Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Proposed Rules 8609

100. Murray, K. H., D. E. Nurse, and A. R.

Mundy, ‘‘Detrusor Behaviour Following

Implantation of the Brantley Scott Artificial

Urinary Sphincter for Neuropathic

Incontinence,’’ British Journal of Urology,

61(2):122–128, 1988.

101. Durrani, A. F., T. P. Rosenbaum,

Shaw, P. J. R., S. K. Singh, and P. H. L.

Worth, ‘‘Does the Kaufman Prosthesis Still

Have a Place? Review of Thirteen Years’

Experience,’’ Urology, 38(4):328–331, 1991.

102. Foley, M., M. Stefan, R. E. Campbell,

and T. R. Malloy, ‘‘The Radiographic

Evaluation of GU Prostheses,’’ Applied

Radiology, 22(10):24–36, 1993.

103. Tiemann, D., L. Shea, C. G. Klutke, K.

Gaehle, and S. Moore, ‘‘Artificial Urinary

Sphincters. Treatment for Post-Prostatectomy

Incontinence,’’ AORN Journal, 57(6):1366–

1372, 1375–1379, 1993.

104. Diokno, A. C., J. B. Hollander, and T.

P. Alderson, ‘‘Artificial Urinary Sphincter for

Recurrent Female Urinary Incontinence:

Indications and Results,’’ The Journal of

Urology, 138(4):778–780, 1987.

105. Herzog, A. R., A. C. Diokno, and N.

H. Fultz, ‘‘Urinary Incontinence: Medical and

Psychosocial Aspects,’’ Annual Review of

Gerontology and Geriatrics, 9:74–119, 1989.

106. Harty, J. I., and L. W. Howerton, Jr.,

‘‘Experience With the Artificial Sphincter

800 in Patients With Severe Urinary

Incontinence,’’ Journal of the Kentucky

Medical Association, 83(9):485–489, 1985.

107. Denes, B., ‘‘Urinary Incontinence. An

Introduction,’’ Trans American Society of

Artificial Internal Organs, 34(4):998–999,

1988.

108. Jakobsen, H., and T. Hald,

‘‘Management of Neurogenic Urinary

Incontinence With AMS Artificial Urinary

Sphincter,’’ Scandinavian Journal of Urology

and Nephrology, 20(2):137–141, 1986.

109. Jumper, B. M., G. A. McLorie, B. M.

Churchill, A. E. Khoury, and A. Toi, ‘‘Effects

of the Artificial Urinary Sphincter on

Prostatic Development and Sexual Function

in Pubertal Boys With Meningomyelocele,’’

The Journal of Urology, 144(2 pt 2):438–342;

Discussion 443–444, 1990.

110. Domanskis, E. J., and J. Q. Owsley,

‘‘Histological Investigations of the Etiology of

Capsule Contraction Following

Augmentation Mammoplasty,’’ Plastic and

Reconstructive Surgery, 58:689–693, 1976.

111. Vargas, A., ‘‘Shedding of Silicone

Particles From Inflated Breast Implants,’’

letter to the editor, Plastic and Reconstructive

Surgery, 64:252–253, 1979.

VI. 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.

VII. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(Pub. L. 96–354). 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 proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed 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 PMA’s for this device

could have been required by FDA as

early as June 30, 1986, and because

firms that distributed this device prior

to May 28, 1976, or whose device has

been found by FDA to be substantially

equivalent will be permitted to continue

marketing the implanted mechanical/

hydraulic urinary continence device

during FDA’s review of the PMA or

notice of completion of the PDP, the

agency certifies that the proposed rule

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 in 21 CFR Part 876

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 876 be amended as follows:

PART 876—GASTROENTEROLOGYUROLOGY DEVICES

1. The authority citation for 21 CFR

part 876 continues to read as follows:

Authority: Secs. 501, 510, 513, 515, 520,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

2. Section 876.5280 is amended by

revising paragraph (c) to read as follows:

§ 876.5280 Implanted mechanical/

hydraulic urinary continence device.

