[Federal Register Volume 72, Number 127 (Tuesday, July 3, 2007)]
[Notices]
[Pages 36463-36468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Clinical Studies of Safety and Effectiveness of Orphan Products; 
Availability of Grants; Request for Applications: RFA-FD08-001; 
Research Project Grants (R01); Catalog of Federal Domestic Assistance 
Number: 93.103

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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I. Funding Opportunity Description

    The Food and Drug Administration (FDA) is announcing changes to its 
Office of Orphan Products Development (OPD) grant program for fiscal 
years (FY) 2009 and 2010. This announcement supersedes the previous 
announcement of this program, which was published in the Federal 
Register of December 19, 2005 (70 FR 75198).

1. Background

    OPD was created to identify and promote the development of orphan 
products. Orphan products are drugs, biologics, medical devices, and 
foods for medical purposes that are indicated for a rare disease or 
condition (that is, one with a prevalence, not incidence, of fewer than 
200,000 people in the United States). Diagnostic tests and vaccines 
will qualify only if the U.S. population of intended use is fewer than 
200,000 people a year. Additional information about OPD is available on 
FDA's Web site at www.fda.gov/orphan.

2. Program Research Goals

    The goal of FDA's OPD grant program is to support the clinical 
development of products for use in rare diseases or conditions where no 
current therapy exists or where the product will improve the existing 
therapy. FDA provides grants for clinical studies on safety and/or 
effectiveness that will either result in, or substantially contribute 
to, market approval of these products. Applicants must include in the 
application's ``Background and Significance'' section documentation to 
support the estimated prevalence of the orphan disease or condition and 
an explanation of how the proposed study will either help gain product 
approval or provide essential data needed for product development. All 
funded studies are subject to the requirements of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 331 et seq.), regulations 
issued under it, and applicable Department of Health and Human Services 
(HHS) statutes and regulations.

II. Award Information

    Except for applications for studies of medical foods that do not 
need premarket approval, FDA will only award grants to support 
premarket clinical studies to determine safety and effectiveness for 
approval under section 505 or 515 of the act (21 U.S.C. 355 or 360e) or 
safety, purity, and potency for licensing under section 351 of the 
Public Health Service Act (the PHS Act) (42 U.S.C. 262). FDA will 
support the clinical studies covered by this notice under the authority 
of section 301 of the PHS Act (42 U.S.C. 241). FDA's research program 
is described in the Catalog of Federal Domestic Assistance (CFDA), No. 
93.103.

1. Award Instrument

    Support will be in the form of a research project (R01) grant. All 
awards will be subject to all policies and requirements that govern the 
research grant programs of the PHS Act as incorporated in the HHS 
Grants Policy Statement, dated October 1, 2006, (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm), including the provisions of 42 CFR 
part 52 and 45 CFR parts 74 and 92. The regulations issued under 
Executive Order 12372 do not apply to this program. The National 
Institutes of Health (NIH) modular grant program does not apply to this 
FDA grant program. All grant awards are subject to applicable 
requirements for clinical investigations imposed by sections 505, 512, 
and 515 of the act (21 U.S.C. 360b), section 351 of the PHS Act, 
regulations issued under any of these sections, and other applicable 
HHS statutes and regulations regarding human subject protection.

