[Federal Register: April 4, 2001 (Volume 66, Number 65)]
[Notices]
[Page 17907-17911]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap01-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Studies of Adverse Effects of Marketed Drugs; Availability of
Grants (Cooperative Agreements); Request for Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA), Center for Drug
Evaluation and Research, is announcing the anticipated availability of
funds for cooperative agreements to study adverse effects of drugs
marketed in the United States and its territories. Subject to the
availability of fiscal year 2002 funds, FDA anticipates that
approximately $900,000 will be available. FDA anticipates making up to
three awards, each for up to $300,000 per year (direct and indirects
costs) for general databases that cover U.S. patients only, cover
multiple States across the United States, had more than 1.5 million
enrolled patients on December 31, 2000, and have the demonstrated
ability to obtain paper copies of anonymized patient medical records.
Support for these agreements may be for up to 3 years subject to
availability of future funds and satisfactory performance during the
preceding year. The purpose of these agreements is to conduct drug
safety analysis to the benefit of the public's health; respond
expeditiously to urgent public safety concerns; provide a mechanism for
collaborative pharmacoepidemiological research designed to test
hypotheses, particularly those arising from suspected adverse reactions
reported to FDA; and enable rapid access to U.S. population-based data
sources to ensure public safety when necessary.
DATES: Submit applications by June 4, 2001.
ADDRESSES: Application kits are available from, and completed
applications should be submitted to Rosemary T. Springer, Division of
Contracts and Procurement Management (HFA-520), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7182.
Note: Applications hand-carried or commercially delivered should be
addressed to 5630 Fishers Lane, rm. 2129, Rockville, MD 20857. Please
DO NOT send applications to the Center for Scientific Review (CSR),
National Institutes of Health (NIH). Applications mailed to CSR and not
received by FDA in time for orderly processing will be returned to the
applicant without consideration. Application forms can also be found at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/grants/phs398/forms-toc.html.
FOR FURTHER INFORMATION CONTACT:
Regarding the administrative and financial management aspects of
this notice: Rosemary T. Springer (address above).
Regarding the programmatic aspects of this notice: David J. Graham,
Office of Postmarketing Drug Risk Assessment (HFD-400), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3238.
SUPPLEMENTARY INFORMATION: As stated later in this document, funding of
the second and third years will be contingent upon: (1) Investigator's
demonstrated success collaborating with FDA scientists, as well as with
other investigators funded by this cooperative agreement program. Such
demonstration may include suggestions for and design of a study,
analysis of data sets, and publication of results among FDA and
cooperative agreement investigators; and (2) the availability of
Federal fiscal year appropriations.
It is determined that these cooperative agreements are exempt from
the protection of human subjects requirements in accordance with 45 CFR
part 46.
FDA's authority to fund research projects is set out in section 301
of the Public Health Service Act (42 U.S.C. 241). FDA's research
program is described in the Catalog of Federal Domestic Assistance, No.
93.103. Applications submitted under this program are not subject to
the requirements of Executive Order 12372.
The Public Health Service (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 activity
to reduce morbidity and mortality and to
[[Page 17908]]
improve the quality of life. Applicants may obtain a hard copy of
``Healthy People 2010'' objectives, volumes I and II, Conference
Edition (B0074) for $22 per set, by writing to the Office of Disease
Prevention and Health Promotion (ODPHP) Communication Support Center,
P.O. Box 37366, Washington, DC 20013-7366. Each of the 28 chapters of
``Healthy People 2010'' is priced at $2 per copy. Telephone orders can
be placed with ODPHP on 301-468-5690. OPDHP also sells the complete
Conference Edition in CD-ROM format (B0071) for $5. This publication is
also available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.health.gov/healthypeople under
``Publications.''
I. Background
New drugs are required to undergo extensive testing before
marketing. Generally, if FDA determines that the manufacturer or
sponsor of a new drug has submitted adequate data on the new drug's
safety and effectiveness, the agency approves a new drug application
(NDA) and that permits a manufacturer to market its product in the
United States. Although the information provided before marketing is
sufficient for approval, it is not adequate to anticipate all effects
of a product once it comes into general use. This request for
applications (RFA) is intended to encourage collaboration between FDA
and researchers with pharmacoepidemiological databases representing
U.S. patients to address postmarketing issues confronting the agency.
FDA is interested in the ability to measure and/or estimate
incidence rates and test hypotheses based on signals of possible drug
safety problems originating from adverse reaction reports received by
FDA.
II. Program Research Goals
FDA shall fund up to three cooperative agreements whose databases
represent, without overlap to each other or agency contracts, different
U.S. patient populations.
The goal for these cooperative agreements is to collaborate with
researchers who have pharmacoepidemiological databases, investigate
suspected associations between specific drug exposures and specific
adverse events, and estimate such risk. The specific objectives are to:
(1) Provide immediate access to existing data sources with the
capability of providing assessments of study feasibility, (2) respond
to specific drug safety questions within a few weeks, and (3) provide a
complete analysis to those questions deemed feasible within a few
months.
Databases
For the purpose of this RFA, all $300,000 awards will be to fund
U.S. longitudinal databases that: (1) Cover U.S. patients only, (2)
cover multiple States across the United States, (3) had more than 1.5
million enrolled patients on December 31, 2000, and (4) have the
demonstrated ability to obtain paper copies of anonymized patient
medical records.
These U.S. databases must be able to: (1) Provide exposure data on
new molecular entities (those approved within the last 5 years in the
United States), (2) perform feasibility studies of multiple drugs and/
or multiple outcomes, (3) identify adverse drug events that occur
infrequently (i.e., at rates lower than can be detected in clinical
trials), (4) provide data and preliminary analysis within a very short
timeframe (2 to 4 weeks depending on the problem), and (5) obtain paper
copies of relevant anonymized patient medical records as required for
completion and validation of studies under the cooperative agreement.
Database characteristics of interest include the ability to: (1)
Estimate adverse event rates or relative risks for a specific event;
(2) estimate the contribution of various risk factors associated with
the occurrence of adverse events (e.g., age, sex, dose, coexisting
disease, disease severity, and concomitant medication); (3) determine
adverse event rates for generic entities as well as for classes of
drugs; and (4) follow patients long term after an exposure to a suspect
drug. Other desirable, but not mandatory, characteristics include the
ability to: (1) Obtain data from laboratory results, (2) link to State
vital statistics, (3) link to cancer registries, and (4) determine
inpatient exposure to drugs.
In addition, FDA is interested in databases capable of innovatively
applying the objectives stated above to general populations.
The ideal data source would: (1) Capture all drug exposures linked
longitudinally to each patient, regardless of health care delivery
setting. Outcomes of interest could be either acute or chronic effects.
All health provider encounters (i.e., medical records) would be
captured whether in the ambulatory, emergency, chronic care, or acute
care setting; (2) have the statistical power to identify rare (1 event
per 5,000 exposures) adverse events in the population of interest; (3)
be automated with a computerized system available for linking each
patient to all relevant medical care data including drug exposure data,
coded medical outcomes, vital records, cancer registries, and birth
defect registries; (4) have a low patient turnover, thereby permitting
long-term longitudinal followup of most patients for delayed adverse
effects (e.g., National Heart, Lung, and Blood Institute Framingham
Heart Study); (5) address effects from chronically used drugs; and (6)
address delayed effects resulting from drug use.
Submitted applications must include an indepth description of the
database and provide descriptive and quantitative information on
diagnoses or drug exposures in the population.
III. Reporting Requirements
Program progress reports will be required semiannually. The
Progress Report Summary required for the Noncompeting Continuation
Application is sufficient, if amended with the following information:
(1) A list of all studies performed or in progress using cooperative
agreement funds, categorized into those studies requested by FDA and
all other studies; (2) copies of or a list of publications, abstracts,
and presentations to professional organizations; (3) a list of the top
100 drug substance exposures for the previous year; and (4) a summary
of any changes in the demographics or capabilities of the database over
the last year. The Program Progress Reports will be submitted as part
of the Noncompeting Continuation Application (PHS-2590, OMB Control No.
0925-0001). You may exceed the two-page limit and should specify what
you have done for the benefit of the public health. A final Progress
Report will be required and must be submitted within 90 days after the
expiration of the project period.
