26140 Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Proposed Rules

accounts’’ raise any issues peculiar to

bank Trust Departments. The OCC and

FRB proposals do not specifically

address the ‘‘sweep account’’ issues

identified herein.

Reporting of Personal Trading

Part 344 currently requires certain

bank officers and bank employees

engaged in or aware of the investment

decisions or recommendations for

customer accounts to provide quarterly

reports regarding their personal trading

of securities. Section 344.6(d). The

regulation does not require reporting of

personal trading where the securities

transactions aggregate $10,000 or less

during the calendar quarter. The SEC

has a similar reporting requirement for

principal underwriters and investment

advisers of registered investment

companies under the Investment

Company Act of 1940. See SEC Rule

17j–1, 12 CFR 270.17j–1. The SEC Rule

does not provide an exemption for

securities transactions involving in the

aggregate $10,000 or less. The FDIC

requests comments on whether the

exemption from reporting personal

trading by bank officers and employees

engaged in or aware of the investment

decisions or recommendations for

customer accounts in section 344.6(d) is

appropriate. Additionally, the FDIC

requests comment on whether all bank

directors, as opposed to just those bank

directors who are also officers or

employees of the bank, should be

required to report on their personal

trading. The OCC and FRB proposals do

not address the personal trading issues

raised herein.

Additional Comment

The FDIC is interested in receiving

any additional comments regarding part

344 which the public feels should be

taken into account as the agency

undertakes to modernize the regulation.

By Order of the Board of Directors.

Dated at Washington, DC, this 14th day of

May, 1996.

Federal Deposit Insurance Corporation.

Robert E. Feldman,

Deputy Executive Secretary.

[FR Doc. 96–12928 Filed 5–23–96; 8:45 am]

BILLING CODE 6714–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 95N–0374]

RIN 0910–AA32

Latex Condoms; User Labeling;

Expiration Dating

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a

proposed regulation that would require

the labeling of latex condoms to contain

an expiration date based upon physical

and mechanical testing performed after

exposing the product to varying

conditions that age latex. Studies show

that latex condoms degrade over time.

Such degradation has a significant effect

on the product’s ability to provide a

barrier to sexually transmitted disease

(STD) agents, including the human

immunodeficiency virus (HIV). This

requirement is being proposed in order

to provide consumers with essential

information regarding the safe use of

these products.

DATES: Written comments on this

proposed rule by August 22, 1996.

Written comments on the information

collection requirements should be

submitted by June 24, 1996. FDA

proposes that any final rule that may be

issue based on this proposal become

effective 180 days after the date of its

publication in the Federal Register.

ADDRESSES: Submit written comments

on this proposed rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Submit written comments on the

information collection requirements to

the Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Donald E. Marlowe, Center for Devices

and Radiological Health (HFZ–150),

Food and Drug Administration, 12200

Wilkins Ave., Rockville, MD 20852,

301–443–7003.

SUPPLEMENTARY INFORMATION:

I. Background

It is estimated that over 1 million

persons in the United States are infected

with HIV (Ref. 1). HIV is transmitted

primarily through sexual contact;

however, nonsexual transmission has

occurred in health care settings as a

result of contact with infected blood.

Additionally, HIV has been isolated

from other body fluids in addition to

blood. With the prevalence of HIV

infection and the risk of transmission of

other infections, the importance of the

quality of an effective barrier to the

transmission of infection is crucial.

Numerous studies in the scientific

literature, including the proceedings of

a conference on ‘‘Latex as a Barrier

Material’’ sponsored by FDA in 1989,

have addressed and overwhelmingly

supported the use of latex membranes,

such as condoms and medical gloves, as

effective barriers against the

transmission of various disease agents,

including hepatitis, HIV, and other

infections (Ref. 2). The Centers for

Disease Control and Prevention (CDC)

and the Surgeon General of the Public

Health Service have recommended, on

the basis of evidence that latex provides

a barrier against the transmission of

STD’s, that latex condoms should be

used according to instructions with

every act of intercourse for maximum

protection against STD’s (Ref. 3). Two

recent studies involving serodiscordant

heterosexual couples (i.e., one partner is

HIV positive, the other HIV negative)

indicate that using latex condoms

substantially reduces the risk of HIV

transmission (Refs. 4 and 5). In one

study, none of the 123 partners who

used condoms consistently became

infected while 12 (10 percent) of 122

partners who used condoms

inconsistently became infected (Ref. 4).

In the second study, 3 (2 percent) of the

171 consistent condom users became

infected compared to 8 (15 percent) of

55 inconsistent condom users (Ref. 5).

The effectiveness of latex condoms as

a barrier, however, is dependent upon

the integrity of the latex material.

Degradation of latex film products (e.g.,

the embrittlement of the latex film, an

increase in the porosity of the

membrane, or other loss of physical

properties) occurs when latex is

exposed to various types of

environmental conditions (such as

elevated temperature, fluorescent lights,

or ozone) normally experienced in

product use, shipment, or storage

situations. Exposure to these

environmental conditions degrades the

film progressively over time, and may

result in bursts, rips, tears or seepage

that allows the transmission of

infectious agents.

To understand the effects of aging and

other storage conditions on latex

properties, the State of Washington’s

Board of Pharmacy initiated an FDAsponsored study of the material integrity
Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Proposed Rules 26141

of latex condoms (the FDA/Washington

study) in July 1989 (Ref. 6). This study

was designed to investigate the effects of

aging on latex condoms by studying

burst pressure, burst volume, tensile

strength, and elongation at breakage,

after storage over different periods of

time at varying temperatures. The study

examined dry (nonlubricated) condoms

and various types of lubricated

condoms, produced by the major

domestic condom manufacturers. The

study consisted of two parts--laboratory

testing, which ran for 3 years, and field

testing, which is an ongoing study of

normal condom aging at eight sites

representing varying temperatures,

elevations, and humidity conditions.

At the laboratories of the FDA/

Washington study, packaged and

unpackaged latex condoms were

exposed to temperatures of 20 and 30 °C

(representing room temperature) for up

to 5 years. In order to represent

exposure to the upper extreme of

environmental temperatures, condoms

were exposed for 100 days to a

temperature of 45 °C. Also, to accelerate

the aging process of the latex, condoms

were exposed to temperatures of 70 and

85 °C for up to 100 days (Refs. 7 through

9). The study revealed that exposed

condoms (i.e., condoms not protected by

packaging) degraded to the point of

being unusable within 1 year at room

temperature, and at higher temperatures

in as little as 10 days. The FDA/

Washington study further shows that

latex condoms stored in intact plastic

packages also degrade over time, though

at a much slower rate. The results of the

FDA/Washington study demonstrate

that aging and other conditions can

significantly affect the integrity,

strength, and quality of latex essential to

maintaining a barrier against the

transmission of disease.

At a meeting with the agency, condom

manufacturers and FDA agreed that,

based upon the American Society for

Testing and Materials (ASTM) standards

and the FDA/Washington study, two

accelerated aging test conditions (i.e.,

storage for 7 days at 70 °C and storage

for 90 days at 40 to 50 °C) properly

evaluate aging properties of latex films.

Given the evidence that aging affects the

latex barrier properties of condoms that

prevent the transmission of infectious

agents, the agency believes latex

condoms should not be used after aging

has compromised latex barrier

properties. Accordingly, FDA believes

that such products should bear

expiration dates, based upon

appropriate testing, that will inform the

user when these products should no

longer be used. FDA is therefore

proposing that latex condoms bear

expiration dates.

Proposed § 801.435(c) would require

an expiration date to appear on the

primary packaging (i.e., the individual

package), as well as higher levels of

labeling, such as the case containing

individually packaged products to

ensure visibility.

To establish the expiration date, FDA

is proposing to require manufacturers to

subject their products to certain aging

condition environments prior to

conducting physical and mechanical

testing that will demonstrate the

product will maintain its barrier

properties during the labeled shelf life

of the product. The accelerated aging

conditions would be based on data and

test protocols proposed by the industry,

and supported by existing condom

standards (Ref. 10), and the findings of

the Mandel and FDA/Washington

studies (Refs. 7 and 6).

