Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring, 61711-61712 [2011-25685]
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Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices
Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25686 Filed 10–4–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0405]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations for In
Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Fax written comments on the
collection of information by November
4, 2011.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0409. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
19:11 Oct 04, 2011
Jkt 226001
Regulations for In Vivo
Radiopharmaceuticals Used for
Diagnosis and Monitoring—21 CFR Part
315 (OMB Control Number 0910–
0409)—Extension
FDA is requesting OMB approval of
the information collection requirements
contained in 21 CFR 315.4, 315.5, and
315.6. These regulations require
manufacturers of diagnostic
radiopharmaceuticals to submit
information that demonstrates the safety
and effectiveness of a new diagnostic
radiopharmaceutical or of a new
indication for use of an approved
diagnostic radiopharmaceutical.
In response to the requirements of
section 122 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115), FDA published
a final rule in the Federal Register of
May 17, 1999 (64 FR 26657), amending
its regulations by adding provisions that
clarify the Agency’s evaluation and
approval of in vivo
radiopharmaceuticals used in the
diagnosis or monitoring of diseases. The
regulation describes the kinds of
indications of diagnostic
radiopharmaceuticals and some of the
criteria that the Agency would use to
evaluate the safety and effectiveness of
a diagnostic radiopharmaceutical under
section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) (the
FD&C Act) and section 351 of the Public
Health Service Act (42 U.S.C. 262) (the
PHS Act). Information about the safety
or effectiveness of a diagnostic
radiopharmaceutical enables FDA to
properly evaluate the safety and
effectiveness profiles of a new
diagnostic radiopharmaceutical or a
new indication for use of an approved
diagnostic radiopharmaceutical.
The rule clarifies existing FDA
requirements for approval and
evaluation of drug and biological
products already in place under the
authorities of the FD&C Act and the PHS
Act. The information, which is usually
submitted as part of a new drug
application or biologics license
application or as a supplement to an
approved application, typically
includes, but is not limited to,
nonclinical and clinical data on the
pharmacology, toxicology, adverse
events, radiation safety assessments,
and chemistry, manufacturing, and
controls. The content and format of an
application for approval of a new drug
are set forth in § 314.50 (21 CFR 314.50).
Under 21 CFR part 315, information
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
61711
required under the FD&C Act and
needed by FDA to evaluate the safety
and effectiveness of in vivo
radiopharmaceuticals still needs to be
reported.
Based on the number of submissions
(that is, human drug applications and/
or new indication supplements for
diagnostic radiopharmaceuticals) that
FDA receives, the Agency estimates that
it will receive approximately two
submissions annually from two
applicants. The hours per response
refers to the estimated number of hours
that an applicant would spend
preparing the information required by
the regulations. Based on FDA’s
experience, the Agency estimates the
time needed to prepare a complete
application for a diagnostic
radiopharmaceutical to be
approximately 10,000 hours, roughly
one-fifth of which, or 2,000 hours, is
estimated to be spent preparing the
portions of the application that would
be affected by these regulations. The
regulation does not impose any
additional reporting burden for safety
and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 2,000 hours
because safety and effectiveness
information is already required by
§ 314.50 (collection of information
approved by OMB under OMB control
number 0910–0001). In fact,
clarification in these regulations of
FDA’s standards for evaluation of
diagnostic radiopharmaceuticals is
intended to streamline overall
information collection burdens,
particularly for diagnostic
radiopharmaceuticals that may have
well-established, low risk safety
profiles, by enabling manufacturers to
tailor information submissions and
avoid unnecessary clinical studies.
Table 1 of this document contains
estimates of the annual reporting burden
for the preparation of the safety and
effectiveness sections of an application
that are imposed by existing regulations.
This estimate does not include the
actual time needed to conduct studies
and trials or other research from which
the reported information is obtained.
In the Federal Register of June 10,
2011 (76 FR 34079), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received no
comments.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\05OCN1.SGM
05OCN1
61712
Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Average
burden per
response
(in hours)
Total annual
responses
Total hours
315.4, 315.5, and 315.6 .......................................................
