Agency Information Collection Activities: Submission for OMB Review; Comment Request, 28048-28049 [E9-13841]
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28048
Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Notices
can be obtained by contacting FASAB at
(202) 512–7350.
Respondents are encouraged to
comment on any part of the exposure
draft. Written comments are requested
by July 17, 2009, and should be sent to:
Wendy M. Payne, Executive Director,
Federal Accounting Standards Advisory
Board, 441 G Street, NW., Suite 6814,
Mail Stop 6K17V, Washington, DC
20548.
FOR FURTHER INFORMATION CONTACT:
Wendy Payne, Executive Director, 441 G
Street, NW., Washington, DC 20548, or
call (202) 512–7350.
Authority: Federal Advisory Committee
Act, Public Law 92–463.
Dated: June 8, 2009.
Charles Jackson,
Federal Register Liaison Officer.
[FR Doc. E9–13803 Filed 6–11–09; 8:45 am]
In the Federal Register Notice of June
3, 2009, in FR Doc. E9–12951, on page
26700, in the third column, under the
heading ‘‘CATEGORIES OF RECORDS
IN THE SYSTEM’’ remove ‘‘DHA’’ and
add ‘‘DHS’’ in its place.
Dated: June 8, 2009.
Kim Mott,
Privacy Act Officer.
[FR Doc. E9–13830 Filed 6–11–09; 8:45 am]
BILLING CODE 6820–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
BILLING CODE 1610–01–M
GENERAL SERVICES
ADMINISTRATION
Privacy Act of 1974; Notice of Updated
Systems of Records; Correction
AGENCY: General Services
Administration.
ACTION: Correction.
SUMMARY: GSA is issuing a correction to
the notice GSA/GOVT–4 Contracted
Travel Services Program. The document
contained an incorrect acronym. GSA
reviewed its Privacy Act systems to
ensure that they are relevant, necessary,
accurate, up-to-date, covered by the
appropriate legal or regulatory
authority, and compliant with OMB M–
07–16.
DATES: Effective June 12, 2009.
FOR FURTHER INFORMATION CONTACT: Call
or e-mail the GSA Privacy Act Officer:
telephone 202–208–1317; e-mail
gsa.privacyact@gsa.gov.
ADDRESSES: GSA Privacy Act Officer
(CIB), General Services Administration,
1800 F Street NW., Washington, DC
20405.
Correction:
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Projects for Assistance in
Transition From Homelessness (PATH)
Program Annual Report (OMB No.
0930–0205)—Revision
The Center for Mental Health Services
awards grants each fiscal year to each of
the States, the District of Columbia, the
Commonwealth of Puerto Rico, the
Virgin Islands, Guam, American Samoa,
and the Commonwealth of the Northern
Mariana Islands from allotments
authorized under the PATH program
established by Public Law 101–645, 42
U.S.C. 290cc–21 et seq., the Stewart B.
McKinney Homeless Assistance
Amendments Act of 1990 (section 521 et
seq. of the Public Health Service (PHS)
Act). Section 522 of the PHS Act
requires that the grantee States and
Territories must expend their payments
under the Act solely for making grants
to political subdivisions of the State,
Number of
respondents
Respondents
States ...............................................................................................................
Local provider agencies ...................................................................................
Totals ........................................................................................................
Written comments and
recommendations concerning the
proposed information collection should
be sent by July 13, 2009 to: SAMHSA
VerDate Nov<24>2008
17:53 Jun 11, 2009
Jkt 217001
56
480
536
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
and to non-profit private entities
(including community-based veterans’
organizations and other community
organizations) for the purpose of
providing services specified in the Act.
Available funding is allotted in
accordance with the formula provision
of section 524 of the PHS Act.
This submission is for a revision of
the current approval of the annual
grantee reporting requirements. Section
528 of the PHS Act specifies that not
later than January 31 of each fiscal year,
a funded entity will prepare and submit
a report in such form and containing
such information as is determined
necessary for securing a record and
description of the purposes for which
amounts received under section 521
were expended during the preceding
fiscal year and of the recipients of such
amounts and determining whether such
amounts were expended in accordance
with statutory provisions.
The proposed changes to the PATH
Annual Report Survey are as follows:
• Reporting on all persons served
with PATH Federal and matching State
funds.
Additional Optional Questions:
Table C
• The number of Enrolled consumers
placed into housing (Transitional,
Supportive, or Permanent).
• The number of Enrolled consumers
who were assisted with successfully
obtaining income benefits (SSI, SSDI,
VA, etc.).
• The number of Enrolled consumers
who were assisted with successfully
obtaining or increasing their earned
income (employment).
• The number of Enrolled consumers
who were assisted with successfully
obtaining medical insurance or coverage
plans (Medicaid, Medicare, and/or
State/local plans).
• The number of Enrolled consumers
who were assisted with successfully
obtaining primary medical care.
The estimated annual burden for
these reporting requirements is
summarized in the table below.
Responses
per
respondent
Burden per
response
(hrs.)
1
1
........................
26
31
........................
Total burden
1,456
14,880
16,336
20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
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Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Notices
respondents are encouraged to submit
comments by fax to: 202–395–6974.
Dated: June 4, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–13841 Filed 6–11–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0137]
Mary E. Sawaya a.k.a. Marty Sawaya;
Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the act) permanently
debarring Dr. Mary E. Sawaya a.k.a.
Marty Sawaya (Dr. Sawaya) 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 Dr. Sawaya
was convicted of a felony under Federal
law for conduct relating to the
development or approval, including the
process for development or approval, of
a drug product, and conduct otherwise
relating to the regulation of a drug
product under the act. After being given
notice of the proposed permanent
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation, Dr. Sawaya
failed to request a hearing. Dr. Sawaya’s
failure to request a hearing constitutes a
waiver of her right to a hearing
concerning this action.
DATES: This order is effective June 12,
2009.
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:
Robert L. Hummel, Sr., Division of
Compliance Policy (HFC–230), Office of
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 240–632–6845.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the act (21
U.S.C. 335a(a)(2)(A)) requires debarment
of an individual if FDA finds that the
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17:53 Jun 11, 2009
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28049
individual has been convicted of a
felony under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product.
Section 306(a)(2)(B) of the act requires
debarment of an individual if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct otherwise relating to the
regulation of any drug product under
the act.
On December 11, 2003, the U.S.
District Court for the Middle District of
Florida accepted Dr. Mary E. Sawaya’s
plea of guilty and convicted her of one
count of making a false statement to a
Federal agency, a Federal felony offense
under 18 U.S.C. 1001. This offense was
committed when Dr. Sawaya created a
medical license by obtaining a copy of
a colleague’s Florida medical license,
altered that license using a photocopy
machine to reflect that the license was
issued in her name, and submitted the
false and fraudulent Florida medical
license to the sponsor of a clinical trial,
for which she was a clinical
investigator. The sponsor submitted that
license to FDA as part of the drug
approval process. When the false license
was due to expire, Dr. Sawaya once
again created a false and fraudulent
medical license with a different
expiration date and submitted that
license to the clinical trial sponsor.
As a result of this conviction, FDA
sent Dr. Sawaya by certified mail on
November 26, 2008, a notice 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)(A) and (a)(2)(B) of the act, that
Dr. Sawaya was convicted of a felony
under Federal law for conduct relating
to the development or approval,
including the process for development
or approval, of a drug product, and
conduct otherwise relating to the
regulation of a drug product under the
act. The proposal also offered Dr.
Sawaya 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. Dr. Sawaya did not request a
hearing and has, therefore, waived her
opportunity for a hearing and any
contentions concerning her debarment
(21 CFR part 12).
Affairs, under section 306(a)(2)(A) and
(a)(2)(B) of the act, and under authority
delegated to her, finds that Dr. Sawaya
has been convicted of a felony under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
a drug product and conduct otherwise
relating to the regulation of a drug
product under the act.
As a result of the foregoing finding,
Dr. Sawaya is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application under
sections 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 sections 306(c)(1)(B) and
(c)(2)(A)(ii) and 201(dd) of the act (21
U.S.C. 321(dd)).) Any person with an
approved or pending drug product
application who knowingly employs or
retains as a consultant or contractor, or
otherwise uses the services of Dr.
