80 FR 50638 - Collecting On-Farm Antimicrobial Use and Resistance Data; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 161 (August 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 161 (August 20, 2015)
| Page Range | 50638-50639 | |
| FR Document | 2015-20557 |
[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)] [Notices] [Pages 50638-50639] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20557] [[Page 50638]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2768] Collecting On-Farm Antimicrobial Use and Resistance Data; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- The Food and Drug Administration (FDA), in collaboration with the U.S. Department of Agriculture (USDA) and the Centers for Disease Control and Prevention (CDC), is announcing plans for a jointly sponsored public meeting to obtain public input on possible approaches for collecting additional on-farm antimicrobial drug use and resistance data. Such data are important for assessing the impact of measures being implemented to foster the judicious use of medically important antimicrobial drugs in food-producing animals. Date and Time: The public meeting will be held September 30, 2015, from 8 a.m. to 4:30 p.m. Although you can comment on the interagency plan for collecting on-farm antimicrobial drug use and resistance data at any time, to ensure that the Agencies consider your comment before updating this plan, submit either electronic or written comments by November 30, 2015. Location: The public meeting will be held in the USDA Jefferson Auditorium (South Building), 1400 Independence Avenue SW., Washington, DC 20250. Please arrive between 7 a.m. and 7:30 a.m. to provide time to get through security. Attendees must provide a valid government issued photo ID (Driver's License, Identification Card, or Passport) to enter the facility. Attendees should enter the building via Wing 5 on the Independence Avenue side of the building. The South Building is accessible by the Smithsonian Metro station (exit Metro station through the ``Independence Avenue Exit'' and walk toward 15th Street on Independence Avenue to reach Wing 5). For more information on directions and parking, visit http://smithsonianassociates.org/ticketing/help/locations/jefferson.htm. Contact Person: Kelly Covington, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5661, FAX: 240-276-9020, email: [email protected]. Registration and Requests for Oral Presentations: Registration is required for this public meeting. Please send registration information (including name, title, organization, address, telephone and fax numbers) by email to [email protected] by September 18, 2015. There is no fee to register for the public meeting, and registration will be on a first-come, first-served basis. If you need special accommodations due to a disability, please contact Kelly Covington (see Contact Person) at least 7 days in advance. Oral presentations can be made by members of the public during the open public comment period of the public meeting. These presentations will be scheduled between approximately 3 p.m. and 4 p.m. on September 30, 2015. Those persons desiring to make an oral presentation should notify the contact person listed in this notice by September 16, 2015, and submit a brief statement of the general nature of information they wish to present. In an effort to accommodate all who desire to speak, time allotted for each presentation may be limited. The contact person will inform each speaker prior to the meeting of the time they are scheduled to speak. Comments: Regardless of attendance at the public meeting, interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, by (see Date and Time). 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. SUPPLEMENTARY INFORMATION: I. Background Antimicrobial drugs have been widely used in human and veterinary medicine for more than 50 years, with tremendous benefits to both human and animal health. The development of resistance to this important class of drugs, and the resulting loss of their effectiveness as antimicrobial therapies, poses a serious threat to public and animal health. Because antimicrobial drug use can contribute to the emergence of drug-resistant organisms, these important drugs must be used judiciously in both animal and human medicine to slow the development of resistance. In December 2013, FDA published Guidance for Industry (GFI) #213 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), which calls on animal drug sponsors of approved medically important antimicrobials administered through medicated feed or water to voluntarily remove production (growth promotion and feed efficiency) uses from their product labels, and bring the remaining therapeutic uses of these products (to treat, control, or prevent disease) under the oversight of a veterinarian by the end of December 2016. All 25 affected drug sponsors have committed to implementing the changes described in GFI #213 by the December 2016 target date. Once the changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, and animal producers will need to obtain authorization from a licensed veterinarian to use them