31454 Federal Register / Vol. 65, No. 97 / Thursday, May 18, 2000 / Rules and Regulations

§ 600.1015 Late charges.

The late charge to fish buyers for fee

payment, collection, deposit, and/or

disbursement shall be one and one-half

(1.5) percent per month, or the

maximum rate permitted by state law,

for the total amount of the fee not paid,

collected, deposited, and/or disbursed

when due to be paid, collected,

deposited, and/or disbursed. The full

late charge shall apply to the fee for

each month or portion of a month that

the fee remains unpaid, uncollected,

undeposited, and/or undisbursed.

§ 600.1016 Enforcement.

In accordance with applicable law or

other authority, NMFS may take

appropriate action against each fish

seller and/or fish buyer responsible for

non-payment, non-collection, nondeposit, and/or non-disbursement of the

fee in accordance with this subpart to

enforce the collection from such fish

seller and/or fish buyer of any fee

(including penalties and all costs of

collection) due and owing the United

States on account of the loan that such

fish seller and/or fish buyer should

have, but did not, pay, collect, deposit,

and/or disburse in accordance with this

subpart. All such loan recoveries shall

be applied to reduce the unpaid balance

of the loan.

§ 600.1017 Prohibitions and penalties.

(a) The following activities are

prohibited, and it is unlawful for any

party to: (1) Vote in any referendum

under this subpart if the party is

ineligible to do so;

(2) Vote more than once in any

referendum under this subpart;

(3) Sign or otherwise cast a ballot on

behalf of a voter in any referendum

under this subpart unless the voter has

fully authorized the party to do so and

doing so otherwise comports with this

subpart;

(4) Interfere with or attempt to hinder,

delay, buy, or otherwise unduly or

unlawfully influence any eligible voter’s

vote in any referendum under this

subpart;

(5) Submit a fraudulent,

unauthorized, incomplete, misleading,

unenforceable by specific performance,

or inaccurate bid in response to an

invitation to bid under this subpart or,

in any other way, interfere with or

attempt to interfere with, hinder, or

delay, any invitation to bid, any bid

submitted under any invitation to bid,

any reduction contract, or any other

reduction process in connection with

any invitation to bid;

(6) Revoke or attempt to revoke any

bid under this subpart;

(7) Fail to comply with the terms and

conditions of any invitation to bid, bid,

or reduction contract under this subpart,

including NMFS’ right under such

reduction contracts to specific

performance;

(8) Fail to fully and properly pay and

collect any fee due payable, and

collectible under this subpart or

otherwise avoid, decrease, interfere

with, hinder, or delay any such payment

and collection,

(9) Convert, or otherwise use for any

purpose other than the purpose this

subpart intends, any paid or collected

fee;

(10) Fail to fully and properly deposit

on time the full amount of all fee

revenue collected under this subpart

into a deposit account and disburse the

full amount of all deposit principal to

the Fund’s lockbox account—all as this

subpart requires;

(11) Fail to maintain full, timely, and

proper fee payment, collection, deposit,

and/or disbursement records or make

full, timely, and proper reports of such

information to NMFS–-all as this

subpart requires;

(12) Fail to advise NMFS of any fish

seller’s refusal to pay, or of any fish

buyer’s refusal to collect, any fee due

and payable under this subpart;

(13) Refuse to allow NMFS or agents

that NMFS designates to review and

audit at reasonable times all books and

records reasonably pertinent to fee

payment, collection, deposit,

disbursement, and accounting under

this subpart or otherwise interfere with,

hinder, or delay NMFS or it agents in

the course of their activities under this

subpart;

(14) Make false statements to NMFS,

any of the NMFS’ employees, or any of

NMFS’ agents about any of the matters

in this subpart;

(15) Obstruct, prevent, or

unreasonably delay or attempt to

obstruct, prevent, or unreasonably delay

any audit or investigation NMFS or its

agents conduct, or attempt to conduct,

in connection with any of the matters in

this subpart; and/or

(16) Otherwise materially interfere

with the efficient and effective conduct

of reduction and the repayment of

reduction loans under this subpart.

