13936 Federal Register / Vol. 66, No. 46 / Thursday, March 8, 2001 / Notices

Dissolution Testing.’’ This guidance is

intended to assist sponsors of new drug

applications (NDA’s) for levothyroxine

sodium tablets who wish to conduct in

vivo pharmacokinetic and

bioavailability studies and in vitro

dissolution testing for their products.

DATES: Submit written comments on

agency guidances at any time.

ADDRESSES: Submit written requests for

single copies of this 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

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance

document.

FOR FURTHER INFORMATION CONTACT: MeiLing Chen, Center for Drug Evaluation

and Research (HFD–350), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5688.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a guidance for industry entitled

‘‘Levothyroxine Sodium Tablets—In

Vivo Pharmacokinetic and

Bioavailability Studies and In Vitro

Dissolution Testing.’’ This guidance

contains agency recommendations on

how to design in vivo pharmacokinetics

and bioavailability studies and perform

in vitro dissolution testing for

levothyroxine sodium tablets, which

were identified as new drugs in a notice

published in the Federal Register of

August 14, 1997 (62 FR 43535).

FDA announced the availability of a

draft version of this guidance in the

Federal Register of June 10, 1999 (64 FR

31280). The June 1999 draft document

gave interested persons 60 days to

submit comments. FDA carefully

considered the comments it received

and has made appropriate revisions. A

separate section on biowaiver has been

added to clarify information that

appeared elsewhere in the draft

guidance. The guidance also specifies

that plasma/serum profiles and

pharmacokinetic measures should be

presented without adjustment of

baseline levels.

This guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

guidance represents the agency’s current

thinking on in vivo pharmacokinetic

and bioavailability studies and in vitro

dissolution testing for levothyroxine

sodium tablets. 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

requirements of the applicable statutes

and regulations.

II. Comments

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). 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 and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain this guidance at http://

www.fda.gov/cder/guidance/index.htm.

Dated: March 1, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–5610 Filed 3–7–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0331]

Medical Devices; Implementation of

Third Party Programs Under the FDA

Modernization Act of 1997; Final

Guidance for Staff, Industry and Third

Parties; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a revision to the guidance

document entitled ‘‘Guidance for Staff,

Industry and Third Parties:

Implementation of Third Party Programs

Under the FDA Modernization Act of

1997.’’ The revised guidance supersedes

the October 30, 1998, guidance. FDA

has amended the October 30, 1998,

guidance to include criteria for the

review of additional moderate risk (class

II) devices by accredited persons under

the Federal Food, Drug, and Cosmetic

Act (the act). The revised guidance will

assist those who are interested in

participating in the expanded program,

which is now in effect.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

guidance entitled ‘‘Implementation of

Third Party Programs Under the FDA

Modernization Act of 1997; Final

Guidance for Staff, Industry and Third

Parties’’ 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 self-addressed adhesive labels

to assist that office in processing your

request, or fax your request to 301–443–

8818. Submit written comments

concerning this guidance 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 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: John

F. Stigi, Center for Devices and

Radiological Health (HFZ–220), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301–443–

6597.

SUPPLEMENTARY INFORMATION:

I. Background

On August 1, 1996, FDA began a

voluntary Third Party Review Pilot

Program for selected medical device

premarket notifications (‘‘510(k)’s’’).

The purpose of the pilot program was

to: (1) Provide manufacturers of eligible

devices an alternative 510(k) review

process that could yield more rapid

marketing clearance decisions; and (2)

enable FDA to target its scientific review

resources at higher risk devices, while

maintaining confidence in the review by

third parties of low-to-moderate risk

devices. Under the program, all class I

devices that were not exempt from

510(k) at that time and 30 class II

devices were eligible for third party

review.

The Food and Drug Administration

Modernization Act of 1997 (FDAMA)

was signed into law by former President

Clinton on November 21, 1997. Section

210 of FDAMA essentially codified and

expanded the Third Party Review Pilot

Program by establishing section 523 of

the act (21 U.S.C. 360m). Section 523 of

the act directs FDA to accredit third

Federal Register / Vol. 66, No. 46 / Thursday, March 8, 2001 / Notices 13937

parties (accredited persons) in the

private sector to conduct the initial

review of 510(k)’s for low-to-moderate

risk devices and make recommendations

to FDA regarding the initial

classification of these devices under

section 513(f)(1) of the act (21 U.S.C.

360c(f)(1)). FDA published criteria in

the Federal Register of May 22, 1998 (63

FR 28388), to grant or deny

accreditation to persons who request to

review 510(k)’s. In addition, FDA issued

a list of devices that were eligible for

review by accredited persons (May 20,

1998), which was updated in June 2000

to include additional class II devices for

which device-specific guidance exists.

This list is available on the Internet at

http//www.fda.gov/cdrh/thirdparty.

