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
Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Notices 12653

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: March 6, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–6590 Filed 3–14–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Privacy Act of 1974; Altered System of

Records

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notification of an altered system

of records.

SUMMARY: In accordance with the

requirements of the Privacy Act, the

Health Resources and Services

Administration (HRSA) is publishing

notice of a proposal to add a new

category of records to 09–15–0054, the

National Practitioner Data Bank for

Adverse Information on Physicians and

Other Health Care Practitioners, HHS/

HRSA/BHPr. HRSA proposes to add

specific information already available to

the public from the Health Care

Financing Administration (HCFA) on

physicians, practitioners, providers, and

other health care entities which the

Office of Inspector General (OIG), HHS

has excluded from participation in and

from recovering payment from the

Medicare and Medicaid programs.

DATES: HRSA invites interested parties

to submit comments on the proposed

internal and routine use of this

information on or before April 28, 1997.

HRSA has sent a Report of Altered

System to the Congress and to the Office

of Management and Budget (OMB) on

March 3, 1997. The alteration to the

system will be effective 40 days from

the date submitted to OMB unless

HRSA receives comments which would

result in a contrary determination.

ADDRESSEES: Please address comments

on the altered system of records to the

Health Resources and Services

Administration (HRSA) Privacy Act

Officer, Department of Health and

Human Services, 5600 Fishers Lane,

Room 14A–20, Rockville, Maryland

20857, telephone (301) 443–3780. This

is not a toll-free number.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Quality Assurance,

BHPr/HRSA. Room 8A–55, Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland, telephone (301) 443–2300.

This is not a toll-free number.

SUPPLEMENTARY INFORMATION: The Office

of the Inspector General, HHS, has the

authority to exclude individuals/entities

from participating in the Medicare and/

or certain State health care plans under

sections 1128(a), 1128(b), 1892, or 1156

of the Social Security Act. The

exclusion also applies to all other

Executive Branch procurement and nonprocurement programs and activities.

Disclosure of the OIG Exclusion List to

HRSA is under authority of section

1106(a) of the Social Security Act, 42

CFR 401.105, and routine use exception

of the Privacy Act (5 U.S.C. 522a(b)(3)).

HCFA is authorized to provide certain

specific information on physicians,

practitioners, providers, and health care

entities which OIG has excluded from

participation in and from recovering

payment from the Medicare and

Medicaid programs. HCFA will retain

full responsibility for the content and

accuracy of HCFA Exclusion reports; the

Data Bank will only act as a disclosure

service. Notification of exclusion from

HCFA programs is made by HCFA.

Inquiries on the appropriateness or

content of HCFA Exclusion Reports will

be referred to HCFA for response. The

National Practitioner Data Bank (Data

Bank) will disclose such information to

authorized health care industry queriers

on request, using the Data Bank’s fully

automated and secure systems and

procedures.

Editorial changes have been made

throughout the system to enhance

clarity and specificity and to

accommodate normal updating changes.

The following notice is written in the

present, rather than the future tense, to

avoid the unnecessary expenditure of

public funds to republish the notice

after the routine use has become

effective.

Dated: March 3, 1997.

Ciro V. Sumaya,

Administrator.

09–15–0054

SYSTEM NAME:

National Practitioner Data Bank for

Adverse Information on Physicians and

Other Health Care Practitioners, HHS/

HRSA/BHPr.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

The SRA Corporation (the Contractor)

operates the National Practitioner Data

Bank (Data Bank) under contract with

the Bureau of Health Professions (BHPr),

Health Resources and Services

Administration (HRSA). Records are

located at the following address:

National Practitioner Data Bank, PO Box

10832, Chantilly, VA 20151. For

security reasons, the street address

cannot be disclosed.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Health care practitioners including

physicians, dentists, and all other health

care practitioners (such as nurses,

optometrists, pharmacists, and

podiatrists), licensed or otherwise

authorized by a State to provide health

care services, on whose behalf a

payment has been made as a result of a

malpractice action or claim; physicians

and dentists who are the subject of

licensure disciplinary actions; and

physicians, dentists and other health

care practitioners who are on medical

staffs or who hold clinical privileges, or

who are members of professional

societies, against whom certain adverse

actions have been taken as a result of a

professional review action.

CATEGORIES OF RECORDS IN THE SYSTEM:

1. For malpractice payments.

Information on the physician, dentist or

other licensed health care practitioner

such as name; work address; home

address, if known; Social Security

number, if known, and obtained in

accordance with section 7 of the Privacy

Act of 1974; date of birth; name of each

professional school attended and year of

graduation; for each professional

license: The license number, the field of

licensure, and the name of the State or

Territory in which the license is held;

Drug Enforcement Administration

registration number(s), if known; and

name of each hospital with which the

practitioner is affiliated, if known.

Information on the person or entity

making the payment, such as the name

and address of the person or entity

making the payment; and the name,

title, and telephone number of the

responsible official submitting the

report on behalf of the entity.

Information on the payments, such as

the date of the occurrence of the acts or

omissions upon which the action or

claim was based occurred; date and

amount of payment; description of the