Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices 62869

verified the applicant’s claim that the

new drug application (NDA) for

VALTREX (NDA 20–487) was initially

submitted on June 23, 1994.

3. The date the human drug was

approved: June 23, 1995. FDA has

verified the applicant’s claim that NDA

20–487 was approved on June 23, 1995.

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 1,052 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before February 5, 1996, 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 June 5, 1996, for a

determination regarding whether the

applicant for extension acted with due

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: November 30, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–29809 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0302]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; ULTANETM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

ULTANETM 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,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brain 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 ULTANETM

(sevoflurane). ULTANETM is indicated

for induction and maintenance of

general anesthesia in adult and pediatric

patients for inpatient and outpatient

surgery. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for ULTANETM (U.S. Patent

No. 4,250,334) from Baxter

International, 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 September 25, 1995, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of ULTANETM

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

ULTANETM is 3,418 days. Of this time,

3,086 days occurred during the testing

phase of the regulatory review period,

while 332 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: January 29, 1986. The

applicant claims January 10, 1986, as

the date the investigational new drug

(IND) became effective. However, FDA

records indicate that the correct IND

effective date was January 29, 1985,

which was 30 days after FDA receipt of

IND 27,645 on December 30, 1985.

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: July 11, 1994. The

applicant claims July 8, 1994, as the

date the new drug application (NDA) for

ULTANETM (NDA 20–478) was initially

submitted. However, FDA records

indicate that the applicant submitted

NDA 20–478 on July 8, 1994, and the

agency received the NDA on July 11,

1994, which is considered to be the

NDA initially submitted date.

3. The date the application was

approved: June 7, 1995. FDA has

verified the applicant’s claim that NDA

20–478 was approved on June 7, 1995.

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 1,826 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before February 5, 1996, submit to

the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,
62870 Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices

any interested person may petition FDA,

on or before June 5, 1996, for a

determination regarding whether the

applicant for extension acted with due

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: November 30, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–29808 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Agency Forms Undergoing Paperwork

Reduction Act Review

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301)–443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Health Education Assistance Loan

(HEAL) Program Physician’s

Certification of Borrower’s Total and

Permanent Disability Form—New—This

form, completed by the HEAL borrower,

the borrower’s physician, and the holder

of the loan, is used to certify that the

HEAL borrower meets the total and

permanent disability provisions. The

PHS will use this form to obtain precise

information about the disability claim

which includes the following: (1) The

borrower’s consent to release medical

records to the Department of Health and

Human Services and to the holder of the

borrower’s HEAL loans, (2) pertinent

information supplied by the certifying

physician, (3) the physician’s

certification that the borrower is unable

to engage in any substantial gainful

activity because of a medically

determinable impairment that is

expected to continue for a long and

indefinite period of time or to result in

death, and (4) information from the

lender on the unpaid balance. Failure to

submit the required documentation will

result in a disability claim not being

honored.

Type of respondent Number of

respondents

Responses

per respondent

Average

burden per

response

Total burden (hours)

Borrower ................................................................................................................................. 42 1.0 0.08 3

Physician ................................................................................................................................ 42 1.0 2.75 116

Lender .................................................................................................................................... 35 1.2 0.17 7

Estimated Total Annual Burden: 126 hours.

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Allison Eydt, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Dated: December 1, 1995.

J. Henry Montes,

Associate Administrator for Policy

Coordination

[FR Doc. 95–29810 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

HHS.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by an agency of the U.S.

Government and are available for

licensing in the U.S. in accordance with

36 U.S.C. 207 or pursuant to 42 U.S.C.

241 to achieve expeditious

commercialization of results of

federally-funded research and

development.

ADDRESSES: Licensing information for

the technologies referenced below may

be obtained by contacting Stephen

Finley, Ph.D., at the Office of

Technology Transfer, National Institutes

of Health, 6011 Executive Boulevard,

Suite 325, Rockville, Maryland 20852–

3804 (telephone 301/496–7056 ext 215;

fax 301/402–0220).

cDNA Sequence of a Clone Encoding

Arylalkylamine N-acetyltransferase

Klein et al. (NICHD)

[DHHS Reference No. E–161–95/0]

and

Human Gene Encoding Serotonin Nacetyltransferase

Klein et al. (NICHD)

[DHHS Reference No. E–222–95/0]

The identification of an

arylalkylamine N-acetyltransferase (AA–

NAT) mRNA in the brain and the

cloning of ovine and human cDNAs

encoding for the pineal enzyme

serotonin N-acetyltransferase. These

findings open a new area of research—

the importance of AA–NAT in the

regulation of brain serotonin and the

development of drugs which raise

serotonin levels by inhibiting this

enzyme. This enzyme is the ratecontrolling step in the conversion of

serotonin to melatonin. The hormone

melatonin has been linked to controlling

circadian rhythms. Development of

regulators of the synthesis of the

hormone melatonin may be the

preferred route to controlling seasonal

reproduction cycles or sleep cycles of

vertebrates. Activators of the serotonin

N-acetyltransferase may be beneficial to

induce or enhance the quality of sleep

at night. Inhibitors of serotonin Nacetyltransferase may lead to drugs that

stimulate the levels of alertness and

physical activity or delay the onset of

fatigue. Licenses for the cDNAs

encoding for this enzyme or the

production of the enzyme are available.