[Federal Register: May 25, 2005 (Volume 70, Number 100)]
[Notices]
[Page 30121-30126]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25my05-121]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food Safety and Security Monitoring Project; Availability of
Cooperative Agreements; Request for Applications: RFA-FDA-ORA-05-1;
Catalog of Federal Domestic Assistance Number: 93.448
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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I. Funding Opportunity Description
The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Division of Federal-State Relations (DFSR), is
announcing the availability of cooperative agreements for equipment,
supplies, personnel, training, and facility upgrades to Food Emergency
Response Laboratory Network (FERN) laboratories of State, local, and
tribal governments. The cooperative agreements are to enable the
analyses of foods and food products in the event that redundancy and/or
additional laboratory surge capacity is needed by FERN for analyses
related to chemical terrorism. These grants are also intended to expand
participation in networks to enhance Federal, State, local, and tribal
food safety and security efforts.
The goal of ORA's cooperative agreement program is to complement,
develop, and improve State, local, and Indian tribal food safety and
security testing programs. With cooperative agreement grant funds this
will be accomplished through the provision of supplies, personnel,
facility upgrades, training in current food testing methodologies,
participation in proficiency testing to establish additional reliable
laboratory sample analysis capacity, and analysis of surveillance
samples. In the event of a large-scale chemical terrorism event
affecting foods or food products, the recipient may be required to
perform selected chemical analyses of domestic and imported food
samples collected and supplied to the laboratory by FDA or other
Federal agencies through FDA. These samples may consist of, but are not
limited to, the following: Vegetables and fruits (fresh and packaged);
juices (concentrate and diluted); grains and grain products; seafood
and other fish products; milk and other dairy products; infant formula;
baby foods; bottled water; condiments; and alcoholic products (beer,
wine, scotch).
All grant application projects that are developed at State, local,
and tribal levels must have national implication or application that
can enhance Federal food safety and security programs. At the
discretion of FDA, successful project formats will be made available to
interested Federal, State, local, and tribal government FERN
laboratories.
There are four key project areas identified for this effort:
(1) The use of Gas Chromatography/Mass Spectrometry (GC/MS)
analysis for the screening and identification of poisons, toxic
substances, and unknown compounds in foods;
(2) The use of Liquid Chromatography/Mass Spectrometry (LC/MS)
analysis for the screening and identification of poisons, toxic
substances, and unknown compounds in foods;
(3) The use of Inductively Coupled Plasma/Mass Spectrometry (ICP/
MS) analysis for the screening and identification of heavy metals and
toxic elements in foods; and,
(4) The use of Enzyme-Linked Immunosorbent Assay (ELISA) and other
antibody-based analyses for the screening and identification of unknown
toxins in foods.
FDA will support the projects covered by this notice under the
authority of section 312 of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public
Law 107-188). This program is described in the Catalog of Federal
Domestic Assistance under number 93.448.
1. Background
ORA is the primary inspection and analysis component of FDA and has
some 1,600 investigators, inspectors, and analysts who cover the
country's approximately 95,000 FDA regulated
[[Page 30122]]
businesses. These investigators inspect more that 15,000 facilities a
year and ORA laboratories analyze several thousand samples per year.
ORA conducts special investigations, conducts food inspection recall
audits, performs consumer complaint inspections, and collects samples
of regulated products. Increasingly, ORA has been called upon to expand
the testing program addressing the increasing threat to food safety and
security through intentional chemical terrorism events. Toward these
ends, ORA has developed a suite of chemical screening and analysis
methodologies that are used to evaluate foods and food products in such
situations. However, in the event of a large-scale emergent incident,
analytical sample capacity in ORA field laboratories has a finite
limit. Information from ongoing relationships with State partners
indicates limited redundancy in State food testing laboratories, both
in terms of analytical capabilities and analytical sample capacity.
Several State food testing laboratories lack the specialized equipment
to perform the analyses and/or the specific methodological expertise in
the types of analyses performed for screening foods and food products
involving chemical terrorism events.
The events of September 11, 2001, reinforced the need to enhance
the security of the United States food supply. Congress responded by
passing the Bioterrorism Act, which President George W. Bush signed
into law on June 12, 2002. The Bioterrorism Act is divided into the
following five titles:
<bullet> Title I--National Preparedness for Bioterrorism and Other
Public Health Emergencies,
<bullet> Title II--Enhancing Controls on Dangerous Biological
Agents and Toxins,
<bullet> Title III--Protecting Safety and Security of Food and Drug
Supply,
<bullet> Title IV--Drinking Water Security and Safety, and
<bullet> Title V--Additional Provisions.
Subtitle A of the Bioterrorism Act, Protection of Food Supply,
section 312-Surveillance and Information Grants and Authorities, amends
part B of Title III of the Public Health Service Act to authorize the
Secretary of Health and Human Services (the Secretary) to award grants
to States and Indian tribes to expand participation in networks to
enhance Federal, State, and local food safety efforts. This may include
meeting the costs of establishing and maintaining the food safety
surveillance, technical, and laboratory capacity needed for such
participation.
2. Program Research Goals
The goal of ORA's cooperative agreement program is to complement,
develop, and improve State, local, and Indian tribal food safety and
security testing programs. This will be accomplished through the
provision of equipment, supplies, personnel, facility upgrades,
training in current food testing methodologies, and participation in
proficiency testing to establish additional reliable laboratory sample
analysis capacity and analysis of surveillance samples. In the event of
a large-scale chemical terrorism event affecting foods or food
products, the recipient may be required to perform selected chemical
analyses of domestic and imported food samples collected and supplied
to the laboratory by FDA or other Federal agencies through FDA. These
samples may consist of, but are not limited to, the following:
Vegetables and fruits (fresh and packaged); juices (concentrate and
diluted); grains and grain products; seafood and other fish products;
milk and other dairy products; infant formula; baby foods; bottled
water; condiments; and alcoholic products (beer, wine, scotch).
II. Award Information
Support will be in the form of a cooperative agreement. Substantive
involvement by the awarding agency is inherent in the cooperative
agreement award. Accordingly, FDA will have substantial involvement in
the program activities of the project funded by the cooperative
agreement. Substantive involvement includes, but is not limited to, the
following: (1) How often samples will be sent, (2) directions on how
tests should be executed, (3) on-site monitoring, (4) supply of
equipment, and (5) FDA training on processes.
FDA will provide specific procedures and protocols for the four
project areas (see section I of this document) to be used for the
analysis of toxic chemicals and toxins in food.
FDA will provide guidance on the specific foods to be collected and
analyzed by the successful applicant. State personnel will be
responsible for the collection and analysis of surveillance samples.
FDA will purchase and have all equipment delivered to the awardee's
laboratory. The equipment purchased will remain the property of FDA
until such time as released as surplus property.
Proposed projects designed to fulfill the specific objectives of
any one or more of the project areas will be considered for funding.
Applicants may also apply for only facility upgrades, personnel,
training, and surveillance sample collection if they have the necessary
equipment and it will be available for these projects. These grants are
not to fund or conduct food inspections for food safety regulatory
agencies.
It should be emphasized that in all of the projects, there is a
particular desire to promote a continuing, reliable capability and
capacity for laboratory sample analyses of foods and food products for
the rapid detection and identification of toxic chemicals or toxins.
With this in mind, it is desirable that sample analyses will be
completed within 2 weeks of receipt, and the results will be reported
to FERN. The format and reporting media will be established by FERN.
1. Award Amount
The total amount of funding available in Fiscal Year (FY) 2005 is
$2,100,000. Cooperative agreements will be awarded up to $350,000 in
total (direct plus indirect) costs per year for up to 3 years. It is
anticipated that six awards will be made. Support of these cooperative
agreements will be for the funding of supplies, facility upgrades,
surveillance sample collection, personnel, the provision of training in
current analytical methodology, and for the analysis of foods and food
products.
2. Length of Support
The length of support will depend on the nature of the project. For
those projects with an expected duration of more than 1 year, a second
or third year of noncompetitive continuation of support will depend on
performance during the preceding year and availability of Federal
funds.
3. Funding Plan
It is anticipated that FDA will make six awards in FY 2005 for this
program. The number of projects funded will depend on the quality of
the applications received and is subject to availability of Federal
funds to support the projects.
Funds may be requested in the budget to travel to FDA for meetings
with program staff about the progress of the project.
III. Eligibility Information
1. Eligible Applicants
This cooperative agreement program is only available to State,
local, and tribal government FERN laboratories and is authorized by
section 312 of the Bioterrorism Act.
