8248 Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices

Littleton, Colorado; FirstBank of

Lakewood, N.A., Lakewood, Colorado;

FirstBank of Littleton, N.A., Littleton,

Colorado; FirstBank of Arapahoe

County, N.A., Littleton, Colorado;

FirstBank of Silverthorne, N.A.,

Silverthorne, Colorado; FirstBank of

Vail, Vail, Colorado; FirstBank North,

N.A., Westminster, Colorado; FirstBank

of Wheat Ridge, N.A., Wheat Ridge,

Colorado; and FirstBank, N.A., Palm

Desert, California.

2. Benedict Enslinger, Trustee,

Benedict Enslinger Revocable Trust,

both of La Crosse, Kansas; to acquire an

additional 1.30 percent, for a total of

11.96 percent, of the voting shares of

NSB Bancshares, Inc., La Crosse,

Kansas, and thereby indirectly acquire

Nekoma State Bank, La Crosse, Kansas.

3. Matthew T. Ley, as Trustee,

Portland, Oregon; to acquire an

additional 38.2 percent, for a total of

40.9 percent, of the voting shares of

State National Bancshares, Inc., Wayne,

Nebraska, and thereby indirectly acquire

State National Bank and Trust

Company, Wayne, Nebraska.

C. Federal Reserve Bank of Dallas

(Genie D. Short, Vice President) 2200

North Pearl Street, Dallas, Texas 75201-

2272:

1. Cecil R. Simmons, San Benito,

Texas; to acquire an additional 2.1

percent, for a total of 14.8 percent, and

Cecil R. Simmons, as Trustee for the

First National Bank Employee Stock

Ownership Plan, San Benito, Texas, to

acquire an additional 11.4 percent, for a

total of 17.3 percent, of the voting shares

of First San Benito Bancshares, Inc., San

Benito, Texas, and thereby indirectly

acquire First National Bank of San

Benito, San Benito, Texas.

Board of Governors of the Federal Reserve

System, February 18, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–4372 Filed 2-21-97; 8:45 am]

BILLING CODE 6210-01-F

Notice of Proposals to Engage in

Permissible Nonbanking Activities or

to Acquire Companies that are

Engaged in Permissible Nonbanking

Activities

The companies listed in this notice

have given notice under section 4 of the

Bank Holding Company Act (12 U.S.C.

1843) (BHC Act) and Regulation

Y, (12 CFR Part 225) to engage de novo,

or to acquire or control voting securities

or assets of a company that engages

either directly or through a subsidiary or

other company, in a nonbanking activity

that is listed in § 225.25 of Regulation

Y (12 CFR 225.25) or that the Board has

determined by Order to be closely

related to banking and permissible for

bank holding companies. Unless

otherwise noted, these activities will be

conducted throughout the United States.

Each notice is available for inspection

at the Federal Reserve Bank indicated.

Once the notice 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

question whether the proposal complies

with the standards of section 4 of the

BHC Act.

Unless otherwise noted, comments

regarding the applications must be

received at the Reserve Bank indicated

or the offices of the Board of Governors

not later than March 10, 1997.

A. Federal Reserve Bank of

Minneapolis (Karen L. Grandstrand,

Vice President) 250 Marquette Avenue,

Minneapolis, Minnesota 55480-2171:

1. Community First Bankshares, Inc.,

Fargo, North Dakota; to engage de novo

through its subsidiary, Community First

Financial, Inc., Fargo, North Dakota, in

leasing personal property or acting as

agent, broker, or adviser in leasing

personal property, pursuant to §

225.25(b)(5) of the Board’s Regulation Y.