Specifically, FDA in proposed

§ 801.435(d) would require that a

manufacturer, before performing tests

on products that demonstrate physical

and mechanical integrity of the product,

subject products from three discrete and

random lots to each of the following

conditions: (1) Storage unpackaged for

the maximum amount of time the

manufacturer allows the product to

remain unpackaged after manufacture,

followed by storage of the packaged

product at 70 °C (plus or minus 2 °C)

for 7 days; (2) storage unpackaged for

the maximum amount of time the

manufacturer allows the product to

remain unpackaged after manufacture,

followed by storage of the packaged

product at 40 to 50 °C (plus or minus

2 °C) for 90 days; and (3) storage

unpackaged for the maximum amount of

time the manufacturer allows the

product to remain unpackaged after

manufacture, followed by storage of the

packaged product at 15 to 30 °C for the

stated shelf life of the product.

Under proposed § 801.435(e), if the

latex barrier properties are adequate

(i.e., pass the manufacturer’s reasonable

physical and mechanical integrity tests)

after undergoing the 70 °C /7-day and 40

to 50 °C/90-day tests, the product may

be labeled with an expiration date of up

to 5 years. If the product, after storage

at either 7- or 90-day test conditions,

fails to meet the manufacturer’s physical

or mechanical integrity tests, the labeled

shelf life of the product would be

required to be demonstrated by realtime storage data at 15 to 30 °C.

Products that pass the 7- and 90-day test

conditions, would be required to

undergo confirmation tests after the

product has been stored at 15 to 30 °C

for the stated shelf life. If the product

fails the 15 to 30 °C confirmation test,

the product would be required to be

relabeled to represent the actual shelf

life supported by real time data.

Although FDA would not require

manufacturers of currently marketed

products to submit new 510(k)

submissions prior to marketing

condoms with expiration dates, all

testing data must be retained in each

company’s files as required by 21 CFR

820.180, and remain available for FDA

inspection. New 510(k) submissions

should include data to establish labeled

expiration dates.

The agency believes that the proposed

180-day time period between the

publication date of the final rule and the

effective date of the final rule would be

sufficient time to conduct the required

tests and ensure that all latex condoms

being initially introduced into interstate

commerce will bear an expiration date.

Latex condoms introduced into

interstate commerce after the effective

date of a final rule based on this

proposal, which do not bear appropriate

expiration dates would be considered to

be misbranded under sections 201(n),

502(a) and (f)(1) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 321(n), 352(a) and (f)(1)) in that

their labeling fails to contain facts

material to the consequences of their

use, and fails to bear adequate

directions for use.

II. Statement of Law

Section 701(a) of the act (21 U.S.C.

371(a)) authorizes FDA to issue

substantive binding regulations for the

efficient enforcement of the act.

Weinberger v. Hynson, Westcott &

Dunning, Inc., 412 U.S. 609 (1973); see

also Weinberger v. Bentex

Pharmaceuticals, Inc., 412 U.S. 645, 653

(1973); National Ass’n of

Pharmaceutical Manufacturers v. FDA,

637 F.2d 877 (2d Cir. 1981); National

Confectioners Ass’n v. Califano, 569

F.2d 690 (D.C. Cir 1978); National

Nutritional Foods Ass’n v. Weinberger,

512 F.2d 688 (2d Cir.) cert. denied, 423

U.S. 825 (1975).

Under the proposed rule, any latex

condom that is not labeled as required

and that is introduced or delivered for

introduction into commerce after the

effective date of a final rule would be

misbranded under sections 201(n) and

502(a) and (f)(1) of the act (21 U.S.C.

321(n) and 352(a) and (f)(1)). Section

502(a) of the act provides that a device

is misbranded if ‘‘its labeling is false or

misleading in any particular.’’ Section

201(n) of the act provides that, in

determining whether labeling of a

regulated article (such as a device) is

misleading:
26142 Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Proposed Rules

* * * there shall be taken into account *

* * not only representations made or

suggested by statement, word, design, device,

or any combination thereof, but also the

extent to which the labeling * * * fails to

reveal facts material in the light of such

representations or material with respect to

consequences which may result from the use

of the article to which the labeling * * *

relates * * *.

The shelf life of latex condoms is

material information that consumers

need in order to safely use latex

products. The omission of shelf life

would constitute an omission of a

material fact and would render latex

condoms without an expiration date

misbranded within the meaning of

section 502(a) of the act. The courts

have upheld FDA’s authority to prevent

false and misleading labeling by

promulgating regulations requiring label

warnings and other affirmative

disclosures, see, e.g., Cosmetic, Toiletry

and Fragrance Association v. Schmidt,

409 F. Supp. 57 (D.D.C. 1976), aff’d

without opinion, Civil No. 75–1715

(D.C. Cir. August 19, 1977), even in the

absence of a proven cause and effect

relationship between product usage and

harm, Council for Responsible Nutrition

v. Goyan, Civil No. 80–1124 (D.D.C.

