Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Rules and Regulations 50497

to perform critical functions are not

adversely affected when the airplane is

exposed to high intensity radiated

fields.

For the purpose of this special

condition, the following definition

applies:

Critical Functions. Functions whose

failure would contribute to or cause a

failure condition that would prevent the

continued safe flight and landing of the

airplane.

2. Engine Torque Loads. In lieu of

compliance with § 25.361(b),

compliance with the following must be

shown:

(b) For turbine engine installations,

the mounts and local supporting

structure must be designed to withstand

each of the following:

(1) The maximum torque load,

considered as limit, imposed by:

(i) sudden deceleration of the engine

due to a malfunction that could result

in a temporary loss of power or thrust

capability, and that could cause a

shutdown due to vibrations; and

(ii) the maximum acceleration of the

engine.

(2) The maximum torque load,

considered as ultimate, imposed by

sudden engine stoppage due to a

structural failure, including fan blade

failure.

(3) The load condition defined in

paragraph (b)(2) of this section is also

assumed to act on adjacent airframe

structure, such as the wing and fuselage.

This load condition is multiplied by a

factor of 1.25 to obtain ultimate loads

when the load is applied to the adjacent

wing and fuselage supporting structure.

Issued in Renton, Washington, on

September 17, 1997.

Vi L. Lipski,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–25509 Filed 9–25–97; 8:45 am]

BILLING CODE 4910–13–M

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: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule that requires 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 diseases (STD’s), including

human immunodeficiency virus (HIV).

This requirement is established in order

to provide consumers with essential

information regarding the safe use of

these products.

EFFECTIVE DATE: March 25, 1998.

FOR FURTHER INFORMATION CONTACT:

Donald E. Marlowe, Center for Devices

and Radiological Health (HFZ–100),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–2444.

SUPPLEMENTARY INFORMATION:

I. Background

It is estimated that over 1 million

persons in the United States are infected

with HIV (Ref. 1). Although nonsexual

transmission can occur, HIV is

transmitted primarily through sexual

contact. With the prevalence of HIV

infection and the risk of transmission of

other STD’s, the importance of the

quality of an effective barrier to the

transmission of infection is crucial.

Because latex membranes, such as

condoms and medical gloves, are

effective barriers against the spread of

various diseases, including hepatitis,

HIV, and other STD’s (Refs. 2, 4, and 5),

the Centers for Disease Control and

Prevention and the Surgeon General of

the Public Health Service have

recommended that latex condoms be

used according to instructions with

every act of intercourse for maximum

protection against STD’s (Ref. 3). 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

conditions. Exposure to these

environmental conditions degrade the

film progressively over time and may

result in bursts, rips, tears, or seepages

that allow the transmission of disease.

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

of latex condoms (the FDA/Washington

study) in July of 1989 (Ref. 6). At the

laboratories of the FDA/Washington

study, packaged and unpackaged latex

condoms were exposed to 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.

Based upon these findings, using

standards established by the American

Society for Testing and Materials

(ASTM), and following meetings with

condom manufacturers, the agency

published in the Federal Register of

May 24, 1996 (61 FR 26140), a proposed

rule that would require latex condoms

to be labeled with an expiration date.

Specifically, FDA proposed that, to

ensure visibility of the expiration date

by customers, an expiration date must

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 establish the expiration date, FDA

proposed 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
50498 Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Rules and Regulations

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.

If the latex barrier properties are

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

physical and mechanical integrity tests)

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

to 50 °C/90-day tests, the proposal

provided for that product to 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.

This final rule incorporates the

principles described in the proposed

rule and requires latex condoms to bear

expiration dates after being subjected to

appropriate testing. When a labeling

change is made to comply with this

rule, products currently cleared for

marketing would not be required to

submit a new 510(k). FDA will modify

agency guidance to reflect this policy.

Of course, latex condom products that

have not been cleared for marketing are

still required to submit to FDA a 510(k)

premarket notification.

II. Summary of Comments

The agency received only three

comments on the proposed rule, two of

which addressed the economic impact

of the rule, but not its content. The

remaining comment, submitted by a

trade association, was generally

supportive of the proposed rule but

raised several issues warranting further

consideration.

