invites comments that can help Advisory Committee Web site at
Associate Commissioner for Policy.
improve: http://www.fda.gov/
[FR Doc. 2015–10000 Filed 4–29–15; 8:45 am]
• The ranking model approach, AdvisoryCommittees/
BILLING CODE 4164–01–P
including the specific criteria, scoring, RiskCommunicationAdvisory
and weighting scheme; Committee.htm. The link will become
• the scientific data and assumptions DEPARTMENT OF HEALTH AND
active shortly before the open session
used to inform scoring used in the begins at 9 a.m.
HUMAN SERVICES Agenda: On June 8 and 9, 2015, the
model;
• the selection of animal drugs Food and Drug Administration Committee will discuss approaches to
evaluated; and communicating information about fetal
• the clarity and the transparency of [Docket No. FDA–2015–N–0001] effects in product labeling for
the risk assessment. methadone or buprenorphine
Risk Communications Advisory maintenance therapy for opioid
II. Comments Committee; Notice of Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES

addiction, and about the maternal
Interested persons may submit either AGENCY: Food and Drug Administration, benefits and risks of treatment, to best
electronic comments to http:// HHS. enable patients and health care
www.regulations.gov or written ACTION: Notice. providers to make informed decisions
comments to the Division of Dockets about the use of these drugs during
Management (see ADDRESSES) regarding This notice announces a forthcoming pregnancy.
the risk assessment. It is only necessary meeting of a public advisory committee FDA intends to make background
to send one set of comments. Identify of the Food and Drug Administration material available to the public no later

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Document Created: 2018-02-21 10:15:14
Document Modified: 2018-02-21 10:15:14

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		Submit either electronic or written comments on the risk assessment by July 29, 2015.
Contact		Jane Van Doren, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.
FR Citation		80 FR 24260

80 FR 24260 - Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 83 (April 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration