Federal Register / Vol. 61, No. 117 / Monday, June 17, 1996 / Notices 30619

other mental health emergency services

as a consequence of national disasters;

(13) collaborates with the alcohol, drug

abuse, and mental health Institutes of

the National Institutes of Health on

services research issues as well as on

other programmatic issues; (14)

promotes the development,

dissemination, and application of

standards and best practices; and (15)

provides a focus for addressing the

mental health needs of individuals with

multiple, co-occurring drug, alcohol,

mental, and physical problems.

G. Center for Substance Abuse

Treatment (MT). The principal function

of the Center is to provide national

leadership for the Federal effort to

enhance approaches and provide

resources to ensure provision of

services’ programs focusing on the

treatment of substance abuse and cooccurring physical and/or psychiatric

conditions. In carrying out this

responsibility, the Center for Substance

Abuse Treatment: (1) collaborates with

States, communities, health care

providers and national organizations to

upgrade the quality of addiction

treatment, to improve the effectiveness

of substance abuse treatment programs,

and to provide resources to ensure

provision of services; (2) provides a

focus for addressing the treatment needs

of individuals with multiple, cooccurring drug, alcohol, mental, and

physical and co-morbidity problems; (3)

administers grants, contracts, and

cooperative agreements which support

the development and application of new

knowledge in the substance abuse

treatment field; (4) coordinates the

evaluation of the Center’s programs; (5)

collaborates with the National Institute

on Drug Abuse (NIDA) and the States to

promote development, dissemination,

and application of treatment outcome

standards; (6) collaborates with the

Office of the Administrator and other

SAMHSA components in treatment data

collection; (7) administers programs for

training of health and allied health care

providers (8) administers the Substance

Abuse Prevention and Treatment Block

Grant Program including compliance

reviews, technical assistance to States,

Territories, and Indian Tribes, and

application and reporting requirements

related to the block grant programs; (9)

conducts managed care activities and

coordinates these activities with

SAMHSA and other DHHS components;

(10) collaborates with alcohol, drug

abuse, and mental health Institutes of

National Institutes of Health on services

research issues as well as on other

programmatic issues.

Section M–30, Order of Succession.

During the absence or disability of the

Administrator, SAMHSA, or in the

event of a vacancy in that office, the first

official listed below would perform the

duties of the Administrator, except that

during a planned period of absence, the

Administrator may specify a different

order of succession: (1) Deputy

Administrator; and (2) Executive

Officer, SAMHSA.

Section M–40, Delegations of

Authority. All delegations and

redelegations of authority to officers and

employees of SAMHSA which were in

effect immediately prior to the effective

date of this reorganization shall

continue in effect pending further

redelegation, providing they are

consistent with this reorganization.

These organizational changes are

effective June 10, 1996.

Dated: June 10, 1996.

Nelba Chavez,

Administrator.

[FR Doc. 96–15340 Filed 6–14–96; 8:45 am]

BILLING CODE 4160–01–M

Administration on Aging

Public Information Collection

Requirement Submitted to the Office of

Management and Budget (OMB) for

Clearance

AGENCY: Administration on Aging, HHS.

The Administration on Aging (AoA),

Department of Health and Human

Services, has submitted to the Office of

Management and Budget (OMB) the

following proposal for the collection of

information in compliance with the

Paperwork Reduction Act (Public Law

96–511):

Title of Information Collection: State

Performance Report (SPR): Reporting

Requirements for Titles III and VII of the

Older Americans Act;

Type of Request: Extension and

Revision;

Use: To revise an existing information

collection form to conform to

amendments to the Older Americans

Act which directed the Administration

on Aging to improve State reporting

requirements;

Frequency: Annually;

Respondents: State Agencies on

Aging;

Estimated Number of Responses: 57;

Total Estimated Burden Hours:

300,000.

Additional Information or Comments:

The Administration on Aging intends to

submit to the Office of Management and

Budget for approval a new reporting

system for the State programs under the

Older Americans Act. AoA printed a

similar set of reporting specifications in

the Federal Register on February 13,

1996 requesting a two year phase-in of

the reporting requirements starting in

FY 1996. Most of the 15 respondents

support implementation of the SPR.

However 5 raised cost considerations in

light of dwindling resources for services

to the elderly. While one respondent

objected to a requirement to collect

information on the nutritional status of

congregate meals clients, 5 other

respondents strongly advocate that the

information be collected. The remaining

comments relate to technical changes

which have been made and to

administrative issues which AoA will

address through training and

operational adjustments. Call the

Administration on Aging, Office of State

and Community Programs at (202) 619–

0011 for copies of the proposed

reporting requirements. Written

comments and recommendations for the

proposed information collection

requirements should be sent within 30

days of the publication of this notice

directly to the following address: OMB

Reports Management Branch, attention:

Allison Eydt, New Executive Office

Building, Room 3208, Washington, DC

20503.

Dated: June 6, 1996.

William F. Benson,

Deputy Assistant Secretary for Governmental

Affairs and Elder Rights.

[FR Doc. 96–15218 Filed 6–14–96; 8:45 am]

BILLING CODE 4150–04–M

Public Comment Regarding Proposed

Guidance on the Use of Medical Food

and Food for Special Dietary Uses in

Older Americans Act Nutrition

Programs

AGENCY: Administration on Aging, HHS.

The Administration on Aging (AoA),

Department of Health and Human

Services, is requesting public comment

on a proposed Program Instruction

regarding the use of medical food and

food for special dietary uses in Older

Americans Act Nutrition Programs.

Type of Request: Public comment.

Use: To inform the Administration on

Aging decision making process

regarding the use of medical food and

food for special dietary uses in Older

Americans Act Nutrition Programs.

Additional Information or Comments:

The proposed Program Instruction

provides guidance regarding the

appropriate use and federal funding of

medical food and food for special

dietary uses in Older Americans Act

(OAA) Nutrition Programs for States,

Tribes and Area Agencies on Aging.
30620 Federal Register / Vol. 61, No. 117 / Monday, June 17, 1996 / Notices

Background

The aging network is being challenged

to serve an increasing number of frailer,

functionally impaired older individuals.

Many community dwelling elders are at

increased nutritional risk due to

chronic/acute diseases and conditions,

including, but not limited to, physical,

oral and mental health problems, that

remain after discharge from acute,

subacute or long-term care facilities.

With development of home and

community-based long-term care

services, the aging network has been

called upon to meet nutritional needs of

elders that go beyond the typical onemeal-a-day service. State Units on Aging

(SUAs), Area Agencies on Aging

(AAAs), and Nutrition Service Providers

(NSPs) have expanded nutrition services

beyond meals to meet the varying

nutritional needs and functional

capabilities of growing numbers of

impaired elders.

Private industry has also recognized

the expanding home and community

care market. As care of frailer elders has

expanded beyond hospitals and nursing

homes, pharmaceutical companies have

begun marketing products to home

health agencies, home and communitybased care providers, nutrition service

providers, caregivers, and elders

themselves. Companies have developed

a wide range of products, such as

thickeners, shake-type beverages, soups,

bars, puddings, cookies, etc., which are

specifically formulated and labeled to

meet the nutritional requirements or

dietary needs of elders who, due to a

disease or health-related condition,

cannot meet their nutritional

requirements using only conventional

food. While often known by a variety of

names, such as nutrition supplements,

‘‘liquid meals,’’ oral supplements, the

most appropriate statutory terms are

medical food and food for special

dietary uses. Although some SUAs,

AAAs, and NSPs across the country

have developed policy regarding the use

and funding of these special products,

AoA has not provided guidance on this

topic in the past.

Terminology

Public Law 100–290, The Orphan

Drug Amendment of 1988, April 18,

1988, defines medical food as

food which is formulated to be consumed or

administered entirely under supervision of a

physician and which is intended for the

specific dietary management of a disease or

condition for which distinctive nutritional

requirements, based on recognized scientific

principles, are established by medical

evaluation.

According to section 201 of the

Federal Food, Drug, and Cosmetic Act of

1932, as amended, the term food for

special dietary uses,

as applied to food for man, means particular

(as distinguished from general) uses of food,

as follows: (i) uses for supplying particular

dietary needs which exist by reason of a

physical, physiological, pathological or other

condition, including but no limited to the

conditions of diseases, convalescence, * * *

underweight and overweight; (ii) uses for

supplying particular dietary needs which

exist by reason of age, * * *; (iii) uses for

supplementary or fortifying the ordinary or

usual diet with any vitamin, mineral or other

dietary property.

Food and Health

Every effort should be made to meet

the special nutritional needs of elders

by using conventional food. Food meets

physiological needs for energy,

nutrients and bulk (fiber). Food also has

important physchological, social and

functional value. Conventional food and

beverages, particularly those that are

nutrient dense are always the first

therapeutic approach to improving or

modifying diets for individuals who can

consume regular food and beverages and

are not severely malnourished. Texture

modification of regular food is the first

approach to chewing or swallowing

problems. At times, however, regular

foods and beverages, even those

modified in texture or nutrient content,

may not be enough. It may then be

appropriate to consider medical food

and food for special dietary uses.

Medical nutrition therapy is the

assessment of the nutritional status of

an individual with a condition, illness,

or injury that puts them at nutritional

risk and the provision of nutrition

support either as diet modification and

counseling or as specialized nutrition

therapies designed to achieve

nutritional goals and desired health

outcomes. Specialized nutrition

therapies may include the use of

medical food and food for special

dietary uses that are administered by

oral (mouth) and non-oral

(nasogastrically, enterally (gut)) routes.

Medical food and food for special

dietary uses that are administered

parenterally (by vein) are classified as

drugs. Nutrition support may be an

important component of the clinical

management of chronic diseases, such

as heart, lung, kidney diseases, stroke,

diabetes, and some types of cancer.

Nutrition support may also be a clinical

management component used in the

treatment of acute conditions, such as

fractures, pre/post surgery, burns and

other traumas. Oral health problems,

more prevalent among older

individuals, may require nutrition

support. Oral health problems, such as

loss of teeth, gingivitis, changes in

salivary function and sense of taste,

affect chewing and swallowing and alter

the type and quantity of food that can

be eaten. Mental health problems, such

as dementia, depression and

Alzheimer’s disease, interfere with

dietary quality and quantity and

therefore may need nutrition support.

Medication side effects influence

appetite and mental functioning.

Texture modification (chopping,

pureeing, thickening, blending) and

supplementation (additional protein,

carbohydrate, fat, fiber) of conventional

food are considered nutrition support

for some physical, oral and mental

problems.

Policy Instruction

Subpart 132.11 of the current OAA

regulations state that:

(a) The State agency on aging shall develop

policies governing all aspects of programs

operated under this part * * * These

policies shall be developed in consultation

with other appropriate parties in the

State * * *

A Tribe is likewise expected to develop

policies governing program operations.

A State or Tribe may choose to allow

the provision of medical food and food

for special dietary uses and to use OAA

and USDA funds if the SUA or Tribal

policy complies with

• Statutory terminology for medical

food and food for special dietary uses;

• Appropriate Use Guidelines (stated

below) for substitution for a meal

component(s) and/or replacement of a

conventional meal; and

• Federal, State, Tribal, and local

laws, regulations, policies and

guidelines.

Appropriate Use Guidelines

AoA would allow funding and USDA

would reimburse on a per meal basis for

medical food and/or food for special

dietary uses when:

• Criteria for the allowable medical

food or food for special dietary use are

met;

• There is a recommendation by an

appropriate health professional such as

a physician or registered/licensed

dietitian as part of an overall medical

nutrition therapy plan for the individual

and the plan is periodically reevaluated

and updated;

• The individual is provided with a

minimum of 331⁄3 percent of the

Recommended Dietary Allowances

established by the Food and Nutrition

Board of the National Research Council

of the National Academy of Sciences,

except in cases where the individual’s
Federal Register / Vol. 61, No. 117 / Monday, June 17, 1996 / Notices 30621

specific medical nutrition therapy plan

dictates otherwise; and

• If the medical food and/or food for

special dietary uses is/are used as a:

• Substitution for part of the

conventional meal components, the

combination of the medical food or food

for special dietary use and conventional

foods must meet the above criteria; or

• Replacement of a conventional

meal, they must meet the above criteria

and consumption of a conventional

meal, even with modifications, had been

considered but is contraindicated.

When a medical food and/or food for

special dietary uses are provided in

addition to a conventional meal, AoA

and USDA view the meal and medical

food or food for special dietary uses

together as constituting a single meal

and would not reimburse separately.

Additional Information

A paper, ‘‘Use of Medical Food and

Food for Special Dietary Uses in Elderly

Nutrition Programs’’, authored by the

National Policy and Resource Center on

Nutrition and Aging (Center),

summarizes the appropriate use of

medical food and food for special

dietary uses in a question and answer

format. In addition, the Center has

compiled information on state policies

on this topic, ‘‘State Policies on

Provision of Medical Food and Food for

Special Dietary Uses.’’ Both

publications are available from the

Administration on Aging, Office of State

and Community Programs; please call

(202) 619–0011 for copies of the paper

and compilation. Written comments and

recommendations regarding the

proposed guidance should be sent

within 60 days of the publication of this

notice directly to the following address:

Edwin L. Walker, Director, Office of

Program Operations and Development,

Administration on Aging, 330

Independence Avenue, SW.,

Washington, DC 20201.

Dated: June 5, 1996.

William F. Benson,

Deputy Assistant Secretary for Govenmental

Affairs and Elder Rights.

[FR Doc. 96–15217 Filed 6–14–96; 8:45 am]

BILLING CODE 4150–04–M

Administration for Children and

Families

[OCS–96–09]

Youth Education and Domestic

Violence Model Programs

AGENCY: Office of Community Services,

ACF, DHHS.

ACTION: Notice and call for information

on current youth education and

domestic violence programs to be

considered as model projects for

evaluation and possible nationwide

distribution.

SUMMARY: The Department of Health and

Human Services (DHHS) is authorized,

in consultation with the Secretary of

Education, to ‘‘select, implement, and

evaluate four separate model programs

for the education of young people about

domestic violence and violence among

intimate partners.’’ The model programs

must address one of four different

audiences: primary schools, middle

schools, secondary schools, and

institutions of higher education, and

shall be selected, implemented, and

evaluated in consultation with

‘‘educational experts, legal and

psychological experts on battering, and

victim advocate organizations such as

battered women’s shelters, State

coalitions, and resource centers.’’

As a first step, we want to identify

and solicit information on programs for

the education of young people about

domestic violence and violence among

intimate partners that are being

conducted for one or more of the four

student audiences. This announcement

contains all instructions for submitting

information on youth education

programs.

DATES: The closing date for submission

of program information is August 16,

1996.

ADDRESSES: Program information may

be mailed to the U.S. Department of

Health and Human Services,

Administration for Children and

Families/Office of Community Services,

(OCS–96–09), 370 L’Enfant Promenade,

SW., Mail Stop 6C–462, Washington, DC

20447.

Hand delivered program information

is accepted during the normal working

hours of 8 a.m. to 4:30 p.m., Monday

through Friday, on or prior to the

established closing date at: U.S.

Department of Health and Human

Services, Administration for Children

and Families, Office of Community

Services, ACF Mailroom, 2nd Floor

Loading Dock, Aerospace Center 901 D

Street, SW., Washington, DC 20447,

between Monday and Friday (excluding

Federal holidays).

SUPPLEMENTARY INFORMATION: The Youth

Education and Domestic Violence

program is authorized by section 317 of

the Family Violence Prevention and

Services Act (the Act), 42 U.S.C. 10417,

as amended by Pub. L. 103–322, the

Violent Crime Control and Law

Enforcement Act of 1994.

Congress has made available $400,000

to carry out the provisions of section

317.

The Office of Community Services,

Administration for Children and

Families (OCS) will select and evaluate

four types of model programs for the

education of four specified audiences of

young people about domestic violence

and violence among intimate partners.

Six to eight programs will be selected to

participate in a national evaluation of

their efforts. These programs may be

recommended to Congress for possible

future nationwide distribution.

Specifically, OCS will proceed as

follows:

First, we will convene an expert panel

to:

(a) Help identify youth education and

domestic violence programs for

evaluation;

(b) Assist in the development of

criteria to be used in the preliminary

selection of programs to be evaluated;

and

(c) Assist in the design and

development of the evaluation study.

Second, we are actively soliciting

information about and descriptions of

current youth education programs. We

are using this Federal Register notice,

Department of Education (DOE)

networks, professional publications,

national resource centers, the electronic

media, and other mechanisms to request

information about such programs.

Third, the expert panel will assist the

DHHS and DOE to review the

information on programs received and

select at least six but no more than eight

for the evaluation.

We do not have a pre-conceived

model or educational approach in mind.

We are interested in obtaining

information on the more outstanding

programs being implemented. These

programs may include, for example,

training curricula, print and visual

training aids (as audiovisual

components of a structured and more

comprehensive program), and model

programs that may be school or nonschool based. They may include a range

of subject matter topics as appropriate to

the specific student audience, such as

interpersonal violence prevention, selfesteem training for girls, conflict

resolution, and the prevention of

acquaintance rape and other forms of

sexual abuse and violence developed for

the high school and college population.

PROGRAM INFORMATION REQUESTED: The

information on the youth education

programs should be narrative and not

exceed 30 pages in length. Program

descriptions should include:

A. Identifying Information

—Name of the Program

—Name and Address of the Sponsoring

Organization