Board of Governors of the Federal Reserve

System, February 18, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–4373 Filed 2-21-97; 8:45 am]

BILLING CODE 6210-01-F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96D–0513]

Guidance on Labeling of Foods That

Need Refrigeration by Consumers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing

guidance on labeling of foods that need

refrigeration by consumers to maintain

safety or quality. This guidance, which

represents FDA’s policy on adequate

safe handling instructions for food,

should reduce the likelihood of

temperature abuse of certain foods by

consumers, and it is intended to reduce

the potential for foodborne illness and

death. The guidance also responds to

the recommendations of the National

Advisory Committee on Microbiological

Criteria for Foods (NACMCF), the

National Food Processors Association

(NFPA), the Association of Food and

Drug Officials (AFDO), and the Centers

for Disease Control and Prevention

(CDC) for labeling foods needing

refrigeration. FDA is soliciting

comments on this guidance.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written comments

on this guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Geraldine A. June, Center for Food

Safety and Applied Nutrition (HFS–

158), Food and Drug Administration,

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

202–205–5099.

SUPPLEMENTARY INFORMATION:

I. Background

Refrigeration has long been used to

retard deterioration of the flavor, color,

and texture of foods. More importantly,

refrigeration helps maintain the

microbiological safety of potentially

hazardous foods. Temperature abuse,

i.e., failure to maintain foods at

appropriate temperatures, may result in

the outgrowth of microorganisms that

may have contaminated the foods

before, or at the time of, harvest or

during processing, handling, or storage.

The rate of growth of these

microorganisms is reduced as the

storage temperature is lowered. Proper

refrigeration, therefore, prevents or

slows the growth of human pathogens

and spoilage microorganisms and

reduces the likelihood of foodborne

illness.

Refrigeration is only one of many

individual factors, called barriers, that

can be used to control microbiological

risks. It is, for many foods, the only

practicable barrier to reduce or prevent

pathogen growth. Examples of other

types of barriers include acidification

(pH ≤ 4.6), use of preservatives, such as

salt, and low water activity (aw ≤ 0.85).

Barriers used individually, or in

combination with each other, may

reduce or retard pathogenic microbial

growth.

In the past, consumers could

generally tell if a product were

perishable by its packaging or lack of

packaging. Products in a can or a jar

were generally considered to be shelfstable (i.e., products that can be stored

on the shelf without spoilage), at least

until opened. However, today’s new

packaging technologies have changed

this situation. Many liquids or semiliquids in flexible packages have airtight
Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices 8249

liners and are shelf-stable. Vacuum

packed foods or foods packaged in

modified (oxygen reduced)

atmospheres, which are shelf-stable,

may appear to the consumer to be safe

to eat, even if they have been

temperature abused. These foods may

not have developed organoleptic signs

(such as deterioration of color, flavor,

texture, etc.) that consumers associate

with spoiled or unsafe foods. However,

foods in these packages may present a

potential hazard if, once opened, they

are stored unrefrigerated.

Recently, there have been reports of

botulism food poisonings resulting from

consumption of food that had been

temperature abused by consumers, even

though the products were labeled ‘‘keep

refrigerated.’’ FDA is concerned that

such foods are not labeled adequately or

conspicuously enough to advise

consumers that the product must be

refrigerated to maintain its safety. The

specific foods implicated in the

botulism poisonings were clam chowder

and black bean dip. Packaging for both

of these products could have made the

food appear shelf-stable to the

consumer.

The potential for foodborne illness

from temperature abused foods is

widely recognized. Efforts to reduce this

health risk in potentially hazardous

foods that need refrigeration to ensure

their safety and quality have included

voluntary use of label statements such

as ‘‘keep refrigerated’’ and ‘‘refrigerate

after opening.’’ Use of such label

statements no longer provides

meaningful consumer information

because the same label statements

appear both on foods needing

refrigeration to ensure safety and foods

needing refrigeration to maintain

quality. NACMCF has made specific

recommendations for label statements

on potentially hazardous foods (Ref. 1)

to address this problem. NFPA has

developed guidelines for the food

industry for voluntary label statements

using the language in the NACMCF

recommendation (Ref. 2). AFDO has

endorsed the guidelines developed by

NFPA (Ref. 3) and has recommended

them to State regulatory agencies to

assist those agencies in requiring and

enforcing improved labeling (Ref. 4).

