81_FR_34457 81 FR 34353 - Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Renewal

81 FR 34353 - Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 104 (May 31, 2016)

Page Range34353-34354
FR Document2016-12657

The Food and Drug Administration (FDA) is announcing the renewal of the Science Advisory Board to the National Center for Toxicological Research (NCTR) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Science Advisory Board to the National Center for Toxicological Research for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 2, 2018.

Federal Register, Volume 81 Issue 104 (Tuesday, May 31, 2016) 
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34353-34354]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Advisory Committee; Science Advisory Board to the National Center 
for Toxicological Research; 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 Science Advisory Board to the National Center for 
Toxicological Research (NCTR) by the Commissioner of Food and Drugs 
(the Commissioner). The Commissioner has determined that it is in the 
public interest to renew the Science Advisory Board to the National 
Center for Toxicological Research for an additional 2 years beyond the 
charter expiration date. The new charter will be in effect until June 
2, 2018.

DATES: Authority for the Science Advisory Board to the National Center 
for Toxicological Research will expire on June 2, 2016, unless the 
Commissioner formally determines that renewal is in the public 
interest.

FOR FURTHER INFORMATION CONTACT: Donna L. Mendrick, National Center for 
Toxicological Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301-
796-8892, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the 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 Science Advisory Board to the National Center for 
Toxicological Research. The committee is a discretionary Federal 
advisory committee established to provide advice to the Commissioner. 
The Science Advisory Board to the National Center for Toxicological 
Research 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 FDA 
has regulatory responsibility. The Board advises the Director, NCTR, in 
establishing, implementing, and evaluation the research programs that 
assist the Commissioner of Food and Drugs in fulfilling his regulatory 
responsibilities. The Board provides an extra-agency review in ensuring 
that the research programs at NCTR are scientifically sound and 
pertinent.
    The Committee shall consist of a core of nine voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of toxicological research. Members will be invited to serve for 
overlapping terms of up to 4 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.
    Further information regarding the most recent charter and other 
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ToxicologicalResearch/ucm148166.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.


[[Page 34354]]


