Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices 69317

Experience Reporting for Human Drug

and Licensed Biological Products:

Clarification of What to Report.’’

One comment suggested adding a box

to the 3500A form to require drug

manufacturers to state the date the

report was forwarded to FDA. This is

currently required for medical device

reporting, but not for drugs and

biologics. However, all manufacturers

must report the date received by the

manufacturer on form 3500A, section

G4. Many large manufacturers have data

bases that contain the date the

information was received and the date

the report was sent to FDA. As a

surrogate, these two dates can be

compared to see if the company is

fulfilling its requirements under the

regulations. The agency can use its

regulatory discretion in deciding

whether or not action is warranted in

the case of delayed reports. What is of

greater concern is the failure to report

and that cannot be detected by adding

this information to the form. Given that

the goal is for both pharmaceutical and

medical device industries to submit the

majority of mandatory reports

electronically, it would present a

financial burden to revamp systems to

accommodate a paper form that will be

virtually obsolete in the future.

One comment suggested a ‘‘tick box

for a 30-day report,’’ for form 3500A. At

this time there is no requirement for a

30-day report.

As both the 3500 instructions and

3500A instructions can be updated

periodically based on questions/

comments from stakeholders and

statutory/regulatory changes, changing

the forms themselves is not seen as

necessary at this point.

At such time it is decided to

repropose revisions, FDA will consult

all interested parties for input into the

design.

FDA estimates the burden for this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center(s) (21 CFR section) No. of respondents

Annual

frequency per

response

Total annual

responses

Hours per

response Total hours

CBER/CDER2

Form 3500 16,198 1 16,198 0.5 8,099

Form 3500A (310.305, 314.80,

314.98, and 600.80) 600 455.2 273,109 1 273,109

CDRH3

Form 3500 2,650 1 2,650 0.5 1,325

Form 3500A (part 803) 2,046 24 49,305 1 49,305

CFSAN4

Form 3500 550 1 550 0.5 275

Form 3500A 0 0 0 1 0

No mandatory requirements

Total Hours 332,113

Form 3500 9,699

Form 3500A 322,414

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

2 Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research.

3 Center for Devices and Radiological Health.

4 Center for Food Safety and Applied Nutrition.

FDA Form 3500 is for voluntary reporting. FDA Form 3500A is for mandatory reporting.

The figures shown in table 1 of this document are based on actual calendar year 1999 reports and respondents.

As more medical products are

approved by the FDA and marketed, and

as knowledge increases regarding the

importance of notifying FDA when

adverse events and product problems

are observed, it is expected that more

voluntary reports will be submitted.

Conversely, with the current plans for

increasing electronic submissions it is

expected that the number of mandatory

reports will decrease.

Dated: November 9, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29324 Filed 11–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1435]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Substantial Evidence of Effectiveness

of New Animal Drugs

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 comments on the

collection of information by December

18, 2000.

ADDRESSES: Submit written comments

on the collection of information to

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:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

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.

69318 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Notices

Substantial Evidence of Effectiveness of

New Animal Drugs—21 CFR Part 514—

(OMB Control No. 0910–0356)—

Extension

Description: Congress enacted the

Animal Drug Availability Act of 1996

(ADAA) (Public Law 104–250) on

October 9, 1996. As directed by the

ADAA, FDA published a final rule July

28, 1999 (64 FR 40746), amending part

514 (21 CFR part 514) to further define

substantial evidence in a manner that

encourages the submission of new

animal drug applications (NADA’s),

supplemental NADA’s and encourages

dose range labeling. Substantial

evidence is the standard that a sponsor

must meet to demonstrate the

effectiveness of a new animal drug for

its intended uses under the conditions

of use suggested in its proposed

labeling. It is defined as evidence

consisting of one or more adequate and

well-controlled studies, such as a study

in a target species, study in laboratory

animals, field study, bioequivalence

study, or an in vitro study, on the basis

of which it could fairly and reasonably

be concluded by qualified experts that

the new animal drug will have the effect

it purports or is represented to have

under the conditions of use prescribed,

recommended, or suggested in the

labeling or proposed labeling thereof.

The provisions of § 514.4(a) provide the

agency with greater flexibility to make

case-specific scientific determinations

regarding the number and types of

adequate and well-controlled studies

that will provide, in an efficient

manner, substantial evidence that a new

animal drug is effective. The agency

believes this regulation over time, will

reduce the number of adequate and

well-controlled studies necessary to

demonstrate the effectiveness of certain

combination new animal drugs, will

eliminate the need for an adequate and

well-controlled dose titration study, and

may, in limited instances, reduce or

eliminate the number of adequate and

well-controlled field investigations

necessary to demonstrate by substantial

evidence the effectiveness of a new

animal drug.

Description of Respondents:

Respondents to this collection of

information are persons and businesses,

including small businesses. In the

Federal Register of August 16, 2000 (65

FR 49989), the FDA published a 60-day

notice concerning the proposed

extension of this collection of

information and requested comments.

No comments were received on the

estimated annual reporting burden. We

therefore believe the total burden

estimate of 544,036 hours for the annual

reporting and recordkeeping burden

should remain unchanged.

FDA estimates the burden of the

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of respondents Annual frequency per

response

Total annual

responses Hours per response Total hours

514.4(a) 190 4.5 860 632.6 544,036

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

The estimated annual reporting

burden is based on consultation by the

Center for Veterinary Medicine with

several of the major research and

development firms that conduct the

majority of studies submitted to

establish substantial evidence of

effectiveness of new animal drugs and

agency records.

Dated: November 9, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29325 Filed 11–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Consumer Roundtable; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing the following

meeting: Consumer roundtable to

discuss consumer protection priorities

for the agency. The roundtable will

provide an opportunity for FDA to

engage in an open dialogue with

individual consumer stakeholders on a

variety of regulatory and consumer

oriented issues. The roundtable is part

of the agency’s ongoing consultation

with stakeholders.

Date and Time: The meeting will be

held on December 13, 2000, 9 a.m. to 4

p.m.

Location: The meeting will be held at

the Penthouse Conference Room, Hubert

H. Humphrey Bldg., 200 Independence

Ave. SW., Washington, DC.

Contact: Karen R. Mahoney, Office of

Consumer Affairs (HFE–88), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4393, FAX 301–827–2866, e-mail:

kmahoney@oc.fda.gov.

Registration: Preregistration is

required as space is limited. Send

registration information (including

name, title, organization name, address,

telephone, fax number, and e-mail) to

the contact person by December 6, 2000.

If you need special accommodations

due to a disability, please contact Karen

R. Mahoney (address above) at least 7

days in advance.

Background information on this

meeting will be available on the FDA

Internet site at http://www.fda.gov/

opacom/hpmeetings.html.

Transcripts: Transcripts of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting at a cost of 10 cents per page.

Dated: November 9, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29424 Filed 10–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Oncologic Drugs 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: Oncologic Drugs

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.