46366 Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Notices

1997. Space is limited, therefore,

interested parties are encouraged to

register early.

If you need special accommodations

due to a disability, please contact R.

Thomas Trout at least 7 days in

advance.

Dated: August 26, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–23243 Filed 8–27–97; 3:24 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0228]

Draft Guidance for Industry on

Computerized Systems Used in

Clinical Trials; Availability; Reopening

of Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is reopening the

comment period on the draft guidance

entitled ‘‘Guidance for Industry:

Computerized Systems Used in Clinical

Trials’’ until November 3, 1997. FDA

published a notice of availability of the

draft guidance in the Federal Register of

June 18, 1997 (62 FR 33094). FDA is

reopening the comment period in

response to requests for additional time

to review the agency’s draft guidance on

the use of computerized systems in

clinical trials.

DATES: Written comments may be

submitted on the draft guidance

document by November 3, 1997.

General comments on agency guidance

documents are welcomed at any time.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

James F. McCormack, Office of

Enforcement (HFC–230), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–0425.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 18, 1997, FDA

announced the availability of a draft

guidance for industry entitled

‘‘Guidance for Industry: Computerized

Systems Used in Clinical Trials.’’ The

draft guidance is intended to assist

applicants who wish to use computer

systems to generate, collect, maintain

and transmit clinical data for

submission to FDA in support of

marketing or research applications. The

notice invited interested persons to

submit written comments on the draft

guidance by August 18, 1997.

The agency received a number of

requests for additional time to comment

on the draft guidance and is reopening

the comment period until November 3,

1997.

Interested persons may submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). 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. The draft guidance and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: August 25, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–23180 Filed 8–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0333]

Reexamination of the Evaluation

Process for Liquid Chemical Sterilants

and High Level Disinfectants;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a position paper entitled

‘‘Reexamination of the Evaluation

Process for Liquid Chemical Sterilants

and High Level Disinfectants.’’ The

position paper is soliciting input from

industry, users’ groups, other regulatory

agencies, and academia on FDA’s

approaches to improving the evaluation

of liquid chemical sterilants and high

level disinfectants.

DATES: Written comments by December

1, 1997.

ADDRESSES: Submit written requests for

single copies of the position paper to the

Division of Small Manufacturers

Assistance (HFZ–220), Center for

Devices and Radiological Health, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

6597 (toll free outside of MD 1–800–

638–2041). Send two self-addressed

adhesive labels to assist that office in

processing your requests. Submit

written comments on the position paper

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of the position paper

and received comments are available for

public examination in the Docket

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

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,

301–594–0616.

SUPPLEMENTARY INFORMATION: FDA

regulates the introduction of medical

devices into interstate commerce. A

person intending to market a liquid

chemical germicide medical device

must submit a premarket notification

under section 510(k) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360(k)) to FDA before

introducing the device into interstate

commerce. Regulations governing the

general content and format of 510(k)

submissions (part 807 (21 CFR part

807)) and other regulatory requirements

are discussed in guidance documents

available from the Center for Devices

and Radiological Health, Division of

Small Manufacturers Assistance

(address above). The effective use of

chemical germicides is important in

preventing nosocomial infections.

Comprehensive, scientifically sound

criteria for the evaluation of chemical

germicides is essential to help ensure

that these agents are safe and effective

for their intended use when used

according to their labeling. FDA

recognizes the importance of providing

applicants, and other interested parties,

with the agency’s evaluation criteria for

chemical germicides in order to

facilitate the assembly of necessary data,

to maintain consistency of review, and

to provide for a more efficient regulatory

process. The purpose of this position

paper is to solicit input from industry,

users’ groups, other regulatory agencies,

and academia on FDA’s approaches to

improving the evaluation of liquid

chemical germicides. The comments

that FDA receives in response to this

position paper will help it in assessing

the current guidance and in developing

the approach that will be used in future

guidances for these products.