(b) Any party who violates one or

more of the prohibitions of paragraph (a)

of this section is subject to the full range

of penalties the Magnuson-Stevens Act

and 15 CFR part 904 provide—

including, but not limited to: civil

penalties, sanctions, forfeitures, and

punishment for criminal offenses—and

to the full penalties and punishments

otherwise provided by any other

applicable law of the United States.

(c) Additionally, NMFS may take any

and all appropriate actions, including

the communication of action at law,

against each party responsible for the

non-payment, non-collection, nondeposit, and/or non-disbursement in

accordance with § 600.1013 and/or

§ 600.1014 to enforce the United States’

receipt from such party of any fee—

including penalties and all costs of

collection—due and owing the United

States on account of the reduction loan

that such party should have, but did

not, pay, collect, deposit, and/or

disburse in accordance with § 600.1013

and/or § 600.1014. All such reduction

loan recoveries shall be applied to

reduce the unpaid balances of reduction

loans.

§ 600.1018 Implementation regulations for

each program. [Reserved]

[FR Doc. 00–12159 Filed 5–17–00; 8:45 am]

BILLING CODE 3510–22–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 99N–1309]

Obstetrical and Gynecological

Devices; Classification of Female

Condoms

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying the

preamendments female condom

intended for contraceptive and

prophylactic purposes. Under this rule,

the preamendments female condom is

being classified into class III (premarket

approval). This action is being taken

under the Federal Food, Drug, and

Cosmetic Act (the act), as amended by

the Medical Device Amendments of

1976, the Safe Medical Devices Act of

1990, and the FDA Modernization Act

of 1997.

DATES: This rule is effective June 19,

2000.

FOR FURTHER INFORMATION CONTACT:

Colin M. Pollard, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1180.

SUPPLEMENTARY INFORMATION:

I. Background

In a proposal published in the Federal

Register of June 10, 1999 (64 FR 31164)

Federal Register / Vol. 65, No. 97 / Thursday, May 18, 2000 / Rules and Regulations 31455

(hereinafter referred to as the June 10,

1999, proposal), FDA solicited

comments regarding the proposed

classification of female condoms. The

June 10, 1999, proposal provided the

regulatory history of female condoms, as

well as the recommendation of the

Obstetrical and Gynecological Device

Classification Panel (the Panel) that this

particular device be classified into class

III. Specifically, the Panel recommended

that this device be classified into class

III because no published laboratory or

clinical study data could be found that

demonstrate its safety and effectiveness.

Also, the Panel believed that general

controls and special controls would not

provide reasonable assurance of the

safety and effectiveness of the device

and the device is purported or

represented to be for a use in supporting

or sustaining human life or for a use

which is of substantial importance in

preventing impairment of human

health, or presents a potential

unreasonable risk of illness or injury.

FDA agreed with the Panel’s

recommended classification.

The Panel also recommended that the

device be identified as an intravaginal

pouch because it is a sheath-like device

that lines the vaginal wall and is

inserted into the vagina prior to the

initiation of coitus. FDA proposed to

change the name of the generic type of

the device to female condom.

The 90-day comment period ended

September 8, 1999, and FDA stated that

upon consideration of public comment

it would issue a final rule classifying

this device. FDA received one comment

endorsing the June 10, 1999, proposal.

II. Conclusion

FDA has concluded that the female

condom be classified into class III

because general controls and special

controls do not provide reasonable

assurance of the safety and effectiveness

of the device, and the device is

purported or represented to be for a use

in supporting or sustaining human life

or for a use which is of substantial

importance in preventing impairment of

human health, or presents a potential

unreasonable risk of illness or injury.

FDA has further concluded that the

generic type of this device be identified

as ‘‘female condom.’’ FDA intends to

issue a call for premarket approval

applications (PMA’s) for these devices.

III. Environmental Impact

The agency has determined under 21

CFR 25.34(b) 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

rule under Executive Order 12866,

Executive Order 13132, the Regulatory

Flexibility Act (5 U.S.C. 601–612) (as

amended by subtitle D of the Small

Business Regulatory Fairness 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 it is not

subject to review under the Executive

Order.