2
1
2
2,000
4,000
Total ..............................................................................
........................
........................
........................
........................
4,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25685 Filed 10–4–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0165]
Deborah Martinez Seldon: 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)
permanently debarring Deborah
Martinez Seldon from providing
services in any capacity to a person that
has an approved or pending drug
product application. FDA bases this
order on a finding that Ms. Seldon was
convicted of multiple felonies under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act. Ms. Seldon was given notice
of the proposed permanent debarment
and an opportunity to request a hearing
within the timeframe prescribed by
regulation. Ms. Seldon failed to
respond. Ms. Seldon’s failure to respond
constitutes a waiver of her right to a
hearing concerning this action.
DATES: This order is effective October 5,
2011.
ADDRESSES: Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Division of Compliance
Policy (HFC–230), Office of Regulatory
Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:11 Oct 04, 2011
Jkt 226001
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the regulation of any
drug product under the FD&C Act.
On March 27, 2009, judgment was
entered against Ms. Seldon in the
United States District Court for the
District of Nevada for mail fraud, in
violation of 18 U.S.C. 1341, aiding and
abetting, in violation of 18 U.S.C. 2, and
misbranding a drug while held for sale,
in violation of 21 U.S.C. 331(k) and
333(a)(2).
The FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein for
conduct relating to the regulation of a
drug product. The factual basis for those
convictions is as follows: Ms. Seldon
was the manager of her husband’s
medical practice called A New You
Medical Aesthetics (A New You) in Las
Vegas, Nevada. As the office manager of
A New You, Ms. Seldon was responsible
for ordering supplies, paying bills,
managing personnel, and managing the
bank accounts.
From, on or about, October 15, 2003,
until on or about September 16, 2005, in
the State and Federal District of Nevada,
Ms. Seldon and her husband, aided and
abetted by each other, devised a scheme
and artifice to fraudulently obtain
money from patients by substituting the
cheaper, non-FDA approved product
marketed by Toxin Research
International that purported to be
Botulinum Neurotoxin Type A (TRItoxin) in treatments provided to patients
at A New You, while falsely and
fraudulently representing to the patients
that they were receiving injections of
the FDA-approved BOTOX product
marketed by Allergan, Inc..
As part of the scheme Ms. Seldon
ordered and caused to be ordered 38
vials of TRI-toxin between October 2003
and September 2004 while at the same
time the practice stopped purchasing
the approved BOTOX in October 2003.
In January 2005, as part of the scheme
and artifice, Ms. Seldon arranged for a
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
secret purchase of, and received 132
vials of TRI-toxin for use at A New You.
Ms. Seldon and her husband
defrauded patients by misleading them
to believe that they were receiving the
FDA-approved drug BOTOX, when, in
fact, the patients were receiving TRItoxin, which was not approved, thereby
exposing patients to severe health risk.
On or about January 12, 2005, Ms.
Seldon caused to be falsified
computerized medical records by
deleting references to BOTOX and
changing these entries to the generic
notation ‘‘Cosmetic Procedure.’’ In
furtherance of their scheme, Ms. Seldon
and Dr. Seldon caused 28 vials of TRItoxin to be returned to the FDA, seeking
to create the misleading impression that
they were returning 28 of the original 38
vials they had purchased. In fact, all of
the original TRI-toxin had been used on
patients at A New You, and Ms. Seldon
was returning vials that were part of the
secret 132 vial purchase.
Ms. Seldon and her husband also
caused advertisements to be placed in
local magazines offering BOTOX,
creating the false impression that the
office was using approved BOTOX
when, in fact, patients were being
injected with unapproved TRI-toxin.
Ms. Seldon also caused patients to sign
consent forms that fraudulently
represented that Dr. Seldon would be
injecting approved BOTOX when she
knew her husband was injecting them
with TRI-toxin.
As a result of her convictions, on May
23, 2011, FDA sent Ms. Seldon a notice
by certified mail proposing to
permanently debar her from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(B) of the FD&C Act (21 U.S.C.
