29416 Federal Register / Vol. 61, No. 112 / Monday, June 10, 1996 / Notices

Under the provisions of the law, States

may receive allotments only after an

application is approved by the

Secretary, DHHS. The uniform

application format provides States with

the forms and instructions for their

applications so they can comply with

the requirements of the law and

regulations implementing the law. The

annual burden estimate is shown below:

No. of

respondents

No. of responses per

respondent

Avg. burden per

response

Total

annual

burden

60 1 561.5

hours.

33,690

hours.

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Virginia Huth, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10236, Washington, DC

20503.

Dated: May 31, 1996.

Patricia S. Bransford,

Acting Executive Officer, Substance Abuse

and Mental Health Services Administration.

[FR Doc. 96–14573 Filed 6–7–96; 8:45 am]

BILLING CODE 4162–20–P

Food and Drug Administration

Import and Private Laboratory

Communities: Public Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meetings.

SUMMARY: The Food and Drug

Administration’s (FDA’s) Office of

Regulatory Affairs (ORA) is announcing

a series of Grassroots Meetings to be

held with the import and private

laboratory communities. These meetings

will follow a prescribed format similar

to what was used recently in the

Grassroots Regulatory Partnership

Meetings held as part of the National

Performance Review and will be

conducted by key agency officials

including ORA’s Division of Field

Science, the Division of Import

Operations and Policy, and other

representatives from the field and

headquarters.

The purpose of the meetings is to

establish a dialogue with the import,

domestic, and private laboratory

communities, trade associations, and

other interested persons. The intent of

the dialogue is to explore ways the

agency might improve current policy

and procedures related to the use of

private laboratories to establish product

compliance with FDA regulations. After

the meetings a report will be prepared

outlining a strategy for making positive

changes in policy and/or procedures

related to the agency’s use of analytical

data from private laboratories.

DATES: The public meetings are

scheduled as follows:

1. Tuesday, June 25, 1996, 9 a.m. to

4:30 p.m., Brooklyn, NY.

2. Friday, June 28, 1996, 9 a.m. to 4:30

p.m., Orlando, FL.

3. Tuesday, July 9, 1996, 9 a.m. to 4:30

p.m., Houston, TX.

4. Thursday, July 11, 1996, 9 a.m. to

4:30 p.m., Oakland, CA.

ADDRESSES: The public meetings will be

held at the following locations:

1. Brooklyn—Fort Hamilton Community

Club, 101st St. and Fort Hamilton

Pkwy., Bldg. 207, Brooklyn, NY.

2. Orlando—Sheraton Plaza Hotel, 1500

Sand Lake Rd., Orlando, FL.

3. Houston—Houston Plaza Hilton, 6633

Travis St., Houston, TX.

4. Oakland—Oakland Federal Bldg.,

Edward Royball Auditorium, 1301 Clay

St., Oakland, CA.

FOR FURTHER INFORMATION CONTACT:

Regarding attendance at the Brooklyn,

NY public meeting: George Walden,

Small Business Representative

Northeast Region, 850 Third Ave.,

Brooklyn, NY 11232, 718–965–

5300, ext. 5528 or FAX 718–965–

5759.

Regarding attendance at the Orlando,

FL public meeting: Barbara WardGroves, Small Business

Representative Southeast Region, 60

Eighth St. NE., Atlanta, GA 30309,

404–347–4001, ext. 5256 or FAX

404–347–4349.

Regarding attendance at the Houston,

TX public meeting: Marie T.

Falcone, Small Business

Representative Southwest Region,

7920 Elmbrook Dr., suite 102,

Dallas, TX 75247–4982, 214–655–

8100, ext. 128 or FAX 214–655–

8130.

Regarding attendance at the Oakland,

CA public meeting: Mark S. Roh,

Small Business Representative

Pacific Region, Oakland Federal

Bldg., 1301 Clay St., suite 1180–N,

Oakland, CA 94612–5217, 510–

637–3980 or FAX 510–637–3977.

In addition to this public notice of the

meetings, invitations will be sent

directly to interested persons

representing private laboratories,

importers, brokers, independent

samplers, scientific and trade

associations, accreditation bodies, and

domestic users of private laboratories.

Interested persons who have not

received an invitation to attend one of

these meetings by June 7, 1996, may

contact the Small Business

Representatives specified above for

registration forms.

