9194 Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices

Opportunity Reconciliation Act of 1996,

Federal law mandate that all States

enact UIFSA by January 1, 1998. The

standard interstate forms in this

information collection will assist the

States in making the transition from

URESA to UIFSA.

Respondents: State governments,

Guam, Virgin Islands, Puerto Rico and

the District of Columbia.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average burden hours

per response

Total burden

hours

Transmittal No. 1 .......................................................................................... 54 11,947 25 minutes ................. 268,805.4

Transmittal No. 2 .......................................................................................... 54 2,987 5 minutes ................... 13,440.2

Transmittal No. 3 .......................................................................................... 54 597 10 minutes ................. 5,376.1

Uniform Petition ............................................................................................ 54 5,973.5 7 minutes ................... 37,632.8

General Testimony ....................................................................................... 54 7,168 20 minutes ................. 129,026.6

Affidavit/Paternity .......................................................................................... 54 2,987 15 minutes ................. 40,320.8

Locate Data Sheet ........................................................................................ 54 358 5 minutes ................... 1,612.8

Notice/Cntrl Order ......................................................................................... 54 8,960 10 minutes ................. 80,641.7

Registration Statement ................................................................................. 54 7,885 10 minutes ................. 70,964.6

Estimated Total Annual Burden Hours: 647,821.

Additional Information

Copies of the proposed collection may

be obtained by writing to The

Administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer.

OMB Comment

OMB is required to make a decision

concerning the collection of information

between 30 and 60 days after

publication of this document in the

Federal Register. Therefore, a comment

is best assured of having its full effect

if OMB receives it within 30 days of

publication. Written comments and

recommendations for the proposed

information collection should be sent

directly to the following: Office of

Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Wendy Taylor.

Dated: February 24, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–4953 Filed 2–27–97; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

[Docket No. 97N–0040]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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 and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

a survey of the food safety practices of

food processors.

DATES: Submit written comments on the

collection of information by April 29,

1997.

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:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

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.

‘‘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.

Survey of Food Safety Practices of Food

Processing Firms—New Collection

FDA is evaluating the marginal costs

of requiring food processors to use

Hazard Analysis and Critical Control

Point (HACCP) systems. HACCP is

already required for seafood processors,

and FDA is considering whether to issue

regulations requiring HACCP for

processors of other foods under the

agency’s jurisdiction. The analysis of

marginal costs requires information

about the prevalence of specific HACCP

systems and practices among food

manufacturers and repackers. FDA will

collect this information through an

anonymous voluntary survey of a

random sample of food processors.

Additionally, through a series of on-site

visits to selected processors, a

contractor will collect information on

the marginal cost of various procedures

required to operate a HACCP system.

The information will help the Center for

Food Safety and Applied Nutrition

determine the baseline level of HACCP
Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices 9195

use from which to estimate the

economic costs to the industry of

mandatory HACCP regulations for foods

other than seafood. FDA will use this

information in tailoring any HACCP

regulations that may issue so that costs

and benefits of such regulations are

appropriately considered.

FDA estimates the burden of this

survey as follows:

ESTIMATED ANNUAL REPORTING BURDEN

Burden Element No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Part 1—Computer Assisted Telephone Interview

(CATI)

Respond to initial recruitment telephone call 1,231 1 1,231 0.2 246.2

Receive and read introductory letter, key term

definitions 1,231 1 1,231 0.25 307.75

Obtain data to prepare for the telephone interview 1,231 1 1,231 0.35 430.85

Respond to telephone interview 1,231 1 1,231 0.5 615.50

Totals 1 1,600.3

Part 2—On-Site Cost Interview

Receive initial recruitment telephone call 17 1 17 0.2 3.4

Receive and read introductory letter and materials 17 1 17 0.25 4.25

Obtain data to prepare for the site visit 17 1 17 0.5 8.5

Respond to questions during site visit 17 1 17 3.0 51.0

Followup questions 17 1 17 0.25 4.25

Total burden hours, on-site interviews 71.4

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

The total burden hours for Part 1—

CATI and Part 2—On-Site Cost

Interview are 1,671.7.

The burden hour estimates are based

on a pretest conducted with three focus

groups.

Dated: February 20, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4955 Filed 2–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0269]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; EXCENEL Sterile

Suspension

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

EXCENEL Sterile Suspension 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 animal 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

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For animal drug

products, the testing phase begins on

the earlier date when either a major

environmental effects test was initiated

for the drug or when an exemption

under section 512(j) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C.

360b(j)) became effective and runs until

the approval phase begins. The approval

phase starts with the initial submission

of an application to market the animal

drug product and continues until FDA

grants permission to market the drug

product. Although only a portion of a

regulatory review period may count

toward the actual amount of extension

that the Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

an animal drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(4)(B).

FDA recently approved for marketing

the animal drug product EXCENEL

Sterile Suspension (ceftiofur

hydrochloride). EXCENEL Sterile

Suspension is indicated for the

treatment and control of swine bacterial

respiratory disease (swine bacterial

pneumonia) associated with

Actinobacillus (Haemophilus)

pleuropneumoniae, Pastureruella

multocida, Salmonella choleraesuis,

and Streptococcus suis Type 2.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

EXCENEL Sterile Suspension (U.S.

Patent No. 4,902,683) from Pharmacia &

Upjohn Co. and requested FDA’s

assistance in determining the patent’s

eligibility for patent term restoration. In

a letter dated November 21, 1996, FDA

advised the Patent and Trademark

Office that this animal drug product had

undergone a regulatory review period

and that the approval of EXCENEL

Sterile Suspension represented the first