21192 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Notices

Project Title: Utah—Single-Parent

Employment Demonstration

(Amendments).

Description: Would amend the current

Single Parent Employment

Demonstration (SPED), requiring

preschool children to be immunized

and other children to attend school;

considering as a single filing unit each

family with a child in common,

including all children in the household

related to either parent; permitting

parents removed from the grant due to

non-cooperation or fraud to remain

eligible for JOBS services, including

support services; and allowing a ‘‘best

estimate’’ of earnings in lieu of actual

earnings so long as estimate is within

$100 of actual earnings. These

amendments would initially be limited

to the Kearns office and later expanded

to other SPED sites.

Date Received: 2/7/96.

Type: AFDC.

Current Status: Pending.

Contact Person: Bill Biggs, (801) 538–

4337.

III. Listing of Approved Proposals Since

April 1, 1995

Project Title: Iowa—Family

Investment Plan (Amendments).

Contact Person: Ann Weibers, (515)

281–7714.

IV. Requests for Copies of a Proposal

Requests for copies of an AFDC or

combined AFDC/Medicaid proposal

should be directed to the

Administration for Children and

Families (ACF) at the address listed

above. Questions concerning the content

of a proposal should be directed to the

State contact listed for the proposal.

(Catalog of Federal Domestic Assistance

Program, No. 93562; Assistance Payments—

Research.)

Dated: May 6, 1996.

Howard Rolston,

Director, Office of Planning, Research and

Evaluation.

[FR Doc. 96–11628 Filed 5–8–96; 8:45 am]

BILLING CODE 4184–01–P

Food and Drug Administration

[Docket No. 96N–0115]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Extension

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995,

Federal agencies are required to publish

notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

reporting and recordkeeping

requirements for firms that process

acidified foods and thermally processed

low-acid foods in hermetically sealed

containers.

DATES: Submit written comments on the

collection of information by July 8,

1996.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Charity B. Smith, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1686.

SUPPLEMENTARY INFORMATION: Section

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

Reduction Act of 1995 (44 U.S.C.

3506(c)(2)(A)) requires Federal agencies

to provide a 60-day notice in the

Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c). To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Food Canning Establishment

Registration, Process Filing and

Recordkeeping for Acidified Foods and

Thermally Processed Low-Acid Foods

in Hermetically Sealed Containers (21

CFR 108.25(c)(1) and (c)(2), (d), (e), (g);

108.35(c)(1), (c)(2), (d), (e), (f), (h);

113.60(c); 113.83; 113.87; 113.89;

113.100; 114.80(b); 114.89; 114.100(a)

through (d)) (OMB Control Number

0910–0037—Extension).

Under the Federal Food, Drug, and

Cosmetic Act (the act), FDA is

authorized to prevent the interstate

distribution of food products that may

be injurious to health or that are

otherwise adulterated, as defined in

section 402 of the act (21 U.S.C. 342).

Under the authority granted to FDA by

section 404 of the act (21 U.S.C. 344),

FDA regulations require registration of

food processing establishments, filing of

process or other data, and maintenance

of processing and production records for

acidified foods and thermally processed

low-acid foods in hermetically sealed

containers. These requirements are

intended to ensure safe manufacturing,

processing, and packing procedures and

to permit FDA to verify that these

procedures are being followed.

Improperly processed low-acid foods

present life-threatening hazards if

contaminated with foodborne

microorganisms, especially Clostridium

botulinum. The spores of Clostridium

botulinum must be destroyed or

inhibited to avoid production of the

deadly toxin that causes botulism. This

is accomplished with good

manufacturing procedures, which must

include the use of adequate heat

processes or other means of

preservation.

To protect the public health, FDA

regulations require that each firm that

manufactures, processes, or packs

acidified foods or thermally processed

low-acid foods in hermetically sealed

containers for introduction into

interstate commerce register the

establishment with the Food and Drug

Administration using Form FDA 2541

(21 CFR 108.25(c)(1) and 108.35(c)(2)).

