81_FR_62322 81 FR 62148 - Advisory Committee; Oncologic Drugs Advisory Committee, Renewal

81 FR 62148 - Advisory Committee; Oncologic Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 174 (September 8, 2016)

Page Range62148-62149
FR Document2016-21550

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.

Federal Register, Volume 81 Issue 174 (Thursday, September 8, 2016) 
[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62148-62149]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

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

62148 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of Average Number of Total annual Activity/21 CFR section records per burden per Total hours recordkeepers records recordkeeper recordkeeping Purchasing controls—820.50(a) .......................................... 24,738 1 24,738 22 544,236 Purchasing data—820.50(b) ................................................ 24,738 1 24,738 6 148,428 Identification—820.60 .......................................................... 24,738 1 24,738 1 24,738 Traceability—820.65 ............................................................ 24,738 1 24,738 1 24,738 Production and process controls—820.70(a) ...................... 24,738 1 24,738 2 49,476 Production and process changes and environmental con- trol—820.70(b) and (c) ..................................................... 24,738 1 24,738 2 49,476 Personnel—820.70(d) .......................................................... 24,738 1 24,738 3 74,214 Contamination control—820.70(e) ....................................... 24,738 1 24,738 2 49,476 Equipment maintenance schedule, inspection, and adjust- ment—820.70(g)(1)–(g)(3) ............................................... 24,738 1 24,738 1 24,738 Manufacturing material—820.70(h) ..................................... 24,738 1 24,738 2 49,476 Automated processes—820.70(i) ........................................ 24,738 1 24,738 8 197,904 Control of inspection, measuring, and test equipment— 820.72(a) .......................................................................... 24,738 1 24,738 5 123,690 Calibration procedures, standards, and records— 820.72(b)(1)–(b)(2) ........................................................... 24,738 1 24,738 1 24,738 Process validation—820.75(a) ............................................. 24,738 1 24,738 3 74,214 Validated process parameters, monitoring, control meth- ods, and data—820.75(b) ................................................ 24,738 1 24,738 1 24,738 Revalidation—820.75(c) ....................................................... 24,738 1 24,738 1 24,738 Acceptance activities—820.80(a)–(e) .................................. 24,738 1 24,738 5 123,690 Acceptance status—820.86 ................................................. 24,738 1 24,738 1 24,738 Control of nonconforming product—820.90(a) .................... 24,738 1 24,738 5 123,690 Nonconforming product review/disposition procedures and rework procedures—820.90(b)(1)–(b)(2) ......................... 24,738 1 24,738 5 123,690 Procedures for corrective/preventive actions— 820.100(a)(1)–(a)(7) ......................................................... 24,738 1 24,738 12 296,856 Corrective/preventive activities—820.100(b) ....................... 24,738 1 24,738 1 24,738 Labeling procedures—820.120(b) ....................................... 24,738 1 24,738 1 24,738 Labeling documentation—820.120(d) .................................. 24,738 1 24,738 1 24,738 Device packaging—820.130 ................................................ 24,738 1 24,738 1 24,738 Handling—820.140 .............................................................. 24,738 1 24,738 6 148,428 Storage—820.150(a) and (b) ............................................... 24,738 1 24,738 6 148,428 Distribution procedures and records—820.160(a) and (b) .. 24,738 1 24,738 1 24,738 Installation—820.170 ........................................................... 24,738 1 24,738 2 49,476 Record retention period—820.180(b) and (c) ...................... 24,738 1 24,738 2 49,476 Device master record—820.181 .......................................... 24,738 1 24,738 1 24,738 Device history record—820.184 .......................................... 24,738 1 24,738 1 24,738 Quality system record—820.186 ......................................... 24,738 1 24,738 1 24,738 Complaint files—820.198(a), (c), and (g) ............................ 24,738 1 24,738 5 123,690 Servicing procedures and reports—820.200(a) and (d) ...... 24,738 1 24,738 3 74,214 Statistical techniques procedures and sampling plans— 820.250 ............................................................................. 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. ACTION:Notice; renewal of advisory Commissioner formally determines that Leslie Kux, committee. renewal is in the public interest. Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2016–21553 Filed 9–7–16; 8:45 am] SUMMARY: The Food and Drug Lauren Tesh, Center for Drug Evaluation BILLING CODE 4164–01–P Administration (FDA) is announcing the and Research, Food and Drug renewal of the Oncologic Drugs Administration, 10903 New Hampshire Advisory Committee by the Ave., Bldg. 31, Rm. 2417, Silver Spring, DEPARTMENT OF HEALTH AND Commissioner of Food and Drugs (the MD 20993–0002, 301–796–9001, HUMAN SERVICES Commissioner). The Commissioner has ODAC@fda.hhs.gov. determined that it is in the public SUPPLEMENTARY INFORMATION: Under 41 Food and Drug Administration interest to renew the Oncologic Drugs CFR 102–3.65 and approval by the mstockstill on DSK3G9T082PROD with NOTICES Advisory Committee for an additional 2 Department of Health and Human [Docket No. FDA–2016–N–0001] years beyond the charter expiration Services pursuant to 45 CFR part 11 and date. The new charter will be in effect by the General Services Administration, Advisory Committee; Oncologic Drugs until September 1, 2018. Advisory Committee, Renewal FDA is announcing the renewal of the DATES: Authority for the Oncologic Oncologic Drugs Advisory Committee. AGENCY: Food and Drug Administration, Drugs Advisory Committee will expire The committee is a discretionary HHS. on September 1, 2016, unless the Federal advisory committee established VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\08SEN1.SGM 08SEN1

Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices 62149 to provide advice to the Commissioner. DEPARTMENT OF HEALTH AND Monica-Tia Bullock via email at The Oncologic Drugs Advisory HUMAN SERVICES MBullock@hrsa.gov. Committee advises the Commissioner or • The conference call-in number is 1– designee in discharging responsibilities Health Resources and Services 800–619–2521. Passcode: 9271697. as they relate to helping to ensure safe Administration • The webinar link is https:// and effective drugs for human use and, hrsa.connectsolutions.com/nacnhsc. as required, any other product for which National Advisory Council on the Public participants may submit the Food and Drug Administration has National Health Service Corps; Notice written statements in advance of the regulatory responsibility. of Meeting scheduled meeting. If you would like to provide oral public comment during the The Committee reviews and evaluates In accordance with section 10(a)(2) of meeting please register with Monica-Tia data concerning the safety and the Federal Advisory Committee Act Bullock at MBullock@hrsa.gov. Public effectiveness of marketed and (Pub. L. 92–463), notice is hereby given comment will be limited to 3 minutes investigational human drug products for of the following meeting: per speaker. Statements and comments use in the treatment of cancer and Name: National Advisory Council on can be addressed to Monica-Tia Bullock makes appropriate recommendations to the National Health Service Corps by emailing her at MBullock@hrsa.gov. the Commissioner of Food and Drugs. (NACNHSC). In addition, please be advised that Dates and Times: September 28, 2016 committee members are given copies of The Committee shall consist of a core 12:00 p.m.–3:30 p.m. EST. of 13 voting members including the all written statements submitted from Place: U.S. Department of Health and the public. Any further public Chair. Members and the Chair are Human Services, Health Resources and participation will be solely at the selected by the Commissioner or Services Administration, 5600 Fishers discretion of the Chair, with approval of designee from among authorities Lane, Rockville, Maryland 20857, the DFO. Registration through the knowledgeable in the fields of general Conference Call Format. designated contact for the public oncology, pediatric oncology, Status: This advisory council meeting comment session is required. hematologic oncology, immunology will be open to the public. Individuals who need reasonable oncology, biostatistics, and other related Purpose: The NACNHSC makes accommodations should contact professions. Members will be invited to recommendations with respect to their Monica-Tia Bullock at least 10 days serve for overlapping terms of up to 4 responsibilities under Subpart II, Part D prior to the meeting. years. Almost all non-Federal members of Title III of the Public Health Service FOR FURTHER INFORMATION CONTACT: of this committee serve as Special Act, as amended (National Health Anyone requesting information Government Employees. The core of Service Corps and Health Professional regarding the NACNHSC should contact voting members may include one Shortage Area Designations), and shall CAPT Jeanean Willis-Marsh, Director, technically qualified member, selected review and comment upon regulations Division of National Health Service by the Commissioner or designee, who promulgated by the Secretary under Corps, Bureau of Health Workforce, is identified with consumer interests Subpart II. Health Resources and Services and is recommended