27362 Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices

available for public examination in the

Dockets Management Branch (address

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

Monday through Friday.

Persons interested in obtaining a copy

of the draft guidance document may do

so by using the World Wide Web. FDA’s

home page address may be accessed at

http://www.fda.gov and then select the

Medical Devices and Radiological

Health option. Next, select the Program

Areas option and then select Medical

Device Reporting. All Relevant

documents will be listed and available

for downloading.

Anyone with a video terminal or

personal computer with a modem can

obtain the draft guidance document

from the electronic docket administered

by the Division of Small Manufacturers

Assistance (1–800–252–1366 or 1–301–

594–2741) by making the following

menu choices: 5–Postmarket

Surveillance; 2–Medical Device

Reports—Policies/Guidelines.

Individuals unable to use the above

two options may request information,

through the CDRH Facts-on-Demand

system, about obtaining paper copies of

the document, by dialing 1–800–899–

0381 or 1–301–827–0111. After

following the voice prompts, request

document number 799. FDA has

arranged to have other government,

industry, and health care organizations

provide paper copies of the document

for a fee that each organization will set

for itself.

FOR FURTHER INFORMATION CONTACT: Earl

W. Robinson, Center for Devices and

Radiological Health (HFZ–530), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301–594–

2735.

SUPPLEMENTARY INFORMATION:

I. Background

Under the Safe Medical Devices Act

of 1990 (Pub. L. 101–629) (SMDA), on

November 26, 1991 (56 FR 60024), FDA

issued a tentative final rule proposing to

implement regulations requiring user

facility and distributor adverse event

reporting (hereinafter referred to as the

November 1991 tentative final rule). In

this November 1991 tentative final rule,

FDA also proposed to amend the

existing manufacturer reporting

regulations to conform to the proposed

user facility and distributor reporting

requirements.

After FDA’s issuance of the November

1991 tentative final rule, the Medical

Device Amendments of 1992 (Pub. L.

102–300) (the 1992 amendments) were

enacted on June 16, 1992, and amended

certain provisions of section 519 of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360i) relating to reporting of

adverse device events.

On December 11, 1995 (60 FR 63578),

FDA published the MDR regulation for

user facilities and manufacturers, based

on comments to the November 1991

tentative final rule. In the Federal

Register of April 11, 1996 (61 FR

16043), the effective date of this final

rule was extended to July 31, 1996, in

order to provide additional time for

compliance. The requirements for

manufacturer and user facility reporting

are found at 21 CFR part 803.

II. Draft Guidance for Manufacturers

Due to the diversity and complexity of

medical device products, no regulation

could address each possible reporting

scenario. Therefore, the agency is

providing additional guidance to the

industry. The agency has developed a

draft guidance document entitled

‘‘Medical Device Reporting for

Manufacturers.’’ This draft guidance

contains information describing: Who is

covered by the MDR rule, who is

responsible for reporting, how to report,

and when to report. The draft guidance

also contains statements of FDA policy,

interpretations of the regulation, and

answers to frequently asked questions.

The agency also addresses in this

guidance, many questions which have

been raised after to the publication of

the November 1991 tentative final rule.

However, because the agency

anticipates that additional new

questions and issues may be raised as

the effective date of the MDR regulation

approaches, the agency is issuing the

manufacturer guidance as a draft

document and specifically invites

questions and comments on matters not

already addressed in the draft guidance.

The agency will consider all submitted

comments when revising the draft

guidance. The agency anticipates that a

revised guidance document for

manufacturers will be available by

November 27, 1996. In the interim, FDA

believes the information contained in

the draft guidance will be useful to

medical device manufacturers as they

seek to implement the requirements of

the new MDR final rule.

III. Significance of a Guidance

A guidance document does not bind

FDA or the public, and does not create

or confer any rights, privileges, or

benefits for or on any person; however,

it does represent the agency’s current

thinking on the subjects discussed

therein. The draft guidance document

announced in this notice represents the

agency’s tentative thinking on issues

related to manufacturer reporting.

IV. Request for Comments

Interested persons may, on or before

August 29, 1996, submit to the Dockets

Management Branch (address above)

written comments regarding the draft

guidance entitled ‘‘Medical Device

Reporting for Manufacturers.’’ Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified by the title of the guidance

and the docket number found in

brackets in the heading of this

document. Copies of the guidance

documents and received comments may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday.

Received comments will be

considered in revising the draft

guidance document.

Dated: May 21, 1996.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 96–13665 Filed 5–30–96; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Mental Health;

Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings of the National Institute of

Mental Health Special Emphasis Panel:

Agenda/Purpose: To review and evaluate

grant applications.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: June 12, 1996.

Time: 6 p.m.

Place: Chevy Chase Holiday Inn, 5520

Wisconsin Avenue, Chevy Chase, MD 20815.

Contact Person: Michael D. Hirsch,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857.

Telephone: 301, 443–1000.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: June 14, 1996.

Time: 12 p.m.

Place: Chevy Chase Holiday Inn, 5520

Wisconsin Avenue, Chevy Chase, MD 20815.

Contact Person: Michael D. Hirsch,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857.

Telephone: 301, 443–1000.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: June 20, 1996.

Time: 8;30 a.m.

Place: The Latham Hotel Georgetown, 3000

M Street, NW., Washington, DC 2007.