2. Award Amount

    Of the estimated FY 2009 funding ($14.2 million), approximately $10 
million will fund noncompeting continuation awards, and approximately 
$4.2 million will fund 10 to 12 new awards, subject to availability of 
funds. It is anticipated that funding for the number of noncompeting 
continuation awards and new awards in FY 2010 will be similar to FY 
2009. Grants will be awarded up to $200,000 or up to $400,000 in total 
(direct plus indirect) costs per year for up to 4 years. Please note 
that the dollar limitation will apply to total costs, not direct costs, 
as in previous years. A fourth year of funding is available only for 
phase 2 or 3 clinical studies. Applications for the smaller grants 
($200,000) may be for phase 1, 2, or 3 studies. Study proposals for the 
larger grants ($400,000) must be for studies continuing in phase 2 or 3 
of investigation.
    Phase 1 studies include the initial introduction of an 
investigational new drug (IND) or device into humans, are usually 
conducted in healthy volunteer subjects, and are designed to determine 
the metabolic and pharmacological actions of the product in humans, the 
side effects including those associated with increasing drug doses. In 
some Phase 1 studies that include subjects with the rare disorder, it 
may also be possible to gain early evidence on effectiveness.
    Phase 2 studies include early controlled clinical studies conducted 
to: (1) Evaluate the effectiveness of the product for a particular 
indication in patients with the disease or condition and (2) determine 
the common short-term side effects and risks associated with it.
    Phase 3 studies gather more information about effectiveness and 
safety that is necessary to evaluate the overall risk-benefit ratio of 
the product and to provide an acceptable basis for product labeling. 
Budgets for each year of requested support may not exceed the $200,000 
or $400,000 total cost limit, whichever is applicable.

3. Length of Support

    The length of support will depend on the nature of the study. For 
those studies with an expected duration of

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more than 1 year, a second, third, or fourth year of noncompetitive 
continuation of support will depend on the following factors: (1) 
Performance during the preceding year; (2) compliance with regulatory 
requirements of IND/investigational device exemption (IDE); and (3) 
availability of Federal funds. A fourth year of funding is available 
only for phase 2 or 3 clinical studies.

4. Funding Plan

    In addition to the requirement for an active IND/IDE discussed in 
section V.B.4 of this document, documentation of assurances with the 
Office of Human Research Protection (OHRP) (see section IV.5.A of this 
document) must be on file with the FDA grants management office before 
an award is made. Any institution receiving Federal funds must have an 
institutional review board (IRB) of record even if that institution is 
overseeing research conducted at other performance sites. To avoid 
funding studies that may not receive or may experience a delay in 
receiving IRB approval, documentation of IRB approval and Federal Wide 
Assurance (FWA or assurance) for the IRB of record for all performance 
sites must be on file with the FDA grants management office before an 
award to fund the study will be made. In addition, if a grant is 
awarded, grantees will be informed of any additional documentation that 
should be submitted to FDA's IRB.

5. Dun and Bradstreet Number (DUNS)

    Beginning 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 and Bradstreet.

6. Central Contractor Registration

    For the grants.gov electronic application process, applicants are 
required to register with the Central Contractor Registration (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 is a requirement and is 
consistent with the governmentwide management reform to create a 
citizen-centered Web presence and build electronic government (e-gov) 
infrastructures in and across agencies to establish a ``single face to 
industry.'' The preferred method for completing a registration is 
through the Internet at http://www.ccr.gov.\1\ This Web site provides a 
CCR handbook with detailed information on data you will need prior to 
beginning the online registration, as well as steps to walk you through 
the registration process. You must have a DUNS number to begin your 
registration. Call Dunn & Bradstreet, Inc. at the telephone number 
listed in section II.5 of this document if you do not have a DUNS 
number.
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    \1\ (FDA has verified the non-FDA Web site addresses throughout 
this document, but we are not responsible for any subsequent changes 
to the Web sites after this document publishes in the Federal 
Register.)
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    In order to access grants.gov, an applicant will be required to 
register with the Credential Provider. Information about this process 
is available at http://www.grants.gov/applicants/iregister_credential_provider.jsp.

III. Eligibility Information

1. Eligible Applicants

    The grants are available to any foreign or domestic, public or 
private, for-profit or nonprofit entity (including State and local 
units of government). Federal agencies that are not part of HHS may 
apply. Agencies that are part of HHS may not apply. For-profit entities 
must commit to excluding fees or profit in their request for support to 
receive grant awards. Organizations that engage in lobbying activities, 
as described in section 501(c)(4) of the Internal Revenue Code of 1968, 
are not eligible to receive grant awards. An application that has 
received two prior disapprovals is not eligible to apply.

2. Cost Sharing or Matching

    This grant program does not require the applicant to match or share 
in the project costs if an award is made.

IV. Application and Submission Information

1. Content and Form of Application Submission

A. General Information
    FDA is accepting new applications for this program electronically 
via www.grants.gov. Applicants should apply electronically by visiting 
the Web site www.grants.gov and following instructions under ``Apply 
for Grants.'' The required application, SF424 R&R (Research & Related 
Portable Document Formats) can be completed and submitted online. We 
strongly encourage using the ``Tips'' posted on www.grants.gov under 
the announcement number when preparing your submission. If you 
experience technical difficulties with your online submission, you 
should contact either the grants.gov Customer Response Center http://www.grants.gov/contactus/contactus.jsp or Dianna Jessee, Grants 
Management Specialist (see Agency Contacts in section VII of this 
document).
    To comply with the President's Management Agenda, HHS is 
participating as a partner in the new governmentwide grants.gov 
application site. Users of grants.gov will be able to download a copy 
of the application package, complete it offline, and then upload and 
submit the application via the grants.gov Web site. When you enter the 
grants.gov Web site, you will find information about submitting an 
application electronically through the Web site. In addition, this 
process is similar to the R01 Grant Application process currently used 
at NIH. You can visit the following Web site for helpful background on 
preparing to apply, preparing an application, and submitting an 
application to grants.gov: http://era.nih.gov/ElectronicReceipt/. In 
order to apply electronically, the applicant must have a DUNS number 
and register in the CCR database as described in sections II.5 and II.6 
of this document.
    In unusual circumstances, additional information may be considered, 
on a case-by-case basis, for inclusion in the ad hoc expert panel 
review; however, FDA cannot assure inclusion of any information after 
the receipt date other than evidence of final IRB approval, FWA or 
assurance, and certification of adequate supply of study product.
    If an application for the same study was submitted in response to a 
previous request for application (RFA) but has not yet been funded, an 
application in response to this notice will be considered a request to 
withdraw the previous application. The applicant for a resubmitted 
application should address the issues presented in the summary 
statement from the previous review and include a copy of the summary 
statement itself as part of the resubmitted application. An application 
that has received two prior disapprovals is not eligible for 
resubmission.
B. Format for Application
    In FY 2009 and 2010, all applications must be submitted 
electronically through grants.gov. The application must be on SF424 R&R 
(Research and Related Portable Document Format). The title of the 
proposed study must include the name of the product and the

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disease/disorder to be studied and the IND/IDE number. The narrative 
portion, excluding appendices, of the application may not exceed 100 
pages in length and must be single-spaced in 12-point font. The 
appendices should also not exceed 100 pages in length (separate from 
the narrative portion of the application).

2. Submission Dates and Times

    For FY 2009, the application receipt date is February 6, 2008, and 
for FY 2010, the application receipt date is February 4, 2009. Please 
note that there is only one receipt date for FY 2009 and one receipt 
date for FY 2010. Applications must be received by the close of 
business on the established receipt date. Late applications may be 
accepted under extreme circumstances beyond the control of the 
applicant. Applications not received on time will not be considered for 
review and will generally be returned to the applicant.
    The protocol in the grant application should be submitted to the 
IND/IDE no later than January 7, 2008, for FY 2009 and no later than 
January 5, 2009, for FY 2010.

3. Intergovernmental Review

    This program is not subject to review under the terms of Executive 
Order 12372.