A. General

1. The comment stated that the

proposed rule did not distinguish

between the testing requirements

applicable to new products as opposed

to currently marketed products. The

comment suggests that some currently

marketed products may already be

labeled with an expiration date that has

been cleared by the agency. To require

these products to undergo testing

following accelerated and intermediate

aging would be unnecessarily redundant

if the existing cleared expiration date

has been established by real time

testing.

The agency agrees that, where a

product bears an expiration date based

on appropriate integrity tests following

storage in real time, accelerated aging

and testing are redundant and should

not be required. This position is

reflected in the final rule that has been

modified accordingly in new

§ 801.435(f).

The agency stresses that testing data

supporting an expiration date must be

available for inspection by the agency,

regardless of whether the agency

previously cleared product labeling

which bears an expiration date. If such

data is not available for inspection, the

manufacturer must generate shelf life

data with accelerated and real time

storage and testing.

2. The comment suggested that the

introductory paragraph of proposed

§ 801.435(d) be modified to read,

‘‘The expiration date must be supported by

the data from reasonable quality control tests

demonstrating the physical and mechanical

integrity of the product after three discrete

and typical lots of the product have been

subjected to each of the following

conditions.’’ (Emphasis added.)

The language in the proposed rule

stated, ‘‘* * * after three discrete and

random lots of the same product have

been subjected to each of the following

conditions.’’ (Emphasis added.)

The agency recognizes that

manufacturers of new products, or new

formulations, may not have produced a

sufficient number of lots to allow a truly

random selection for testing. The

purpose of selecting random lots is to

ensure that the tests are conducted on

products that are representative of the

products being produced. The word

‘‘representative’’ is more commonly

used in the context of sampling analyses

than its synonym, ‘‘typical.’’ The agency

believes the comment that suggested

substituting the word ‘‘typical’’ for

‘‘random’’ is appropriately addressed by

substituting the word ‘‘representative’’

for the word ‘‘random.’’ The final

regulation has been modified

accordingly.

The agency also recognizes that the

proposed requirement to conduct testing

on lots of the same product needs

further clarification in light of the

agency’s October 1989 ‘‘General

Guidance for Modifying Condom

Labeling to Include Shelf Life,’’ that

states that shelf life data may not be

needed for each variation from a

‘‘standard’’ condom. The agency

continues to consider its October 1989

guidance to be an accurate statement of

agency policy. FDA recognizes that a

manufacturer may produce several

variations of a tested condom, including

variations of packaging, design (e.g.,

texture, thickness, etc.), latex

formulation (including color additives),

dusting powders, spermicides,

desensitizers, and lubricants. As stated

in the agency guidance, ‘‘FDA

recognizes that some variations may not

warrant separate shelf life testing.’’

Certain variations, however, may affect

condom strength, integrity, and even

response to environmental factors in a

variety of ways. Therefore, the

regulation has been revised to state in

§ 801.435(g) that, if a manufacturer

applies shelf life data to a variation of

the tested condom, the manufacturer

must document and provide upon

request appropriate justification.

3. The comment stated that the

requirement that the condoms to be

tested be stored unpackaged for the

maximum amount of time the

manufacturer allows the product to

remain unpackaged, before packaging,

storage, and testing, is unnecessary and

overly burdensome. The comment states

that this provision would require

manufacturers to develop new data for

holding periods with respect to

products that are currently labeled with

approved expiration dating.

The agency disagrees that this

provision is unnecessary and overly

burdensome. Degradation of latex films

is cumulative. Shelf life data derived

from a lot of condoms that were

packaged the day following production

may not necessarily be applicable to the

same product that is left unpackaged for

180 days. In requiring a manufacturer to

conduct tests on products that have

been stored unpackaged for the

maximum time the manufacturer allows

the product to remain unpackaged, the

agency is ensuring that the integrity of

the tested products would be

representative of the products receiving

the greatest exposure to environmental

conditions. Thus, shelf life data

generated by testing these products

could be applied with the greatest

confidence.

As discussed in comment 1 in section

II.A of this document, the agency

believes that currently cleared

expiration dates that have been

determined by real time testing of the

product may continue to be applied. In

the event this real time testing did not

account for time periods products

remain unpackaged, however,

manufacturers would be required to

perform confirmation testing to account

for maximum holding periods for their

products that are already labeled with

an expiration date. This testing will be

initiated by the effective date of the
Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Rules and Regulations 50499

regulation. Until the confirmation tests

are completed, the previously cleared

products may remain on the market

labeled with the expiration date based

on previous real time testing. The

regulation has been modified in

§ 801.435(f) to clarify this issue.