    Dated: May 24, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-12657 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices 34353 treatment of chronic hepatitis C (see DATES). Furthermore, any SUPPLEMENTARY INFORMATION: Pursuant infection as a component of a interested person may petition FDA for to 41 CFR 102–3.65 and approval by the combination antiviral treatment a determination regarding whether the Department of Health and Human regimen. Subsequent to this approval, applicant for extension acted with due Services pursuant to 45 CFR part 11 and the USPTO received patent term diligence during the regulatory review by the General Services Administration, restoration applications for OLYSIO period. To meet its burden, the petition FDA is announcing the renewal of the (U.S. Patent Nos. 7,671,032 and must be timely (see DATES) and contain Science Advisory Board to the National 8,349,869) from Medivir AB and Janssen sufficient facts to merit an FDA Center for Toxicological Research. The R&D Ireland, and the USPTO requested investigation. (See H. Rept. 857, part 1, committee is a discretionary Federal FDA’s assistance in determining the 98th Cong., 2d sess., pp. 41–42, 1984.) advisory committee established to patents’ eligibility for patent term Petitions should be in the format provide advice to the Commissioner. restoration. In a letter dated October 15, specified in 21 CFR 10.30. The Science Advisory Board to the 2015, FDA advised the USPTO that this Submit petitions electronically to National Center for Toxicological human drug product had undergone a http://www.regulations.gov at Docket Research advises the Commissioner or regulatory review period and that the No. FDA–2013–S–0610. Submit written designee in discharging responsibilities approval of OLYSIO represented the petitions (two copies are required) to the as they relate to helping to ensure safe first permitted commercial marketing or Division of Dockets Management (HFA– and effective drugs for human use and, use of the product. Thereafter, the 305), Food and Drug Administration, as required, any other product for which USPTO requested that FDA determine 5630 Fishers Lane, rm. 1061, Rockville, FDA has regulatory responsibility. The the product’s regulatory review period. MD 20852. Board advises the Director, NCTR, in II. Determination of Regulatory Review Dated: May 24, 2016. establishing, implementing, and Period Leslie Kux, evaluation the research programs that FDA has determined that the Associate Commissioner for Policy. assist the Commissioner of Food and applicable regulatory review period for [FR Doc. 2016–12708 Filed 5–27–16; 8:45 am] Drugs in fulfilling his regulatory OLYSIO is 2,006 days. Of this time, BILLING CODE 4164–01–P responsibilities. The Board provides an 1,766 days occurred during the testing extra-agency review in ensuring that the phase of the regulatory review period, research programs at NCTR are while 240 days occurred during the DEPARTMENT OF HEALTH AND scientifically sound and pertinent. approval phase. These periods of time HUMAN SERVICES The Committee shall consist of a core were derived from the following dates: of nine voting members including the 1. The date an exemption under Food and Drug Administration Chair. Members and the Chair are section 505(i) of the Federal Food, Drug, [Docket No. FDA–2016–N–0001] selected by the Commissioner or and Cosmetic Act (the FD&C Act) (21 designee from among authorities U.S.C. 355(i)) became effective: May 28, Advisory Committee; Science Advisory knowledgeable in the fields of 2008. FDA has verified the Medivir AB Board to the National Center for toxicological research. Members will be and Janssen R&D Ireland claim that May Toxicological Research; Renewal invited to serve for overlapping terms of 28, 2008, is the date the investigational AGENCY: Food and Drug Administration, up to 4 years. Almost all non-Federal new drug application (IND) became HHS. members of this committee serve as effective. Special Government Employees. The 2. The date the application was ACTION:Notice; renewal of advisory committee. core of voting members may include one initially submitted with respect to the technically qualified member, selected human drug product under section SUMMARY: The Food and Drug 505(b) of the FD&C Act: March 28, 2013. by the Commissioner or designee, who Administration (FDA) is announcing the is identified with consumer interests FDA has verified the applicant’s claim renewal of the Science Advisory Board that the new drug application (NDA) for and is recommended by either a to the National Center for Toxicological consortium of consumer-oriented OLYSIO (NDA 205123) was initially Research (NCTR) by the Commissioner submitted on March 28, 2013. organizations or other interested of Food and Drugs (the Commissioner). persons. 3. The date the application was The Commissioner has determined that approved: November 22, 2013. FDA has it is in the public interest to renew the Further information regarding the verified the applicant’s claim that NDA Science Advisory Board to the National most recent charter and other 205123 was approved on November 22, Center for Toxicological Research for an information can be found at http:// 2013. additional 2 years beyond the charter www.fda.gov/AdvisoryCommittees/ This determination of the regulatory CommitteesMeetingMaterials/ expiration date. The new charter will be review period establishes the maximum ToxicologicalResearch/ucm148166.htm in effect until June 2, 2018. potential length of a patent extension. or by contacting the Designated Federal However, the USPTO applies several DATES: Authority for the Science Advisory Board to the National Center Officer (see FOR FURTHER INFORMATION statutory limitations in its calculations CONTACT). In light of the fact that no of the actual period for patent extension. for Toxicological Research will expire on June 2, 2016, unless the change has been made to the committee In its applications for patent extension name or description of duties, no and amendments, the applicants seek Commissioner formally determines that renewal is in the public interest. amendment will be made to 21 CFR sradovich on DSK3TPTVN1PROD with NOTICES 801 or 280 days of patent term 14.100. extension. FOR FURTHER INFORMATION CONTACT: Donna L. Mendrick, National Center for This document is issued under the III. Petitions Toxicological Research, Food and Drug Federal Advisory Committee Act (5 Anyone with knowledge that any of Administration, 10903 New Hampshire U.S.C. app.). For general information the dates as published are incorrect may Ave., Bldg. 32, Rm. 2208, Silver Spring, related to FDA advisory committees, submit either electronic or written MD 20993–0002, 301–796–8892, please visit us at http://www.fda.gov/ comments and ask for a redetermination donna.mendrick@fda.hhs.gov. AdvisoryCommittees/default.htm. VerDate Sep<11>2014 20:07 May 27, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1