335a(a)(2)(B)), that Ms. Seldon was
convicted of felonies under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act. The
proposal also offered Ms. Seldon 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
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61711-61712]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25685]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0405]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Regulations for In
Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 4, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0409.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and
Monitoring--21 CFR Part 315 (OMB Control Number 0910-0409)--Extension
FDA is requesting OMB approval of the information collection
requirements contained in 21 CFR 315.4, 315.5, and 315.6. These
regulations require manufacturers of diagnostic radiopharmaceuticals to
submit information that demonstrates the safety and effectiveness of a
new diagnostic radiopharmaceutical or of a new indication for use of an
approved diagnostic radiopharmaceutical.
In response to the requirements of section 122 of the Food and Drug
Administration Modernization Act of 1997 (Pub. L. 105-115), FDA
published a final rule in the Federal Register of May 17, 1999 (64 FR
26657), amending its regulations by adding provisions that clarify the
Agency's evaluation and approval of in vivo radiopharmaceuticals used
in the diagnosis or monitoring of diseases. The regulation describes
the kinds of indications of diagnostic radiopharmaceuticals and some of
the criteria that the Agency would use to evaluate the safety and
effectiveness of a diagnostic radiopharmaceutical under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) (the FD&C Act)
and section 351 of the Public Health Service Act (42 U.S.C. 262) (the
PHS Act). Information about the safety or effectiveness of a diagnostic
radiopharmaceutical enables FDA to properly evaluate the safety and
effectiveness profiles of a new diagnostic radiopharmaceutical or a new
indication for use of an approved diagnostic radiopharmaceutical.
The rule clarifies existing FDA requirements for approval and
evaluation of drug and biological products already in place under the
authorities of the FD&C Act and the PHS Act. The information, which is
usually submitted as part of a new drug application or biologics
license application or as a supplement to an approved application,
typically includes, but is not limited to, nonclinical and clinical
data on the pharmacology, toxicology, adverse events, radiation safety
assessments, and chemistry, manufacturing, and controls. The content
and format of an application for approval of a new drug are set forth
in Sec. 314.50 (21 CFR 314.50). Under 21 CFR part 315, information
required under the FD&C Act and needed by FDA to evaluate the safety
and effectiveness of in vivo radiopharmaceuticals still needs to be
reported.
Based on the number of submissions (that is, human drug
applications and/or new indication supplements for diagnostic
radiopharmaceuticals) that FDA receives, the Agency estimates that it
will receive approximately two submissions annually from two
applicants. The hours per response refers to the estimated number of
hours that an applicant would spend preparing the information required
by the regulations. Based on FDA's experience, the Agency estimates the
time needed to prepare a complete application for a diagnostic
radiopharmaceutical to be approximately 10,000 hours, roughly one-fifth
of which, or 2,000 hours, is estimated to be spent preparing the
portions of the application that would be affected by these
regulations. The regulation does not impose any additional reporting
burden for safety and effectiveness information on diagnostic
radiopharmaceuticals beyond the estimated burden of 2,000 hours because
safety and effectiveness information is already required by Sec.
314.50 (collection of information approved by OMB under OMB control
number 0910-0001). In fact, clarification in these regulations of FDA's
standards for evaluation of diagnostic radiopharmaceuticals is intended
to streamline overall information collection burdens, particularly for
diagnostic radiopharmaceuticals that may have well-established, low
risk safety profiles, by enabling manufacturers to tailor information
submissions and avoid unnecessary clinical studies. Table 1 of this
document contains estimates of the annual reporting burden for the
preparation of the safety and effectiveness sections of an application
that are imposed by existing regulations. This estimate does not
include the actual time needed to conduct studies and trials or other
research from which the reported information is obtained.
In the Federal Register of June 10, 2011 (76 FR 34079), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments.
FDA estimates the burden of this collection of information as
follows:
[[Page 61712]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR Section respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
315.4, 315.5, and 315.6......... 2 1 2 2,000 4,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25685 Filed 10-4-11; 8:45 am]
BILLING CODE 4160-01-P