Finally, CDC sent FDA a memorandum

expressing concern about the recent

botulism outbreaks and recommending,

among other things, better labeling for

foods requiring refrigeration (Ref. 5).

II. Inadequacy of Current Labeling

Because of the recent reports of

botulism food poisonings from

consumption of foods that had been

temperature abused by consumers, FDA

has evaluated the labeling on foods that

must be refrigerated to prevent

outgrowth of pathogens and has found

that most of this labeling does not

adequately advise the consumer of the

need to keep the food refrigerated or of

the health risk if it is not. For example,

the packaging for the clam chowder and

black bean dip that were implicated in

the recent botulism poisonings made the

foods appear shelf-stable. The clam

chowder was packaged in a plastic bag

inside a cardboard carton. The bean dip

was packaged in a resealable plastic tub.

These items were displayed in

refrigerated cases in the supermarket.

While both items had a ‘‘keep

refrigerated’’ statement on their labels,

consumers failed to maintain these

products under refrigeration.

Most consumers seem to understand

that foods that are displayed only in the

refrigerated section of a grocery store,

such as dairy products, eggs, cold cuts,

fresh meats, poultry, and seafood, must

be refrigerated to maintain their quality.

While it is unlikely that a majority of

consumers are aware of the hazards and

food safety issues that temperature

abuse of these products can present, it

is likely that most consumers will

refrigerate these foods even in the

absence of labeling instructions to do so

for safety. Therefore, the fact that these

foods are refrigerated does not really

provide evidence of the effectiveness of

the ‘‘keep refrigerated’’ instructions in

their labeling.

Foods such as mustard, salad

dressings, jams, jellies, salsa, and

spaghetti sauce bear a statement

advising refrigeration once the product

is opened to retard deterioration in the

quality of the food. Nonetheless,

consumers often do not refrigerate these

foods. Although consumers may notice

a deterioration in flavor, color, or

texture over time, they may not

associate foodborne illness with

consumption of these products.

Therefore, consumers do not seem to

associate safety concerns with the ‘‘keep

refrigerated’’ or ‘‘refrigerate after

opening’’ statements.

The agency is concerned that

consumers may not be aware that some

newer, less traditional, packaged foods

need refrigeration to maintain their

safety. Some examples are fresh cut

fruits and vegetables, food packaged in

cardboard containers resembling shelfstable packages (such as the previously

mentioned clam chowder and bean dip),

and vacuum or modified (reduced

oxygen) atmosphere packaged products

in clear flexible packaging. Consumer

understanding of the significance or

reason for advising that a product be

kept refrigerated is likely hampered by

the rapidly expanding marketing of

foods having convenient preparation

and ‘‘close to fresh’’ product

characteristics.

In addition, as previously mentioned,

the food industry is developing new

types of foods with extended shelf life

(i.e., the length of time that a product

may be stored without deterioration)

that have to be refrigerated. Foods

known as ‘‘partially processed’’ or

‘‘minimally processed’’ may have

received a heat process or other

preservation treatment during

manufacturing that reduces the

microbiological load in the food but that

does not render the food ‘‘commercially

sterile.’’ These partially processed foods

share the hazard common to all

potentially hazardous foods, i.e., ability

to support the growth of pathogens,

unless they are refrigerated. Thus, if

only a ‘‘keep refrigerated’’ label appears

on these types of foods, and consumers

choose not to pay attention to it, the

consumers would be taking a significant

risk.

The agency is also concerned about

the potential abuse of a category of

products (e.g., low acid canned foods

that are not otherwise preserved) that

need refrigeration after being opened.

The potential for temperature abuse of

these products may be even greater than

that for foods that need constant

refrigeration. These products are

generally displayed in a section of the

store that is not refrigerated, and these

products are provided in packaging

similar to foods that do not need

refrigeration even after opening. Even

though these shelf-stable foods may bear

storage instructions for the unused

portion, the need for refrigeration is

frequently not conveyed on the label, or

not conveyed in a way that consumers

can see and understand.

