66978 Federal Register / Vol. 60, No. 248 / Wednesday, December 27, 1995 / Notices

fifteen percent of their time enforcing

the Maine Act. Debt collector licensing

is also the primary responsibility of the

Superintendent and Deputy

Superintendent of the Bureau of

Consumer Credit Protection.

The Maine Bureau reviews the

financial posture of collection firms

applying for licenses and handles

numerous written debt collector

complaints each year, along with

hundreds of telephone complaints and

questions. Three additional individuals

in the office (consumer assistance

specialists) are trained to respond to

these inquiries about the activities of

debt collectors, with regard to both

federal and state debt collection law;

they also routinely petition the

administrator to initiate enforcement

proceedings to deal with suspected

violations of the Maine Act. The agency

has been involved in at least four court

actions in the past two years relating to

unlicensed practice or license

revocation. In addition, the Maine

Bureau has obtained voluntary

Assurances of Discontinuance from ten

debt collectors during the same time

period. The Maine Bureau publishes its

enforcement actions and mails the

information to all licensed companies as

a deterrent to further violative practices.

All license fees and examination

reimbursement costs accrue to the

agency as dedicated revenue within the

State’s budget process. In addition, a

portion of creditor and lender ‘‘volume

fees’’ based upon the amount of

consumer credit extended is also

dedicated to enforcement activities of

the Maine Bureau, on the theory that the

hiring of collection agencies by

consumer creditors justifies the funding

by those creditors of a portion of the

cost of regulating them. Approximately

$100,000 of the Maine Bureau’s total

budget of $800,000 is derived from

sources of revenue related to debt

collection activity and directed toward

enforcement of the Maine Act.

Thus, the personnel, facilities and

funding devoted to administering and

enforcing the Maine Act are comparable

to the resources expended by the

Commission in enforcing the FDCPA.

The fact that these resources will be

directed at the activities of debt

collectors in one state supports Maine’s

contention that it will have a greater

enforcement presence in the State of

Maine under the Maine Act than the

Commission does nationally under the

FDCPA.

C. Conclusion

After consideration of the facilities,

personnel and funding devoted to

administrative enforcement of the

Maine Act and the Maine Act’s

provisions for civil liability and

appropriate statutes of limitations for

both private and governmental actions,

the Commission finds that provisions

for enforcement of the Maine Act are

adequate, as required by Section

901.4(b) of the Procedures.

Action Taken

Based on the submissions of the

Maine Bureau of Consumer Credit

Protection in support of its request for

an exemption and upon the comments

received, the Commission concludes

that the Maine Act is substantially

similar to, and in some instances

provides greater protection than, the

FDCPA and contains provisions for

adequate enforcement. As such, it meets

all of the criteria set forth in Section

901.4 (a) and (b) of the Procedures. The

Commission has granted to the State of

Maine an exemption from Sections 803–

812 of the FDCPA for debt collection

practices conducted within the State on

that basis, in accordance with Section

817 of the FDCPA. The exemption will

remain in effect as long as state law

continues to afford substantially

equivalent protection to that of the

FDCPA.

To ensure that the conditions for an

exemption continue to be met, the State

of Maine must provide notice to the

Commission of any change in its law,

policies or procedures, including court

decisions, that would significantly affect

whether the state law continues to

afford substantially equivalent

protection and whether the State is

effectively enforcing the Maine Act. In

any event, the State of Maine must

provide a report to the Commission not

later than two years after the date this

exemption becomes effective, and every

two years thereafter, concerning the

manner in which the State has enforced

its law. The Commission reserves the

right to revise this reporting

requirement at a later date if

circumstances warrant or to request

additional information as needed.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 95–31316 Filed 12–26–95; 45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committees; Notice of

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces

forthcoming meetings of public advisory

committees of the Food and Drug

Administration (FDA). This notice also

summarizes the procedures for the

meetings and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETINGS: The following advisory

committee meetings are announced:

Allergenic Products Advisory

Committee

Date, time, and place. January 22,

1996, 3 p.m., Food and Drug

Administration, Bldg. 29, conference

room 121, 8800 Rockville Pike,

Bethesda, MD.

Type of meeting and contact person.

This meeting will be held by a

telephone conference call. A speaker

telephone will be provided in the

conference room to allow public

participation in the meeting. Open

public hearing, 3 p.m. to 4 p.m., unless

public participation does not last that

long; open committee discussion, 4 p.m.

to 4:40 p.m.; closed committee

deliberations, 4:40 p.m. to 5:30 p.m.;

William Freas or Sheila D. Langford,

Center for Biologics Evaluation and

Research (HFM–21), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–0314, or
Federal Register / Vol. 60, No. 248 / Wednesday, December 27, 1995 / Notices 66979

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Allergenic Products Advisory

Committee, code 12388.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

allergenic biological products intended

for use in the diagnosis, prevention, or

treatment of human disease.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before January 16, 1996,

then submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

name and addresses of the proposed

participants, and the indication of the

approximate time to make comments.