Financial Status Reports (SF-269, prescribed by OMB Circulars A-102
and A-110) will be required annually. These reports must be submitted
within 90 days after the last day of the budget period of the
cooperative agreement. Send the original and one copy of each document
to the Grants Office at the address listed above. Failure to file the
Annual Progress Report or the Financial Status Report (SF-269) in a
timely fashion will be grounds for suspension or termination of the
grant.
Program monitoring of the grantees will be conducted on an ongoing
basis and written reports will be prepared by the Project Officer. The
monitoring may be in the form of telephone conversations between the
Project Officer and/or Grants Management Specialist and the Principal
Investigator. Periodic site visits with appropriate
[[Page 17909]]
officials of the grantee organization may also be conducted. The
results of these reports will be recorded in the Official Grant File
and may be available to the grantee upon request.
A final Program Progress Report and Financial Status Report (SF-
269) must be submitted within 90 days after the expiration of the
project period as noted on the Notice of Grant Award. Send the original
and one copy to the Grants Management Officer at the address listed
above.
Up to two representatives from each cooperative agreement may be
required, if requested by the Project Officer, to travel to FDA up to
twice a year for no more than 2 days at a time. These meetings will
include, but are not limited to, presentation on study design and
findings and discussions with FDA staff involved in the collaborative
research. At least one FDA employee may visit the cooperative agreement
site at least once a year for collaboration and information exchange.
IV. Mechanism of Support
A. Award Instrument
Support of this program will be in the form of cooperative
agreements. All awards will be subject to all policies and requirements
that govern the research grant programs of PHS, including the
provisions of 42 CFR part 52, 45 CFR parts 74 and 92 and the PHS Grants
Policy Statement.
B. Eligibility
These cooperative agreements are available to any domestic (U.S.)
public or private nonprofit organization (including State and local
governments) and any for-profit organization. For-profit organizations
must exclude fees or profit from their requests for support.
Organizations described in section 501(c)4 of the Internal Revenue Code
of 1968 that engage in lobbying are not eligible to receive grant/
cooperative agreement awards.
C. Length of Support
The first year will be competitive and future support for the
second and third years will be noncompetitive. Future support will be
contingent upon: (1) Investigator's demonstrated success collaborating
with FDA scientists, as well as other investigators funded by this
cooperative agreement program. Such demonstration may include
suggestions for and design of a study, analysis of data sets, and
publication of results from investigations performed by FDA and
cooperative agreement investigators; and (2) the availability of
Federal fiscal year appropriations.
D. Funding Plan
Up to three cooperative agreements may be funded for up to $300,000
each per year with the intent that they will have large, general U.S.
databases with the ability to address a variety of questions in the
field of pharmacoepidemiology. These databases must: (1) Cover U.S.
patients only, (2) cover multiple States across the United States, (3)
have greater than 1.5 million enrolled patients on December 31, 2000,
and (4) have demonstrated ability to obtain paper copies of anonymized
patient medical records. It is anticipated that these cooperative
agreements will have a total of $900,000 available per year.
These amounts are to include all direct and indirect costs. Federal
funds for this program are limited, therefore, if two or more
cooperative agreements are perceived as duplicative or very similar
data sources with one another, FDA will support only the source with
the best score. If any data source is perceived as duplicative or very
similar to an existing FDA research contract, the contract will take
precedence over the application. (FDA contracts include IMS Health,
Inc., databases: National Prescription Audit Plus, National Disease and
Therapeutic Index, Provider Prospective, Retail Prospective, Direct to
Consumer-Integrated Promotional Services (Contract No. 223-01-5501)).
V. Delineation of Substantive Involvement
Inherent in the cooperative agreement award is substantive
involvement by the awarding agency. Accordingly, FDA will have a
substantive involvement in the programmatic activities of all projects
funded under this RFA. Involvement may be modified to fit the unique
characteristics of each application. Substantive involvement includes,
but is not limited to, the following:
1. FDA will appoint Project Officers who will actively monitor the
FDA supported program under each award and collaborate with award
recipients.
2. FDA Project Officers will participate in the selection and
approval of the drug and medical events to be studied as predicated by
the needs of FDA and the public interest. The drug and medical events
to be studied will be jointly agreed upon by the Principal Investigator
and the FDA Project Officer.
