[Federal Register Volume 61, Number 122 (Monday, June 24, 1996)]
[Proposed Rules]
[Pages 32618-32621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15990]




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Part VII





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 801



Latex-Containing Devices; User Labeling; Proposed Rule

Federal Register / Vol. 61, No. 122 / Monday, June 24, 1996 / 
Proposed Rules
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0119]
RIN 0910-AA34

21 CFR Part 801


Latex-containing Devices; User Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the regulations to require all medical devices containing natural 
rubber latex that may directly or indirectly contact living human 
tissue to be labeled with a statement identifying the product as one 
which contains natural rubber latex and which may cause allergic 
reactions. The agency is also amending the regulation to require that 
hypoallergenicity claims be removed from latex medical gloves and other 
natural rubber latex medical devices because the modified human Draize 
test currently used to support hypoallergenicity claims addresses only 
chemical sensitivity, and it is inappropriate for determining protein 
sensitivity in humans. These requirements are being proposed in 
response to numerous reports that have been received of severe allergic 
reactions to a wide range of medical devices containing natural rubber 
latex.

DATES: Comments by September 23, 1996. FDA is proposing that the final 
regulation based on this proposal be effective 180 days after the date 
of its publication in the Federal Register.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Donald E. Marlowe, Center for Devices 
and Radiological Health (HFZ-100), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-2444.

SUPPLEMENTARY INFORMATION: 

I. Background

    Natural rubber latex is a milky fluid produced by the Heavea 
brasiliensis (rubber) tree. There is often confusion concerning the 
terminology used to describe the raw agricultural material derived from 
the rubber tree and the chemical nomenclature that refers to emulsions 
of synthetic rubbers and plastics to which natural rubber latex has 
been added.
    Latex, either natural or synthetic, is a colloidal dispersion of a 
polymeric material in a liquid system mostly aqueous in nature (Ref. 
1). ``Natural rubber latex,'' for the purpose of this proposed rule, 
means a milky fluid that consists of extremely small particles of 
rubber, obtained from the H. brasiliensis (rubber) tree, dispersed in 
an aqueous medium. It contains a variety of naturally occurring 
substances, including carbohydrates, lipids, phospholipids, proteins, 
minerals, small amounts of complex organic material, water, and cis-1,4 
polyisoprene, in a colloidal suspension.
    The phrase ``natural rubber latex'' refers to the raw material used 
in the manufacture of both natural rubber latex products and dry 
natural rubber products. These products are formed by two commonly 
employed manufacturing processes. One of these is the natural rubber 
latex manufacturing process (NRL process), which involves the use of 
natural latex in a concentrated liquid form. Products are formed from 
NRL processing by dipping, extruding, or coating, and are typically 
referred to as containing or made of ``natural rubber latex.'' Examples 
of devices manufactured by the NRL process include medical gloves, 
catheters, and condoms.
    The dry natural rubber manufacturing process (DNR process) involves 
the use of coagulated natural latex in dried or milled sheets. Products 
are formed from the DNR process by compression molding, extrusion, or 
by converting the sheets into a solution for dipping. These products 
are typically referred to as containing or made of ``dry rubber.'' 
Examples of devices or device components containing dry rubber include 
syringes with dry rubber plungers, vial stoppers, and intravascular 
injection ports.
    The phrase, ``contains natural rubber latex,'' as used herein, 
encompasses products made by either process, as well as products 
described as made of ``synthetic latex'' that include natural rubber 
latex in their formulations. This proposed rule would not apply to 
products made from synthetic latex, which do not include natural rubber 
latex in their formulation.
    Since 1988, FDA has noted an increase in the number of reports 
submitted to its Medical Device Reporting (MDR) system regarding 
sensitivity to natural rubber latex proteins contained in medical 
devices. In May of 1990, FDA became aware of deaths associated with 
barium enema procedures. Further investigation of the problem revealed 
that these deaths were associated with anaphylactic reactions to the 
natural latex cuff on the tip of the barium enema catheters. In several 
hundred reports of adverse reactions to natural rubber latex that the 
agency has received since October 1988, 16 have involved deaths from 
anaphylactic shock. Furthermore, several scientific journals have 
reported incidents of sensitivity to natural rubber latex proteins in a 
wide range of medical devices. (See Refs. 2 through 18.)
    Section 701(a) of the Federal Food, Drug, and Cosmetic Act (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).)
    Section 502(a) of the act (21 U.S.C. 352(a)) provides that a device 
is misbranded ``If its labeling is false or misleading in any 
particular.'' Section 201(n) of the act (21 U.S.C. 321(n)) provides 
that, in determining whether labeling of a regulated article (such as a 
device) is misleading

