Federal Acquisition Regulation; Submission for OMB Review; Debarment and Suspension, 38429 [E9-18466]
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Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
the General Services Administration,
Regulatory Secretariat (VPR), 1800 F
Street, Room 4041, Washington, DC
20405, telephone (202) 501–4755.
Please cite OMB Control No. 9000–
0026, Change Order Accounting, in all
correspondence.
Dated: July 28, 2009.
Al Matera,
Director, Office of Acquisition Policy.
[FR Doc. E9–18465 Filed 7–31–09; 8:45 am]
BILLING CODE 6820–EP–P
Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to: FAR Desk Officer, OMB,
Room 10102, NEOB, Washington, DC
20503, and a copy to the General
Services Administration, Regulatory
Secretariat (VPR), 1800 F Street, NW.,
Room 4041, Washington, DC 20405.
FOR FURTHER INFORMATION CONTACT:
Edward Loeb, Contract Policy Division,
GSA (202) 501–0650 or via e-mail at
Edward.Loeb@gsa.gov.
The FAR requires contracts to be
awarded to only those contractors
determined to be responsible. Instances
where a firm or its principals have been
indicted, convicted, suspended,
proposed for debarment, debarred, or
had a contract terminated for default are
critical factors to be considered by the
contracting officer in making a
responsible determination, 52.209–5,
Certification Responsibility Matters,
requires the disclosure of this
information.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
rates and payment procedures for fiscal
year (FY) 2010 animal drug user fees.
The Federal Food, Drug, and Cosmetic
Act (the act), as amended by the Animal
Drug User Fee Act of 2003 (ADUFA) and
the Animal Drug User Fee Amendments
of 2008 (ADUFA II), authorizes FDA to
collect user fees for certain animal drug
applications and supplements, on
certain animal drug products, on certain
establishments where such products are
made, and on certain sponsors of such
animal drug applications and/or
investigational animal drug
submissions. This notice establishes the
fee rates for FY 2010.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s Web site at https://www.fda.gov/
ForIndustry/UserFees/AnimalDrug
UserFeeActADUFA/default.htm or
contact Lisa Kable, Center for Veterinary
Medicine (HFV–10), Food and Drug
Administration, 7529 Standish Pl.,
Rockville, MD 20855, 240–276–9718.
For general questions, you may also email the Center for Veterinary Medicine
(CVM) at: cvmadufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
B. Annual Reporting Burden
I. Background
Respondents: 89,995.
Responses per Respondent: 12.223.
Annual Responses: 1,100,000.
Hours per Response: 0.0833.
Total Burden Hours: 91,667.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (VPR), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 9000–0094,
Debarment and Suspension, in all
correspondence.
Section 740 of the act (21 U.S.C. 379j12) establishes four different kinds of
user fees: (1) Fees for certain types of
animal drug applications and
supplements, (2) annual fees for certain
animal drug products, (3) annual fees
for certain establishments where such
products are made, and (4) annual fees
for certain sponsors of animal drug
applications and/or investigational
animal drug submissions (21 U.S.C.
379j-12(a)). When certain conditions are
met, FDA will waive or reduce fees (21
U.S.C. 379j-12(d)).
For FY 2009 through FY 2013, the act
establishes aggregate yearly base
revenue amounts for each of these fee
categories. Base revenue amounts
established for years after FY 2009 are
subject to adjustment for workload. Fees
for applications, establishments,
products, and sponsors are to be
established each year by FDA so that the
revenue for each fee category will
approximate the level established in the
statute, after the level has been adjusted
for workload.
For FY 2010, the animal drug user fee
rates are: $209,400 for an animal drug
application; $145,200 for a
supplemental animal drug application
for which safety or effectiveness data is
required and for an animal drug
application subject to the criteria set
forth in section 512(d)(4) of the act (21
U.S.C. 360b(d)(4)); $6,185 for an annual
ADDRESSES:
DEPARTMENT OF DEFENSE
SUPPLEMENTARY INFORMATION:
GENERAL SERVICES
ADMINISTRATION
A. Purpose
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[OMB Control No. 9000–0094]
Federal Acquisition Regulation;
Submission for OMB Review;
Debarment and Suspension
sroberts on DSKD5P82C1PROD with NOTICES
AGENCIES: Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice of request for an
extension to an existing OMB clearance.