3. FDA Project Officers and scientists will collaborate with
awardees in study design and data analysis. Collaboration may include
sharing of the analysis data set, interpretation of findings, review of
manuscripts, design of protocols, and where appropriate, coauthorship
of publications.
VI. Review Procedure and Criteria
A. Review Procedure
All applications submitted must be responsive to the RFA.
Responsiveness is defined as adherence to the following review
criteria. The requested budget should be within the limits of $300,000
total cost (direct and indirect costs). Any application received that
requests support in excess of the maximum amount allowable will be
considered nonresponsive and returned to the applicant unreviewed.
Also, this RFA is limited to databases that: (1) Cover U.S. patients
only (2) cover multiple States across the United States, (3) had
greater than 1.5 million enrolled patients as of December 31, 2000, and
(4) have the demonstrated ability to obtain paper copies of anonymized
patient medical records. Those applications failing to meet any of the
above criteria will be classified as nonresponsive, will not be
considered for funding under this RFA, and will be returned to the
applicant unreviewed.
Responsive applications will undergo dual peer review. A review
panel of experts, comprised primarily of non-Federal scientists, in the
fields of epidemiology, statistics, and database management will review
and evaluate each application based on its scientific merit. Responsive
applications will also be subject to a second level review by a
National Advisory Council for concurrence with the recommendations made
by the first level reviewers, and the final funding decisions will be
made by the Commissioner of Food and Drugs (the Commissioner) or the
Commissioner's designee.
B. Review Criteria
Applicants are strongly encouraged to contact FDA to resolve any
questions regarding criteria or administrative procedures prior to the
submission of their application. See the For Further Information
Contact section of this document for contact information.
Applications will be reviewed according to the following criteria,
with each criteria being of equal weight within each major category,
unless otherwise specified. All applications will be scored with a
maximum of 500 points allowable.
The size and characteristics of the general, longitudinal database
should include the following:
1. Database Characteristics (255 points)
a. Structure (70 points). Raw data from multiple State sites is
stored in a central database repository at one site.
[[Page 17910]]
All analysis data sets are efficiently derived from this central
database. (70 points)
There is no central database where raw data from all State sites is
collected and stored. However, the same data elements defined in the
same way are stored in multiple databases corresponding to the multiple
State sites. The data structure at each of these multiple sites allows
easy integration across sites to create a unified analysis data set.
(30 points)
b. Size (70 points). Applicants should list number of patients
enrolled in their database as of December 31, 2000.
3 million covered lives (70 points)
2.5 to 3 million covered lives (40 points)
2 to 2.5 million covered lives (30 points)
1.5 to 2 million covered lives (10 points)
c. Duration (55 points). The calendar time-period for which
detailed patient longitudinal data are available and linked for
routine, day-to-day analysis from at least 80 percent of the multiple
State sites.
5 years of data online (0 points)
5 years of data online (25 points)
6 points for each additional year beyond 5 years of online
data to a possible total of 55 points
d. General database features (60 points). A maximum of five points
and a minimum of zero points will be awarded for each of the following
criterion:
1. Provide a detailed process description and timeline of the
process for creating a cohort based on drug exposure or clinical
diagnosis. Include a list of data fields available for determining drug
exposure and clinical diagnoses or procedures. In addition, include an
estimate of the number and type of personnel and percentage of
personnel commitment necessary for achieving this task.
2. Provide a detailed description of how patient demographic,
health provider encounters, and drug exposure data are linked for the
purposes of analysis. Include information on the specific variable(s)
used to link the data together, and a description of information pulled
from each file.
3. Provide age, ethnicity, gender distribution, and total number of
participants where appropriate for the populations listed below as
categories (a) through (e). All questions should be answered using the
2000 calendar year as a reference. (Please note that this list is only
a sample for evaluation purposes, and that the specific target
populations of future interest to FDA and the public may not be
explicitly defined here.) Include the definitions used to obtain the
cohorts listed. Please also provide, wherever possible, publications or
studies regarding any of the following special populations that
describe studies of adverse drug reactions conducted in your database:
(a) Children (those under 21 years of age as of December 31, 2000),
(b) Women between the ages of 18 and 50 as of December 31, 2000,
(c) Persons aged 65 and above as of December 31, 2000,
(d) Deliveries as of December 31, 2000, and
(e) Persons diagnosed with human immunodeficiency virus/acquired
immunodeficiency syndrome (HIV/AIDS) as of December 31, 2000 (include
definition of HIV/AIDS).