    * * * 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 light of such 
representations * * * with respect to consequences which may result 
from the use of the article to which the labeling * * * relates 
under the conditions of use prescribed in the labeling or 
advertising thereof or under such conditions of use as are customary 
or usual.
    The courts have upheld FDA's authority to prevent false or 
misleading labeling by issuing 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

[[Page 32619]]

adequate directions under which a layperson can use a device safely and 
for the purpose for which it was intended. (See 21 CFR 801.5 and 
801.6.)

II. Latex Labeling

    FDA is proposing that medical devices containing natural rubber 
latex that may directly or indirectly contact living human tissue be 
labeled with a statement identifying the product as one which contains 
natural rubber latex, which may cause allergic reactions. Direct 
contact with living human tissue occurs when a natural rubber latex-
containing medical device touches the skin, mucous, or serosal 
surfaces. Examples of indirect contact with living human tissue by a 
natural rubber latex-containing medical device include, but are not 
limited to, the following: Contact with natural rubber latex proteins 
that have become suspended in liquid, which can occur when injections 
are given through a natural rubber latex-containing injection port or a 
syringe with a natural rubber latex-containing plunger; contact with 
natural rubber latex protein that is airborne, often in conjunction 
with the use of glove dusting powder; and contact with natural latex 
residues that have been transferred to nonrubber latex-containing 
medical devices, or other objects or surfaces. Devices affected by this 
proposed rule would be required to be labeled with one of the following 
statements: ``This product contains natural rubber latex which may 
cause allergic reactions in some individuals''; ``This product has 
components that contain natural rubber latex which may cause allergic 
reactions in some individuals''; or ``This product is made from natural 
rubber latex which may cause allergic reactions in some individuals''.
    The agency has provided three labeling options so that 
manufacturers may choose the language most appropriate for their 
products. The agency invites comments regarding whether FDA should 
require a single, uniform, labeling statement for all natural latex-
containing medical devices, and the agency will consider comments 
recommending alternative language for the proposed labeling statements.
    Representative examples of natural rubber latex-containing medical 
devices which would require such labels include, but are not limited to 
the following: Cuffed-barium enema tips and enteroclysis catheters; 
contraceptive devices such as condoms with or without spermicidal 
lubricant, cervical caps, diaphragms and accessories, and therapeutic 
douche apparati; airway and respiratory devices such as oxygen 
cannulas, nasopharyngeal airways, tracheal tubes and inflatable cuffs, 
tracheobronchial suction catheters, breathing bags and mouthpieces; 
dental and surgical equipment such as dental dams, orthodontic 
appliances and headgear, anaesthetic gas masks, epistaxis balloons, and 
endotracheal tubes; and frequently used hospital equipment such as 
urinary catheters and accessories, blood pressure cuffs, intravascular 
equipment with latex injection ports, electrode pads, tourniquets, 
enema bags, hot or cold water bottles, rubber sheets, stomach and 
intestinal tubes, hemodialysis equipment, wound drains, adhesive tape, 
elastic bandages, and medical gloves.
    Medical gloves include surgeon's gloves, as classified at 21 CFR 
878.4460, and patient examination gloves, as classified at 21 CFR 
880.6250. Some medical gloves are made of materials that may not 
contain natural rubber latex in their formulations and, therefore, 
would not be subject to this proposal. It should be further noted that 
the term ``medical gloves'' is used to distinguish them from nonmedical 
gloves that are not regulated by FDA. Nonmedical gloves, commonly 
referred to as utility, industrial, protective, or general purpose 
gloves, are not medical devices if they are not intended and/or labeled 
for a medical purpose, such as prevention of disease. Such products 
would not be subject to this proposed rule.
    This rule is being proposed because medical devices that are 
composed of natural rubber latex, or which contain components 
formulated from natural latex, pose a significant health risk to some 
health care consumers and providers. A statement on the label of 
medical devices identifying the presence of natural latex, and its 
risks, is considered to be necessary for the safe and effective use of 
such devices. The primary purpose of such a statement is to inform 
health care professionals and consumers about the presence and risks of 
natural rubber latex, and to ensure a safe medical environment for 
persons who have been identified as sensitive to natural rubber latex.
    The agency believes that a statement on the labeling of the devices 
stating that the product contains natural rubber latex, and that the 
presence of natural rubber latex may cause allergic reactions, is 
essential. The omission of such information from the labeling of such a 
device would constitute an omission of a material fact, and would 
render the device misbranded within the meaning of section 502(a) of 
the act (21 U.S.C. 352(a)). Moreover, because users need to be aware of 
safety problems that may be caused by natural rubber latex, FDA 
believes that a device containing natural rubber latex, which is not 
labeled with information regarding the presence of natural rubber latex 
and its potential risks, fails to bear adequate directions for use, and 
is, therefore, also misbranded under section 502(f)(1) of the act.
    Section 502(c) of the act provides that a device is misbranded 
``[i]f any word, statement, or other information required by or under 
authority of this Act to appear on the label or labeling is not 
prominently placed thereon with such conspicuousness (as compared with 
other words, statements, designs, or devices, in the labeling) and in 
such terms as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use.'' 
Accordingly, the proposed regulation would require the rubber latex 
sensitivity statement to be displayed prominently and conspicuously on 
the device labeling. If the labeling statement is not prominently 
displayed, the product would be deemed misbranded under section 502(c) 
of the act.
    Accordingly, under the proposed rule, any natural rubber latex-
containing medical device that is not labeled as required, and that is 
initially introduced or initially delivered for introduction into 
interstate commerce after the effective date of the final rule, would 
be misbranded under sections 201(n) and 502(a), (c), and (f)(1) of the 
act.
    FDA believes that it is also necessary to prohibit certain labeling 
statements on devices that contain natural rubber latex. FDA has 
received reports of sensitivity to medical gloves labeled as 
``hypoallergenic.'' FDA believes that this term, traditionally used 
with cosmetics, erroneously implies that the user of products labeled 
as hypoallergenic is assured that the risk of an allergic reaction to 
the chemicals or other materials in the products would be minimal. In 
the past, use of the ``hypoallergenic'' label has been based on results 
of the modified (human) Draize test. While this test may be appropriate 
for detecting sensitivity to residual levels of processing chemicals, 
the test cannot accurately detect the presence or absence of natural 
latex protein levels. Furthermore, current manufacturing processes 
cannot remove from devices the natural latex proteins below the level 
to which some individuals may be sensitive. Thus the risk of allergic 
reaction remains.
    Therefore, the agency believes that the presence of the term 
``hypoallergenic''

