Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33099

implementation and its monitoring over

time; the use of these resources to

leverage additional resources for plan

implementation; the plans to

institutionalize specific interventions;

specific objectives that are realistic,

measurable and time phased; clear

definition of both process and outcome

measures for the evaluation of

implementation activities.

6. Management and Staffing for

Intervention Activities (15 points)

The current functioning of asthma

staff (program and surveillance) within

the health agency; the description of

staff to be hired or contracts to be

developed; the link of staff to program

objectives; the continued role of the

statewide partnership group. Assurance

that key personnel will attend

scheduled grantee meetings and CDCsponsored national asthma conferences,

and that the applicant agrees to share

innovations, information, data and

materials.

7. Budget (Not scored)

The extent to which the budget is

reasonable, adequately justified and

consistent with the intended use of the

cooperative agreement funds.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of

1. Annual progress reports;

2. financial status report, no more

than 90 days after the end of the budget

period; and

3. final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment 2 of the

announcement in the application kit.

AR–7 Executive Order 12372 Review

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301 and 317 of the Public

Health Service Act, [42 U.S.C. section

241 and 247b], as amended. The Catalog

of Federal Domestic Assistance number

is 93.283.

J. Where to Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address http://www.cdc.gov

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’

To obtain business management

technical assistance, contact: Sonia

Rowell, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

number: (770) 488–2724, Email address:

svp1@cdc.gov.

For program technical assistance,

contact: Leslie P. Boss, Air Pollution

and Respiratory Health Branch, National

Center for Environmental Health,

Centers for Disease Control and

Prevention, Mailstop E–17, 1600 Clifton

Rd., NE, Atlanta, GA 30333, Telephone

number: (404) 498–1002, Email address:

LBoss@cdc.gov.

Dated: June 14, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–15476 Filed 6–19–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0051]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Adverse

Event Pilot Program for Medical

Devices and Blood Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written or electronic

comments on the collection of

information by July 20, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information via the Internet at http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Office of Information

and Regulatory Affairs, OMB, New

Executive Office Bldg., 725 17th St.

NW., rm. 10235, Washington, DC 20503,

Attn: Wendy Taylor, Desk Officer for

FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Adverse Event Pilot Program for

Medical Devices and Blood Products

Under section 519 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360i), FDA is authorized to

require manufacturers to report medical

device related deaths, serious injuries,

and malfunctions and to require user

facilities to report device-related deaths

directly to FDA and to manufacturers,

and to report serious injuries to the

manufacturer. Section 213 of the FDA

Modernization Act of 1997 (FDAMA)

amended section 519(b) of the act

relating to mandatory reporting by user

facilities of deaths and serious injuries

and serious illnesses associated with the

use of medical devices. This

amendment required FDA to, by

regulation, replace universal userfacility reporting with a system that is

limited to a ‘‘ * * * subset of user

facilities that constitutes a

representative profile of user reports’’

for device-related deaths and serious

injuries. This amendment is reflected in

section 519(b)(5)(A) of the act.

FDA is the Federal agency charged

with the responsibility for ensuring that

marketed medical products are safe and

effective. To carry out its

responsibilities, the agency needs to be

informed whenever an adverse event or

product problem occurs. Only if FDA is

provided with such information will it

be able to evaluate the risk, if any,

associated with the product and take

whatever action is necessary to reduce

or eliminate the public’s exposure to

this risk. Data collected from user

facilities about problems with medical

devices assist FDA to carry out that

mission as it pertains to medical

devices. Prior to implementing the

regulation to change from universal

user-facility reporting to reporting by a

subset of user facilities, FDA is planning

to conduct a pilot program to evaluate

various aspects of the new program. The

new user-facility program that will be

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/