4. Provide a detailed description of the patient enrollment and
turnover rates for the past 5 years. Include data specifying the
numbers of new patients and departing patients for each year, as well
as the average length of enrollment.
5. Provide a description of the drug and disease classification
systems used in the database. Include the generally accepted name of
the system, revision currently used, and a reference to the
organization that maintains the classification standard.
6. Provide a detailed process description and timeline for
retrieving and reviewing 100 medical records for validity of a
diagnosis. Include an estimate of the number and type of personnel and
percentage of personnel commitment necessary for achieving this task.
7. Provide a published reference or report referencing the occasion
in which the database was used to link to a cancer registry and to
State vital statistics for an investigation. If no report or reference
is available, please describe in detail how these linkages could be
accomplished using the database. Include a list of variables available
for linking and a detailed description of the linking algorithm.
8. Provide three reports or references in which a drug-drug
interaction was the focus of the investigation. If no reports or
references are available, provide a detailed description of how such a
study could be conducted using the database. Include an explanation of
how the cohort for the study would be created and followed and how drug
interactions would be defined.
9. Provide a detailed process description and timeline between a
patient event (office visit, hospitalization, etc.) and the
availability of data from that event for analysis.
10. Provide a list of the top 50 drug substances of exposure
contained in the database. Include the drug and number of exposures as
of December 31, 2000.
11. Provide the name and description of the software package used
to calculate person-time at risk and time of event occurrence in the
database. If the software package is not commercially available (e.g.,
SAS, SPSS, S+, Stata), include the algorithm used by the software.
12. Provide a description of the applicant organization's ability
to generate anonymized data sets that can be provided to authorized FDA
personnel for further analysis or data pooling purposes. Include a
description and timeline of the clearance or other procedures necessary
for this process to occur. If this is not possible due to database or
other constraints, provide a detailed explanation of why data sets
cannot be exported for research purposes.
2. New Molecular Entity (NME) Identification (200 points)
In table 1 of this document, 40 recently approved NME's are listed.
Applicants should respond with the number of unique patients in their
system with at least 1 outpatient prescription for each of the 40 drug
products listed in table 1. For each drug, points will be awarded by
the review panel according to the following schedule:
25,000 exposed patients (5 points)
20,001 to 25,000 exposed patients (4 points)
15,001 to 20,000 exposed patients (3 point)
10,001 to 15,000 exposed patients (2 points)
5,001 to 10,000 exposed patients (1 point)
5,000 or fewer exposed patients (0 points).
FDA recognizes that no database will receive full points for every
drug requested, or necessarily have each of the drugs listed in the
table in their formulary. FDA is interested in the ability of each
database to address potential safety issues related to recently
approved drugs, now and in the future. NME's eligible for scoring with
the previously described criteria are shown in table 1 below:
Table 1.--New Molecular Entities
------------------------------------------------------------------------
Brand Year
Name Approved
---------------
Aciph 1999
ex
Acton 1998
el
Actos 1999
Amerg 1998
e
Avand 1999
ia
Avelo 1999
x
Celeb 1998
rex
[[Page 17911]]
Celex 1998
a
Comta 1999
n
Detro 1998
l
Evist 1997
a
Evoxa 2000
c
Floma 1997
x
Gabit 1997
ril
Lotro 2000
nex
Maxal 1998
t
Merid 1997
ia
Micar 1998
dis
Mirap 1997
ex
Mobic 2000
Pleta 1999
l
Posic 1997
or
Prand 1997
in
Proto 2000
nix
Provi 1998
gil
Raxar 1997
Relen 1999
za
Rezul 1997
in
Singu 1998
lair
Sonat 1999
a
Tamif 1999
lu
Tasma 1998
r
Tikos 1999
yn
Trova 1997
n
Viagr 1998
a
Vioxx 1999
Xenic 1999
al
Ziage 1998
n
Zomig 1997
Zyvox 2000
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3. Personnel (20 points)
Personnel should have the following qualifications:
a. Scientific (15 points).--Extensive research experience,
training, and competence. Special consideration will be given to teams
with knowledge and previous experience in drug epidemiology. Applicants
with strong acute and chronic disease epidemiology backgrounds and a
demonstrated ability to draw on consultative expertise (particularly in
the areas of postmarketing surveillance and epidemiology) are
encouraged to apply. (If consultants are used, letters of intent or
other contractual agreements, including beginning and end dates, shall
be included in the application to fulfill this requirement.)
