Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Notices 70357

docket number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT:

Deborah M. Moore, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 2098

Gaither Rd., Rockville, MD 20850, 301–

594–1293.

SUPPLEMENTARY INFORMATION:

I. Background

ASCA is a test system intended to

measure S. cerevisiae antibodies in

human serum or plasma as an aid in the

diagnosis of Crohn’s disease. The

guidance sets forth the risk associated

with this generic type of device, and

lists recommendations for submission of

a premarket notification. Designation of

this guidance as a special control means

that manufacturers of ASCA devices

who comply with either the

recommendations of this guidance or

some alternate means that provide

equivalent assurance of safety and

effectiveness will be able to market their

device after they have submitted a

premarket notification (510(k)) and

received a finding of substantial

equivalence for their device. The

guidance focuses on the following

issues: Labeling, design controls, and

clinical information. FDA believes that

this special control, when combined

with the general controls of the act, will

provide reasonable assurance of the

safety and effectiveness for this type of

device.

II. Significance of Guidance

This guidance document represents

the agency’s current thinking on the

submission of premarket notifications

for ASCA test systems. 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, regulations, or both.

The agency has adopted good

guidance practices (GGP’s), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (65 FR 56468, September 19,

2000). This guidance document is

issued as a Level 2 guidance consistent

with GGP’s.

III. Electronic Access

In order to receive ‘‘Guidance for

Industry and FDA Reviewers: Class II

Special Control Guidance Document for

Anti-Saccharomyces cerevisiae (S.

cerevisiae) Antibody (ASCA) Premarket

Notifications’’ via your fax machine, call

the CDRH Facts-on-Demand system at

800–899–0381 or 301–827–0111 from a

touchtone telephone. At the first voice

prompt press 1 to access DSMA Facts,

at second voice prompt press 2, and

then enter the document number (1183)

followed by the pound sign (#). Then

follow the remaining voice prompts to

complete your request.

Persons interested in obtaining a copy

of the 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 ‘‘Guidance

for Industry and FDA Reviewers: Class

II Special Control Guidance Document

for Anti-Saccharomyces cerevisiae (S.

cerevisiae) Antibody (ASCA) Premarket

Notifications,’’ 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.

IV. Comments

Interested persons may, at any time,

submit written comments regarding the

guidance to the Dockets Management

Branch (address above). Such comments

will be considered when determining

whether to amend the current guidance.

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 guidance document and

received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: November 9, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–29842 Filed 11–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00D–1557 and 00D–1558]

Guidance Documents for Premarket

Notification (510(k)) Submissions for

Indwelling Blood Gas Analyzers;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of two guidance documents.

These two guidance documents are

intended to serve as special controls for

three devices that FDA has proposed

previously to reclassify from class III

(premarket approval) to class II (special

controls). Elsewhere in this issue of the

Federal Register, FDA is reopening the

comment period on the proposed

reclassification of the three devices.

FDA is now inviting comment on these

two guidance documents because they

were not available for comment at the

time of the publication of the proposed

reclassification.

DATES: Submit written comments on the

agency guidances by February 20, 2001.

ADDRESSES: Submit written comments

on the agency guidances to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Comments should be identified with the

docket number for the appropriate

guidance document found in table 1.

Submit written requests for single

copies on a 3.5′′ diskette of one or both

of these guidance documents 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. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance documents.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ–215),

Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301–

827–2974.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 15,

1999 (64 FR 12774), FDA published a

proposed rule to reclassify 38

70358 Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Notices

preamendments class III devices into

class II and to establish special controls

for these devices. FDA invited

interested persons to comment on the

proposed rule by June 14, 1999. FDA

received one request to reopen the

comment period for six devices. The

request noted that FDA had not made

the guidance documents that were

proposed as special controls for these

six devices available for comment

through FDA’s good guidance practices

(GGP’s) (65 FR 56468, September 19,

2000). The request further noted that it

was impossible to comment on the

proposed reclassification without the

guidance documents being available.

Therefore, the requester asked that FDA

extend the comment period until at least

90 days after the guidance documents

are publicly available. FDA agreed with

the request. FDA also identified three

additional devices for which the agency

had not issued the guidance documents

proposed as special controls in

accordance with the GGP policy. These

three devices are the Indwelling Blood

Carbon Dioxide Partial Pressure (Pco2)

Analyzer (21 CFR 868.1150), the

Indwelling Blood Hydrogen Ion

Concentration (pH) Analyzer (21 CFR

868.1170), and the Indwelling Blood

Oxygen Partial Pressure (P02) Analyzer

(21 CFR 868.1200).

The agency is announcing the

availability of the two guidance

documents (with separate docket

numbers) for these three additional

devices; the guidance documents, with

their docket numbers, and Facts-onDemand (FOD) numbers are as follows:

TABLE 1.

Name of Guidance Docket Number Facts-on-Demand Number

Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions 00D–1557 1126

Guidance for Electrical Safety, Electromagnetic Compatibility and Mechanical

Testing for Indwelling Blood Gas Analyzer Premarket Notification Submissions

00D–1558 1161

II. Significance of Guidance Documents

These guidance documents represent

the agency’s current thinking on

premarket notifications for these

devices. These guidance documents do

not create or confer any rights for or on

any person and do not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the applicable statute,

regulations, or both. Under FDA’s GGP

policy, each of these guidance

documents is a Level 2 guidance.

III. Electronic Access

In order to receive these guidance

documents via your fax machine, call

the CDRH FOD 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 listed above followed by the

pound sign (#). Follow the remaining

voice prompts to complete your request.

Persons interested in obtaining a copy of

these guidance documents may do so by

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 these

guidance documents, 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.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding

these guidance documents by February

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 for the guidance

document as listed in table 1. If you

wish to comment on more than one

guidance document, please submit your

comments separately for each guidance

document. The guidance documents

and received comments may be seen in

the Dockets Management Branch

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

through Friday.

Dated: October 31, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–29840 Filed 11–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Statement of Organization, Functions,

and Delegations of Authority

This notice amends Part R of the

Statement of Organization, Functions

and Delegations of Authority of the

Department of Health and Human

Services (DHHS), Health Resources and

Services Administration (60 FR 56605

as amended November 6, 1995, as last

amended at 65 FR 48007, dated August

4, 2000).

This notice reflects the change in the

organizational structure of the Maternal

and Child Health Bureau (RM).

Establish the Office of Communications

(RM8)

The Office of Communications plans,

designs, executes and evaluates national

and international communication and

information dissemination programs

which include the development of

written and broadcast materials

conveying complex information about

the Maternal and Child Health Bureau,

the maintenance of effective working

relationships with high-level public and

private sector policy makers and

development of recommendations to

improve MCHB program effectiveness.

Specifically: (1) From various public

and private sources, collects, translates,

interprets and distributes for public use,

information on maternal and child

health care legislation, innovations,

research and data trends; (2) develops

and provides information materials to

MCHB health program planners,

providers, consumers and others to

assist in decision making and

maintaining effective, efficient

operations; (3) develops and produces

in-house communications to help

ensure the understanding of current

maternal and child health issues and

Bureau program objectives; (4) fosters

and maintains relationships with and

provides a referral service to Federal

agencies, State and local governmental

units, private health and medical

organizations, and other organizations

with which the Bureau has mutual

interests; (5) provides technical

assistance to Bureau program managers

and project officers in identifying

maternal and child health information