Sawaya, in any capacity, during Dr.
Sawaya’s permanent debarment, will be
subject to civil money penalties (section
307(a)(6) of the act (21 U.S.C.
335b(a)(6))). If Dr. Sawaya , during her
period of debarment, provides services
in any capacity to a person with an
approved or pending drug product
application, she will be subject to civil
money penalties (section 307(a)(7) of the
act). In addition, FDA will not accept or
review any abbreviated new drug
applications submitted by or with the
assistance of Dr. Sawaya during her
period of debarment (section
306(c)(1)(B) of the act).
Any application by Dr. Sawaya for
special termination of debarment under
section 306(d)(4) of the act should be
identified with Docket No. FDA–2008–
N–0137 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).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
II. Findings and Order
Therefore, the Acting Director, Office
of Enforcement, Office of Regulatory
BILLING CODE 4160–01–S
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Fmt 4703
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Dated: June 1, 2009.
Alyson L. Saben,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. E9–13929 Filed 6–11–09; 8:45 am]
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]]>Agencies
[Federal Register Volume 74, Number 112 (Friday, June 12, 2009)]
[Notices]
[Pages 28048-28049]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13841]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Project: Projects for Assistance in Transition From Homelessness (PATH)
Program Annual Report (OMB No. 0930-0205)--Revision
The Center for Mental Health Services awards grants each fiscal
year to each of the States, the District of Columbia, the Commonwealth
of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the
Commonwealth of the Northern Mariana Islands from allotments authorized
under the PATH program established by Public Law 101-645, 42 U.S.C.
290cc-21 et seq., the Stewart B. McKinney Homeless Assistance
Amendments Act of 1990 (section 521 et seq. of the Public Health
Service (PHS) Act). Section 522 of the PHS Act requires that the
grantee States and Territories must expend their payments under the Act
solely for making grants to political subdivisions of the State, and to
non-profit private entities (including community-based veterans'
organizations and other community organizations) for the purpose of
providing services specified in the Act. Available funding is allotted
in accordance with the formula provision of section 524 of the PHS Act.
This submission is for a revision of the current approval of the
annual grantee reporting requirements. Section 528 of the PHS Act
specifies that not later than January 31 of each fiscal year, a funded
entity will prepare and submit a report in such form and containing
such information as is determined necessary for securing a record and
description of the purposes for which amounts received under section
521 were expended during the preceding fiscal year and of the
recipients of such amounts and determining whether such amounts were
expended in accordance with statutory provisions.
The proposed changes to the PATH Annual Report Survey are as
follows:
Reporting on all persons served with PATH Federal and
matching State funds.
Additional Optional Questions:
Table C
The number of Enrolled consumers placed into housing
(Transitional, Supportive, or Permanent).
The number of Enrolled consumers who were assisted with
successfully obtaining income benefits (SSI, SSDI, VA, etc.).
The number of Enrolled consumers who were assisted with
successfully obtaining or increasing their earned income (employment).
The number of Enrolled consumers who were assisted with
successfully obtaining medical insurance or coverage plans (Medicaid,
Medicare, and/or State/local plans).
The number of Enrolled consumers who were assisted with
successfully obtaining primary medical care.
The estimated annual burden for these reporting requirements is
summarized in the table below.
----------------------------------------------------------------------------------------------------------------
Burden per
Respondents Number of Responses per response Total burden
respondents respondent (hrs.)
----------------------------------------------------------------------------------------------------------------
States.......................................... 56 1 26 1,456
Local provider agencies......................... 480 1 31 14,880
Totals...................................... 536 .............. .............. 16,336
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent by July 13, 2009 to: SAMHSA Desk
Officer, Human Resources and Housing Branch, Office of Management and
Budget, New Executive Office Building, Room 10235, Washington, DC
20503; due to potential delays in OMB's receipt and processing of mail
sent through the U.S. Postal Service,
[[Page 28049]]
respondents are encouraged to submit comments by fax to: 202-395-6974.
Dated: June 4, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9-13841 Filed 6-11-09; 8:45 am]
BILLING CODE 4162-20-P