Demonstrated ability to initiate, conduct, complete, and publish
epidemiology studies in a timely manner.
b. Support (5 points).--Project management and information systems
expertise with previous experience in the organization and manipulation
of large data sets and specific experience in databases under
agreement.
4. Data Sharing (15 points)
To provide study data sets (free of patient identifiers and in a
format usable to the agency) to Project Officers of FDA for analysis
and with other cooperative agreement holders in studies that would
require data pooling.
5. Budget (10 points)
Reasonableness of the proposed budget. Special consideration will
be given to methodology which is cost effective (e.g., well-structured
medical records and/or records linkage) if otherwise scientifically
acceptable.
VII. Submission Requirements
The original and two copies of the completed Grant Application Form
PHS 398 (revised 4/98 OMB Control No. 0925-0001) or the original and
two copies of Form 5161 for State and local governments (Revised 7/00,
OMB Control No. 0348-0042), with sufficient copies of the appendix for
each application should be delivered to Rosemary T. Springer (address
above). State and local governments may choose to use the PHS 398
application in lieu of the PHS 5161. No supplemental material will be
accepted after the closing date. The outside of the mailing package
should be labeled ``Response to RFA-FDA-CDER-02-1''. The application
receipt date is June 4, 2001.
VIII. Method of Application
A. Submission Instructions
Applications will be accepted during normal working hours, 8 a.m.
to 4:30 p.m., Monday through Friday, on or before June 4, 2001.
Applications will be considered received on time if sent or mailed
on or before the receipt date as evidenced by the legible U.S. Postal
Service dated postmark or a legible date receipt from a commercial
carrier, unless they arrive too late for orderly processing. Private
metered postmarks shall not be acceptable as proof of timely mailing.
Applications not received on time will not be considered for review and
will be returned to the applicant.
Note: 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.
Do not send applications to CSR, NIH. Any application that is sent
to NIH, that is then forwarded to FDA and received after the applicable
due date, will be deemed unresponsive and returned to the applicant.
Instructions for completing the application forms can be found on the
NIH home page on the Internet (address http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/grants/funding/phs398/phs398.html; the application forms can be found at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/grants/funding/phs398/forms__toc.html). However, as
noted above, applications are not to be mailed to NIH. Applicants are
advised that FDA does not adhere to the page limitations or type size
and line spacing requirements imposed by NIH on its applications.
Applications must be submitted via mail delivery as stated above. FDA
is unable to receive applications via the Internet.
B. Format of Application
Applications must be submitted on Grant Application Form PHS 398
(revised 4/98). All ``General Instructions'' and ``Specific
Instructions'' in the application kit should be followed with the
exception of the receipt dates and the mailing label addresses. Do not
send applications to CSR, NIH. Applications from State and local
governments may be submitted on Form PHS 5161 (revised 6/99) or PHS 398
(revised 4/98). The face page of the application must reflect the
request for applications number RFA-FDA-CDER-02-1. This information
collection is approved under OMB control number 0925-0001.
C. Legend
Data included in the application, if restricted with the legend
specified below, may be entitled to confidential treatment as trade
secret or confidential commercial information within the meaning of the
Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(4)) and FDA's
implementing regulations (21 CFR 20.61).
Unless disclosure is required by FOIA 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 the application that have been specifically identified by page
number, paragraph, etc., by the applicant as containing confidential
commercial information or other information that is exempt from public
disclosure will not be used or disclosed except for evaluation
purposes.
Dated: March 29, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-8246 Filed 4-3-01; 8:45 am]
BILLING CODE 4160-01-S