6894 Federal Register / Vol. 65, No. 29 / Friday, February 11, 2000 / Rules and Regulations

monocular glaucoma, lens rupture) have

been reported. The risks of damage to

the corneal endothelium, the lens, and

the retina are slight. The Panel believes

these risks can be kept minimal by

ensuring proper device design of laser

beam accuracy and precision.

FDA considered the Panel’s

recommendations and tentatively agreed

that the generic type of device, Nd:YAG

laser for peripheral iridotomy, be

reclassified from class III to class II.

FDA recommended that the generic

designation of the device be changed

from Nd:YAG laser for posterior

capsulotomy to ND:YAG laser for

posterior capsulotomy and peripheral

iridotomy.

Subsequently, in the Federal Register

of March 8, 1996 (61 FR 9373), FDA

issued the Panel’s recommendation for

public comment.

After reviewing the data in the

petition and presented before the Panel,

and after considering the Panel’s

recommendation, FDA, based on its and

the Panel’s review, issued an order to

the petitioner on August 13, 1999,

reclassifying the Nd:YAG laser for

posterior capsulotomy, and

substantially equivalent devices of this

generic type, from class III to class II,

with design parameters as the special

controls. Additionally, FDA changed the

generic designation of the device from

Nd:YAG laser for posterior capsulotomy

to Nd:YAG laser for posterior

capsulotomy and peripheral iridotomy.

FDA believes the risks mentioned above

can be kept minimal by ensuring proper

device design of the laser beam accuracy

and precision, and through proper

device labeling disclosures whereby the

surgeon can control the risk of

intraocular pressure rise through

available, established medical

treatments.

Accordingly, as required by

§ 860.134(b)(6) and (b)(7) of the

regulations, FDA is announcing the

reclassification of the generic Nd:YAG

laser for posterior capsulotomy and

peripheral iridotomy from class III into

class II. In addition, FDA is issuing the

notice to codify the reclassification of

the device by revising 21 CFR 886.4392.

II. Environmental Impact

The agency has determined under 21

CFR 25.34(b) that this reclassification 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.

III. 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) (as amended by subtitle

D of the Small Business Regulatory

Fairness Enforcement Act of 1996

(Public Law 104–121), and the

Unfunded Mandates Reform Act of 1995

(Public Law 104–4)). 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. Reclassification of the device

from class III to class II will relieve all

manufacturers of the device of the cost

of complying with the premarket

approval requirements in section 515 of

the act. Because reclassification will

reduce regulatory costs with respect to

this device, it will impose no significant

economic impact on any small entities,

and it may permit small potential

competitors to enter the marketplace by

lowering their costs. The Commissioner

of Food and Drugs therefore certifies

that this final rule will not have a

significant economic impact on a

substantial number of small entities. In

addition, this notice will not impose

costs of $100 million or more on either

the private sector or State, local, and

tribal governments in the aggregate, and

therefore a summary statement or

analysis under section 202(a) of the

Unfunded Mandates Reform Act of 1995

is not required.

IV. Paperwork Reduction Act of 1995

FDA concludes that this final rule

contains no information that is subject

to review by the Office of Management

and Budget under the Paperwork

Reduction Act of 1995. The special

controls do not require the respondent

to submit additional information to the

public. Therefore, no burden is placed

on the public.

List of Subjects in 21 CFR Part 886

Medical devices, Ophthalmic goods

and services.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 886 is

amended as follows:

PART 886—OPHTHALMIC DEVICES

1. The authority citation for 21 CFR

part 886 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Section 886.4392 is revised to read

as follows:

§ 886.4392 Nd:YAG laser for posterior

capsulotomy and peripheral iridotomy.

(a) Identification. The Nd:YAG laser

for posterior capsulotomy and

peripheral iridotomy consists of a modelocked or Q-switched solid state

Nd:YAG laser intended for disruption of

the posterior capsule or the iris via

optical breakdown. The Nd:YAG laser

generates short pulse, low energy, high

power, coherent optical radiation. When

the laser output is combined with

focusing optics, the high irradiance at

the target causes tissue disruption via

optical breakdown. A visible aiming

system is utilized to target the invisible

Nd:YAG laser radiation on or in close

proximity to the target tissue.

(b) Classification. Class II (special

controls). Design Parameters: Device

must emit a laser beam with the

following parameters: wavelength =

1064 nanometers; spot size = 50 to 100

micros; pulse width = 3 to 30

nanoseconds; output energy per pulse =

0.5 to 15 millijoules (mJ); repetition rate

= 1 to 10 pulses; and total energy = 20

to 120 mJ.

Dated: January 24, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–3173 Filed 2–10–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Department of the Army

32 CFR Part 505

[Army Reg. 340–21]

Privacy Act; Implementation

AGENCY: Department of the Army, DoD.

ACTION: Final rule.

SUMMARY: The Department of the Army

is administratively amending an

Federal Register / Vol. 65, No. 29 / Friday, February 11, 2000 / Rules and Regulations 6895

existing exemption rule for a Privacy

Act system of records. The Army is

providing reasons from which

information maintained within this

system of records may be exempt. These

were administratively omitted when last

published.

EFFECTIVE DATE: February 11, 2000.

ADDRESSES: Privacy Act Officer, Records

Management Program Division, U.S.

Total Army Personnel Command,

ATTN: TAPC-PDR-P, Stop C55, Ft.

Belvoir, VA 22060-5576.

FOR FURTHER INFORMATION CONTACT: Ms.

Janice Thornton at (703) 806-4390 or

DSN 656-4390.