Persons who are unable to attend, or

who cannot be accommodated due to

space limitations are invited to provide

written comments. Written comments

may be submitted to Liza Lehman,

Division of Field Science (HFC–140),

5600 Fishers Lane, rm. 12–41, Rockville,

MD 20857. Issues submitted in writing

will be included for discussion at the

meetings and will appear in the final

report.

Questions related to these meetings

should be directed to Richard A.

Baldwin or Liza Lehman (address

above) or by calling 301–443–7103

between 8 a.m. and 4:30 p.m.

SUPPLEMENTARY INFORMATION: The

following background information is

provided for meeting participants. The

term ‘‘private laboratory’’ refers to those

private sector laboratories that conduct

analysis on freely marketed, FDA

regulated products whose analytical

data is submitted to the agency in order

to demonstrate a product’s compliance

with laws and regulations administered

by FDA.

Meeting Objectives

(1) To establish a dialogue with the

import, domestic, and private laboratory

communities; trade associations; and

other interested persons on ways the

agency might improve current policy

and procedures related to the use of

private laboratories to establish product

compliance with FDA laws and

regulations.

(2) To obtain information and views

from interested persons on ways the

agency might enhance its use of private

laboratories to facilitate getting products

that comply with applicable laws and

regulations to the consumer while

removing non-compliant products from

the marketplace.

The following workshops will be

offered at each meeting:

Workshop I

Workshop I will focus on the

following issues:

(1) What practices, procedures, or

policies should be changed so that

private sector testing expedites the

removal of products that do not comply

with FDA laws and regulations and the

distribution of products that are fully

compliant?

(2) What is FDA’s experience with

how the current process works?

(3) What needs to be changed about

the current process?

(4) Why and how?
Federal Register / Vol. 61, No. 112 / Monday, June 10, 1996 / Notices 29417

(5) To what extent are training and

education involved?

(6) What are the training needs of

private laboratories?

(7) How can FDA, industry, and

private laboratories work together to

meet these training needs?

Background for Workshop I

FDA has long recognized the role of

private laboratories in evaluating the

quality and safety of FDA regulated

commodities produced both

domestically and abroad. Certificates of

analysis (or analytical data) issued (or

generated) by private laboratories are

sometimes used by FDA to assist it in

making regulatory decisions. This most

often occurs when Certificates of

Analysis are received for products

offered for import to this country that

have been detained without FDA

examination due to previous violations

or when FDA is concerned about a

potential public health problem. FDA

may also make compliance decisions

with the help of private laboratory

results for domestic products that have

undergone reconditioning under the

terms of a consent decree of

condemnation, or to comply with the

terms of a consent decree of permanent

injunction, so that the firm may lawfully

resume operations.

FDA needs to ensure that private

laboratories submitting analytical

results are capable of performing the

analyses and that the results submitted

were obtained using reliable and

appropriate methods. The current

guidance for the review of private

laboratory results submitted in support

of regulated products is outlined in

chapter 21 of the Laboratory Procedures

Manual (LPM). The stated purpose of

this guidance is to establish a uniform,

systematic, and effective approach to

ensure that private laboratories

conducting analyses on FDA regulated

products submit appropriate and

reliable data to the agency. Based on

LPM chapter 21, the existing

mechanism for FDA’s acceptance of

private laboratory data involves the

review of analytical data for scientific

validity along with the evaluation of a

laboratory’s capabilities through

assessment visits and audit sampling.

In recent meetings with the private

laboratory community, an issue has

been raised concerning the lack of

uniformity among the FDA District

Offices (the Districts) in evaluating

private laboratory submissions. FDA is

committed to attaining a uniform

application of policy and program

guidelines among all Districts in the

handling of private laboratory

submissions. Possible solutions FDA

may consider implementing to improve

uniformity include: (1) The

establishment of a national data base on

private laboratories to be used as a

mechanism for sharing information

among the Districts (see Attachment);

(2) providing better coordination of

assessment and review efforts through

training and strengthening the guidance

provided to the Districts; and (3)

identifying other ways to foster

communications among interested

parties involved in private laboratory

issues.