[[Page 32620]]

on the labeling of a natural rubber latex-containing device is false 
and misleading because it incorrectly implies that the product labeled 
as ``hypoallergenic'' may be used safely by latex sensitive persons. 
FDA also believes that products with such labeling fail to bear 
adequate directions for use because they do not state that rubber 
latex-containing products labeled as hypoallergenic may still cause 
allergic reactions. For these reasons, FDA is proposing that the 
hypoallergenic claim be removed from the labeling of natural rubber 
latex-containing medical devices. Accordingly, under the proposed rule, 
FDA would consider natural rubber latex-containing medical devices 
labeled as hypoallergenic that are initially introduced or delivered 
for introduction after the effective date of the final rule, to be 
misbranded under section 502(a) and (f)(1) of the act. Although 
manufacturers would no longer be permitted to label their rubber latex-
containing devices as ``hypoallergenic,'' persons wishing to make 
claims regarding the sensitizing potential of manufacturing chemical 
residues (MTB's, thiurams, and carbamates) in finished latex products 
should contact the Division of Small Manufacturers Assistance (1-800-
638-2041) and request a copy of the guidance document entitled 
``Testing for Skin Sensitization to Chemicals in Latex Products.''
    FDA does not intend to require a new submission under section 
510(k) of the act (21 U.S.C. 360) (510(k) submission) based upon 
labeling changes made to comply with this proposed regulation, provided 
that no other changes requiring a new 510(k) submission under 21 CFR 
807.81 are made to the device. FDA does not intend to require 
manufacturers of devices subject to an approved premarket approval 
(PMA) application to submit a PMA supplement under 21 CFR 814.39(d), 
for any change to the product labeling that would be required by this 
regulation. FDA intends, instead, to require manufacturers to submit an 
annual report under 21 CFR 814.39(e) for such changes.