FDA also issued a guidance document

entitled ‘‘Guidance for Staff, Industry

and Third Parties: Implementation of

Third Party Programs Under the FDA

Modernization Act of 1997’’ (October

30, 1998). On November 21, 1998, FDA

began accepting reviews and

recommendations from accredited

persons. Concurrently, FDA terminated

the Third Party Review Pilot Program

that began on August 1, 1996.

Industry use of third parties has been

low. In an effort to encourage greater use

of the Accredited Persons Program, the

agency announced in the Federal

Register of July 18, 2000 (65 FR 44540),

a proposal to initiate a pilot that would

allow third parties to review a

significantly greater number of devices

(hereinafter referred to as the July 2000

notice). Accordingly, FDA issued a draft

revision of the October 30, 1998,

guidance document and made available

a proposed list of additional devices

that would be eligible under the pilot.

The pilot would expand the device

list by allowing, subject to certain

specified conditions, third party review

of class II devices for which devicespecific guidance does not exist. Until

now, device-specific guidance has

existed for each class II device that is

eligible for third party review. The pilot

program would also include devices for

which there is an exemption from

510(k). That is, if a new version of an

exempted device requires a 510(k)

because it exceeds the limitations of the

510(k) exemption for that device (as

described in FDA’s device classification

regulations), the device would be

eligible for third party review. The pilot,

together with the existing device list,

would allow third party review of all

class I and class II devices regulated by

CDRH that the agency believes are not

prohibited from such review under the

statute. Section 523(a)(3)(A) of the act

specifies that an accredited person may

not review: (1) A class III device, (2) a

class II device which is intended to be

permanently implanted or lifesupporting or life-sustaining, or (3) a

class II device which requires clinical

data in the report submitted under

section 510(k). (Section 523 of the act

sets limits on the number of class II

devices that may be ineligible for

accredited person review because

clinical data are required.)

As with the current Accredited

Persons Program, the pilot would not

include 510(k)’s that require multiCenter review (e.g., 510(k)’s for drug/

device combination products) or devices

for which the Center for Biologics

Evaluation and Research has primary

responsibility for review. FDA believes

that the expanded number of devices

resulting from the pilot and the existing

program will be sufficient to satisfy the

criteria in section 523(c) of the act that

trigger a 4- or 5-year timeframe for the

duration of the Accredited Persons

Program.

Both the draft revised guidance

document and the July 2000 notice

provided an opportunity for public

comment, which closed September 1,

2000. Based on the comments received,

the following substantive changes have

been incorporated into the final version

of the revised guidance.

1. Section II.B (Outline of the

Accredited Persons Review Program—

Purpose and Nature of the Program) has

been revised as follows:

• FDA has clarified that accredited

persons should receive expanded

accreditation in order to review devices

in the pilot.

• The recommended conditions for

participation in the pilot have been

revised. The condition that an

accredited person complete three

successful 510(k) reviews under the

third party program in order to

participate in the pilot has been

retained. However, the condition that at

least one of the reviews be in the same

or a similar medical specialty area as the

pilot devices that the accredited person

intends to review has been removed.

Also, the condition that an accredited

person contact the appropriate CDRH

Office of Device Evaluation (ODE)

Branch Chief (or designee) before

initiating a review of a device under the

pilot has been revised. The revised

condition for prereview contact applies

only if the accredited person has not

previously reviewed this type of device,

i.e., a prereview contact is expected for

the accredited person’s first review of a

particular device type but not for

subsequent reviews of the same device

type.

• The stated purpose of the prereview

contacts has been revised for

consistency with the above changes.

Also, FDA has clarified that an

accredited person’s summary of

prereview contacts: (1) Should be

submitted to ODE with the accredited

person’s 510(k) review, (2) does not

require prior ODE review or

concurrence, and (3) is intended to be

a simple record of the contacts rather

than an ‘‘agreement’’ or de facto

guidance.

2. Section II.B (Outline of the

Accredited Persons Review Program—

Devices Eligible for Accredited Person

Review) has been revised to state that

FDA will monitor the pilot continuously

and will conduct a review 24 months,

rather than 12 months, after it begins.

3. Section II.B (Outline of the

Accredited Persons Review Program—

Identification of an Accredited Person)

has been revised to remove language

encouraging manufacturers to use

multiple accredited persons. In this

context, the language was interpreted as

suggesting that manufacturers should

not interact repeatedly with the same

accredited person, which was not FDA’s

intent.

FDA believes that the revised

guidance will contribute to timely and

consistent third party reviews of

510(k)’s for the expanded list of devices.

Accredited persons who wish to expand

their accreditation to include devices in

the pilot should submit a request to

FDA, as described in Section III of the

revised guidance document.

II. Significance of Guidance

This guidance represents the agency’s

current thinking on expanding the scope

of the Accredited Persons Program to

include all devices not excluded by

statute. 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 1 guidance consistent

with FDA’s GGP’s regulation.

