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administratively withdrawn, if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
28882 Federal Register / Vol. 61, No. 110 / Thursday, June 6, 1996 / Notices

and Applied Nutrition (HFS–451), Food

and Drug Administration, 200 C St. SW.,

rm. 2804, Washington, DC 20204, 202–

205–4168.

SUPPLEMENTARY INFORMATION: FDA has a

contract with NHLBI to provide partial

support of the NAS project entitled

‘‘Calcium and Related Nutrients: Needs

of Americans.’’ Recent research and data

have suggested that calcium intakes may

be inadequate to meet the needs of

many population groups in the United

States, particularly with regard to the

calcium intake during adolescence and

young adulthood. However, controversy

exists regarding what the optimal intake

should be for calcium and related

nutrients (such as vitamin D,

magnesium, phosphorus, and fluoride)

in order to prevent deficiency states

(such as osteomalacia and rickets) while

at the same time reducing the risk of

degenerative diseases (such as

osteoporosis) and also taking into

account the potential effects of chronic

ingestion of lower levels of intake

during some life stages.

In response to recent suggestions that

calcium requirements of healthy

Americans are greater than previous

estimates, the NAS/IOM is undertaking

a study to review both the scientific

literature on calcium metabolism in

humans throughout their lives and also

available data on calcium intakes by the

U.S. population. The analysis also will

include a review of the requirements for

the related nutrients, vitamin D,

magnesium, phosphorus, and fluoride.

The impact of these nutrients and of

other nonnutrient components of foods

(such as phytosterols, fiber) on

bioavailability of calcium will also be

evaluated.

The study also will review existing

data and will develop estimates of

dietary intake levels that are compatible

with good nutrition throughout the life

cycle, which may result in decreasing

risk of chronic disease. In addition,

reviews will be conducted to determine

upper safe levels of intake that will

diminish the potential risk of adverse

effects.

On July 9 and 10, 1996, a meeting to

solicit scientific opinion on the

functional indicators of calcium,

phosphorus, magnesium, fluoride, and

vitamin D status for each stage of the life

span will be held. This meeting will be

held by the panel on calcium and

related nutrients, a subunit of the

standing committee on the Scientific

Evaluation of Dietary Reference Intakes,

a committee of the FNB of the IOM.

Speakers have been invited to present

their views on appropriate measures to

ensure adequate intake of these

nutrients. In addition, interested

individuals and organizations may

present their perspectives regarding the

determination of dietary reference

intakes during the open forum session

of the meeting. In order to be considered

for a 3-minute presentation to the panel,

an abstract with references must be

submitted to the FNB by June 24, 1996.

Interested parties should contact Sandra

A. Schlicker (address above) for further

information.

On July 15 and 16, 1996, a meeting to

solicit scientific opinion on criteria to

evaluate risk assessment data in

developing a model for establishing

maximum levels of nutrient intake

compatible with low risk of adverse

effects will be held. This meeting will

be held by the Subcommittee on Upper

Reference Levels of Nutrients, a subunit

of the Standing Committee on the

Scientific Evaluation of Dietary

Reference Intakes, a committee of the

FNB of the IOM. Speakers have been

invited to present their views on

appropriate measures of adequacy for

these nutrients. In addition, interested

individuals and organizations may

present their perspectives regarding the

determination of dietary reference

intakes during the open forum session

of the meeting. In order to be considered

for a 3-minute presentation to the panel,

an abstract with references must be

submitted to the FNB by June 17, 1996.

Interested parties should contact Sandra

A. Schlicker (address above) for further

information. This study will provide

guidance useful in the development of

recommendations for requirements and

upper safe limits of the topic nutrients.

Dated: May 29, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–14137 Filed 6–5–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[2728, R–142]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

1. Type of Information Collection

Request: Reinstatement, with change, of

a previously approved collection for

which approval has expired; Title of

Information Collection: End Stage Renal

Disease Medical Evidence Report

Medicare Entitlement and/or Patient

Registration; Form No.: HCFA–2728;

Use: This form captures the necessary

medical information required to

determine Medicare eligibility of an end

stage renal disease claimant. It also

captures the specific medical data

required for research and policy

decisions on this population as required

by law. Frequency: Annually; Affected

Public: Individuals or households,

Business or other for-profit, Not-forprofit institutions; Number of

Respondents: 60,000; Total Annual

Hours Requested: 25,000.

2. Type of Information Collection

Request: Reinstatement, with change, of

a previously approved collection for

which approval has expired; Title of

Information Collection: Information

Collection Requirements Contained in

BPD–393, Examination and Treatment

for Emergency Medical Conditions and

Women in Labor; Form No.: HCFA–R–

142; Use: BPD–393 contains information

collection requirements for hospitals

that would seek to prevent them from

inappropriately transferring individuals

with emergency medical conditions, as

mandated by Congress. HCFA will use

this information to help assure

compliance with this mandate. This

information is not contained elsewhere

in regulations. Frequency: On occasion;

Affected Public: Individuals or

households, Not-for-profit institutions,

Federal Government, and State, Local or

Tribal Government; Number of

Respondents: 7,000; Total Annual

Responses: 7,000; Total Annual Hours

Requested: 8,818,577.

To request copies of the proposed

paperwork collections referenced above,

E-mail your request, including your

address, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections should be sent

within 30 days of this notice directly to