All grant application projects that are developed at State, local,
and tribal levels must have national implication or
[[Page 30123]]
application that can enhance Federal food safety and security programs.
At the discretion of FDA, successful project formats will be made
available to interested Federal, State, local, and tribal government
FERN laboratories.
2. Cost Sharing or Matching
Cost sharing is not required.
3. Other
A. Dun and Bradstreet Number (DUNS)
As of October 1, 2003, applicants are required to have a DUNS
number to apply for a grant or cooperative agreement from the Federal
Government. The DUNS number is a 9-digit identification number that
uniquely identifies business entities. Obtaining a DUNS number is easy
and there is no charge. To obtain a DUNS number, call 1-866-705-5711.
Be certain that you identify yourself as a Federal grant applicant when
you contact Dun & Bradstreet, Inc.
IV. Application and Submission
1. Addresses to Request Application
The application request and the completed application should be
submitted to Cynthia Polit, Grants Management Specialist, Division of
Contracts and Grants Management (HFA-500), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7180,
e-mail: cynthia.polit@fda.gov or cpolit@oc.fda.gov. If the application
is hand-carried or commercially delivered it should be addressed to
5630 Fishers Lane, rm. 2105, Rockville, MD 20857.
The original and two copies of the completed grant application form
PHS 5161-1, with copies of the appendices for each of the copies,
should be submitted to Cynthia Polit (see previous paragraph). The
outside of the mailing package should be labeled ``Response to RFA-FDA-
ORA-05-1.''
FDA is also accepting applications for this program electronically
via Grants.gov. Applicants are strongly encouraged to apply
electronically by visiting the Web site http://www.grants.gov and
following the instructions under ``APPLY.'' In order to apply
electronically, the applicant must have a DUNS number and register in
the Central Contractor Registration (CCR) database as described in
section IV.6.A of this document.
If the submission is electronic, the application package is posted
under the ``APPLY'' section of this announcement under http://www.grants.gov.
The required application PHS 424, which is part of the
PHS 5161-1 form, can be completed and submitted online.
2. Content and Form of Application
A. Content of Application
The applicant must specifically address the following in the
cooperative agreement application:
Laboratory Facilities. A complete description of the name and
address of the facility, and the name of the most responsible
individual of the facility where the equipment will be installed must
be provided.
For the facility, the following information must be provided:
(1) Floor diagrams of the laboratory;
(2) Area where the equipment is to be installed. The installation
of equipment in a laboratory will require adequate and appropriate
space and physical plant supplies (power, water, etc.);
(3) A description of the envisaged space, to include a floor-plan
diagram;
(4) Operational support areas to be used for the project, including
details about the availability of ancillary laboratory safety and
support equipment and facilities, such as the numbers and types of
chemical fume hoods available;
(5) Details describing the sample receiving and sample storage
areas and a description of any existing chain-of-custody procedures;
(6) A detailed description of the proposed facilities upgrade
including drawings and cost estimates; and
(7) A detailed description of laboratory access procedures,
including a description of practices and systems which limit access to
laboratory space by unauthorized personnel. Additional procedures for
access to the space(s) dedicated to the equipment provided, if any,
should also be provided.
Laboratory Personnel Qualifications. Qualifications of all
personnel that will be assigned to the project must be provided. In
particular, information on personnel that have experience in GC/MS, LC/
MS, ICP/MS, and ELISA must be provided.
Laboratory Management Practices. For the laboratory, the following
management information must be provided:
(1) A summary description of any security procedures or processes
to evaluate the background of laboratory personnel. This should include
any procedures to evaluate subcontractors who have access to laboratory
space, such as cleaning personnel;
(2) A summary description of any quality management system defined,
in development, or in place as it relates to quality control and
quality assurance procedures and practices;
(3) A summary description of staffing management, specifically to
include abilities and procedures in place to recall personnel,
establish extended workweeks, etc.; and
(4) A summary description of procedures in place to monitor sample
workflow, including the tracking and monitoring of sample analyses in
progress to include a description of the laboratory work product review
process. Additionally, the ability to perform and complete the analyses
and provide a report of a sample analysis within a 2-week time frame
must be described.
Sample Analysis Commitment. The laboratory will be required to
analyze surveillance and emergency response food samples. Therefore, an
estimate of the number of food samples that will be analyzed for toxic
chemicals and toxins by each project area (i.e., GC/MS, LC/MS, ICP/MS,
ELISA), must be submitted. This estimate should be for a 3-year period.
The estimate should also address the number of samples that can be
analyzed in a 2-week period. The procedures to be used will be supplied
by FDA. This information will be provided after the award is given so
recipients will be aware of requirements/responsibilities.
In addition, if a cooperative agreement is awarded, awardees will
be informed of any additional documentation that should be submitted to
FERN.
B. Format for Application
Submission of the application must be on grant application form PHS
5161-1 (revised 7/00). All ``General Information Instructions'' and
specific instructions in the application kit must be followed. The face
page of the application should reflect the request for application
number RFA-FDA-ORA-05-1 under ``Federal Identifier.''
Data and information included in the application will generally not
be available publicly prior to the funding of the application. After
funding has been awarded, data and information included in the
application will be given confidential treatment to the extent
permitted by the Freedom of Information Act (5 U.S.C. 552(b)(4)) and
FDA's implementing regulations (including 21 CFR 20.61, 20.105, and
20.106 (21 CFR 20.61, 20.105, and 20.106)). By accepting funding, the
applicant agrees to allow ORA to publish specific information about the
grant.
The requirements requested on form PHS 5161-1 (revised 7/00) have
been sent by PHS to the Office of Management and Budget (OMB) and have
been approved and assigned OMB control number 0248-0043.
[[Page 30124]]
3. Submission Dates and Times
The application receipt date is June 24, 2005.
Applications will be accepted from 8 a.m. to 4:30 p.m., Monday
through Friday, until the established receipt date. Applications will
be considered received on time if hand delivered to the address noted
previously (see Addresses to Request Application in section IV of this
document) before the established receipt date, or sent or mailed by the
receipt date as shown by a legible U.S. Postal Service dated postmark
or a legible dated receipt from a commercial carrier. Private metered
postmarks shall not be acceptable as proof of timely mailing. If not
received on time applications will not be considered for review and
will be returned to the applicant. (Applicants should note that the
U.S. Postal Service does not uniformly provide dated postmarks. Before
relying on this method, applicants should check with their local post
office). Please do not send applications to the National Institutes of
Health (NIH). Any application sent to NIH that is forwarded to FDA's
Grants Management Office and not received in time for orderly
processing will be judged nonresponsive and returned to the applicant.
Applications must be submitted via U.S. mail or commercial carrier or
hand delivered as stated previously in this document.
Applications submitted electronically must be received by close of
business on the published receipt date.
No addendum material will be accepted after the receipt date.
4. Intergovernmental Review
The regulations issued under Executive Order 12372,
Intergovernmental Review of Department of Health and Human Services
Programs and Activities (45 CFR part 100) apply to the Food Safety and
Security Monitoring Project. Applicants (other than federally
recognized Indian tribal governments) should contact the State's Single
Point of Contact (SPOC) as early as possible to alert the SPOC to the
prospective application(s) and to receive any necessary instructions on
the State's review process. A current listing of SPOCs is included in
the application kit or at http://www.whitehouse.gov/omb/grants/spoc.html.
(FDA has verified the Web site address, but FDA is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.) The SPOC should send any State
review process recommendations to the FDA administrative contact (see
Addresses to Request Application in section IV of this document). The
due date for the State process recommendations is no later than 60 days
after the deadline date for the receipt of applications. FDA does not
guarantee to accommodate or explain SPOC comments that are received
after the 60-day cutoff.
5. Funding Restrictions
These grants are not to fund or conduct food inspections for food
safety regulatory agencies. They may not be utilized for new building
construction, however, remodeling of existing facilities is allowed,
provided that remodeling costs do not exceed 25 percent of the grant
award amount.
6. Other Submission Requirements
A. CCR
In anticipation of the Grants.gov electronic application process
applicants are encouraged to register with the CCR database. This
database is a governmentwide warehouse of commercial and financial
information for all organizations conducting business with the Federal
Government. Registration with CCR will eventually become a requirement
and is consistent with the governmentwide management reform to create a
citizen-centered web presence and build e-gov infrastructures in and
across agencies to establish a ``single face to industry.'' The
preferred method for completing a registration is via the Internet at
http://www.ccr.gov. (FDA has verified the Web site address, but FDA is
not responsible for subsequent changes to the Web site after this
document publishes in the Federal Register.) This web site provides a
CCR handbook with detailed information on data needed prior to
beginning the online registration, as well as steps to walk applicants
through the registration process. The applicant must have a DUNS number
to begin registration. Call Dun & Bradstreet, Inc., at the number
listed in the previous paragraph of this document if you do not have a
DUNS number.