Another topic of discussion

concerned the training needs of private

laboratories. FDA is often asked to

answer questions related to sample

collection, analytical methodology, and

the documentation needed to

demonstrate product compliance with

FDA laws and regulations. As a result of

these inquiries, training seminars have

been conducted for private laboratories

(and importers) on a variety of topics.

Some of these seminars have included

training on the use of sample collection

and analysis techniques employed by

FDA.

FDA would like to better identify the

training needs of private laboratories.

We would also like to explore

mechanisms for effectively providing

any necessary training to private

laboratories.

Workshop II

Workshop II will focus on the

following issues:

(1) How should FDA ensure the

competency and proficiency of private

laboratories?

(2) What should be FDA’s guiding

principles in ensuring the competency

and proficiency of private laboratories?

(3) What criteria should FDA use to

assess integrity and quality of private

sector sampling and analysis data?

(4) Under what circumstances should

FDA base public health protection

decisions on private sector sampling

and analysis of regulated products?

(5) What are the barriers or hurdles to

what FDA proposes?

(6) How do private laboratories

demonstrate their competency to their

customers?

(7) Is this mechanism appropriate for

FDA to use?

Background for Workshop II

There are several mechanisms the

agency could use to ensure the

proficiency and integrity of private

sector sampling and analysis of

regulated products. They include

options such as maintaining the current

program, adjusting the current program

to focus on assuring a more consistent

agency approach, adding components to

the current program such as an

independent sampling and direct

reporting requirement, seeking

regulatory authority to inspect and

impose Good Laboratory Practices

regulations on private laboratories, and

formally accrediting or recognizing third

party accreditations of private

laboratories.

FDA currently has serious concerns

about the effectiveness of our current

program. We presently are unable to

ensure the integrity of the sample

collection process because we do not

require that all samples be collected

independently or by qualified sample

collection agents. When the sample is

collected improperly, or is not truly

representative of the lot to be tested,

then even the most reliable and effective

analytical testing procedures will be

invalid. An additional concern

regarding our current procedures is that

the analytical results obtained by a

private laboratory are not required to be

submitted directly to the agency for

review. Because FDA does not require

that an initial or subsequent violative

result be submitted directly from the

private laboratory, a violative product

can be retested until results are obtained

that will remove the appearance of a

violation. The validity of this laboratory

result is, of course, questionable based

on previous results, but FDA does not

have the information concerning earlier

testing on which to base the appropriate

consumer protection decision. FDA is

considering incorporating these two

concepts of mandatory independent

sampling, and direct reporting of

analytical results by private laboratories

to FDA into our current program.

Workshop III

Workshop III will focus on the

following issues:

(1) How can FDA best enhance its use

of private laboratories to test regulated

products?

(2) What is meeting participants’

comfort level with shared consumer

protection authority and liability?

(3) What are FDA and private sector

common interests and how can we

capitalize on them?

(4) What are our mutual

responsibilities and to whom?

(5) On what basis can FDA and the

private sector collaborate?

Background for Workshop

FDA would like to enhance its use of

the private sector in monitoring

imported foods and possibly other

regulated products as well. Several

initiatives along this line have already

been implemented. For example, the
29418 Federal Register / Vol. 61, No. 112 / Monday, June 10, 1996 / Notices

New York District recently completed a

pilot program in which importers of

seafood products were allowed to

choose between having their products

sampled and tested by FDA or by a

private laboratory at their own expense.

A similar pilot program was conducted

in Boston District. The New York and

Boston pilot programs are currently

being evaluated to see if further pilot

studies can be developed to make better

use of non-FDA laboratories for

monitoring imported products.

Our intention is to improve our

current policy and program regarding

the use of data from private laboratories.

The existing mechanism for the

assessment of private laboratories and

review of analytical packages may be

adequate for our current needs as we

move to enhance our use of the private

sector for analytical testing, however,

we will likely find the need for a more

streamlined and effective approach to

assessing the competency of a private

laboratory and the validity of its test

results.