SUPPLEMENTARY INFORMATION: Executive

Order 12866. It has been determined

that this Privacy Act rule for the

Department of Defense does not

constitute ‘significant regulatory action’.

Analysis of the rule indicates that it

does not have an annual effect on the

economy of $100 million or more; does

not create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency; does not

materially alter the budgetary impact of

entitlements, grants, user fees, or loan

programs or the rights and obligations of

recipients thereof; does not raise novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in Executive

Order 12866 (1993).

Regulatory Flexibility Act. It has been

determined that this Privacy Act rule for

the Department of Defense does not

have significant economic impact on a

substantial number of small entities

because it is concerned only with the

administration of Privacy Act systems of

records within the Department of

Defense.

Paperwork Reduction Act. It has been

determined that this Privacy Act rule for

the Department of Defense imposes no

information requirements beyond the

Department of Defense and that the

information collected within the

Department of Defense is necessary and

consistent with 5 U.S.C. 552a, known as

the Privacy Act of 1974.

List of Subjects in 32 CFR Part 505

Privacy.

1. The authority citation for 32 CFR

part 505 continues to read as follows:

Authority: Pub. L. 93–579, 88 Stat. 1896

(5 U.S.C. 552a).

2. Section 505.5, is amended by

revising paragraph (e)(18) as follows:

§ 505.5 Exemptions.

* * * * *

(e) Exempt Army records. * * *

(18) System identifier: A0025 JDIM

(i) System name: HQDA

Correspondence and Control/Central

Files System.

(ii) Exemptions: Documents within

this system of records are generated by

other elements of the Department of the

Army or are received from other

agencies and individuals. Because of the

broad scope of the contents of this

system of records, and since the

introduction of documents is largely

unregulatable, specific portions or

documents that may require an

exemption can not be predetermined.

Therefore, and to the extent that such

material is received and maintained,

selected individual documents may be

exempt.

(A) Information specifically

authorized to be classified under E.O.

12958, as implemented by DoD 5200.1–

R, may be exempt pursuant to 5 U.S.C.

552a(k)(1).

(B) Investigatory material compiled

for law enforcement purposes may be

exempt pursuant to 5 U.S.C. 552a(k)(2).

However, if an individual is denied any

right, privilege, or benefit for which he

would otherwise be entitled by Federal

law or for which he would otherwise be

eligible, as a result of the maintenance

of such information, the individual will

be provided access to such information

except to the extent that disclosure

would reveal the identity of a

confidential source.

(C) Records maintained in connection

with providing protective services to the

President and other individuals under

18 U.S.C. 3506, may be exempt pursuant

to 5 U.S.C. 552a(k)(3).

(D) Records maintained solely for

statistical research or program

evaluation purposes and which are not

used to make decisions on the rights,

benefits, or entitlement of an individual

except for census records which may be

disclosed under 13 U.S.C. 8, may be

exempt pursuant to 5 U.S.C. 552a(k)(4).

(E) Investigatory material compiled

solely for the purpose of determining

suitability, eligibility, or qualifications

for federal civilian employment,

military service, federal contracts, or

access to classified information may be

exempt pursuant to 5 U.S.C. 552a(k)(5),

but only to the extent that such material

would reveal the identity of a

confidential source.

(F) Testing or examination material

used solely to determine individual

qualifications for appointment or

promotion in the Federal service may be

exempt pursuant to 5 U.S.C. 552a(k)(6),

if the disclosure would compromise the

objectivity or fairness of the test or

examination process.

(G) Evaluation material used to

determine potential for promotion in the

Military Services may be exempt

pursuant to 5 U.S.C. 552a(k)(7), but only

to the extent that the disclosure of such

material would reveal the identity of a

confidential source.

(H) Portions of this system of records

may be exempt pursuant to 5 U.S.C.

552a (k)(1) through (k)(7) from

subsections (c)(3), (d), (e)(1), (e)(4)(G)

and (H), and (f).

(iii) Authority: 5 U.S.C. 552a(k)(1)

through (k)(7).

(iv) Reasons: (A) From subsection

(c)(3) because the release of the

disclosure accounting could alert the

subject of an investigation of an actual

or potential criminal, civil, or regulatory

violation to the existence of the

investigation and the fact that they are

subjects of the investigation. It could

permit the subject of an investigation or

matter under investigation to obtain

valuable information concerning the

nature of that investigation which will

present a serious impediment to law

enforcement.

(B) From subsection (d) because

access to the records contained in this

system would inform the subject of an

investigation of the existence of that

investigation, provide the subject of the

investigation with information that

might enable him to avoid detection of

apprehension, and would present a

serious impediment to law enforcement.

(C) From subsection (e)(1) because in

the course of criminal investigations

information is often obtained

concerning the violation of laws or civil

obligations of others not relating to

active case or matter. In the interest of

effective law enforcement, it is

necessary that this information be

retained since it can aid in establishing

patterns of activity and provide valuable

leads for other agencies and future cases

that may be brought.

(D) From subsections (e)(4)(G) and (H)

because this system of records is exempt

from individual access pursuant to

subsections (k)(2) of the Privacy Act of

1974.

(E) From subsection (f) because this

system of records has been exempted

from the access provisions of subsection

(d).

* * * * *

Dated: February 4, 2000.

L.M. Bynum,

Alternate OSD Federal Register Liaison

Officer, Department of Defense

[FR Doc. 00–3071 Filed 2–10–00; 8:45 am]

BILLING CODE 5001–10–F