Current labeling of shelf-stable

packaged foods is not adequate because

the same label statements, e.g., ‘‘keep

refrigerated’’ or ‘‘refrigerate after

opening,’’ appear both on foods that are

potentially hazardous and on foods that

do not pose a hazard but that are

refrigerated to retard deterioration in

quality. The labeling of potentially

hazardous foods that need refrigeration

should distinguish these products from

products for which refrigeration is only

to protect quality. FDA is concerned

that, without adequate labeling on these

potentially hazardous products, efforts

by the food industry to develop new

types of foods with extended shelf life

prior to being refrigerated and while

under refrigeration will result in more

illnesses.

Further, different formulations and

processing methods for different
8250 Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices

versions of the same food, such as

pumpkin pie, may or may not need

refrigeration for safety. In addition,

different versions of these foods can be

displayed in different sections of the

retail store, with the ‘‘keep refrigerated’’

statement on the version of the food that

needs refrigeration as the only

indication that there is a difference in

safety considerations among the

versions of the product. Furthermore,

the ‘‘keep refrigerated’’ statement often

appears in small print and is placed on

an obscure part of the label. Therefore,

the consumer may not understand or

interpret the ‘‘keep refrigerated’’

statement as an instruction about what

must be done to maintain the safety of

the product.

Moreover, ‘‘keep refrigerated’’ or

‘‘refrigerate after opening’’ statements

generally do not include the reason the

product is to be refrigerated. The agency

regards it as unlikely that most

consumers know and are able to

distinguish the underlying reasons for a

‘‘keep refrigerated’’ label statement

when comparing products that bear that

statement to maintain microbiological

safety with products that bear that

statement for maintaining quality.

Therefore, consumers would have no

reason to consider one such statement

any more important for product safety

than another. Thus, the statements

‘‘keep refrigerated’’ or ‘‘refrigerate after

opening’’ alone are not adequate to

appropriately alert consumers to the

importance of properly handling

potentially hazardous foods.

III. Labeling Options Considered

The agency has considered the

recommendations offered by CDC,

NACMCF, AFDO, and NFPA. In a

memorandum dated February 14, 1995

(Ref. 5), CDC recommended that food

labels advising refrigeration should be

reviewed. CDC maintained that labels

advising ‘‘keep refrigerated’’ may not be

sufficient to warn consumers about the

health risks associated with

noncompliance. Further, CDC advised

that for foods for which refrigeration is

the only barrier to prevent growth of C.

botulinum, the label should identify the

risks of botulism if mishandled.

FDA has also considered the labeling

recommendations for foods requiring

refrigeration by consumers that have

been offered by NACMCF, NFPA, and

AFDO (Refs. 1, 2, and 4). NACMCF

maintained that consumers have

difficulty distinguishing the differences

among various label statements and

their relationship to product safety.

Therefore, it recommended that the

following label statement be used on

packaged food that poses a safety hazard

if temperature abused: ‘‘IMPORTANT

MUST BE KEPT REFRIGERATED’’.

Recommendations from NFPA and

AFDO recognize two categories of foods.

Group A foods are potentially

hazardous, packaged, processed foods

that must be refrigerated for safety

reasons, and Group B foods are products

that are intended to be refrigerated but

that do not pose a safety hazard if

temperature abused. The recommended

label statement for Group A foods is:

‘‘IMPORTANT: Must Be Kept

Refrigerated’’.

The recommended label statement for

Group B foods is ‘‘keep refrigerated,’’

although such products would be

allowed to utilize the Group A

suggested label statement.

A. Analysis of Options

FDA agrees with CDC that the label

statement ‘‘keep refrigerated’’ may not

be sufficient to warn consumers about a

health risk. However, the agency does

not agree that the label should

specifically identify the risk of botulism

because it is not the only risk if foods

that need refrigeration are temperature

abused.

While FDA finds considerable merit

in the labeling recommendations of

NACMCF, NFPA, and AFDO, the agency

is concerned that these

recommendations do not inform

consumers of the reasons for

refrigeration of foods and do not fully

differentiate the types of foods that

should bear a ‘‘keep refrigerated’’ label.