4. The comment objected to the

requirement that new premarket

notification submissions, required

under section 510(k) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360(k)), for latex condoms

should include data to establish labeled

expiration dates, especially in light of

the agency’s allowance that such data

need only be held as part of the

manufacturing records for currently

marketed products. This comment

suggested that new 510(k) submissions

only be required to state the claimed

expiration dating period, and identify

whether it has been tentatively

established through accelerated aging or

established under real time conditions

consistent with the requirements of

§ 801.435.

The agency agrees with this comment.

The agency believes that a 510(k)

submission that includes statements

that appropriate tests were performed

and that the condoms passed

appropriate mechanical and physical

integrity tests should not generally have

to include underlying test data. FDA

intends to revise its existing guidance

on 510(k) submissions for latex

condoms to reflect its position that

underlying data for expiration dating

should not be submitted. All shelf life

data generated under the requirements

of this final rule shall be retained in

each company’s files, as required by

§ 820.180 (21 CFR 820.180), and shall be

made available upon request for

inspection by FDA.

5. The comment requests that the

agency draw a clear distinction in the

regulation between closed-ended latex

condoms, that are used for prevention of

STD transmission and pregnancy, and

open-ended condom catheters that are

used for continence and chronic care.

The agency confirms that the rule

does not apply to open-ended condom

catheters. The agency, however, does

not believe that the regulation requires

any modification to clarify this issue. As

proposed and finalized, the regulation

states that ‘‘this section applies to the

subset of condoms as identified in

§ 884.5300, and condoms with

spermicidal lubricant as identified in

§ 884.5310 of this chapter, which

products are formed from latex films.’’

Sections 884.5300 and 884.5310 (21

CFR 884.5300 and 884.5310)

specifically describe the intended uses

of closed ended condoms. The

regulation, therefore, clearly establishes

that open-ended condom catheters are

not subject to this rule.

Moreover, in order to avoid future

confusion, the agency is taking this

opportunity to clarify the fact that this

rule does not apply to female condoms.

Female condoms are distinguished from

the products identified in the scope of

this rule in two significant details: (1)

Sections 884.5300 and 884.5310 do not

describe female condoms, and (2)

female condoms are formed from

polyurethane, not latex.

6. The agency is also taking this

opportunity to clarify its position

regarding latex condoms that are sold

with spermicidal lubricants. Such

products are currently cleared for

marketing provided they bear labeling

that reflects expiration dates and

statements relating to the spermicidal

agents. On August 9, 1982, in response

to a petition by Schmidt Laboratories,

Inc., FDA issued an order reclassifying

a condom with a spermicidal lubricant

(nonoxyl-9) from class III to class II. In

the preamble to the final rule published

in the Federal Register of October 29,

1982 (47 FR 49021), which reclassified

generic condoms with spermicidal

lubricants into class II, FDA advised

that the generic device was reclassified

into class II only insofar as its labeling

bore an expiration date for the

spermicidal agent and the following

statement ‘‘The expiration date on this

product applies only to the spermicidal

agent in it.’’

Because the effectiveness of condoms

with spermicidal lubricants depends on

both the integrity of the latex and the

stability of the spermicide, the

expiration date should warn against use

of the product after a date that either the

spermicide or the latex could be

ineffective. FDA is advising that it

would consider a condom with

spermicidal lubricant that bears the

earlier expiration date that is related to

the condom’s latex or spermicidal

properties, substantially equivalent to a

class II condom with spermicidal

lubricant under § 884.5310.

FDA has added § 801.435(h) to the

final rule to state that if a latex condom

contains spermicide, and the expiration

date based upon spermicidal stability

testing is different from the expiration

date based on latex integrity testing, the

product shall bear only the earlier

expiration date. Accordingly, the

statement required by the August 9,

1982, Reclassification Order that ‘‘The

expiration date on this product applies

only to the spermicidal agent in it’’

would be incorrect and shall not appear

on the labeling of latex condoms with

spermicidal lubricants following the

effective date of this regulation. Any

labeling changes to comply with

§ 801.435(h) will not require the filing of

a new 510(k).