for prevention, control, or treatment of a specifically identified disease. On March 27, 2015, the White House released the National Action Plan for Combating Antibiotic-resistant Bacteria (``National Action Plan'') (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf). Developed in response to Executive Order 13676, which was issued by President Barack Obama on September 18, 2014, the National Action Plan is intended to guide the activities of the U.S. Government as well as the actions of public health, health care, and veterinary partners in a common effort to address the urgent and serious public health threat of drug-resistant bacterial infections. Objective 2.4 of the National Action Plan is to enhance monitoring of antibiotic resistance patterns, as well as antibiotic sales, usage, and management practices, at multiple points in the production chain for food animals and retail meat. The public meeting being announced in this Federal Register notice is consistent with Sub-Objective 2.4.3 of the National Action Plan, which calls for the USDA and FDA to seek public input on a plan for collecting drug use and resistance data on farms. In April 2015, USDA's Animal and Plant Health Inspection Service published an Info Sheet entitled ``Proposed Initiatives From the USDA Antimicrobial Resistance Action Plan'' (http://www.aphis.usda.gov/animal_health/nahms/amr/downloads/ProposedInitiatives.pdf). The Info Sheet provides a brief synopsis of initiatives [[Page 50639]] proposed in the USDA Action plan, including a number of initiatives related to collecting on-farm antibiotic use and resistance data. Gathering information on the way medically important antimicrobials are used in food-producing animals is essential to measuring the impact of the FDA's GFI #213. FDA is collaborating with USDA and CDC to develop a plan for collecting additional on-farm data on antimicrobial use and resistance. Such data are intended to supplement existing information, including data on the quantity of antimicrobials sold or distributed for use in food-producing animals (reported under section 105 of the Animal Drug User Fee Amendments of 2008) and data on antimicrobial resistance (e.g., collected under the National Antimicrobial Resistance Monitoring System and the National Animal Health Monitoring System). Data from multiple sources are needed to provide a comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture. A data collection plan is needed to obtain additional information necessary to: (1) Assess the rate of adoption of changes outlined in the FDA's GFI #213; (2) help gauge the success of antibiotic stewardship efforts and guide their continued evolution and optimization; and (3) assess associations between antibiotic use practices and resistance. FDA is continuing to work with the USDA and CDC in developing this plan, and is holding this public meeting in order to obtain input from the public. This meeting is the first opportunity for public input as part of our ongoing effort to develop and implement plans for collecting additional on-farm antimicrobial drug use and resistance data. II. Agenda The public meeting will provide an opportunity for public comment on possible approaches for collecting additional antimicrobial drug use data. The final agenda for the public meeting will be made available on the Agency's Web site at http://www.fda.gov/AnimalVeterinary/NewsEvents/WorkshopsConferencesMeetings/ucm456380.htm no later than 2 weeks prior to the meeting. III. Transcript FDA will prepare a meeting transcript and make it available on the Agency's Web site (see section II) after the meeting. FDA anticipates that the transcript will be available approximately 60 business days after the meeting. A copy of the transcript will be available for public examination at the Division of Dockets Management (see Comments) between 9 a.m. and 4 p.m., Monday through Friday. In addition, copies of the transcript will be available in either hardcopy or on CD-ROM after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. Dated: August 14, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-20557 Filed 8-19-15; 8:45 am] BILLING CODE 4164-01-P
![50638 Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Notices
DEPARTMENT OF HEALTH AND for this public meeting. Please send In December 2013, FDA published
HUMAN SERVICES registration information (including Guidance for Industry (GFI) #213
name, title, organization, address, (http://www.fda.gov/downloads/
Food and Drug Administration telephone and fax numbers) by email to AnimalVeterinary/
[Docket No. FDA–2015–N–2768] Kelly.Covington@fda.hhs.gov by GuidanceComplianceEnforcement/
September 18, 2015. There is no fee to GuidanceforIndustry/UCM299624.pdf),
Collecting On-Farm Antimicrobial Use register for the public meeting, and which calls on animal drug sponsors of
and Resistance Data; Public Meeting; registration will be on a first-come, first- approved medically important
Request for Comments served basis. If you need special antimicrobials administered through
accommodations due to a disability, medicated feed or water to voluntarily