In addition to registering the plant, each

firm is required to provide data on the

processes used to produce these foods,

using Form FDA 2541a for all methods

except aseptic processing, or Form FDA

2541c for aseptic processing of low-acid

foods in hermetically sealed containers

(21 CFR 108.25(c)(2), 108.35(c)(2)). Plant

registration and process filing may be

accomplished simultaneously. Process

data must be filed prior to packing any

new product, and operating processes
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Notices 21193

and procedures must be posted near the

processing equipment or made available

to the operator (§ 113.87(a)).

Regulations in parts 108, 113, and 114

(21 CFR parts 108, 113, and 114) require

firms to maintain records showing

adherence to the substantive

requirements of the regulations. These

records must be made available to FDA

on request. Firms are also required to

document corrective actions when

process controls and procedures do not

fall within specified limits (§§ 113.89,

114.89, and 114.100(c)); to report any

instance of potential health-endangering

spoilage, process deviation, or

contamination with microorganisms

where any lot of the food has entered

distribution in commerce (§§ 108.25(d)

and 108.35(d) and (e)); and to develop

and keep on file plans for recalling

products that may endanger the public

health (§§ 108.25(e) and 108.35(f)). To

permit lots to be traced after

distribution, acidified foods and

thermally processed low-acid foods in

hermetically sealed containers must be

marked with an identifying code

(§§ 113.60(c) (thermally processed

foods), 114.80(b) (acidified foods)).

FDA estimates the burden of

complying with the information

collection provisions of the agency’s

regulations for acidified foods and

thermally processed low-acid foods in

hermetically sealed containers as

follows:

Estimated Annual Reporting Burden

Form No. CFR Section No. of Respondents

Annual Frequency per

Response

Total Annual

Responses

Hours Per

Response

Total

Hours

Form FDA 2541 (Registration) 108.25(c)(1) and

108.35(c)(1) 300 1 300 .17 51

Form FDA 2541a (Process Filing) 108.25(c)(2) and

108.35(c)(2) 1,000 6.5 6,500 .333 2,165

Form FDA 2541c (Process Filing) 108.35(c)(2) 1,000 .50 500 .75 375

113.60(c) ? ? ? ? ?

114.80(b) ? ? ? ? ?

Where question marks appear in the burden estimates, FDA does not have current information available. Public comments will be greatly appreciated.

Estimated Annual Recordkeeping Burden

21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping

Total Annual

Records

Hours Per Recordkeeper Total Hours

21 CFR Parts

108, 113, 114

5,388 1 5,388 250 1,347,000

There are no capital or operating and maintenance costs associated with this collection.

The reporting burden for §§ 108.25(d)

and 108.35(d) and (e) isinsignificant

because notification of spoilage, process

deviation, or contamination of product

in distribution occurs less than once a

year. Most firms discover these

problems before the product is

distributed and, therefore, are not

required to report the occurrence. To

avoid double-counting, estimates for

§§ 108.25(g) and 108.35(h) have not

been included because they merely

cross-reference recordkeeping

requirements contained in parts 113 and

114.

Dated: May 1, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–11515 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96F–0139]

Bio-Cide International, Inc.; Filing of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Bio-Cide International, Inc., has

filed a petition proposing that the food

additive regulations be amended to

provide for the safe use of acidified

sodium chlorite solutions in processing

water and ice which directly contact

seafood such as finfish, shellfish, and

crustaceans for the control of naturally

occurring spoilage microorganisms to

increase shelf life and to enhance

seafood product freshness.

DATES: Written comments on the

petitioner’s environmental assessment

by June 10, 1996.

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:

Robert L. Martin, Center for Food Safety

and Applied Nutrition (HFS–217), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204–0001, 202–418–

3074.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

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

notice is given that a food additive

petition (FAP 6A4499) has been filed by

Bio-Cide International, Inc., 2845 Broce

Dr., Norman, OK 73072. The petition

proposes to amend the food additive

regulations in part 173 Secondary Direct

Food Additives Permitted in Food for

Human Consumption (21 CFR part 173)

to provide for the safe use of acidified

sodium chlorite solutions in processing

water and ice which directly contact

seafood such as finfish, shellfish, and

crustaceans for the control of naturally

occurring spoilage microorganisms to

increase shelf life and to enhance