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
Federal Register / Vol. 62, No. 22 / Monday, February 3, 1997 / Notices 5013

priority areas. Title IV directly

addresses the Healthy People 2000

objectives related to the priority area of

HIV infection. Potential applicants may

obtain a copy of Healthy People 2000

(Full Report; Stock Number 017–001–

0474–0) or Healthy People 2000

(Summary Report: Stock No. 017–001–

00473–1) through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325

(telephone 202–512–1800).

The PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-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

routine education, library, day care,

child care or early development services

are provided to children.

ADDRESSES: Federal Register notices

and application guidance for MCHB

programs are available on the World

Wide Web via the Internet at address:

http://www.os.dhhs.gov/hrsa/mchb.

Click on the file name you want to

download to your computer. It will be

saved as a self-extracting (Macintosh or)

WordPerfect 5.1 file. To decompress the

file once it is downloaded, type in the

file name followed by a <return>. The

file will expand to a WordPerfect 5.1

file.

For applicants for Ryan White Title IV

Grants who are unable to access

application materials electronically, a

hard copy (Revised PHS form 5161–1,

approved under OMB clearance number

0937–0189) may be obtained from the

HRSA Grants Application Center. The

Center may be contacted at: Telephone

Number: 1–888–300–HRSA, FAX

Number: 301–309–0579, E-mail

Address: HRSA.GAC@ix.netcom.com.

Completed applications should be

returned to: Grants Management Officer

(CFDA #93.153), HRSA Grants

Application Center, 40 West Gude

Drive, Suite 100, Rockville, Maryland

20850.

DATES: The application deadline date for

Ryan White Title IV grants is April 18,

1997. Competing applications will be

considered to be on time if they are:

(1) Received on or before the deadline

date, or

(2) Postmarked on or before the

deadline date and received in time for

orderly processing.

As proof of timely mailing, applicants

should obtain a legibly dated receipt

from the commercial carrier or the U.S.

Postal Service; private metered

postmarks will not be accepted as proof

of timely mailing. Late applications not

accepted for processing will be returned

to the applicant.

FOR FURTHER INFORMATION CONTACT:

Additional information regarding

technical and program issues may be

obtained from: Marilyn J. Vranas,

Project Officer, Division of Services for

Children with Special Health Care

Needs, Maternal and Child Health

Bureau, Health Resources and Services

Administration, Room 18–A–19,

Parklawn Building, 5600 Fishers Lane,

Rockville, Maryland 20857, telephone

301–443–9051. Requests for information

concerning administration and business

management issues should be directed

to: Sandra Perry, Chief, Grants

Management Branch, Maternal and

Child Health Bureau, 5600 Fishers Lane,

Room 18–12, Rockville, Maryland,

20857, telephone 301–443–1440.

SUPPLEMENTARY INFORMATION:

Program Background and Objectives

The Pediatric AIDS Program was

initiated in 1988. The program grew

from 13 projects funded at $4.4 million

to a total of 51 projects funded at $27.4

million in FY 1995. Since 1988, the

program has evolved from a primary

focus on the coordination of services for

the management and care of infected

children and their families to also

address the broader prevention and care

needs of youth and women infected/

affected by HIV. In FY 1994, Congress

funded the Pediatric AIDS Program

under section 2671, Title IV of the Ryan

White Comprehensive AIDS Resources

Emergency (CARE) Act 1990, Public

Law 101–381 (Title IV). As a

consequence of authorization under

Title IV, the focus of the program was

expanded to include the development of

innovative models linking clinical trials

offered by the National Institutes of

Health (NIH) and other research entities,

with systems of comprehensive

primary/community-based medical and

social services.

In 1994, published results from a NIH

clinical trial (ACTG 076) demonstrated

the potential for reducing perinatal HIV

transmission by two-thirds when

pregnant women and their newborns

were given zidovidine (ZDV). The ZDV

therapy regimen has been published in

the Centers for Disease Control’s

Morbidity and Mortality Weekly Report

(MMWR 1994:43(RR–11)).

In 1995, the CDC issued

recommendations for enhanced

voluntary HIV counseling and testing

for women of child bearing age, and the

HRSA issued an Advisory: The Use of

Zidovidine (ZDV) to Reduce Perinatal

HIV Transmission in HRSA-Funded

Programs. This advisory contains

practical, specific steps for

implementing PHS recommendations

for offering ZDV to pregnant women. A

copy of this advisory will be included

in the application kit. All Title IV

grantees are expected to implement the

ZDV recommendations.

The 1996 amendments to the Ryan

White CARE Act impose new

requirements on the services to be

provided or arranged by the applicant,

require coordination with other

providers of health care services under

the Ryan White Care Act and Title V of

the Social Security Act, enhance

opportunities for and participation in

clinical and other research by Title IV

clients, specify arrangements that must

exist between Title IV programs and

research entities, and enhance

opportunities for Title IV clients to

participate in clinical research. The law

requires new grantees to enroll a

significant number of clients in clinical

trials or other research by the end of the

second grant year.

The amended Ryan White law does

not define the term ‘‘significant

participation’’. Nor does it define the

type of research in which patients are to

participate; it specifies only ‘‘research

for the prevention and treatment of HIV

disease’’. The law mandates the

Secretary to establish a group composed

of providers, consumers and researchers

to recommend priority research

protocols to be put on a list. Given that

these two key legislative terms will not

be defined prior to the application due

date, we will not use significant

participation in research protocols as an

evaluation criterion in the review of

applications for new FY 1997 grants.

Rather, new applicants will be expected

to have demonstrable research linkages

or credible plans to link services to

research; offer clients research

opportunities; and support client

participation in research through case

management, transportation, and other

required services. See REVIEW

CRITERIA for the list of evaluation

criteria.

Eligible Applicants

Ryan White Title IV grants may be

made only to public and nonprofit

private entities that provide primary

care, directly or through contracts.

Funding Categories

For FY 1997, there will be a single

funding category for competition: Grants

for coordinated HIV services and access

to research for children, youth, women,

and families. Applications which do not

fall within this category will not be

considered for funding. Up to 23 grants,
5014 Federal Register / Vol. 62, No. 22 / Monday, February 3, 1997 / Notices

at an estimated $15.5 million will be

awarded. The project period is 3 years.

These grants will develop and support

innovative projects that foster

collaboration between clinical research

institutions and family-centered,

primary/community-based medical and

social service programs, and that

coordinate systems of comprehensive

HIV care for children, youth, women

and their families. Projects are expected

to focus on local capacity-building,

making maximum use of all available

public and private resources, and to

strengthen existing comprehensive care

infrastructures.

Activities under these grants should

address the goals of:

—Increasing client access by linking

HIV/AIDS clinical research trials and

activities with comprehensive care;

and

—Fostering the development and

support of comprehensive, culturally

competent, community-based and

family-centered care infrastructures;

and emphasizing prevention within

the care system.

Preference for funding in Category (1)

will be given to projects that have:

—Established and currently support a

comprehensive, coordinated, system

of HIV care serving either children,

youth, women, or families; and

—Linked with, or initiated activities to

link with, clinical trials or other

research.

This means that these projects will be

funded ahead of new groups of

applications in this category.

Special consideration for funding may

be given to projects which help to

achieve an equitable geographical

distribution of projects across all States

and territories. This means that the

score of an individual project may be

favorably adjusted if it addresses this

objective.

Special Concerns

Grantees supported by Title IV of the

Ryan White CARE Act should

coordinate their projects with other

Federal, State, and local programs

concerned with HIV and/or serving the

target population of children, youth,

women and families affected by or at

risk for HIV, particularly: Title V

Maternal and Child Health programs;

Ryan White Titles I, II and III(b)

programs; providers funded by the

Substance Abuse and Mental Health

Services Administration; the Health

Resources and Services Administration;

the Centers for Disease Control and

Prevention efforts; and clinical trials

funded by NIH or other sources.

HRSA’s Maternal and Child Health

Bureau places special emphasis on

improving service delivery to women,

children and youth from communities

with limited access to comprehensive

care. In order to assure access and

cultural competence, it is expected that

projects will involve individuals from

the populations to be served in the

planning and implementation of the

project. The Bureau’s intent is to ensure

that project interventions are responsive

to the cultural and linguistic needs of

special populations, that services are

accessible to consumers, and that the

broadest possible representation of

culturally distinct and historically

underrepresented groups is supported

through programs and projects

sponsored by the MCHB.

In keeping with the goals of

advancing the development of human

potential, strengthening the Nation’s

capacity to provide high quality

education by broadening participation

in MCHB programs of institutions that

may have perspectives uniquely

reflecting the Nation’s cultural and

linguistic diversity, and increasing

opportunities for all Americans to

participate in and benefit from Federal

public health programs, HRSA will

place a funding priority on projects from

Historically Black Colleges and

Universities (HBCU) or Hispanic

Serving Institutions (HSI) in all

categories and subcategories in this

notice for which applications from

academic institutions are encouraged.

This is in conformity with the Federal

Government’s policies in support of

White House Initiatives on Historically

Black Colleges and Universities

(Executive Order 12876) and

Educational Excellence for Hispanic

Americans (Executive Order 12900). An

approved proposal from a HBCU or HSI

will receive a 0.5 point favorable

adjustment of the priority score in a 4

point range before funding decisions are

made.

Review Criteria

Applications will be reviewed with

particular attention to inclusion of

women and persons from culturally

distinct populations. Funding will be

provided to those which, in the

Department’s view, best meet the

statutory purposes of the Ryan White

Title IV program and address

achievement of the Healthy People 2000

objectives related to HIV infection.

Applications for grants will be

reviewed and rated by objective review

panels according the following weighted

criteria:

—Documentation of the HIV medical

and social support service needs of

children, youth, women and families

(weight 15%);

—Demonstration of capacity to

coordinate and support a

comprehensive system of HIV care for

this population (weight 20%);

—Demonstrated capacity to enhance

client access to clinical trials or other

research and/or to establish linkages

with providers offering clinical trials

or other research (weight 20%);

—The degree to which the Title IV’s

program priority of consumer

involvement has been implemented

(weight 10%);

—The degree to which the proposed

plan: Addresses the issues identified

in response to the first criterion on

this list; reflects the legislative and

programmatic priorities of the Title IV

program (access to clinical trials,

reduction of perinatal HIV

transmission and consumer

involvement); contains goals and

objectives that are clear, measurable,

time framed and address identified

needs; and presents an evaluation

strategy capable of documenting the

achievement of project goals (weight

25%); and

—The degree to which the proposed

budget clearly supports

administrative and programmatic

activities necessary to manage the

program and accomplish proposed

goals and activities. (weight 10%)

Review criteria will be described in

further detail in the application

guidance.

Allowable Costs

The HRSA may support reasonable

and necessary costs of HIV Project

grants within the scope of approved

projects. Allowable costs may include

salaries, equipment and supplies, travel,

contractual arrangements, consultants,

and others, as well as indirect costs. The

HRSA adheres to administrative

standards reflected in the Code of

Federal Regulations (45 CFR part 92 and

45 CFR part 74). All other sources of

funding to support this project must be

accurately reflected in the applicant’s

budget.

Reporting Requirements

A successful applicant under this

notice will submit reports in accordance

with the provisions of the general

regulations which apply under 45 CFR

part 74, subpart J, Monitoring and

Reporting of Program Performance, with

the exception of State and local

governments to which 45 CFR 92.40

will apply. Financial reporting will be

required in accordance with 45 CFR part

74, subpart I, with the exception of State
Federal Register / Vol. 62, No. 22 / Monday, February 3, 1997 / Notices 5015

and local governments, to which 45 CFR

part 92, subpart C will apply.

Public Health System Reporting

Requirements

This program is subject to the Public

Health System Reporting Requirements

(approved under OMB No. 0937–0195).

Under these requirements, the

community-based nongovernmental

applicant must prepare and submit a

Public Health System Impact Statement

(PHSIS). The PHSIS is intended to

provide information to State and local

health officials to keep them apprised of

proposed health services grant

applications submitted by communitybased nongovernmental organizations

within their jurisdictions.

Community-based nongovernmental

applicants are required to submit the

following information to the head of the

appropriate State and local health

agencies in the area(s) to be impacted no

later than the Federal application

receipt due date:

(a) A copy of the face page of the

application (SF 5161).

(b) A summary of the project (PHSIS),

not to exceed one page, which provides:

(1) A description of the population to

be served.

(2) A summary of the services to be

provided.

(3) A description of the coordination

planned with the appropriate State and

local health agencies.

The project abstract may be used in

lieu of the one-page PHSIS, if the

applicant is required to submit a PHSIS.

Executive Order 12372

The Title IV Program has been

determined to be subject to the

provisions of Executive Order 12372

concerning intergovernmental review of

Federal programs by appropriate health

planning agencies, as implemented by

45 CFR part 100. Executive Order 12372

allows States the option of setting up a

system for reviewing applications from

within their States for assistance under

certain Federal programs. The

application packages to be made

available under this notice (Form PHS

5161–1 with revised face sheet HHS

Form 424 and with Program Narrative

and Checklist approved under OMB

0937–0189) will contain a listing of

States which have chosen to set up such

a review system and will provide a

single point of contact (SPOC) in the

States for review. Applicants (other than

federally-recognized Indian tribal

governments) should contact their State

SPOCs as early as possible to alert them

to the prospective applications and

receive any necessary instructions on

the State process. For proposed projects

serving more than one State, the

applicant is advised to contact the SPOC

of each affected State. The due date for

State process recommendations is 60

days after the application deadline for

new and competing awards. The

granting agency does not guarantee to

‘‘accommodate or explain’’ State process

recommendations it receives after that

date. (See part 148, Intergovernmental

Review of PHS Programs under

Executive Order 12372 and 45 CFR part

100 for a description of the review

process and requirements.)

(The OMB Catalog of Federal Domestic

Assistance number for the HIV Program for

Children, Youth, Women, and Families is

93.153.)

Dated: January 27, 1997.

Ciro V. Sumaya,

Administrator.

[FR Doc. 97–2374 Filed 1–31–97; 8:45 am]

BILLING CODE 4160–15–P

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory bodies scheduled to meet

during the month of March, 1997.

Name: Advisory Commission on

Childhood Vaccines (ACCV).

Date and Time: March 13, 1997; 9:00

a.m.—4:30 p.m.

Place: Parklawn Building, Conference

Room E, 5600 Fishers Lane, Rockville,

Maryland 20857.

The meeting is open to the public.

The first day of the meeting, Wednesday,

March 12, will consist of a meeting of one of

the Commission’s workgroups.

Name: Workgroup on Intent, Provisions

and Process.

Time: March 12, 1997; 10:00 a.m.—5:00

p.m.

Purpose: The Workgroup will address

issues related to the operation process of the

National Vaccine Injury Compensation

Program.

Agenda: Agenda items will include, but

not be limited to, discussion of the following

issues: Status of recommendations from the

September and December 1996 WIPP

meetings; Program and policy issues related

to the operation of the Vaccine Injury

Compensation Program, including proposals

to revise the wage loss calculation, to provide

for an interim payment of attorneys fee and

expenses, and to extend the statute of

limitations; and a report on the Department

of Justice’s Process Improvement Initiatives.

The full Commission will meet on

Thursday, March 13, from 9:00 a.m. to 4:30

p.m. Agenda items will include, but not be

limited to: an overview of the Vaccine Injury

Compensation Program; reports from the

Workgroup on Intent, Provision, and Process

and the Vaccine Safety Subcommittee; an

update on the Proposed Vaccine Information

Statement for DTaP; and routine Program

reports.

Public comment will be permitted before

lunch and at the end of the Workgroup

meeting on March 12, as well as the full

Commission meeting on March 13. Oral

presentations will be limited to 5 minutes per

public speaker.

Persons interested in providing an oral

presentation should submit a written request,

along with a copy of their presentation to:

Ms. Melissa Palmer, Principal Staff Liaison,

Division of Vaccine Injury Compensation,

Bureau of Health Professions, Health

Resources and Services Administration,

Room 8A–35, 5600 Fishers Lane, Rockville,

MD 20857, Telephone (301) 443–6593.

Requests should contain the name, address,

telephone number, and any business or

professional affiliation of the person desiring

to make an oral presentation. Groups having

similar interests are requested to combine

their comments and present them through a

single representative. The allocation of time

may be adjusted to accommodate the level of

expressed interest. The Division of Vaccine

Injury Compensation Program will notify

each presenter by mail or telephone of their

assigned presentation time. Persons who do

not file an advance request for presentation,

but desire to make an oral statement, may

sign-up in Conference Room E on March 12–

13. These persons will be allocated time as

time permits.

Anyone requiring information regarding

the Commission should contact Ms. Palmer.

Agenda Items are subject to change as

priorities dictate.

Dated: January 28, 1997.

J. Henry Montes,

Director, Office of Policy and Information

Coordination, HRSA.

[FR Doc. 97–2487 Filed 1–31–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4200–N–19]

Submission for OMB Review:

Comment Request

AGENCY: Office of the Assistant

Secretary for Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due date: April 4,

1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be

received within seven days from the

date of this Notice. Comments should