AGENCY: Food and Drug Administration, please contact Kelly Covington (see remove production (growth promotion
HHS. Contact Person) at least 7 days in and feed efficiency) uses from their
ACTION: Notice of public meeting; advance. product labels, and bring the remaining
request for comments. Oral presentations can be made by therapeutic uses of these products (to
members of the public during the open treat, control, or prevent disease) under
The Food and Drug Administration the oversight of a veterinarian by the
(FDA), in collaboration with the U.S. public comment period of the public
meeting. These presentations will be end of December 2016. All 25 affected
Department of Agriculture (USDA) and drug sponsors have committed to
the Centers for Disease Control and scheduled between approximately 3
p.m. and 4 p.m. on September 30, 2015. implementing the changes described in
Prevention (CDC), is announcing plans GFI #213 by the December 2016 target
for a jointly sponsored public meeting to Those persons desiring to make an oral
presentation should notify the contact date. Once the changes are fully
obtain public input on possible implemented, it will be illegal to use
approaches for collecting additional on- person listed in this notice by
September 16, 2015, and submit a brief these medically important antibiotics
farm antimicrobial drug use and for production purposes, and animal
resistance data. Such data are important statement of the general nature of
producers will need to obtain
for assessing the impact of measures information they wish to present. In an
authorization from a licensed
being implemented to foster the effort to accommodate all who desire to
veterinarian to use them for prevention,
judicious use of medically important speak, time allotted for each
control, or treatment of a specifically
antimicrobial drugs in food-producing presentation may be limited. The
identified disease.
animals. contact person will inform each speaker On March 27, 2015, the White House
Date and Time: The public meeting prior to the meeting of the time they are released the National Action Plan for
will be held September 30, 2015, from scheduled to speak. Combating Antibiotic-resistant Bacteria
8 a.m. to 4:30 p.m. Although you can Comments: Regardless of attendance (‘‘National Action Plan’’) (https://
comment on the interagency plan for at the public meeting, interested persons www.whitehouse.gov/sites/default/files/
collecting on-farm antimicrobial drug may submit either electronic comments docs/national_action_plan_for_
use and resistance data at any time, to to http://www.regulations.gov or written combating_antibotic-resistant_
ensure that the Agencies consider your comments to the Division of Dockets bacteria.pdf). Developed in response to
comment before updating this plan, Management (HFA–305), Food and Drug Executive Order 13676, which was
submit either electronic or written Administration, 5630 Fishers Lane, Rm. issued by President Barack Obama on
comments by November 30, 2015. 1061, Rockville, MD 20852, by (see Date September 18, 2014, the National Action
Location: The public meeting will be and Time). It is only necessary to send Plan is intended to guide the activities
held in the USDA Jefferson Auditorium one set of comments. Identify comments of the U.S. Government as well as the
(South Building), 1400 Independence with the docket number found in actions of public health, health care,
Avenue SW., Washington, DC 20250. brackets in the heading of this and veterinary partners in a common
Please arrive between 7 a.m. and 7:30 document. Received comments may be effort to address the urgent and serious
a.m. to provide time to get through seen in the Division of Dockets public health threat of drug-resistant
security. Attendees must provide a valid Management between 9 a.m. and 4 p.m., bacterial infections. Objective 2.4 of the
government issued photo ID (Driver’s Monday through Friday, and will be National Action Plan is to enhance
License, Identification Card, or posted to the docket at http:// monitoring of antibiotic resistance
Passport) to enter the facility. Attendees www.regulations.gov. patterns, as well as antibiotic sales,
should enter the building via Wing 5 on usage, and management practices, at
the Independence Avenue side of the SUPPLEMENTARY INFORMATION: multiple points in the production chain
building. The South Building is I. Background for food animals and retail meat. The
accessible by the Smithsonian Metro public meeting being announced in this
station (exit Metro station through the Antimicrobial drugs have been widely Federal Register notice is consistent
‘‘Independence Avenue Exit’’ and walk used in human and veterinary medicine with Sub-Objective 2.4.3 of the National
toward 15th Street on Independence for more than 50 years, with tremendous Action Plan, which calls for the USDA
Avenue to reach Wing 5). For more benefits to both human and animal and FDA to seek public input on a plan
information on directions and parking, health. The development of resistance to for collecting drug use and resistance
visit http://smithsonianassociates.org/ this important class of drugs, and the data on farms.