August 1, 1980).

Section 502(f)(1) of the act provides

that a device is also misbranded unless

its labeling bears adequate directions for

use. Adequate directions for use means

adequate directions under which a

layperson can use a device safely and

for the purpose for which it is intended

(see 21 CFR 801.4 and 801.5).

Information concerning latex condom

shelf life is necessary to allow lay users

to use these products safely by avoiding

use of products that may have degraded.

Failure to include such information

would render the products misbranded

under section 502(f)(1) of the act.

FDA may impose testing requirements

in a labeling regulation issued under its

general rulemaking authority. See, e.g.,

American Frozen Food Inst. v. Mathews,

413 F. Supp. 548 (D.D.C. 1976), aff’d per

curiam sub nom. American Frozen Food

Inst. v. Califano, 555 F.2d 1059 (D.C. Cir

1977); see also National Nutritional

Foods Ass’n v. Weinberger, supra. Thus,

FDA may require that all latex condom

manufacturers use the same conditions

to test aging to ensure that the

expiration date reflects the period of

time a product can be used safely. A

similar requirement is imposed in 21

CFR 801.430(f) for absorbency tests for

menstrual tampons, and in 21 CFR

801.420(c)(4) on hearing aid

manufacturers and distributors who

must determine and state technical data

values for hearing aid labeling in

accordance with specified test

procedures. The hearing aid regulation

has been upheld. American Speech and

Hearing Ass’n v. Califano, Medical

Devices Report (CCH) No. 77–1327

§§ 15004, 15007 (D.D.C. August 23,

1977), aff’d No. 77–1327 (D.C. Cir. Dec.

19, 1977). Food regulations issued

under section 701(a) of the act also

impose many such specific testing

requirements (see, e.g., 21 CFR 113.40

(tests for low-acid canned foods); 21

CFR 155.190(b)(2)(i) (test for

determining drained weight of canned

tomatoes); 21 CFR 161.190 (method for

determining color designation of tuna)).

Consumers must be aware of the

potential for degradation of latex

condoms in order to safely use such

products to provide a barrier from

infectious agents. Accordingly, FDA

believes that the shelf life is a material

fact to the consequences of use of latex

condoms. FDA also believes that a shelf

life is necessary to provide the

consumer with adequate directions for

use. After the effective date of the final

regulation, FDA will consider latex

condoms that do not provide this

information to be misbranded under

sections 201(n), 502(a) and (f)(1) of the

act because they fail to contain facts

material to the consequences of their

use, and fail to bear adequate directions

for use.

III. Preemption

FDA advises that any labeling

requirement based upon this proposal

would, under section 521(a) of the act

(21 U.S.C. 360k(a)), preempt any State

or local requirement that is different

from, or in addition to, FDA’s labeling

requirement. Section 521(a) of the act

provides that no State or local

government may establish any

requirement applicable under the act if

such requirement is different from, or in

addition to, a requirement which is

applicable to the device under the act.

In 1991, the State of Washington

requested an advisory opinion regarding

the preemption of its State requirement

that condom labels bear a 3-year

expiration date. One condom

manufacturer had objected to the State

law, on the grounds that its 510(k)

clearance included labeling for a 5-year

shelf life. The agency determined that

the State requirement was not

preempted by section 521(a) of the act

because, at that time, there was no

counterpart Federal requirement with

respect to expiration date labeling for

condoms. FDA’s ‘‘General Guidance for

Modifying Condom Labeling to Include

Shelf Life’’ (Ref. 11) provided premarket

notification procedures for

manufacturers who choose voluntarily

to affix shelf life dates to their condom

packages. That document did not

establish a ‘‘requirement’’ within the

meaning of section 521(a) of the act.

This proposed rule, when final,

however, would constitute a

requirement which will preempt any

State or local requirement regarding the

expiration date labeling of latex

condoms which is different from, or in

addition to, the final regulation.

