[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Rules and Regulations]
[Pages 29552-29590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14311]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 801
[Docket No. 96N-0119]
Amended Economic Impact Analysis of Final Rule Requiring Use of
Labeling on Natural Rubber Containing Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; amended economic analysis statement.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an amended
economic analysis statement relating to a final rule that published in
the Federal Register of September 30, 1997 (62 FR 51021), requiring
labeling statements concerning the presence of natural rubber latex in
medical devices. This rule was issued in response to numerous reports
of severe allergic reactions and deaths related to a wide range of
medical devices containing natural rubber. The final rule becomes
effective on September 30, 1998. In order to allow further comment on
the economic impact of the September 30, 1997 final rule, FDA is
publishing an amended economic impact statement, including an amended
initial regulatory flexibility analysis (IRFA) that it has prepared
under the Regulatory Flexibility Act (RFA), as amended by the Small
Business Regulatory Enforcement and Fairness Act (SBREFA). FDA will
respond to comments to this amended economic analysis statement, and
publish in the Federal Register an amended final economic impact
statement prior to the effective date of the September 30, 1997 rule.
DATES: Submit written comments by July 1, 1998 on this amended economic
analysis statement.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. Comments should be identified with the docket
numbers found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Donald E. Marlowe, Center for Devices
and Radiological Health (HFZ-100), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20850, 301-443-2444, FAX 301-443-2296.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 30, 1997 (62 FR 51021), FDA
published a final rule (to be codified at 21 CFR 801.437), under its
authority in section 505(a) and (f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352(a) and (f)), requiring certain labeling
statements on medical devices that contain or have packaging that
contains natural rubber. This rule becomes effective on September 30,
1998. The agency issued this rule because medical devices composed of
natural rubber may pose a significant health risk to some consumers and
health care providers who are sensitized to natural latex proteins. FDA
has received numerous reports about adverse effects related to
reactions to natural latex proteins contained in medical devices,
including 16 deaths following barium enemas. These deaths were
associated with anaphylactic reactions to the natural rubber latex cuff
on the tip of barium enema catheters. Scientific studies and case
reports have documented sensitivity to natural latex proteins found in
a wide range of medical devices. It is estimated that 5 to 17 percent
of health care workers are sensitive to latex proteins (Refs. 1 through
5).
The September 30, 1997 rule (hereinafter referred to as the final
rule) specifically requires that devices that contain natural rubber
that is intended to contact or is likely to contact the health care
worker or patient bear one or more of four labeling statements,
depending on the type of natural rubber in the device and depending on
whether the natural rubber is in the device itself or in its packaging.
These statements are as follows: ``This Product Contains Dry Natural
Rubber.''; ``Caution: This Product Contains Natural Rubber Latex Which
May Cause Allergic Reactions.''; ``The Packaging of This Product
Contains Dry Natural Rubber.''; and ``The Packaging of This Product
Contains Natural Rubber Latex Which
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May Cause Allergic Reactions.'' The final rule also prohibits the use
of the word ``hypoallergenic'' on devices that contain natural rubber
latex.
FDA, in response to a comment on the proposed latex labeling
regulation (61 FR 32618, June 24, 1996) concerning the application of
the rule to combination products, stated in the preamble to the final
rule that it intended to require combination products (i.e., drug/
device and biologic/device combinations) that contain natural rubber
device components to be labeled in accordance with the final rule (62
FR 51021 at 51026).
After publication of the final rule, the agency received numerous
inquiries about, and objections to the application of the natural
rubber labeling requirements to combination drug/device products, and
combination biologic/device products that currently are regulated under
drug and biologic authorities. In the Federal Register of May 6, 1998
(63 FR 24934), FDA issued a notice stating that upon consideration of
these comments, and the need to provide a uniform labeling approach for
all drug and biological products, including combination products, FDA
had decided that further opportunity for public comment should be
provided on how natural rubber labeling requirements should be applied
to all products regulated as drugs and biologics. Accordingly, FDA
announced that it does not intend to apply the final rule to
combination products currently regulated as drugs or biologics, and
instead intends to initiate a separate proceeding to propose rulemaking
requirements for labeling statements on natural rubber-containing
products regulated as drugs and biologics, including combination
products, currently regulated under drug or biologic authorities.
