Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 4163

second test, we will consider the

following factors:

(1) Would the disclosure further a

commercial interest of the requester, or

of someone on whose behalf the

requester is acting? ‘‘Commercial

interests’’ include interests relating to

business, trade, and profit. Not only

profit-making corporations have

commercial interests—so do nonprofit

corporations, individuals, unions, and

other associations. The interest of a

representative of the news media in

using the information for news

dissemination purposes will not be

considered a commercial interest.

(2) If disclosure would further a

commercial interest of the requester,

would that effect outweigh the

advancement of the public interest

defined in paragraph (b) of this section?

Which effect is primary?

(d) Deciding between waiver and

reduction. If the disclosure passes both

tests, we will normally waive fees.

However, in some cases we may decide

only to reduce the fees. For example, we

may do this when disclosure of some

but not all of the requested records

passes the tests.

(e) Procedure for requesting a waiver

or reduction. You must make your

request for a waiver or reduction at the

same time you make your request for

records. You should explain why you

believe a waiver or reduction is proper

under the analysis in paragraphs (a)

through (d) of this section. Only FOI

Officers may make the decision whether

to waive, or reduce, the fees. If we do

not completely grant your request for a

waiver or reduction, the denial letter

will designate a review official. You

may appeal the denial to that official. In

your appeal letter, you should discuss

whatever reasons are given in our denial

letter. The process prescribed in

§ 402.190 of this part will also apply to

these appeals.

§ 402.190 Officials who may deny a

request for records under FOIA.

Only the Director, Office of Disclosure

Policy, SSA, or her or his designee is

authorized to deny a written request to

obtain, inspect, or copy any social

security record.

§ 402.195 How a request is denied.

(a) Oral requests. If we cannot comply

with your oral request because the

Director of the Office of Disclosure

Policy (or designee) has not previously

made a determination to release the

record you want, we will tell you that

fact. If you still wish to pursue your

request, you must put your request in

writing.

(b) Written requests. If you make a

written request and the information or

record you requested will not be

released, we will send you an official

denial in writing. We will explain why

the request was denied (for example, the

reasons why the requested document is

subject to one or more clearly described

exemptions), will include the name and

title or position of the person who made

the decision, and what your appeal

rights are. (c) Unproductive searches. We make a

diligent search for records to satisfy

your request. Nevertheless, we may not

be able always to find the records you

want using the information you

provided, or they may not exist. If we

advise you that we have been unable to

find the records despite a diligent

search, this does not constitute a denial

of your request.

§ 402.200 How to appeal a decision

denying all or part of a request.

(a) How to appeal. If all or part of your

written request was denied, you may

request that the Commissioner of Social

Security, 6401 Security Boulevard,

Baltimore, MD 21235 review that

determination. Your request for review: (1) Must be in writing;

(2) Must be mailed within 30 days

after you received notification that all or

part of your request was denied or, if

later, 30 days after you received

materials in partial compliance with

your request; and (3) May include additional

information or evidence to support your

request. (b) How the review is made. After

reviewing the prior decision and after

considering anything else you have

submitted, the Commissioner or his or

her designee will affirm or revise all or

part of the prior decision. The

Commissioner (or a designee) will

affirm a denial only after consulting

with the appropriate SSA official(s),

including legal counsel. The decision

must be made within 20 working days

after your appeal is received. The

Commissioner or a designee may extend

this time limit up to 10 additional

working days if one of the situations in

§ 402.140(a) exists, provided that, if a

prior extension was used to process this

request, the sum of the extensions may

not exceed 10 working days. You will be

notified in writing of any extension, the

reason for the extension, and the date by

which your appeal will be decided. (c) How you are notified of the

Commissioner’s decision. The

Commissioner or a designee will send

you a written notice of the decision

explaining the basis of the decision (for

example, the reasons why an exemption

applies) which will include the name

and title or position of the person who

made the decision. The notice will tell

you that if any part of your request

remains unsatisfied, you have the right

to seek court review.

§ 402.205 U.S. District Court action.

If the Commissioner or a designee,

upon review, affirms the denial of your

request for records, in whole or in part,

you may ask a U.S. District Court to

review that denial. See 5 U.S.C.

552(a)(4)(B). If we fail to act on your

request for a record or for review of a

denial of such a request within the time

limits in § 402.140(a) or in § 402.190(b),

you may ask a U.S. District Court to

treat this as if the Commissioner had

denied your request.

PART 422—ORGANIZATION AND

PROCEDURES

Subpart E of Part 422—[Removed]

3. Under the authority of section

106(b) of Pub. L. 103–296, Social

Security Independence and Program

Improvements Act of 1994, subpart E of

part 422, is removed and reserved.

[FR Doc. 97–1271 Filed 1–28–97; 8:45 am]

BILLING CODE 4190–29–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

Animal Drugs, Feeds, and Related

Products; Tripelennamine

Hydrochloride Injection

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to more clearly

reflect the currently approved

conditions of use of a new animal drug

application (NADA) held by Solvay

Animal Health, Inc. The NADA

provides for use of tripelennamine

hydrochloride injection for

antihistaminic therapy in horses and

cattle. The amendment provides for

tolerances for drug residues in edible

cattle tissues and in milk and the

corresponding drug withdrawal and

milk discard periods. When the NADA

was reviewed under the National

Academy of Sciences/National Research

Council Drug Study Implementation

Program and the results of the review

finalized in 1983, this information was

inadvertently omitted from the

regulations.
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