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rule does not

contain policies that have substantial

direct effects on the States, on the

relationship between the National

Government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Accordingly, the

agency has concluded that the rule does

not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. FDA believes that there is no

interest at this time in marketing the

device to be classified by this rule. FDA

is taking this action because it has

determined that premarket approval is

necessary to provide reasonable

assurance of the safety and effectiveness

of the device, if there is any interest in

marketing one in the future. Without

this rule (and a subsequent requirement

for PMA’s), a person could market a

device by claiming substantial

equivalence to the Gee Bee Ring. All

premarket submissions for ‘‘female

condom’’ type devices that FDA has

received to date have been for devices

that have been found to be not

substantially equivalent to the Gee Bee

Ring and, therefore, those devices are

not preamendments devices and are not

to be classified by this rule. Under

section 501(f)(2)(B) of the act (21 U.S.C.

351(f)(2)(B)), a rule requiring PMA’s for

this device could not take effect any

sooner than 30 months after the

effective date of a final rule classifying

the device or 90 days after publication

of the final rule requiring the PMA’s,

whichever is later.

The agency therefore certifies that this

rule will not have a significant

economic impact on a substantial

number of small entities. In addition,

this rule 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.

V. Paperwork Reduction Act of 1995

FDA tentatively concludes that this

rule requires no collection of

information. Therefore, clearance by the

Office of Management and Budget under

the Paperwork Reduction Act of 1995 is

not required.

List of Subjects in 21 CFR Part 884

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 884 is

amended as follows:

PART 884—OBSTETRICAL AND

GYNECOLOGICAL DEVICES

1. The authority citation for 21 CFR

part 884 continues to read as follows:

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

360j, 371.

2. Section 884.5330 is added to

subpart F to read as follows:

§ 884.5330 Female condom.

(a) Identification. A female condom is

a sheath-like device that lines the

vaginal wall and is inserted into the

vagina prior to the initiation of coitus.

It is indicated for contraceptive and

prophylactic (preventing the

transmission of sexually transmitted

diseases) purposes.

(b) Classification. Class III (premarket

approval).

(c) Date premarket approval

application (PMA) or notice of

completion of a product development

protocol (PDP) is required. No effective

date has been established of the

requirement for premarket approval for

the devices described in paragraph (b) of

this section. See § 884.3 for effective

31456 Federal Register / Vol. 65, No. 97 / Thursday, May 18, 2000 / Rules and Regulations

1Copies may be obtained: http://

www.whs.osd.mil/corres.htm.

2See footnote 1 to § 701.100.

3Copies may be obtained: Chief of Naval

Operations, 2000 Navy Pentagon, Washington, DC

20350–2000.

dates of requirement for premarket

approval.

Dated: May 9, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–12526 Filed 5–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Department of the Navy

32 CFR Part 701

Department of the Navy Privacy Act

Program

AGENCY: Department of the Navy.

ACTION: Final rule.

SUMMARY: On September 14, 1999, at 64

FR 49850, the Department of the Navy

unintentionally deleted subparts F and

G to 32 CFR part 701. These subparts

provide the policies and procedures for

the Department of the Navy Privacy

Program and are still current and

relevant to the Navy’s Privacy Program.

Therefore, this final rule adds subparts

F and G to 32 CFR part 701.

EFFECTIVE DATE: September 14, 1999.

FOR FURTHER INFORMATION CONTACT: Mrs.

Doris Lama at (202) 685-6545.

SUPPLEMENTARY INFORMATION:

Executive Order 12866, ‘Regulatory

Planning and Review’

It has been determined that 32 CFR

part 701, subparts F and G are not

significant regulatory action. The rule

does not:

(1) Have an annual effect to the

economy of $100 million or more; or

adversely affect in a material way the

economy; a section of the economy;

productivity; competition; jobs; the

environment; public health or safety; or

state, local, or tribal governments or

communities;

(2) Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another Agency;

(3) Materially alter the budgetary

impact of entitlements, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof;

(4) Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in this Executive Order.

