27984 Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices

from approving a subsequently filed

ANDA containing a paragraph IV

certification.

Pediatric exclusivity was created by

the passage of the Food and Drug

Administration Modernization Act,

enacted on November 21, 1997. This

provision, contained in section 505A of

the act, provides an incentive for

innovator companies to perform and

submit to the agency pediatric studies

that may produce health benefits in the

pediatric population. This benefit is

available to a new drug application

holder for the submission of pediatric

studies in response to a written request

issued by the agency. Pediatric

exclusivity extends for 6 months

existing patent and/or exclusivity

protection on the innovator drug and

begins to run on the date the existing

patent and/or exclusivity protection on

the innovator drug would otherwise

expire. ANDAs referencing the

innovator drug may not be approved

during the pediatric exclusivity period.

FDA seeks public comment on

whether pediatric exclusivity runs

concurrently or consecutively with 180-

day generic drug exclusivity when a

favorable court decision in a paragraph

IV patent challenge lawsuit is issued

less than 180 days before the beginning

of or during the pediatric exclusivity

period.

II. Request for Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments by June 20,

2001. Two copies of any comments 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. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Dated: May 14, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12615 Filed 5–15–01; 4:12 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0197]

Clinical Development Programs for

Drugs, Biological Products, and

Devices for the Treatment of

Ankylosing Spondylitis (AS) and

Related Disorders; Request for

Assistance

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

assistance in developing guidance for

industry on issues related to drugs,

biological products, and devices for the

treatment of AS and related disorders.

Once finalized, the guidance would aid

sponsors and others interested in

developing new agents to treat AS and

related disorders.

Before the agency can develop such

guidance, a critical appraisal of certain

fundamentals of the science related to

AS is needed. FDA is interested

specifically in identifying a party, or

parties, willing to take the lead in

coordinating this critical appraisal.

DATES: Submit written comments on

this notice by July 20, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Mary Jane Walling, Center for Drug

Evaluation and Research (HFD–105),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2268.

SUPPLEMENTARY INFORMATION: Because of

the positive response to the agency’s

guidance on rheumatoid arthritis, the

agency has recognized the need for more

information on the development of

drugs, biological products, and devices

for the treatment of AS and related

disorders. FDA intends to put the

information received in response to this

notice in a public docket so that

interested parties can learn of each other

and coordinate these activities.

Specifically, the agency is interested

in identifying an interested group or

consortium of interested groups from

academia, industry, practitioners, and

patients and their representatives

willing to take the lead in a critical

appraisal of certain fundamentals of the

science related to AS. Initially, the

parties may want to organize a public

meeting to discuss relevant questions (a

number of which are noted below). The

agency hopes this meeting will lead to

conceptual advances now not present

and their expression in a series of

concept papers. Subsequent workshops

would then be able to fully discuss

these concept papers, soliciting

feedback from all quarters including

regulators from the United States and

elsewhere. Emphasis should be on

debating the rationale for various

approaches to key issues. The agency

welcomes other suggestions of activities

that could be undertaken as part of this

guidance development effort.

To provide a starting point for

discussion, the agency has developed a

list of some key concepts that the

interested parties may want to consider

at the meeting:

1. Scope: Should the guidance discuss

AS alone, or a broader

spondyloarthropathy rubric? What

about the clinical subgroups and

pediatric expressions of the disorder(s)?

2. Claims: What type of claims

structure is optimal to encompass the

types of clinical benefit a therapeutic

product might have on patients with

AS? What type of evidence would be

needed to support each proposed claim?

3. Measures of disease activity: Are

currently available instruments for

measuring disease activity adequate or

are new measures required? Which

disease activity should be measured in

clinical trials in AS, and on what basis:

(1) A consensus approach, which aims

for agreement (clinicians, patients, and

others) based on a blend of an observerdriven approach and performance

characteristics; (2) a decision based on

the comparative statistical

characteristics of each measurement

using concepts such as random

measurement error; or (3) a fully datadriven approach where each

measurement is tested in a standard

venue to assess its predictive capacity.

4. Overall trial design: Are

longitudinal comparison of means

optimal? Because longer trials inevitably

have substantial dropouts, would a

survival analysis be more appropriate?

