Poison Prevention Packaging Requirements; Exemption of Powder Formulations of Colesevelam Hydrochloride and Sevelamer Carbonate, 43847-43851 [2011-18511]
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Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Rules and Regulations
other than English at home.2 Marketers are
well-aware of this trend, and today they often
tout a wide array of products and services,
including home loans, in languages other
than English.
It is essential that our consumer protection
laws keep pace with such marketplace
realities, and we are pleased that the MAP
Rule broadly bans deception in commercial
communications concerning residential
mortgages regardless of the language or
languages in which they are made. For
example, under the MAP Rule it can be
unlawful to offer a consumer one set of terms
in her native language but then deliver
different terms in loan documents written in
English.3 In addition, because the ‘‘net
impression’’ of an advertisement is the
lynchpin of deception analysis,4 a fine print
disclaimer or qualifying statement may be
insufficient to cure an otherwise misleading
advertisement.5 This principle, as applied to
advertising that uses multiple languages,
means that, in advertising that targets
consumers in a language other than English,
a disclaimer in English may be insufficient to
cure misleading claims in another language.6
But there are many questions about the
communication of mortgage loan terms that
go beyond the scope of this rulemaking,
among them whether mortgage disclosure
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2 U.S.
Census Bureau, Language Use in the United
States: 2007 (Apr. 2010), available at https://
www.census.gov/prod/2010pubs/acs-12.pdf.
3 In fact, the FTC has challenged such a practice
as deceptive under Section 5 of the FTC Act. See
FTC v. Mortgages Para Hispanos.com Corp., No.
4:06–cv19 (E.D. Tex. 2006) (alleging mortgage
broker engaged in deceptive practices by orally
offering Spanish-speaking customers one thing in
Spanish and then delivering something else in loan
documents written entirely in English).
4 See, e.g., FTC v. Cyberspace.com, LLC, 453 F.3d
1196, 1200 (9th Cir. 2006); FTC v. Nat’l Urological
Group, Inc., 645 F. Supp. 2d 1167, 1189 (N.D. Ga.
2008), aff’d, 356 Fed. App’x (11th Cir. 2009).
5 See, e.g., Cyberspace.com, 453 F.3d at 1200.
6 In 2008, the Board of Governors of the Federal
Reserve System amended Regulation Z under the
Truth in Lending Act to prohibit advertising certain
information only in a foreign language while
providing, in the same advertisement, other critical
information in English. See Final Rule, Truth in
Lending, 73 FR 44522, 44601 (Jul. 30, 2008)
(codified at 12 CFR 226.24(i)(7)). This approach is
consistent with longstanding FTC requirements that
mandatory disclosures be made in the language of
the target audience. See 16 CFR 14.9 (under FTC
rules, cease-and-desist orders, and guides that
require the ‘‘clear and conspicuous’’ disclosure of
information, such disclosure must be made in the
language of the target audience); 16 CFR
610.4(a)(3)(ii) (in marketing free credit reports,
mandatory disclosures must be made in the same
language as that principally used in the
advertisement); 16 CFR 429.1(a) (in door-to-door
sales, failure to furnish a completed receipt or
contract in the same language as the oral sales
presentation is an unfair and deceptive act or
practice); 16 CFR 455.5 (where used car sales
pitches are conducted in Spanish, mandatory
disclosures must be made in Spanish); 16 CFR
308.3(a)(1) (mandatory disclosures about pay-percall services must be made in the same language as
that principally used in the advertisement); see also
FTC Final Rule, Free Annual File Disclosures, 75
FR 9726, 9733 (Mar. 3, 2010) (noting ‘‘the
Commission’s belief that a disclosure in a language
different from that which is principally used in an
advertisement would be deceptive’’).
