4164 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations

EFFECTIVE DATE: January 29, 1997.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: Solvay

Animal Health, Inc., 1201 Northland

Dr., Mendota Heights, MN 55120, is

sponsor of NADA 6–417. The

application provides for intravenous or

intramuscular use of tripelennamine

hydrochloride injection in cattle and

intramuscular use in horses for treating

conditions in which antihistaminic

therapy may be expected to lead to

alleviation of some signs of disease.

FDA is amending the regulations to

reflect additional limitations currently

in the approved drug labeling and

publishing tolerances for drug residues

in cattle tissues and in milk. The

product is for veterinary prescription

use only. The regulations are amended

in 21 CFR 522.2615(c) to reflect the

required withdrawal period and milk

discard time and in 21 CFR part 556 to

reflect the tolerance for residues in

cattle tissues and in milk.

List of Subjects

21 CFR Part 522

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

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 parts 522 and 556 are amended as

follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

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

2. Section 522.2615 is amended by

redesignating paragraph (c) as paragraph

(d), adding new paragraph (c), and

revising newly redesignated paragraph

(d)(3) to read as follows:

§ 522.2615 Tripelennamine hydrochloride

injection.

* * * * *

(c) Related tolerances. See § 556.741

of this chapter.

(d) * * *

(3) Limitations. Do not use in horses

intended for food purposes. Treated

cattle must not be slaughtered for food

during treatment and for 4 days

following the last treatment. Milk that

has been taken during treatment and for

24 hours (two milkings) after the last

treatment must not be used for food. A

withdrawal period has not been

established for this product in

preruminating calves. Do not use in

calves to be processed for veal. Federal

law restricts this drug to use by or on

the order of a licensed veterinarian.

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

3. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: Secs. 402, 512, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 342, 360b, 371).

4. New § 556.741 is added to read as

follows:

§ 556.741 Tripelennamine.

A tolerance of 200 parts per billion

(ppb) is established for residues of

tripelennamine in uncooked edible

tissues of cattle and 20 ppb in milk.

Dated: January 7, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–2140 Filed 1–28–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 812 and 813

[Docket No. 91N–0292]

Investigational Device Exemptions;

Intraocular Lenses

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule to remove the regulations on

investigational device exemptions

(IDE’s) for intraocular lenses (IOL’s). An

IOL is an implant intended to surgically

replace the natural lens of the human

eye. FDA believes it is no longer

necessary to maintain particularized

regulations on IOL investigations

because approved IOL’s are now widely

available and investigations of IOL’s can

be conducted under the investigational

device regulations applicable to medical

devices generally. This action is

intended to eliminate confusion within

the clinical research community and to

provide uniformity to investigational

device studies.

EFFECTIVE DATE: March 31, 1997.

FOR FURTHER INFORMATION CONTACT:

Joanne R. Less, Center for Devices and

Radiological Health (HFZ–403), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has two regulations on

investigational use of medical devices.

Part 812 (21 CFR part 812) covers

investigational devices generally, and

part 813 (21 CFR part 813) applies only

to IOL’s. The existence of a separate

regulation for investigational use of

IOL’s is due to provisions of the Medical

Device Amendments of 1976 (1976

amendments) (Pub. L. 94–295) that

addressed IOL’s and to particular issues

surrounding IOL products at that time.

FDA has determined that maintaining

two closely related sets of

investigational device regulations is no

longer necessary. Thus, FDA has

reexamined the need to retain part 813,

and the agency has concluded that

maintaining a regulatory distinction

between IOL studies and studies of

other medical devices is no longer

justified. Therefore, in order to

eliminate confusion within the clinical

research community and to provide

uniformity to investigational device

studies, FDA is removing the IOL

regulations in their entirety and

removing § 812.2(c)(8) to exempt IOL’s

from part 812 when the IOL’s are the

subject of an approved premarket

approval application under section 515

of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 360e).

In the Federal Register of October 6,

1993 (58 FR 52142), FDA published a

proposed rule to remove the regulations

on IOL’s. In that same issue, FDA also

proposed procedures for

disqualification of clinical investigators

for inclusion in the current general

investigational device regulations. FDA

provided an opportunity for interested

persons to submit comments on the

proposed removal of the IOL regulations

by December 6, 1993. Subsequently, in

the Federal Register of December 6,

1993 (58 FR 64209), FDA extended the

comment period to January 5, 1994. In

a future issue of the Federal Register,

FDA will issue final procedures for

disqualification of clinical investigators

as part of the current general

investigational device regulations in

part 812.

