27360 Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices

guidelines regarding pre- and post-test

counseling and partner notification of

HIV-seropositive patients. A copy of the

guidelines will be included in the

application kit. Recipients must also

comply with State and local health

department requirements relating to

specific reportable diseases or

conditions. Recipients must provide

referrals for HIV diagnosis and

treatment.

HIV/AIDS Requirements: Recipients

must comply with the document

entitled ‘‘Content of AIDS-Related

Written Materials, Pictorials,

Audiovisuals, Questionnaires, Survey

Instruments, and Educational Sessions’’

(June 1992), a copy of which is included

in the application kit. In complying

with the requirements for a program

review panel, recipients are encouraged

to use an existing program review panel

such as the one created by the State

health department’s HIV/AIDS

prevention program. If the recipient

forms its own program review panel, at

least one member must be an employee

(or a designated representative) of a

government health department

consistent with the Content guidelines.

The names of the review panel members

must be listed on the Assurance of

Compliance form (CDC 0.1113), which

is included in the application kit.

Application Submission and Deadline

The original and two copies of the

application must be submitted to: Van

Malone, Grants Management Officer,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E–15, Atlanta, GA

30305, on or before July 29, 1996.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date, or

(b) Sent on or before the deadline date

and received in time for submission to

the objective review committee.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.(a) or

1.(b) are considered late applications.

Late applications will not be considered

in the current competition and will be

returned to the applicant.

Where to Obtain Additional

Information

Business management technical

assistance may be obtained from Juanita

Dangerfield, Grants Management

Specialist, at telephone (404) 842–6577,

fax: (404) 842–6513, or INTERNET

address: <jdd2@opspgo1.em.cdc.gov>.

Programmatic technical assistance

may be obtained from Eugene McCray,

M.D., Division of Tuberculosis

Elimination, at telephone (404) 639–

8117.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the ‘‘INTRODUCTION’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Atlanta, Georgia, will be the host of

the 1996 Summer Olympics Games (July

19 through August 4, 1996). As a result

of this event, it is likely that the

Procurement and Grants Office (PGO)

may experience delays in the receipt of

both regular and overnight mail

deliveries. Contacting PGO employees

during this time frame may also be

hindered due to the possible telephone

disruptions.

To the extent authorized, please

consider the use of voice mail, e-mail,

and facsimile transmissions to the

maximum extent practicable. Please do

not fax lengthy documents or grant

applications.

This announcement will be available

on one of two Internet sites on the

publication date: CDC’s home page at

http://www.cdc.gov, or at the

Government Printing Office home page

(including free access to the Federal

Register) at http://www.access.gpo.gov.

Dated: May 24, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–13675 Filed 5–30–96; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 96D–0148]

Medical Devices; Medical Device User

Facility and Distributor Reporting;

Guidance Documents; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of three guidance

documents entitled ‘‘Medical Device

Reporting: An Overview,’’ ‘‘Medical

Device Reporting for User Facilities,’’

and ‘‘Medical Device Reporting for

Distributors.’’ These guidance

documents provide information to help

facilitate compliance with the agency’s

Medical Device Reporting (MDR)

requirements. The agency is also

announcing the availability of the

following final MDR reporting forms:

FDA Form 3419, Semiannual User

Facility Report; FDA Form 3417,

Baseline Report; and FDA Form 3381,

Annual Certification. Elsewhere in this

issue of the Federal Register, FDA is

publishing a notice of availability of,

and requesting comments on, a draft

guidance document focusing on

reporting by manufacturers.

DATES: Written comments on the

guidance documents may be submitted

at any time.

ADDRESSES: Submit written comments

on the three guidance documents to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Comments on the

three guidance documents should be

kept separate and identified by their

respective titles. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

guidance documents and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Persons interested in obtaining copies

of the guidance documents and

reporting forms may use 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 scroll

down to Medical Device Reporting. The

documents will be listed and available

for downloading.

