Center for Drug Evaluation and Research Medical Policy Council; Request for Comments, 16679-16680 [2013-06142]
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Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices
16679
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Numbers of
respondents
Numbers of
responses
per
respondent
Total
annual
responses
Average
burden
per
response
Total
hours
Total
capital
costs
Submission of rotational plans for health
warning label statements .....................
100
1
100
60
6,000
$1,200
1 There
are no operating and maintenance costs associated with this collection of information.
FDA estimates a total of 100
respondents at 1 response each and 60
burden hours per response for a total of
6,000 burden hours (100 respondents ×
1 response × 60 burden hours = 6,000
total burden hours). In addition, capital
costs are based on all 100 respondents
mailing in their submission at a postage
rate of $12 for a 5-pound parcel
(business parcel post mail delivered
from the furthest delivery zone).
Therefore, FDA estimates that the total
postage cost for mailing the rotational
warning plans to be $1,200.
Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–06127 Filed 3–15–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0206]
Center for Drug Evaluation and
Research Medical Policy Council;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket,
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
establishment of a docket to receive
suggestions, recommendations, and
comments for topics from interested
parties, including academic institutions,
regulated industry, patient
representatives, and other interested
organizations, on medical policy issues
that may be considered by the CDER
Medical Policy Council (Council) in
FDA’s Center for Drug Evaluation and
Research (CDER). These comments will
help the Agency identify and address
medical policy issues that need
clarification through guidance, notice
and comment procedures, or other
means.
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
Submit either electronic or
written comments by July 16, 2013.
DATES:
VerDate Mar<14>2013
15:16 Mar 15, 2013
Jkt 229001
Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–301), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Sandra J. Benton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340,
Silver Spring, MD 20993–0002, 301–
796–1042, FAX: 301–847–3529, email:
cdermedicalpolicycouncil@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
In January 2012, CDER established the
Council to ensure better coordination of
medical policy development and
implementation within CDER and
consistent, predictable communication
of medical policy decisions to the
public through guidance, notice and
comment procedures, or other means.
Chaired by CDER’s Associate Director
for Medical Policy, the Council provides
a senior-level forum through which
medical policy issues can be raised,
considered, developed, and
implemented. Council members include
the following senior clinical leaders:
The Center Director, the Deputy Center
Director for Clinical Science, the
Director of the Office of New Drugs, and
the Director of the Office of Surveillance
and Epidemiology. Experts from within
CDER and other FDA offices provide
expertise as needed for specific policy
topics under consideration. By
establishing this docket, FDA
encourages the public to recommend
specific topics for consideration by the
Council. The Agency believes that this
process will also ensure additional
transparency in CDER’s approach to
medical policy development and
implementation.
II. Range of Medical Policy Issues To Be
Considered
FDA envisions a variety of topics that
may be relevant for consideration by the
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Council. Specific topics could address
issues related to the following: (1)
Clinical evidence of effectiveness or
safety, (2) clinical study/trial design, (3)
professional and patient labeling, (4)
prescription drug promotion, (5) human
subjects protection, (6) bioresearch
monitoring, (7) good clinical practice,
(8) counter-terrorism drug development
(such as in the application of the
Animal Rule, 21 CFR 314.600), and (9)
postmarketing surveillance. To be
considered by the Council, a medical
policy issue typically would meet one
or more of the following criteria:
• A novel medical policy issue
requiring senior management input;
• An issue on which CDER seems to
have taken inconsistent positions;
• An existing medical policy position
that should be reconsidered in light of
scientific or regulatory advances;
• A complex safety management issue
requiring senior management input;
• A medical policy that may be
triggered by a specific product, but that
will be applicable to other products; or
• Strategies for implementation of a
new policy.
III. Establishment of a Docket and
Request for Comments
FDA is requesting public suggestions,
recommendations, and comments for
topics (including scientific, clinical,
regulatory, or other topics) on existing
or novel medical policy issues that may
warrant consideration by the Council.
Comments should describe the
following: (1) The medical policy issue
recommended for discussion, (2) the
rationale for doing so (e.g., clarifying
previous advice or precedents,
reconciling apparently differing
perspectives within CDER or between
CDER and regulated industry), (3)
recommendations on how the medical
policy issue could be addressed or
implemented; and (4) existing policy
documents (e.g., final guidance) relevant
to the medical policy issue. Note that
policy issues concerning any draft
guidance should be submitted to the
docket for that draft guidance.