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documents should be provided to nonEnglish speakers in languages other than
English.7 Congress has charged the Consumer
Financial Protection Bureau with the longoverdue task of simplifying and clarifying
mortgage disclosure documents,8 and has
granted the new agency broad rulemaking
authority with respect to the advertising and
communication of mortgage loan terms. We
look forward to the results of the CFPB’s
work in this area, including its consideration
of the needs of non-native English speaking
consumers when carrying out that important
mandate.9
More generally, given our country’s
changing demographics, we believe that
government and industry alike will need to
pay greater attention to ensuring that
consumers, no matter what language they
speak, have access to important information
regarding their purchases and are protected
from unfair and deceptive practices.
Appendix B—Response of Commissioner J.
Thomas Rosch to the Concurring Statement
of Commissioner Ramirez, in Which
Chairman Leibowitz and Commissioner Brill
Join
Final Rule: Mortgage Acts and Practices—
Advertising
July 19, 2011
I agree with the concurring statement of
Commissioner Ramirez concerning the
Mortgages Acts and Practices—Advertising
Rule to the extent it reiterates the assertions
of the Statement of Basis and Purpose that
the ‘‘net impression’’ of an advertisement is
a touchstone of FTC deception analysis
7 The CFPB has begun testing draft prototype
mortgage disclosure documents in English and
Spanish in advance of a formal rulemaking process.
See CFPB, Consumer Financial Protection Bureau
Announces Initiative to Combine Mortgage Loan
Disclosures (May 18, 2011), available at https://
www.consumerfinance.gov/pressrelease/consumerfinancial-protection-bureau-announces-initiativeto-combine-mortgage-loan-disclosures/.
8 See generally James M. Lacko & Janis K.
Pappalardo, Federal Trade Commission Staff
Report, Improving Consumer Mortgage Disclosures:
An Empirical Assessment of Current And Prototype
Mortgage Disclosure Forms (2007), available at
https://www.ftc.gov/os/2007/06/P025505Mortgage
DisclosureReport.pdf.
9 Our colleague, Commissioner Rosch, expresses
concern that we may be advancing an argument
about mortgage disclosures that is not supported by
the record before us. But far from prejudging the
outcome of any work to be performed by the CFPB,
we are simply highlighting some of the important
consumer protection issues that may arise in
connection with mortgage advertisements targeting
consumers whose primary language is not English.
As we noted above, the matters before the
Commission in this rulemaking were narrow, and
the evidence received on the issue of the use of
multiple languages in advertising—a mere four
comments—does not address the questions to be
examined by the CFPB concerning improvements to
mortgage disclosure documents. While this limited
record does not purport to address such issues, we
have no doubt that in considering this and other
questions, the CFPB will develop a full and
complete record that properly takes into account
the impact on all stakeholders of any measure that
is designed to ensure that consumers receive clear
and accurate information to assist them in making
sound decisions about mortgages.
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43847
regardless of the language or combination of
languages. It is also axiomatic that
government and industry need to be vigilant
that all consumers, regardless of what
language they speak, are not victims of unfair
and deceptive practices.
However, insofar as the concurring
statement suggests that the Consumer
Financial Protection Bureau should require
that mortgage disclosure documents be
provided to non-English speaking consumers
in their native language, I disagree. There is
no basis for making any recommendation to
‘‘go beyond’’ the MAP Rule or Section 5 as
respects requirements that lenders furnish
‘‘non-English speakers’’ with disclosures that
are not in English. See Concurring Statement
at 3. Specifically, Census Bureau data
showing that nearly 20 percent of people in
the United States in 2007 ‘‘reported speaking
a language other than English at home’’ (id.
at 1) does not suggest that they could not
read or understand English. Indeed, so far as
the rulemaking record for the MAP Rule is
concerned, it is my understanding that a
majority of the comments received favored
making disclosures only in English. Thus,
there is currently no basis for the Federal
government to burden this industry with
disclosure requirements that would oblige
the industry to make disclosures in a
language other than English except when the
‘‘net impression’’ left by not doing so would
violate Section 5.
