81_FR_71305 81 FR 71106 - Advisory Committee; Antimicrobial Drugs Advisory Committee, Renewal

81 FR 71106 - Advisory Committee; Antimicrobial Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 199 (October 14, 2016)

Page Range71106-71107
FR Document2016-24810

The Food and Drug Administration (FDA) is announcing the renewal of the Antimicrobial Drugs 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 Antimicrobial Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 7, 2018.

Federal Register, Volume 81 Issue 199 (Friday, October 14, 2016) 
[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)]
[Notices]
[Pages 71106-71107]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Advisory Committee; Antimicrobial Drugs 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 Antimicrobial Drugs 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 Antimicrobial 
Drugs Advisory Committee for an additional 2 years beyond the charter 
expiration date. The new charter will be in effect until October 7, 
2018.

DATES: Authority for the Antimicrobial Drugs Advisory Committee will 
expire on October 7, 2016, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Lauren Tesh, 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: [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the

[[Page 71107]]

Department of Health and Human Services pursuant to 45 CFR part 11 and 
by the General Services Administration, FDA is announcing the renewal 
of the Antimicrobial Drugs Advisory Committee. The committee is a 
discretionary Federal advisory committee established to provide advice 
to the Commissioner. The Antimicrobial Drugs Advisory Committee advises 
the Commissioner or designee in discharging responsibilities 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 for use in the 
treatment of infectious diseases and disorders and makes appropriate 
recommendations to the Commissioner of Food and Drugs.
    The Committee shall consist of a core of 13 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of infectious disease, internal medicine, microbiology, 
pediatrics, 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/Anti-InfectiveDrugsAdvisoryCommittee/ucm094132.htm or by contacting the Designated Federal Officer (see FOR 
FURTHER INFORMATION CONTACT). In light of the fact that 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: October 7, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-24810 Filed 10-13-16; 8:45 am]
 BILLING CODE 4164-01-P