IV. Labeling For Other Latex-Film

Products

The agency recognizes that the unique

packaging of latex condoms (i.e.,

product sealed individually in air-tight

packages) makes it difficult to

extrapolate the data relating to latex

condoms to other latex-film medical

devices that have packaging which may

provide a different level of protection

from environmental conditions. Given

the evidence that aging affects the

integrity of latex films, FDA believes

that medical devices containing or

composed of a latex film should provide

information regarding the age of the

latex film. In order to address this issue,

FDA is initiating a study to determine

at what rate latex gloves degrade under

various environmental conditions.

Until the agency compiles sufficient

data to propose an expiration date for

latex devices other than condoms, the

agency is considering whether to require

devices containing or consisting of latex

films, other than latex condoms, to be

labeled with the date of manufacture

(i.e., the date the latex film was formed

by dipping). Although the date of

manufacture provides no information

about the expected life of the product,

it will provide age information. Based

upon such age information, consumers

may make a more informed choice

regarding the use of the product.

Furthermore, as shown in the FDA/

Washington study cited above, latex

films are far more stable in intact

packages than when exposed. Because

the normal use of some products (such

as nonsterile examination gloves, sold

in dispenser boxes of 100), includes

storage in opened packages, FDA is also

considering additional labeling

information requirements for products

normally dispensed in open containers,

including the statement ‘‘Heat and light

accelerate the degradation of latex films.

Store opened containers away from heat

and light.’’

FDA invites advance comments on

these issues. Meanwhile, FDA

encourages manufacturers to voluntarily

provide information to consumers

regarding the age of latex film devices,

and additional educational materials

and ancillary information regarding the
Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Proposed Rules 26143

stability and best storage conditions of

such products, as appropriate.

V. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(11) 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.

VI. 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. This proposed regulation

would require physical and mechanical

integrity tests. Because condom

manufacturers routinely conduct such

tests on their products, the required

testing would affect manufacturers only

by establishing storage conditions prior

to testing such products. This proposed

rule would also require a labeling

change. The proposed 180-day time

period between the publication date and

effective date of the final rule based

upon this proposal would allow most

manufacturers to exhaust their existing

supply of labels. Accordingly, for the

above-stated reasons, the agency

certifies that the proposed rule will not

have a significant economic impact on

small entities. Therefore, under the

Regulatory Flexibility Act, no further

analysis is required.

VII. Paperwork Reduction Act of 1995

This proposed rule contains

information collections which are

subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995.

The title, description, and respondent

description of the information collection

are shown below with an estimate of the

annual reporting burden. Included in

the estimate is the time for reviewing

instructions, gathering and maintaining

the data needed, and completing and

reviewing the collection of information.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Title: Labeling Requirements for Latex

Condoms—Expiration Date Labeling.

Description: These information

collection requirements apply to

condom manufacturers. This proposed

rule expands the labeling of latex

condoms to contain an expiration date.

The expiration date must be supported

by data from quality control tests

demonstrating physical and mechanical

integrity of three random lots of the

same product which were stored under

accelerated and real time conditions.

Quality control testing under

accelerated conditions must include

tests of: (1) Unpackaged bulk product

for the maximum amount of time the

manufacturer allows the product to

remain unpackaged; (2) packaged

product stored at a specified

temperature for 7 days; and (3) packaged

product stored at a specified

temperature for 90 days. Quality control

testing must also be done under real

time conditions, i.e., on packaged

product at a specified temperature for

the entire expiration period (up to 5

years).

The recording of shelf life testing by

condom manufacturers is used to

support the inclusion of expiration

dating on the labeling of latex condoms.

Information concerning latex condom

shelf life is necessary to allow lay users

to use these products safely by avoiding

use of products that may have degraded.

The effectiveness of latex condoms as a

barrier to the transmission of infectious

agents is dependent upon the integrity

of the latex material. The shelf life of

latex condoms is material information

that consumers need in order to safely

use latex products.

Condom manufacturers will use the

information collected from the testing to

establish the expiration date to be

printed on the labeling and purchasers

will use the information collected to

determine likely effectiveness.

Section 510(h) of the act (21 U.S.C.

360(h)) requires that condom

manufacturers as device manufacturers

be inspected at least once in a 2-year

period. During that inspection, FDA

inspectors will review the test records

used to support the expiration date in

order to ensure that the expiration date

is accurate.

Description of Respondents:

Businesses or other for profit

organizations.