* * * * *

(c) Date PMA or notice of completion

of a PDP is required. A PMA or notice

of completion of a PDP is required to be

filed with the FDA on or before (insert

date 90 days after the effective date of

a final rule based on this proposed rule),

for any implanted mechanical/hydraulic

urinary continence device that was in

commercial distribution before May 28,

1976, or that has on or before (insert

date 90 days after the effective date of

a final rule based on this proposed rule),

been found to be substantially

equivalent to the implanted mechanical/

hydraulic urinary continence device

that was in commercial distribution

before May 28, 1976. Any other

implanted mechanical/hydraulic

urinary continence device shall have an

approved PMA or declared completed

PDP in effect before being placed in

commercial distribution.

Dated: January 10, 1995.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 95–3805 Filed 2–14–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Parts 1 and 3

[Docket No. 941120–4320]

RIN 0651–AA76

Changes to Implement 20-Year Patent

Term and Provisional Applications

AGENCY: Patent and Trademark Office,

Commerce.

ACTION: Proposed rule; change in public

hearing location.

SUMMARY: The public hearing scheduled

for February 16, 1995, concerning the

notice of proposed rulemaking

published on December 12, 1994 at 59

FR 63951, with a supplemental request

for comments published on January 17,

1995, at 60 FR 3398, will be held in the

Roanoke Room, Stouffer Hotel at Crystal

City, 2399 Jefferson Davis Highway,

Arlington, Virginia, instead of in the

Commissioner’s Conference Room,

Crystal Park 2, Room 912, 2121 Crystal

Drive, Arlington, Virginia, as previously

indicated. The change in location is

being made to accommodate more

people.

DATES: Written comments must be

submitted on or before February 17,

1995. A public hearing will be held

Thursday, February 16, 1995, at 9:30

a.m., in the Roanoke Room, Stouffer

Hotel at Crystal City, 2399 Jefferson

Davis Highway, Arlington, Virginia.

Oral testimony on the effects of patent

expiration dates and patent term

extension will begin at 1:00 p.m.

Requests to present oral testimony

should be received on or before

February 14, 1995.
8610 Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Proposed Rules

ADDRESSES: Address written comments

and requests to present oral testimony to

the Commissioner of Patents and

Trademarks, Washington, DC 20231.

Attention: Stephen G. Kunin, Deputy

Assistant Commissioner for Patent

Policy and Projects, Crystal Park 2, Suite

910, or by fax to (703) 305–8825.

FOR FURTHER INFORMATION CONTACT:

Magdalen Y. Greenlief or John F.

Gonzales, Special Program Examiners,

Office of the Deputy Assistant

Commissioner for Patent Policy and

Projects, at (703) 305–9285, or by mail

marked to their attention and addressed

to the Commissioner of Patents and

Trademarks, Washington, DC 20231.

Dated: February 9, 1995.

Bruce A. Lehman,

Assistant Secretary of Commerce and

Commissioner of Patents and Trademarks.

[FR Doc. 95–3742 Filed 2–14–95; 8:45 am]

BILLING CODE 3510–16–M

POSTAL SERVICE

39 CFR Part 265

Demands for Testimony or Records in

Certain Legal Proceedings

AGENCY: Postal Service.

ACTION: Proposed rule.

SUMMARY: The Postal Service proposes

establishing a procedure for Postal

Service response to subpoenas or other

demands for Postal Service employees

to testify about, or produce records

concerning, Postal Service matters in

private litigation or other proceedings in

which the United States is not a party.

This proposed rule should minimize the

disruption of official duties caused by

compliance with those demands,

maintain Postal Service control over the

release of official information, and

otherwise protect the interests of the

United States. This proposed rule would

prohibit Postal Service employees from

complying with those demands without

the General Counsel’s permission.

DATES: Comments must be received on

or before March 17, 1995.

ADDRESSES: Written comments should

be mailed or delivered to: Library,

Attention Federal Register Comments,

U.S. Postal Service, 475 L’Enfant Plaza,

SW, Room 11800, Washington, DC

20260–1540. Copies of all written

comments will be available for public

inspection and photocopying between

8:15 a.m. and 4:45 p.m., Monday

through Friday, in Room 11800 at the

above address.

FOR FURTHER INFORMATION CONTACT: Julie

A. Holvik, Attorney, (312) 765–5230.

SUPPLEMENTARY INFORMATION: The

proposed rule provides that, in response

to subpoenas or other demands for

testimony or records concerning Postal

Service matters in private litigation or

other proceedings in which the United

States is not a party, Postal Service

employees may testify or produce

records only if the General Counsel or

the General Counsel’s delegate

authorizes compliance with the

demand. In making this determination,

the General Counsel or his or her

delegate will consider whether

compliance is in accordance with

applicable laws, privileges, rules,

authority, and regulations and would

not be contrary to the interests of the

United States.

Several federal agencies have enacted

this type of regulation, including the

Department of Justice, the Department

of Transportation, and the Department

of Veterans Affairs. The courts have

recognized the authority of federal

agencies to limit compliance with

demands in this manner. See, United

States ex. rel. Touhy v. Ragen, 340 U.S.

462 (1951). Moreover, subpoenas by

state courts, legislatures, or legislative

committees that attempt to assert

jurisdiction over federal agencies are

inconsistent with the Supremacy Clause

of the U.S. Constitution, and a federal

regulation regarding compliance with

those subpoenas reinforces this

principle. See, McCulloch v. Maryland,

17 U.S. (4 Wheat.) 316 (1819); United

States v. McLeod, 385 F.2d 734 (5th Cir.

1967).

This proposed rule would not apply

to situations in which the United States

is a party in a lawsuit. It also would not

apply to instances in which an

employee is requested to appear in legal

proceedings unrelated to federal

activities or the employee’s duties at the

Postal Service. Finally, the proposed

rule would not apply to subpoenas or

requests for information submitted by

either House of Congress or by a

congressional committee or

subcommittee with jurisdiction over the

matter for which the testimony or

information is requested.

List of Subjects in 39 CFR Part 265

Administrative practice and

procedure, Government employees,

Release of information.

For the reasons set out in this notice,

39 CFR part 265 is proposed to be

amended as follows.

PART 265—RELEASE OF

INFORMATION

1. The authority citation for part 265

is revised to read as follows:

Authority: 39 U.S.C. 401, 403, 410, 1001,

2601; 5 U.S.C. 552; Inspector General Act of

1978, as amended (Pub. L. 95–452, as

amended, 5 U.S.C. App. 3).

2. Section 265.12 is added to read as

follows:

§ 265.12 Demands for testimony or

records in certain legal proceedings.

(a) Scope and applicability of this

section. (1) This section establishes

procedures to be followed if the Postal

Service or any Postal Service employee

receives a demand for testimony

concerning or disclosure of:

(i) Records contained in the files of

the Postal Service; or

(ii) Information relating to records

contained in the files of the Postal

Service; or

(iii) Information or records acquired

or produced by the employee in the

course of his or her official duties or

because of the employee’s official status.

(2) This section does not create any

right or benefit, substantive or

procedural, enforceable by any person

against the Postal Service.

(3) This section does not apply to any

of the following:

(i) Any legal proceeding in which the

United States is a party;

(ii) A demand for testimony or records

made by either House of Congress or, to

the extent of matter within its

jurisdiction, any committee or

subcommittee of Congress; or

(iii) An appearance by an employee in

his or her private capacity in a legal

proceeding in which the employee’s

testimony does not relate to the

employee’s official duties or the

functions of the Postal Service; or

(iv) A demand for testimony or

records submitted to the Postal

Inspection Service (a demand for

Inspection Service records or testimony

will be handled in accordance with

rules published at § 265.11).

(4) This section does not exempt a

request from applicable confidentiality

requirements, including the

requirements of the Privacy Act. 5

U.S.C. 552a.

(b) Definitions. The following

definitions apply to this section:

(1) Adjudicative authority includes,

but is not limited to, the following:

(i) A court of law or other judicial

forums, whether local, state, or federal;

and

(ii) Mediation, arbitration, or other

forums for dispute resolution.

(2) Demand includes a subpoena,

subpoena duces tecum, request, order,