Enhancing FDA’s use of private

laboratories may also be dependent on

the private sector’s ability to comply

with international standards. As a

result, another potential issue for

discussion includes the standards for

analytical laboratories being developed

by the joint Food and Agriculture

Organization of the United Nations and

World Health Organization’s Codex

Alimentarius Commission. At the 20th

Session of the Codex Committee on

Methods of Analysis and Sampling (the

Committee), the Committee agreed that

certain criteria for quality assurance be

adopted by laboratories involved in the

official import and export control of

foods. The Committee recommendations

include compliance with the general

criteria for testing laboratories laid

down in ISO/IEC Guide 25:1990,

‘‘General Requirements for the

Competence of Calibration and Testing

Laboratories,’’ participation in

appropriate proficiency testing schemes,

the use validated analytical methods,

and the application of internal quality

control procedures. These criteria have

been referred to the Codex Committee

on Food Import and Export Inspection

and Certification Systems for

consideration and review to be used for

the development of objective criteria for

assessing the competency of laboratories

involved in the testing of foods at the

international level. FDA is committed to

using international standards whenever

appropriate, and to working with

international standards organizations

like Codex to develop and adopt

international standards that provide

adequate health protection.

Because of the agency’s commitment

to international harmonization efforts,

the fact that the Committee has made

these recommendations is significant to

FDA. Successful application of these

criteria may be viewed as providing a

sound basis for judging the level of

quality of both public and private

laboratories. Discussion of how (and if)

FDA should implement these criteria in

evaluating the competency of private

laboratories may be included during this

workshop.

Attachment—Proposal for the Development

of a National Data base on Private

Laboratories

An internal FDA-wide private laboratory

inventory will be established. This data base

is envisioned as being a repository of basic

information on private laboratories that

routinely submit analytical packages to the

agency. The data base will be simple in

design serving mainly to foster

communication between the Districts.

The following guidance will be issued

related to the use of the private laboratory

inventory (PLI):

This data base contains information on

certain private laboratories that submit

analytical results for review to the agency.

Private laboratories that do not routinely

submit analytical packages to the agency do

not appear on this list, since creating a

directory of all private laboratories capable of

analyzing regulated products, including

those laboratories that are associated with

regulated industry, or laboratories that have

not submitted analytical data for agency

review, is not our intention.

The information provided in the PLI is to

be used only as a tool to help District

personnel make appropriate individual

product compliance decisions. The

information is not intended to be used as a

final evaluation of the acceptability of results

for the noted types of analyses from a given

private laboratory. As always, Districts

should make individual product compliance

decisions based on all information available

regarding whether or not private laboratory

analyses are sufficient to demonstrate

product compliance.

This data base may not be treated as an all

inclusive listing of private laboratories that

are capable of submitting high quality data

or analytical results on regulated products to

the agency.

The following information will be included

in the data base:

Private Laboratory Data

Private Laboratory Name

Private Laboratory Contact/Phone

Complete Mailing Address

Home District Contact/Phone

Submission Data

Type(s) of analytical packages submitted

(Chemistry, Micro, Filth, etc)

Date and type of analytical package

submission (Date, product, analysis type)

Analysis results

Audit sample results

Narrative describing the audit sample results

Analytical package review (Accepted,

accepted with Comment, Unacceptable)

Analytical package review comments

Private Laboratory Assessment Data

Status of initial assessment records on file

per analysis type (complete, in process)

Date of most recent on-site assessment visit

per analysis type (month/year)

Narrative results of assessment visit(s) per

analysis type.

Dated: May 30, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–14586 Filed 6–7–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[MB–098–CN]

RIN 0938–AH30

Medicaid Program; Limitations on

Aggregate Payments to

Disproportionate Share Hospitals:

Federal Fiscal Year 1996; Correction

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Correction notice.

SUMMARY: In the May 9, 1996 issue of

the Federal Register (61 FR 21195), we

announced the preliminary Federal

fiscal year (FFY) 1996 national target

and individual State allotments for

Medicaid payment adjustments made to

hospitals that serve a disproportionate

number of Medicaid recipients and lowincome patients with special needs. In

that notice, we inadvertently omitted

the chart that contained the listing of

the individual State allotments and the

regulation identification number (RIN)

in the heading of the notice. In addition,

only a portion of the Catalog of Federal

Domestic Assistance identification at

the end of the document prior to the

signatures was included. For the benefit

of the readers, we are reprinting the

entire notice. The corrected notice reads

as follows:

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[MB–098–N]

RIN 0938–AH30

Medicaid Program; Limitations on

Aggregate Payments to

Disproportionate Share Hospitals:

Federal Fiscal Year 1996

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

preliminary Federal fiscal year (FFY)

1996 national target and individual