Estimated Annual Recordkeeping Burden

21 CFR

Section

No. of

Recordkeepers

Annual Frequency

of Recordkeeping

Total Annual

Records

Hours per

Recordkeeper

Total

Hours

Total Capital

Costs

Total Operating and

Maintenance Costs

801.435(d) 58 1 58 1201 6,9601 $9,2802 $125,2801

1The annual burden reported here represents a year in which a manufacturer would have conducted testing at 0 days, 7 days, 90 days, and 5

years (in support of a labeled expiration period of 5 years). However, FDA expects that testing at 0 days, 7 days, and 90 days would be conducted during 1 year to justify a 5-year expiration period, and that testing on 5-year-old product would be conducted in another year. 2 Capital costs are one time start-up costs and consist of a revision of policies and procedures.

As required by section 3507(d) of the

Paperwork Reduction Act of 1995, FDA

has submitted the collections of

information contained in the proposed

rule to OMB for review. Other

organizations and individuals should

submit comments on the information

collection requirements by June 24,

1996, and should direct them to the
26144 Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Proposed Rules

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

VIII. Comments

Interested persons may, on or before

August 22, 1996, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

IX. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Center for Disease Control and

Prevention, ‘‘HIV Prevalence Estimates and

AIDS Case Projections for The United States:

Report Based Upon a Workshop,’’ Morbidity

and Mortality Weekly Report, vol. 39/No.

RR–16, November 30, 1990.

2. Conference on Latex as a Barrier

Material, University of Maryland, (sponsored

by FDA), May 1989.

3. Center for Disease Control, ‘‘Update:

Barrier Protection Against HIV Infection and

Other Sexually Transmitted Diseases,’’

Morbidity and Mortality Weekly Report, vol.

42/No. 30, August 6, 1993.

4. DeVincenzi, L., European Study Group

on Heterosexual Transmission of HIV,

Heterosexual Transmission of HIV in a

European Cohort of Couples (abstract No.

WSCO2–1), vol.1, IXth International

Conference on AIDS/HIV STD World

Congress. Berlin, 83, June 9, 1993.

5. Saracco, A., M. Musicco, A. Nicolosi, et

al., ‘‘Man-to-Woman Sexual Transmission of

HIV: Longitudinal Study of 343 Steady

Partners of Infected Men,’’ Journal of

Acquired Immune Deficiency Syndrome,

6:497–502, 1993.

6. Final Report: Lubricated Latex

Condoms—Study of the Effects of

Environmental Parameters on Deterioration:

Program for Appropriate Technology in

Health (PATH), FDA Contract No. 223–88–

4285, October 1993.

7. Mandel, J. et al., ‘‘Measurement of the

Aging of Rubber Vulcanizates’’ Journal of

Research of the National Bureau of

Standards, vol. 63C, No. 2, OctoberDecember, 1959.

8. Barker, L. R., Accelerated and LongTerm Ageing of Natural Rubber Vulcanisates:

Journal of Natural Rubber Research, vol. 2,

No. 4, pp. 201–213 (1987).

9. Barker, L. R., Accelerated Long-Term

Ageing of Natural Rubber Vulcanisates, Part

2: Results From Ageing Tests at 40 C, Journal

of Natural Rubber Research, vol. 5, No. 3, pp.

266–274, 1990.

10. ASTM D 3492, Standard Specification

for Rubber Contraceptives (Condoms),

American Society for Testing and Materials,

Philadelphia, PA.

11. ‘‘General Guidance for Modifying

Condom Labeling to Include Shelf Life,’’

Division of Small Manufacturers Assistance,

Center for Devices and Radiological Health,

Rockville, MD.

List of Subjects in 21 CFR Part 801

Labeling, Medical devices, Reporting

and recordkeeping requirements.

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 801 be amended as follows:

PART 801—LABELING

1. The authority citation for 21 CFR

part 801 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 507,

519, 520, 701, 704 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 331, 351,

352, 357, 360i, 360j, 371, 374).

2. New § 801.435 is added to subpart

H to read as follows:

§ 801.435 User labeling for latex condoms.

(a) This section applies to the subset

of condoms as identified in § 884.5300

of this chapter, and condoms with

spermicidal lubricant as identified in

§ 884.5310, which products are formed

from latex films.

