Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice, 19975-19976 [2016-07899]
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19975
Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices
Proposed Project
National Program of Cancer Registries
Cancer Surveillance System (NPCR CSS,
OMB No. 0920–0469, exp. 5/31/2016)—
Revision—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 2012, the most recent year for
which complete information is
available, more than 580,000 people
died of cancer and more than 1.5
million were diagnosed with cancer. It
is estimated that 13.8 million Americans
are currently alive with a history of
cancer (2). In the U.S., state-based
cancer registries are the only method for
systematically collecting and reporting
population based information about
cancer incidence and outcomes such as
survival. These data are used to measure
the changing incidence and burden of
each cancer; identify populations at
increased or increasing risk; target
preventive measures; and measure the
success or failure of cancer control
efforts in the U.S.
In 1992, Congress passed the Cancer
Registries Amendment Act which
established the National Program of
Cancer Registries (NPCR). The NPCR
provides support for state-based cancer
registries that collect, manage and
analyze data about cancer cases. The
state-based cancer registries report
information to CDC through the
National Program of Cancer Registries
Cancer Surveillance System (NPCR
CSS), (OMB No. 0920–0469 5/31/2016).
CDC plans to request OMB approval to
continue collecting this information for
three years. Data definitions will be
updated to reflect changes in national
standards for cancer diagnosis and
coding, but the number of respondents
and the burden per respondent will not
change.
The NPCR CSS allows CDC to collect,
aggregate, evaluate and disseminate
cancer incidence data at the national
level. The NPCR CSS is the primary
source of information for United States
Cancer Statistics (USCS), which CDC
has published annually since 2002. The
latest USCS report published in 2015
provided cancer statistics for 99% of the
United States population from all cancer
registries whose data met national data
standards. Prior to the publication of
USCS, cancer incidence data at the
national level were available for only
14% of the population of the United
States.
The NPCR CSS also allows CDC to
monitor cancer trends over time,
describe geographic variation in cancer
incidence throughout the country, and
provide incidence data on racial/ethnic
populations and rare cancers. These
activities and analyses further support
CDC’s planning and evaluation efforts
for state and national cancer control and
prevention. In addition, datasets can be
made available for secondary analysis.
Respondents are NPCR-supported
central cancer registries (CCR) in 45 U.S.
states, 2 territories, and the District of
Columbia. Thirty-eight CCR submit data
elements specified for the Standard
NPCR CSS Report. Ten specialized CCR
submit data elements specified for the
Enhanced NPCR CSS Report, which
includes additional information about
treatment and follow-up for cases of
breast, colorectal, and chronic myeloid
leukemia cases diagnosed in 2011. Each
CCR is asked to transmit two data files
to CDC per year. The first file, submitted
in January, is a preliminary report
consisting of one year of data for the
most recent year of available data. CDC
evaluates the preliminary data for
completeness and quality and provides
a report back to the CCR. The second
file, submitted by November, contains
cumulative cancer incidence data from
the first diagnosis year for which the
cancer registry collected data with the
assistance of NPCR funds (e.g., 1995)
through 12 months past the close of the
most recent diagnosis year (e.g., 2014).
The cumulative file is used for analysis
and reporting. The burden for each file
transmission is estimated at two hours
per response. Because cancer incidence
data are already collected and
aggregated at the state level the
additional burden of reporting the
information to CDC is small.
All information is transmitted to CDC
electronically. Participation is required
as a condition of the cooperative
agreement with CDC. There are no costs
to respondents except their time.
The total estimated annualized
burden hours are 192 (152 for the
Standard NPCR CSS Report, and 40 for
the Enhanced NPCR CSS Report).
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Number of
respondents
Form name
Central Cancer Registries in States, Territories and the District of Columbia.
Number of
responses
per
respondent
Average
burden per
response
(in hours)
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38
2
2
Enhanced NPCR CSS Report
Leroy A. Richardson,
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.
Standard NPCR CSS Report
10
2
2
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Amendment of
Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
SUMMARY:
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amendment to the notice of a meeting of
the Endocrinologic and Metabolic Drugs
Advisory Committee. This meeting was
announced in the Federal Register of
March 16, 2016. The amendment is
being made to reflect a change in the
Date and Time portion of the document.
The Date of the meeting is changed to
May 25, 2016. There are no other
changes.
FOR FURTHER INFORMATION CONTACT:
LaToya Bonner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
E:\FR\FM\06APN1.SGM
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19976
Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533,
EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 16, 2016 (81
FR 14115), FDA announced that a
meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee
would be held on May 24, 2016. On
page 14115, in the second column, the
Date and Time portion of the document
is changed to read as follows:
Date and Time: The meeting will be
held on May 25, 2016, from 8 a.m. to 5
p.m.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: April 1, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–07899 Filed 4–5–16; 8:45 am]
Electronic Submissions
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1099]
Inorganic Arsenic in Rice Cereals for
Infants: Action Level; Draft Guidance
for Industry; Supporting Document for
Action Level for Inorganic Arsenic in
Rice Cereals for Infants; Arsenic in
Rice and Rice Products Risk
Assessment: Report; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled
‘‘Inorganic Arsenic in Rice Cereals for
Infants: Action Level,’’ a supporting
document entitled ‘‘Supporting
Document for Action Level for Inorganic
Arsenic in Rice Cereals for Infants’’ (the
supporting document), and a risk
assessment report entitled ‘‘Arsenic in
Rice and Rice Products Risk
Assessment: Report’’ (the risk
assessment report). The draft guidance,
when finalized, will identify for
industry an action level for inorganic
arsenic in rice cereals for infants that
will help protect public health and is
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SUMMARY:
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achievable with the use of current good
manufacturing practice. It also will
describe our intended sampling and
enforcement approach. The risk
assessment report includes a
quantitative component (a mathematical
model) that estimates occurrence of lung
cancer and bladder cancer from longterm exposure to inorganic arsenic in
rice and rice products, and a qualitative
component that describes our review
and evaluation of the scientific
literature of certain non-cancer health
risks, in certain susceptible life stages,
from inorganic arsenic in rice and rice
products.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider
your comment on this draft guidance
before we begin work on the final
version of the guidance, submit either
electronic or written comments on the
draft guidance, the supporting
document, or the risk assessment report
by July 5, 2016.
ADDRESSES: You may submit comments
as follows:
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
PO 00000
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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–
2016–D–1099 for ‘‘Inorganic Arsenic in
Rice Cereals for Infants: Action Level;
Draft Guidance for Industry; Supporting
Document for Action Level for Inorganic
Arsenic in Rice Cereals for Infants;
Arsenic in Rice and Rice Products Risk
Assessment: Report; Availability.’’
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
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]]>Agencies
[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 19975-19976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07899]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Endocrinologic and Metabolic Drugs Advisory Committee; Amendment
of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of a meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee. This meeting was announced in the
Federal Register of March 16, 2016. The amendment is being made to
reflect a change in the Date and Time portion of the document. The Date
of the meeting is changed to May 25, 2016. There are no other changes.
FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
[[Page 19976]]
Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533,
EMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area). Please call the
Information Line for up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 16, 2016
(81 FR 14115), FDA announced that a meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee would be held on May 24, 2016. On
page 14115, in the second column, the Date and Time portion of the
document is changed to read as follows:
Date and Time: The meeting will be held on May 25, 2016, from 8
a.m. to 5 p.m.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: April 1, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-07899 Filed 4-5-16; 8:45 am]
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