Federal Register / Vol. 61, No. 105 / Thursday, May 30, 1996 / Notices 27085

petitioner is required to include in the

petition.

FDA estimates the burden resulting

from the requirements of § 101.12(h) as

follows:

TABLE 4.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of Respondents Annual Frequency per

Response

Total Annual Responses Hours per Response Total Hours

Total Operating

& Maintenance

Costs

101.12(h) 5 1 5 80 400 $400,000

There are no capital costs associated with this collection.

Since the enactment of the 1990

amendments that revised the act by

adding section 403(q), FDA has received

nine petitions to amend existing

reference amounts. Based upon these

submissions, FDA estimates that no

more than five such petitions will be

submitted annually. The estimate for

operating and maintenance costs is

based on the average cost of conducting

a consumer survey to support a

reference amount petition.

Dated: May 22, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13536 Filed 5–29–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96F–0164]

Asahi Denka Kogyo K.K.; Filing of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Asahi Denka Kogyo K.K. has filed

a petition proposing that the food

additive regulations be amended to

provide for the safe use of sodium 2,2’-

methylenebis(4,6-di-tertbutylphenyl)phosphate as a clarifying

agent in high density polyethylene

intended for use in contact with food.

DATES: Written comments on the

petitioner’s environmental assessment

by July 1, 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: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–216), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

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 6B4504) has been filed by

Asahi Denka Kogyo K.K., 2–13

Shirahata 5–Chome, Urawa City,

Saitama 336, Japan. The petition

proposes to amend the food additive

regulations in § 178.3295 Clarifying

agents for polymers (21 CFR 178.3295)

to provide for the safe use of sodium

2,2’-methylenebis(4,6-di-tertbutylphenyl)phosphate as a clarifying

agent in high density polyethylene

intended for use in contact with food.

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

display at the Dockets Management

Branch (address above) for public

review and comment. Interested persons

may, on or before July 1, 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: May 14, 1996.

George H. Pauli,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–13464 Filed 5–29–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0385]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; PRECOSETM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

PRECOSETM and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis