13388 Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Notices

CEREBYX is 3,748 days. Of this time,

3,218 days occurred during the testing

phase of the regulatory review period,

while 530 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: May 4, 1986. FDA has

verified the applicant’s claim that the

date that the investigational new drug

application became effective was on

May 4, 1986.

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: February 23, 1995. The

applicant claims July 14, 1994, as the

date the new drug application (NDA) for

CEREBYX (NDA 20–450) was initially

submitted. However, FDA records

indicate that NDA 20–450, received by

the agency on July 15, 1994, was

incomplete. FDA refused this

application and notified the applicant of

this fact by letter dated September 12,

1994. The completed NDA was then

received on February 23, 1995, which is

considered to be the NDA initially

submitted date.

3. The date the application was

approved: August 5, 1996. FDA has

verified the applicant’s claim that NDA

20–450 was approved on August 5,

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 1,826 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before May 20, 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 22, 1997, 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: March 12, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–6976 Filed 3–19–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0440]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; HYCAMTINTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

HYCAMTINTM 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 HYCAMTINTM

(topotecan hydrochloride).

HYCAMTINTM is indicated for the

treatment of patients with metastatic

carcinoma of the ovary after failure of

initial or subsequent chemotherapy.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

HYCAMTINTM (U.S. Patent No.

5,004,758) from SmithKline Beecham

Corp. 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 HYCAMTINTM 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

HYCAMTINTM is 2,644 days. Of this

time, 2,485 days occurred during the

testing phase of the regulatory review

period, while 159 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: March 4, 1989. The

applicant claims January 30, 1989, as

the date the investigational new drug

application (IND) for HYCAMTINTM

(IND 32,693) became effective. However,

FDA records indicate that IND 32,693

was received at FDA on February 2,

1989, and became effective 30 days later

on March 4, 1989.

2. The date the application was

initially submitted with respect to the

human drug product under section
Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Notices 13389

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

Cosmetic Act: December 22, 1995. The

applicant claims December 21, 1995, as

the date the new drug application

(NDA) for HYCAMTINTM (NDA 20–671)

was initially submitted. However, FDA

records indicate that NDA 20–671 was

submitted on December 22, 1995.

3. The date the application was

approved: May 28, 1996. FDA has

verified the applicant’s claim that NDA

20–671 was approved on May 28, 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 572 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before May 20, 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 22, 1997, 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: March 12, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–6977 Filed 3–19–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[HCFA 1728 and HCFA 9049]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

1. Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Home Health

Agency Cost Report; Form No.: HCFA–

1728; Use: The HCFA 1728 is the form

used by Home Health Agencies to report

their health care costs to determine the

amount reimbursable for services

furnished to Medicare beneficiaries.

Frequency: Annually; Affected Public:

Business or other for profit, Not for

profit institutions, and State, Local or

Tribal Gov.; Number of Respondents:

8,950; Total Annual Hours: 1,575,200.

2. Type of Information Collection

Request: Reinstatement, with change, of

a previously approved collection for

which approval has expired; Title of

Information Collection: Information on

Provider Refunds—HCFA 9049, 42 CFR

489.40–41; Form No.: HCFA–9049; Use:

When a Medicare claim is denied and

then paid as a result of a

reconsideration, there is a possibility

that the provider has already been paid

by the beneficiary. These questions on

provider refunds will be used on

intermediary forms to verify that the

provider has refunded the beneficiary’s

money. Frequency: On occasion;

Affected Public: Business or other for

profit; Number of Respondents: 4,236;

Total Annual Hours: 1,059.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Financial and Human

Resources, Management Analysis and

Planning Staff, Attention: Louis Blank,

Room C2–26–17, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: March 13, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources.

[FR Doc. 97–7085 Filed 3–19–97; 8:45 am]

BILLING CODE 4120–03–P

Public Health Service

Centers for Disease Control and

Prevention; Statement of Organization,

Functions, and Delegations of

Authority

Part C (Centers for Disease Control

and Prevention) of the Statement of

Organization, Functions, and

Delegations of Authority of the

Department of Health and Human

Services (45 FR 67772–76, dated

October 14, 1980, and corrected at 45 FR

69296, October 20, 1980, as amended

most recently at 61 FR 49785–49787,

dated September 23, 1996) is amended

to retitle the Office of Health

Communication (OHC), National Center

for Injury Prevention and Control

(NCIPC), to the Office of

Communication Resources, and revise

the functional statement.

Delete the title and functional

statement for the Office of Health

Communication (CE14) and insert the

following:

Office of Communication Resources

(EC14). (1) Plans, develops, coordinates,

and evaluates NCIPC’s, publications,

graphics, and technical information

activities for intentional injury,

unintentional injury, and acute care and

rehabilitation; (2) disseminates injury

control information to public and

professional audiences; (3) in

conjunction with the CDC Office of

Public Affairs, interacts with the news

media to ensure that injury topics are

covered accurately and remain high on

the public agenda; (4) provides expert

consultation on the effective use and

design of graphic materials for

presentations, publications, and

exhibits; (5) designs and produces

professional quality graphic materials

for use in NCIPC presentations and

publications and designs and

electronically typesets publications; (6)

develops, maintains, and manages a

graphics information retrieval system

that allows ready access to slides and

graphic presentations on injury topics;