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
21194 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Notices

seafood product freshness.The potential

environmental impact of this action is

being reviewed. To encourage public

participation consistent with regulations

promulgated under the National

Environmental Policy Act (40 CFR

1501.4(b)), the agency is placing the

environmental assessment submitted

with the petition that is the subject of

this notice on public display at the

Dockets Management Branch (address

above) for public review and comment.

Interested persons may, on or before

June 10, 1996, submit to the Dockets

Management Branch (address above)

written comments. 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 brackets in the

heading of this document. Received

comments may be seen in the office

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

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: April 22, 1996.

George H. Pauli,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–11512 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 92F–0219]

Transcommerz AG; Withdrawal of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 2B4325), filed by Transcommerz

AG, proposing that the food additive

regulations be amended to provide for

the safe use of α-hydro-ω-hydroxypoly-

(oxytetramethylene), diphenylmethane

diisocyanate, 1,4-butanediol,

ethylenediamine, 1,3-

benzenedimethanamine,

diethanolamine, and 1,3,5-tris(4-tertbutyl-3-hyroxy-2,6-dimethylbenzyl)-

1,3,5-triazine-2,4,6-(1H,3H,5H)trione as

components of a polyurethane

elastomer; and dimethyl-polysiloxane,

α-(ρ-nonylphenyl)-ωhydroxypoly(oxyethylene), and parrafin

oil as components of sizing and

finishing oils for the polyurethane

elastomer in food-contact articles used

in the processing and packaging of food,

including meat and poultry.

FOR FURTHER INFORMATION CONTACT:

Andrew J. Zajac, Center for Food Safety

and Applied Nutrition (HFS–216), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3095.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 9, 1992 (57 FR 30496), FDA

announced that a food additive petition

(FAP 2B4325) had been filed by

Transcommerz AG, c/o 7300 West

Camino Real, Boca Raton, FL 33433.

The petition proposed to amend the

food additive regulations to provide for

the safe use of α-hydro-ω-hydroxypoly-

(oxytetramethylene), diphenylmethane

diisocyanate, 1,4-butanediol,

ethylenediamine, 1,3-

benzenedimethanamine,

diethanolamine, and 1,3,5-tris(4-tertbutyl-3-hyroxy-2,6-dimethylbenzyl)-

1,3,5-triazine-2,4,6-(1H,3H,5H)trione as

components of a polyurethane

elastomer; and dimethyl-polysiloxane,

α-(ρ-nonylphenyl)-ωhydroxypoly(oxyethylene), and parrafin

oil as components of sizing and

finishing oils for the polyurethane

elastomer in food-contact articles used

in the processing and packaging of food,

including meat and poultry.

Transcommerz AG has now withdrawn

the petition without prejudice to a

future filing (21 CFR 171.7).

Dated: April 23, 1996.

Eugene C. Coleman,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–11513 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95S–0181]

U.S.–European Union Mutual

Recognition Agreement Activities;

Pharmaceutical GMP’s and Medical

Devices; Establishment of a Public

Docket

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

establishment of a public docket

through which it will make available

information concerning its participation

in bilateral Mutual Recognition

Agreement (MRA) talks in the areas of

pharmaceutical GMP’s and medical

devices being led by the Office of the

U.S. Trade Representative (USTR) and

the Department of Commerce (DOC) and

by representatives of the European

Commission.

ADDRESSES: Documents concerning

FDA’s bilateral MRA talks are available

for public examination in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857, between 9 a.m. and 4 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Walter M. Batts, Office of International

Affairs (HFY–50), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–4480.

SUPPLEMENTARY INFORMATION: The U.S.

Government, led by USTR and DOC, is

engaged in formal talks with the

European Union (EU), led by

Directorate-General I (External

Relations) of the European Commission.

The EU initiated these talks to facilitate

access to foreign markets for their

products and to facilitate access to the

EU market for foreign products. The EU

indicated that the latter purpose was in

response to concerns raised by foreign

countries, including the United States,

that the ‘‘Single Internal Market by

1992’’ program would result in a

‘‘fortress Europe’’ that would

disadvantage foreign firms. The EU is

also pursuing separate MRA talks with

other countries, including Canada,

Australia, and Japan.

As a result of an EU request to

identify products to be covered by the

MRA talks and their proposal that

pharmaceuticals and medical devices be

included, the U.S. Government with

support by the industry agreed that

pharmaceuticals, GMP’s, and medical

devices should be among those areas

included in the talks. FDA’s discussions

with the EU cover GMP’s for human and

animal drugs, human biologicals, and

medical devices.

In 1989, prior to the initiation of the

MRA talks by Directorate-General I,

USTR, and DOC, FDA and DirectorateGeneral III (Industrial Affairs) of the

European Commission decided to begin

discussions that may lead to an

agreement in the pharmaceutical good

manufacturing practices (GMP’s) and

medical devices area. FDA’s primary

motivation in seeking such an

agreement was at that time, and still is,

a desire to most effectively utilize

limited resources. FDA recognized the