13302 Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Rules and Regulations

17 CFR Part 140

Change in Titles of Personnel

AGENCY: Commodity Futures Trading

Commission.

ACTION: Final rule; correction.

SUMMARY: CFTC is correcting an error in

a change to titles of personnel

previously published in the Federal

Register on May 13, 1996, (61 FR

21955). The original document

contained an erroneous paragraph

reference.

EFFECTIVE DATE: May 13, 1996.

FOR FURTHER INFORMATION CONTACT:

Stacy Dean Yochum, Counsel to the

Executive Director, Commodity Futures

Trading Commission, Three Lafayette

Centre, 1155 21st St. NW., Washington,

DC 20581, (202) 418–5157.

Correction

In the final rule FR Doc. 96–11923,

beginning on page 21954 in the Federal

Register issue of May 13, 1996, make

the following correction:

On page 21955, in the first column, in

amendment 4. to § 140.735–8, the

reference to ‘‘paragraph (a)(3)’’ is

corrected to read ‘‘paragraph (b)(3).’’

Dated: March 14, 1997.

Jean A. Webb,

Secretary of the Commission.

[FR Doc. 97–6971 Filed 3–19–97; 8:45 am]

BILLING CODE 6351–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor for two new animal

drug applications (NADA’s) from

Biocraft Laboratories, Inc., to Teva

Pharmaceuticals USA.

EFFECTIVE DATE: March 20, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Biocraft

Laboratories, Inc., 92 Route 46,

Elmwood Park, NJ 07407, has informed

FDA that it has transferred ownership

of, and all rights and interests in,

NADA’s 65–492 (amoxicillin trihydrate

tablets) and 65–495 (amoxicillin

trihydrate for oral suspension) to Teva

Pharmaceuticals USA, 650 Cathill Rd.,

Sellersville, PA 18960. Accordingly, the

agency is amending the regulations in

21 CFR 520.88b and 520.88f to reflect

the transfer of ownership.

List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 520.88b [Amended]

2. Section 520.88b Amoxicillin

trihydrate for oral suspension is

amended in paragraph (c) by removing

the number ‘‘000332’’ and adding in its

place ‘‘000093’’.

§ 520.88f [Amended]

3. Section 520.88f Amoxicillin

trihydrate tablets is amended in

paragraph (b) by removing the number

‘‘000332’’ and adding in its place

‘‘000093’’.

Dated: March 11, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–7002 Filed 3–19–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 803 and 804

[Docket No. 91N–0295]

RIN 0910–AA09

Medical Devices; Medical Device

Reporting; Annual Certification

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

medical device manufacturer and

distributor adverse event certification

regulations. The revised certification

requirements allow manufacturers and

distributors to designate more than one

certifying official, who would each sign

a certification statement for his or her

identified organizational component or

site; amend the certification statement

to minimize concerns relating to

liability from unintentional reporting

errors; and indicate that the certifying

official is making the certification

statements, to the best of his/her

knowledge and belief. This action is

being taken to help FDA carry out its

public health protection responsibilities

relating to medical devices. This action

provides reporting entities with greater

flexibility in the certification process

while reducing the regulatory burden.

DATES: Effective May 19, 1997. Submit

written comments on the information

collection requirements by April 21,

1997.

ADDRESSES: Submit written comments

on the final rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Submit written comments on the

information collection requirements to

the Office of Information and Regulatory

Affairs, Office of Management and

Budget (OMB), New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Earl

W. Robinson, Center for Devices and

Radiological Health (HFZ–530), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301–594–

2735.

SUPPLEMENTARY INFORMATION:

I. Background

Section 519(d) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360i(d)) provides that each

manufacturer, importer, and distributor

shall certify that they did file a certain

number of medical device reports

(MDR’s) in the previous 12 months or

they did not file any MDR’s.

Distribution certification regulations

implementing this statutory provision

became effective on May 28, 1992, when

requirements relating to distributor

reporting that were proposed in the

Federal Register of November 26, 1991

(56 FR 60024), became final by

operation of law. In the Federal Register

of December 11, 1995 (60 FR 63578),

FDA published a final rule similar to the

distributor certification provisions, that

required manufacturers to submit

certification statements (§ 803.57 (21

CFR 803.57)) (hereinafter referred to as

the December 1995 final rule).

Distributors and manufacturers were

required to certify that they filed reports

for all reportable events required under