80_FR_24344 80 FR 24261 - Risk Communications Advisory Committee; Notice of Meeting

80 FR 24261 - Risk Communications Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range24261-24262
FR Document2015-10024

Federal Register, Volume 80 Issue 83 (Thursday, April 30, 2015) 
[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24261-24262]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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    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: http://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 http://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 http://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 http://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 http://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 http://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

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 VerDate Sep<11>2014 17:01 Apr 29, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\30APN1.SGM 30APN1

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


Document Created: 2018-02-21 10:15:03
Document Modified: 2018-02-21 10:15:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation80 FR 24261 
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