Moreover, the suggested label

statements will not eliminate the

confusion generated by the current

voluntary label statements used on

foods to be refrigerated, especially if

foods that do not pose a safety hazard

are permitted to bear the same labeling

statements as those that do pose a safety

hazard if not refrigerated.

Having considered these

recommendations, the agency is

recommending an approach that is

somewhat different than those suggested

in the recommendations that it has

received. In the agency’s view, labeling

will be more effective if it is more

specific to the types of hazards that are

presented, and to the types of storage

conditions that are necessary, after the

product is opened. In FDA’s view, this

specificity is provided if foods that need

refrigeration are divided into three

groups. The first group, Group A, are the

foods that were in NFPA’s and AFDO’s

Group A foods that are potentially

hazardous and that must be kept

refrigerated for safety reasons. Group B

includes foods that are shelf-stable but

that need refrigeration after opening for

safety. Group C (described as Group B

foods in the NFPA and AFDO

recommendations) include foods that

are refrigerated only to retard

deterioration in quality.

FDA has sought to craft label

statements that will help consumers to

differentiate among these types of foods.

Phrases such as ‘‘to maintain safety’’

and ‘‘for quality’’ are essential in

drawing a distinction between Groups A

and B on the one hand and Group C on

the other. Furthermore, the agency

agrees with the recommendations of

NACMCF, NFPA, and AFDO that the

term ‘‘Important’’ would help to

underscore this distinction and to

indicate the significance of the

statement. The phrase ‘‘after opening,’’

or some similar statement, is essential to

distinguish Group B from Group A.

Thus, the agency considers that the

statement ‘‘Important must be kept

refrigerated to maintain safety’’ for

Group A foods is appropriate because it

can adequately convey to consumers

that continued refrigeration is

mandatory to reduce safety risks.

Similarly, the agency considers

‘‘Important must be refrigerated after

opening to maintain safety’’ an

appropriate label statement for Group B

foods because such foods are shelfstable and may pose a health hazard

only after opening. In contrast,

‘‘refrigerate for quality’’ or ‘‘keep

refrigerated for quality’’ for Group C

foods is sufficient, in the agency’s

opinion, to distinguish this category

from Groups A and B and to inform

consumers that refrigeration is only

necessary to retard deterioration in

product quality.

B. Labeling Placement and Prominence

In addition to label statements that are

focused on the type of product and the

risk it represents, placing the statements

on the label in a way that gives them

appropriate prominence is critical to

ensuring that the label statements will

be seen, read, and understood. The

placement and prominence guidelines

suggested by NFPA are particularly

useful and helpful in this regard. NFPA

recommended that the label statements

be set off by the use of hairlines at the

top and bottom of the statement area.

The type should: (1) Be on a contrasting

background; (2) utilize a single, easy-toread style and size; (3) have at least one

point leading (space between two lines

of text); and (4) ensure that letters never

touch. On Group A and B foods, the

word ‘‘IMPORTANT’’ should be in all

capital letters, while the remaining

words should use uppercase and

lowercase letters, with the first letter in

each word capitalized. The hairlined

area should appear on the label
Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices 8251

prominently and conspicuously as

compared to other words, statements,

designs, or devices. FDA strongly agrees

and urges all firms to follow these

recommendations. In addition, the

agency notes that its general approach to

type size of label information is that it

should be not less than one-sixteenth

inch unless the package is too small to

accommodate this type size. The agency

encourages placement of this statement

on the principal display panels, at least

for group A and B foods. If the statement

does not fit on the principal display, it

should be placed on the information

panel.

C. FDA Labeling Policy

To clarify this guidance, the agency

has delineated each of the three groups

and developed model statements for

each:

1. Group A Foods

Group A foods are potentially

hazardous foods, which, if subjected to

temperature abuse, will support the

growth of infectious or toxigenic

microorganisms that may be present.

