Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices 28877

rationale for the significance of the

research to the field of occupational

safety and health must be presented in

the grant application.

The Agenda identifies 21 research

priorities. These priorities reflect a

remarkable degree of concurrence

among a large number of stakeholders.

The NORA priority research areas are

grouped into three categories: Disease

and Injury, Work Environment and

Workforce, and Research Tools and

Approaches. The NORA document is

available through the NIOSH Home

Page; http://www.cdc.gov/niosh/

nora.html.

NORA Priority Research Areas

Disease and Injury

Allergic and Irritant Dermatitis

Asthma and Chronic Obstructive

Pulmonary Disease

Fertility and Pregnancy Abnormalities

Hearing Loss

Infectious Diseases

Low Back Disorders

Musculoskeletal Disorders of the

Upper Extremities

Traumatic Injuries

Work Environment and Workforce

Emerging Technologies

Indoor Environment

Mixed Exposures

Organization of Work

Special Populations at Risk

Research Tools and Approaches

Cancer Research Methods

Control Technology and Personal

Protective Equipment

Exposure Assessment Methods

Health Services Research

Intervention Effectiveness Research

Risk Assessment Methods

Social and Economic Consequences of

Workplace Illness and Injury

Surveillance Research Methods

Application Submission and Deadline

1. Preapplication Letter of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter should

be submitted to the Grants Management

Branch, CDC, at the address provided in

this section. It should be postmarked no

later than June 15, 1996. The letter

should identify the announcement

number, name of principal investigator,

and specify the priority area to be

addressed by the proposed project. The

letter of intent does not influence

review or funding decisions, but it will

enable CDC to plan the review more

efficiently and will ensure that each

applicant receives timely and relevant

information prior to application

submission.

The original and two copies of the

application PHS Form 5161–1 (Revised

7/92, OMB Number 0937–0189) must be

submitted to Ron Van Duyne, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), Mailstop

E–13, 255 East Paces Ferry Road, NE.,

Room 300, Atlanta, GA 30305, on or

before July 17, 1996.

1. Deadline: Applications will be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date, or

(b) Sent on or before the deadline date

and received in time for submission to

the objective review group. (The

applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or the U.S. Postal

Service. Private metered postmarks will

not be acceptable as proof of timely

mailing.)

2. Late Applicants: Applications that

do not meet the criteria in 1.(a) or 1.(b)

above are considered late applications.

Late applications will not be considered

in the current competition and will be

returned to the applicants.

Where To Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and telephone number and will

need to refer to Announcement 624.

You will receive a complete program

description and information on

application procedures and application

forms. If you have questions after

reviewing the contents of all the

documents, business management

technical assistance may be obtained

from Oppie Byrd, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E–13, Atlanta, GA

30305, telephone (404) 842–6546; fax:

(404) 842–6513; Internet:

oxb3@opspgo1.em.cdc.gov.

Programmatic technical assistance

may be obtained from Naomi G.

Swanson, Ph.D., Chief, Motivation and

Stress Research Section, Applied

Psychology and Ergonomics Branch,

Division of Biomedical and Behavioral

Science, National Institute for

Occupational Safety and Health, Centers

for Disease Control and Prevention

(CDC), Mailstop C–24, 4676 Columbia

Parkway, Cincinnati, OH 45226–1998,

telephone (513) 533–8165; fax: (513)

533–8596; Internet:

nws3@niobbs1.em.cdc.gov.

Please refer to Announcement 624

when requesting information and

submitting an application.

There may be delays in mail delivery

as well as difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics (July 19–August 4). Therefore,

CDC suggests the following to get more

timely responses to any questions: use

Internet/email, follow all instructions in

this announcement, and leave messages

on the contact person’s voice mail.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the Introduction section through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: May 30, 1996.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 96–14171 Filed 6–5–96; 8:45 am]

BILLING CODE 4163–19–P

Food and Drug Administration

Clinical Studies of Safety and

Effectiveness of Orphan Products;

Availability of Grants; Request for

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

following changes to its Orphan

Products Development (OPD) grant

program for fiscal year (FY) 1997. The

previous announcement of this program,

which was published in the Federal

Register of August 15, 1994, is

superseded by this announcement. In

the future, a new announcement will be

published annually. This and future

announcements will provide the

programmatic requirements and criteria,

as well as the two dates for receipt of

applications, the estimated amount of

funds available, and the estimated

number of awards to be made in each

FY.

