41474 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by August 4,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Guidance for Industry: Submitting and

Reviewing Complete Responses to

Clinical Holds

On November 21, 1997, the President

signed into law the Food and Drug

Administration Modernization Act (the

Modernization Act) (Public Law 105–

115). Section 117 of the Modernization

Act provides that a written request to

FDA from the applicant of an

investigation that a clinical hold be

removed shall receive a decision in

writing, specifying the reasons for that

decision, within 30 days after receipt of

such request. A clinical hold is an order

issued by FDA to the applicant to delay

a proposed clinical investigation or to

suspend an ongoing investigation for a

drug or biologic. An applicant may

respond to a clinical hold.

Section 505(i)(3)(C) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

355(i)(3)(C)) requires that any written

request to FDA from the sponsor of an

investigation that a clinical hold be

removed must receive a decision, in

writing and specifying the reasons,

within 30 days after receipt of the

request. The request must include

sufficient information to support the

removal of the clinical hold.

In the Federal Register of May 14,

1998 (63 FR 26809), FDA published a

notice of availability of a guidance that

described how applicants should submit

responses to clinical holds so that they

may be identified as complete

responses, and the agency can track the

time to respond. FDA is now issuing a

revised guidance.

The revised guidance states that FDA

will respond in writing within 30

calendar days of receipt of a sponsor’s

request to release a clinical hold and a

complete response to the issue(s) that

led to the clinical hold. An applicant’s

complete response to an investigational

new drug application (IND) clinical

hold is a response in which all clinical

hold issues identified in the clinical

hold letter have been addressed.

The guidance requests that applicants

type in large, bold letters at the top of

the cover letter of the complete response

‘‘Clinical Hold Complete Response’’ to

expedite review of the response. The

guidance also requests that applicants

submit the complete response letter in

triplicate to the IND, and that they fax

a copy of the cover letter to FDA’s

contact, listed in the clinical hold letter,

who is responsible for the IND. The

guidance requests more than an original

and two copies, i.e., three copies, of the

cover letter in order to ensure that the

submission is received and handled in

a timely manner.

Based on data concerning the number

of complete responses to clinical holds

received by the Center for Drug

Evaluation and Research (CDER) from

July 1, 1998, to June 30, 1999, CDER

estimates that approximately 48

responses are submitted annually from

approximately 43 applicants, and that it

takes approximately 284 hours to

prepare and submit to CDER each

response.

Based on data concerning the number

of complete responses to clinical holds

received by the Center for Biologics

Evaluation and Research (CBER) in

fiscal year 1999, CBER estimates that

approximately 134 responses are

submitted annually from approximately

110 applicants, and that it takes

approximately 284 hours to prepare and

submit to CBER each response.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Complete responses to clinical holds No. of

respondents

No. of

responses per

respondent

Total annual

responses

Hours per

response Total hours

CDER 43 approx. 1 48 284 13,632

CBER 110 approx. 1 134 284 38,056

Total 51,688

1There are no capital costs or operating and maintenance costs associated with this collection of information.

In the Federal Register of April 13,

2000 (65 FR 19911), the agency

requested comments on the proposed

collections of information. No

significant comments were received.

Dated: June 27, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16813 Filed 7–3–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Microbiology Devices Panel of the

Medical Devices Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Microbiology

Devices Panel of the Medical Devices

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 27, 2000, 10:30 a.m. to 5:30

p.m. and July 28, 2000, 8 a.m. to 5 p.m.

Location: Holiday Inn, Walker/

Whetstone Rooms, Two Montgomery

Village Ave., Gaithersburg, MD.

Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices 41475

Contact Person: Freddie M. Poole,

Center for Devices and Radiological

Health (HFZ–440), Food and Drug

Administration, 2098 Gaither Rd.,

Rockville, MD 20850, 301–594–2096, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12517. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On July 27, 2000, the

committee will discuss and make

recommendations on issues concerning

the appropriate types of data and

information required to assess the safety

and effectiveness of diagnostic tests

intended to identify biothreat agents, or

to provide evidence of exposure to

biothreat agents, when used on different

specimen types and under different

conditions for use.