Contact Person: Phyllis D. Artis, Parklawn

Building, Room 9C–26, 5600 Fishers Lane,
Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices 27363

Rockville, MD 20857. Telephone: 301, 443–

6470.

The meetings will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Numbers 93.242, 93.281, 93.282)

Dated: May 22, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–13660 Filed 5–30–96; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–3778–N–87]

Office of the Assistant Secretary for

Community Planning and

Development; Federal Property

Suitable as Facilities To Assist the

Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

DATES: May 31, 1996.

FOR FURTHER INFORMATION CONTACT:

Mark Johnston, Department of Housing

and Urban Development, Room 7256,

451 Seventh Street, SW, Washington,

DC 20410; telephone (202) 708–1226;

TDD number for the hearing- and

speech-impaired (202) 708–2565, (these

telephone numbers are not toll-fee), or

call the toll-free Title V information line

at 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with the December 12, 1988

court order in National Coalition for the

Homeless v. Veterans Administration,

No. 88–2503–OG (D.D.C.), HUD

publishes a Notice, on a weekly basis,

identifying unutilized, underutilized,

excess and surplus Federal buildings

and real property that HUD has

reviewed for suitability for use to assist

the homeless. Today’s Notice is for the

purpose of announcing that no

additional properties have been

determined suitable or unsuitable this

week.

Dated: May 23, 1996.

Jacquie M. Lawing,

Deputy Assistant Secretary for Economic

Development.

[FR Doc. 96–13480 Filed 5–30–96; 8:45 am]

BILLING CODE 4210–29–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Availability of the Final Joint

Programmatic Environmental Impact

Report and Environmental Impact

Statement on the Proposed Issuance

of Incidental Take Permits for the

Coastal California Gnatcatcher and Six

Other Listed Species in the Central and

Coastal Natural Community

Conservation Planning Subregion of

Orange County, CA

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of availability.

SUMMARY: This notice advises the public

that the Final Environmental Impact

Report/Environmental Impact Statement

(EIR/EIS) on the proposed issuance of

nine incidental take permits for seven

listed species in the Central and Coastal

Natural Community Conservation

Planning (NCCP) Subregion of Orange

County, California, is available.

Publication of the Record of Decision

and issuance of the permits will occur

no sooner than 30 days from the date of

this notice. This notice is provided

pursuant to regulations implementing

the National Environmental Policy Act

(40 CFR 1506.6).

ADDRESSES: The documents discussed

herein are available for public

inspection, by appointment, during

normal business hours, at the Carlsbad

Field Office, U.S. Fish and Wildlife

Service, 2730 Loker Avenue West,

Carlsbad, California 92008 (telephone:

619–431–9440); and at the Planning

Department, Orange County

Environmental Management Agency,

300 North Flower Street, Santa Ana,

California 92702 (telephone: 714–834–

5550).

FOR FURTHER INFORMATION CONTACT: Mr.

Gail Kobetich, Field Supervisor, U.S.

Fish and Wildlife Service (see

ADDRESSES above), telephone: 619–431–

9440; or Mr. Tim Neely, Planning and

Zoning Administrator, Orange County

Environmental Management Agency

(see ADDRESSES above), telephone: 714–

834–2552.

SUPPLEMENTARY INFORMATION:

Availability of Documents

Copies of the Final EIR/EIS and

associated documents (comment letters

on the Draft EIS/EIR, response to

comments, the final Implementation

Agreement, and final maps) can be

obtained by contacting the Carlsbad or

Santa Ana offices listed above (see

ADDRESSES). The response to comments

addresses changes that were made in

draft documents associated with the

permit applications that previously

were made available for public review.

The complete application file may be

viewed during normal business hours,

by appointment, at the Carlsbad and

Santa Ana offices. A letter announcing

availability of the Final EIR/EIS has

been forwarded to all parties who

previously received the notice of

availability of the Draft EIR/EIS, and/or

who requested a copy of, or commented

on, the Draft EIR/EIS.

Background

On March 30, 1993, the U.S. Fish and

Wildlife Service (Service) published a

final rule determining the coastal

California gnatcatcher (Polioptila

californica californica) as a threatened

species (58 FR 16742). The ‘‘take’’ of

threatened and endangered species is

prohibited under section 9 of the Act

and its implementing regulations. Take

is defined in part as killing, harming or

harassing listed species, including

significant habitat modification that

kills or injures listed species. The

Service, however, may issue permits

under section 10 of the Act to conduct

activities involving the take of

threatened and endangered species

under certain circumstances, including

carrying out scientific activities,

enhancing the propagation or survival of

the species, or incidentally taking the

species in connection with otherwise

lawful activities. Regulations governing

such permits are at 50 CFR 17.22 and

17.32.

On December 10, 1993, the Service

issued a final special rule for the coastal

California gnatcatcher, pursuant to

section 4(d) of the Act (58 FR 65088).

Incidental take of the gnatcatcher is

allowed under the special rule if such

take results from activities conducted

under a plan prepared pursuant to the

NCCP Act of 1991, NCCP Process

Guidelines, and the NCCP Southern

California Coastal Sage Scrub

Conservation Guidelines. The special

rule also requires Federal approval of

the NCCP Plan/Habitat Conservation

Plan (HCP).

The County of Orange (lead

applicant), University of California-