71106 Federal Register / Vol. 81, No. 199 / Friday, October 14, 2016 / Notices Administration, 10903 New Hampshire public comment. The IMDRF SaMD III. Electronic Access Ave., Bldg. 66, Rm. 5431, Silver Spring, Working Group (WG) includes Persons interested in obtaining a copy MD 20993–0002. Send one self- representatives from the IMDRF of the draft guidance may do so by addressed adhesive label to assist that members, as well as members from the downloading an electronic copy from office in processing your requests. Medical Device Regulatory Authorities the Internet. A search capability for all FOR FURTHER INFORMATION CONTACT: and Regional Harmonization Initiatives Center for Devices and Radiological Regarding the draft guidance: Bakul from around the world. The draft Health guidance documents is available Patel, Center for Devices and guidance is the product of the IMDRF at http://www.fda.gov/MedicalDevices/ Radiological Health, Food and Drug SaMD WG. Comments about this draft DeviceRegulationandGuidance/ Administration, 10903 New Hampshire will be considered by FDA and the GuidanceDocuments/default.htm. Ave., Bldg. 66, Rm. 5458, Silver Spring, IMDRF SaMD WG. Guidance documents are also available MD 20993–0002, 301–796–5528. We welcome comments on all aspects at http://www.regulations.gov. Persons Regarding the IMDRF: Melissa A. of the draft guidance as well as the unable to download an electronic copy Torres, Center for Devices and following specific issues: of ‘‘Software as a Medical Device Radiological Health, Food and Drug 1. Does the document address the (SaMD): Clinical Evaluation’’ may send Administration, 10903 New Hampshire intention captured in the introduction/ an email request to CDRH-Guidance@ Ave., Bldg. 66, Rm. 5432, Silver Spring, scope or vice versa? fda.hhs.gov to receive an electronic MD 20993–0002, 301–796–5576. copy of the document. Please use the 2. Does the document appropriately SUPPLEMENTARY INFORMATION: translate and apply current clinical document number 16039 to identify the vocabulary for SaMD? guidance you are requesting. I. Background 3. Are there other types of SaMD Dated: October 6, 2016. In recent years, many important initiatives have been undertaken by beyond those intended for non- Leslie Kux, regulatory authorities and industry diagnostic, diagnostic and therapeutic Associate Commissioner for Policy. associations to promote international purposes that should be highlighted/ [FR Doc. 2016–24805 Filed 10–13–16; 8:45 am] harmonization of regulatory considered in the document? BILLING CODE 4164–01–P requirements. One of the goals of global 4. Does the document adequately harmonization is to identify and then address the relevant clinical evaluation reduce differences in regulatory policies methods and processes for SaMD to DEPARTMENT OF HEALTH AND among regulatory agencies. IMDRF generate clinical evidence? HUMAN SERVICES seeks to advance international 5. Are there other appropriate Food and Drug Administration harmonization or convergence of methods for generating clinical medical device regulation. evaluation evidence that are relevant for [Docket No. FDA–2016–N–0001] IMDRF was organized to provide an SaMD beyond those described in the opportunity for global harmonization document? Advisory Committee; Antimicrobial initiatives to be developed with input 6. Are the recommendations Drugs Advisory Committee, Renewal from both regulatory and industry identified in section 7.2 related to the AGENCY: Food and Drug Administration, representatives. The current members of ‘‘importance of clinical evidence and HHS. the Management Committee of the expectations’’ appropriate as outlined IMDRF are regulatory officials from ACTION:Notice; renewal of advisory for the different SaMD categories? committee. Australia (Therapeutic Goods 7. Are the recommendations Administration), Brazil (National Health SUMMARY: The Food and Drug identified in section 7.3 related to the Surveillance Agency), Canada (Health Administration (FDA) is announcing the ‘‘importance of independent review’’ Canada), China (China Food and Drug renewal of the Antimicrobial Drugs appropriate as outlined for the different Administration), European Union Advisory Committee by the SaMD categories? (European Commission Directorate- Commissioner of Food and Drugs (the General for Internal Market, Industry, 8. Given the uniqueness of SaMD and the proposed framework—is there any Commissioner). The Commissioner has Entrepreneurship and Small and determined that it is in the public Medium-sized Enterprises), Japan impact on currently regulated devices or any possible adverse consequences? interest to renew the Antimicrobial (Pharmaceuticals and Medical Devices Drugs Advisory Committee for an Agency and the Ministry of Health, The draft guidance and the IMDRF additional 2 years beyond the charter Labour and Welfare), Russia (Ministry of comment page are available at http:// expiration date. The new charter will be Healthcare), and the United States (U.S. www.imdrf.org/consultations/ in effect until October 7, 2018. FDA). The World Health Organization consultations.asp#current. DATES: Authority for the Antimicrobial and the Asia-Pacific Economic II. Significance of Guidance Cooperation Life Sciences Innovation Drugs Advisory Committee will expire Forum Regulatory Harmonization This draft guidance is being issued on October 7, 2016, unless the Steering Committee are Official consistent with FDA’s good guidance Commissioner formally determines that Observers. The Asian Harmonization practices regulation (21 CFR 10.115). renewal is in the public interest. Working Party and the Pan American The draft guidance, when finalized, will FOR FURTHER INFORMATION CONTACT: Health Organization are IMDRF Affiliate represent the current thinking of FDA Lauren Tesh, Center for Drug Evaluation rmajette on DSK2TPTVN1PROD with NOTICES Organizations. on ‘‘Software as a Medical Device and Research, Food and Drug In September 2016, the IMDRF (SaMD): Clinical Evaluation.’’ It does Administration, 10903 New Hampshire Management Committee endorsed the not establish any rights for any person Ave., Bldg. 31, Rm. 2417, Silver Spring, draft guidance entitled ‘‘Software as a and is not binding on FDA or the public. MD 20993–0002, 301–796–9001, email: Medical Device (SaMD): Clinical You can use an alternative approach if AMDAC@fda.hhs.gov. Evaluation’’ and agreed that the it satisfies the requirements of the SUPPLEMENTARY INFORMATION: Pursuant guidance should be made available for applicable statutes and regulations. to 41 CFR 102–3.65 and approval by the VerDate Sep<11>2014 14:29 Oct 13, 2016 Jkt 241001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\14OCN1.SGM 14OCN1

