80_FR_27018 80 FR 26928 - Request for Nominations on the Vaccines and Related Biological Products Advisory Committee

80 FR 26928 - Request for Nominations on the Vaccines and Related Biological Products Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 90 (May 11, 2015)

Page Range26928-26929
FR Document2015-11258

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 Vaccines and Related Biological 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 Vaccines and Related Biological 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.

Federal Register, Volume 80 Issue 90 (Monday, May 11, 2015) 
[Federal Register Volume 80, Number 90 (Monday, May 11, 2015)]
[Notices]
[Pages 26928-26929]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11258]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Request for Nominations on the Vaccines and Related Biological 
Products Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 Vaccines and 
Related Biological 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 Vaccines and Related Biological 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 the FDA by June 
10, 2015, (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by June 10, 2015.

ADDRESSES: All statements of interest from interested industry 
organizations interested in participating in the selection process of 
nonvoting industry representative nomination should be sent to Sujata 
Vijh (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: Sujata Vijh, Division of Scientific 
Advisors and Consultants, Center for Biologics Evaluation and Research, 
10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-
0002, 240-402-7107, FAX: 301-595-1307, email: [email protected].

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

[[Page 26929]]

I. CBER Vaccines and Related Biological Products Advisory Committee

    The CBER Vaccines and Related Biological Products Advisory 
Committee (the Committee) reviews and evaluates data concerning the 
safety, effectiveness, and appropriate use of vaccines and related 
biological products which are intended for use in the prevention, 
treatment, or diagnosis of human diseases, and, as required, any other 
product for which FDA has regulatory responsibility. The Committee also 
considers the quality and relevance of FDA's research program which 
provides scientific support for the regulation of these products and 
makes appropriate recommendations to the Commissioner of Food and 
Drugs.

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 
(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 (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).
    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: May 5, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-11258 Filed 5-8-15; 8:45 am]
 BILLING CODE 4164-01-P

