800 Federal Register / Vol. 66, No. 3 / Thursday, January 4, 2001 / Notices

The proposed consent order has been

placed on the public record for thirty

(30) days for reception of comments by

interested persons. Comments received

during this period will become part of

the public record. After thirty (30) days,

the Commission will again review the

agreement and the comments received

and will decide whether it should

withdraw from the agreement and take

other appropriate action or make final

the agreement’s proposed order.

This matter concerns advertising,

packaging, labeling, and promotional

practices related to the sale of Kwikset

Corporation’s lockset products,

including locksets, deadbolts, knobs,

and handles. The Commission’s

complaint charges that respondents

misrepresented on packaging and in

advertising that certain Kwikset

Corporation products are all or virtually

all made in the United States. In truth

and in fact, these products are actually

made with significant foreign content

and/or processing.

The proposed consent order contains

a provision that is designed to remedy

the charges and to prevent the

respondents from engaging in similar

acts and practices in the future. Part I of

the proposed order prohibits Kwikset

Corporation from misrepresenting the

extent to which any Kwikset lockset is

made in the United States. The order

defines Kwikset lockset products as any

product that is manufactured or sold by

Kwikset Corporation that is used to

secure doors, including but not limited

to locksets, deadbolts, knobs, and

handles. The proposed order would

allow Kwikset Corporation to represent

that such products are made in the

United States as long as all, or virtually

all, of the components of the products

are of U.S. origin, and all, or virtually

all, of the labor in manufacturing them

is performed in the United States.

The proposed order also prohibits

Kwikset Corporation from representing

that its products are ‘‘All American

Made’’ or ‘‘All American Made and

Proud of it’’ or otherwise entirely made

in the United States, unless such

products are in fact 100% made in the

United States.

Part II of the proposed order requires

respondents to maintain materials relied

upon in disseminating any

representation covered by the order.

Part III of the proposed order requires

Kwikset Corporation to distribute copies

of the order to certain company officials

and employees. Part IV of the proposed

order requires the respondents to notify

the Commission of any change in the

corporation that may affect compliance

obligations under the order. Part V of

the proposed order requires the

respondents to file one or more

compliance reports. Part VI of the

proposed order is a provision whereby

the order, absent certain circumstances,

terminates twenty years from the date of

issuance.

The purpose of this analysis is to

facilitate public comment on the

proposed consent order. If is not

intended to constitute an official

interpretation of the agreement and

proposed order or to modify in any way

their terms.

By direction of the Commission.

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 01–247 Filed 1–3–01; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1678]

Expansion of Medical Device Industry

Initiatives

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

some changes in its standard practices

for medical device, drug, food, and

biologics inspections based on the

outcome of the expansion of the medical

device industry initiatives pilot

program. FDA is discontinuing the

practice of post-inspection notification

letters for all inspections because the

agency now provides inspected

establishments with a copy of the

establishment inspection report (EIR)

when the inspection is deemed closed.

FDA has decided to maintain preannounced inspections and annotations

of the inspectional observations (FDA

483) as standard practices for medical

device inspections but with respect to

inspections of other program areas, to

apply these initiatives at the discretion

of district management.

DATES: The changes to the medical

device and expansion programs are

effective January 1, 2001, with the

publication of FDA’s 2001 edition of the

Investigations Operations Manual

(IOM). Written comments may be

submitted at any time in accordance

with FDA’s good guidance practices.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Denise D. Dion, Office of Regulatory

Affairs (HFC–130), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–5645,

FAX 301–443–6919.

SUPPLEMENTARY INFORMATION: During the

FDA/medical device industry grassroots

forums in 1995, several issues were

discussed concerning FDA’s interaction

with the medical device industry. A

decision was made to consider action on

three of the inspectional issues

discussed. These included instituting:

(1) Pre-announced inspections, (2)

listing promised or completed corrective

actions on FDA 483 items, and (3) postinspection notification to

establishments regarding their

compliance status.

In fiscal year (FY) 1996, FDA initiated

a pilot program for the medical device

industry, implementing these three

changes. The pilot program took place

during the 1996 calendar year and was

limited to inspections of medical device

manufacturers that did not manufacture

products that crossed other program

areas such as drugs or biologics. Preannounced inspections were offered to

those medical device firms that met the

criteria for inclusion in the pilot

program. The criteria included

nonviolative current good

manufacturing practices inspectional

histories and a history that records and

individuals were available at earlier preannounced inspections. FDA 483

annotations and the post-inspection

notification were done for all medical

device inspections whether or not the

inspection was pre-announced.

Based on industry input, FDA

initiated another year-long pilot

program in January 1999, to provide

similar coverage for program areas

including drugs (both human and

animal) and biologics. Food inspections

were limited to FDA 483 annotations

and post-inspection notification. In FY

2000, FDA considered the impact of the

second pilot’s effects on field

operations. The intent of the medical

device pilot program was to optimize

resource utilization, enhance FDA/

industry communications, and provide

firms prompt closure for nonviolative

inspections and for corrected inspection

observations. However, FDA determined

that the additional burdens placed on

field staff by the expansion into other

program areas failed to capitalize

resources and reduced overall field

inspectional productivity.

FDA believes that the new inspection

method for medical device firms (the

quality system inspection technique)

implemented in October 1999 provides

Federal Register / Vol. 66, No. 3 / Thursday, January 4, 2001 / Notices 801

a clear direction in the inspection of

these establishments, and provides

logical stopping points, thus making the

time it takes to complete an inspection

more predictable. FDA concludes that

pre-announcement of medical device

inspections will remain standard

procedure based on the defined criteria.