The Agency will carefully consider all
comments submitted. FDA generally
will not respond directly to the person
or organization submitting the
E:\FR\FM\18MRN1.SGM
18MRN1
16680
Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices
comment. In general, medical policy
decisions reached by the Council are
communicated and implemented in
accordance with FDA’s good guidance
practices regulation (21 CFR 10.115) or
notice and comment procedures.
IV. Request for Comments
Interested persons may submit either
written comments regarding this notice
to the Division of Dockets Management
(see ADDRESSES) or electronic comments
to https://www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–06142 Filed 3–15–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1044]
Shu Bei Yuan: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Shu Bei Yuan for a period of 5 years
from importing articles of food or
offering such articles for importation
into the United States. FDA bases this
order on a finding that Ms. Yuan was
convicted of one felony count under
Federal law for conduct relating to the
importation into the United States of an
article of food. Ms. Yuan was given
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of December 31, 2012 (30
days after receipt of the notice), Ms.
Yuan had not responded. Ms. Yuan’s
failure to respond constitutes a waiver
of her right to a hearing concerning this
action.
DATES: This order is effective March 18,
2013.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<14>2013
15:16 Mar 15, 2013
Jkt 229001
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a
felony for conduct relating to the
importation into the United States of
any food.
On June 22, 2012, Ms. Yuan was
convicted, as defined in section
306(l)(1)(B) of the FD&C Act, when the
U.S. District Court for the Northern
District of Illinois accepted her plea of
guilty and entered judgment against her
for the following offense: One count of
entry of goods into the United States by
means of false statements, in violation
of 18 U.S.C. 542.
FDA’s finding that debarment is
appropriate is based on the felony
conviction referenced herein for
conduct relating to the importation into
the United States of any food. The
factual basis for this conviction is as
follows: In or around March 2005 and
continuing until in or around November
2005, Ms. Yuan conducted a scheme to
fraudulently enter goods into the United
States by means of false statements and
documents in violation of 18 U.S.C. 542.
The purpose of Ms. Yuan’s scheme was
to import, enter, and sell Chinese-origin
honey into the United States and avoid
the payment of antidumping duties by
falsely declaring to the U.S. Department
of Homeland Security, Bureau of
Customs and Border Protection (CBP)
that the imported honey originated from
countries other than China, including
South Korea, when in fact Ms. Yuan
knew that the honey originated from
China.
Between August and November 2005,
Ms. Yuan and others caused the
fraudulent import and entry into the
United States of approximately 26
entries of Chinese origin honey falsely
declared as Korean honey, having a total
declared entry value of approximately
$808,287, thereby avoiding antidumping
duties totaling approximately
$1,485,631.
As a result of her conviction, on
November 30, 2012, FDA sent Ms. Yuan
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
a notice by certified mail proposing to
debar her for a period of 5 years from
importing articles of food or offering
such articles for import into the United
States. The proposal was based on a
finding under section 306(b)(1)(C) of the
FD&C Act that Ms. Yuan was convicted
of a felony under Federal law for
conduct relating to the importation into
the United States of an article of food
because she committed an offense
related to the importation of Chinese
honey into the United States by means
of false statements.
The proposal was also based on a
determination, after consideration of the
factors set forth in section 306(c)(3) of
the FD&C Act, that Ms. Yuan should be
subject to a 5-year period of debarment.
The proposal also offered Ms. Yuan an
opportunity to request a hearing,
providing her 30 days from the date of
receipt of the letter in which to file the
request, and advised her that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Ms.
Yuan failed to respond within the
timeframe prescribed by regulation and
has, therefore, waived her opportunity
for a hearing and waived any
contentions concerning her debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Associate
Commissioner for Regulatory Affairs,
Office of Regulatory Affairs, under
section 306(b)(1)(C) of the FD&C Act,
and under authority delegated to the
Associate Commissioner (Staff Manual
Guide 1410.21), finds that Ms. Shu Bei
Yuan has been convicted of a felony
under Federal law for conduct relating
to the importation of an article of food
into the United States and that she is
subject to a 5-year period of debarment.
As a result of the foregoing finding,
Ms. Yuan is debarred for a period of 5
years from importing articles of food or
offering such articles for import into the
United States, effective (see DATES).
Under section 301(cc) of the FD&C Act
(21 U.S.C. 331(cc)), the importing or
offering for import into the United
States of an article of food by, with the
assistance of, or at the direction of Ms.
Yuan is a prohibited act.
Any application by Ms. Yuan for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2012–
N–1044 and sent to the Division of
Dockets Management (see ADDRESSES).
All such submissions are to be filed in
four copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j).
E:\FR\FM\18MRN1.SGM
18MRN1
]]>Agencies
[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Pages 16679-16680]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06142]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0206]
Center for Drug Evaluation and Research Medical Policy Council;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of docket, request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a docket to receive suggestions, recommendations, and
comments for topics from interested parties, including academic
institutions, regulated industry, patient representatives, and other
interested organizations, on medical policy issues that may be
considered by the CDER Medical Policy Council (Council) in FDA's Center
for Drug Evaluation and Research (CDER). These comments will help the
Agency identify and address medical policy issues that need
clarification through guidance, notice and comment procedures, or other
means.
DATES: Submit either electronic or written comments by July 16, 2013.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
301), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Identify comments with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Sandra J. Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042, FAX: 301-847-3529, email:
cdermedicalpolicycouncil@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In January 2012, CDER established the Council to ensure better
coordination of medical policy development and implementation within
CDER and consistent, predictable communication of medical policy
decisions to the public through guidance, notice and comment
procedures, or other means.
Chaired by CDER's Associate Director for Medical Policy, the
Council provides a senior-level forum through which medical policy
issues can be raised, considered, developed, and implemented. Council
members include the following senior clinical leaders: The Center
Director, the Deputy Center Director for Clinical Science, the Director
of the Office of New Drugs, and the Director of the Office of
Surveillance and Epidemiology. Experts from within CDER and other FDA
offices provide expertise as needed for specific policy topics under
consideration. By establishing this docket, FDA encourages the public
to recommend specific topics for consideration by the Council. The
Agency believes that this process will also ensure additional
transparency in CDER's approach to medical policy development and
implementation.
II. Range of Medical Policy Issues To Be Considered
FDA envisions a variety of topics that may be relevant for
consideration by the Council. Specific topics could address issues
related to the following: (1) Clinical evidence of effectiveness or
safety, (2) clinical study/trial design, (3) professional and patient
labeling, (4) prescription drug promotion, (5) human subjects
protection, (6) bioresearch monitoring, (7) good clinical practice, (8)
counter-terrorism drug development (such as in the application of the
Animal Rule, 21 CFR 314.600), and (9) postmarketing surveillance. To be
considered by the Council, a medical policy issue typically would meet
one or more of the following criteria:
A novel medical policy issue requiring senior management
input;
An issue on which CDER seems to have taken inconsistent
positions;
An existing medical policy position that should be
reconsidered in light of scientific or regulatory advances;
A complex safety management issue requiring senior
management input;
A medical policy that may be triggered by a specific
product, but that will be applicable to other products; or
Strategies for implementation of a new policy.
III. Establishment of a Docket and Request for Comments
FDA is requesting public suggestions, recommendations, and comments
for topics (including scientific, clinical, regulatory, or other
topics) on existing or novel medical policy issues that may warrant
consideration by the Council. Comments should describe the following:
(1) The medical policy issue recommended for discussion, (2) the
rationale for doing so (e.g., clarifying previous advice or precedents,
reconciling apparently differing perspectives within CDER or between
CDER and regulated industry), (3) recommendations on how the medical
policy issue could be addressed or implemented; and (4) existing policy
documents (e.g., final guidance) relevant to the medical policy issue.
Note that policy issues concerning any draft guidance should be
submitted to the docket for that draft guidance.
The Agency will carefully consider all comments submitted. FDA
generally will not respond directly to the person or organization
submitting the
[[Page 16680]]
comment. In general, medical policy decisions reached by the Council
are communicated and implemented in accordance with FDA's good guidance
practices regulation (21 CFR 10.115) or notice and comment procedures.
IV. Request for Comments
Interested persons may submit either written comments regarding
this notice to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06142 Filed 3-15-13; 8:45 am]
BILLING CODE 4160-01-P