Outgrowth of these microorganisms

would render the food unsafe. Foods

that must be refrigerated for food safety

possess the following characteristics: (1)

Product pH > 4.6; (2) water activity aw

> 0.85; (3) do not receive a thermal

process or other treatment in the final

package that is adequate to destroy

foodborne pathogens that can grow

under conditions of temperature abuse

during storage and distribution; and (4)

have no barriers (e.g., preservatives such

as benzoates, salt, acidification), built

into the product formulation that

prevent the growth of foodborne

pathogens that can grow under

conditions of temperature abuse during

storage and distribution.

The appropriate label statement for

Group A foods is:

IMPORTANT Must Be Kept Refrigerated To Maintain Safety

2. Group B Foods

Group B includes those foods that are

shelf-stable as a result of processing, but

once opened, the unused portion is

potentially hazardous unless

refrigerated. These foods possess the

following characteristics: (1) Product pH

> 4.6; (2) water activity aw > 0.85; (3)

receive a thermal process or other

treatment that is adequate to destroy or

inactivate foodborne pathogens in the

unopened package, but after opening,

surviving or contaminating

microorganisms can grow and render

the product unsafe; and (4) have no

barriers (for example, preservatives such

as benzoates, salt, acidification) built

into the product formulation to prevent

the growth of foodborne pathogens after

opening and subsequent storage under

temperature abuse conditions.

The appropriate label statement for

Group B foods is:

IMPORTANT Must Be Refrigerated After Opening To Maintain Safety

3. Group C Foods

Group C are those foods that do not

pose a safety hazard even after opening

if temperature abused, but that may

experience a more rapid deterioration in

quality over time if not refrigerated. The

manufacturer determines whether to

include on the label a statement that

refrigeration is needed to maintain the

quality characteristics of the product to

maximize acceptance by the consumer.

These foods do not pose a safety

problem. Foods in this group possess

one or more of the following

characteristics to ensure that the food

does not present a hazard if temperature

abused: (1) Product pH ≤ 4.6 to inhibit

the outgrowth and toxin production of

C. botulinum; or (2) water activity aw ≤

0.85; or (3) have barriers built into the

formulation (for example, preservative

systems such as benzoates, salt,

acidification) to prevent the growth of

foodborne pathogens if the product is

temperature abused.

The suggested optional label

statement for Group C foods is:

‘‘Refrigerate for Quality’’

or some other statement that explains to

the consumer that the storage conditions

are recommended to protect the quality

of the product. To avoid confusion

between refrigeration for safety

purposes and refrigeration for quality

reasons, Group A and Group B

statements should not be used on Group

C foods.

The agency is publishing this

document to provide this guidance by

the quickest means to as many

manufacturers as possible, so that they

may begin using the label statements. If

manufacturers follow this guidance, the

consumer will have clear, concise, and

prominent labeling information for

maintaining the safety of potentially

hazardous food products. Inclusion of

these statements in the labeling of

appropriate foods will help the

consumer recognize when appropriate

storage temperatures are needed to

maintain the safety or quality of those

foods. Such information will reduce the

likelihood of temperature abuse of the

food and, consequently, reduce the

potential for foodborne illness and

death.

While this guidance is primarily

intended to address the need for safe

handling of potentially hazardous foods

by consumers, the agency recognizes

that there also is a need for safe

handling during the transportation and

distribution of these foods. The Food

Safety and Inspection Service of the

U.S. Department of Agriculture and

FDA have jointly published an advance

notice of proposed rulemaking in the

Federal Register of November 22, 1996

(61 FR 59372) to solicit comments on

approaches that the two agencies may

take to foster safety improvements in the

storage and transportation of potentially

hazardous foods. Therefore, this

guidance does not address how foods

that need refrigeration during

transportation and storage should be

labeled.

