Request for Nominations on the Blood Products Advisory Committee, 85231-85232 [2016-28306]

Download as PDF Federal Register / Vol. 81, No. 227 / Friday, November 25, 2016 / Notices petition (Docket No. FDA–2016–P–1873, available at https:// www.regulations.gov/). This revised draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the design of BE studies to support ANDAs for cyclobenzaprine hydrochloride extended release capsules. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons with access to the Internet may obtain the revised draft guidance at either http://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov/. Dated: November 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–28334 Filed 11–23–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Request for Nominations on the Blood Products Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Blood Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:57 Nov 23, 2016 Jkt 241001 FDA by December 23, 2016. See sections I and II of this document for further details. Concurrently, nomination materials for prospective candidates should be sent to FDA by December 23, 2016. ADDRESSES: All statements of interest from industry organizations that wish to participate in the selection process of nonvoting industry representative nomination should be sent to Bryan Emery (see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting industry representatives may be submitted electronically by accessing the FDA Advisory Committee Membership Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or 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. Information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA’s Web site http:// www.fda.gov/AdvisoryCommittees/ default.htm. FOR FURTHER INFORMATION CONTACT: Bryan Emery, Division of Scientific Advisors and Consultants, CBER, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993–0002, 240–402–8054, Fax: 301–595–1307, email: bryan.emery@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting industry representative(s) to the following advisory committee: I. CBER Blood Products Advisory Committee The Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood; products derived from blood and serum or biotechnology intended for use in the diagnosis, prevention, or treatment of human diseases; and, as required, any other product for which FDA has regulatory responsibility. The Committee then advises the Commissioner of Food and Drugs of its findings regarding screening, testing, and labeling of products on clinical and laboratory studies involving such products on the affirmation or revocation of biological products licenses, as well as on the quality and relevance of FDA’s research program that provides the scientific support for regulating these agents. The Committee will function at times as a medical device panel under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) Medical Device Amendments of 1976. As such, the Committee: (1) PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 85231 Recommends classification of devices subject to its review into regulatory categories, (2) recommends the assignment of a priority for the application of regulatory requirements for devices classified in the standards or premarket approval category, (3) advises on formulation of product development protocols and reviews premarket approval applications for those devices to recommend changes in classification as appropriate, (4) recommends exemption of certain devices from the application of portions of the FD&C Act, (5) advises on the necessity to ban a device, and (6) responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. III. Application Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the committee of interest should be sent to the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES) within 30 days of publication of this document (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). E:\FR\FM\25NON1.SGM 25NON1 85232 Federal Register / Vol. 81, No. 227 / Friday, November 25, 2016 / Notices 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 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: November 18, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–28301 Filed 11–23–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Dated: November 18, 2016. Janice M. Soreth, Associate Commissioner, Special Medical Programs. National Institute of Neurological Disorders and Stroke; Notice of Meeting [FR Doc. 2016–28306 Filed 11–23–16; 8:45 am] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the National Advisory Neurological Disorders and Stroke Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Time Sensitive R21 Application Review Group. Date: December 9, 2016. Time: 1:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: NIEHS/National Institutes of Health, Keystone Building, Room 1002, 530 Davis Drive, Research Triangle Park, NC 27709 (Telephone Conference Call). Contact Person: Laura A. Thomas. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Name of Committee: National Advisory Neurological Disorders and Stroke Council. Date: February 9–10, 2017. Open: February 9, 2017, 8:00 a.m. to 3:30 p.m. Agenda: Report by the Director, NINDS; Report by the Director, Division of Extramural Research; and Administrative and Program Developments. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892. Closed: February 9, 2017, 3:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892. Closed: February 10, 2017, 8:00 a.m. to 11:00 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health asabaliauskas on DSK3SPTVN1PROD with NOTICES National Institute of Environmental Health Sciences; Notice of Closed Meeting VerDate Sep<11>2014 18:57 Nov 23, 2016 Jkt 241001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 Contact Person: Robert Finkelstein, Ph.D., Director, Division of Extramural Research, National Institute of Neurological Disorders and Stroke, NIH, 6001 Executive Blvd., Suite 3309, MSC 9531, Bethesda, MD 20892, (301) 496–9248. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: http:// www.ninds.nih.gov, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS). Dated: November 18, 2016. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–28303 Filed 11–23–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Social and Behavioral Influences on HIV Prevention and Treatment. Date: December 6, 2016. E:\FR\FM\25NON1.SGM 25NON1

Agencies

[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Notices]
[Pages 85231-85232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Request for Nominations on the Blood Products Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting that any 
industry organizations interested in participating in the selection of 
a nonvoting industry representative to serve on the Blood Products 
Advisory Committee for the Center for Biologics Evaluation and Research 
(CBER) notify FDA in writing. FDA is also requesting nominations for a 
nonvoting industry representative(s) to serve on the Blood Products 
Advisory Committee. A nominee may either be self-nominated or nominated 
by an organization to serve as a nonvoting industry representative. 
Nominations will be accepted for current vacancies effective with this 
notice.

DATES: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to FDA by December 
23, 2016. See sections I and II of this document for further details. 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by December 23, 2016.

ADDRESSES: All statements of interest from industry organizations that 
wish to participate in the selection process of nonvoting industry 
representative nomination should be sent to Bryan Emery (see FOR 
FURTHER INFORMATION CONTACT). All nominations for nonvoting industry 
representatives may be submitted electronically by accessing the FDA 
Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or 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. Information about becoming a member of an FDA 
advisory committee can also be obtained by visiting FDA's Web site 
http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Bryan Emery, Division of Scientific 
Advisors and Consultants, CBER, 10903 New Hampshire Ave., Bldg. 71, Rm. 
6128, Silver Spring, MD 20993-0002, 240-402-8054, Fax: 301-595-1307, 
email: bryan.emery@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting 
industry representative(s) to the following advisory committee:

I. CBER Blood Products Advisory Committee

    The Committee reviews and evaluates available data concerning the 
safety, effectiveness, and appropriate use of blood; products derived 
from blood and serum or biotechnology intended for use in the 
diagnosis, prevention, or treatment of human diseases; and, as 
required, any other product for which FDA has regulatory 
responsibility. The Committee then advises the Commissioner of Food and 
Drugs of its findings regarding screening, testing, and labeling of 
products on clinical and laboratory studies involving such products on 
the affirmation or revocation of biological products licenses, as well 
as on the quality and relevance of FDA's research program that provides 
the scientific support for regulating these agents. The Committee will 
function at times as a medical device panel under the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) Medical Device Amendments of 
1976. As such, the Committee: (1) Recommends classification of devices 
subject to its review into regulatory categories, (2) recommends the 
assignment of a priority for the application of regulatory requirements 
for devices classified in the standards or premarket approval category, 
(3) advises on formulation of product development protocols and reviews 
premarket approval applications for those devices to recommend changes 
in classification as appropriate, (4) recommends exemption of certain 
devices from the application of portions of the FD&C Act, (5) advises 
on the necessity to ban a device, and (6) responds to requests from the 
Agency to review and make recommendations on specific issues or 
problems concerning the safety and effectiveness of devices.

II. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests should send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed an interest, attaching 
a complete list of all such organizations and a list of all nominees 
along with their current resumes. The letter will also state that it is 
the responsibility of the interested organizations to confer with one 
another and to select a candidate, within 60 days after the receipt of 
the FDA letter, to serve as the nonvoting member to represent industry 
interests for the committee. The interested organizations are not bound 
by the list of nominees in selecting a candidate. However, if no 
individual is selected within 60 days, the Commissioner will select the 
nonvoting member to represent industry interests.

III. Application Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Contact information, a current curriculum vitae, and 
the name of the committee of interest should be sent to the FDA 
Advisory Committee Membership Nomination Portal (see ADDRESSES) within 
30 days of publication of this document (see DATES). FDA will forward 
all nominations to the organizations expressing interest in 
participating in the selection process for the committee. (Persons who 
nominate themselves as nonvoting industry representatives will not 
participate in the selection process).

[[Page 85232]]

    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
    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: November 18, 2016.
Janice M. Soreth,
Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-28306 Filed 11-23-16; 8:45 am]
 BILLING CODE 4164-01-P