III. Request for Comments

    FDA recognizes that this regulation applies to an array of devices 
that vary widely in their manufacture and use. FDA welcomes comments on 
all aspects of the regulation, but particularly invites comments on the 
following areas:
    1. Some of the devices to which this regulation applies may be sold 
in bulk packages which are then divided up and used individually. How 
can FDA best ensure that the message that the regulation is intended to 
convey reaches the ultimate user?
    2. It has been suggested that the message could be conveyed by 
using a symbol, especially on smaller devices. FDA invites comments on 
whether using a symbol would be useful, and, if so, what would be an 
appropriate symbol?

IV. Exemptions and Variances

    Affected persons may request an exemption or variance from the 
requirements of this regulation, if they believe that full compliance 
with the regulation is not necessary for the safe and effective use of 
the device. Requests for exemption or variance must be submitted in 
accordance with the requirements for a citizen petition set forth in 21 
CFR 10.30.

V. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) 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 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 rule primarily requires a labeling 
change which would not have a significant economic impact on small 
entities, because the 180 days before the final rule based upon this 
proposal would become effective will allow most manufacturers to 
exhaust their existing supply of labels. Therefore, under the 
Regulatory Flexibility Act, no further analysis is required.

VII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that the labeling requirements in this 
proposed rule are not subject to review by the Office of Management and 
Budget because they do not constitute a ``collection of information'' 
under the Paperwork Reduction Act of 1995 (Pub. L. 104-13). Rather, the 
proposed warning statements are ``public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)).

VIII. Comments

    Interested persons may submit written comments regarding this 
proposed rule, by September 23, 1996, to the Dockets Management Branch 
(address above). 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. ``Introduction to Latex Compounding and Processing,'' The 
Vanderbilt Latex Handbook, 3d edition, 1987.
    2. Turjanmaa, K., ``Incidence of Immediate Allergy to Latex 
Gloves in Hospital Personnel,'' Contact Dermatitis, 17: 27-275, 
1987.
    3. Turjanmaa, K., K. Laurila, S. Makinen-Kiljunen, and T. 
Reunala, ``Rubber Contact Urticaria-Allergenic Properties of 19 
Brands of Latex Gloves,'' Contact Dermatitis, 19: 362-364, 1989.
    4. Turjanmaa, K. and T. Reunala, ``Condoms as a Source of Latex 
Allergen and Cause of Contact Urticaria,'' Contact Dermatitis, 20: 
360-364, 1989.
    5. FDA medical alert--allergenic reactions to latex-containing 
medical devices, March 29, 1991.
    6. Heese, A., J. Hintzenstern, K-P Peters, H. Koch, and O. 
Hornstein, ``Allergic and Irritant Reactions to Rubber Gloves in 
Medical Health Services,'' Journal of the American Academy of 
Dermatology, No. 5 (part 1): 831-839, November, 1991.
    7. Hintzenstern, J., A. Heese, H. Koch, K-P Peters, and O. 
Hornstein, ``Frequency, Spectrum and Occupational Relevance of Type 
IV Allergies to Rubber Chemicals,'' Contact Dermatitis, 24: 244-252, 
1991.
    8. Tomazic, V., T. Withrow, B. Fisher, and S. Dillard, ``Short 
Analytical Review-Latex-

[[Page 32621]]