DATES: Application receipt dates are:

October 15, 1996, and March 15, 1997.

If the receipt date falls on a weekend, it

will be extended to Monday; if the date

falls on a holiday, it will be extended to

the following workday.
28878 Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices

ADDRESSES: Application forms are

available from, and completed

applications should be submitted to:

Robert L. Robins, Grants Management

Officer, Division of Contracts and

Procurement Management (HFA–520),

Food and Drug Administration, Park

Bldg., 5600 Fishers Lane, rm. 3–40,

Rockville, MD 20857, 301–443–6170.

(Applications hand-carried or

commercially delivered should be

addressed to the Park Bldg., 12420

Parklawn Dr., rm. 3–40, Rockville, MD

20857. Do not send applications to the

Division of Research Grants, National

Institutes of Health (NIH).)

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and

financial management aspects of

this notice: Robert L. Robins

(address above).

Regarding the programmatic aspects

of this notice: Patricia R. Robuck,

Office of Orphan Products

Development (HF–35), Food and

Drug Administration, 5600 Fishers

Lane, rm. 8–73, Rockville, MD

20857, 301–827–3666.

SUPPLEMENTARY INFORMATION: FDA is

announcing the anticipated availability

of funds for FY 1997 for awarding grants

to support clinical trials on the safety

and effectiveness of products for a rare

disease or condition (i.e., one with a

prevalence, not incidence, of fewer than

200,000 people in the United States).

Contingent on availability of FY 1997

funds, it is anticipated that $12 million

will be available, of which $8.5 million

will be for noncompeting continuation

awards. This will leave $3.5 million for

funding approximately 20 new

applications. Any phase clinical trial is

eligible for up to $100,000 in direct

costs per annum plus applicable

indirect costs for up to 3 years. Phase 2

and 3 clinical trials are eligible for up

to $200,000 in direct costs per annum

plus applicable indirect costs for up to

3 years.

FDA will support the clinical studies

covered by this notice under section 301

of the Public Health Service Act (the

PHS act) (42 U.S.C. 241). FDA’s research

program is described in the Catalog of

Federal Domestic Assistance, No.

93.103.

The Public Health Service (PHS)

strongly encourages all grant recipients

to provide a smoke-free work place 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.

PHS urges applicants to submit work

plans that address specific objectives of

‘‘Healthy People 2000.’’ Potential

applicants may obtain a copy of

‘‘Healthy People 2000’’ (Full Report,

stock no. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, stock no. 017–001–00473–1)

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

202–783–3238.

PHS policy is that applicants for PHS

clinical research grants are required to

include minorities and women in study

populations so that research findings

can be of benefit to all persons at risk

of the disease, disorder, or condition

under study; special emphasis must be

placed on the need for inclusion of

minorities and women in studies of

diseases, disorders, and conditions

which disproportionately affect them.

This policy is intended to apply to

males and females of all ages. If women

or minorities are excluded or

inadequately represented in clinical

research, particularly in proposed

population-based studies, a clear

compelling rationale must be provided.

I. Program Research Goals

OPD was established to identify and

facilitate the availability of orphan

products. In the OPD grant program,

orphan products are defined as drugs,

biologics, medical devices, and foods for

medical purposes, which are indicated

for a rare disease or condition (i.e., 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 lower than 200,000.

One way to make orphan products

available is to support clinical research

to determine whether the products are

safe and effective. All funded studies

are subject to the requirements of the

Federal Food, Drug, and Cosmetic Act

(the act) and regulations issued

thereunder. The grants are funded under

the legislative authority of section 301

of the PHS Act (42 U.S.C. 241).

The goal of FDA’s OPD grant program

is to encourage clinical development of

products for use in rare diseases or

conditions where no current therapy

exists or where current therapy would

be improved. FDA provides grants to

conduct clinical studies intended to

provide data acceptable to the agency

which will either result in or

substantially contribute to approval of

these products. Applicants should keep

this goal in mind and must include an

explanation in the ‘‘Background and

Significance’’ section of the application

of how their proposed study will either

facilitate product approval or provide

essential data needed for product

development. Information regarding

meetings and/or discussions with FDA

reviewing division staff about the

product to be studied should also be

provided as an appendix to the

application. This information is

extremely important for the review

process.

