Federal Register / Vol. 66, No. 9 / Friday, January 12, 2001 / Notices 2911

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that medical device.

ADDRESSES: Submit written comments

and petitions to the Dockets

Management Branch (HFA 305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Regulatory Policy

Staff (HFD–007), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–5645.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and

Patent Term Restoration Act (Public

Law 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 medical devices,

the testing phase begins with a clinical

investigation of the device and runs

until the approval phase begins. The

approval phase starts with the initial

submission of an application to market

the device and continues until

permission to market the device is

granted. 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 (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 medical device will include

all of the testing phase and approval

phase as specified in 35 U.S.C.

156(g)(3)(B).

FDA recently approved for marketing

the medical device Synvisc Hylan G–F

20 (5,099,013). Synvisc Hylan G–F 20

(5,099,013) is indicated for the

treatment of pain in osteoarthritis of the

knee in patients who have failed to

respond adequately to conservative

nonpharmacologic therapy and to

simple analgesics (e.g., acetaminophen).

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for Synvisc

Hylan G–F 20 (5,099,013) (U.S. Patent

No. 5,099,013) from Biomatrix, 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

December 11, 1998, FDA advised the

Patent and Trademark Office that this

medical device had undergone a

regulatory review period and that the

approval of Synvisc Hylan G–F 20

(5,099,013) 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

Synvisc Hylan G–F 20 (5,099,013) is

2,949 days. Of this time, 1,783 days

occurred during the testing phase of the

regulatory review period, while 1,166

days occurred during the approval

phase. These periods of time were

derived from the following dates:

1. The date a clinical investigation

involving this device was begun: July 14,

1989. FDA has verified the applicant’s

claim that the date the investigational

device exemption (IDE) required under

section 520(g) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360j(g)) for human tests to begin became

effective July 14, 1989.

2. The date the application was

initially submitted with respect to the

device under section 515 of the act (21

U.S.C. 360e): May 31, 1994. FDA has

verified the applicant’s claim that the

premarket approval application (PMA)

for Synvisc Hylan G–F 20 (5,099,013)

(PMA P940015) was initially submitted

May 31, 1994.

3. The date the application was

approved: August 8, 1997. FDA has

verified the applicant’s claim that PMA

P940015 was approved on August 8,

1997.

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 396 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may

submit to the Dockets Management

Branch (address above) written

comments and ask for a redetermination

by March 13, 2001. Furthermore, any

interested person may petition FDA for

a determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period by July 11, 2001. 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. Three

copies of any information are to be

submitted, except that individuals may

submit one copy. Comments are to be

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: December 20, 2000.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug

evaluation and Research.

[FR Doc. 01–974 Filed 1–11–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Anti-Infective Drugs Advisory

Committee; Amendment of Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

amendment to the notice of meeting of

the Anti-Infective Drugs Advisory

Committee. This meeting was

announced in the Federal Register of

December 27, 2000 (65 FR 81874). The

amendment is being made to cancel the

entire session on January 29, 2001. This

meeting will be open to the public.

There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Thomas H. Perez, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–6758, e-mail:

PerezT@cder.fda.gov, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12530.

Please call the Information Line for upto-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 27, 2000

(65 FR 81874), FDA announced that a

meeting of the Anti-Infective Drugs

Advisory Committee would be held on

January 29 and 30, 2001. On page

81874, beginning in the first column,

the Date and Time, Location, Agenda,

and Procedure portions of this meeting

are amended to read as follows:

2912 Federal Register / Vol. 66, No. 9 / Friday, January 12, 2001 / Notices

Date and Time: The meeting will be

held on January 30, 2001, 8 a.m. to 6

p.m.

Location: Holiday Inn, The Ballrooms,

Two Montgomery Ave., Gaithersburg,

MD.

Agenda: The committee will consider

the safety and efficacy of a new drug

application (NDA) 50–755, Augmentin

ESTM (amoxicillin/clavulanate) 90

milligrams per kilograms per day,

SmithKline Beecham Pharmaceuticals,

for the treatment of pediatric patients

with acute otitis media due to penicillin

resistant Streptococcus pneumoniae.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by January 22, 2001. Oral

presentations from the public will be

scheduled between approximately 2:45

p.m. to 3:45 p.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before January 22, 2001, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: January 5, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–1056 Filed 1–11–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–26]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, DHHS.

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 this 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.

Type of Information Request:

Extension of a currently approved

collection; Title of Information

Collection: Clinical Laboratory

Improvement Amendments (CLIA) and

the ICRs contained in the supporting

regulations in 42 CFR 493.1–.2001;

Form Number: HCFA–R–26 (OMB

approval #: 0938–0612); Use: The ICRs

referenced in 42 CFR part 493 outline

the requirements necessary to determine

an entity’s compliance with CLIA. CLIA

requires laboratories that perform

testing on human beings to meet

performance requirements (quality

standards) in order to be certified by

HHS; Frequency:Other: As needed;

Affected Public; Business or other forprofit, Not-for-profit institutions,

Federal government, State, local or

tribal gov’t; Number of Respondents:

149,700; total Annual Responses:

700,650; Total Annual Hours Requested:

10,230,714.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, 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 Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, Room N2–14–

26, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–1069 Filed 1–11–01; 8:45 am]

BILLING CODE 4120–03–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Docket Identifier: HCFA–1500]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, DHHS.

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 this 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.

Type of Information Request:

Extension of a currently approved

collection; Title of Information

Collection; Medicare/Medicaid Health

Insurance Common Claim Form,

Instructions, and Supporting

Regulations: 42 CFR 414.40, 424.32,

424.44; Form Number: NCFA–1500,

HCFA–1490U, HCFA–1490S (OMB

approval #: 0938–0008); Use: This form

is a standardized form for use in the

Medicare/Medicaid programs to apply

for reimbursement for covered services.

In addition, it reduces cost and

administrative burdens associated with

claims since only one coding system is

used and maintanined; Frequency: On

occasion; Affected Public: Business or

other for-profit, Not-for-profit

institutions; Number of Respondents:

1,321,417; Total Annual Responses:

1,321,417; Total Annual Hours

Requested: 44,189,007.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports