80 FR 22201 - Request for Nominations on the Allergenic Products Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 76 (April 21, 2015)

Page Range		22201-22202
FR Document		2015-09082

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 Allergenic Products Advisory Committee for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on the Allergenic 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 or upcoming vacancies effective with this notice.

Federal Register, Volume 80 Issue 76 (Tuesday, April 21, 2015)

[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22201-22202]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09082]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Request for Nominations on the Allergenic 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 Allergenic Products 
Advisory Committee for the Center for Biologics Evaluation and Research 
notify FDA in writing. FDA is also requesting nominations for a 
nonvoting industry representative to serve on the Allergenic 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 or upcoming 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 May 
21, 2015, (see sections I and II for further details). Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
by May 21, 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 Janie 
Kim (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 
at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Janie Kim, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-9016, FAX: 301-595-
1307, email: [email protected].

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

I. Allergenic Products Advisory Committee

    The Committee reviews and evaluates available data concerning the 
safety, effectiveness, and adequacy of labeling of marketed and 
investigational allergenic biological products or materials that are 
administered to humans for the diagnosis, prevention, or treatment of 
allergies and allergic disease, and makes appropriate recommendations 
to the Commissioner of Food and Drugs of its findings regarding the 
affirmation or revocation of biological product licenses, on the 
safety, effectiveness, and labeling of the products, on clinical and 
laboratory studies of such products, on amendments or revisions to 
regulations governing the manufacture, testing and licensing of 
allergenic biological products, and on the quality and relevance of 
FDA's research programs which provide the scientific support for 
regulating these agents.

[[Page 22202]]

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, 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).
    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: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09082 Filed 4-20-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22201

5. Increase refugee knowledge of The tools will collect information status, and types and quantity of
financial and monetary topics including from grantees that will help ORR training provided. Tools will be used for
developing a household budget; determine whether they are meeting the semi-annual reports as well as for
6. Assist refugees in advancing their objectives of the program. Data to be monitoring to ensure progress towards
education; collected will only include specialized, success, and appropriate use of federal
and relevant information to the program funds.
7. Increase home ownership among such as, number of people enrolled,
refugees; and Respondents: Office of Refugee
amount in dollar allocated for matching
8. Assist refugees in gaining access to IDA savings, number and value of assets Resettlement Individual Development
capital. purchased, confirmation of refugee Accounts Program grantees.

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Program Status Report .................................................................................... 22 2 1 44
Community Impact Report ............................................................................... 22 2 1 44
Demographic .................................................................................................... 22 2 1 44

Estimated Total Annual Burden ACTION: Notice. Ave., Bldg. 32, Rm. 5103, Silver Spring,
Hours: 132 hours. MD 20993–0002. Information about
Additional Information: Copies of the SUMMARY: The Food and Drug becoming a member of an FDA advisory
proposed collection may be obtained by Administration (FDA) is requesting that committee can also be obtained by
writing to the Administration for any industry organizations interested in
visiting FDA’s Web site at http://
Children and Families, Office of participating in the selection of a
www.fda.gov/AdvisoryCommittees/
Planning, Research and Evaluation, 370 nonvoting industry representative to
default.htm.
L’Enfant Promenade SW., Washington, serve on the Allergenic Products
DC 20447, Attn: ACF Reports Clearance Advisory Committee for the Center for FOR FURTHER INFORMATION CONTACT:
Officer. All requests should be Biologics Evaluation and Research Janie Kim, Center for Biologics
identified by the title of the information notify FDA in writing. FDA is also Evaluation and Research, Food and
collection. Email address: requesting nominations for a nonvoting Drug Administration, 10903 New
infocollection@acf.hhs.gov. industry representative to serve on the Hampshire Ave., Silver Spring, MD
OMB Comment: OMB is required to Allergenic Products Advisory
20993, 301–796–9016, FAX: 301–595–
make a decision concerning the Committee. A nominee may either be
1307, email: janie.kim@fda.hhs.gov.
collection of information between 30 self-nominated or nominated by an
and 60 days after publication of this organization to serve as a nonvoting SUPPLEMENTARY INFORMATION: The
document in the Federal Register. industry representative. Nominations Agency intends to add a nonvoting
Therefore, a comment is best assured of will be accepted for current or industry representative to the following
having its full effect if OMB receives it upcoming vacancies effective with this advisory committee:
within 30 days of publication. Written notice.
comments and recommendations for the I. Allergenic Products Advisory
DATES: Any industry organization
proposed information collection should interested in participating in the Committee
be sent directly to the following: Office selection of an appropriate nonvoting The Committee reviews and evaluates
of Management and Budget, Paperwork member to represent industry interests available data concerning the safety,
Reduction Project, Email: OIRA_ must send a letter stating that interest to effectiveness, and adequacy of labeling
SUBMISSION@OMB.EOP.GOV, Attn: the FDA by May 21, 2015, (see sections of marketed and investigational
Desk Officer for the Administration for I and II for further details).
allergenic biological products or
Children and Families. Concurrently, nomination materials for
materials that are administered to
prospective candidates should be sent to
Robert Sargis, humans for the diagnosis, prevention, or
FDA by May 21, 2015.
Reports Clearance Officer. treatment of allergies and allergic
ADDRESSES: All statements of interest
[FR Doc. 2015–09192 Filed 4–20–15; 8:45 am] disease, and makes appropriate
from interested industry organizations
BILLING CODE 4184–01–P recommendations to the Commissioner
interested in participating in the
of Food and Drugs of its findings
selection process of nonvoting industry
regarding the affirmation or revocation
DEPARTMENT OF HEALTH AND representative nomination should be
sent to Janie Kim (see FOR FURTHER of biological product licenses, on the
HUMAN SERVICES safety, effectiveness, and labeling of the
INFORMATION CONTACT). All nominations
for nonvoting industry representatives products, on clinical and laboratory
Food and Drug Administration
may be submitted electronically by studies of such products, on
[Docket No. FDA–2015–N–0001] amendments or revisions to regulations
tkelley on DSK3SPTVN1PROD with NOTICES