4. Funding Restrictions

A. Protection of Human Research Subjects
    All institutions engaged in human subject research financially 
supported by HHS must file an assurance of protection for human 
subjects with the OHRP (45 CFR part 46). Applicants are advised to 
visit the OHRP Web site at http://www.hhs.gov/ohrp for guidance on 
human subject protection issues.
    The requirement to file an assurance applies to both ``awardee'' 
and collaborating ``performance site'' institutions. Awardee 
institutions are automatically considered to be ``engaged'' in human 
subject research whenever they receive a direct HHS award to support 
such research, even where all activities involving human subjects are 
carried out by a subcontractor or collaborator. In such cases, the 
awardee institution bears the responsibility for protecting human 
subjects under the award.
    The awardee institution is also responsible for, among other 
things, ensuring that all collaborating performance site institutions 
engaged in the research hold an approved assurance prior to their 
initiation of the research. No awardee or performance site institution 
may spend funds on human subject research or enroll subjects without 
the approved and applicable assurance(s) on file with OHRP. An awardee 
institution must, therefore, have its own IRB of record and assurance. 
The IRB of record may be an IRB already being used by one of the 
``performance sites,'' but it must specifically be registered as the 
IRB of record with OHRP.
    For further information, applicants should review the section on 
human subjects in the application instructions as posted on the 
grants.gov application Web site. The clinical protocol should comply 
with ICHE6 ``Good Clinical Practice Consolidated Guidance'' which sets 
an international ethical and scientific quality standard for designing, 
conducting, recording, and reporting trials that involve the 
participation of human subjects. All human subject research regulated 
by FDA is also subject to FDA's regulations regarding the protection of 
human subjects (21 CFR parts 50 and 56). Applicants are encouraged to 
review the regulations, guidance, and information sheets on human 
subject protection and good clinical practice available on the Internet 
at http://www.fda.gov/oc/gcp/.
B. Key Personnel and Human Subject Protection Education
    The awardee institution is responsible for ensuring that all key 
personnel receive appropriate training in their human subject 
protection responsibilities. Key personnel include all principal 
investigators, co-investigators, and performance site investigators 
responsible for the design and conduct of the study. HHS, FDA, and OPD 
do not prescribe or endorse any specific education programs. Many 
institutions have already developed educational programs on the 
protection of research subjects and have made participation in such 
programs a requirement for their investigators. Other sources of 
appropriate instruction might include the online tutorials offered by 
the Office of Human Subjects Research, NIH at http://ohsr.od.nih.gov/ 
and by OHRP at use http://www.hhs.gov/ohrp/education/.
    Within 30 days of the award, the principal investigator should 
provide a letter to FDA's grants management office that includes the 
names of the key personnel, the title of the human subjects protection 
education program completed for each key personnel, and a one-sentence 
description of the program. This letter should be signed by the 
principal investigator and cosigned by an institution official and sent 
to the Grants Management Specialist whose name appears on the official 
Notice of Grant Award (NGA).

5. Other Submission Requirements

Informed Consent
    Consent forms, assent forms, and any other information given to a 
subject are part of the grant application and must be provided, even if 
in a draft form. The applicant is referred to HHS regulations at 45 CFR 
46.116 and 21 CFR 50.25 for details regarding the required elements of 
informed consent.

V. Application Review Information

1. Criteria

A. General Information
    FDA grants management and program staff will review all 
applications sent in response to this notice. To be responsive, an 
application must be submitted in accordance with the requirements of 
this notice. Applications found to be nonresponsive will be returned to 
the applicant without further consideration.
    Applicants are strongly encouraged to contact FDA to resolve any 
questions about criteria before submitting their application. Please 
direct all questions of a technical or scientific nature to the OPD 
program staff and all questions of an administrative or financial 
nature to the grants management staff (see Agency Contacts in section 
VII of this document).
B. Program Review Criteria
    1. Applications must propose clinical trials intended to provide 
safety and/or efficacy data.
    2. There must be an explanation in the ``Background and 
Significance'' section of how the proposed study will either contribute 
to product approval or provide essential data needed for product 
development.
    3. The ``Background and Significance'' section of the application 
must contain information documenting the prevalence, not incidence, of 
the population to be served by the product is fewer than 200,000 
individuals in the United States. The applicant should include a 
detailed explanation supplemented by authoritative references in 
support of the prevalence figure. Diagnostic tests and vaccines will 
qualify only if the population of intended use is fewer than 200,000 
individuals in the United States per year.
    4. The study protocol proposed in the grant application must be 
under an active IND or IDE (not on clinical hold) to qualify the 
application for scientific and technical review. Additional IND/IDE 
information is described as follows:

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     The proposed clinical protocol should be submitted to the 
applicable FDA IND/IDE review division a minimum of 30 days before the 
grant application deadline. The number assigned to the IND/IDE that 
includes the proposed study should appear on the face page of the 
application with the title of the project. The date the subject 
protocol was submitted to FDA for the IND/IDE review should also be 
provided. Protocols that would otherwise be eligible for an exemption 
from the IND regulations must be conducted under an active IND to be 
eligible for funding under this FDA grant program. If the sponsor of 
the IND/IDE is other than the principal investigator listed on the 
application, a letter from the sponsor permitting access to the IND/IDE 
must be submitted in both the IND/IDE and in the grant application. The 
name(s) of the principal investigator(s) named in the application and 
in the study protocol must be submitted to the IND/IDE. Studies of 
already approved products, evaluating new orphan indications, are also 
subject to these IND/IDE requirements.
     Only medical foods that do not need premarket approval and 
medical devices that are classified as nonsignificant risk (NSR) are 
free from these IND/IDE requirements. Applicants studying an NSR device 
should provide a letter in the application from FDA's Center for 
Devices and Radiological Health indicating the device is an NSR device.
    5. The requested budget must be within the limits, either $200,000 
in total costs per year for up to 3 years for any phase study, or 
$400,000 in total costs per year for up to 4 years for phase 2 or 3 
studies. Any application received that requests support over the 
maximum amount allowable for that particular study will be considered 
non-responsive.
    6. In an appendix to the application, there must be evidence that 
the product to be studied is available to the applicant in the form and 
quantity needed for the clinical trial proposed. A current letter from 
the supplier as an appendix will be acceptable. If negotiations 
regarding the supply of the study product are underway but have not 
been finalized at the time of application, please provide a letter 
indicating such in the application. Verification of adequate supply of 
study product will be necessary before an award is made.
    7. The protocol should be submitted in the application. The 
narrative portion of the application should be no more than 100 pages, 
single-spaced, with 1/2-inch margins, and in unreduced 12-point font. 
The appendices should also be no more than 100 pages (separate from the 
narrative portion of the application).
C. Scientific/Technical Review Criteria
    The ad hoc expert panel will review the application based on the 
following scientific and technical merit criteria:
    1. The soundness of the rationale for the proposed study;
    2. The quality and appropriateness of the study design, including 
the design of the monitoring plans;
    3. The statistical justification for the number of patients chosen 
for the study, based on the proposed outcome measures, and the 
appropriateness of the statistical procedures for analysis of the 
results;
    4. The adequacy of the evidence that the proposed number of 
eligible subjects can be recruited in the requested timeframe;
    5. The qualifications of the investigator and support staff, and 
the resources available to them;
    6. The adequacy of the justification for the request for financial 
support;
    7. The adequacy of plans for complying with regulations for 
protection of human subjects and monitoring; and
    8. The ability of the applicant to complete the proposed study 
within its budget and within time limits stated in this RFA.

2. Review and Selection Process

    Responsive applications 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. Consultation with the proper 
FDA review division may also occur during this phase of the review to 
determine whether the proposed study will provide acceptable data that 
could contribute to product approval. Responsive applications will be 
subject to a second review by the National Cancer Institute, National 
Cancer Advisory Board (NCAB) for concurrence with the recommendations 
made by the first-level reviewers, and funding decisions will be made 
by the Commissioner of Food and Drugs or his designee.
    A score will be assigned 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 OPD grant program.

VI. Award Administration Information

1. Award Notices

    A formal notification in the form of an NGA will be provided to the 
applicant organization. The NGA signed by the grants management officer 
is the authorizing document. Once all administrative and programmatic 
issues have been resolved, the NGA will be generated via e-mail or hard 
copy from FDA to the authorized grantee business official.
    Selection of an application for award is not an authorization to 
begin performance. Any costs incurred before receipt of the NGA are at 
the recipient's risk. These costs may be reimbursed only to the extent 
they are considered allowable pre-award costs.

2. Administrative Requirements

    All FDA grant awardees must adhere to the requirements stated in 
the RFA, the NGA, associated Terms and Conditions, as well as any 
relevant FDA or HHS statutory or regulatory requirements.

3. Reporting

A. Reporting Requirements
    When multiple years are involved, awardees will be required to 
submit the Non-Competing Grant Progress Report (PHS 2590) annually and 
financial statements as required in the HHS Grants Policy Statement, 
dated October 1, 2006, (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm). Also, all new and continuing grants must comply with all 
regulatory requirements necessary to keep the status of their IND/IDE 
``active'' and ``in effect,'' that is, not on ``clinical hold.'' 
Failure to meet regulatory requirements will be grounds for suspension 
or termination of the grant.
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 officer/grants management 
officer or specialist and the principal investigator. Information 
including, but not limited to, information regarding study progress, 
enrollment, problems, adverse events, changes in protocol, and study 
monitoring activities will be requested. 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

[[Page 36467]]

regulations. Also, the grantee organization must comply with all 
special terms and conditions of the grant, including those which state 
that future funding of the study will depend on recommendations from 
the OPD project officer. The scope of the recommendations will confirm 
the following: (1) There has been acceptable progress toward 
enrollment, based on specific circumstances of the study; (2) there is 
an adequate supply of the product/device; and (3) there is continued 
compliance with all applicable FDA and HHS regulatory requirements for 
the trial.
    The grantee must file a final program progress report, financial 
status report, and invention statement within 90 days after the end 
date of the project period as noted on the notice of grant award.

VII. Agency Contacts

    FDA encourages your inquiries concerning this funding opportunity 
and welcome the opportunity to answer questions from potential 
applicants. Inquiries may fall into two areas:
    Scientific/Research Contact: Debra Y. Lewis, Director, Orphan 
Products Grants Program, Office of Orphan Products Development (HF-35), 
Food and Drug Administration 5600 Fishers Lane, rm. 6A-55, Rockville, 
MD 20857, 301-827-3666, e-mail: [email protected].
     Administrative/Financial Management Contact: Dianna L. Jessee, 
Grants Management Specialist, Division of Acquisition Support and 
Grants, Office of Acquisitions & Grant Services (HFA-500), Food and 
Drug Administration, 5630 Fishers Lane, rm. 2141, Rockville, MD 20857, 
301-827-7177, e-mail: [email protected].

