Advisory Committee; Oncologic Drugs Advisory Committee, Renewal, 62148-62149 [2016-21550]

Download as PDF 62148 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers Activity/21 CFR section Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Purchasing controls—820.50(a) .......................................... Purchasing data—820.50(b) ................................................ Identification—820.60 .......................................................... Traceability—820.65 ............................................................ Production and process controls—820.70(a) ...................... Production and process changes and environmental control—820.70(b) and (c) ..................................................... Personnel—820.70(d) .......................................................... Contamination control—820.70(e) ....................................... Equipment maintenance schedule, inspection, and adjustment—820.70(g)(1)–(g)(3) ............................................... Manufacturing material—820.70(h) ..................................... Automated processes—820.70(i) ........................................ Control of inspection, measuring, and test equipment— 820.72(a) .......................................................................... Calibration procedures, standards, and records— 820.72(b)(1)–(b)(2) ........................................................... Process validation—820.75(a) ............................................. Validated process parameters, monitoring, control methods, and data—820.75(b) ................................................ Revalidation—820.75(c) ....................................................... Acceptance activities—820.80(a)–(e) .................................. Acceptance status—820.86 ................................................. Control of nonconforming product—820.90(a) .................... Nonconforming product review/disposition procedures and rework procedures—820.90(b)(1)–(b)(2) ......................... Procedures for corrective/preventive actions— 820.100(a)(1)–(a)(7) ......................................................... Corrective/preventive activities—820.100(b) ....................... Labeling procedures—820.120(b) ....................................... Labeling documentation—820.120(d) .................................. Device packaging—820.130 ................................................ Handling—820.140 .............................................................. Storage—820.150(a) and (b) ............................................... Distribution procedures and records—820.160(a) and (b) .. Installation—820.170 ........................................................... Record retention period—820.180(b) and (c) ...................... Device master record—820.181 .......................................... Device history record—820.184 .......................................... Quality system record—820.186 ......................................... Complaint files—820.198(a), (c), and (g) ............................ Servicing procedures and reports—820.200(a) and (d) ...... Statistical techniques procedures and sampling plans— 820.250 ............................................................................. 24,738 24,738 24,738 24,738 24,738 1 1 1 1 1 24,738 24,738 24,738 24,738 24,738 22 6 1 1 2 544,236 148,428 24,738 24,738 49,476 24,738 24,738 24,738 1 1 1 24,738 24,738 24,738 2 3 2 49,476 74,214 49,476 24,738 24,738 24,738 1 1 1 24,738 24,738 24,738 1 2 8 24,738 49,476 197,904 24,738 1 24,738 5 123,690 24,738 24,738 1 1 24,738 24,738 1 3 24,738 74,214 24,738 24,738 24,738 24,738 24,738 1 1 1 1 1 24,738 24,738 24,738 24,738 24,738 1 1 5 1 5 24,738 24,738 123,690 24,738 123,690 24,738 1 24,738 5 123,690 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 24,738 12 1 1 1 1 6 6 1 2 2 1 1 1 5 3 296,856 24,738 24,738 24,738 24,738 148,428 148,428 24,738 49,476 49,476 24,738 24,738 24,738 123,690 74,214 24,738 1 24,738 1 24,738 Total .............................................................................. ........................ ........................ ........................ ........................ 8,410,920 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 1, 2016. Leslie Kux, Associate Commissioner for Policy. Notice; renewal of advisory committee. ACTION: BILLING CODE 4164–01–P mstockstill on DSK3G9T082PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Advisory Committee; Oncologic Drugs Advisory Committee, Renewal AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic 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 Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until September 1, 2018. DATES: Authority for the Oncologic Drugs Advisory Committee will expire on September 1, 2016, unless the SUMMARY: [FR Doc. 2016–21553 Filed 9–7–16; 8:45 am] PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 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, ODAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under 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 Oncologic Drugs Advisory Committee. The committee is a discretionary Federal advisory committee established E:\FR\FM\08SEN1.SGM 08SEN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices to provide advice to the Commissioner. The Oncologic 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 data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer 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 general oncology, pediatric oncology, hematologic oncology, immunology oncology, biostatistics, and other related professions. 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. 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/ OncologicDrugsAdvisoryCommittee/ ucm107395.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: September 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–21550 Filed 9–7–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: National Advisory Council on the National Health Service Corps (NACNHSC). Dates and Times: September 28, 2016 12:00 p.m.–3:30 p.m. EST. Place: U.S. Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Rockville, Maryland 20857, Conference Call Format. Status: This advisory council meeting will be open to the public. Purpose: The NACNHSC makes recommendations with respect to their responsibilities under Subpart II, Part D of Title III of the Public Health Service Act, as amended (National Health Service Corps and Health Professional Shortage Area Designations), and shall review and comment upon regulations promulgated by the Secretary under Subpart II. Agenda: The NACNHSC has concluded its discussion for Fiscal Year 2016 and will present its formal recommendations for each priority area. The Council will discuss policy recommendations for the National Health Service Corps scholarship and loan repayment programs with respect to clinician recruitment and retention in underserved communities throughout the service areas of the NHSC, telehealth, Medication Assisted Treatment (MAT) certification, mentorship, and NHSC discipline expansion, specifically for mental and behavioral, and oral health providers. The content of the agenda is subject to change prior to the meeting. The NACNHAC final agenda will be available 3 days in advance of the meeting at http://nhsc.hrsa.gov/ corpsexperience/aboutus/ nationaladvisorycouncil/ meetingsummaries/index.html. SUPPLEMENTARY INFORMATION: Further information regarding the NACNHSC, including the roster of members and past meetings summaries, is available at http://nhsc.hrsa.gov/corpsexperience/ aboutus/nationaladvisorycouncil/ index.html. Members of the public and interested parties may request to participate in the meeting by contacting PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 62149 Monica-Tia Bullock via email at MBullock@hrsa.gov. • The conference call-in number is 1– 800–619–2521. Passcode: 9271697. • The webinar link is https:// hrsa.connectsolutions.com/nacnhsc. Public participants may submit written statements in advance of the scheduled meeting. If you would like to provide oral public comment during the meeting please register with Monica-Tia Bullock at MBullock@hrsa.gov. Public comment will be limited to 3 minutes per speaker. Statements and comments can be addressed to Monica-Tia Bullock by emailing her at MBullock@hrsa.gov. In addition, please be advised that committee members are given copies of all written statements submitted from the public. Any further public participation will be solely at the discretion of the Chair, with approval of the DFO. Registration through the designated contact for the public comment session is required. Individuals who need reasonable accommodations should contact Monica-Tia Bullock at least 10 days prior to the meeting. FOR FURTHER INFORMATION CONTACT: Anyone requesting information regarding the NACNHSC should contact CAPT Jeanean Willis-Marsh, Director, Division of National Health Service Corps, Bureau of Health Workforce, Health Resources and Services Administration, in one of three ways: (1) Send a request to the following address: CAPT Jeanean Willis-Marsh, Director, Division of National Health Service Corps, Bureau of Health Workforce, Health Resources and Services Administration, 5600 Fishers Lane, Room 14N108, Rockville, Maryland 20857; (2) call (301) 443–4494; or (3) send an email to jwillis@hrsa.gov. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016–21581 Filed 9–7–16; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Delegation of Authorities Notice is hereby given that I have delegated to the Commissioner of Food and Drugs (the Commissioner) the authorities vested in the Secretary of the Department of Health and Human Services under sections 102(b)(2), (c); 103(b), (c), (d), (h); 104; 105(b); 106(b), (c); 113(b); 114(d); 115; 201(c); 202(b); 204; 205(b)(2), (c); 206(b); 207(b); 304(b); 305; 306(b); 308; and 309 of the FDA E:\FR\FM\08SEN1.SGM 08SEN1

Agencies

[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62148-62149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21550]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Advisory Committee; Oncologic 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 Oncologic 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 Oncologic Drugs Advisory 
Committee for an additional 2 years beyond the charter expiration date. 
The new charter will be in effect until September 1, 2018.

DATES: Authority for the Oncologic Drugs Advisory Committee will expire 
on September 1, 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, ODAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under 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 Oncologic Drugs Advisory Committee. The committee is a 
discretionary Federal advisory committee established

[[Page 62149]]

to provide advice to the Commissioner. The Oncologic 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 data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of cancer 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 general oncology, pediatric oncology, hematologic oncology, 
immunology oncology, biostatistics, and other related professions. 
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. 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/OncologicDrugsAdvisoryCommittee/ucm107395.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: September 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21550 Filed 9-7-16; 8:45 am]
 BILLING CODE 4164-01-P