Public Law 96–354, ‘Regulatory

Flexibility Act’ (5 U.S.C. 601)

It has been certified that this rule is

not subject to the Regulatory Flexibility

Act (5 U.S.C. 601) because it would not,

if promulgated, have a significant

economic impact on a substantial

number of small entities.

Public Law 96–511, ‘Paperwork

Reduction Act’ (44 U.S.C. Chapter 35)

It has been certified that this part does

not impose any reporting or record

keeping requirements under the

Paperwork Reduction Act of 1995.

List of Subjects in 32 CFR Part 701

Privacy.

Accordingly, Chapter I, 32 CFR part

701, is amended by adding subparts F

and G to read as follows:

Subpart F—Department of the Navy Privacy

Act Program

Sec.

701.100 Purpose.

701.101 Applicability.

701.102 Definitions.

701.103 Policy.

701.104 Responsibility and authority.

701.105 Systems of records.

701.106 Safeguarding records in systems of

records.

701.107 Criteria for creating, altering,

amending and deleting Privacy Act

systems of records.

701.108 Collecting information about

individuals.

701.109 Access to records.

701.110 Amendment of records.

701.111 Privacy Act appeals.

701.112 Disclosure of records.

701.113 Exemptions.

701.114 Enforcement actions.

701.115 Computer matching program.

Subpart G—Privacy Act Exemptions

701.116 Purpose.

701.117 Exemption for classified records.

701.118 Exemptions for specific Navy

record systems.

701.119 Exemptions for specific Marine

Corps records systems.

Subpart F—Department of the Navy

Privacy Act Program

Authority: Pub. L. 93–579, 88 Stat 1896 (5

U.S.C. 552a).

§ 701.100 Purpose.

Subparts F and G of this part

implement the Privacy Act (5 U.S.C.

552a), and DoD Directive 5400.11,1 and

DoD 5400.11–R,2 (32 CFR part 310) and

provides Department of the Navy

policies and procedures for:

(a) Governing the collection,

safeguarding, maintenance, use, access,

amendment, and dissemination of

personal information kept by

Department of the Navy in systems of

records;

(b) Notifying individuals if any

systems of records contain a record

pertaining to them;

(c) Verifying the identity of

individuals who request their records

before the records are made available to

them;

(d) Notifying the public of the

existence and character of each system

of records.

(e) Exempting systems of records from

certain requirements of the Privacy Act;

and

(f) Governing the Privacy Act rules of

conduct for Department of the Navy

personnel, who will be subject to

criminal penalties for noncompliance

with 5 U.S.C. 552a, as amended by the

Computer Matching Act of 1988.

§ 701.101 Applicability.

This subpart and subpart G of this

part apply throughout the Department of

the Navy. It is also applicable to

contractors by contract or other legally

binding action, whenever a Department

of the Navy contract provides for the

operation of a system of records or

portion of a system of records to

accomplish a Department of the Navy

function. For the purposes of any

criminal liabilities adjudged, any

contractor or any employee of such

contractor is considered to be an

employee of Department of the Navy. In

case of a conflict, this subpart and

subpart G of this part take precedence

over any existing Department of the

Navy directive that deals with the

personal privacy and rights of

individuals regarding their personal

records, except for disclosure of

personal information required by 5

U.S.C. 552 (1988) as amended by the

Freedom of Information Reform Act and

implemented by Secretary of the Navy

Instruction 5720.42F,3 ‘Department of

the Navy Freedom of Information Act

Program.’

§ 701.102 Definitions.

For the purposes of this subpart and

subpart G of this part, the following

meanings apply.

Access. The review or copying of a

record or parts thereof contained in a

system of records by any individual.

Agency. For the purposes of

disclosing records subject to the Privacy

Act between or among Department of

Defense (DoD) components, the

Department of Defense is considered a

single agency. For all other purposes,

Department of the Navy is considered

an agency within the meaning of

Privacy Act.