II. Comments

The agency received two comments in

response to the proposal of October 6,

1993, with respect to IOL’s. One of the

comments was submitted by a trade

association. The other comment was

submitted by a manufacturer. A
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 4165

summary of the comments and the

agency’s response to them is provided

below:

(1) One comment concurred with

FDA’s proposal to remove the separate

regulation on IDE’s for IOL’s contained

in part 813. However, because part 813

contains some provisions that are not

reflected in part 812, the comment

suggested that FDA identify what, if

any, additional information FDA would

require IDE submissions for IOL’s to

include.

Under the final rule, any requirements

unique to part 813 would no longer

apply. The content of IDE submissions

for IOL’s only need to include

information required in IDE

submissions for investigational devices

generally. For example, with respect to

institutional review boards (IRB’s)

(referred to in part 813 as institutional

review committees), the sponsor will

only be required to submit the

information required by § 812.20(b)(6)

and not that required by § 813.20(b)(7).

(2) Both comments recommended that

FDA provide in the final rule a

mechanism for IOL clinical

investigations that are in progress before

the final rule becomes effective to

continue under part 813 until those

investigations are completed or

terminated. One comment also noted

that, because investigators have not

signed statements agreeing to conform

to part 812, application of the

requirements of part 812 to ongoing IOL

studies would create confusion and add

to the cost of the ongoing studies.

FDA does not believe that the

continuation of part 813 requirements

for existing studies is necessary. The

differences between parts 812 and 813

are relatively minor. Investigators who

are in compliance with part 813 will

also generally be in compliance with

part 812. Sponsors may seek a waiver

under part 812, if there are any

difficulties as a result of the change

from part 813 to part 812. FDA, however

does not anticipate any difficulties.

(3) Both comments emphasized that

part 812 has certain requirements that

are not included in part 813. For

example, § 812.150(b)(4) requires the

sponsor to submit a semi-annual

investigator list to FDA; § 812.150(b)(5)

requires the sponsor to submit annual

progress reports to all reviewing IRB’s;

and § 812.150(b)(8) requires the sponsor

to submit to FDA a copy of any report

by an investigator under § 812.150(a)(5)

within 5 working days of receipt. Both

comments requested that these

additional rules not be imposed on IOL

studies conducted under part 812.

FDA does not believe that

maintaining this type of distinction is

necessary. Experience over the past 15

years has shown that the requirements

of part 812 are reasonable and that

sponsors of investigations under part

812 have not had undue difficulty

complying with these provisions. As

noted in section II (2) of this document,

part 812 contains a waiver provision

that can be utilized on a case-by-case

basis, if needed.

(4) One comment asked how IRB’s

would be notified of the new rule.

FDA will send letters to sponsors of

all active IOL IDE investigations, and

the agency will request that sponsors

inform investigators and IRB’s of the

change. Additionally, FDA will

publicize the new rule at the regional

IRB meetings and at other appropriate

forums.

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

IV. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because the final rule removes

existing regulations on investigational

studies of IOL’s and requires such

investigations to be conducted under

the IDE regulations in part 812

applicable to medical devices generally,

the agency certifies that the final rule

will not impose any significant new

burdens on sponsors and investigators

of IOL’s and will not have a significant

economic impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

List of Subjects

21 CFR Part 812

Health records, Medical devices,

Medical research, Reporting and

recordkeeping requirements.

21 CFR Part 813

Medical devices, Medical research,

Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, chapter I of title 21

of the Code of Federal Regulations is

amended in 21 CFR parts 812 and 813

as follows:

PART 812—INVESTIGATIONAL

DEVICE EXEMPTIONS

1. The authority citation for 21 CFR

part 812 continues to read as follows:

Authority: Secs. 301, 501, 502, 503, 505,

506, 507, 510, 513–516, 518–520, 701, 702,

704, 721, 801 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 331, 351, 352, 353,

355, 356, 357, 360, 360c–360f, 360h–360j,

371, 372, 374, 379e, 381); secs. 215, 301, 351,

354–360F of the Public Health Service Act

(42 U.S.C. 216, 241, 262, 263b–263n).

§ 812.2 [Amended]

2. Section 812.2 Applicability is

amended by removing paragraph (c)(8).

PART 813—INVESTIGATIONAL

EXEMPTIONS FOR INTRAOCULAR

LENSES

Part 813 [Removed and Reserved]

3. Part 813, consisting of §§ 813.1

through 813.170, is removed and

reserved.

Dated: January 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–2169 Filed 1–28–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF EDUCATION

34 CFR Part 75

RIN 1880–AA61

Direct Grant Programs

AGENCY: Department of Education.

ACTION: Final regulations.

SUMMARY: The Secretary amends the

Department’s regulations on direct grant

programs to expand the basis for

selecting applications for new grants to

include a recipient’s previous