III. Electronic Access

In order to receive ‘‘Implementation

of Third Party Programs Under the FDA

Modernization Act of 1997; Final

Guidance for Staff, Industry, and Third

Parties’’ via your fax machine, call

CDRH Facts-on-Demand (FOD) system

at 800–899–0381 or 301–827–0111 from

a touch-tone telephone. At the first

13938 Federal Register / Vol. 66, No. 46 / Thursday, March 8, 2001 / Notices

voice prompt press 1 to access DSMA

Facts, at second voice prompt press 2,

and then enter the document number

(1160) 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 the civil

money penalty guidance documents

package, 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

‘‘Implementation of Third Party

Programs Under the FDA Modernization

Act of 1997; Final Guidance for Staff,

Industry and Third Parties’’ is available

at http://www.fda.gov/cdrh/thirdparty.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding the

guidance at any time. 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: February 26, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–5611 Filed 3–7–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Fiscal Year (FY) 2001 Funding

Opportunities

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Notice of funding availability.

SUMMARY: The Substance Abuse and

Mental Health Services Administration

(SAMHSA) Center for Mental Health

Services (CMHS) announces the

availability of FY 2001 funds for grants

for the following activity. This notice is

not a complete description of the

activity; potential applicants must

obtain a copy of the Guidance for

Applicants (GFA), including Part I,

Circles of Care, and Part II, General

Policies and Procedures Applicable to

all SAMHSA Applications for

Discretionary Grants and Cooperative

Agreements, before preparing and

submitting an application.

Activity Application deadline Est. funds FY 2001 Est. No. of

awards Project period

Circles of Care ................................ May 10, 2001 ................................. $2.4 million ..................................... 7–9 3 years.

The actual amount available for the

award may vary, depending on

unanticipated program requirements

and the number and quality of

application received. FY 2001 funds for

the activity discussed in this

announcement were appropriated by

Congress under Public Law No. 106–

310. SAMHSA’s policies and

procedures for peer review and

Advisory Council review of grant and

cooperative agreement application were

published in the Federal Register (Vol.

58, No. 126) on July 2, 1993.

General Instructions: Applicants must

use application form PHS 5161–1 (Rev.

7/00). The application kit contains the

two-part application materials

(complete programmatic guidance and

instructions for preparing and

submitting applications), the PHS 5161–

1 which includes Standard Form 424

(Face Page), and other documentation

and forms. Application kits may be

obtained from: National Mental Health

Services Knowledge Exchange, Network

(KEN), PO Box 42490, Washington, DC

20015, Telephone: 1–800–789–2647.

The PHS 5161–1 application form and

the full text of the activity are also

available electronically via SAMHSA’s

World Wide Web Home Page: http://

www.samhsa.gov.

When requesting an application kit,

the applicant must specify the particular

activity for which detailed information

is desired. All information necessary to

apply, including where to submit

applications and application deadline

instructions, are included in the

application kit.

Purpose: Substance Abuse and Mental

Health Services Administration

(SAMHSA) Center for Mental Health

Services (CMHS) announces the

availability of FY 2001 funds for grants

to federally recognized tribal

governments and urban Indian

organizations to plan, design, and assess

the feasibility of implementing a

culturally appropriate system of care for

American Indian and Alaska Native (AI/

AN) children and their families who are

experiencing or are at risk of serious

emotional/behavioral disturbance. This

is the second issuance of the grant

program which seeks to provide tribal

communities with tools and resources to

design systems of care for their children

that reflect the unique needs of their

communities. This grant program will

not fund actual services. An important

focus will be to integrate traditional

healing methods indigenous to the

communities with conventional

treatment methodologies.

Eligibility: Tribal governments and

urban Indian organizations as defined

by the Indian Self Determination Act,

Pub. L. 93–638, and the Indian Health

Care Improvement Act, Pub. L. 94–437

can apply. The terms ‘‘Indian,’’ ‘‘tribal,’’

‘‘AI/AN,’’ and ‘‘Native American’’

include Alaska Native organizations.

Collaboration with tribal colleges or

universities is strongly encouraged.

Previous Circle of Care grantees are not

eligible to apply.

Availability of Funds: Approximately

$2.4 million will be available for 7–9

awards. The average award will be

approximately $275,000 per year in total

costs (direct and indirect), with awards

ranging from $250,000–$350,000. Actual

funding levels will depend on the

availability of funds, state population,

problems identified in the National

Household Survey on Drug Abuse, and

other factors.

Period of Support: Support may be

requested for up to 3 years. Annual noncompetitive awards depend on the

availability of funds and progress

achieved.

Criteria for Review and Funding—

General Review Criteria: Competing

applications requesting funding under

this activity will be reviewed for

technical merit in accordance with