Except for medical foods that do not

require premarket approval, FDA will

only consider awarding grants to

support clinical studies for determining

whether the products are safe and

effective for premarket approval under

the act (21 U.S.C. 301 et seq.) or under

section 351 of the PHS Act (42 U.S.C.

262). All studies of new drug and

biological products must be conducted

under FDA’s investigational new drug

(IND) procedures and studies of medical

devices must be conducted under the

investigational device exemption (IDE)

procedures. Studies of approved

products to evaluate new orphan

indications are also acceptable;

however, these are also required to be

conducted under an IND or IDE to

support a change in official labeling.

(See section V.B. of this document

(Program Review Criteria) for critical

requirements concerning IND/IDE status

of products to be studied under these

grants.)

Studies submitted for the larger grants

($200,000) must be continuing in phase

2 or phase 3 of investigation. Phase 2

trials include controlled clinical studies

conducted to evaluate the effectiveness

of the product for a particular indication

in patients with the disease or condition

and to determine the common or shortterm side effects and risks associated

with it. Phase 3 trials gather additional

information about effectiveness and

safety that is necessary to evaluate the

overall risk-benefit relationship of the

product and to provide an adequate

basis for physician labeling. Studies

submitted for the smaller grants

($100,000) may be phase 1, 2, or 3 trials.

Applications must propose a clinical

trial of one therapy for one indication.

The applicant must provide supporting

evidence that a sufficient quantity of the

product to be investigated is available to

the applicant in the form needed for the

clinical trial. The applicant must also

provide supporting evidence that the

patient population has been surveyed

and that there is reasonable assurance

that the necessary number of eligible

patients is available for the study.

Funds may be requested in the budget

for travel to FDA to meet with reviewing

division staff about product

development progress.
Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices 28879

II. Human Subject Protection and

Informed Consent

A. Research Involving Human Subjects

Applicants should carefully review

the section on human subjects in the

application kit. ‘‘Section C. Specific

Instructions—Forms, Item 4, Human

Subjects,’’ on pages 7 and 8 of the

application kit should be carefully

reviewed for the certification of

Institutional Review Board (IRB)

approval requirements. Documentation

of IRB approval for every participating

center is required to be on file with the

Grants Management Officer, FDA. The

goal should be to include enough

information on the protection of human

subjects in a sufficiently clear fashion so

reviewers will have adequate material to

make a complete review.

B. Informed Consent

Consent and/or assent forms, and any

additional information to be given to a

subject, should accompany the grant

application. Information that is given to

the subject or the subject’s

representative must be in language that

the subject or his or her representative

can understand. No informed consent,

whether oral or written, may include

any language through which the subject

or the subject’s representative is made to

waive any of the subject’s legal rights,

or by which the subject or

representative releases or appears to

release the investigator, the sponsor, or

the institution or its agent from liability.

If a study involves both adults and

children, separate consent forms should

be provided for the adults and the

parents or guardians of the children.

C. Elements of Informed Consent

The elements of informed consent are

stated in the regulations at 45 CFR

46.116 and 21 CFR 50.25 as follows:

1. Basic Elements of Informed Consent

In seeking informed consent, the

following information shall be provided

to each subject.

(a) A statement that the study

involves research, an explanation of the

purposes of the research and the

expected duration of the subject’s

participation, a description of the

procedures to be followed, and

identification of any procedures which

are experimental.

(b) A description of any reasonably

foreseeable risks or discomforts to the

subject.

(c) A description of any benefits to the

subject or to others which may

reasonably be expected from the

research.

(d) A disclosure of appropriate

alternative procedures or courses of

treatment, if any, that might be

advantageous to the subject.

(e) A statement that describes the

extent, if any, to which confidentiality

of records identifying the subject will be

maintained, and that notes the

possibility that FDA may inspect the

records.

(f) For research involving more than

minimal risk, an explanation as to

whether any compensation and any

medical treatments are available if

injury occurs and, if so, what they

consist of or where further information

may be obtained.

(g) An explanation of whom to contact

for answers to pertinent questions about

the research and research subject’s

rights, and whom to contact in the event

of research-related injury to the subject.

(h) A statement that participation is

voluntary, that refusal to participate will

involve no penalty or loss of benefits to

which the subject is otherwise entitled,

and that the subject may discontinue

participation at any time without

penalty or loss of benefits to which the

subject is otherwise entitled.

2. Additional Elements of Informed

Consent

When appropriate, one or more of the

following elements of information shall

also be provided to each subject.

(a) A statement that the particular

treatment or procedure may involve

risks to the subject (or the embryo or

fetus, if the subject is or may become

pregnant), which are currently

unforeseeable.

(b) Anticipated circumstances under

which the subject’s participation may be

terminated by the investigator without

regard to the subject’s consent.

(c) Any costs to the subject that may

result from participation in the research.

(d) The consequences of a subject’s

decision to withdraw from the research

and procedures for orderly termination

of participation by the subject.

(e) A statement that significant new

findings developed during the course of

the research which may relate to the

subject’s willingness to continue

participation will be provided to the

subject.

(f) The approximate number of

subjects involved in the study.

The informed consent requirements

are not intended to preempt any

applicable Federal, State, or local laws

which require additional information to

be disclosed for informed consent to be

legally effective.

Nothing in the notice is intended to

limit the authority of a physician to

provide emergency medical care to the

extent that a physician is permitted to

do so under applicable Federal, State, or

local law.

III. Reporting Requirements

An annual Financial Status Report

(SF–269) is required. The original and

two copies of this report must be

submitted to FDA’s Grants Management

Officer within 90 days of the budget

expiration date of the grant. Failure to

file the Financial Status Report (SF–269)

in a timely fashion will be grounds for

suspension or termination of the grant.

For continuing grants, an annual

program progress report is also required.

The noncompeting continuation

application (PHS 2590) will be

considered the annual program progress

report.

Additionally, all continuing grants

must comply with all regulatory

requirements necessary to maintain

active status of their IND/IDE. This

includes, but is not limited to,

submission of an annual report to the

appropriate regulatory review division

within FDA. Failure to meet regulatory

requirements will be grounds for

suspension or termination of the grant.

Program monitoring of 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/grants

management specialist and the principal

investigator. Periodic site visits with

appropriate 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 consistent with FDA disclosure

regulations.

A final program progress report,

Financial Status Report (SF–269), and

Invention Statement must be submitted

within 90 days after the expiration of

the project period as noted on the

Notice of Grant Award.

IV. Mechanism of Support

A. Award Instrument

Support will be in the form of a grant.

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 and 45 CFR parts 74 and 92. The

regulations issued under Executive

Order 12372 do not apply to this

program.

All grant awards are subject to

applicable requirements for clinical

investigations imposed by sections 505,

507, 512, and 515 of the act (21 U.S.C.

355, 357, 360b, and 360e), section 351
28880 Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices

of the PHS act (42 U.S.C. 262), and

regulations promulgated under any of

these sections.

B. Eligibility

These grants are available to any

public or private nonprofit entity

(including State and local units of

government) and any for-profit entity.

For-profit entities must commit to

excluding fees or profit in their request

for support.

C. Length of Support

The length of the study will depend

upon the nature of the study. For those

studies with an expected duration of

more than 1 year, a second or third year

of noncompetitive continuation of

support will depend on: (1) Performance

during the preceding year; (2) the

availability of Federal funds; and (3)

compliance with regulatory

requirements of the IND/IDE.

D. Funding Plan

The number of studies funded will

depend on the quality of the

applications received and the

availability of Federal funds to support

the projects. Before an award will be

made, OPD will verify the active status

of the IND/IDE for the proposed study.

If the IND/IDE for the proposed study is

not active, no award will be made.

Further, documentation of IRB

approvals for all performance sites must

be on file with the Grants Management

Officer, FDA (address above), before an

award can be made.

V. Review Procedure and Criteria

A. Review Method

All applications submitted in

response to this request for applications

(RFA) will first be reviewed by grants

management and program staff for

responsiveness to this RFA. If

applications are found to be

nonresponsive, they will be returned to

the applicant without further

consideration.

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. Responsive

applications will also be subject to a

second level of review by a National

Advisory Council for concurrence with

the recommendations made by the firstlevel reviewers, and funding decisions

will be made by the Commissioner of

Food and Drugs.

B. Program Review Criteria

Applications will be evaluated by

program and grants management staff

for responsiveness. Applications

considered nonresponsive will be

returned to the applicant, unreviewed.

Applicants are strongly encouraged to

contact FDA to resolve any questions

regarding criteria prior to the

submission of their application. All

questions of a technical or scientific

nature must be directed to the OPD

program staff and all questions of an

administrative or financial nature must

be directed to the grants management

staff. (See ‘‘For Further Information

Contact’’ section of this document.)

Responsiveness will be based on the

following criteria:

1. The application must propose a

clinical trial intended to provide safety

and/or efficacy data of one therapy for

one orphan indication. Additionally,

there must be an explanation in the

‘‘Background and Significance’’ section

of how the proposed study will either

facilitate product approval or provide

essential data needed for product

development.

2. The prevalence, not incidence, of

the population to be served by the

product must be fewer than 200,000

individuals in the United States. The

applicant should include, in the

‘‘Background and Significance’’ section,

a detailed explanation supplemented by

authoritative references in support of

the prevalence figure. If the product has

been designated by FDA as an orphan

product for the proposed indication, a

statement of that fact will suffice.

Diagnostic tests and vaccines will

qualify only if the population of

intended use is fewer than 200,000

individuals in the United States.

3. The number assigned to the IND/

IDE for the proposed study should

appear on the face page of the

application with the title of the project.

Only medical foods that do not require

premarket approval are exempt from

this requirement. The IND/IDE must be

in active status and in compliance with

all regulatory requirements of FDA at

the time of submission of the

application. In order to meet this

requirement, the original IND/IDE

application, pertinent amendments, and

the protocol for the proposed study

must have been submitted to FDA a

minimum of 30 days prior to the due

date of the grant application. Studies of

already approved products, evaluating

new orphan indications, must also have

an active IND. Exempt IND’s must have

their status changed to active to be

eligible for this program. If the sponsor

of the IND/IDE is other than the

principal investigator listed on the

application, a letter from the sponsor

verifying access to the IND/IDE is

required, and both the identity of the

application’s principal investigator and

the study protocol must have been

submitted to the IND/IDE.

4. The requested budget should be

within the limits (either $100,000 in

direct costs for up to 3 years for any

phase study, or $200,000 in direct costs

for up to 3 years for phase 2 or 3

studies) as stated in this RFA.

5. Consent and/or assent forms, and

any additional information to be given

to a subject, should be included in the

grant application.

6. All applicants should follow

guidelines specified in the PHS 398

Grant Application kit.

C. Scientific/Technical Review Criteria

The ad hoc expert panel will provide

the first level of review. The application

will be judged 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 to include the rationale

for the statistical procedures;

3. The statistical justification for the

number of patients chosen for the trial,

based on the proposed outcome

measures and the appropriateness of the

statistical procedures to be used in

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 evidence that a sufficient

quantity of the product is available to

the applicant in the form needed for the

investigation. A current letter from the

supplier as an appendix will be

acceptable;

7. The adequacy of the justification

for the request for financial support;

8. The adequacy of plans for

complying with regulations for

protection of human subjects; and

9. The ability of the applicant to

complete the proposed study within its

budget and within time limitations

stated in this RFA.

The priority score will be based on

the scientific/technical review criteria

in section V.C. of this document. In

addition, the reviewers may advise the

program staff concerning the

appropriateness of the proposal to the

goals of the OPD Grant Program

described in section I. (Program

Research Goals) of this document.

D. Award Criteria

Resources for this program are

limited. Therefore, should two or more

applications be received and approved

by FDA which propose duplicative or
Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices 28881

very similar studies, FDA will support

only the study with the best score.

VI. Submission Requirements

The original and five copies of the

completed Grant Application Form PHS

398 (Rev. 5/95) or the original and two

copies of the PHS 5161 (Rev. 7/92) for

State and local governments, with

copies of the appendices for each of the

copies, should be delivered to Robert L.

Robins (address above). State and local

governments may choose to use the PHS

398 application form in place of the

PHS 5161. Application receipt dates are

October 15, 1996, and March 15, 1997.

