James A. Holland; Denial of Hearing; Final Debarment Order, 9904-9905 [2010-4449]
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9904
Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices
submit reports, keep records, or provide
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3506(c)(2)(A)) requires Federal agencies
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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, AoA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following collection
of information, AoA invites comments
on: (1) Whether the proposed collection
of information is necessary for the
proper performance of AoA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
AoA’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
when appropriate, and other forms of
information technology.
The Administration on Aging collects
annual program data at the state level
and has sponsored studies to collect
information regarding the Area Agencies
on Aging. The third component of the
Aging Network that administers and
implements OAA programs, the Local
Service Providers are poorly understood
and characterized. The purpose of this
data collection is to better understand
the relationship between the Area
Agencies on Aging and the Local
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to provide OAA programs to seniors.
This data collection focuses on two
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needs of the expected increase in the
percentage of persons 60 years and
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tools may be found on the AoA Web site
at https://www.aoa.gov/AoARoot/
Program_Results/
Program_Evaluation.aspx.
AoA estimates the burden of this
collection of information as follows: 200
hours
VerDate Nov<24>2008
16:39 Mar 03, 2010
Jkt 220001
Dated: March 1, 2010.
Kathy Greenlee,
Assistant Secretary for Aging.
[FR Doc. 2010–4602 Filed 3–3–10; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0205]
James A. Holland; Denial of Hearing;
Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is denying James
A. Holland’s request for a hearing and
is issuing an order under the Federal
Food, Drug, and Cosmetic Act (the act)
debarring Holland for 5 years from
providing services in any capacity to a
person who has an approved or pending
drug product application. FDA bases
this order on a finding that Holland was
convicted of a misdemeanor under
Federal law for conduct relating to the
development or approval of a drug
product or otherwise relating to the
regulation of a drug product under the
act and that the type of conduct
underlying the conviction undermines
the process for the regulation of drugs.
In determining the appropriateness and
length of Holland’s debarment period,
FDA has considered the relevant factors
listed in the act. Holland has failed to
file with the agency information and
analysis sufficient to create a basis for
a hearing concerning this action.
DATES: The order is effective March 4,
2010.
Submit applications for
termination of debarment to the Dockets
Management Branch (HFA–305), Food
and Drug Administration, 12420
Parklawn Dr., rm. 1–23, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT: G.
Matthew Warren, Office of Scientific
Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–4613.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
On April 24, 2007, Holland, formerly
the head of the oncology program at the
Stratton Veterans Affairs Medical
Center, pled guilty to failing to establish
and maintain a required record under
section 505(i) of the act (21 U.S.C.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
355(i)) in violation of sections 301(e) of
the act (21 U.S.C. 331(e)). On March 31,
2009, the United States District Court
for the Northern District of New York
sentenced Holland to 5 years of
probation for his resulting Federal
misdemeanor conviction under section
303(a)(1) of the act (21 U.S.C. 333(a)(1)).
The basis for this conviction was
Holland’s failure to establish and
maintain adequate and accurate case
histories for the subjects of clinical trials
he oversaw.
Holland is subject to debarment based
on a finding, under section 306(b) of the
act, (1) that he was convicted of a
misdemeanor under Federal law for
conduct relating to the development or
approval of a drug product or otherwise
relating to the regulation of a drug
product under the act and (2) that the
type of conduct underlying the
conviction undermines the process for
the regulation of drugs. Holland’s
conduct related to the development or
approval of a drug product in that it
involved clinical trials designed to
study the effectiveness of drug products
for possible approval by FDA.
By letter dated June 1, 2009, FDA
served Holland a notice proposing to
debar him for 5 years from providing
services in any capacity to a person
having an approved or pending drug
product application. By letter dated July
1, 2009, Holland, through counsel,
requested a hearing on the proposal. In
his request for a hearing, Holland does
not dispute his misdemeanor conviction
under Federal law, as alleged by FDA.
However, he asserts that he has
appealed the conviction to the United
States Court of Appeals for the Second
Circuit.
We reviewed Holland’s request for a
hearing and find that Holland has not
created a basis for a hearing because
hearings will be granted only if there is
a genuine and substantial issue of fact.
Hearings will not be granted on issues
of policy or law, on mere allegations,
denials, or general descriptions of
positions and contentions, or on data
and information insufficient to justify
the factual determination urged or the
action requested (see 21 CFR 12.24(b)).
The Acting Chief Scientist and
Deputy Commissionerhas considered
Holland’s arguments and concludes that
they are unpersuasive and fail to raise
a genuine and substantial issue of fact
requiring a hearing.
II. Arguments
In support of his hearing request,
Holland argues that the conviction on
which FDA bases his proposed
debarment is currently on appeal.
However, under 306(b)(2)(B)(i), Holland
E:\FR\FM\04MRN1.SGM
04MRN1
Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices
with the assistance of Holland during
his period of debarment.
Any application by Holland for
termination of debarment under section
306(d) of the act should be identified
with Docket No. FDA–2009–N–0205
and sent to the Dockets Management
Branch (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). Publicly
available submissions may be seen in
the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday
through Friday.
Publicly available submissions may
be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Findings and Order
mstockstill on DSKH9S0YB1PROD with NOTICES
is subject to debarment if FDA finds that
he ‘‘has been convicted of—* * * a
misdemeanor under Federal law’’ and
that ‘‘the type of conduct which served
as the basis for such conviction
undermines the process for the
regulation of drugs.’’ FDA has made both
findings, and Holland does not dispute
either finding. Section 306 contains no
requirement that a conviction be
finalized on appeal before it subjects an
individual to debarment. In fact, under
306(l)(1)(A), ‘‘a person is considered to
have been convicted of a criminal
offense—* * * when a judgment of
conviction has been entered against the
person * * * regardless of whether
there is an appeal pending.’’ Moreover,
under 306(d)(3), Holland may apply to
FDA to have the debarment order
withdrawn if his conviction is reversed.
It is therefore clear from section 306 that
a pending appeal for a conviction does
not preclude FDA’s reliance on that
conviction for debarment.
BILLING CODE 4160–01–S
Therefore, the Acting Chief Scientist
and Deputy Commissioner, under
section 306(b)(2)(B)(i)(I) of the act and
under authority delegated to him, finds
(1) that Holland has been convicted of
a misdemeanor under Federal law for
conduct relating to the development or
approval of a drug product or otherwise
relating to the regulation of a drug
product under the act and (2) that the
type of conduct which served as the
basis for that conviction undermines the
process for the regulation of drugs. FDA
has considered the relevant factors
listed in section 306(c)(3) of the act and
determined that a debarment of 5 years
is appropriate.
As a result of the foregoing findings,
Holland is debarred for 5 years from
providing services in any capacity to a
person with an approved or pending
drug product application under section
505, 512, or 802 of the act (21 U.S.C.
355, 360b, or 382), or under section 351
of the Public Health Service Act (42
U.S.C. 262), effective (see DATES) (see 21
U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii)
and 21 U.S.C. 321(dd)). Any person
with an approved or pending drug
product application who knowingly
uses the services of Holland, in any
capacity during his period of
debarment, will be subject to civil
money penalties. If Holland, during his
period of debarment, provides services
in any capacity to a person with an
approved or pending drug product
application, he will be subject to civil
money penalties. In addition, FDA will
not accept or review any abbreviated
new drug applications submitted by or
VerDate Nov<24>2008
16:39 Mar 03, 2010
Jkt 220001
Dated: January 22, 2010.
Jesse L. Goodman,
Acting Chief Scientist and Deputy
Commissioner for Science and Public Health.
[FR Doc. 2010–4449 Filed 3–3–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2006–D–0223] (formerly
2006D–0383)
Guidance for Industry:
Characterization and Qualification of
Cell Substrates and Other Biological
Materials Used in the Production of
Viral Vaccines for Infectious Disease
Indications; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Characterization
and Qualification of Cell Substrates and
Other Biological Materials Used in the
Production of Viral Vaccines for
Infectious Disease Indications,’’ dated
February 2010. The guidance document
provides recommendations to
manufacturers of viral vaccines for the
characterization and qualification of cell
substrates, viral seeds, and other
biological materials used for the
production of viral vaccines for human
use. The guidance announced in this
notice finalizes the draft guidance
entitled ‘‘Guidance for Industry:
Characterization and Qualification of
Cell Substrates and Other Biological
Starting Materials Used in the
Production of Viral Vaccines for the
Prevention and Treatment of Infectious
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
9905
Diseases,’’ dated September 2006, and
replaces the information specific to viral
vaccines for the prevention and
treatment of infectious diseases that the
agency provided in the 1993 document
entitled ‘‘Points to Consider in the
Characterization of Cell Lines Used to
Produce Biologicals.’’
DATES: Submit electronic or written
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit electronic or written
comments on the guidance. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul
E. Levine, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Characterization and
Qualification of Cell Substrates and
Other Biological Materials Used in the
Production of Viral Vaccines for
Infectious Disease Indications,’’ dated
February 2010. The guidance document
provides manufacturers of viral vaccines
with recommendations for the
characterization and qualification of cell
substrates, viral seeds, and other
biological materials used for the
production of viral vaccines for human
use. The recommendations in the
guidance may be used to support a
Biologics License Application or an
application for an Investigational New
Drug.
In the Federal Register of September
29, 2006 (71 FR 57547), FDA announced
the availability of the draft guidance
entitled ‘‘Guidance for Industry:
Characterization and Qualification of
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 75, Number 42 (Thursday, March 4, 2010)]
[Notices]
[Pages 9904-9905]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4449]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0205]
James A. Holland; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is denying James A.
Holland's request for a hearing and is issuing an order under the
Federal Food, Drug, and Cosmetic Act (the act) debarring Holland for 5
years from providing services in any capacity to a person who has an
approved or pending drug product application. FDA bases this order on a
finding that Holland was convicted of a misdemeanor under Federal law
for conduct relating to the development or approval of a drug product
or otherwise relating to the regulation of a drug product under the act
and that the type of conduct underlying the conviction undermines the
process for the regulation of drugs. In determining the appropriateness
and length of Holland's debarment period, FDA has considered the
relevant factors listed in the act. Holland has failed to file with the
agency information and analysis sufficient to create a basis for a
hearing concerning this action.
DATES: The order is effective March 4, 2010.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: G. Matthew Warren, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301-796-4613.
SUPPLEMENTARY INFORMATION:
I. Background
On April 24, 2007, Holland, formerly the head of the oncology
program at the Stratton Veterans Affairs Medical Center, pled guilty to
failing to establish and maintain a required record under section
505(i) of the act (21 U.S.C. 355(i)) in violation of sections 301(e) of
the act (21 U.S.C. 331(e)). On March 31, 2009, the United States
District Court for the Northern District of New York sentenced Holland
to 5 years of probation for his resulting Federal misdemeanor
conviction under section 303(a)(1) of the act (21 U.S.C. 333(a)(1)).
The basis for this conviction was Holland's failure to establish and
maintain adequate and accurate case histories for the subjects of
clinical trials he oversaw.
Holland is subject to debarment based on a finding, under section
306(b) of the act, (1) that he was convicted of a misdemeanor under
Federal law for conduct relating to the development or approval of a
drug product or otherwise relating to the regulation of a drug product
under the act and (2) that the type of conduct underlying the
conviction undermines the process for the regulation of drugs.
Holland's conduct related to the development or approval of a drug
product in that it involved clinical trials designed to study the
effectiveness of drug products for possible approval by FDA.
By letter dated June 1, 2009, FDA served Holland a notice proposing
to debar him for 5 years from providing services in any capacity to a
person having an approved or pending drug product application. By
letter dated July 1, 2009, Holland, through counsel, requested a
hearing on the proposal. In his request for a hearing, Holland does not
dispute his misdemeanor conviction under Federal law, as alleged by
FDA. However, he asserts that he has appealed the conviction to the
United States Court of Appeals for the Second Circuit.
We reviewed Holland's request for a hearing and find that Holland
has not created a basis for a hearing because hearings will be granted
only if there is a genuine and substantial issue of fact. Hearings will
not be granted on issues of policy or law, on mere allegations,
denials, or general descriptions of positions and contentions, or on
data and information insufficient to justify the factual determination
urged or the action requested (see 21 CFR 12.24(b)).
The Acting Chief Scientist and Deputy Commissionerhas considered
Holland's arguments and concludes that they are unpersuasive and fail
to raise a genuine and substantial issue of fact requiring a hearing.
II. Arguments
In support of his hearing request, Holland argues that the
conviction on which FDA bases his proposed debarment is currently on
appeal. However, under 306(b)(2)(B)(i), Holland
[[Page 9905]]
is subject to debarment if FDA finds that he ``has been convicted of--*
* * a misdemeanor under Federal law'' and that ``the type of conduct
which served as the basis for such conviction undermines the process
for the regulation of drugs.'' FDA has made both findings, and Holland
does not dispute either finding. Section 306 contains no requirement
that a conviction be finalized on appeal before it subjects an
individual to debarment. In fact, under 306(l)(1)(A), ``a person is
considered to have been convicted of a criminal offense--* * * when a
judgment of conviction has been entered against the person * * *
regardless of whether there is an appeal pending.'' Moreover, under
306(d)(3), Holland may apply to FDA to have the debarment order
withdrawn if his conviction is reversed. It is therefore clear from
section 306 that a pending appeal for a conviction does not preclude
FDA's reliance on that conviction for debarment.
III. Findings and Order
Therefore, the Acting Chief Scientist and Deputy Commissioner,
under section 306(b)(2)(B)(i)(I) of the act and under authority
delegated to him, finds (1) that Holland has been convicted of a
misdemeanor under Federal law for conduct relating to the development
or approval of a drug product or otherwise relating to the regulation
of a drug product under the act and (2) that the type of conduct which
served as the basis for that conviction undermines the process for the
regulation of drugs. FDA has considered the relevant factors listed in
section 306(c)(3) of the act and determined that a debarment of 5 years
is appropriate.
As a result of the foregoing findings, Holland is debarred for 5
years from providing services in any capacity to a person with an
approved or pending drug product application under section 505, 512, or
802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 of
the Public Health Service Act (42 U.S.C. 262), effective (see DATES)
(see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved or pending drug product application who
knowingly uses the services of Holland, in any capacity during his
period of debarment, will be subject to civil money penalties. If
Holland, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, he will be subject to civil money penalties. In addition,
FDA will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Holland during his period of
debarment.
Any application by Holland for termination of debarment under
section 306(d) of the act should be identified with Docket No. FDA-
2009-N-0205 and sent to the Dockets Management Branch (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). Publicly available submissions may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Publicly available submissions may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: January 22, 2010.
Jesse L. Goodman,
Acting Chief Scientist and Deputy Commissioner for Science and Public
Health.
[FR Doc. 2010-4449 Filed 3-3-10; 8:45 am]
BILLING CODE 4160-01-S