This regulation does not impose new

testing requirements to determine

expiration dates based upon spermicide

stability. Manufacturers should

continue to perform the appropriate

tests to determine spermicide amount

and biological activity that have

supported the expiration dating for the

spermicide in the past.

B. Comments on the Economic Impact

7. The agency received two comments

addressing the economic impact of the

proposed rule. One comment stated that

the agency significantly underestimated

the cost burden of establishing an

expiration date for latex condoms

because, in order to accurately establish

shelf life data, a manufacturer would

need to test packaging integrity,

packaging material, and lubricants used,

as well as latex compound integrity.

The agency disagrees. The testing

requirements in the proposed and final

rules would provide shelf life data

based upon the aggregate effect of the

factors identified by the comment. The

agency believes that no real purpose

would be served by additionally

requiring the suggested tests.

8. One comment suggested that

requiring manufacturers of new

products to submit shelf life data with

their 510(k) submissions subjects

manufacturers of those products to an

additional administrative burden that is

unnecessarily restrictive and may delay

the public access to new and improved

products.

As discussed in comment 4 in section

II.A of this document, the agency has

revised its position and is not requiring

that manufacturers submit shelf life data

with their 510(k) submissions. Instead,

shelf life data shall be retained in each

company’s files, as required by

§ 820.180, and shall be made available

upon request for inspection by FDA.

C. Comments on the Estimated

Recordkeeping Burden

9. One comment stated that the

agency significantly underestimated the

recordkeeping burden that would be

created by shelf life testing. The

comment stated that the number of

condom variations that would require

testing is much higher than estimated,

however, no guidance was given for

estimating the number more accurately.

The comment also stated that the

industry practice in gathering real time

testing data is to test the product each

year. That is, instead of testing the

product at 0 days, 7 days (accelerated
50500 Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Rules and Regulations

aging), 90 days (intermediate aging), and

5 years (real time) as discussed in the

paperwork burden section of the

proposed rule (61 FR 26140 at 26143),

manufacturers would actually be testing

at 0 days, 7 days, 90 days, 1 year, 2

years, 3 years, 4 years, and 5 years. This

would represent a doubling of the

testing burden for each product over the

course of 5 years.

The agency agrees that the testing of

products in intermediate years 1, 2, 3,

and 4 is an appropriate and customary

method of gathering real time shelf life

data. This would be reflected in the

burden chart as a doubling of the

estimated burden. However, in response

to other comments, the agency has

required manufacturers of latex

condoms that already have expiration

dating data, based on real time testing,

to do only a confirmation test, as

appropriate. These products would be

required to be tested only once in 5

years. The Paperwork Reduction Act

analysis is modified to address these

changes in testing frequency.

Moreover, the agency has adjusted the

Paperwork Reduction statement to

address the comment stating that

manufacturers would be required to

collect expiration dating data for more

than one variation of a standard

condom. The agency has attributed an

average of two variations that would

require testing for each standard

condom considered in its original

estimate. Furthermore, the agency has

provided that manufacturers may apply

expiration dating data collected on a

standard to a variation of the standard,

provided the manufacturer documents

its justification. The burden estimates

have been modified to reflect the cost of

such documentation.

The Paperwork Reduction Act

analysis is further modified to annualize

the cost of shelf life testing over 5 years.

Whereas the proposed Paperwork

Reduction Act analysis reflected an

annual burden of testing products at 0

days, 7 days, 90 days, and 5 years, the

agency has determined that it would be

more appropriate to consider the testing

of products at 0 days, 7 days, 90 days,

1 year, 2 years, 3 years, 4 years, and 5

years, as a burden spread out over the

5 years it would take to complete the

tests.

III. 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.

IV. 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 Act of 1996 (Pub. L. 104–121),

and the Unfunded Mandates Reform Act

of 1995 (Pub. L. 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. This regulation requires

physical and mechanical integrity tests.

Because condom manufacturers

routinely conduct such tests on their

products as part of their quality control

practices, the required testing would

affect manufacturers primarily by

establishing storage conditions prior to

testing such products, and increasing

sampling sizes subjected to testing. This

rule also requires a labeling change.

However, the 180-day time period

between the publication date and

effective date of this rule will allow

most manufacturers to exhaust their

existing supply of labels. Accordingly,

the agency certifies that the final rule

will not have a significant economic

impact on small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

V. Paperwork Reduction Act of 1995

This final 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 collections are shown

below and an estimate of the annual

recordkeeping and periodic 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.

