Federal Register / Vol. 62, No. 22 / Monday, February 3, 1997 / Notices 5011

Place: Omni Shoreham Hotel, 2500 Calvert

Street, N.W., Washington, D.C. 20008.

Status: Open to the public, limited only by

the space available. Preregistration is

recommended, and there is no registration

fee. Please obtain registration information

from the contact person listed below.

Purpose: The agenda will focus on

collaborations for health information sharing

among the various stakeholders and partners

in public health. Papers presented will

address the theme, ‘‘Partnerships,

Technologies, and Communities: Evolving

Roles for Health Data.’’ Each day will focus

on a public health issue as follows: Day 1,

‘‘Health Information Partnerships—National,

State, and Local;’’ Day 2, ‘‘Information

Technology and Informatics;’’ and Days 3

and 4, ‘‘Communities at Risk.’’ This agenda

will cover a broad spectrum of current and

future public health concerns. Agenda items

are subject to change as priorities dictate.

Contact Person For More Information:

Substantive program and registration

information for the meeting may be obtained

from Barbara Butler, Public Health

Conference on Records and Statistics, Office

of Data Standards, Program Development,

and Extramural Programs, NCHS, CDC, Room

1100, Presidential Building, 6525 Belcrest

Road, Hyattsville, Maryland 20782,

telephone 301/436–7122, extension 144.

Dated: January 28, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–2580 Filed 1–31–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 97F–0035]

Ashland Chemical Co.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Ashland Chemical Co. has filed a

petition proposing that the food additive

regulations be amended to provide for

the safe use of polypropylene glycol

with a molecular weight of 1,200 to

3,000 as a defoaming agent in water for

sliced potatoes.

DATES: Written comments on the

petitioner’s environmental assessment

by March 5, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Vivian M. Gilliam, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3167.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 6A4490) has been filed by

Ashland Chemical Co., One Drew Plaza,

Boonton, NJ 07005. The petition

proposes to amend the food additive

regulations in § 173.340 Defoaming

agents (21 CFR 173.340) to provide for

the use of polypropylene glycol with a

molecular weight of 1,200 to 3,000 as a

component of defoaming agents in water

for sliced potatoes.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the original

petition that is the subject of this notice

on public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before March 5,

1997, submit to the Dockets

Management Branch (address above)

written comments. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: January 17, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–2532 Filed 1–31–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0391]

Review of Infant Formula Nutrient

Requirements for Preterm Infants;

Announcement of Open Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) and the Life

Sciences Research Office (LSRO) of the

Federation of American Societies for

Experimental Biology (FASEB) are

announcing an open meeting on the

review of infant formula nutrient

requirements for preterm infants. The

LSRO/FASEB has undertaken this

review and will prepare a documented

scientific report that summarizes the

available information. To assist in the

preparation of its scientific report,

LSRO/FASEB is inviting the submission

of scientific data, information, and

views bearing on this topic both in

writing and orally at the open meeting.

DATES: The LSRO will hold a 1-day

open meeting on this topic on March 26,

1997. The meeting will begin at 9 a.m.

Requests to make oral presentations at

the open meeting must be submitted in

writing and received by March 7, 1997.

To be included in the review process,

written presentations of scientific data,

information, and views should be

submitted on or before June 30, 1997.

Written materials arriving at LSRO/

FASEB on or before March 20, 1997,

will be part of the official record of the

open meeting.

ADDRESSES: The open meeting will be

held in the Chen Auditorium, Lee Bldg.,

Federation of American Societies for

Experimental Biology, 9650 Rockville

Pike, Bethesda, MD. Written requests to

make oral presentations of scientific

data, information, and views at the open

meeting should be submitted to Daniel

J. Raiten (address below) 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

are to be submitted to each office. These

two copies are to be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Daniel J. Raiten, Life Sciences Research

Office, Federation of American Societies

for Experimental Biology, 9650

Rockville Pike, Bethesda, MD 20814–

3998, 301–530–7030 or Linda H.

Tonucci, Center for Food Safety and

Applied Nutrition (HFS–456), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–5372.
5012 Federal Register / Vol. 62, No. 22 / Monday, February 3, 1997 / Notices

SUPPLEMENTARY INFORMATION: FDA has a

contract (223–92–2185) with FASEB

concerning the analysis of scientific

issues that bear on the safety of foods

and cosmetics. The objectives of this

contract are to provide information to

FDA on general and specific issues of

scientific fact associated with the

analysis of human nutrition.

Infant formulas for infants with low

birthweight are regulated as exempt

infant formulas under the Infant

Formula Act of 1980 and its 1986

amendments (21 U.S.C. 350a). Exempt

infant formulas may have nutrients or

nutrient levels that are different from

those that are codified in 21 CFR

107.100, if the manufacturer of the

infant formula can justify the nutrient

deviation. LSRO will perform a review

to consider the scientific basis for

having different recommendations for

energy and macronutrients (protein, fat,

including long-chain polyunsaturated

fatty acids (LCPUFA’s), and

carbohydrates) in formulas for low

birthweight preterm infants.

In the Federal Register of November

15, 1996 (61 FR 58566), FDA announced

that it asked FASEB, as a task under

contract 223–92–2185, to provide FDA’s

Center for Food Safety and Applied

Nutrition with both an up-to-date

review of nutrient requirements of

preterm infants and of the effects of new

information about nutritional needs of

preterm infants on recommendations for

levels of nutrients in formulas for

preterm infants. In response to this

request, FASEB has directed LSRO to

obtain state-of-the-art scientific

information on infant nutrient

requirements and related scientific

questions on specifications for preterm

infant formula. The LSRO/FASEB has

undertaken a study and will prepare a

documented scientific report that

summarizes the available information

related to these questions.

LSRO is performing a review of the

scientific and medical literature with a

particular emphasis on studies

published since 1986, when 21 U.S.C.

350a was last amended. Requirements of

other governmental bodies are also

being considered in this review.

Specifically, LSRO will address the

following issues in its review:

(1) What scientific basis is there to

support requirements for energy and

macronutrients (protein, fat, and

carbohydrates) in infant formulas

intended for use by preterm infants as

distinct from the requirements for

energy and macronutrients in formulas

for term infants? The American

Academy of Pediatrics, the European

Society for Pediatric Gastroenterology

and Nutrition, and the Canadian

Pediatric Society have proposed some

nutrient requirements for preterm

infants distinct from those for term

infants.

(2) Has scientific knowledge advanced

to the point that distinct composition

standards for energy and macronutrients

in formulas for these preterm infants are

warranted?

(3) Nutrient requirements of

hospitalized preterm infants who are fed

enteral formulas are sometimes

described according to stages, such as a

first or transition stage (between birth

and 10 days of age), a stable growing

stage (from about 10 days until

discharge from hospital, 6 to 8 weeks

after birth), and a post-discharge stage

(from discharge home to approximately

1 year of age). Is there scientific

evidence to support more than one set

of energy and macronutrient

requirements to support growth and

development of the hospitalized

preterm infant at the different stages of

development? If so, how should the

stages be defined?

(4) Are the energy and macronutrient

requirements for infant formulas for

term infants sufficient for healthy postdischarge preterm infants?

(5) Is there scientific evidence to

support specific deviations from current

nutrient standards for healthy postdischarge preterm infants, and if so,

what would they be, and to what stage

(age/weight) should these special

formulas be given?

(6) Does available evidence establish

the essentiality of addition of

subcomponents of the macronutrients

(specifically, taurine, carnitine, and

LCPUFA’s) to formulas for preterm

infants, and if so, does the evidence

establish what the amount and ratios of

these compounds should be in the

formula? For example, the Canadian

Guidelines for the Composition and

Clinical Testing for Formulas for

Preterm Infants (p. 17) finds that term

infant formulas that contain adequate

and balanced 18:2n-6 and 18:3n-3 fatty

acids do not require addition of the 20

and 22 carbon n-6 and n-3 fatty acids.

(7) Is there available evidence to

suggest that this result also applies to

preterm infant formulas? If so, is there

an optimum level and ratio of 18:2n-6

and 18:3n-3 fatty acids in formulas for

preterm infants?

(8) Does the available evidence

address the issue of safety of various

sources of these LCPUFA’s for use in

preterm infant formulas? If so, is there

a safe source of LCPUFA’s?

(9) Does available evidence establish

the essentiality of the addition of

nucleotides to formulas for preterm

infants, and if so, does the evidence

establish what the amounts should be in

the formulas?

LSRO will use these questions as a

guide in the drafting of its report. LSRO

notes that, in arriving at answers to the

above questions, it will consult with the

American Academy of Pediatrics’

Committee on Nutrition and, to the

extent possible, the Institute of

Medicine’s Food and Nutrition Board.

LSRO will prepare a comprehensive

final report that documents and

summarizes the results of its evaluation.

Under its contract with FDA, FASEB

will provide the agency with its

scientific report on or about September

30, 1997.

Dated: January 24, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–2493 Filed 1–31–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Ryan White Title IV; Grants for

Coordinated HIV Services and Access

to Research for Children, Youth,

Women, and Families

AGENCY: Health Resources and Services

Administration, HRSA.

ACTION: Notice of availability of funds.

SUMMARY: The HRSA announces that

approximately $15.5 million in fiscal

year (FY) 1997 funds will be available

for project grants that enhance access to

clinical research trials and other

research, and develop and support the

provision of coordinated comprehensive

services and activities for children,

youth, women and families infected/

affected by the Human

Immunodeficiency Virus (HIV). Grants

will be funded that link clinical

research and other research activities

with comprehensive care systems, and

improve and expand the coordination of

a system of comprehensive care for

children, youth, women, and families

who are infected/affected by HIV. These

projects are authorized under Section

2671 of the Public Health Service Act,

as amended by the Ryan White

Comprehensive AIDS Resource

Emergency (CARE) Act Amendments of

1996, Public Law 104–146 (42 U.S.C.

300f–71). Within the HRSA, Ryan White

Title IV projects are administered by the

Maternal and Child Health Bureau

(MCHB).

The PHS is committed to achieving

the health promotion and disease

prevention objectives of Healthy People

2000, a PHS national activity for setting