(b) Data show that the material

integrity of latex condoms degrades over

time. To protect the public health and

minimize the risk of device failure, latex

condoms must bear an expiration date

which is supported by testing as

described in paragraph (d) of this

section.

(c) The expiration date, as

demonstrated by testing procedures

described in paragraph (d) of this

section, must be displayed prominently

and legibly on the primary packaging

(e.g., individual package), and higher

levels of packaging (e.g., boxes of

condoms), in order to ensure visibility

of the expiration date.

(d) The expiration date must be

supported by data from reasonable

quality control tests demonstrating the

physical and mechanical integrity of the

product after three discrete and random

lots of the same product have been

subjected to each of the following

conditions:

(1) Storage of unpackaged bulk

product for the maximum amount of

time the manufacturer allows the

product to remain unpackaged, followed

by storage of the packaged product at 70

°C (plus or minus 2 °C) for 7 days;

(2) Storage of unpackaged bulk

product for the maximum amount of

time the manufacturer allows the

product to remain unpackaged, followed

by storage of the packaged product at a

selected temperature between 40 and 50

°C (plus or minus 2 °C) for 90 days; and

(3) Storage of unpackaged bulk

product for the maximum amount of

time the manufacturer allows the

product to remain unpackaged, followed

by storage of the packaged product at a

monitored or controlled temperature

between 15 and 30 °C for the lifetime of

the product (real-time storage).

(e) If a product fails the

manufacturer’s reasonable quality

control tests for physical and

mechanical integrity after the

completion of the accelerated storage

tests described in paragraphs (d)(1) and

(d)(2) of this section, the product

expiration date must be demonstrated

by real-time storage conditions

described in paragraph (d)(3) of this

section. If all of the products tested after

storage at temperatures as described in

paragraphs (d)(1) and (d)(2) of this

section pass the manufacturer’s

reasonable physical and mechanical

integrity tests, the manufacturer may

label the product with an expiration

date of up to 5 years from the date of

product packaging. If the extrapolated

expiration date, under paragraphs (d)(1)

and (d)(2) of this section, is used, the

labeled expiration date must be

confirmed by reasonable physical and

mechanical integrity tests performed at

the end of the stated expiration period

as described in paragraph (d)(3) of this

section. If the data from tests following

real-time storage described in paragraph

(d)(3) of this section fails to confirm the

extrapolated expiration date, the

manufacturer must, at that time, relabel

the product to reflect the actual shelf

life.

(f) The time period upon which the

expiration date is based shall start with

the date of packaging.

(g) All testing data must be retained

in each company’s files, as required by

§ 820.180 of this chapter, and shall be

made available, upon request, for

inspection by FDA.

(h) Any latex condom not labeled

with an expiration date as required by

paragraph (c) of this section, and

delivered for introduction into interstate

commerce after the effective date of this

regulation is misbranded under sections

201(n) and 502(a) and (f) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

321(n), 352(a) and (f)).
Federal Register / Vol. 61, No. 102 / Friday, May 24, 1996 / Proposed Rules 26145

1Note that states may require applications to be

submitted earlier than required under section

503(c). See Subchapter X, Section 5–1005 of

Vermont’s rules.

Dated: May 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13174 Filed 5–23–96; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 70

[AD–FL–5510–2]

Clean Air Act Interim Approval of

Operating Permits Program;

Delegation of Section 112 Standards;

State of Vermont

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: The EPA proposes interim

approval of the Operating Permits

Program submitted by Vermont for the

purpose of complying with Federal

requirements for an approvable State

program to issue operating permits to all

major stationary sources, and to certain

other sources. EPA is also approving

Vermont’s authority to implement

hazardous air pollutant requirements.

DATES: Comments on this proposed

action must be received in writing by

June 24, 1996.

ADDRESSES: Comments should be

addressed to Donald Dahl, Air Permits,

CAP, U.S. Environmental Protection

Agency, Region I, JFK Federal Building,

Boston, MA 02203–2211. Copies of the

State’s submittal and other supporting

information used in developing the

proposed interim approval are available

for inspection during normal business

hours at the following location: U.S.

Environmental Protection Agency,

Region 1, One Congress Street, 11th

floor, Boston, MA 02203–2211.

FOR FURTHER INFORMATION CONTACT:

Donald Dahl, CAP, U.S. Environmental

Protection Agency, Region 1, JFK

Federal Building, Boston, MA 02203–

2211, (617) 565–4298.

