33100 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

comprised of a subset of user facilities

is called the Medical Product

Surveillance Network (MedSuN). The

60-day Federal Register notice

announced that two FDA Centers, the

Center for Devices and Radiological

Health (CDRH) and the Center for

Biologics Evaluation and Research

(CBER) would be participating in this

project. However, CBER will no longer

participate in this project; CDRH will be

the sole participant. Data collected from

the pilot will aid FDA in fulfilling its

mission to monitor the safety and

effectiveness of marketed medical

devices as they are used in clinical

settings and to determine what aspects

of the pilot program should be

implemented in the national program.

The current FDA universal user-facility

reporting system remains in place

during the piloting of the new program,

and will remain until FDA implements

the new MedSuN national system by

regulation.

An electronic format of the medical

device related sections of the mandatory

MedWATCH form (form 3500A; OMB

Control number 0910–0291) will be

accessible to the participating medical

device user facilities. The facilities

participating in the collection of

medical device-related adverse events

will use this electronic format in

reporting to FDA. The electronic format

will include some additional items that

are not on the 3500A form. These will

be voluntary for participants to

complete, such as hospital profile

information and several questions

related to the use of medical devices.

Participation in this pilot will be

voluntary and will initially include 25

hospitals that will respond to the

medical device questions. It is

anticipated that during this pilot the

number of participants will increase to

approximately 250 facilities reporting

medical device problems. The electronic

version will take approximately 45

minutes, or less, to complete.

In the Federal Register of February 8,

2001 (66 FR 9580), the agency requested

comments on the proposed collection of

information. No comments were

received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency

perResponse

Total Annual Responses Hoursper Response Total Hours

Medical devices: 83 ................................. 15 1,245 .75 934

Total ..................................................... 934

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The number of respondents for

medical devices was determined by the

average number of respondents given

that 25 facilities will be enrolled in the

first year, up to 100 the second year, and

up to 250 the third year. Eighty-three is

the average of the final complement of

250 facilities. The annual frequency of

response is based on FDA’s experience

with its mandatory and voluntary

reporting systems.

Dated: June 14, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15440 Filed 6–19–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P–1496]

Determination That Metformin

Hydrochloride Tablets, 625 and 750

Milligrams Were Not Withdrawn From

Sale for Reasons of Safety or

Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

that metformin hydrochloride (HCl)

tablets (Glucophage), 625 and 750

milligrams (mg), were not withdrawn

from sale for reasons of safety or

effectiveness. This determination will

allow FDA to approve abbreviated new

drug applications (ANDAs) for

metformin HCl 625- and 750-mg tablets.

FOR FURTHER INFORMATION CONTACT: Paul

C. Varki, Center for Drug Evaluation and

Research (HFD–7), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20855, 301–594–2041.

SUPPLEMENTARY INFORMATION: In 1984,

Congress enacted the Drug Price

Competition and Patent Term

Restoration Act of 1984 (the 1984

amendments) (Public Law 98–417),

which authorized the approval of

duplicate versions of drug products

approved under an ANDA procedure.

ANDA sponsors must, with certain

exceptions, show that the drug for

which they are seeking approval

contains the same active ingredient in

the same strength and dosage form as

the ‘‘listed drug,’’ which is a version of

the drug that was previously approved

under a new drug application (NDA).

Sponsors of ANDAs do not have to

repeat the extensive clinical testing

otherwise necessary to gain approval of

an NDA. The only clinical data required

in an ANDA are data to show that the

drug that is the subject of the ANDA is

bioequivalent to the listed drug.

The 1984 amendments include what

is now section 505(j)(7) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

355(j)(7)), which requires FDA to

publish a list of all approved drugs.

FDA publishes this list as part of the

‘‘Approved Drug Products With

Therapeutic Equivalence Evaluations,’’

generally known as the ‘‘Orange Book.’’

Under FDA regulations, drugs are

withdrawn from the list if the agency

withdraws or suspends approval of the

drug’s NDA or ANDA for reasons of

safety or effectiveness or if FDA

determines that the listed drug was

withdrawn from sale for reasons of

safety or effectiveness (21 CFR 314.162).

Regulations also provide that the agency

must make a determination as to

whether a listed drug was withdrawn

from sale for reasons of safety or

effectiveness before an ANDA that refers

to that listed drug may be approved

(§ 314.161(a)(1) (21 CFR 314.161(a)(1))).

FDA may not approve an ANDA that

does not refer to a listed drug.

Metformin HCl 625- and 750-mg

tablets are the subject of NDA 20–357.

When first approved, the NDA provided

for 500- and 850-mg tablets. On July 8,

1998, Bristol-Myers Squibb Co.

submitted a supplemental NDA to

market the 625-, 750-, and 1000-mg

tablets. FDA approved this supplement

on November 5, 1998. On November 11,

1998, Bristol-Myers Squibb notified

FDA that it would not market the 750-

mg strength tablet. The 625-mg strength

tablet has not been marketed either.

On August 31, 2000, Lachman

Consultant Services, Inc., submitted a

citizen petition (Docket No. 00P–1496/

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