[FR Doc. 2011–18605 Filed 7–20–11; 11:15 am]
BILLING CODE 6750–01–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1700
[CPSC Docket No. CPSC–2011–0007]
Poison Prevention Packaging
Requirements; Exemption of Powder
Formulations of Colesevelam
Hydrochloride and Sevelamer
Carbonate
Consumer Product Safety
Commission.
ACTION: Final rule.
AGENCY:
The Consumer Product Safety
Commission (‘‘CPSC,’’ ‘‘Commission,’’
or ‘‘we’’) is amending its child-resistant
packaging requirements to exempt
powder formulations of two oral
prescription drugs, colesevelam
hydrochloride and sevelamer carbonate.
Colesevelam hydrochloride, currently
marketed as Welchol ®, is available in a
powder formulation and is indicated to
reduce elevated LDL cholesterol levels
and improve glycemic control in adults
with type 2 diabetes mellitus. Sevelamer
carbonate, currently marketed as
Renvela ®, is also available as a powder
formulation and is indicated for the
control of elevated serum phosphorus in
chronic kidney disease patients on
dialysis. The rule exempts these
SUMMARY:
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prescription drug products on the basis
that child-resistant packaging is not
needed to protect young children from
serious injury or illness from powder
formulations of colesevelam
hydrochloride and sevelamer carbonate
because the products are not acutely
toxic, lack adverse human experience
associated with acute ingestion, and, in
powder form, are not likely to be
ingested in large quantities by children
under 5 years of age.
DATES: The rule becomes effective on
July 22, 2011.
FOR FURTHER INFORMATION CONTACT: John
Boja, Office of Compliance, Consumer
Product Safety Commission, Bethesda,
MD 20814–4408; telephone (301) 504–
7300; jboja@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
1. The Poison Prevention Packaging Act
of 1970 and Implementing Regulations
The Poison Prevention Packaging Act
of 1970 (‘‘PPPA’’), 15 U.S.C. 1471–1476,
gives the Commission authority to
establish standards for the ‘‘special
packaging’’ of household substances,
such as drugs, when child-resistant
(‘‘CR’’) packaging is necessary to protect
children from serious personal injury or
illness due to the substance and the
special packaging is technically feasible,
practicable, and appropriate for such
substance. Accordingly, CPSC
regulations require that oral prescription
drugs be in CR packaging. 16 CFR
1700.14(a)(10). The powder forms of
cholestyramine and colestipol, two
drugs that are chemically similar to
colesevelam hydrochloride and
sevelamer carbonate, currently are
exempt from CR packaging. Id.
1700.14(a)(10)(v) and (xv).
CPSC regulations allow companies to
petition the Commission for exemption
from CR requirements. 16 CFR part
1702. Among the possible grounds for
granting an exemption are that:
The degree or nature of the hazard to
children in the availability of the substance,
by reason of its packaging, is such that
special packaging is not required to protect
children from serious personal injury or
serious illness resulting from handling, using
or ingesting the substance.
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16 CFR 1702.17.
2. The Products for Which Exemptions
Are Sought
a. Welchol ® (Colesevelam
Hydrochloride)
On February 24, 2009, Daiichi
Sankyo, Inc. (‘‘Daiichi’’) petitioned the
Commission to exempt the powdered
form of colesevelam hydrochloride,
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which it markets as Welchol ®, from the
special packaging requirements for oral
prescription drugs. The petitioner stated
that the exemption is justified because
of lack of toxicity and lack of adverse
human experience with the drug.
Welchol ® has been marketed in tablet
form and dispensed in CR packaging.
On October 2, 2009, the U.S. Food and
Drug Administration (‘‘FDA’’) approved
a new powder formulation of the drug.
The petition requested an exemption
only for the powder dosage form of
Welchol ®. The product, in tablet form,
would continue to be in CR packaging.
