Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Notices 12651

Services, 370 L’Enfant Promenade SW.,

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: March 12, 1997.

Bob Sargis,

Acting Reports Clearnce Officer.

[FR Doc. 97–6610 Filed 3–14–97; 8:45 am]

BILLING CODE 4184–01–M

Office of Community Services

State Median Income Estimates for

Four-Person Families (FY 1998); Notice

of the Fiscal Year (FY) 1998 State

Median Income Estimates for Use

Under the Low Income Home Energy

Assistance Program (LIHEAP)

Administered by the Administration for

Children and Families, Office of

Community Services, Division of

Energy Assistance

AGENCY: Administration for Children

and Families (ACF), DHHS.

ACTION: Notice of estimated state median

income for FY 1998.

SUMMARY: This notice announces the

estimated median income for fourperson families in each state and the

District of Columbia for FY 1998

(October 1, 1997 to September 30, 1998).

In the past, the date for adoption of the

state median income estimates has been

the first day of the fiscal year after their

publication. Beginning with the state

median income estimates for FY 1996,

the adoption date for the estimates was

changed to be consistent with the

adoption date for the poverty income

guidelines. Therefore, LIHEAP grantees

may adopt the state median income

estimates at any time between the date

of this publication and the first day of

FY 1998, at the LIHEAP grantee’s

option. This means that LIHEAP

grantees could also choose to implement

this notice during the period between

the heating and cooling seasons.

However, by October 1, 1997, or by the

beginning of a grantee’s fiscal year,

whichever is later, LIHEAP grantees

using state median income estimates

must adjust their income eligibility

criteria to be in accord with the FY 1998

state median income estimates.

This listing of estimated state median

incomes concerns maximum income

levels for households to which LIHEAP

grantees may make payments under

LIHEAP.

EFFECTIVE DATE: The estimates are

effective at any time between the date of

this publication and October 1, 1997, or

by the beginning of a LIHEAP grantee’s

fiscal year, whichever is later.

FOR FURTHER INFORMATION CONTACT:

Leon Litow, Administration for

Children and Families, HHS, Office of

Community Services, Division of Energy

Assistance, 5th Floor West, 370 L’Enfant

Promenade, SW., Washington, DC

20447; Telephone: (202) 401–5304;

Internet E-Mail: llitow@acf.dhhs.gov

SUPPLEMENTARY INFORMATION: Under the

provisions of section 2603(7) of Title

XXVI of the Omnibus Budget

Reconciliation Act of 1981 (Pub. L. 97–

35, as amended), we are announcing the

estimated median income of a fourperson family for each state, the District

of Columbia, and the United States for

FY 1998 (the period of October 1, 1997,

through September 30, 1998).

Section 2605(b)(2)(B)(ii) of the

LIHEAP statute provides that 60 percent

of the median income for each state, as

annually established by the Secretary of

Health and Human Services, is one of

the income criteria that LIHEAP

grantees may use in determining a

household’s eligibility for LIHEAP.

LIHEAP is currently authorized

through the end of FY 1999 by the

Human Services Amendments of 1994,

Public Law 103–252, which was enacted

on May 18, 1994.

Estimates of the median income of

four-person families for each state and

the District of Columbia for FY 1998

have been developed by the Bureau of

the Census of the U.S. Department of

Commerce, using the most recently

available income data. In developing the

median income estimates for FY 1998,

the Bureau of the Census used the

following three sources of data: (1) The

March 1996 Current Population Survey;

(2) the 1990 Decennial Census of

Population; and (3) 1995 per capita

personal income estimates, by state,

from the Bureau of Economic Analysis

of the U.S. Department of Commerce.

Like the estimates for FY 1997, the FY

1998 estimates include income

estimates from the March Current

Population Survey that are based on

population controls from the 1990

Decennial Census of Population.

Previous income estimates from the

March Current Population Survey had

been based on population controls from

the 1980 Decennial Census of

Population. Generally, the use of 1990

population controls results in somewhat

lower estimates of income.

For further information on the

estimating method and data sources,

contact Edward Welniak, Chief of the

Income Statistics Branch, Housing and

Household Economic Statistics

Division, at the Bureau of the Census

(301–763–8576).

A state-by-state listing of median

income, and 60 percent of median

income, for a four-person family for FY

1998 follows. The listing describes the

method for adjusting median income for

families of different sizes as specified in

regulations applicable to LIHEAP, at 45

CFR 96.85(b), which was published in

the Federal Register on March 3, 1988

at 53 FR 6824.

Dated: March 11, 1997.

Donald Sykes,

Director, Office of Community Services.