The following draft questions are

proposed for discussion and may be

subject to changes prior to the

committee meeting:

1. What types of data and information

would be recommended to evaluate

effectiveness when the assay is used:

(a) To definitively identify or rule-out

identification of isolates;

(b) to identify biothreat agents directly

in specimens from individuals

suspected (clinically or using other

diagnostic procedures) to have been

infected with the agent of interest; and

(c) to identify/detect the biothreat

agent directly in specimens from

individuals without clinical or other

diagnostic evidence of infection, who

may have been exposed to the biothreat

agent.

2. For each of these potential uses

what is the level of inaccuracy that can

be tolerated, or would the same criteria

apply to all?

3. To determine or infer effectiveness

for these devices, can specimens from

naturally- or experimentally-infected

animals be used when appropriate

specimens from humans cannot be

obtained? What are the constraints/

limitations for use of animal data as

evidence for effectiveness?

4. Are there any other issues not

addressed in the previous questions that

would affect the reliable use of these

assays for human diagnosis?

FDA will consider these

recommendations in the future

development of review criteria for in

vitro diagnostic devices, developed in

response to the threat of bioterrorism,

for the identification of biothreat agents,

as valid scientific evidence to determine

whether there is reasonable assurance

that these devices are safe and effective.

On July 28, 2000, the committee will

discuss, make recommendations, and

vote on a premarket approval

application (PMA) for an in vitro

diagnostic nucleic acid amplification

test for the qualitative detection of

hepatitis C virus (HCV) ribonucleic acid

(RNA) in human serum or plasma. On

the same day the committee will

discuss, make recommendations, and

vote on a PMA for an automated in vitro

diagnostic nucleic acid amplification

test for the qualitative detection of HCV

RNA in human serum or plasma. These

devices are not intended for use in

blood or plasma donor screening.

Procedure: On July 27, 2000, from

10:30 a.m. to 5:30 p.m. and on July 28,

2000, from 9 a.m. to 5 p.m., the meeting

is open to the public. 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 July 12, 2000. Oral

presentations from the public will be

scheduled between approximately 11:45

a.m. and 12:30 p.m. on July 27, 2000,

and between approximately 11:30 a.m.

and 12:15 p.m., and 3 p.m. and 3:30

p.m. on July 28, 2000. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 12, 2000, 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.

Closed Committee Deliberations: On

July 28, 2000, from 8 a.m. to 9 a.m., the

meeting will be closed to permit FDA

staff to present to the committee trade

secret and/or confidential commercial

information regarding pending and

future device submissions. This portion

of the meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 26, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–16809 Filed 7–3–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Ear, Nose, and Throat Devices Panel of

the Medical Devices Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Ear, Nose, and

Throat Devices Panel of the Medical

Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 20, 2000, 9:45 a.m. to 5

p.m., and July 21, 2000, 8:30 a.m. to 5

p.m.

Location: Holiday Inn, Goshen Room,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact Person: Sara M. Thornton,

Center for Devices and Radiological

Health (HFZ–460), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850,

SMT@CDRH.FDA.GOV, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12522.

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

Agenda: On July 20, 2000, the

committee will discuss, make

recommendations, and vote on a

premarket approval application (PMA)

for a direct-drive implantable middle

ear hearing device intended to provide

a useful level of sound perception via

mechanical stimulation of the ossicles.

On July 21, 2000, the committee will

discuss, make recommendations and

vote on a PMA for an implant intended

to restore useful hearing to individuals

with Neurofibromatosis Type II who

have become deaf as a result of surgery

to remove bilateral auditory nerve

tumors.

Procedure: On July 20, 2000, from

9:45 a.m. to 5 p.m., and on July 21,

2000, from 9:15 a.m. to 5 p.m., the

meeting is open to the public. 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 July 13, 2000. Oral

presentations from the public will be