ticketing/help/locations/jefferson.htm. resulting loss of their effectiveness as In April 2015, USDA’s Animal and
Contact Person: Kelly Covington, antimicrobial therapies, poses a serious Plant Health Inspection Service
tkelley on DSK3SPTVN1PROD with NOTICES
Center for Veterinary Medicine (HFV– threat to public and animal health. published an Info Sheet entitled
6), Food and Drug Administration, 7519 Because antimicrobial drug use can ‘‘Proposed Initiatives From the USDA
Standish Pl., Rockville, MD 20855, 240– contribute to the emergence of drug- Antimicrobial Resistance Action Plan’’
402–5661, FAX: 240–276–9020, email: resistant organisms, these important (http://www.aphis.usda.gov/animal_
Kelly.Covington@fda.hhs.gov. drugs must be used judiciously in both health/nahms/amr/downloads/
Registration and Requests for Oral animal and human medicine to slow the ProposedInitiatives.pdf). The Info Sheet
Presentations: Registration is required development of resistance. provides a brief synopsis of initiatives
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![Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Notices 50639
proposed in the USDA Action plan, the meeting. A copy of the transcript 741–8138 (301–443–0572 in the
including a number of initiatives related will be available for public examination Washington, DC area). A notice in the
to collecting on-farm antibiotic use and at the Division of Dockets Management Federal Register about last minute
resistance data. (see Comments) between 9 a.m. and 4 modifications that impact a previously
Gathering information on the way p.m., Monday through Friday. In announced advisory committee meeting
medically important antimicrobials are addition, copies of the transcript will be cannot always be published quickly
used in food-producing animals is available in either hardcopy or on CD– enough to provide timely notice.
essential to measuring the impact of the ROM after submission of a Freedom of Therefore, you should always check the
FDA’s GFI #213. FDA is collaborating Information request. The Freedom of Agency’s Web site at http://
with USDA and CDC to develop a plan Information office address is available www.fda.gov/AdvisoryCommittees/
for collecting additional on-farm data on on the Agency’s Web site at http:// default.htm and scroll down to the
antimicrobial use and resistance. Such www.fda.gov. appropriate advisory committee meeting
data are intended to supplement link, or call the advisory committee
Dated: August 14, 2015.
existing information, including data on information line to learn about possible
the quantity of antimicrobials sold or Leslie Kux,
modifications before coming to the
distributed for use in food-producing Associate Commissioner for Policy. meeting.
animals (reported under section 105 of [FR Doc. 2015–20557 Filed 8–19–15; 8:45 am] Agenda: The committee will discuss
the Animal Drug User Fee Amendments BILLING CODE 4164–01–P new drug application (NDA) 207959,
of 2008) and data on antimicrobial enclomiphene citrate 12.5 milligram
resistance (e.g., collected under the (mg) and 25 mg capsules, submitted by
National Antimicrobial Resistance DEPARTMENT OF HEALTH AND Repros Therapeutics, Inc., for the
Monitoring System and the National HUMAN SERVICES proposed treatment of secondary
Animal Health Monitoring System). hypogonadism in fertile men (men with
Data from multiple sources are needed Food and Drug Administration more than 15 million sperm/milliliter
to provide a comprehensive and [Docket No. FDA–2015–N–0001] (ml)), younger than 60 years of age with
science-based picture of antimicrobial a Body Mass Index (BMI) over 25
drug use and resistance in animal Bone, Reproductive, and Urologic kilograms (kg)/meters squared (m2).
