Federal Register / Vol. 61, No. 105 / Thursday, May 30, 1996 / Notices 27083

Estimated Total Annual Burden

Hours: 4,575.

In compliance with the requirements

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

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, SW., Washington, DC.

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by title.

In addition, requests for copies may

be made and comments forwarded to

the Reports Clearance Office over the

Internet by sending message to

rsargis@acf.dhhs.gov. Internet message

must be submitted as an ASCII file

without special characters or

encryption.

The Department specifically requests

comments on: (a) Whether the proposed

collection of information is necessary

for the proper performance of the

function of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

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

of other forms of information

technology. Consideration will be given

to comments and suggestions submitted

within 60 days of this publication.

Dated: May 23, 1996.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 96–13526 Filed 5–29–96; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

[Docket No. 96N–0122]

Agency Information Collection

Activities: Proposed Collections;

Comment Request; Extension/

Reinstatement

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

a notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension or reinstatement 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 requirements

contained in existing FDA regulations

governing temporary marketing permit

applications, State petitions for

exemption from preemption, State

enforcement notifications, and reference

amount petitions.

DATES: Submit written comments on the

collections of information by July 29,

1996.

ADDRESSES: Submit written comments

on the collections 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 or

reinstatement 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

collections of information listed below.

With respect to each of the following

collections 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.

1. Temporary Marketing Permit

Applications (21 CFR 130.17(c) and (i))

(OMB Control Number 0910–0133—

Extension)

Section 401 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

341) directs FDA to issue regulations

establishing definitions and standards of

identity for food ‘‘whenever * * * such

action will promote honesty and fair

dealing in the interest of consumers.’’

Under section 403(g) of the act (21

U.S.C. 343(g)), a food that is subject to

a definition and standard of identity

prescribed by regulation is misbranded

if it does not conform to such definition

and standard of identity. Section 130.17

(21 CFR 130.17) provides for the

issuance by FDA of temporary

marketing permits that enable the food

industry to test consumer acceptance

and measure the technological and

commercial feasibility in interstate

commerce of experimental packs of food

that deviate from applicable definitions

and standards of identity. Section

130.17(c) specifies the information that

a firm must submit to FDA to obtain a

temporary marketing permit. The

information required in a temporary

marketing permit application under

§ 130.17(c) enables the agency to

monitor the manufacture, labeling, and

distribution of experimental packs of

food that deviate from applicable

definitions or standards of identity. The

information so obtained can be used in

support of a petition to establish or

amend the applicable definition or

standard of identity to provide for the

variations. Section 130.17(i) specifies

the information that a firm must submit

to FDA to obtain an extension of a

temporary marketing permit.

FDA estimates the burden of the

temporary marketing permit application

requirements as follows:
27084 Federal Register / Vol. 61, No. 105 / Thursday, May 30, 1996 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of Respondents Annual Frequency per Response

Total Annual Responses Hours per Response Total Hours

130.17 15 1.33 20 11.5 230

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

The estimated number of temporary

marketing permit applications and

hours per response is an average based

on the agency’s experience with

applications received from October 30,

1991, through September 30, 1994.

2. State Petitions for Exemption From

Preemption (21 CFR 100.1(d)) (OMB

Control Number 0910–0277—

Reinstatement)

Under section 403A(b) of the act (21

U.S.C. 343–1(b)), States may petition

FDA for exemption from Federal

preemption of State food labeling and

standard of identity requirements.

Section 100.1(d) (21 CFR 100.1(d)) sets

forth the information a State is required

to submit in such a petition. The

information required under § 100.1(d)

enables FDA to determine whether the

State food labeling or standard of

identity requirement comports with the

statutory criteria for exemption from

Federal preemption.

FDA estimates the burden resulting

from the requirements of § 100.1(d) as

follows:

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of Respondents Annual Frequency per Response

Total Annual Responses Hours per Response Total Hours

100.1(d) 5 1 5 40 200

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

Since the enactment of section

403A(b) of the act as part of the

Nutrition Labeling and Education Act of

1990 (the 1990 amendments), FDA has

received eight petitions for exemption

from preemption. Based upon these

submissions, FDA estimates that no

more than five petitions will be

submitted annually. Because § 100.1(d)

implements a statutory information

collection requirement, only the

additional burden attributable to the

regulation has been included in the

estimate.

3. State Enforcement Notification (21

CFR 100.2(d)) (OMB Control Number

0910–0275—Reinstatement)

Section 310(b) of the act (21 U.S.C.

337(b)) authorizes States to enforce

certain sections of the act in their own

names, but provides that States must

notify FDA before doing so. Section

100.2(d) (21 CFR 100.2(d)) sets forth the

information that a State must provide to

FDA in a letter of notification when it

intends to take enforcement action

under the act against a particular food

located in the State. The information

required under § 100.2(d) will enable

FDA to identify the food against which

the State intends to take action and

advise the State whether Federal action

has been taken against it. With certain

narrow exceptions, Federal enforcement

action precludes State action under the

act.

FDA estimates the burden of

complying with the enforcement

notification requirement as follows:

TABLE 3.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of Respondents Annual Frequency per Response

Total Annual Responses Hours per Response Total Hours

100.2(d) 5 1 5 2 10

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

Based upon the small number of

enforcement notifications received from

the States since the enactment of section

310(b) of the act in 1990, FDA estimates

that no more than five notifications will

be submitted annually. Because 21 CFR

100.21(d) implements a statutory

information collection requirement,

only the additional burden attributable

to the regulation has been included in

the estimate.

4. Reference Amount Petitions (21 CFR

101.12(h)) (OMB Control Number 0910–

0286—Reinstatement)

Section 403(q)(1)(A) of the act (21

U.S.C. 343(q)(1)(A)) requires that the

label or labeling of food provide

nutrition information that includes the

serving size or, if the food is not

typically expressed in a serving size, the

common household unit of measure that

expresses the serving size of the food. In

response to section 2(b)(1)(B) of the

1990 amendments, FDA issued

regulations defining the serving size (or

other unit of measure) for various types

of food. Food producers are required to

use the reference amount values

provided in § 101.12 (21 CFR 101.12)

and the rules for establishing serving

sizes that are prescribed in § 101.9(b)

(21 CFR 101.9(b)) to determine the

appropriate serving size for their

products; however, a manufacturer or

other interested person may submit a

petition to establish or amend the

reference amount value for a food or to

create a new food subcategory with its

own reference amount. Section

101.12(h) sets forth the information the
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