In the June 24, 1996 proposed rule, FDA stated that it did not
believe that the proposed rule would be a significant regulatory action
as defined by Executive Order 12866, and certified under the Regulatory
Flexibility Act (5 U.S.C. 601-602) that the rule would not have a
significant economic impact on a substantial number of small entities.
FDA stated that it believed the rule's proposed effective date 180 days
after publication would allow manufacturers to exhaust their existing
labeling supplies.
FDA received comments concerning the economic impact of the
proposed rule stating that the requirement would have a major impact on
multinational companies, costing at least $15,000 per device for
labeling. Another comment stated that the agency underestimated the
impact of the proposed rule, as each manufacturer will need to draft,
review, and relabel primary and secondary packages of hundreds, if not
thousands of devices.
Based on FDA's information, the agency responded that it did not
agree that the regulation would require the relabeling of hundreds or
thousands of devices, and that agency estimates of relabeling costs
were between $1,000 to $2,000 for each type of device. The agency also
noted that the extended 1 year effective date should allow most
manufactures to exhaust their current labeling stock prior to the
effective date of the regulation. On this basis, the agency stated that
the final rule was not a significant regulatory action under the
Executive Order, and certified that although a substantial number of
small entities would be affected by the rule, the estimated $1,000 to
$2,000 cost of implementing the final rule would not have a significant
economic impact on those entities.
On October 7, 1997, the Office of the Chief Counsel for Advocacy
of the U.S. Small Business Administration submitted a comment stating
that the agency had not supplied data in the preamble to the final rule
to support its cost estimates. The agency also received information
from industry, subsequent to the issuance of the final rule,
identifying additional products that would be subject to the final
rule. On the basis of this information, FDA has decided to issue an
amended economic impact analysis, including an Initial Regulatory
Flexibility Analysis (IRFA), and offer opportunity for further comment
before the implementation of the rule. If comments received persuade
the agency that the conclusions of its amended economic analysis are
erroneous, FDA will decide whether to issue the rule on its current
effective date, to stay the effective date of the final rule, and/or
repropose the rule. In any event, FDA will respond, in the Federal
Register, to comments received in response to this amended economic
impact statement.
II. Federal Rules that May Duplicate, Overlap, or Conflict with the
Final Rule
FDA does not believe that the final rule duplicates, overlaps, or
conflicts with any existing Federal rules. Although 21 CFR 801.5
defines adequate directions for use, and lists certain situations where
directions for use may be considered inadequate, there is no regulation
requiring a specific labeling statement that reduces the risks
associated with natural rubber products by informing consumers about
the presence natural rubber. Without the final regulation,
manufacturers may provide a wide variety of information about natural
rubber that may not be adequate to provide consumer protection, or may
provide no information at all. FDA believes that this regulation will
assure that necessary safety information is provided to the public, and
that standardized information is the best method to inform the public
about risks presented by natural rubber containing products.
III. Public Outreach
Each of the Federal Register documents concerning these products is
available to small businesses on FDA's website. In addition to the
publication in the Federal Register of the proposed rule, the final
rule, and this amended economic analysis, FDA has conducted extensive
outreach to a wide audience, including small businesses, on labeling
requirements for products containing natural rubber.
Prior to the issuance of any proposal, FDA has discussed agency
concerns about latex allergies and the need for labeling on products
containing natural rubber at numerous public meetings, including
several meetings of the American Society for Testing Materials (ASTM),
a major consensus standards development organization in the United
States. After the proposal was published, FDA continues a public
dialogue on the labeling regulations at a variety of meetings,
including meetings with the U.S. Pharmacopeia, the ASTM, and
representatives of the Health Industry Manufacturers Association
(HIMA), a trade association representing medical device manufacturers,
including many that qualify as small businesses. FDA's Division of
Small Manufacturers Assistance (DSMA) handled numerous telephone
inquiries from businesses that were interested in obtaining information
about the proposal.
At the same time the final labeling regulation was published, DSMA
faxed correspondence to 100 industry organizations for further
broadcast to their membership. That correspondence provided information
about the labeling requirements as well as agency contacts who would
handle inquiries and comments about the regulation. FDA then held
further meetings concerning the rule with standards setting
organizations whose membership includes small businesses as well as
additional meetings with HIMA members. FDA also sponsored a national
conference devoted to latex issues that reached the largest audience of
any teleconference previously produced by FDA. Interested
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individuals and businesses at 5,000 downlinks had an opportunity at
that teleconference to exchange views with agency staff and industry
experts on the subject of latex allergies and the implementation and
impact of FDA's labeling requirements.
IV. Analysis of Impacts
FDA has examined the impacts of the rule under Executive Order
12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act (2 U.S.C 1501 et. seq.). 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). Under the Regulatory
Flexibility Act, if a rule has a significant impact on a substantial
number of small entities, an agency must analyze regulatory options
that would minimize any significant impact of the rule on small
entities. Title II of the Unfunded Mandates Reform Act (21 U.S.C. 1532)
requires that agencies prepare a written assessment of anticipated
costs and benefits before proposing any rule that may result in an
expenditure in any 1 year by State, local, and tribal governments, in
the aggregate, or by the private sector of $100 million (adjusted
annually for inflation).
The agency believes that this rule is consistent with the
regulatory philosophy and principles identified in Executive Order
12866 and in these two statutes. The purpose of this rule is to add
labeling statements that will help ensure the safe and effective use by
health care workers and patients of natural rubber devices. Potential
benefits include early recognition of symptoms that could develop into
severe natural latex allergies, and the prevention of severe allergic
reactions and death that may occur if persons who are allergic to
natural rubber inadvertently use natural rubber devices. The agency
contracted with Eastern Research Group, Inc., (ERG), Lexington, MA, to
conduct an economic analysis of this rule. The substantive portions of
the ERG analysis are reproduced in their entirety in Appendix 1.
Based on other information referenced in this document, and on the
analysis performed by the ERG, FDA has prepared an amended economic
analysis statement, including an amended IRFA. Since the rule does not
impose any mandates on State, local or tribal governments, or the
private sector that will result in an expenditure in any 1 year of $100
million or more, FDA is not required to perform a cost-benefit analysis
according to the Unfunded Mandates Reform Act. The rule is not a
significant regulatory action as defined by the Executive Order.
The ERG analysis estimated that this rule will affect approximately
1,110 small businesses. Total annualized compliance costs for small
businesses are estimated at $1.3 million, which represent 0.04 percent
of revenues for small medical device manufacturers. Although this
economic analysis indicates that this rule will not have a significant
economic impact on a substantial number of small entities, the agency
is soliciting comments on this IRFA. In the event that FDA, after
receiving further comments to this amended analysis, determines that
the rule does have a significant effect on a substantial number of
small entities, FDA is providing the following discussion and analysis
of alternatives that minimize effects on small businesses.
V. Alternatives
A. Voluntary Compliance
FDA could have issued guidance stating that FDA considered
statements about the presence of natural rubber necessary to comply
with existing general statutory and regulatory prohibitions against
false and misleading labeling (21 U.S.C. 352(a)), and failure to
provide adequate directions for use (21 U.S.C. 352(f)). Given the
significant health risks associated with natural rubber products, FDA
does not believe that existing general statutory labeling authority and
regulations provide adequate protection to ensure that health care
workers and patients are warned about the risks associated with natural
rubber.
Without the final regulation, manufacturers may not provide any
information at all. The ERG report and FDA's own experience indicate
that some manufacturers never voluntarily revise their labeling. Even
if it could be assumed that all manufacturers would voluntarily provide
some labeling information about the presence of natural rubber, such
information is likely to be presented in a variety of ways that may
confuse consumers and limit the effectiveness of the natural rubber
statement. FDA believes that the provision of consistent, accurate
information to consumers is critical. FDA believes that this
regulation, which provides accurate, consistent information in a
standardized manner, will assure that the safety information is
communicated effectively to the public.
B. Implementation Periods
FDA considered various implementation periods for the effective
date after the issuance of the final rule. The June 24, 1996, proposed
rule proposed an effective date 6 months after the publication of the
final rule. The final rule has reduced the impact on small businesses
by extending the effective date to 1 year after issuance of the final
rule. Based on the ERG report figures, the total industry cost of
compliance for this rule with a 1 year implementation period is $48.7
million. The total annualized costs are calculated at $3.2 million per
year. The costs for a 1 year effective date are 28 percent lower than a
6 month effective date. Allowing a 24 month implementation date would
reduce costs by 40 percent. FDA rejected the 6 month implementation
period and extended the implementation period to 1 year to allow
manufacturers of products containing natural rubber latex, including
small businesses, to reduce costs by depleting existing inventories and
coordinating this labeling change with other planned labeling changes.
Although costs could further be reduced by allowing a 24 month
implementation period, FDA believes that the public need for this
information about devices that pose serious risks justifies rejecting
this alternative.
C. Exempting Small Businesses
FDA has considered the option of exempting small businesses from
the final regulation. The ERG report estimates that approximately 83
percent of the manufacturers of natural rubber latex products are small
businesses. FDA believes that given that the large majority of
manufacturers of products containing natural rubber latex are small
businesses, and given the risks associated with these devices,
exempting small businesses from this regulation would result in a
significant decrease of consumer protection. Accordingly, FDA does not
believe that small businesses should be exempt from this regulation.
D. Allowance of Supplementary Labeling
FDA could have chosen a regulatory alternative that would require
that all labeling be directly printed on the existing packaging and
labeling. Such a regulatory provision would decrease the possibility
that the required statement would become dislodged during distribution.
Instead, the final rule
[[Page 29555]]
allows the use of supplementary labeling (stickers) to provide the
required labeling information. As noted in the ERG report, this will
allow a number of firms, including small businesses, to reduce costs by
avoiding extensive repackaging of existing product inventory that will
not be sold prior to the end of the regulatory implementation period.
FDA decided to include this option in the final rule.
E. Requiring a Labeling Statement on Only One Level of Labeling
Under the provisions of the final rule, FDA estimates that most
devices covered under the rule will bear the required natural rubber
statement on two or three levels of labeling. FDA considered requiring
labeling statements on only one level of labeling. This alternative was
rejected because of the importance of the information contained in the
required labeling statements. Users may not have the necessary
opportunity to read the statement if it is included only on some levels
of labeling. For some products, especially those with multiple users,
some labeling may be discarded prior to use by subsequent consumers.
The inclusion of the statement on each level of labeling increases the
likelihood that consumers will be aware of the risks posed by the
natural rubber in the product.
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. Kibby, T., and M. Akl, ``Prevalence of Latex Sensitization in
a Hospital Employee Population,'' Annals of Allergy, 78:41-44, 1997.
2. Kaczmarek, R., B. Silverman, T. Gross, et al., ``Prevalence
of Latex-specific IgE Antibodies in Hospital Personnel,'' Annals of
Allergy, Asthma & Immunology, 76:51-56, 1996.
3. Arellano, R., J. Bradley, and G. Sussman, ``Prevalence of
Latex Sensitization Among Hospital Employees Occupationally Exposed
to Latex Gloves,'' Anesthesiology, 77:905-908, 1992.
4. Lagier, F., D. Vervloet, I. Lhermet, et al.,``Prevalence of
Latex Allergy in Operating Room Nurses,'' Journal of Allergy and
Clinical Immunology, 90:319-322, 1992.
5. Yassin, M., M. Lierl, T. Fischer, et. al., ``Latex Allergy in
Hospital Employees,'' Annals of Allergy, 72:245-249, 1994.
VII. Requests for Comments
Interested persons may, on or before July 1, 1998 submit to the
Dockets management Branch (address above) written comments regarding
this amended economic analysis statement on issues relating to natural
rubber devices. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket numbers 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.
Dated: May 26, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
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[FR Doc. 98-14311 Filed 5-29-98; 8:45 am]
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