SUPPLEMENTARY INFORMATION:

I. Background and Purpose

A. Introduction

As required under title V of the 1990

Clean Air Act Amendments (sections

501–507 of the Clean Air Act (‘‘the

Act’’)), EPA has promulgated rules

which define the minimum elements of

an approvable State operating permits

program and the corresponding

standards and procedures by which the

EPA will approve, oversee, and

withdraw approval of State operating

permits programs (see 57 FR 32250 (July

21, 1992)). These rules are codified at 40

Code of Federal Regulations (CFR) Part

70. Title V requires States to develop,

and submit to EPA, programs for issuing

these operating permits to all major

stationary sources and to certain other

sources.

The Act requires that States develop

and submit these programs to EPA by

November 15, 1993, and that EPA act to

approve or disapprove each program

within 1 year after receiving the

submittal. The EPA’s program review

occurs pursuant to section 502 of the

Act and the part 70 regulations, which

together outline criteria for approval or

disapproval. Where a program

substantially, but not fully, meets the

requirements of Part 70, EPA may grant

the program interim approval for a

period of up to 2 years. If EPA has not

fully approved a program by 2 years

after the November 15, 1993 date, or by

the end of an interim program, it must

establish and implement a Federal

program.

B. Federal Oversight and Sanctions

If EPA were to finalize this proposed

interim approval, it would extend for

two years following the effective date of

final interim approval, and could not be

renewed. During the interim approval

period, the State of Vermont would be

protected from sanctions, and EPA

would not be obligated to promulgate,

administer and enforce a Federal

permits program for the State of

Vermont. Permits issued under a

program with interim approval have full

standing with respect to part 70, and the

1-year time period for submittal of

permit applications by subject sources

begins upon the effective date of interim

approval, as does the 3-year time period

for processing the initial permit

applications 1.

Following final interim approval, if

the State of Vermont failed to submit a

complete corrective program for full

approval by the date 6 months before

expiration of the interim approval, EPA

would start an 18-month clock for

mandatory sanctions. If the State of

Vermont then failed to submit a

corrective program that EPA found

complete before the expiration of that

18-month period, EPA would apply

sanctions as required by section

502(d)(2) of the Act, which would

remain in effect until EPA determined

that the State of Vermont had corrected

the deficiency by submitting a complete

corrective program. If, six months after

application of the first sanction, the

State of Vermont still has not submitted

a corrective program that EPA finds

complete, a second sanction will be

required.

If, following final interim approval,

EPA were to disapprove the State of

Vermont’s complete corrective program,

EPA would be required under section

502(d)(2) to apply sanctions on the date

18 months after the effective date of the

disapproval, unless prior to that date the

State of Vermont had submitted a

revised program and EPA had

determined that it corrected the

deficiencies that prompted the

disapproval. If, six months after EPA

applies the first sanction, the State of

Vermont has not submitted a revised

program that EPA has determined

corrected the deficiencies that prompted

disapproval, a second sanction will be

required.

Moreover, if EPA has not granted full

approval to the State of Vermont’s

program by the expiration of an interim

approval and that expiration occurs

after November 15, 1995, EPA must

promulgate, administer and enforce a

Federal permits program for the State of

Vermont upon interim approval

expiration.

II. Proposed Action and Implications

A. Analysis of State Submission

The analysis contained in this

document focuses on specific elements

of Vermont’s title V operating permits

program that must be corrected to meet

the minimum requirements of 40 CFR

part 70. The full program submittal,

technical support document (TSD),

dated April 19, 1996 entitled ‘‘Technical

Support Document—Vermont Operating

Permits Program’’, which contains a

detailed analysis of the submittal, and

other relevant materials are available for

inspection as part of the public docket.

The docket may be viewed during

regular business hours at the address

listed above.

1. Title V Program Support Materials

Vermont’s title V program was

submitted by the State on April 28, 1995

(PROGRAM). The submittal was found

to be administratively complete on June

12, 1995. The PROGRAM consisted of a

Governor’s letter, program description,

Attorney General’s legal opinion,

permitting regulations and enabling

legislation, and permitting program

documentation. Included with the

PROGRAM submittal was a draft

implementation agreement which will

be finalized by EPA and Vermont. The