Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33101

CP1) under 21 CFR 10.30 to FDA. The

petition requested that the agency

determine whether metformin HCl

tablets, 625- and 750-mg were

withdrawn from sale for reasons of

safety or effectiveness.

FDA has reviewed its records and,

under § 314.161, has determined that

Bristol-Myers Squibb’s decision not to

market metformin HCl 625- and 750-mg

tablets was not due to concerns about

safety or effectiveness of the product.

Accordingly, the agency will maintain

metformin HCl 625- and 750-mg tablets

in the ‘‘Discontinued Drug Product List’’

section of the Orange Book.

The ‘‘Discontinued Drug Product List’’

delineates, among other items, drug

products that have been discontinued

from marketing for reasons other than

safety or effectiveness. ANDAs that refer

to metformin HCl 625- and 750-mg

tablets may be approved by the agency.

Dated: June 12, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15442 Filed 6–19–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Biological Response Modifiers

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Biological

Response Modifiers Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 13, 2001, 8:30 a.m. to 4

p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact: Gail Dapolito or Rosanna L.

Harvey (HFM–71), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–0314, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12389. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will meet to:

(1) Discuss responses to the March 6,

2000, FDA gene therapy letter (http://

www.fda.gov/cber/letters.htm) relating

to adenovirus vector titer measurements

and replication competent adenovirus

levels reporting, and (2) hear updates on

the NIH final action on serious adverse

reporting.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 6, 2001. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 noon. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 6, 2001, 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

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 12, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–15443 Filed 6–19–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–1075]

Public Health Impact of Vibrio

Parahaemolyticus in Raw Molluscan

Shellfish; Draft Risk Assessment

Document; Availability; Reopening of

Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; reopening of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening until

July 18, 2001, the comment period on its

draft risk assessment on the relationship

between Vibrio parahaemolyticus in

raw molluscan shellfish and human

health (66 FR 5517, January 19, 2001).

Interested persons were initially given

until March 20, 2001, with an extension

to May 21, 2001 (66 FR 13546, March

6, 2001), to comment on the draft risk

assessment. This reopening of the

comment period is in response to a

request from the National Fisheries

Institute (NFI) on behalf of the Gulf

Oyster Industry Council, the Pacific

Coast Shellfish Growers Association,

and the Molluscan Shellfish Institute.

The agency does not anticipate further

extensions of the comment period for

this draft risk assessment.

DATES: Submit written comments by

July 18, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Two copies

of comments are to be submitted, except

that individuals may submit one copy.

Comments must be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be reviewed at the

Dockets Management Branch (address

above) between 9 a.m. and 4 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Sherri B. Dennis, Risk Assessment

Coordinator, Center for Food Safety and

Applied Nutrition (HFS–32), Food and

Drug Administration, 200 C St., SW.,

Washington, DC 20204, 202–260–3984,

FAX 202–260–9653, e-mail:

sdennis@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 19, 2001 (66

FR 5517), FDA announced the

availability of a draft risk assessment on

the relationship between Vibrio

parahaemolyticus in raw molluscan

shellfish and human health. Comments

were sought on the technical aspects of

the draft risk assessment in the

following areas: (1) The assumptions

made, (2) the modeling technique, (3)

the data used, and (4) the transparency

of the draft risk assessment document.

Interested persons were given until

March 20, 2001, to comment on the

draft risk assessment. In the Federal

Register of March 6, 2001, FDA

extended the comment period to May

21, 2001 (66 FR 13546), because a

public meeting to receive comments on

the document was scheduled for March

20, 2001 (March 6, 2001, 66 FR 13544),

the same day the comment period

closed. The NFI, on behalf of the Gulf

Oyster Industry Council, the Pacific

Coast Shellfish Growers Association,

and the Molluscan Shellfish Institute,

has requested a second extension of the

comment period to allow additional

time to review, analyze, and

constructively respond to the draft risk

assessment. The extended comment

period closed on May 21, 2001. FDA, in

response to the NFI request, is

33102 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

reopening the comment period until

July 18, 2001. The agency does not

anticipate further extensions of the

comment period for this draft risk

assessment.

You must submit written comments to

the Dockets Management Branch

(address above) by July 18, 2001, in

order for those comments to be

considered.

A printed copy of the draft risk

assessment and/or a CD–ROM of the

risk assessment model may be requested

by faxing your name and mailing

address with the names of the

documents you are requesting to the

CFSAN Outreach and Information

Center at 1–877–366–3322. The

documents may be reviewed at the

Dockets Management Branch at the

address and hours noted above. The

draft risk assessment is also available

electronically at www.cfsan.fda.gov,

www.foodsafety.gov, and

www.foodriskclearinghouse.umd.edu.

Dated: June 12, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15441 Filed 6–19–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–855]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Medicare

Federal Health Care Programs Provider/

Supplier Enrollment Application; Form

No.: HCFA–855 (OMB# 0938–0685);

Use: This information is needed to

enroll providers and suppliers into the

Medicare program by identifying them,

pricing and paying their claims, and

verifying their qualifications and

eligibility to participate in Medicare;

Frequency: Initial enrollment/

recertification and Every three years;

Affected Public: Business or other forprofit, Individuals or Households, and

Not-for-profit institutions; Number of

Respondents: 1,300,000; Total Annual

Responses: 604,000; Total Annual

Hours: 1,302,000.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, DC 20503.

Dated: May 29, 2001.

John P. Burke, III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–15449 Filed 6–19–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–0280]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Request:

Extension of a currently approved

collection; Title of Information

Collection: Medigap Compare; HCFA

Form Number: HCFA–R–0280 (OMB

approval #: 0938–0767); Use: HCFA

electronically collects plan-specific

Medigap data, including but not limited

to premiums charged and additional

benefits offered, from each insurer

offering Medigap plans and provides the

data on www.medicare.gov to assist

beneficiaries in obtaining accurate

information on all their health care

coverage options; Frequency: Annually,

Semi-annually; Affected Public:

Business or other for-profit, Federal

Government, State, Local, or Tribal

Government, Not-for-profit institutions;

Number of Respondents: 300; Total

Annual Responses: 450; Total Annual

Burden Hours: 75.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: May 29, 2001.

John P. Burke, III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–15450 Filed 6–19–01; 8:45 am]

BILLING CODE 4120–03–P