26928 Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Notices applicants (both treatment and control) participants on a semi-annual basis over coordinated Tribal evaluation, and other through baseline data collection; and (3) the grant period of performance and future research and evaluation efforts individual enrolled program intake information on eligible sponsored by ACF. participants’ activities and outcomes. applicants (both treatment and control) Respondents: Grantee- and The universe of information through baseline data collection. The participant-level data to be collected by collection proposed for HPOG Next Gen data system will meet the performance program staff in the approximately 40 includes the HPOG Next Gen data needs of the HPOG Next Gen grantee organizations (higher education Participant Accomplishment and Grant grantees and of the ACF Office of institutions, workforce investment Evaluation System (PAGES). PAGES is a Family Assistance to monitor the boards, private training institutions, performance management system that performance of the grants and prepare nonprofit organizations, and tribal will collect information from all the report to Congress on the grants, as entities). Applicants at the 40 grantee grantees on their programs and well as support an impact study, a organizations. ANNUAL BURDEN ESTIMATES Annual Number of Average Total number Annual burden Instrument number of responses per burden hours of respondents hours respondents respondent per response PAGES Grantee—and Participant-Level Data Collection (all grantees) .................................................................... 120 40 2 31.75 2,540 PAGES Participant-Level Baseline Data Collection (partici- pants at non-Tribal grantees participating in impact study) ................................................................................ 31,500 10,500 1 .5 5,250 PAGES Participant-Level Baseline Data Collection (partici- pants at Tribal grantees) .................................................. 1,200 400 1 .25 100 Estimated Total Annual Burden Hours: ........................ ........................ ........................ ........................ ........................ 7,890 Additional Information: Copies of the DEPARTMENT OF HEALTH AND I and II of this document for further proposed collection may be obtained by HUMAN SERVICES details). Concurrently, nomination writing to the Administration for materials for prospective candidates Children and Families, Office of Food and Drug Administration should be sent to FDA by June 10, 2015. Planning, Research and Evaluation, 370 [Docket No. FDA–2015–N–0001] ADDRESSES: All statements of interest L’Enfant Promenade SW., Washington, from interested industry organizations DC 20447, Attn: OPRE Reports Request for Nominations on the interested in participating in the Clearance Officer. All requests should Vaccines and Related Biological selection process of nonvoting industry be identified by the title of the Products Advisory Committee representative nomination should be information collection. Email address: sent to Sujata Vijh (see FOR FURTHER AGENCY: Food and Drug Administration, OPREinfocollection@acf.hhs.gov. INFORMATION CONTACT). All nominations HHS. for nonvoting industry representatives OMB Comment: OMB is required to ACTION: Notice. may be submitted electronically by make a decision concerning the accessing the FDA Advisory Committee collection of information between 30 SUMMARY: The Food and Drug Administration (FDA) is requesting that Membership Nomination Portal: https:// and 60 days after publication of this www.accessdata.fda.gov/scripts/ document in the Federal Register. any industry organizations interested in participating in the selection of a FACTRSPortal/FACTRS/index.cfm or by Therefore, a comment is best assured of mail to Advisory Committee Oversight having its full effect if OMB receives it nonvoting industry representative to serve on the Vaccines and Related and Management Staff, Food and Drug within 30 days of publication. Written Administration, 10903 New Hampshire Biological Products Advisory comments and recommendations for the Ave., Bldg. 32, Rm. 5103, Silver Spring, Committee for the Center for Biologics proposed information collection should MD 20993–0002. Information about Evaluation and Research (CBER) notify be sent directly to the following: Office FDA in writing. FDA is also requesting becoming a member of an FDA advisory of Management and Budget, Paperwork nominations for a nonvoting industry committee can also be obtained by Reduction Project, Email: OIRA_ representative(s) to serve on the visiting FDA’s Web site: http:// SUBMISSION@OMB.EOP.GOV, Attn: Vaccines and Related Biological www.fda.gov/AdvisoryCommittees/ Desk Officer for the Administration for Products Advisory Committee. A default.htm. Children and Families. nominee may either be self-nominated FOR FURTHER INFORMATION CONTACT: Karl Koerper, or nominated by an organization to Sujata Vijh, Division of Scientific serve as a nonvoting industry Advisors and Consultants, Center for OPRE Reports Clearance Officer. representative. Nominations will be Biologics Evaluation and Research, [FR Doc. 2015–11266 Filed 5–8–15; 8:45 am] accepted for current vacancies effective 10903 New Hampshire Ave., Bldg. 71, with this notice. Rm. 6128, Silver Spring, MD 20993– tkelley on DSK3SPTVN1PROD with NOTICES BILLING CODE 4184–72–P DATES: Any industry organization 0002, 240–402–7107, FAX: 301–595– interested in participating in the 1307, email: Sujata.vijh@fda.hhs.gov. selection of an appropriate nonvoting SUPPLEMENTARY INFORMATION: The member to represent industry interests Agency intends to add a nonvoting must send a letter stating that interest to industry representative(s) to the the FDA by June 10, 2015, (see sections following advisory committee: VerDate Sep<11>2014 17:00 May 08, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\11MYN1.SGM 11MYN1

Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Notices 26929 I. CBER Vaccines and Related nonvoting industry representatives will 741–8138 (301–443–0572 in the Biological Products Advisory not participate in the selection process). Washington, DC area). A notice in the Committee FDA seeks to include the views of Federal Register about last minute women, and men, members of all racial modifications that impact a previously The CBER Vaccines and Related and ethnic groups, and individuals with announced advisory committee meeting Biological Products Advisory and without disabilities on its advisory cannot always be published quickly Committee (the Committee) reviews and committees and, therefore encourages enough to provide timely notice. evaluates data concerning the safety, nominations of appropriately qualified Therefore, you should always check the effectiveness, and appropriate use of candidates from these groups. Agency’s Web site at http:// vaccines and related biological products This notice is issued under the www.fda.gov/AdvisoryCommittees/ which are intended for use in the Federal Advisory Committee Act (5 default.htm and scroll down to the prevention, treatment, or diagnosis of U.S.C. app. 2) and 21 CFR part 14, appropriate advisory committee meeting human diseases, and, as required, any relating to advisory committees. link, or call the advisory committee other product for which FDA has Dated: May 5, 2015. information line to learn about possible regulatory responsibility. The modifications before coming to the Jill Hartzler Warner, Committee also considers the quality meeting. and relevance of FDA’s research Associate Commissioner for Special Medical Agenda: The committee will discuss Programs. program which provides scientific biologics license application (BLA) [FR Doc. 2015–11258 Filed 5–8–15; 8:45 am] support for the regulation of these 125526, for mepolizumab for injection, products and makes appropriate BILLING CODE 4164–01–P submitted by GlaxoSmithKline for the recommendations to the Commissioner proposed indication of add-on of Food and Drugs. maintenance treatment in patients 12 DEPARTMENT OF HEALTH AND years and older with severe eosinophilic II. Selection Procedure HUMAN SERVICES asthma identified by blood eosinophils Any industry organization interested Food and Drug Administration greater than or equal to 150 cells/ in participating in the selection of an microliter at initiation of treatment or [Docket No. FDA–2015–N–0001] blood eosinophils greater than or equal appropriate nonvoting member to represent industry interests should send to 300 cells/microliter in the past 12 Pulmonary-Allergy Drugs Advisory months. a letter stating that interest to the FDA Committee; Notice of Meeting contact (see FOR FURTHER INFORMATION FDA intends to make background CONTACT) within 30 days of publication AGENCY: Food and Drug Administration, material available to the public no later (see DATES). Within the subsequent 30 HHS. than 2 business days before the meeting. days, FDA will send a letter to each ACTION: Notice. If FDA is unable to post the background organization that has expressed an material on its Web site prior to the interest, attaching a complete list of all This notice announces a forthcoming meeting, the background material will meeting of a public advisory committee be made publicly available at the such organizations; and a list of all of the Food and Drug Administration location of the advisory committee nominees along with their current (FDA). The meeting will be open to the meeting, and the background material resumes. The letter will also state that public. will be posted on FDA’s Web site after it is the responsibility of the interested Name of Committee: Pulmonary- the meeting. Background material is organizations to confer with one another Allergy Drugs Advisory Committee. available at http://www.fda.gov/ and to select a candidate, within 60 General Function of the Committee: AdvisoryCommittees/Calendar/ days after the receipt of the FDA letter, To provide advice and default.htm. Scroll down to the to serve as the nonvoting member to recommendations to the Agency on appropriate advisory committee meeting represent industry interests for the FDA’s regulatory issues. link. committee. The interested organizations Date and Time: The meeting will be Procedure: Interested persons may are not bound by the list of nominees in held on June 11, 2015, from 8 a.m. to 5 present data, information, or views, selecting a candidate. However, if no p.m. orally or in writing, on issues pending individual is selected within 60 days, Location: Hilton Washington DC before the committee. Written the Commissioner will select the North/Gaithersburg, Grand Ballroom, submissions may be made to the contact nonvoting member to represent industry 620 Perry Pkwy., Gaithersburg, MD person on or before May 28, 2015. Oral interests. 20877. Answers to commonly asked presentations from the public will be III. Application Procedure questions including information scheduled between approximately 1 regarding special accommodations due p.m. and 2 p.m. Those individuals Individuals may self-nominate and/or to a disability, visitor parking, and interested in making formal oral an organization may nominate one or transportation may be accessed at: presentations should notify the contact more individuals to serve as a nonvoting http://www.fda.gov/ person and submit a brief statement of industry representative. Contact AdvisoryCommittees/ the general nature of the evidence or information, a current curriculum vitae, AboutAdvisoryCommittees/ arguments they wish to present, the and the name of the committee of ucm408555.htm. names and addresses of proposed interest should be sent to the FDA Contact Person: Kristina Toliver, participants, and an indication of the Advisory Committee Membership Center for Drug Evaluation and approximate time requested to make tkelley on DSK3SPTVN1PROD with NOTICES Nomination Portal (see ADDRESSES) Research, Food and Drug their presentation on or before May 19, within 30 days of publication (see Administration, 10903 New Hampshire 2015. Time allotted for each DATES). FDA will forward all Ave., Bldg. 31, Rm. 2417, Silver Spring, presentation may be limited. If the nominations to the organizations MD 20993–0002, 301–796–9001, FAX: number of registrants requesting to expressing interest in participating in 301–847–8533, email: speak is greater than can be reasonably the selection process for the committee. PADAC@fda.hhs.gov, or FDA Advisory accommodated during the scheduled (Persons who nominate themselves as Committee Information Line, 1–800– open public hearing session, FDA may VerDate Sep<11>2014 17:00 May 08, 2015 Jkt 235001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\11MYN1.SGM 11MYN1


Document Created: 2018-02-21 10:25:48
Document Modified: 2018-02-21 10:25:48
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.
DatesAny 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 the FDA by June 10, 2015, (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by June 10, 2015.
ContactSujata Vijh, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993- 0002, 240-402-7107, FAX: 301-595-1307, email: [email protected]
FR Citation80 FR 26928 
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