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

Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Notices 70359

needs and developing information

products; (6) provides technical

assistance to Bureau program managers

in information and communications

product packaging, desktop publishing,

and media relations; (7) produces

reports, articles, briefings, speeches,

exhibits and other multi-media

communications on Bureau programs;

(8) develops and implements new and

innovative communication strategies

including utilization of automated

methods and electronic media in

carrying out its responsibilities

including managing and maintaining

content of the Bureau’s electronic web

site, and liaison with the HRSA

webmaster for technical support and

design; and participation, coordination

and content development in use of

technologies such as satellite

transmission and distance learning; (9)

functions as media advisor to the

Bureau Associate Administrator and

other senior program staff; (10) reviews

federal, state, and local legislation,

issues, programs and policies and their

impact on health care organization

financing and service delivery to special

populations served by Bureau programs;

(11) identifies issues and problems and

conducts appropriate analyses and

studies in order to develop technical

assistance products, presentations,

seminars, and communications for the

information and service needs of the

intended audience; and (12) serves as

principal liaison on behalf of MCHB in

coordinating with HRSA’s Office of

Communications; through appropriate

channels with other agency information,

communications, and/or clearinghouses;

with national constituency

organizations such as the Association of

Maternal and Child Health Programs,

the American Academy of Pediatrics;

with international organizations such as

the World Health Organization and the

Pan American Health Organization, and

with health planners, service providers,

and consumers, with respect to the

development and dissemination of

information on current and emerging

health care issues, trends and problems

affecting the services, program and

populations served by the MCHB.

Delegations of Authority

All delegations and redelegations of

authority which were in effect

immediately prior to the effective date

hereof have been continued in effect in

them or their successors pending further

redelegations.

This reorganization is effective upon

date of signature.

Dated: October 12, 2000.

Claude Earl Fox,

Administrator.

[FR Doc. 00–29843 Filed 11–21–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Availability of a Draft

Environmental Assessment and

Receipt of an Application for an

Incidental Take Permit for the Harding

Property, Douglas County, CO

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of availability and

receipt of application.

SUMMARY: This notice advises the public

that Susan K. Harding (Applicant) has

applied to the Fish and Wildlife Service

(Service) for an incidental take permit

pursuant to section 10(a)(1)(B) of the

Endangered Species Act of 1973 as

amended. The Service proposes to issue

a 3-year permit to the Applicant that

would authorize the incidental take of

the Preble’s meadow jumping mouse

(Preble’s) (Zapus hudsonius preblei),

federally listed as threatened, and loss

and modification of its habitat

associated with construction of a singlefamily residence in Douglas County,

Colorado. Construction of the single

family residence will result in the loss

of up to 0.294 acres of grassland that

provides potential foraging and

hibernation habitat for the mouse. The

permit application includes a combined

Environmental Assessment/Habitat

Conservation Plan (EA/HCP), which is

available for public review and

comment. The HCP fully describes the

proposed project and the measures the

Applicant would undertake to minimize

and mitigate project impacts to the

Preble’s.

The Service requests comments on the

EA/HCP for the proposed issuance of

the incidental take permit. We provide

this notice pursuant to section 10(a) of

the Endangered Species Act and

National Environmental Policy Act

regulations (40 CFR 1506.6). All

comments on the EA and permit

application will become part of the

administrative record and will be

available to the public.

DATES: Written comments on the permit

application and EA/HCP should be

received on or before December 22,

2000.

ADDRESSES: Comments regarding the

permit application or the EA/HCP, or

requests for the documents, should be

addressed to LeRoy Carlson, Field

Supervisor, Fish and Wildlife Service,

Colorado Field Office, 755 Parfet Street,

Suite 361, Lakewood, Colorado 80215.

Comments may be sent by facsimile to

(303) 275–2371. Please reference permit

number PRT–TE035844–0 in any

comments submitted.

FOR FURTHER INFORMATION CONTACT: Ms.

Kathleen Linder, Fish and Wildlife

Biologist, Colorado Field Office,

telephone (303) 275–2370.

SUPPLEMENTARY INFORMATION:

Document Availability

Individuals wishing copies of the EA/

HCP and associated documents for

review should immediately contact the

above office. Documents also will be

available for public inspection, by

appointment, during normal business

hours at the above address.

Background

Section 9 of the Endangered Species

Act and Federal regulation prohibit the

‘‘take’’ of a species listed as endangered

or threatened (take is defined under the

Endangered Species Act as to harass,

harm, pursue, hunt, shoot, wound, kill,

trap, capture or collect, or to attempt to

engage in any such conduct). However,

the Service may issue permits to

authorize ‘‘incidental take’’ (defined by

the Endangered Species Act as take that

is incidental to, and not the purpose of,

the carrying out of an otherwise lawful

activity) of listed species under limited

circumstances. Regulations governing

permits for threatened species are

promulgated in 50 CFR 17.32.

Regulations governing permits for

endangered species are promulgated in

50 CFR 17.22.

The proposed action is the issuance of

a permit under section 10(a)(1)(B) of the

Endangered Species Act to allow the

incidental take of Preble’s during the

construction of a single family residence

at the site. The proposed project will

directly affect approximately 0.294 acres

of potential habitat for Preble’s. An HCP

has been developed as part of the

preferred alternative. The proposed HCP

will allow for the incidental take of the

Preble’s by permitting a single family

residence to be constructed in an area

that may be periodically used as

foraging or hibernation habitat.

Construction will result in about 0.12

acres of permanent habitat loss and

another 0.18 acres of temporary effects

to the habitat associated with this

localized disturbance.

Alternatives considered in addition to

the proposed action were; building at an

alternate location, waiting for the