accessing the FDA Advisory Committee
Membership Nomination Portal: governing the manufacture, testing and
Request for Nominations on the licensing of allergenic biological
https://www.accessdata.fda.gov/scripts/
Allergenic Products Advisory products, and on the quality and
FACTRSPortal/FACTRS/index.cfm or by
Committee
mail to Advisory Committee Oversight relevance of FDA’s research programs
AGENCY: Food and Drug Administration, and Management Staff, Food and Drug which provide the scientific support for
HHS. Administration, 10903 New Hampshire regulating these agents.

VerDate Sep<11>2014 18:07 Apr 20, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\21APN1.SGM 21APN1

22202 Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices

II. Selection Procedure DEPARTMENT OF HEALTH AND 1320.3(c) and includes Agency requests
HUMAN SERVICES or requirements that members of the
Any industry organization interested public submit reports, keep records, or
in participating in the selection of an Food and Drug Administration provide information to a third party.
appropriate nonvoting member to Section 3506(c)(2)(A) of the PRA (44
[Docket No. FDA–2012–N–0386]
represent industry interests should send U.S.C. 3506(c)(2)(A)) requires Federal
a letter stating that interest to the FDA Agency Information Collection Agencies to provide a 60-day notice in
contact (see FOR FURTHER INFORMATION Activities; Proposed Collection; the Federal Register concerning each
CONTACT) within 30 days of publication Comment Request; Registration and proposed collection of information,
of this document (see DATES). Within the Product Listing for Owners and including each proposed extension of an
subsequent 30 days, FDA will send a Operators of Domestic Tobacco existing collection of information,
letter to each organization that has Product Establishments and Listing of before submitting the collection to OMB
expressed an interest, attaching a Ingredients in Tobacco Products for approval. To comply with this
complete list of all such organizations; requirement, FDA is publishing notice
AGENCY: Food and Drug Administration, of the proposed collection of
and a list of all nominees along with HHS.
their current resumes. The letter will information set forth in this document.
ACTION: Notice. With respect to the following
also state that it is the responsibility of
collection of information, FDA invites
the interested organizations to confer SUMMARY: The Food and Drug comments on these topics: (1) Whether
with one another and to select a Administration (FDA) is announcing an the proposed collection of information
candidate, within 60 days after the opportunity for public comment on the is necessary for the proper performance
receipt of the FDA letter, to serve as the proposed collection of certain of FDA’s functions, including whether
nonvoting member to represent industry information by the Agency. Under the the information will have practical
interests for the committee. The Paperwork Reduction Act of 1995 (the utility; (2) the accuracy of FDA’s
interested organizations are not bound PRA), Federal Agencies are required to estimate of the burden of the proposed
by the list of nominees in selecting a publish notice in the Federal Register collection of information, including the
candidate. However, if no individual is concerning each proposed collection of validity of the methodology and
selected within 60 days, the information including each proposed assumptions used; (3) ways to enhance
Commissioner will select the nonvoting extension of an existing collection of the quality, utility, and clarity of the
member to represent industry interests. information, and to allow 60 days for information to be collected; and (4)
public comment in response to the ways to minimize the burden of the
III. Application Procedure notice. This notice solicits comments on collection of information on
the proposed extension of an existing respondents, including through the use
Individuals may self-nominate and/or collection of information pertaining to of automated collection techniques,
an organization may nominate one or registration and product listing for when appropriate, and other forms of