For other establishments, preannouncement of inspections remains

voluntary at the discretion of the local

FDA office. FDA will continue generally

not to pre-announce inspections of food,

blood bank, and plasmapheresis centers,

but this, too, will be left to the district’s

discretion.

FDA investigators traditionally have

discussed their observations with

appropriate management at the

establishment at the conclusion of the

inspection. These discussions are

reported in the Establishment

Inspection Report. FDA will continue

that practice, and will rely on the

discretion of the investigator/team to

determine whether to annotate the FDA

483. Since the medical device industry

specifically asked FDA for annotations

of the FDA 483, and since FDA has not

found this practice to adversely affect

the inspection process for medical

devices, annotations will remain

standard procedure for medical device

inspections only.

In April 1997, FDA implemented a

Field Management Directive (FMD 145)

that requires FDA field offices to

provide a copy of the EIR to the

inspected establishment once the

inspection is deemed closed. The copy

of the EIR is provided along with a letter

referred to as the ‘‘FMD 145 letter.’’ FDA

has found that the issuance of both a

post-inspection notification (PIN) letter

and a FMD 145 letter is redundant.

Because of this redundancy and the

burden this puts on the field, the PIN

letters will be discontinued in all

program areas. FMD 145 will remain in

place and these letters will continue to

be issued. Establishments will receive a

copy of their EIR when the inspection

is deemed closed based on 21 CFR

20.64(d).

The 2001 IOM will be posted to FDA’s

website at www.fda.gov/ora under

Inspection References/Investigations

Operations Manual. The IOM sections

that apply are: 510, 512.3, 516, 529 and

551.1. FMD 145 is posted to FDA’s

website at www.fda.gov/ora under

Inspection References/Field

Management Directives.

Dated: December 27, 2000.

John Marzilli,

Deputy Associate Commissioner for

Regulatory Affairs.

[FR Doc. 01–141 Filed 1–3–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1681]

Draft Guidance on Potassium Iodide as

a Thyroid Blocking Agent in Radiation

Emergencies; 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

‘‘Potassium Iodide as a Thyroid

Blocking Agent in Radiation

Emergencies.’’ This draft guidance

updates a notice of availability entitled

‘‘Potassium Iodide as a ThyroidBlocking Agent In a Radiation

Emergency: Final Recommendations On

Use’’ published in the Federal Register

on June 29, 1982, concerning the

prophylactic use of potassium iodide

(KI) in the event of release of radioactive

isotopes of iodine. In the draft guidance,

FDA maintains its position that KI is a

safe and effective means by which to

prevent radioiodine uptake by the

thyroid gland, under certain specified

condition for use, and thus to obviate

the risk of thyroid cancer in the event

of a radiation emergency.

DATES: February 5, 2001.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm. Submit written requests for

single copies of the draft guidance to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rose

E. Cunningham, Executive Operations

(HFD–06), Center for Drug Evaluation

and Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–6779.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance entitled ‘‘Potassium Iodide as

a Thyroid Blocking Agent in Radiation

Emergencies.’’

The Federal Emergency Management

Agency has established roles and

responsibilities for Federal agencies in

assisting State and local governments in

their radiological emergency planning

and preparedness activities. The Federal

agencies, including the Department of

Health and Human Services (DHHS), are

expected to accomplish these roles and

responsibilities as part of the Federal

Radiological Preparedness Coordinating

Committee. Among other

responsibilities, the DHHS is to provide

guidance on the use of radioprotective

substances to reduce radiation doses to

specific organs from the release into the

environment of large quantities of

radioactivity. FDA is specifically

charged with providing guidance on the

prophylactic use of KI in the event of

release of radioactive isotopes of iodine.

FDA is announcing the availability of

a draft guidance that updates the notice

of availability, ‘‘Potassium Iodide as a

Thyroid-Blocking Agent In a Radiation

Emergency: Final Recommendations On

Use,’’ published in the Federal Register

of June 29, 1982 (47 FR 28158). In this

draft guidance, FDA maintains its

position that KI is a safe and effective

means by which to prevent radioiodine

uptake by the thyroid gland, under

certain specified conditions of use, and

thus to lessen the risk of thyroid cancer

in the event of a radiation emergency. In

this draft guidance, FDA proposes lower

radioactive exposure thresholds for KI

prophylaxis as well as lower doses of KI

for neonates, infants, and children than

previously recommended. FDA’s

revised recommendations are in general

accordance with those of the World

Health Organization (WHO), as

expressed in its ‘‘Guidelines for Iodine

Phrophylaxis Following Nuclear

Accidents’’ (1999), though they differ

from those of the WHO in two areas.

First, for the sake of logistical

simplicity, FDA recommends the 65-

milligram (mg) dose of KI for all schoolage children while allowing for the full

adult dose of 130 mg in adolescents

approaching adult size. WHO

recommends 130 mg KI for adults and

adolescents (over 12 years of age).

Second, FDA recommends that KI

prophylaxis in those under age 19 and

in pregnant or lactating women be

triggered at a predicted thyroid

radioiodine exposure of 5 centiGray

(cGy), while WHO establishes 1 cGy as

the threshold for intervention. FDA has

concluded from the Chernobyl data that

the most reliable evidence demonstrates