ESTIMATED STATE MEDIAN INCOME

FOR 4-PERSON FAMILIES, BY STATE,

FISCAL YEAR 1998 1

States

Estimated

state median income

4-person

families 2

60 percent

of estimated

state median income

4-person

families

Alabama ............ $42,617 $25,570

Alaska ............... 56,045 33,627

Arizona .............. 44,526 26,716

Arkansas ........... 38,520 23,112

California ........... 51,519 30,911

Colorado ............ 50,941 30,565

Connecticut ....... 62,157 37,294

Delaware ........... 54,519 32,711

District of Col .... 49,837 29,902

Florida ............... 44,626 26,776

Georgia ............. 48,850 29,310

Hawaii ............... 54,749 32,849

Idaho ................. 42,142 25,285

Illinois ................ 53,807 32,284

Indiana .............. 47,465 28,479

Iowa ................... 47,314 28,388

Kansas .............. 46,611 27,967

Kentucky ........... 40,587 24,352

Louisiana ........... 41,442 24,865

Maine ................ 45,507 27,304

Maryland ........... 60,239 36,143

Massachusetts .. 59,191 35,515

Michigan ............ 52,955 31,773

Minnesota .......... 54,396 32,638

Mississippi ......... 37,328 22,397

Missouri ............. 45,795 27,477

Montana ............ 42,987 25,792

Nebraska ........... 44,886 26,932

Nevada .............. 50,064 30,038

New Hampshire 54,492 32,695

New Jersey ....... 61,409 36,845

New Mexico ...... 37,365 22,419

New York .......... 50,672 30,403

North Carolina ... 47,367 28,420

North Dakota ..... 43,483 26,090

Ohio ................... 50,893 30,536
12652 Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Notices

ESTIMATED STATE MEDIAN INCOME

FOR 4-PERSON FAMILIES, BY STATE,

FISCAL YEAR 1998 1—Continued

States

Estimated

state median income

4-person

families 2

60 percent

of estimated

state median income

4-person

families

Oklahoma .......... 42,124 25,274

Oregon .............. 46,229 27,737

Pennsylvania ..... 50,884 30,530

Rhode Island ..... 51,362 30,817

South Carolina .. 44,048 26,429

South Dakota .... 42,269 25,361

Tennessee ........ 44,312 26,587

Texas ................ 43,977 26,386

Utah ................... 45,611 27,367

Vermont ............. 47,376 28,426

Virginia .............. 50,032 30,019

Washington ....... 51,415 30,849

West Virginia ..... 39,731 23,839

Wisconsin .......... 50,628 30,377

Wyoming ........... 45,925 27,555

Note—FY 1998 covers the period of October 1, 1997 through September 30, 1998. The

estimated median income for 4-person families

living in the United States is $49,687 for FY

1998. The estimates are effective for the Low

Income Home Energy Assistance Program

(LIHEAP) at any time between the date of this

publication and October 1, 1997, or by the beginning of a LIHEAP grantee’s fiscal year,

whichever is later. 1 In accordance with 45 CFR 96.85, each

state’s estimated median income for a 4-person family is multiplied by the following percentages to adjust for family size: 52% for one

person, 68% for two persons, 84% for three

persons, 100% for four persons, 116% for five

persons, and 132% for six persons. For family

sizes greater than six persons, add 3% to

132% for each additional family member and

multiply the new percentage by the state’s estimated median income for a 4-person family. 2Prepared by the Bureau of the Census

from the March 1996 Current Population Survey, 1990 Decennial Census of Population

and Housing, and 1995 per capita personal income estimates, by state, from the Bureau of

Economic Analysis.

[FR Doc. 97–6606 Filed 3–14–97; 8:45 am]

BILLING CODE 4184–01–P

Food and Drug Administration

[Docket No. 96E–0465]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; IVY BLOCKTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for IVY

BLOCKTM 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

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 human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human 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

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product IVY BLOCKTM

(bentoquatam). IVY BLOCKTM is

indicated to help protect against poison

ivy, poison oak, and poison sumac rash

when applied before exposure.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for IVY

BLOCKTM (U.S. Patent No. 4,861,584)

from United Catalysts, Inc., and the

Patent and Trademark Office requested

FDA’s assistance in determining this

patent’s eligibility for patent term

restoration. In a letter dated January 13,

1997, FDA advised the Patent and

Trademark Office that this human drug

product had undergone a regulatory

review period and that the approval of

IVY BLOCKTM represented the first

permitted commercial marketing or use

of the product. Shortly thereafter, the

Patent and Trademark Office requested

that FDA determine the product’s

regulatory review period.

FDA has determined that the

applicable regulatory review period for

IVY BLOCKTM is 2,644 days. Of this

time, 1,946 days occurred during the

testing phase of the regulatory review

period, while 698 days occurred during

the approval phase. These periods of

time were derived from the following

dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: June 2, 1989. The

applicant claims May 27, 1989, as the

date the investigational new drug

application (IND) for IVY BLOCKTM

(IND 33,133) became effective. However,

FDA records indicate that the effective

date for IND 33,133 was June 2, 1989,

which was 30 days after FDA receipt of

the IND on May 3, 1989.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: September 29, 1994. The

applicant claims September 28, 1994, as

the date the new drug application

(NDA) for IVY BLOCKTM (NDA 20–532)

was initially submitted. However, FDA

records indicate that NDA 20–532 was

submitted on September 29, 1994.

3. The date the application was

approved: August 26, 1996. FDA has

verified the applicant’s claim that NDA

20–532 was approved on August 26,

1996.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,825 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before May 16, 1997, submit to the

Dockets Management Branch (address

above) written comments and ask for a

redetermination. Furthermore, any

interested person may petition FDA, on

or before September 15, 1997, for a

determination regarding whether the

applicant for extension acted with due