by either a Agenda: The NACNHSC has Administration, in one of three ways: (1) consortium of consumer oriented concluded its discussion for Fiscal Year Send a request to the following address: organizations or other interested 2016 and will present its formal CAPT Jeanean Willis-Marsh, Director, persons. In addition to the voting recommendations for each priority area. Division of National Health Service members, the Committee may include The Council will discuss policy Corps, Bureau of Health Workforce, one non-voting member who is recommendations for the National Health Resources and Services identified with industry interests. Health Service Corps scholarship and Administration, 5600 Fishers Lane, loan repayment programs with respect Further information regarding the Room 14N108, Rockville, Maryland to clinician recruitment and retention in most recent charter and other 20857; (2) call (301) 443–4494; or (3) underserved communities throughout information can be found at http:// send an email to jwillis@hrsa.gov. the service areas of the NHSC, www.fda.gov/AdvisoryCommittees/ telehealth, Medication Assisted Jason E. Bennett, CommitteesMeetingMaterials/Drugs/ Treatment (MAT) certification, Director, Division of the Executive Secretariat. OncologicDrugsAdvisoryCommittee/ mentorship, and NHSC discipline [FR Doc. 2016–21581 Filed 9–7–16; 8:45 am] ucm107395.htm or by contacting the expansion, specifically for mental and BILLING CODE 4165–15–P Designated Federal Officer (see FOR behavioral, and oral health providers. FURTHER INFORMATION CONTACT). In light The content of the agenda is subject of the fact that no change has been made to change prior to the meeting. The DEPARTMENT OF HEALTH AND to the committee name or description of NACNHAC final agenda will be HUMAN SERVICES duties, no amendment will be made to available 3 days in advance of the 21 CFR 14.100. meeting at http://nhsc.hrsa.gov/ Office of the Secretary This document is issued under the corpsexperience/aboutus/ nationaladvisorycouncil/ Delegation of Authorities Federal Advisory Committee Act (5 U.S.C. app.). For general information meetingsummaries/index.html. Notice is hereby given that I have related to FDA advisory committees, SUPPLEMENTARY INFORMATION: Further delegated to the Commissioner of Food please visit us at http://www.fda.gov/ information regarding the NACNHSC, and Drugs (the Commissioner) the mstockstill on DSK3G9T082PROD with NOTICES AdvisoryCommittees/default.htm. including the roster of members and authorities vested in the Secretary of the Dated: September 1, 2016. past meetings summaries, is available at Department of Health and Human http://nhsc.hrsa.gov/corpsexperience/ Services under sections 102(b)(2), (c); Leslie Kux, aboutus/nationaladvisorycouncil/ 103(b), (c), (d), (h); 104; 105(b); 106(b), Associate Commissioner for Policy. index.html. Members of the public and (c); 113(b); 114(d); 115; 201(c); 202(b); [FR Doc. 2016–21550 Filed 9–7–16; 8:45 am] interested parties may request to 204; 205(b)(2), (c); 206(b); 207(b); 304(b); BILLING CODE 4164–01–P participate in the meeting by contacting 305; 306(b); 308; and 309 of the FDA VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\08SEN1.SGM 08SEN1


Document Created: 2018-02-09 13:12:45
Document Modified: 2018-02-09 13:12:45
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 Oncologic Drugs Advisory Committee will expire on September 1, 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 protected]
FR Citation81 FR 62148 
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