agriculture. Drugs Advisory Committee; Notice of FDA intends to make background
A data collection plan is needed to Meeting material available to the public no later
obtain additional information necessary than 2 business days before the meeting.
to: (1) Assess the rate of adoption of AGENCY: Food and Drug Administration, If FDA is unable to post the background
changes outlined in the FDA’s GFI #213; HHS. material on its Web site prior to the
(2) help gauge the success of antibiotic ACTION: Notice. meeting, the background material will
stewardship efforts and guide their be made publicly available at the
This notice announces a forthcoming location of the advisory committee
continued evolution and optimization;
meeting of a public advisory committee meeting and the background material
and (3) assess associations between
of the Food and Drug Administration will be posted on FDA’s Web site after
antibiotic use practices and resistance.
(FDA). The meeting will be open to the the meeting. Background material is
FDA is continuing to work with the
public. available at http://www.fda.gov/
USDA and CDC in developing this plan,
Name of Committee: Bone, AdvisoryCommittees/Calendar/
and is holding this public meeting in
Reproductive, and Urologic Drugs default.htm. Scroll down to the
order to obtain input from the public.
Advisory Committee. appropriate advisory committee meeting
This meeting is the first opportunity for
General Function of the Committee: link.
public input as part of our ongoing
To provide advice and Procedure: Interested persons may
effort to develop and implement plans
recommendations to the Agency on present data, information, or views,
for collecting additional on-farm
FDA’s regulatory issues. orally or in writing, on issues pending
antimicrobial drug use and resistance
Date and Time: The meeting will be before the committee. Written
data.
held on November 3, 2015, from 8:30 submissions may be made to the contact
II. Agenda a.m. to 5 p.m. person on or before October 20, 2015.
The public meeting will provide an Location: FDA White Oak Campus, Oral presentations from the public will
opportunity for public comment on 10903 New Hampshire Ave., Bldg. 31 be scheduled between approximately 1
possible approaches for collecting Conference Center, the Great Room (rm. p.m. and 2 p.m. Those individuals
additional antimicrobial drug use data. 1503), Silver Spring, MD 20993–0002. interested in making formal oral
The final agenda for the public meeting Answers to commonly asked questions presentations should notify the contact
will be made available on the Agency’s including information regarding special person and submit a brief statement of
Web site at accommodations due to a disability, the general nature of the evidence or
http://www.fda.gov/ visitor parking, and transportation may arguments they wish to present, the
AnimalVeterinary/NewsEvents/ be accessed at: http://www.fda.gov/ names and addresses of proposed
WorkshopsConferencesMeetings/ AdvisoryCommittees/ participants, and an indication of the
ucm456380.htm no later than 2 weeks AboutAdvisoryCommittees/ approximate time requested to make
prior to the meeting. ucm408555.htm. their presentation on or before October
Contact Person: Kalyani Bhatt, Center 9, 2015. Time allotted for each
III. Transcript
tkelley on DSK3SPTVN1PROD with NOTICES
for Drug Evaluation and Research, Food presentation may be limited. If the
FDA will prepare a meeting transcript and Drug Administration, 10903 New number of registrants requesting to
and make it available on the Agency’s Hampshire Ave., Bldg. 31, Rm. 2417, speak is greater than can be reasonably
Web site (see section II) after the Silver Spring, MD 20993–0002, 301– accommodated during the scheduled
meeting. FDA anticipates that the 796–9001, FAX: 301–847–8533, email: open public hearing session, FDA may
transcript will be available BRUDAC@fda.hhs.gov, or FDA Advisory conduct a lottery to determine the
approximately 60 business days after Committee Information Line, 1–800– speakers for the scheduled open public
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Document Created: 2015-12-15 11:08:27
Document Modified: 2015-12-15 11:08:27
| 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 of public meeting; request for comments. | |
| FR Citation | 80 FR 50638 |
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