Associated Allergies and Anaphylactic Reactions,'' Clinical 
Immunology and Immunopathology, 64: 89-97, 1992.
    9. Slater, J. and S. Chhabra, ``Latex Antigens,'' Journal of 
Allergy and Clinical Immunology, 89: 673-678, 1992.
    10. Lahti, A. and K. Turjanmaa, ``Prick and Use Tests with 6 
Globe Brands in Patients with Immediated Allergy to Rubber 
Proteins,'' Contact Dermatitis, 26: 259-262, 1992.
    11. Jaeger, D., D. Kleinhans, A. Czuppon, and X. Baur, ``Latex-
Specific Proteins Causing Immediate-Type Cutaneous, Nasal, 
Bronchial, and Systemic Reactions,'' Journal of Allergy and Clinical 
Immunology, 89: 759-768, 1992.
    12. Berky, Z., J. Luciano, and W. James, ``Latex Glove Allergy--
A Survey of the US Army Dental Corps,'' Journal of the American 
Medical Association, 268: 2695-2697, 1992.
    13. Gonzalez, E., ``Latex Hypersensitivity: A New and Unexpected 
Problem,'' Hospital Practice, pp. 137-151, February 15, 1996.
    14. Stehlin, D., ``Latex Allergies: When Rubber Rubs the Wrong 
Way,'' FDA Consumer, pp. 16-21, September 1992.
    15. ACAI (American College of Allergy & Immunology), Interim 
Recommendations to Health Professionals & Organizations Regarding 
Latex Allergy Precautions, March, 1992.
    16. Young, M., M. Meyers, L. McCulloch, and L. Brown, ``Latex 
Allergy-A guideline for perioperative nurses,'' AORN Journal, 56: 
488-502, 1992.
    17. Hamann, C. P., ``Natural Rubber Latex Protein Sensitivity in 
Review,'' American Journal of Contact Dermatitis, 4:1. March 1993, 
4-21.
    18. Marzulli, F. N., and H. I. Maibach, ``The Use of Graded 
Concentrations in Studying Skin Sensitizers: Experimental Contact 
Sensitization in Man,'' Food, Cosmetics, and Toxicology, 12:219-227, 
1974.
    19. USDHHS/PHS/FDA/CDRH, Regulatory Requirements for Medical 
Gloves--A Workshop Manual, FDA 93-4257, as amended May, 1993.

List of Subjects in 21 CFR Part 801

    Labeling, Medical devices, and 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:

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 Sec. 801.437 is added to subpart H to read as follows:


Sec. 801.437  User labeling for rubber latex-containing medical 
devices.

    (a) This section applies to all medical device products composed of 
or containing, or having components which are composed of or contain, 
natural rubber latex that may directly or indirectly contact living 
human tissue. The term ``natural rubber latex'' includes natural rubber 
latex, dry rubber, and synthetic latex which contains natural rubber 
latex in its formulation.
    (b) Data in the Medical Device Reporting System and scientific 
literature indicate that some individuals may be at risk of a severe 
anaphylactic reaction to natural rubber latex proteins. In order to 
protect the public health and minimize the risk to rubber latex 
sensitive individuals, medical devices containing natural rubber latex 
shall be labeled as set forth in paragraphs (c) and (d) of this 
section.
    (c) Natural rubber latex-containing medical devices shall 
prominently and legibly bear one of the following statements on the 
device labeling, in conformance with section 502(c) of the act: ``This 
product contains natural rubber latex which may cause allergic 
reactions in some individuals''; ``This product has components that 
contain natural rubber latex which may cause allergic reactions in some 
individuals''; or ``This product is made from natural rubber latex 
which may cause allergic reactions in some individuals''.
    (d) Because the natural rubber latex proteins to which some 
individuals are sensitive cannot be completely removed from latex 
gloves, the term ``hypoallergenic'' is inappropriate. Therefore, rubber 
latex gloves and other natural rubber latex-containing medical devices 
shall not contain the term ``hypoallergenic'' on their labeling.
    (e) Any affected person may request an exemption or variance from 
the requirements of this section by submitting a citizen petition in 
accordance with Sec. 10.30 of this chapter.
    (f) Any device subject to this section that is not labeled in 
accordance with paragraphs (c) and (d) of this section, and that is 
initially introduced or initially delivered for introduction into 
interstate commerce after the effective date of this final regulation, 
is misbranded under sections 201(n) and 502(a) and (f)(1) of the act. 
Any such device that is not labeled in accordance with paragraph (c) of 
this section, is also misbranded under section 502(c) of the act.

    Dated: June 17, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-15990 Filed 6-21-96; 8:45 am]
BILLING CODE 4160-01-F