Open committee discussion. The

committee will discuss issues relevant

to an extension of the deadline for the

distribution of standardized and

nonstandardized grass pollen extracts.

Closed committee deliberations. The

committee will review trade secret and/

or confidential commercial information

relevant to three investigational new

drug applications. This portion of the

meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Vaccines and Related Biological

Products Advisory Committee

Date, time, and place. January 29, 30,

and 31, l996, 8 a.m., Parklawn Bldg.,

conference rooms D and E, 5600 Fishers

Lane, Rockville, MD.

Type of meeting and contact person.

Closed committee deliberations, January

29, 1996, 8 a.m. to 9 a.m.; open

committee discussion, 9 a.m. to 6:30

p.m.; open public hearing, January 30,

l996, 8 a.m. to 8:30 a.m., unless public

participation does not last that long;

open committee discussion, 8:30 a.m. to

3 p.m.; open public hearing, 3 p.m. to

3:30 p.m., unless public participation

does not last that long; open committee

discussion, 3:30 p.m. to 5:30 p.m.;

closed committee deliberations, January

31, l996, 8 a.m. to 10 a.m.; open public

hearing, 10 a.m. to 10:15 a.m., unless

public participation does not last that

long; open committee discussion, 10:15

a.m. to 1 p.m.; Nancy T. Cherry or

Sandy M. Salins, Scientific Advisors

and Consultants Staff (HFM–21), Center

for Biologics Evaluation and Research,

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Vaccines and

Related Biological Products Advisory

Committee, code 12388.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

vaccines intended for use in the

diagnosis, prevention, or treatment of

human diseases.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before January 22, 1996,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time required to make their

comments.

Open committee discussion. On

January 29, 1996, the committee will

review safety and efficacy data relating

to a product licensing application for a

rabies vaccine by Behringwerke A. G.

and a product licensing application for

a combined diphtheria, tetanus, and

acellular pertussis (whooping cough)

vaccine with infant indication from

Connaught Laboratories. On January 30,

l996, the committee will discuss the

influenza virus vaccine formulation for

1996–1997 and sequential schedules of

inactivated polio vaccines and oral

polio vaccines. On January 31, l996, the

committee will review safety and

efficacy data relating to a product

licensing application from Merck for an

inactivated Hepatitis A vaccine.

Closed committee deliberations. On

January 29 and 31, l996, the committee

will review trade secret and/or

confidential commercial information

relevant to pending product licensing

applications. These portions of the

meeting will be closed to permit

discussion of this information (5 U.S.C

552b(c)(4)).

Each public advisory committee

meeting listed above may have as many

as four separable portions: (1) An open

public hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. The dates and times reserved

for the separate portions of each

committee meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.
66980 Federal Register / Vol. 60, No. 248 / Wednesday, December 27, 1995 / Notices

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.

Dated: December 18, 1995.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 95–31292 Filed 12–26–95; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5–digit number.

This 5–digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5–

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETING: The following advisory

committee meeting is announced:

Cardiovascular and Renal Drugs

Advisory Committee

Date, time, and place. January 25,

1996, 8:30 a.m., and January 26, 1996,

9 a.m., National Institutes of Health,

Clinical Center, Bldg. 10, Jack Masur

Auditorium, 9000 Rockville Pike,

Bethesda, MD 20892. Parking in the

Clinical Center Visitor area is reserved

for clinical center patients and their

visitors. If you must drive, please use an

outlying lot such as Lot 41B. Free

shuttle bus service is provided from Lot

41B to the Clinical Center every 8

minutes during rush hour and every 15

minutes at other times.

Type of meeting and contact person.

Open public hearing, January 25, 1996,

8:30 a.m. to 9:30 a.m., unless public

participation does not last that long;

open committee discussion, 9:30 a.m. to

5:30 p.m.; open committee discussion,

January 26, 1996, 9 a.m. to 4:30 p.m.;

Joan C. Standaert (HFD–110), 419–259–

6211; or Valerie M. Mealy (HFD–21),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–4695, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area)

Cardiovascular Drugs Advisory

Committee, code 12533.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in cardiovascular and

renal disorders.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before January 13, 1996,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time required to make their

comments.

Open committee discussion. On

January 25, 1996, the committee will

discuss a Current Controversy: Calcium

Channel Blockers. On January 26, 1996,

the committee will review the Center for

Biologics Evaluation and Research’s

product license application 95–1210,

imciromaba pentetate (Myoscint,

Centocor), a monoclonal antibody for

use as an imaging agent for diagnosis of

cardiac necrosis.

FDA public advisory committee

meetings may have as many as four

separable portions: (1) An open public

hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open portions of each committee

meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,