Advisory Committee; Science Board to the Food and Drug Administration, Renewal, 47396-47397 [2016-17182]
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47396
Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices
2016)—Revision—National Center for
Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C.), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability of the population
of the United States.
The National Death Index (NDI) is a
national data base containing
identifying death record information
submitted annually to NCHS by all the
state vital statistics offices, beginning
with deaths in 1979. Searches against
update the three data collection forms
submitted by NDI users when applying
for use of the NDI and when actually
using the service. The form updates
include editorial changes needed to
capture current modes of data transfer
and service payment options, direction
clarifications, the inclusion of an item to
capture any resulting publications, as
well as, additional terms and condition
associated with the confidentiality
agreement. There is no cost to
respondents except for their time. The
total estimated annual burden hours are
507, an increase of 325 hours due to an
anticipated increase of both the number
of applicants and an overall average
increased time to complete the
application form.
the NDI file provide the states and dates
of death, and the death certificate
numbers of deceased study subjects.
Using the NDI Plus service,
researchers have the option of also
receiving cause of death information for
deceased subjects, thus reducing the
need to request copies of death
certificates from the states. The NDI
Plus option currently provides the
International Classification of Disease
(ICD) codes for the underlying and
multiple causes of death for the years
1979–2015. Health researchers must
complete administrative forms in order
to apply for NDI services, and submit
records of study subjects for computer
matching against the NDI file. A threeyear Revision request is submitted to
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total burden
hours
Type of respondent
Form name
Researchers ......................................
Researchers ......................................
Researchers ......................................
Application Form ..............................
Repeat Request Form ......................
Data Transmittal Form .....................
100
70
120
1
1
1
4.5
18/60
18/60
450
21
36
Total ...........................................
...........................................................
........................
........................
........................
507
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2016–17170 Filed 7–20–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Science Board to
the Food and Drug Administration,
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Science Board to the
Food and Drug Administration by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Science Board to
the Food and Drug Administration for
an additional 2 years beyond the charter
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:15 Jul 20, 2016
Jkt 238001
expiration date. The new charter will be
in effect until June 26, 2018.
DATES: Authority for the Science Board
to the Food and Drug Administration
will expire on June 26, 2018, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Rakesh Raghuwanshi, Office of the
Chief Scientist, Office of the
Commissioner, Food and Drug
Administration, Bldg. 1, Rm. 3309,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–4769,
rakesh.raghuwanshi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Science Board to the Food and Drug
Administration. The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Science Board
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility. The
Science Board shall provide advice to
the Commissioner and other appropriate
officials on specific complex scientific
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
and technical issues important to FDA
and its mission, including emerging
issues within the scientific community.
Additionally, the Science Board will
provide advice that supports the Agency
in keeping pace with technical and
scientific developments, including in
regulatory science; and input into the
Agency’s research agenda; and on
upgrading its scientific and research
facilities and training opportunities. It
will also provide, where requested,
expert review of Agency-sponsored
intramural and extramural scientific
research programs.
The Committee shall consist of a core
of 21 voting members including a Chair
and Co-Chair. The members, Chair and
Co-Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of food science, safety, and nutrition;
chemistry; pharmacology; translational
and clinical medicine and research;
toxicology; biostatistics; medical
devices; imaging; robotics; cell and
tissue based products; regenerative
medicine; public health and
epidemiology; international health and
regulation; product safety; product
manufacturing sciences and quality; and
other scientific areas relevant to FDA
regulated products such as systems
biology, informatics, nanotechnology,
and combination products. Members
E:\FR\FM\21JYN1.SGM
21JYN1
Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices
will be invited to serve for overlapping
terms of up to 4 years. Almost all nonFederal members of this committee
serve as Special Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. The Committee may
also include technically qualified
federal members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
ScienceBoardtotheFoodand
DrugAdministration/ucm115356.htm or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: July 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17182 Filed 7–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–D–0155 (formerly
2005D–0219)]
General Principles for Evaluating the
Human Food Safety of New Animal
Drugs Used in Food-Producing
Animals; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
revised guidance for industry #3
entitled ‘‘General Principles for
Evaluating the Human Food Safety of
New Animal Drugs Used in FoodProducing Animals.’’ This draft revised
guidance describes the type of
information that FDA’s Center for
Veterinary Medicine (CVM)
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:15 Jul 20, 2016
Jkt 238001
recommends sponsors provide to
address the human food safety of new
animal drugs used in food-producing
animals.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 19,
2016.
ADDRESSES: You may submit comments
as follows:
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,
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–
2005–D–0155 for ‘‘General Principles
for Evaluating the Human Food Safety
PO 00000
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Fmt 4703
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47397
of New Animal Drugs used in FoodProducing Animals.’’ 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
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.
Submit written requests for single
copies of the draft guidance to the
Policy and Regulations Staff (HFV–6),
Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
E:\FR\FM\21JYN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47396-47397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17182]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Science Board to the Food and Drug
Administration, Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Science Board to the Food and Drug Administration by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the Science Board
to the Food and Drug Administration for an additional 2 years beyond
the charter expiration date. The new charter will be in effect until
June 26, 2018.
DATES: Authority for the Science Board to the Food and Drug
Administration will expire on June 26, 2018, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the
Chief Scientist, Office of the Commissioner, Food and Drug
Administration, Bldg. 1, Rm. 3309, 10903 New Hampshire Ave., Silver
Spring, MD 20993, 301-796-4769, rakesh.raghuwanshi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Science Board to the Food and Drug Administration. The
committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Science Board advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective drugs for human use and, as
required, any other product for which FDA has regulatory
responsibility. The Science Board shall provide advice to the
Commissioner and other appropriate officials on specific complex
scientific and technical issues important to FDA and its mission,
including emerging issues within the scientific community.
Additionally, the Science Board will provide advice that supports the
Agency in keeping pace with technical and scientific developments,
including in regulatory science; and input into the Agency's research
agenda; and on upgrading its scientific and research facilities and
training opportunities. It will also provide, where requested, expert
review of Agency-sponsored intramural and extramural scientific
research programs.
The Committee shall consist of a core of 21 voting members
including a Chair and Co-Chair. The members, Chair and Co-Chair are
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of food science, safety, and nutrition;
chemistry; pharmacology; translational and clinical medicine and
research; toxicology; biostatistics; medical devices; imaging;
robotics; cell and tissue based products; regenerative medicine; public
health and epidemiology; international health and regulation; product
safety; product manufacturing sciences and quality; and other
scientific areas relevant to FDA regulated products such as systems
biology, informatics, nanotechnology, and combination products. Members
[[Page 47397]]
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 one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. The Committee may also include technically qualified federal
members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm115356.htm or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light of the fact that no change has
been made to the committee name or description of duties, no amendment
will be made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: July 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17182 Filed 7-20-16; 8:45 am]
BILLING CODE 4164-01-P