5. Intrinsic trial design: Which

measures should be included in the

primary analysis of the clinical trial to

assess whether the therapeutic product

is associated with a clinical benefit? Do

all measures need equal-weight in the

primary analysis? Can they be unequally

weighted? Is the use of composites

justified? Are outcomes of secondary

endpoints essential for determining the

success of the trial?

Interested persons should submit to

the Dockets Management Branch

(address above) comments and

Federal Register / Vol. 66, No. 98 / Monday, May 21, 2001 / Notices 27985

expressions of interest in taking a lead

in a critical appraisal. Two copies of any

comments 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. Received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: May 11, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12625 Filed 5–18–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0193]

Medical Devices Premarket

Notifications [510(k)] for Biological

Indicators Intended to Monitor

Sterilizers Used in Health Care

Facilities; Draft Guidance for Industry

and FDA Reviewers; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Premarket Notifications

[510(k)] for Biological Indicators

Intended to Monitor Sterilizers Used in

Health Care Facilities; Draft Guidance

for Industry and FDA Reviewers.’’ This

draft guidance document provides

specific recommendations on data and

information medical device

manufacturers should submit in

premarket notifications (510(k)s) for

biological indicators intended to

monitor sterilizers used in health care

facilities. This draft guidance is neither

final nor is it in effect at this time.

DATES: Submit written comments on the

draft guidance by August 20, 2001.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

draft guidance document entitled

‘‘Premarket Notifications [510(k)] for

Biological Indicators Intended to

Monitor Sterilizers Used in Health Care

Facilities; Draft Guidance for Industry

and FDA Reviewers’’ to the Division of

Small Manufacturers Assistance (HFZ–

220), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. Submit

written comments concerning this draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance

document.

FOR FURTHER INFORMATION CONTACT:

Chiu S. Lin, Center for Devices and

Radiological Health (HFZ–480), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8913.

SUPPLEMENTARY INFORMATION:

I. Background

FDA regulates biological indicators

intended to monitor sterilizers used in

health care facilities as class II medical

devices, requiring premarket

notification (510(k)). The effective

performance of sterilizers used in health

care facilities is important to prevent

nosocomial infections. Biological

indicators provide users with

information on the effectiveness of the

sterilization process. This draft

guidance document recommends the

kind of data and information you should

submit in a 510(k) for these devices. The

use of comprehensive, scientifically

sound review criteria helps ensure the

safety and effectiveness of these devices.

FDA recognizes that providing FDA

reviewers, 510(k) applicants, and other

interested parties information on its

review process can promote a consistent

and efficient regulatory process.

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on premarket notifications (510(k)) for

biological indicators intended to

monitor sterilizers used in health care

facilities. It does not create or confer any

rights for or on any person and does not

operate to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the applicable

statute and regulations.

The agency has adopted good

guidance practices (GGPs), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (21 CFR 10.115; 65 FR

56468, September 19, 2000). This draft

guidance document is issued as a Level

1 guidance consistent with the GGP

regulations.

III. Electronic Access

In order to receive ‘‘Premarket

Notifications [510(k)] for Biological

Indicators Intended to Monitor

Sterilizers Used in Health Care

Facilities; Draft Guidance for Industry

and FDA Reviewers’’ via your fax

machine, call the CDRH Facts-OnDemand system at 800–899–0381 or

301–827–0111 from a touch-tone

telephone. Press 1 to enter the system.

At the second voice prompt press 1 to

order a document. Enter the document

number (1320) followed by the pound

sign (#). Follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

using the Internet. CDRH maintains an

entry on the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Internet. Updated on a regular basis, the

CDRH home page includes the civil

money penalty guidance documents

package, device safety alerts, Federal

Register reprints, information on

premarket submissions (including lists

of approved applications and

manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, Mammography Matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. ‘‘Premarket

Notifications [510(k)] for Biological

Indicators Intended to Monitor

Sterilizers Used in Health Care

Facilities; Draft Guidance for Industry

and FDA Reviewers’’ is also available at

http://www.fda.gov/cdrh/ode/guidance/

1320.pdf. Guidance documents are also

available on the Dockets Management

Branch Web site at http://www.fda.gov/

ohrms/dockets/default.htm.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

draft guidance by August 20, 2001.

Submit two copies of any comments,

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. The draft guidance

document and received comments may

be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: May 8, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–12624 Filed 5–18–01; 8:45 am]

BILLING CODE 4160–01–S