VIII. Other Information

Required Federal Citations

Clinical Trials Data Bank
    The Food and Drug Administration Modernization Act of 1997 
established a requirement that certain information be entered into the 
Clinical Trials Data Bank (CTDB) for federally and privately funded 
clinical effectiveness trials conducted under an IND for drugs 
(including trials for biological products) to treat serious or life-
threatening diseases or conditions (42 U.S.C. 282(j)). Information on 
noneffectiveness trials, or for drugs to treat diseases or conditions 
not considered serious or life-threatening, may also be entered into 
this database but such information is not required. This CTDB provides 
patients, family members, healthcare providers, researchers, and 
members of the public easy access to information on clinical trials for 
a wide range of diseases and conditions. The U.S. National Library of 
Medicine has developed this site in collaboration with NIH and FDA. The 
CTDB is available to the public through the Internet at http://clinicaltrials.gov.
    The CTDB contains the following information: (1) Information about 
clinical trials, both federally and privately funded, of experimental 
treatments (drug and biological products) for patients with serious or 
life-threatening diseases or conditions; (2) a description of the 
purpose of each experimental drug; (3) the patient eligibility 
criteria; (4) a description of the location of clinical trial sites; 
and (5) a point of contact for those wanting to enroll in the trial. In 
2007, the Best Pharmaceuticals for Children Act also required that the 
CTDB include a description of whether, and through what procedure, the 
manufacturer or sponsor of an IND will respond to a request for 
protocol exception, with appropriate safeguards, for single-patient and 
expanded access use of the investigational drug, particularly in 
children. The OPD program staff will provide more information to 
grantees about entering the required information in the CTDB after 
awards are made.
Freedom of Information Act (FOIA)
    Data included in the application may be considered trade secret or 
confidential commercial information within the meaning of the Freedom 
of Information Act (5 U.S.C. 552) and FDA's statute and implementing 
regulations. FDA will protect trade secret or confidential commercial 
information to the extent allowed under applicable law.
Use of Animals in Research
    Recipients of PHS support for activities involving live vertebrate 
animals must comply with PHS Policy on Humane Care and Use of 
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension 
Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Inclusion of Women And Minorities in Clinical Research
    Applicants for PHS clinical research grants are encouraged to 
include minorities and women in study populations so research findings 
can be of benefit to all people at risk of the disease or condition 
under study. It is recommended that applicants place special emphasis 
on including minorities and women in studies of diseases, disorders, 
and conditions that disproportionately affect them. This policy applies 
to research subjects of all ages. If women or minorities are excluded 
or poorly represented in clinical research, the applicant should 
provide a clear and compelling rationale that shows inclusion is 
inappropriate.
Inclusion of Children as Participants in Clinical Research
    FDA regulations at 21 CFR part 50, subpart D contain additional 
requirements that must be met by IRBs reviewing clinical investigations 
regulated by FDA and involving children as subjects. FDA is part of 
HHS; accordingly, the research project grants under this program are 
supported by HHS, and HHS regulations at 45 CFR part 46, subpart D also 
apply to research involving children as subjects.
Standards for Privacy of Individually Identifiable Health Information
    HHS issued final modification to the ``Standards for Privacy of 
Individually Identifiable Health Information,'' the ``Privacy Rule,'' 
on August 14, 2002. The Privacy Rule is a federal regulation under the 
Health Insurance Portability and Accountability Act (HIPAA) of 1996 
that governs the protection of individually identifiable health 
information, and is administered and enforced by the HHS Office for 
Civil Rights (OCR).
    Decisions about applicability and implementation of the Privacy 
Rule reside with the researcher and his/her institution. The OCR Web 
site http://www.hhs.gov/ocr/ provides information on the Privacy Rule, 
including a complete regulation text and a set of decision tools on 
``Am I a covered entity?'' Information on the impact of the HIPAA 
Privacy Rule on NIH processes involving the review, funding, and 
progress monitoring of grants, cooperative agreements, and research 
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
Healthy People 2010
    PHS is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2010,'' a PHS-led national 
activity for setting priority areas. This Funding Opportunity 
Announcement is related to one or more of the priority areas. Potential 
applicants may obtain a

[[Page 36468]]

copy of ``Healthy People 2010'' at http://www.health.gov/healthypeople.
Smoke-Free Workplace
    The PHS strongly encourages all grant recipients to provide a 
smoke-free workplace and discourage the use of all tobacco products. In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children. This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.
Authority and Regulations
    This program is described in the CFDA at http://www.cfda.gov/ and 
is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review. Awards are made 
under the authorization of sections 301 and 405 of the PHS Act as 
amended (42 U.S.C. 241 and 284) and under federal regulations 42 CFR 
part 52 and 45 CFR parts 74 and 92. All awards are subject to the terms 
and conditions, cost principles, and other considerations described in 
the HHS Grants Policy Statement, dated October 1, 2006, (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm).

    Dated: June 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-12881 Filed 7-2-07; 8:45 am]
BILLING CODE 4160-01-S