Title: Labeling Requirements for Latex

Condoms—Expiration Date Labeling.

Description: These information

collection requirements apply to

manufacturers of latex condoms. This

rule expands the labeling of latex

condoms to include an expiration date.

The expiration date must be supported

by data from quality control tests

demonstrating physical and mechanical

integrity of three sample lots of the

product being tested that were stored

under accelerated and real time aging

conditions. Quality control testing

under accelerated aging conditions must

include tests of unpackaged bulk

product for the maximum amount of

time the manufacturer allows the

product to remain unpackaged, followed

by: (1) Storage of the packaged product

at 70 °C (plus or minus 2 °C) for 7 days;

(2) 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 the packaged product at a

monitored or controlled temperature

between 15 and 30 °C for the lifetime of

the product (up to 5 years).

Manufacturers who already have shelf

life data based upon real time testing are

not required to perform the 7-day and

90-day accelerated aging testing.

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 have degraded. The

effectiveness of latex condoms as a

barrier 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 the product.

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 the likely effectiveness of the

product.

Section 510(h) of the act, 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.
Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Rules and Regulations 50501

ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR

Section

No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours Total CapitalCosts

Total Operating and

Maintenance Costs

801.435(d) 58 1 58 96 5,568 $1,8561 $94,6552

1 Capital costs are one time start-up costs and consist of a revision of policies and procedures. These costs have been annualized over a period of 5 years. 2The annual burden reported here represents the recordkeeping burden of testing a product of 0 days, 7 days, 90 days, 1 year, 2 years, 3

years, 4 years, and 5 years. The cost of this burden is annualized over the 5-year period required to conduct all the necessary testing.

The agency received one comment on

the Paperwork Reduction Act statement

of the proposed rule. As discussed in

comment 9 in section II.C of this

document, the agency has adjusted the

estimated burden according to the

suggestions made by the comment. The

revised estimated burden has been

adjusted to include the burden of testing

a product at intermediate years during

real time aging, and the burden of

testing more than one variation on a

standard condom. The revised estimated

burden reflects a burden annualized

over the 5 years required to perform all

necessary testing.

Persons are not required to respond to

a collection of information unless it

displays a currently valid OMB control

number. This final rule contains

information collection requirements

which have been submitted to OMB for

approval. FDA will publish a notice in

the Federal Register prior to the

effective date of this final rule of OMB’s

decision to approve, modify, or

disapprove the information collection

requirements.

VI. 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 and

Prevention, ‘‘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.

WS–CO2–1), vol. 1, IXth International

Conference on AIDS/IVth 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, October–

December, 1959.

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

Vulcanizates,’’ Journal of Natural Rubber

Research, vol. 2, No. 4, pp. 201–213, 1987.

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

Ageing of Natural Rubber Vulcanizates, Part

2: Results From Aging 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,’’ FDA

Guidance Document.

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, 21 CFR part 801 is

amended as follows:

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 of this chapter, which

products are formed from latex films.

(b) Data show that the material

integrity of latex condoms degrade 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 paragraphs (d) and (h) of

this section.

(c) The expiration date, as

demonstrated by testing procedures

required by paragraphs (d) and (h) of

this section, must be displayed

prominently and legibly on the primary

packaging (i.e., individual package), and

higher levels of packaging (e.g., boxes of

condoms), in order to ensure visibility

of the expiration date by consumers.

(d) Except as provided under

paragraph (f) of this section, the

expiration date must be supported by

data demonstrating physical and

mechanical integrity of the product after

three discrete and representative lots of

the 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 physical and

mechanical integrity tests commonly

used by industry 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 physical and mechanical
50502 Federal Register / Vol. 62, No. 187 / Friday, September 26, 1997 / Rules and Regulations

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 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) Products that already have

established shelf life data based upon

real time storage and testing and have

such storage and testing data available

for inspection are not required to

confirm such data using accelerated and

intermediate aging data described in

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

section. If, however, such real time

expiration dates were based upon

testing of products that were not first

left unpackaged for the maximum

amount of time as described in

paragraph (d)(3) of this section, the real

time testing must be confirmed by

testing products consistent with the

requirements of paragraph (d)(3) of this

section. This testing shall be initiated no

later than the effective date of this

regulation. Until the confirmation

testing in accordance with paragraph

(d)(3) of this section is completed, the

product may remain on the market

labeled with the expiration date based

upon previous real time testing.