In order to access Grants.gov an applicant will be required to
register with the Credential Provider. Information about this
requirement is available at http://www.grants.gov/CredentialProvider.
(FDA has verified the Web site address, but FDA is not responsible for
subsequent changes to the Web site after this document publishes in the
Federal Register.)
V. Application Review Information
1. Criteria
A. Scientific/Technical Review Criteria
All grant application projects that are developed at State, local,
and tribal levels must have national implication or application that
can enhance Federal food safety and security programs. At the
discretion of FDA, successful project formats will be made available to
interested Federal, State, local, and tribal government FERN
laboratories.
The ad hoc expert panel will review the application based on the
following scientific and technical merit criteria which will carry
equal weight:
<bullet> The adequacy of facilities, expertise of project staff,
equipment, support services, commitment to analyze surveillance
samples, commitment to analyze emergency response samples, and quality
management practices needed for the project;
<bullet> Expertise in the use of GC/MS for the analysis of foods or
animal tissues;
<bullet> Expertise in the use of LC/MS for the analysis of foods or
animal tissues;
<bullet> Expertise in the use of ICP/MS for the analysis of foods
or animal tissues;
<bullet> Expertise in use of ELISA and other antibody-based
analyses for the identification of toxins in foods or animal tissues;
<bullet> Current food or animal tissue analysis programs;
<bullet> The rationale and design to meet the goals of the
cooperative agreement;
<bullet> Quality control and quality assurance procedures and
practices; and
<bullet> Abilities and procedures in place to recall personnel and
establish extended workweeks.
2. Review and Selection Process
A. General Information
FDA grants management and program staff will review applications
sent in response to this notice. To be responsive, an application must
be submitted in accordance with the requirements of this notice and
must bear the original signature of the applicant institution's/
organization's authorized official. If submitted electronically the
original signature requirement does not apply.
If an application is found to be nonresponsive it will be returned
to the applicant without further consideration. Applicants are strongly
encouraged to contact FDA to resolve any questions about criteria
before submitting an application. Please direct all questions of a
technical or scientific nature to ORA program staff and all questions
of an administrative or financial nature to the grants management staff
(see section VII of this document).
[[Page 30125]]
B. Program Review Criteria
All grant application projects that are developed at State, local,
and tribal levels must have national implication or application that
can enhance Federal food safety and security programs. At the
discretion of FDA, successful project formats will be made available to
interested Federal, State, local, and tribal government FERN
laboratories.
Applications will be considered for funding on the basis of their
overall technical merit as determined through the review process.
Program criteria will include availability of funds and overall program
balance in terms of geography with respect to existing and projected
laboratory sample analysis and testing capacity. Final funding
decisions will be made by the Commissioner of Food and Drugs (the
Commissioner) or his designee.
A responsive application will be reviewed and evaluated for
scientific and technical merit by an ad hoc panel of experts in the
subject field of the specific application. Funding decisions will be
made by the Commissioner or his designee.
A score will be assigned to each responsive application based on
the scientific/technical review criteria. The review panel may advise
the program staff about the appropriateness of the proposal to the
goals of the ORA/ORO/DFSR cooperative agreement.
3. Anticipated Announcement and Award
Notification regarding the results of the review in the form of a
summary statement is anticipated by September 1, 2005. It is
anticipated that all awards will be made by September 29, 2005.
VI. Award Administration Information
1. Award Notices
FDA's Grants Management Office will notify applicants who have been
selected for an award. Awards will either be issued on a Notice of
Grant Award (PHS 5152) signed by the FDA Chief Grants Management
Officer and be sent to the applicant by mail or transmitted
electronically.
2. Administrative and National Policy Requirements
These agreements will be subject to all policies and requirements
that govern the research grant programs of PHS, including provisions of
42 CFR part 52, 45 CFR parts 74 and 92, and the PHS Grants Policy
Statement.
Applicants must adhere to the requirements of this notice. Special
terms and conditions regarding FDA regulatory requirements and adequate
progress of the study may be part of the awards notice.
PHS strongly encourages all grant recipients to provide a smoke-
free workplace and to discourage the use of all tobacco products. This
is consistent with the PHS mission to protect and advance the physical
and mental health of the American people.
FDA is committed to achieving the health promotion and disease
prevention objectives of ``Healthy People 2010,'' a national effort
designed to reduce morbidity and mortality and to improve quality of
life. Applicants may obtain a paper copy of the ``Healthy People 2010''
objectives, vols. I and II, for $70 ($87.50 foreign) S/N 017-000-00550-
9, by writing to the Superintendent of Documents, P.O. Box 371954,
Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-
2250. The document is also available in CD-ROM format, S/N 017-001-
00549-5 for $19 ($23.50 foreign) as well as on the Internet at http://www.healthypeople.gov
under ``Publications.'' (FDA has verified the Web
site address, but FDA is not responsible for subsequent changes to the
Web site after this document publishes in the Federal Register.)
3. Reporting
A. Reporting Requirements
The original and two copies of an annual Financial Status Report
(FSR) (SF-269) must be sent to FDA's grants management officer within
90 days of the budget period end date of the grant. Failure to file the
FSR in a timely fashion will be grounds for suspension or termination
of the grant. A final FSR will be due 90 days after the expiration of
the project period as noted on the Notice of Grant Award.
For continuing cooperative agreements, quarterly reports and an
annual program progress report are also required. For such cooperative
agreements, the noncompeting continuation application (PHS 5161-1) will
be considered the program progress report for the fourth quarter of the
budget period.
Quarterly progress reports must contain, but are not limited to the
following:
1. A status report on the installation, training, and operational
readiness of any equipment that is provided;
2. A summary report on any proficiency testing performed;
3. A summary status of samples analyzed and time to complete
individual sample testing; and
4. A summary description of any other testing performed on the
equipment.
A final program progress report, FSR, and invention statement must
be submitted within 90 days after the expiration of the project period
as noted on the Notice of Grant Award.
The final program progress report must provide full written
documentation of the project, and summaries of laboratory operations,
as described in the grant application. The documentation must be in a
form and contain sufficient detail such that other State, local, and
tribal government FERN laboratories could reproduce the final project.
B. Monitoring Activities
The program project officer will monitor grantees periodically. The
monitoring may be in the form of telephone conversations, e-mails, or
written correspondence between the project office/grants management
office and the principal investigator. Periodic site visits with
officials of the grantee organization may also occur. The results of
these monitoring activities will be recorded in the official grant file
and will be available to the grantee upon request consistent with
applicable disclosure statutes and with FDA disclosure regulations.
Also, the grantee organization must comply with all special terms and
conditions of the cooperative agreement, including those which state
that future funding of the study will depend on recommendations from
the project officer. The scope of the recommendation will confirm that:
(1) There has been acceptable progress on the project; (2) there is
continued compliance with all FDA regulatory requirements; (3) if
necessary, there is an indication that corrective action has taken
place; and (4) assurance that any replacement of personnel will meet
the testing requirements.
VII. Agency Contacts
Regarding the administrative and financial management aspects of
this notice: Cynthia Polit (see Addresses to Request Application in
section IV of this document).
Regarding the programmatic or technical aspects of this notice:
Thomas Savage, Division of Field Science, Office of Regulatory Affairs,
Food and Drug Administration (HFC-140), 5600 Fishers Lane, rm. 12-41,
Rockville, MD 20857, 301-827-1026, e-mail: tsavage@ora.fda.gov.
VIII. Other Information
Data included in the application, if restricted with the legend
specified in this section of the document, may be entitled to
confidential treatment as trade secret or confidential commercial
[[Page 30126]]
information within the meaning of the Freedom of Information Act and
FDA's implementing regulations (21 CFR 20.61).
Unless disclosure is required under the Freedom of Information Act
as amended (5 U.S.C. 552), as determined by the freedom of information
officials of the Department of Health and Human Services or by a court,
data contained in the portions of this application that have been
specifically identified by page number, paragraph, etc., by the
applicant as containing restricted information, shall not be used or
disclosed except for evaluation purposes.
Dated: May 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10435 Filed 5-20-05; 2:41 pm]
BILLING CODE 4160-01-S