SUMMARY: Under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35), the Federal
Acquisition Regulation (FAR)
Secretariat will be submitting to the
Office of Management and Budget
(OMB) a request to review and approve
an extension of a currently approved
information collection requirement
concerning [subject]. A request for
public comments was published in the
Federal Register at 74 FR 18716 on
April 24, 2009. No comments were
received.
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
DATES: Submit comments on or before
September 2, 2009.
VerDate Nov<24>2008
16:05 Jul 31, 2009
Jkt 217001
38429
Dated: July 28, 2009.
Al Matera,
Director, Office of Acquisition Policy.
[FR Doc. E9–18466 Filed 7–31–09; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0336]
Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2010
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
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[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Notices]
[Page 38429]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18466]
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DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
[OMB Control No. 9000-0094]
Federal Acquisition Regulation; Submission for OMB Review;
Debarment and Suspension
AGENCIES: Department of Defense (DOD), General Services Administration
(GSA), and National Aeronautics and Space Administration (NASA).
ACTION: Notice of request for an extension to an existing OMB
clearance.
-----------------------------------------------------------------------
SUMMARY: Under the provisions of the Paperwork Reduction Act of 1995
(44 U.S.C. Chapter 35), the Federal Acquisition Regulation (FAR)
Secretariat will be submitting to the Office of Management and Budget
(OMB) a request to review and approve an extension of a currently
approved information collection requirement concerning [subject]. A
request for public comments was published in the Federal Register at 74
FR 18716 on April 24, 2009. No comments were received.
Public comments are particularly invited on: Whether this
collection of information is necessary for the proper performance of
functions of the FAR, and whether it will have practical utility;
whether our estimate of the public burden of this collection of
information is accurate, and based on valid assumptions and
methodology; ways to enhance the quality, utility, and clarity of the
information to be collected; and ways in which we can minimize the
burden of the collection of information on those who are to respond,
through the use of appropriate technological collection techniques or
other forms of information technology.
DATES: Submit comments on or before September 2, 2009.
ADDRESSES: Submit comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to: FAR Desk Officer, OMB, Room 10102, NEOB,
Washington, DC 20503, and a copy to the General Services
Administration, Regulatory Secretariat (VPR), 1800 F Street, NW., Room
4041, Washington, DC 20405.
FOR FURTHER INFORMATION CONTACT: Edward Loeb, Contract Policy Division,
GSA (202) 501-0650 or via e-mail at Edward.Loeb@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
The FAR requires contracts to be awarded to only those contractors
determined to be responsible. Instances where a firm or its principals
have been indicted, convicted, suspended, proposed for debarment,
debarred, or had a contract terminated for default are critical factors
to be considered by the contracting officer in making a responsible
determination, 52.209-5, Certification Responsibility Matters, requires
the disclosure of this information.
B. Annual Reporting Burden
Respondents: 89,995.
Responses per Respondent: 12.223.
Annual Responses: 1,100,000.
Hours per Response: 0.0833.
Total Burden Hours: 91,667.
Obtaining Copies of Proposals: Requesters may obtain a copy of the
information collection documents from the General Services
Administration, Regulatory Secretariat (VPR), 1800 F Street, NW., Room
4041, Washington, DC 20405, telephone (202) 501-4755. Please cite OMB
Control No. 9000-0094, Debarment and Suspension, in all correspondence.
Dated: July 28, 2009.
Al Matera,
Director, Office of Acquisition Policy.
[FR Doc. E9-18466 Filed 7-31-09; 8:45 am]
BILLING CODE 6820-EP-P