If the receipt date falls on a weekend, it

will be extended to Monday; if the date

falls on a holiday, it will be extended to

the following workday. No

supplemental or addendum material

will be accepted after the receipt date.

Evidence of final IRB approval will be

accepted for the file after the receipt

date.

The outside of the mailing package

and item 2 of the application face page

should be labeled, ‘‘Response to RFA

FDA OP–97–1’’

If an application for the same study

was submitted in response to the

previous RFA, a submission in response

to this RFA will be considered a request

to withdraw the previous application.

Applications originally submitted for

the October closing date will also be

administratively withdrawn, if

resubmitted the following March.

Resubmissions are treated as new

applications; therefore, the applicant

may wish to include previous summary

statements from past reviews.

VII. 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 the established receipt dates.

Applications will be considered

received on time if sent or mailed on or

before the receipt dates as evidenced by

a 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. (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.)

B. Format for Application

Submission of the application must be

on Grant Application Form PHS 398

(Rev. 5/95). All ‘‘General Instructions’’

and ‘‘Specific Instructions’’ in the

application kit should be followed with

the exception of the receipt dates and

the mailing label address. Do not send

applications to the Division of Research

Grants, NIH. Applications from State

and local governments may be

submitted on Form PHS 5161 (Rev. 7/

92) or Form PHS 398 (Rev. 5/95).

The face page of the application

should reflect RFA–FDA–OP–97–1. The

title of the proposed study should

include the name of the product and the

disease/disorder to be studied along

with the IND/IDE number.

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 (5 U.S.C. 552(b)(4)) and FDA’s

implementing regulations (21 CFR

20.61).

Information collection requirements

requested on Form PHS 398 and the

instructions have been submitted by the

PHS to the Office of Management and

Budget (OMB) and were approved and

assigned OMB control number 0925–

0001.

C. Legend

Unless disclosure is required by 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 which

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 29, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–14234 Filed 6–5–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0162]

Review of the Calcium and Related

Nutrient Needs of the U.S. Population;

Announcement of Open Meetings and

Request for Data

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the National Academy of Sciences

(NAS), Institute of Medicine (IOM), and

Food and Nutrition Board (FNB) will

begin a review of data on calcium

intakes in the U.S. population and data

on calcium metabolism in humans

throughout their lives. This review will

also include the metabolism of related

nutrients (such as vitamin D,

magnesium, phosphorus, and fluoride)

and of nonnutrient components of foods

(such as phytosterols and fiber) as they

relate to bioavailability of calcium.

Reviews will also be conducted to

determine upper safe levels of intake

that will diminish the potential risk of

adverse effects. This review by NAS/

IOM/FNB was requested by the

Government, and it is intended to

provide FDA and the National Institutes

of Health (NIH), and the National Heart,

Lung, and Blood Institute (NHLBI) with

an up-to-date review of the needs of the

American public for calcium and related

nutrients. To assist in the preparation of

its scientific report, NAS/IOM/FNB is

inviting the submission of scientific

data and information on this topic. In

addition, FDA is announcing that NAS/

IOM/FNB will provide an opportunity

for oral presentations at two open

meetings on the review of calcium and

related nutrient needs of the U.S.

population.

DATES: The first meeting will be held on

July 9 and 10, 1996, 8:30 a.m. to 5:30

p.m. Submit an abstract with references

to the FNB by June 17, 1996, to be

considered for a 3-minute presentation

to the panel. The second meeting will be

held on July 15 and 16, 1996, 8:30 a.m

to 5:30 p.m. Submit an abstract with

references to the FNB by June 24, 1996,

to be considered for a 3-minute

presentation to the panel.

ADDRESSES: The meetings will be held at

the National Academy of Sciences Bldg.,

Auditorium, 2101 Constitution Ave.

NW., Washington, DC 20418. Submit

written requests to make oral

presentations of scientific data,

information, and views at the open

meetings to Sandra A. Schlicker, Food

and Nutrition Board, Institute of

Medicine, National Academy of

Sciences Bldg., 2101 Constitution Ave.

NW., rm. 3046, Washington, DC 20418,

202–334–1383, and to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Two copies of the scientific data,

information, and views should be

submitted to each office.

FOR FURTHER INFORMATION CONTACT:

James T. Tanner, Center for Food Safety