Federal Register / Vol. 81, No. 199 / Friday, October 14, 2016 / Notices 71107 Department of Health and Human Dated: October 7, 2016. have been adopted by the Secretary are Services pursuant to 45 CFR part 11 and Janice M. Soreth, included in the Recommended Uniform by the General Services Administration, Acting Associate Commissioner, Special Screening Panel and constitute part of FDA is announcing the renewal of the Medical Programs. the comprehensive guidelines Antimicrobial Drugs Advisory [FR Doc. 2016–24810 Filed 10–13–16; 8:45 am] supported by HRSA. Pursuant to section Committee. The committee is a BILLING CODE 4164–01–P 2713 of the Public Health Service Act, discretionary Federal advisory codified at 42 U.S.C. 300gg–13, non- committee established to provide advice grandfathered health plans are required to the Commissioner. The Antimicrobial DEPARTMENT OF HEALTH AND to cover screenings included in the Drugs Advisory Committee advises the HUMAN SERVICES HRSA-supported comprehensive Commissioner or designee in guidelines without charging a co- discharging responsibilities as they Health Resources and Services payment, co-insurance, or deductible for relate to helping to ensure safe and Administration plan years (i.e., policy years) beginning effective drugs for human use and, as on or after the date that is 1-year from Advisory Committee on Heritable the Secretary’s adoption of the required, any other product for which Disorders in Newborns and Children condition for screening. the Food and Drug Administration has regulatory responsibility. The AGENCY: Health Resources and Service The Committee will hear Committee reviews and evaluates Administration (HRSA), Department of presentations and discussions on topics available data concerning the safety and Health and Human Services. related to newborn screening activities, effectiveness of marketed and ACTION: Notice of meeting. technologies, policies, guidelines, and investigational human drug products for programs for effectively reducing use in the treatment of infectious SUMMARY: In accordance with section morbidity and mortality in newborns diseases and disorders and makes 10(a)(2) of the Federal Advisory and children having, or at risk for, appropriate recommendations to the Committee Act (Pub. L. 92–463, codified heritable disorders. The Committee will Commissioner of Food and Drugs. at 5 U.S.C. App.), notice is hereby given also hear updates from the Laboratory The Committee shall consist of a core that a meeting is scheduled for the Standards and Procedures workgroup, of 13 voting members including the Advisory Committee on Heritable Follow-up and Treatment workgroup, Chair. Members and the Chair are Disorders in Newborns and Children. and Education and Training workgroup. selected by the Commissioner or This meeting will be open to the public Agenda items are subject to changes as designee from among authorities but advance registration is required to priorities indicate. Tentatively, the knowledgeable in the fields of infectious ensure sufficient webinar capacity. The Committee is expected to review and/or disease, internal medicine, registration link is https:// vote on the following: Approving www.blsmeetings.net/ newborn screening surveillance case microbiology, pediatrics, epidemiology achdncnovember2016/. The registration definitions and whether or not the or statistics, and related specialties. deadline is Wednesday, November 2, nominated condition Guanidinoacetate Members will be invited to serve for 2016, 11:59 p.m. Eastern Time. Methyltransferase deficiency should be overlapping terms of up to four years. DATES AND TIMES: November 3, 2016, referred for a full evidence-based Almost all non-Federal members of this 9:00 a.m. to 5:00 p.m. (Meeting time is review. The Committee will not be committee serve as Special Government tentative.) voting on a proposed addition of a Employees. The core of voting members November 4, 2016, 9:00 a.m. to 1:00 condition to the Recommended Uniform may include one technically qualified p.m. (Meeting time is tentative.) Screening Panel. The meeting agenda member, selected by the Commissioner ADDRESSES: This meeting will be held will be available 2 days prior to the or designee, who is identified with meeting on the Committee’s Web site: consumer interests and is recommended by webinar only. http://www.hrsa.gov/ by either a consortium of consumer- FOR FURTHER INFORMATION CONTACT: advisorycommittees/mchbadvisory/ oriented organizations or other Anyone interested in obtaining other heritabledisorders. interested persons. In addition to the relevant information should contact Members of the public may submit voting members, the Committee may Alaina Harris, Maternal and Child written and/or present oral comments at include one non-voting member who is Health Bureau, HRSA, Room 18W66, the meeting. All comments are part of identified with industry interests. 5600 Fishers Lane, Rockville, Maryland the official Committee record. Advance Further information regarding the 20857; email: aharris@hrsa.gov. registration is required to submit written most recent charter and other SUPPLEMENTARY INFORMATION: The comments and/or present oral information can be found at http:// Advisory Committee on Heritable comments. Written comments must be www.fda.gov/AdvisoryCommittees/ Disorders in Newborns and Children submitted by October 19, 2016, 11:59 CommitteesMeetingMaterials/Drugs/ (Committee), as authorized by the p.m. Eastern Time in order to be Anti-InfectiveDrugsAdvisoryCommittee/ Public Health Service Act, Title XI, included in the November meeting ucm094132.htm or by contacting the § 1111 (42 U.S.C. 300b–10), was briefing book. Written comments should Designated Federal Officer (see FOR established to advise the Secretary of identify the individual’s name, address, FURTHER INFORMATION CONTACT). In light the Department of Health and Human email, telephone number, professional of the fact that no change has been made Services about the development of or business affiliation, type of expertise to the committee name or description of newborn screening activities, (i.e., parent, researcher, clinician, public duties, no amendment will be made to technologies, policies, guidelines, and health, etc.), and the topic/subject rmajette on DSK2TPTVN1PROD with NOTICES 21 CFR 14.100. programs for effectively reducing matter of comments. This document is issued under the morbidity and mortality in newborns Individuals who wish to provide oral Federal Advisory Committee Act (5 and children having, or at risk for, comments must register by October 30, U.S.C. app.). For general information heritable disorders. In addition, the 2016, 11:59 p.m. Eastern Time. To related to FDA advisory committees, Committee’s recommendations ensure that all individuals who have please visit us at http://www.fda.gov/ regarding additional conditions/ registered to make oral comments can be AdvisoryCommittees/default.htm. inherited disorders for screening that accommodated, the allocated time may VerDate Sep<11>2014 14:29 Oct 13, 2016 Jkt 241001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\14OCN1.SGM 14OCN1


Document Created: 2016-10-14 00:01:24
Document Modified: 2016-10-14 00:01:24
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 Antimicrobial Drugs Advisory Committee will expire on October 7, 2016, unless the Commissioner formally determines that renewal is in the public interest.
ContactLauren Tesh, 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: [email protected]
FR Citation81 FR 71106 
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