more individuals to serve as a nonvoting owners and operators of domestic information technology.
industry representative. Contact tobacco product establishments and
information, current curriculum vitae, listing of ingredients in tobacco Registration and Product Listing for
and the name of the committee of products. Owners and Operators of Domestic
interest should be sent to the FDA Tobacco Product Establishments and
DATES: Submit either electronic or
Advisory Committee Membership Listing of Ingredients in Tobacco
written comments on the collection of Products (OMB Control Number 0910–
Nomination Portal (see ADDRESSES) information by June 22, 2015.
within 30 days of publication of this 0650)—Extension)
ADDRESSES: Submit electronic
document (see DATES). FDA will forward comments on the collection of On June 22, 2009, the President
all nominations to the organizations information to http:// signed the Tobacco Control Act (Pub. L.
expressing interest in participating in 111–31) into law. The Tobacco Control
www.regulations.gov. Submit written
the selection process for the committee. Act amended the Federal Food, Drug,
comments on the collection of
(Persons who nominate themselves as and Cosmetic Act (the FD&C Act) (21
information to the Division of Dockets
nonvoting industry representatives will U.S.C. 301) by, among other things,
Management (HFA–305), Food and Drug
not participate in the selection process). adding a chapter granting FDA
Administration, 5630 Fishers Lane, Rm.
important authority to regulate the
FDA seeks to include the views of 1061, Rockville, MD 20852. All
manufacture, marketing, and
women, and men, members of all racial comments should be identified with the
distribution of tobacco products to
and ethnic groups and individuals with docket number found in brackets in the
protect the public health generally and
and without disabilities on its advisory heading of this document.
to reduce tobacco use by minors.
committees and, therefore encourages FOR FURTHER INFORMATION CONTACT: FDA Section 905(b) of the FD&C Act (21
nominations of appropriately qualified PRA Staff, Office of Operations, Food U.S.C. 387e(b)), as amended by the
candidates from these groups. and Drug Administration, 8455 Tobacco Control Act, requires that every
Colesville Rd., COLE–14526, Silver person who owns or operates any
This notice is issued under the Spring, MD 20993–0002, PRAStaff@
Federal Advisory Committee Act (5 establishment in any State engaged in
fda.hhs.gov. the manufacture, preparation,
U.S.C. app. 2) and 21 CFR part 14,
SUPPLEMENTARY INFORMATION: Under the compounding, or processing of a
relating to advisory committees.
tkelley on DSK3SPTVN1PROD with NOTICES

PRA (44 U.S.C. 3501–3520), Federal tobacco product or tobacco products
Dated: April 15, 2015. Agencies must obtain approval from the register with FDA the name, places of
Leslie Kux, Office of Management and Budget business, and all establishments owned
Associate Commissioner for Policy. (OMB) for each collection of or operated by that person. Every person
[FR Doc. 2015–09082 Filed 4–20–15; 8:45 am] information they conduct or sponsor. must register by December 31 of each
‘‘Collection of information’’ is defined year. Section 905(c) of the FD&C Act
BILLING CODE 4164–01–P
in 44 U.S.C. 3502(3) and 5 CFR requires that first-time persons engaging

VerDate Sep<11>2014 18:07 Apr 20, 2015 Jkt 235001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\21APN1.SGM 21APN1

Document Created: 2015-12-16 08:33:58
Document Modified: 2015-12-16 08:33:58

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		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 May 21, 2015, (see sections I and II for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by May 21, 2015.
Contact		Janie Kim, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-9016, FAX: 301-595- 1307, email: [email protected]
FR Citation		80 FR 22201

80 FR 22201 - Request for Nominations on the Allergenic Products Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 76 (April 21, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration