Request for Nominations for Voting Members on the Food Advisory Committee, 73327-73328 [2014-28889]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss biologics license application (BLA) 125553 for EP2006, a proposed biosimilar to Amgen Inc.’s NEUPOGEN (filgrastim), submitted by Sandoz, Inc. The proposed indications (uses) for this product are: (1) To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; (2) for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia; (3) to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation; (4) for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and (5) for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before December 22, 2014. Oral presentations from the public will be scheduled between approximately 2:15 p.m. to 3:15 p.m. Those individuals VerDate Sep<11>2014 17:48 Dec 09, 2014 Jkt 235001 interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before December 12, 2014. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by December 15, 2014. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 3, 2014. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2014–28847 Filed 12–8–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–2032] Request for Nominations for Voting Members on the Food Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 73327 nominations for voting members to serve on the Food Advisory Committee, Office of Regulations, Policy, and Social Sciences, Center for Food Safety and Applied Nutrition. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before January 30, 2015, will be given first consideration for membership on the Food Advisory Committee. Nominations received after January 30, 2015, will be considered for nomination to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002, or by FAX to 301–847– 8640. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s Web site at https://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION: Regarding all nominations questions for membership, the primary contact is: Karen Strambler, Office of Regulations, Policy, and Social Sciences, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., Rm. 1C–016, College Park, MD 20740, 240–402–2589, FAX: 301–436– 2637, FoodAdvisoryCommittee@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members on the Food Advisory Committee. I. General Description of the Committee Duties The Food Advisory Committee provides advice to the Commissioner of Food and Drugs and other appropriate officials on emerging food safety, food science, nutrition, and other foodrelated health issues that FDA considers of primary importance for its food and cosmetics programs. The Committee may be charged with reviewing and evaluating available data and making recommendations on matters such as those relating to: (1) Broad scientific and technical food- or cosmetic-related E:\FR\FM\10DEN1.SGM 10DEN1 73328 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices issues; (2) the safety of food ingredients and new foods; (3) labeling of foods and cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe exposure limits for food contaminants. The Committee may also be asked to provide advice and make recommendations on ways of communicating to the public the potential risks associated with these issues and on approaches that might be considered for addressing the issues. DEPARTMENT OF HOMELAND SECURITY II. Criteria for Voting Members SUMMARY: The Committee consists of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among individuals knowledgeable in the fields of food science, microbiology, epidemiology, pediatric immunology, nutrition, food technology, biochemistry, and environmental health. Members are invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. Of the 15 members who vote, 2 are technically qualified members identified with consumer interests. In addition to the voting members, the Committee has two nonvoting members who are identified with industry interests. mstockstill on DSK4VPTVN1PROD with NOTICES III. Nomination Procedures Any interested person may nominate one or more qualified individuals for membership on the Committee. Selfnominations are also accepted. Nominations must include a current ´ ´ resume or curriculum vitae for each nominee, including a current business address and/or home address, telephone number, and email address if available. Nominations must also specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, research grants, and/or contracts to permit evaluation of possible sources of conflicts of interest. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: December 5, 2014. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2014–28889 Filed 12–9–14; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:48 Dec 09, 2014 Jkt 235001 [Docket No. DHS–2014–0005] PRA Extension: 1670–0023 Technical Assistance Request and Evaluation National Protection and Programs Directorate, DHS. ACTION: 60-day notice and request for comments; reinstatement of a previously approved collection: 1670–0023. AGENCY: The Department of Homeland Security (DHS), National Protection and Programs Directorate (NPPD), Office of Cybersecurity and Communications (CS&C), Office of Emergency Communications, (OEC) will submit the following Information Collection Request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chapter 35). DATES: Comments are encouraged and will be accepted until February 9, 2015. This process is conducted in accordance with 5 CFR 1320.1. ADDRESSES: Written comments and questions about this Information Collection Request should be forwarded to DHS/NPPD/CS&C/OEC, 245 Murray Lane SW., Mail Stop 0640, Arlington,VA 20598–0640. Emailed requests should go to Kendall Carpenter, Kendall.Carpenter@hq.dhs.gov. Written comments should reach the contact person listed no later than February 9, 2015. Comments must be identified by ‘‘DHS–2014–0005’’and may be submitted by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov . • Email: Kendall.Carpenter@ hq.dhs.gov Æ Include the docket number in the subject line of the message. Instructions: All submissions received must include the words ‘‘Department of Homeland Security’’ and the docket number for this action. Comments received will be posted without alteration at https://www.regulations.gov, including any personal information provided. OEC formed under Title XVIII of the Homeland Security Act of 2002, 6 U.S.C.574 et seq., as amended, is authorized to provide technical assistance at no charge to State, regional, local, and tribal government officials. OEC will use the Technical Assistance Request Form to identify the number and type of technical assistance requests from each State and territory. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00052 Fmt 4703 Sfmt 9990 OEC will use the Technical Assistance Evaluation Form to support quality improvement of its technical assistance services. Both Forms may be submitted electronically or in paper form. OMB is particularly interested in comments that: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. Analysis Agency: Department of Homeland Security, National Protection and Programs Directorate, Office of Emergency Communications. Title: Technical Asistance Request and Evaluation. OMB Number: 1670–0023. Frequency: Annually. Affected Public: State, local and tribal government. Number of Respondents: 56 respondents (estimate). Estimated Time per Respondent: 15 minutes. Total Burden Hours: 175 annual burden hours. Total Burden Cost (capital/startup): $0. Total Recordkeeping Burden: $0. Total Burden Cost (operating/ maintaining): $4,273.50. Dated: December 2, 2014. Scott Libby, Deputy Chief Information Officer, National Protection and Programs Directorate, Department of Homeland Security. [FR Doc. 2014–28885 Filed 12–9–14; 8:45 am] BILLING CODE 9110–9P–P E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73327-73328]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28889]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2032]


Request for Nominations for Voting Members on the Food Advisory 
Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting members to serve on the Food Advisory Committee, 
Office of Regulations, Policy, and Social Sciences, Center for Food 
Safety and Applied Nutrition. FDA seeks to include the views of women 
and men, members of all racial and ethnic groups, and individuals with 
and without disabilities on its advisory committees and, therefore, 
encourages nominations of appropriately qualified candidates from these 
groups.

DATES: Nominations received on or before January 30, 2015, will be 
given first consideration for membership on the Food Advisory 
Committee. Nominations received after January 30, 2015, will be 
considered for nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be submitted 
electronically by logging into the FDA Advisory Committee Membership 
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and 
Management Staff, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX to 
301-847-8640.
    Information about becoming a member on an FDA advisory committee 
can also be obtained by visiting FDA's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION: Regarding all nominations questions for 
membership, the primary contact is: Karen Strambler, Office of 
Regulations, Policy, and Social Sciences, Center for Food Safety and 
Applied Nutrition, 5100 Paint Branch Pkwy., Rm. 1C-016, College Park, 
MD 20740, 240-402-2589, FAX: 301-436-2637, 
FoodAdvisoryCommittee@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members on the Food Advisory Committee.

I. General Description of the Committee Duties

    The Food Advisory Committee provides advice to the Commissioner of 
Food and Drugs and other appropriate officials on emerging food safety, 
food science, nutrition, and other food-related health issues that FDA 
considers of primary importance for its food and cosmetics programs. 
The Committee may be charged with reviewing and evaluating available 
data and making recommendations on matters such as those relating to: 
(1) Broad scientific and technical food- or cosmetic-related

[[Page 73328]]

issues; (2) the safety of food ingredients and new foods; (3) labeling 
of foods and cosmetics; (4) nutrient needs and nutritional adequacy; 
and (5) safe exposure limits for food contaminants. The Committee may 
also be asked to provide advice and make recommendations on ways of 
communicating to the public the potential risks associated with these 
issues and on approaches that might be considered for addressing the 
issues.

II. Criteria for Voting Members

    The Committee consists of a core of 15 voting members including the 
Chair. Members and the Chair are selected by the Commissioner or 
designee from among individuals knowledgeable in the fields of food 
science, microbiology, epidemiology, pediatric immunology, nutrition, 
food technology, biochemistry, and environmental health. Members are 
invited to serve for overlapping terms of up to 4 years.
    Almost all non-Federal members of this committee serve as Special 
Government Employees. Of the 15 members who vote, 2 are technically 
qualified members identified with consumer interests. In addition to 
the voting members, the Committee has two nonvoting members who are 
identified with industry interests.

III. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on the Committee. Self-nominations are also 
accepted. Nominations must include a current r[eacute]sum[eacute] or 
curriculum vitae for each nominee, including a current business address 
and/or home address, telephone number, and email address if available. 
Nominations must also specify the advisory committee for which the 
nominee is recommended. Nominations must also acknowledge that the 
nominee is aware of the nomination unless self-nominated. FDA will ask 
potential candidates to provide detailed information concerning such 
matters as financial holdings, employment, research grants, and/or 
contracts to permit evaluation of possible sources of conflicts of 
interest.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: December 5, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-28889 Filed 12-9-14; 8:45 am]
BILLING CODE 4164-01-P
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