Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee, 72809-72810 [2016-25497]
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72809
Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices
sometimes been sent for the wrong
reasons.
In addition to content and format
recommendations for each type of DHCP
letter, the guidance also includes advice
on consulting with FDA to develop a
DHCP letter, when to send a letter, what
type of letter to send, and conducting an
assessment of the letter’s impact.
Based on a review of FDA’s Document
Archiving, Reporting and Regulatory
Tracking System for 2012 to 2015, we
identified DHCP letters that were sent
and the identity of each sponsor sending
out a DHCP letter for each year. We
estimate that we will receive
approximately 25 DHCP Letters
annually from approximately 18
application holders. FDA professionals
familiar with DHCP letters and with the
recommendations in the guidance
estimate that it should take an
application holder approximately 100
hours to prepare and send DHCP letters
in accordance with the guidance.
In the Federal Register of March 10,
2016 (81 FR 12734), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
FDA estimates the annual reporting
burden of this collection of information
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of respondents
Number of responses per
respondent
Total annual
responses
Average burden per response (hours)
Total hours
Annual average ....................................................................
18
1.4
25
100
2,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25481 Filed 10–20–16; 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 for Voting
Members on a Public Advisory
Committee; Food Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Food Advisory Committee
(the 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 December 20, 2016, will be given
first consideration for membership on
the Food Advisory Committee.
Nominations received after December
20, 2016, will be considered for
nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by logging into the FDA
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:06 Oct 20, 2016
Jkt 241001
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.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is:
Karen Strambler, 5001 Campus Drive,
Rm. 1C–008, College Park, MD 20740,
email: karen.strambler@fda.hhs.gov,
240–402–2589, Fax: 301–436–2367.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
Web site by using the following link:
https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is
requesting nomination for voting
members on the Committee.
I. General Description of the Committee
Duties
The Committee reviews and evaluates
emerging food safety, nutrition, and
other food- or cosmetic-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
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
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Fmt 4703
Sfmt 4703
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 of Food and Drugs
(the Commissioner) designee from
among authorities knowledgeable in the
fields of physical sciences, biological
and life sciences, food science, risk
assessment, nutrition, food technology,
molecular biology, epidemiology and
other relevant scientific and technical
disciplines. 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 two
technically qualified member(s),
selected by the Commissioner or
designee, who are identified with
consumer interests and are
recommended by either a consortium of
consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include two non-voting member(s) who
are identified with industry interests.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
´
´
complete resume or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available. Nominations must also
E:\FR\FM\21OCN1.SGM
21OCN1
72810
Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices
specify the advisory committee for
which the nominee 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 related to financial holdings,
employment, and 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: October 18, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–25497 Filed 10–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0600]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Drug User
Fee Cover Sheet
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection requirements
of the Animal Drug User Fee cover
sheet.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by December 20, 2016.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
VerDate Sep<11>2014
19:06 Oct 20, 2016
Jkt 241001
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–N–0600 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Animal
Drug User Fee Cover Sheet.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
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Fmt 4703
Sfmt 4703
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
E:\FR\FM\21OCN1.SGM
21OCN1
Agencies
[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72809-72810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25497]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Request for Nominations for Voting Members on a Public Advisory
Committee; 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
(the 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 December 20, 2016, will be
given first consideration for membership on the Food Advisory
Committee. Nominations received after December 20, 2016, will be
considered for nomination to the committee as later vacancies occur.
ADDRESSES: All nominations for membership should be sent electronically
by logging into 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.
FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, the primary contact is: Karen Strambler, 5001 Campus Drive,
Rm. 1C-008, College Park, MD 20740, email: karen.strambler@fda.hhs.gov,
240-402-2589, Fax: 301-436-2367.
Information about becoming a member on an FDA advisory committee
can also be obtained by visiting FDA's Web site by using the following
link: https://www.fda.gov/AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting
members on the Committee.
I. General Description of the Committee Duties
The Committee reviews and evaluates emerging food safety,
nutrition, and other food- or cosmetic-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 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 of Food
and Drugs (the Commissioner) designee from among authorities
knowledgeable in the fields of physical sciences, biological and life
sciences, food science, risk assessment, nutrition, food technology,
molecular biology, epidemiology and other relevant scientific and
technical disciplines. 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 two technically qualified member(s), selected by
the Commissioner or designee, who are identified with consumer
interests and are recommended by either a consortium of consumer-
oriented organizations or other interested persons. In addition to the
voting members, the Committee may include two non-voting member(s) who
are identified with industry interests.
III. Nomination Procedures
Any interested person may nominate one or more qualified
individuals for membership on the advisory committee. Self-nominations
are also accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address and/or home address, telephone number, and
email address if available. Nominations must also
[[Page 72810]]
specify the advisory committee for which the nominee 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 related to
financial holdings, employment, and 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: October 18, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-25497 Filed 10-20-16; 8:45 am]
BILLING CODE 4164-01-P