IV. Consumer Education

Most consumers are not aware of the

hazards associated with temperature

abuse of foods needing refrigeration,

especially foods that use newer, less

traditional means of packaging. If firms

follow the guidance set out in this

document, it will help consumers to

recognize the difference between the

messages, ‘‘refrigerate for safety’’ and

‘‘refrigerate for quality.’’ The agency

recognizes, however, that a coordinated

public education campaign is needed to

ensure that consumers understand the
8252 Federal Register / Vol. 62, No. 36 / Monday, February 24, 1997 / Notices

significance of the differences in these

messages. Given the significance of the

underlying problem, FDA intends to

undertake an educational effort,

including press releases and consumer

pamphlets. The agency requests the

cooperation and assistance of industry

and other private groups in this effort.

The agency also requests comments on

additional ways to educate the

consumer.

The guidance represented here

reflects FDA’s current thinking on safe

handling labeling for foods that need

refrigeration by the consumer. This

document does not bind FDA and does

not create or confer any rights,

privileges, benefits, or immunities for or

on any persons.

Interested persons may submit written

comments on the guidance to the

Dockets Management Branch (address

above). 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 the brackets in the heading of

this document. The guidance and

received comments may be seen in the

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

Monday through Friday.

V. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. Recommendations of the National

Advisory Committee on Microbiological

Criteria for Foods for Refrigerated Foods

Containing Cooked, Uncured Meat or Poultry

Products that are Packaged for Extended

Refrigerated Shelf Life and that are Ready-ToEat or Prepared with Little or No Additional

Heat Treatment, January 31, 1990.

2. Guidelines for the Development,

Production, Distribution, and Handling of

Refrigerated Foods, National Food Processors

Association, 1989.

3. Letter from J. Corby, New York

Department of Agriculture and Markets to A.

Dell’Aria, Virginia Department of

Agriculture, September 8, 1995.

4. Memorandum from A. Dell’Aria, AFDO,

December 20, 1995.

5. Letter from P. Griffin and R. Tauxe, CDC

to K. Wachsmuth, FDA, February 14, 1995.

Dated: February 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4364 Filed 2–21–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[R–38]

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.

Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Conditions of

Participation for Rural Health Clinics,

42 CFR 491.9 Subpart A; Form No.:

HCF–AR–38; Use: This information is

needed to determine if rural health

clinics meet the requirements for

approval for Medicare participation.

Frequency: Other (Initial application for

Medicare); Affected Public: Individuals

or Households; Business or other for

profit; Not for profit institutions; Farms;

Federal Government; and State, Local or

Tribal Government; Number of

Respondents: 3,076; Total Annual

Hours: 9,744.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s Web Site Address at http://

www.hcfa.gov/regs/prdact95.htm, or to

obtain the supporting statement and any

related forms, e-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Dated: February 13, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–4374 Filed 2–21–97; 8:45 am]

BILLING CODE 4120–03–P

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

DHHS.

ACTION: Notice.

The inventions listed below are

owned by agencies of the U.S.

Government and are available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of

federally-funded research and

development. Foreign patent

applications are filed on selected

inventions to extend market coverage

for U.S. companies and may also be

available for licensing.

ADDRESS: Licensing information and

copies of the U.S. patent applications

listed below may be obtained by writing

to the indicated licensing contact at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804 (telephone 301/

496–7057; fax 301/402–0220). A signed

Confidential Disclosure Agreement

(CDA) will be required to receive copies

of the patent applications.

Chromosomal Markers and Diagnostic

Tests For Manic-Depressive Illness

S Detera-Wadleigh (NIMH), E Gershon

(NIMH), J Badner (NIMH), L Goldin

(NIMH), W Berrettini (Thomas

Jefferson University), T Yoshikawa

(NIMH), A Sanders (NIMH), L

Esterling (NIMH)

Serial No. 60/029,278 filed 28 Oct 96

Licensing Contact: Stephen Finley,

301/496–7735, ext. 215.

Bipolar disease, or manic-depressive

illness, affects approximately 1% of the

population and is generally controlled

through medication. Not all patients

respond similarly to a given medication.

A medication that works well in one

individual may be ineffective in another

individual. It is unclear why this is, but

it has been theorized that bipolar

disease may involve multi-genes,

possible on several chromosomes. It is

not known if one genetic locus

dominates over another, but if one does,

then it may explain the variable