81_FR_28173 81 FR 28084 - Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal

81 FR 28084 - Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 89 (May 9, 2016)

Page Range28084-28085
FR Document2016-10766

The Food and Drug Administration (FDA) is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Anesthetic and Analgesic Drug Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 1, 2018.

Federal Register, Volume 81 Issue 89 (Monday, May 9, 2016) 
[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Notices]
[Pages 28084-28085]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-10766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Advisory Committee; Anesthetic and Analgesic Drug Products 
Advisory Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Anesthetic and Analgesic Drug Products Advisory 
Committee by the Commissioner of Food and Drugs (the Commissioner). The 
Commissioner has determined that it is in the public interest to renew 
the Anesthetic and Analgesic Drug Products Advisory Committee for an 
additional 2 years beyond the charter expiration date. The new charter 
will be in effect until May 1, 2018.

DATES: Authority for the Anesthetic and Analgesic Drug Products 
Advisory Committee will expire on May 1, 2016, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Stephanie L. Begansky, 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, [email protected].

SUPPLEMENTARY INFORMATION: Issued in 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services issued in 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Anesthetic and Analgesic Drug Products Advisory 
Committee. The committee is a discretionary Federal advisory committee 
established to provide advice to the Commissioner. The Anesthetic and 
Analgesic Drug Products Advisory Committee advises the Commissioner or 
designee in discharging responsibilities

[[Page 28085]]

as they relate to helping to ensure safe and effective drugs for human 
use and, as required, any other product for which the Food and Drug 
Administration has regulatory responsibility. The Committee reviews and 
evaluates available data concerning the safety and effectiveness of 
marketed and investigational human drug products including analgesics, 
e.g., abuse-deterrent opioids, novel analgesics, and issues related to 
opioid abuse, and those for use in anesthesiology and makes appropriate 
recommendations to the Commissioner of Food and Drugs.
    The Committee shall consist of a core of 11 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of anesthesiology, analgesics (such as: abuse deterrent opioids, 
novel analgesics, and issues related to opioid abuse) epidemiology or 
statistics, and related specialties. Members will be invited to serve 
for overlapping terms of up to four years. Almost all non-Federal 
members of this committee serve as Special Government Employees. The 
core of voting members may include one technically qualified member, 
selected by the Commissioner or designee, who is identified with 
consumer interests and is recommended by either a consortium of 
consumer-oriented organizations or other interested persons. In 
addition to the voting members, the Committee may include one non-
voting member who is identified with industry interests.
    Further information regarding the most recent charter and other 
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm094127.htm or by 
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION 
CONTACT). Since no change has been made to the committee name or 
description of duties, no amendment will be made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 3, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-10766 Filed 5-6-16; 8:45 am]
 BILLING CODE 4164-01-P

28084 Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices comments, that information will be accordance with 21 CFR 10.20 and other Hearing Aids’’ for 30 days, until June posted on http://www.regulations.gov. applicable disclosure law. For more 30, 2016. The Agency believes that a 30- • If you want to submit a comment information about FDA’s posting of day extension allows adequate time for with confidential information that you comments to public dockets, see 80 FR interested persons to submit comments do not wish to be made available to the 56469, September 18, 2015, or access without significantly delaying public, submit the comment as a the information at: http://www.fda.gov/ regulation on these important issues. written/paper submission and in the regulatoryinformation/dockets/ Dated: May 3, 2016. manner detailed (see ‘‘Written/Paper default.htm. Leslie Kux, Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to Associate Commissioner for Policy. Written/Paper Submissions read background documents or the electronic and written/paper comments [FR Doc. 2016–10798 Filed 5–6–16; 8:45 am] Submit written/paper submissions as received, go to http:// BILLING CODE 4164–01–P follows: www.regulations.gov and insert the • Mail/Hand delivery/Courier (for docket number, found in brackets in the written/paper submissions): Division of heading of this document, into the DEPARTMENT OF HEALTH AND Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts HUMAN SERVICES and Drug Administration, 5630 Fishers and/or go to the Division of Dockets Lane, rm. 1061, Rockville, MD 20852. Food and Drug Administration Management, 5630 Fishers Lane, Rm. • For written/paper comments [Docket No. FDA–2016–N–0001] 1061, Rockville, MD 20852. submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: Management, FDA will post your Advisory Committee; Anesthetic and comment, as well as any attachments, Srinivas Nandkumar, Food and Drug Analgesic Drug Products Advisory except for information submitted, Administration, Center for Devices and Committee, Renewal marked and identified, as confidential, Radiological Health, Bldg. 66, Rm. 2436, if submitted as detailed in 10903 New Hampshire Ave., Silver AGENCY: Food and Drug Administration, ‘‘Instructions.’’ Spring, MD 20993, 301–796–6480, FAX: HHS. Instructions: All submissions received 301–847–8126, Srinivas.nandkumar@ ACTION:Notice; renewal of advisory must include the Docket No. FDA– fda.hhs.gov. committee. 2015–N–4602 for ‘‘Streamlining SUPPLEMENTARY INFORMATION: In the Regulations for Good Manufacturing SUMMARY: The Food and Drug Federal Register of January 7, 2016 (81 Practices for Hearing Aids; Public Administration (FDA) is announcing the FR 784), FDA published a document Workshop; Request for Comments.’’ renewal of the Anesthetic and Analgesic with a 30-day comment period to Received comments will be placed in Drug Products Advisory Committee by request comments on the appropriate the docket and, except for those the Commissioner of Food and Drugs level of GMPs regulation to ensure the submitted as ‘‘Confidential (the Commissioner). The Commissioner safety and effectiveness of air- Submissions,’’ publicly viewable at has determined that it is in the public conduction hearing aid devices; the http://www.regulations.gov or at the interest to renew the Anesthetic and current regulations for air-conduction Division of Dockets Management Analgesic Drug Products Advisory hearing aids that may hinder between 9 a.m. and 4 p.m., Monday Committee for an additional 2 years innovation, reduce competition, and through Friday. beyond the charter expiration date. The lead to increased cost and reduced use • Confidential Submissions—To new charter will be in effect until May of these devices by Americans with age- submit a comment with confidential 1, 2018. related hearing loss; and the potential information that you do not wish to be DATES: Authority for the Anesthetic and exemption of hearing aids from the made publicly available, submit your Quality System Regulation (QSReg,) Analgesic Drug Products Advisory comments only as a written/paper through use of alternative standards Committee will expire on May 1, 2016, submission. You should submit two developed in collaboration with key unless the Commissioner formally copies total. One copy will include the stakeholders and standards determines that renewal is in the public information you claim to be confidential development organizations, and interest. with a heading or cover note that states recognized by FDA and recordkeeping FOR FURTHER INFORMATION CONTACT: ‘‘THIS DOCUMENT CONTAINS to ensure product quality. Comments on Stephanie L. Begansky, Center for Drug CONFIDENTIAL INFORMATION.’’ The the ‘‘Streamlining Regulations for Good Evaluation and Research, Food and Agency will review this copy, including Manufacturing Practices for Hearing Drug Administration, 10903 New the claimed confidential information, in Aids’’ will inform the Agency on an Hampshire Ave., Bldg. 31, Rm. 2417, its consideration of comments. The alternative model for quality Silver Spring, MD 20993–0002, (301) second copy, which will have the verification. 796–9001, AADPAC@fda.hhs.gov. claimed confidential information The Agency has received requests for SUPPLEMENTARY INFORMATION: Issued in redacted/blacked out, will be available a 30-day extension of the comment 41 CFR 102–3.65 and approval by the for public viewing and posted on http:// period for the document. Each request Department of Health and Human www.regulations.gov. Submit both conveyed concern that the current 30- Services issued in 45 CFR part 11 and copies to the Division of Dockets day comment period does not allow by the General Services Administration, Management. If you do not wish your sufficient time to develop a meaningful FDA is announcing the renewal of the name and contact information to be or thoughtful response to the document Anesthetic and Analgesic Drug Products mstockstill on DSK3G9T082PROD with NOTICES made publicly available, you can on ‘‘Streamlining Regulations for Good Advisory Committee. The committee is provide this information on the cover Manufacturing Practices for Hearing a discretionary Federal advisory sheet and not in the body of your Aids.’’ committee established to provide advice comments and you must identify this FDA has considered the requests and to the Commissioner. The Anesthetic information as ‘‘confidential.’’ Any is extending the comment period for the and Analgesic Drug Products Advisory information marked as ‘‘confidential’’ document on ‘‘Streamlining Regulations Committee advises the Commissioner or will not be disclosed except in for Good Manufacturing Practices for designee in discharging responsibilities VerDate Sep<11>2014 17:44 May 06, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\09MYN1.SGM 09MYN1

Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices 28085 as they relate to helping to ensure safe U.S.C. app.). For general information Study Abstract: The Office of and effective drugs for human use and, related to FDA advisory committees, Adolescent Health (OAH), U.S. as required, any other product for which please visit us at http://www.fda.gov/ Department of Health and Human the Food and Drug Administration has AdvisoryCommittees/default.htm. Services (HHS) is requesting approval regulatory responsibility. The Dated: May 3, 2016. by OMB on a revised data collection. Committee reviews and evaluates Jill Hartzler Warner, The Positive Adolescent Futures (PAF) available data concerning the safety and Study will provide information about Associate Commissioner for Special Medical effectiveness of marketed and Programs. program design, implementation, and investigational human drug products impacts through a rigorous assessment [FR Doc. 2016–10766 Filed 5–6–16; 8:45 am] including analgesics, e.g., abuse- of program impacts and implementation BILLING CODE 4164–01–P deterrent opioids, novel analgesics, and of two programs designed to support issues related to opioid abuse, and those expectant and parenting teens. These for use in anesthesiology and makes DEPARTMENT OF HEALTH AND programs are located in Houston, Texas appropriate recommendations to the HUMAN SERVICES and throughout the state of California. Commissioner of Food and Drugs. This revised information collection The Committee shall consist of a core Office of the Secretary request includes the 24-month follow- of 11 voting members including the up survey instrument related to the Chair. Members and the Chair are [Document Identifier: OMB # 0990–0424– 60D] impact study. The data collected from selected by the Commissioner or this instrument in the two study sites designee from among authorities Agency Information Collection will provide a detailed understanding of knowledgeable in the fields of Activities; Proposed Collection; Public program impacts about two years after anesthesiology, analgesics (such as: Comment Request youth are enrolled in the study and first abuse deterrent opioids, novel have access to the programming offered analgesics, and issues related to opioid AGENCY: Office of the Assistant by each site. abuse) epidemiology or statistics, and Secretary for Health, Office of related specialties. Members will be Adolescent Health, HHS. Need and Proposed Use of the invited to serve for overlapping terms of Information: The data will serve two ACTION: Notice. up to four years. Almost all non-Federal main purposes. First, the data will be members of this committee serve as SUMMARY: In compliance with section used to determine program effectiveness Special Government Employees. The 3506(c)(2)(A) of the Paperwork by comparing outcomes on repeat core of voting members may include one Reduction Act of 1995, the Office of the pregnancies, sexual risk behaviors, technically qualified member, selected Secretary (OS), Department of Health health and well-being, and parenting by the Commissioner or designee, who and Human Services, announces plans behaviors between treatment (program) is identified with consumer interests to submit an Information Collection and control youth. Second, the data will and is recommended by either a Request (ICR), described below, to the be used to understand whether the consortium of consumer-oriented Office of Management and Budget programs are more effective for some organizations or other interested (OMB). Prior to submitting that ICR to youth than others. The findings from persons. In addition to the voting OMB, OS seeks comments from the these analyses of program impacts will members, the Committee may include public regarding the burden estimate, be of interest to the general public, to one non-voting member who is below, or any other aspect of the ICR. policymakers, and to organizations identified with industry interests. DATES: Comments on the ICR must be interested in supporting expectant and Further information regarding the received on or before July 8, 2016. parenting teens. most recent charter and other ADDRESSES: Submit your comments to Likely Respondents: The 24-month information can be found at http://www. Information.CollectionClearance@ follow-up survey data will be collected fda.gov/AdvisoryCommittees/ hhs.gov or by calling (202) 690–6162. through a web-based survey or through CommitteesMeetingMaterials/Drugs/ FOR FURTHER INFORMATION CONTACT: telephone interviews with study AnestheticAndAnalgesicDrugProducts Information Collection Clearance staff, participants; i.e. adolescents randomly AdvisoryCommittee/ucm094127.htm or Information.CollectionClearance@ assigned to a program for expectant and by contacting the Designated Federal hhs.gov or (202) 690–6162. parenting teens being tested for program Officer (see FOR FURTHER INFORMATION SUPPLEMENTARY INFORMATION: When effectiveness, or to a control group. The CONTACT). Since no change has been submitting comments or requesting mode of survey administration will made to the committee name or information, please include the primarily be based on the preference of description of duties, no amendment document identifier OMB # 0990–0424– the study participants. The survey will will be made to 21 CFR 14.100. 60D for reference. be completed by 1,515 respondents This document is issued under the Information Collection Request Title: across the two study sites. Clearance is Federal Advisory Committee Act (5 Positive Adolescent Futures (PAF) requested for three years. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Average Number of Number of burden per Total burden Form name responses per respondents response hours mstockstill on DSK3G9T082PROD with NOTICES respondent (in hours) 24-month follow-up survey of impact study participants ................................. 505 1 30/60 252.5 Total .......................................................................................................... ........................ ........................ ........................ 252.5 VerDate Sep<11>2014 17:44 May 06, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\09MYN1.SGM 09MYN1


Document Created: 2018-02-07 14:50:32
Document Modified: 2018-02-07 14:50:32
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; renewal of advisory committee.
DatesAuthority for the Anesthetic and Analgesic Drug Products Advisory Committee will expire on May 1, 2016, unless the Commissioner formally determines that renewal is in the public interest.
ContactStephanie L. Begansky, 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, [email protected]
FR Citation81 FR 28084 
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