(g) If a manufacturer uses testing data

from one product to support expiration

dating on any variation of that product,

the manufacturer must document and

provide, upon request, an appropriate

justification for the application of the

testing data to the variation of the tested

product.

(h) If a latex condom contains a

spermicide, and the expiration date

based on spermicidal stability testing is

different from the expiration date based

upon latex integrity testing, the product

shall bear only the earlier expiration

date.

(i) The time period upon which the

expiration date is based shall start with

the date of packaging.

(j) As provided in part 820 of this

chapter, all testing data must be retained

in each company’s files, and shall be

made available upon request for

inspection by the Food and Drug

Administration.

(k) Any latex condom not labeled

with an expiration date as required by

paragraph (c) of this section, and

initially 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 Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 321(n) and 352(a) and (f)).

Dated: August 20, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–25587 Filed 9-25-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8731]

RIN 1545–AU92

Section 42(d)(5) Federal Grants

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final and temporary

regulations.

SUMMARY: This document contains final

regulations with respect to the lowincome housing tax credit relating to the

application of section 42(d)(5) to certain

rental assistance programs under section

42(g)(2)(B)(i). The regulations clarify

that certain types of federal rental

assistance payments do not result in a

reduction in the eligible basis of a lowincome housing building.

DATES: These regulations are effective

September 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Christopher J. Wilson, (202) 622–3040

(not a toll-free call).

SUPPLEMENTARY INFORMATION:

Background

Temporary regulations (TD 8713) and

a notice of proposed rulemaking crossreferencing the temporary regulations

were published in the Federal Register

for January 27, 1997 (62 FR 3792, 3848).

Those regulations provide that certain

federal rental assistance payments made

to the owner of a building on behalf of

low-income tenants are not federal

grants with respect to a building or its

operation that require a reduction in the

building’s eligible basis under section

42(d)(5) of the Internal Revenue Code

(Code). These payments include rental

assistance payments made under section

8 of the United States Housing Act of

1937 (Act) (42 U.S.C. 1437f), certain

payments made under section 9 of the

Act (42 U.S.C. 1437g), and payments

made under such other programs or

methods of rental assistance as may be

designated in the Federal Register or

the Internal Revenue Bulletin. The

notice of proposed rulemaking indicated

that comments would be considered on

those areas addressed in the temporary

regulations. Written comments

responding to the notice of proposed

rulemaking were received. There was no

request for a public hearing, and no

public hearing was held. After

consideration of all the written

comments, the proposed regulations

have been adopted, without change, by

this Treasury decision.

Summary of Comments

One commenter suggested that the

final regulations provide additional

guidance for state agencies to use in

determining whether similar programs

beyond those described in the

regulations should be considered grants

that cause a reduction in a building’s

eligible basis under section 42(d)(5) of

the Code. The final regulations do not

adopt this suggestion. The scope of this

regulation is limited to specified rental

assistance payments that are not grants

requiring a reduction in a building’s

eligible basis and any additional

payments the Secretary may designate

in the future.

Another commenter suggested that

§ 1.42–16(c)(3) should be deleted if it is

intended to impose conditions beyond

the restrictions under section 9 of the

Act, because the Service is improperly

infringing upon the Department of

Housing and Urban Development’s

(HUD) authority to provide subsidies

under section 9. The final regulations do

not adopt this suggestion. Section 1.42–

16 does not interpret HUD’s authority

for paying subsidies under section 9; it

describes the extent to which section 9

payments may be made without a

reduction in a building’s eligible basis

under section 42(d)(5) of the Code. The

conditions imposed on section 9

payments in § 1.42–16(c)(3) serve to

differentiate section 9 assistance for

operating expenses that function in a

manner similar to rental assistance

payments under section 8 of the Act

from section 9 assistance that is applied

to uses more closely associated with

operational expenses requiring a

reduction in a building’s eligible basis

under section 42(d)(5).

This commenter also suggested that if

§ 1.42–16(c)(3) were to be retained, it

should be clarified to provide that

actual operating costs be determined by

HUD and/or the appropriate public

housing agency. The commenter reasons

that HUD is already making this

determination in the context of deciding

the proper amount of assistance to make