34354 Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices Dated: May 24, 2016. FOR FURTHER INFORMATION CONTACT: Lori DEPARTMENT OF HEALTH AND Jill Hartzler Warner, Benner and/or Jessica Barnes, Center for HUMAN SERVICES Associate Commissioner for Special Medical Drug Evaluation and Research, Food Programs. and Drug Administration, 10903 New Food and Drug Administration [FR Doc. 2016–12657 Filed 5–27–16; 8:45 am] Hampshire Ave., Bldg. 22, Rm. 6221 [Docket No. FDA–2016–N–0001] BILLING CODE 4164–01–P Silver Spring, MD 20993–0002, 301– 796–1300. Clinical Chemistry and Clinical SUPPLEMENTARY INFORMATION: FDA is Toxicology Devices Panel of the DEPARTMENT OF HEALTH AND announcing a public workshop Medical Devices Advisory Committee; HUMAN SERVICES regarding antibacterial drug Notice of Meeting development for patients with unmet AGENCY: Food and Drug Administration, Food and Drug Administration need and developing antibacterial drugs HHS. [Docket No. FDA–2016–N–0001] that target a single species. Discussions ACTION: Notice. will focus on potential development Facilitating Antibacterial Drug pathways, aspects of clinical trials SUMMARY: The Food and Drug Development for Patients With Unmet including patient population, trial Administration (FDA) announces a Need and Developing Antibacterial designs, and endpoints, and the role of forthcoming public advisory committee Drugs That Target a Single Species clinical trial networks in antibacterial meeting of the Clinical Chemistry and Media; Public Workshop drug development. Clinical Toxicology Devices Panel of the AGENCY: Food and Drug Administration, Registration: Registration is free for Medical Devices Advisory Committee. HHS. the public workshop. Interested parties The general function of the committee is are encouraged to register early. Seating to provide advice and recommendations ACTION: Notice of public workshop. will be available on a first-come, first- to the Agency on FDA’s regulatory SUMMARY: The Food and Drug served basis. To register electronically, issues. The meeting will be open to the Administration (FDA) is announcing a email registration information public. public workshop regarding antibacterial (including name, title, firm name, DATES: The meeting will be held on drug development for patients with address, telephone, and fax number) to August 10, 2016, from 8 a.m. to 6 p.m. unmet need and developing unmetneed2016@fda.hhs.gov. Persons ADDRESSES: Gaithersburg Holiday Inn, antibacterial drugs that target a single without access to the Internet can call Ballroom, Two Montgomery Village species. FDA is interested in discussing 301–796–1300 to register. Ave., Gaithersburg, MD 20879. The the scientific challenges pertaining to If you need special accommodations hotel’s telephone number is 301–948– such development programs, including due to a disability, please contact Jessica 8900. Answers to commonly asked enrollment challenges, clinical trial Barnes or Lori Benner (see FOR FURTHER questions including information designs, and trial population. This INFORMATION CONTACT) at least 7 days in regarding special accommodations due public workshop is intended to provide advance. to a disability, visitor parking, and information for and gain perspective Agenda: The workshop draft Agenda transportation may be accessed at: from health care providers, other U.S. will be made available at: http:// http://www.fda.gov/ government Agencies, public health wwwfda.gov/Drugs/NewsEvents/ AdvisoryCommittees/ organizations, academic experts, and ucm497650.htm at least 2 days prior to AboutAdvisoryCommittees/ industry on various aspects of drug the meeting. The Agency encourages ucm408555.htm. development for new antibacterial drugs individuals, industry, health care FOR FURTHER INFORMATION CONTACT: for patients with unmet need and new professionals, researchers, public health Patricio G. Garcia, Center for Devices antibacterial drugs that target a single organizations and other interested and Radiological Health, Food and Drug species. The input from this public persons to attend this public workshop. Administration, 10903 New Hampshire workshop will also help in developing Transcripts: Please be advised that as Ave., Bldg. 66, rm. 1611, Silver Spring, topics for future discussion. soon as a transcript is available, it will MD 20993–0002, Patricio.Garcia@ DATES: The public workshop will be be accessible at http:// fda.hhs.gov, 301–796–6875, or FDA held on July 18, 2016, from 8:30 a.m. to www.regulations.gov. It may be viewed Advisory Committee Information Line, 5 p.m. and July 19, 2016, from 8:30 a.m. at the Division of Dockets Management 1–800–741–8138 (301–443–0572 in the to 4 p.m. See the SUPPLEMENTARY (HFA–305), Food and Drug Washington, DC area). A notice in the INFORMATION section for registration Administration, 5630 Fishers Lane, Rm. Federal Register about last minute information. 1061, Rockville, MD 20852. A transcript modifications that impact a previously will also be available in either hardcopy announced advisory committee meeting ADDRESSES: The public workshop will or on CD–ROM, after submission of a be held at FDA’s White Oak campus, cannot always be published quickly Freedom of Information request. The enough to provide timely notice. 10903 New Hampshire Ave., Bldg. 31 Freedom of Information office address is Conference Center, the Great Room (Rm. Therefore, you should always check the available on the Agency’s Web site at Agency’s Web site at http:// 1503), Silver Spring, MD 20993–0002. http://www.fda.gov. Transcripts will Entrance for the public workshop www.fda.gov/AdvisoryCommittees/ also be available on the Internet at: default.htm and scroll down to the participants (non-FDA employees) is http://wwwfda.gov/Drugs/NewsEvents/ through Building 1 where routine appropriate advisory committee meeting sradovich on DSK3TPTVN1PROD with NOTICES ucm497650.htm approximately 45 days link, or call the advisory committee security check procedures will be after the workshop. performed. For parking and security information line to learn about possible information, please refer to http:// Dated: May 24, 2016. modifications before coming to the www.fda.gov/AboutFDA/ Leslie Kux, meeting. WorkingatFDA/BuildingsandFacilities/ Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: Agenda: WhiteOakCampusInformation/ [FR Doc. 2016–12684 Filed 5–27–16; 8:45 am] On August 10, 2016, the committee will ucm241740.htm. BILLING CODE 4164–01–P discuss, make recommendations, and VerDate Sep<11>2014 20:07 May 27, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1


Document Created: 2016-05-28 03:58:01
Document Modified: 2016-05-28 03:58:01
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 Science Advisory Board to the National Center for Toxicological Research will expire on June 2, 2016, unless the Commissioner formally determines that renewal is in the public interest.
ContactDonna L. Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301- 796-8892, [email protected]
FR Citation81 FR 34353 
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