Federal Register / Vol. 62, No. 74 / Thursday, April 17, 1997 / Notices 18773

been affected adversely by this declared

major disaster:

The counties of Grays Harbor, King and

Mason for Individual Assistance and Hazard

Mitigation.

(Catalog of Federal Domestic Assistance No.

83.516, Disaster Assistance)

James L. Witt,

Director.

[FR Doc. 97–9933 Filed 4–16–97; 8:45 am]

BILLING CODE 6718–02–P

FEDERAL EMERGENCY

MANAGEMENT AGENCY

[FEMA–1159–DR]

Washington; Amendment to Notice of

a Major Disaster Declaration

AGENCY: Federal Emergency

Management Agency (FEMA).

ACTION: Notice.

SUMMARY: This notice amends the notice

of a major disaster for the State of

Washington, (FEMA–1159–DR), dated

January 17, 1997, and related

determinations.

EFFECTIVE DATE: April 2, 1997.

FOR FURTHER INFORMATION CONTACT:

Magda Ruiz, Response and Recovery

Directorate, Federal Emergency

Management Agency, Washington, DC

20472, (202) 646–3260.

SUPPLEMENTARY INFORMATION: The notice

of a major disaster for the State of

Washington, is hereby amended to

include the following areas among those

areas determined to have been adversely

affected by the catastrophe declared a

major disaster by the President in his

declaration of January 17, 1997:

The counties of Adams, Benton, Chelan,

Columbia, Cowlitz, Douglas, Ferry, Franklin,

Garfield, Grant, Klickitat, Lewis, Lincoln,

Okanogan, Pacific, San Juan, Stevens, Walla

Walla, and Whitman for Individual

Assistance (already designated for Public

Assistance and Hazard Mitigation).

(Catalog of Federal Domestic Assistance No.

83.516, Disaster Assistance)

Lacy E. Suiter,

Executive Associate Director, Response and

Recovery Directorate.

[FR Doc. 97–9934 Filed 4–16–97; 8:45 am]

BILLING CODE 6718–02–P

FEDERAL RESERVE SYSTEM

Change in Bank Control Notices;

Acquisitions of Shares of Banks or

Bank Holding Companies

The notificants listed below have

applied under the Change in Bank

Control Act (12 U.S.C. 1817(j)) and §

225.41 of the Board’s Regulation Y (12

CFR 225.41) to acquire a bank or bank

holding company. The factors that are

considered in acting on the notices are

set forth in paragraph 7 of the Act (12

U.S.C. 1817(j)(7)).

The notices are available for

immediate inspection at the Federal

Reserve Bank indicated. Once the

notices have been accepted for

processing, they will also be available

for inspection at the offices of the Board

of Governors. Interested persons may

express their views in writing to the

Reserve Bank indicated for that notice

or to the offices of the Board of

Governors. Comments must be received

not later than May 1, 1997.

A. Federal Reserve Bank of Kansas

City (John E. Yorke, Senior Vice

President) 925 Grand Avenue, Kansas

City, Missouri 64198-0001:

1. Thomas Rily Ford, Paul Emil

Nelson, and Henry Thomas Southway,

all of Alamosa, Colorado; to each

acquire an additional 3.0 percent, for a

total of 26.6 percent each, of the voting

shares of Alamosa Bancorporation Ltd.,

Alamosa, Colorado, and thereby

indirectly acquire Alamosa National

Bank, Alamosa, Colorado.

Board of Governors of the Federal Reserve

System, April 11, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–9890 Filed 4–16–97; 8:45 am]

BILLING CODE 6210–01–F

FEDERAL RESERVE SYSTEM

Formations of, Acquisitions by, and

Mergers of Bank Holding Companies

The companies listed in this notice

have applied to the Board for approval,

pursuant to the Bank Holding Company

Act of 1956 (12 U.S.C. 1841 et seq.)

(BHC Act), Regulation Y (12 CFR Part

225), and all other applicable statutes

and regulations to become a bank

holding company and/or to acquire the

assets or the ownership of, control of, or

the power to vote shares of a bank or

bank holding company and all of the

banks and nonbanking companies

owned by the bank holding company,

including the companies listed below.

The applications listed below, as well

as other related filings required by the

Board, are available for immediate

inspection at the Federal Reserve Bank

indicated. Once the application has

been accepted for processing, it will also

be available for inspection at the offices

of the Board of Governors. Interested

persons may express their views in

writing on the standards enumerated in

the BHC Act (12 U.S.C. 1842(c)). If the

proposal also involves the acquisition of

a nonbanking company, the review also

includes whether the acquisition of the

nonbanking company complies with the

standards in section 4 of the BHC Act.

Unless otherwise noted, nonbanking

activities will be conducted throughout

the United States.

Unless otherwise noted, comments

regarding each of these applications

must be received at the Reserve Bank

indicated or the offices of the Board of

Governors not later than May 12, 1997.

A. Federal Reserve Bank of Chicago

(James A. Bluemle, Vice President) 230

South LaSalle Street, Chicago, Illinois

60690-1413:

1. Country Bancorporation,

Crawfordsville, Iowa; to acquire up to

100 percent of the voting shares of

Hiawatha Bank and Trust Company,

Hiawatha, Iowa.

B. Federal Reserve Bank of San

Francisco (Kenneth R. Binning,

Director, Bank Holding Company) 101

Market Street, San Francisco, California

94105-1579:

1. Tehama Bancorp, Red Bluff,

California; to become a bank holding

company by acquiring 100 percent of

the voting shares of Tehema Bank, Red

Bluff, California.

Board of Governors of the Federal Reserve

System, April 11, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–9891 Filed 4–16–97; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Agency Information Collection

Activities; Proposed Collections;

Comment Request

The Department of Health and Human

Services, Office of the Secretary will

periodically publish summaries of

proposed information collections

projects and solicit public comments in

compliance with the requirements of

Section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995. To request more

information on the project or to obtain

a copy of the information collection

plans and instruments, call the OS

Reports Clearance Officer on (202) 690–

6207.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the
18774 Federal Register / Vol. 62, No. 74 / Thursday, April 17, 1997 / Notices

proposed collection of information; (c)

ways to enhance the quality, utility and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Projects: Comparative

Analysis of Caregiving Patterns for

Disabled Elders with Long-Term

Insurance—New—The Assistant

Secretary for Planning and Evaluation

(ASPE) is participating in a survey

which will compare the usage of formal

and informal caregiving services

between the disabled elderly with longterm care insurance policies and the

disabled elderly in the general

population. Respondents: Individuals or

households—Burden Information for the

Home Care Instrument—Number of

respondents: 700; Average time per

response: 1.5 hours; Burden for Home

Care Instrument: 1,050 hours—Burden

Information for the Nursing Home

Instrument—Number of respondents:

350; Average time per response: 1.5

hours; Burden for Nursing Home

Instrument: 525 hours—Burden

Information for the Informal Caregiver

Telephone Survey: Number of

respondents: 700; Average time per

response: 20 minutes; Burden for

Informal Caregiver Telephone Survey:

233 hours—Burden Information for the

Policy Holder Screening Instrument—

Number of respondents: 1500; Average

time per response: 7 minutes; Burden

for Policy Holder Screening Instrument:

175 hours—Total Burden: 1983. hours.

Send comments to Cynthia Agens

Bauer, OS Reports Clearance Officer,

Room 503H, Humphrey Building, 200

Independence Avenue SW.,

Washington, DC 20201. Written

comments should be received within 60

days of this notice.

Dennis P. Williams,

Deputy Assistant Secretary, Budget.

[FR Doc. 97–9883 Filed 4–16–97; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0086]

Food Labeling: Draft Guidance on Diet

Plans

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing draft

guidance to the marketers of food plans

that are represented as a total diet and

that have been formulated so that the

dietary intake of various nutrients by

those who participate in the plan is

controlled. The agency hopes that this

guidance, if finalized, will help to

minimize any problems that may

develop should firms proceed to market

with these plans.

DATES: Written comments by July 1,

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:

Christine J. Lewis, Center for Food

Safety and Applied Nutrition (HFS–

451), Food and Drug Administration,

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

202–205–4168.

SUPPLEMENTARY INFORMATION: FDA is

aware that there is interest in the food

industry in offering a food plan in

which most of the food in the diet is

purchased through the plan. The foods

sold in these plans would be formulated

so that the total diet of those who

comply with the plan provides

controlled levels of such nutrients as fat,

saturated fat, cholesterol, and sodium.

FDA applauds innovative efforts to

help consumers maintain healthy

dietary practices. The agency notes that

one of the main purposes of the

Nutrition Labeling and Education Act

(the 1990 amendments) was to

encourage such practices, and, thus,

such plans can be seen, at least

conceptually, as consistent with that

statute. The agency also recognizes that

diets can be structured to be useful in

the management of certain chronic

conditions. The agency has no desire to

do anything that would discourage

efforts to achieve these innovative goals.

While these plans have the potential

to be useful, they also have the potential

to create a number of significant

concerns under the Federal Food, Drug,

and Cosmetic Act (the act). The

purveyors of such programs will need to

take care to ensure that, in presenting

these programs to the American

consumer, they do not run afoul of any

of the provisions of the act. Given this

need for care, FDA has concluded that

it would be useful to companies that

either have decided, or who may decide,

to offer such programs, and that it

would help to prevent regulatory

problems, if the agency outlined the

statutory concerns that it can foresee

could be created by these programs. The

agency is also setting out its thoughts on

these concerns. The agency would

welcome comments on these

preliminary views from interested

persons. The major concerns that FDA

has at least preliminarily identified

follow.

A. Health Claims

Under section 403(r)(1)(B) of the act

(21 U.S.C. 343(r)(1)(B)) and 21 CFR

101.14(a)(1), a health claim is:

* * * any claim made on the label or in

labeling of a food, including a dietary

supplement, that expressly or by implication,

including ‘‘third party’’ references, written

statements (e.g., a brand name including a

term such as ‘‘heart’’), symbols (e.g., a heart

symbol), or vignettes, characterizes the

relationship of any substance to a disease or

health-related condition. Implied health

claims include those statements, symbols,

vignettes, or other forms of communication

that suggest, within the context in which

they are presented, that a relationship exists

between the presence or level of a substance

in the food and a disease or health-related

condition.

Thus, for a claim to be a health claim,

one of the essential elements is that it

be, expressly or by implication, about a

particular substance and not about the

total diet. The agency points out that, in

adopting the health claim final rule, it

said that:

* * * phrases on labeling such as ‘‘eat a

variety of foods to lllll,’’ ‘‘eat a variety

of fresh fruits and vegetables to lllll,’’

or ‘‘follow the food pyramid to lllll,’’

without any reference, either express or

implied, to a substance that might be in the

foods, would not satisfy this element. The

latter types of claims would not be subject to

regulation as health claims.

(58 FR 2478 at 2480, January 6, 1993).

The agency thus recognizes that claims

about the effects of a diet plan,

depending on how the claim is made,

would arguably not be subject to

regulation as a health claim.

FDA advises that it will carefully

scrutinize any claims that are made for

a diet plan to determine whether they

are health claims. For example, a claim

that the diet has been designed to

provide high levels of vitamin A to

reduce the risk of cancer would be a

health claim because the statement links

the two basic components of a health

claim, a food substance and a disease or

health-related condition. Any claims

that are made that are health claims

must be made in accordance with FDA’s

authorizing regulations, or they will

misbrand the products under section

403(r)(1)(B) of the act.

B. Nutrient Content Claims

A claim that expressly or by

implication characterizes the level of a

nutrient in a food is a nutrient content