Anyone with a video terminal or

personal computer with a modem can

obtain these documents from the

electronic docket administered by

DSMA (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

about obtaining paper copies of these

documents through the CDRH Facts-onDemand system by dialing 1–800–899–
Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices 27361

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 these

documents 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

On November 26, 1991 (56 FR 60024),

under the Safe Medical Devices Act of

1990 (Pub. L. 101–629), 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

the 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.

Subsequent to FDA’s issuance of the

November 1991 tentative final rule, the

Medical Device Amendments of 1992

(Pub. L. 102–300) 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),

the agency published the MDR

regulation for user facilities and

manufacturers, based on comments to

the November 1991 tentative final rule.

The requirements for manufacturer and

user facility reporting are found in part

803 (21 CFR part 803). The reporting

requirements for distributors fell under

a different implementation timetable.

On May 28, 1992, the provisions of the

November 1991 tentative final rule

pertaining to distributor reporting

became final by operation of law.

Accordingly, medical device

distributors are currently subject to the

reporting regulations contained in the

November 1991 tentative final rule and

codified in part 804 (21 CFR part 804).

FDA intends to issue a proposed rule to

make the distributor reporting

requirements consistent with the

manufacturer and user facility reporting

requirements.

A. Guidance for User Facilities and

Distributors

Due to the diversity and complexity of

medical device products, no regulation

could address each possible reporting

scenario. Therefore, the agency is

providing three guidance documents

entitled ‘‘Medical Device Reporting: An

Overview,’’ ‘‘Medical Device Reporting

for User Facilities,’’ and ‘‘Medical

Device Reporting for Distributors.’’

These guidance documents contain

information describing who is covered

by the MDR rule, who is responsible for

reporting, how to report, and when to

report. The documents also contain

statements of FDA’s policy,

interpretations of the regulation, and

answers to frequently asked questions.

Elsewhere in this issue of the Federal

Register, FDA is publishing a notice of

availability of, and requesting comments

on, a draft guidance document focusing

on reporting by manufacturers.

B. MDR Reporting Forms

The MDR final rule requires that MDR

reports be submitted using the

appropriate form, or an approved

electronic equivalent. The actual forms

were made available for public

comment, were approved by the Office

of Management and Budget (OMB)

through February 28, 1999, under OMB

control number 0910–0059, and were

announced as final in the Federal

Register of April 11, 1996 (61 FR

16043). The April 11, 1996, final rule

also extended the effective date of the

MDR final rule for manufacturers and

user facilities to July 31, 1996, in order

to provide additional time for

compliance. This notice announces the

availability of the following MDR forms:

FDA Form 3419, Semiannual User

Facility Report; FDA Form 3417,

Baseline Report; and FDA Form 3381,

Annual Certification. FDA Form 3500A,

the MEDWATCH Form, has been in use

for several years and is available from

the same sources listed above. This

form, or an approved electronic

equivalent, will continue to be used for

reporting individual adverse events.

Although manufacturers, distributors,

and device user facilities may

immediately begin using the forms

announced in this notice to submit

reports required under the MDR

regulations, use of the forms will not be

required until July 31, 1996, the

effective date of the MDR final rule.

II. 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.

III. Request for Comments

All guidance documents developed by

FDA are open to public comment.

Therefore, interested persons may

submit comments regarding the final

guidance documents that are being

announced in this notice. Interested

persons may, at any time, submit to the

Dockets Management Branch (address

above) written comments regarding the

three guidance documents. 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 respective guidance

document and with the docket number

found in brackets in the heading of this

document. Copies of the three 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 reviewing and revising

the guidance documents.

Dated: May 21, 1996.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 96–13666 Filed 5–30–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96D–0137]

Medical Device Reporting, Draft

Guidance Document for

Manufacturers; Notice of Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled

‘‘Medical Device Reporting for

Manufacturers.’’ This guidance contains

information to help facilitate

manufacturer compliance with the new

Medical Device Reporting (MDR)

regulation. FDA is inviting comments

on the draft guidance, particularly on

matters not already addressed in the

draft manufacturer device reporting

guidance.

DATES: Submit written comments by

August 29, 1996.

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 by title

and the docket number found in

brackets in the heading of this

document. A copy of the draft guidance

document and received comments are