Risk Communications Advisory Committee; Notice of Meeting, 24261-24262 [2015-10024]

Download as PDF Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES 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 https:// 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 VerDate Sep<11>2014 17:01 Apr 29, 2015 Jkt 235001 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 https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the risk assessment at either https://www.fda.gov/Food/FoodScience Research/RiskSafetyAssessment/ ucm443549.htm or https:// 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 https://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 https://www.fda.gov/Food/ FoodScienceResearch/RiskSafety Assessment/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 https:// www.fda.gov/ScienceResearch/ SpecialTopics/PeerReviewof ScientificInformationandAssessments/ 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 24261 (FDA). The meeting will be open to the public. Name of Committee: Risk Communications Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on June 8, 2015, from 9 a.m. to 5 p.m. and June 9, 2015, from 9 a.m. to 12 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503) Silver Spring, MD 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. Contact Person: Luis G. Bravo, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3367, 240–402– 5274, FAX: 301–847–3540, RCAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. If you are unable to join us in person, we encourage you to watch the free Webcast. Visit the Risk Communication Advisory Committee Web site at https://www.fda.gov/ AdvisoryCommittees/ RiskCommunicationAdvisory Committee.htm. The link will become active shortly before the open session begins at 9 a.m. Agenda: On June 8 and 9, 2015, the Committee will discuss approaches to communicating information about fetal effects in product labeling for methadone or buprenorphine maintenance therapy for opioid addiction, and about the maternal benefits and risks of treatment, to best enable patients and health care providers to make informed decisions about the use of these drugs during pregnancy. FDA intends to make background material available to the public no later E:\FR\FM\30APN1.SGM 30APN1 mstockstill on DSK4VPTVN1PROD with NOTICES 24262 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/ RiskCommunication AdvisoryCommittee.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 1, 2015. Oral presentations from the public will be scheduled between approximately 2 p.m. and 3:30 p.m. on June 8, 2015. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 22, 2015. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 26, 2015. Interested persons can also log on to https://www.fda.gov/ AdvisoryCommittees/ RiskCommunicationAd visoryCommittee.htm to see and hear the proceedings. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Luis G. Bravo at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisory Committees.htm for procedures on VerDate Sep<11>2014 17:01 Apr 29, 2015 Jkt 235001 public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 24, 2015. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis. [FR Doc. 2015–10024 Filed 4–29–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on June 10, 2015, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel phone number is 301– 977–8900. Contact Person: Philip Bautista, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, EMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 modifications before coming to the meeting. Agenda: The committee will discuss the safety and efficacy of biologics license application (BLA) 125522, proposed trade name REPATHA (established name: Evolocumab) for injection, submitted by Amgen Inc., as adjunct to diet to reduce low-density lipoprotein cholesterol (LDL–C), total cholesterol (TC), apolipoprotein B (ApoB), non-high-density lipoprotein cholesterol (non-HDL–C), TC/HDL–C, ApoB/ApoA1, very low-density lipoprotein cholesterol, triglyceride, and lipoprotein A, and to increase HDL–C and ApoA1, in adults with hyperlipidemia or mixed dyslipidemia, either in combination with a statin or statin with other lipid-lowering therapies (e.g., ezetimibe), or alone, or in combination with other lipidlowering therapies in patients who are statin-intolerant, or alone or in combination with other lipid-lowering therapies in patients for whom a statin is not considered clinically appropriate. In addition, the committee will discuss the safety and efficacy of evolocumab to reduce LDL–C, TC, ApoB, and nonHDL–C, in combination with other lipid-lowering therapies (e.g. statins, LDL apheresis) in patients at least 12 years of age with homozygous familial hypercholesterolemia. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 27, 2015. Oral presentations from the public will be scheduled between approximately 1:15 p.m. to 2:15 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 18, E:\FR\FM\30APN1.SGM 30APN1

Agencies

[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24261-24262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10024]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Risk Communications Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Risk Communications Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 8, 2015, from 9 
a.m. to 5 p.m. and June 9, 2015, from 9 a.m. to 12 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503) Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Luis G. Bravo, Office of Planning, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3367, 240-402-
5274, FAX: 301-847-3540, RCAC@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees.htm and scroll down to the appropriate advisory 
committee meeting link, or call the advisory committee information line 
to learn about possible modifications before coming to the meeting.
    If you are unable to join us in person, we encourage you to watch 
the free Webcast. Visit the Risk Communication Advisory Committee Web 
site at https://www.fda.gov/AdvisoryCommittees/RiskCommunicationAdvisoryCommittee.htm. The link will become active 
shortly before the open session begins at 9 a.m.
    Agenda: On June 8 and 9, 2015, the Committee will discuss 
approaches to communicating information about fetal effects in product 
labeling for methadone or buprenorphine maintenance therapy for opioid 
addiction, and about the maternal benefits and risks of treatment, to 
best enable patients and health care providers to make informed 
decisions about the use of these drugs during pregnancy.
    FDA intends to make background material available to the public no 
later

[[Page 24262]]

than 2 business days before the meeting. If FDA is unable to post the 
background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/RiskCommunicationAdvisoryCommittee.htm. Scroll down to the appropriate 
advisory committee meeting link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before June 
1, 2015. Oral presentations from the public will be scheduled between 
approximately 2 p.m. and 3:30 p.m. on June 8, 2015. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before May 22, 2015. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by May 26, 2015. Interested 
persons can also log on to https://www.fda.gov/AdvisoryCommittees/RiskCommunicationAdvisoryCommittee.htm to see and hear the proceedings.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Luis G. Bravo at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees.htm for procedures on public 
conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-10024 Filed 4-29-15; 8:45 am]
 BILLING CODE 4164-01-P

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