Welchol ® is a bile acid sequestrant
indicated as an adjunct to: (1) Reduce
elevated low-density lipoprotein
cholesterol (LDL–C) levels; and (2)
improve glycemic control in adults with
type 2 diabetes mellitus. The new
dosage form of Welchol ® provides 1.875
g or 3.75 g of the powdered drug in unit
dose packages to be mixed with water
and taken orally as a suspension. (A
unit dose package of Welchol ® is a
pouch that contains an individual dose.)
b. Renvela ® (Sevelamer Carbonate)
On March 6, 2009, Genzyme
Corporation (‘‘Genzyme’’) petitioned the
Commission to exempt the powdered
form of sevelamer carbonate, which it
markets as Renvela, ® from the special
packaging requirements for oral
prescription drugs. The petitioner stated
that the exemption is justified because
of lack of toxicity and lack of adverse
human experience with the drug.
Renvela ® is a phosphate binder
indicated for the control of serum
phosphorus in patients with chronic
kidney disease on dialysis. The tablets
are marketed with a pill crusher for
patients who have trouble swallowing
the tablets. The company reformulated
Renvela ® as a powder to be taken as an
oral suspension, and the FDA approved
this powder formulation on August 12,
2009. The new dosage form of Renvela ®
provides either 0.8 g or 2.4 g of
Renvela ® powder in unit dose packages
to be mixed with 2 ounces of water.
B. Proposed Rule
On February 16, 2011, we published
a notice of proposed rulemaking
(‘‘NPR’’) proposing to exempt from
special packaging the powder forms of
colesevelam hydrochloride (Welchol ®)
and sevelamer carbonate (Renvela ®). 76
FR 8942. As explained in the preamble
to the proposed rule, we considered the
two exemption petitions together
because Welchol ® and Renvela ® have
similar chemical structures, biological
properties, and powder formulations.
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C. Toxicity and Human Experience
Data
1. Summary of Data From Proposed
Rule
As noted in the preamble to the
proposed rule (76 FR at 8943), the
systemic toxicity of colesevelam
hydrochloride and sevelamer carbonate
is limited because they are not absorbed
from the gastrointestinal (GI) tract.
There is no data indicating that either
drug is acutely toxic. Acute toxicity is
the type of toxicity that is of concern
when considering whether CR
packaging is appropriate. Even in
patients taking these drugs chronically,
the adverse effects are mostly minor,
such as diarrhea, nausea, constipation,
flatulence, and dyspepsia.
If a child were to ingest accidentally
Welchol ® or Renvela ®, the potential for
the occurrence of mild to moderate GI
discomfort, such as indigestion,
constipation, nausea, and vomiting does
exist. However, a review of relevant data
indicates that an acute ingestion of these
drugs would not result in serious
toxicity.
CPSC’s CR packaging regulations
exempt cholestyramine and colestipol
in powder form, two bile acid
sequestrants that are similar chemically
to Welchol ® and Renvela.® We have not
found any relevant articles in the
medical literature describing toxic
effects following the acute ingestion of
either cholestyramine or colestipol from
1975 through 2010.
As discussed in the preamble to the
proposed rule (76 FR at 8944), we
searched the following databases for
incidents related to Welchol ® and
Renvela ® occurring between 2000 and
2009: the Injury and Potential Injury
Incident database (‘‘IPII’’), the National
Electronic Injury Surveillance System
database (‘‘NEISS’’), and the Death
Certificates database (‘‘DTHS’’). We
found one incident involving Welchol ®
in the NEISS database. In that incident,
11-month-old twin boys were taken to
the emergency room after they had been
playing with their grandmother’s
prescription medications. It is not clear
how many, if any, pills the boys
ingested, but the children were treated
and released from the hospital. We also
searched Poisindex,® Pub Med, and
Google for Welchol,® Renvela,®
colestipol, and cholestyramine, and
found no relevant incidents of acute
poisoning in humans.
Before publication of the proposed
rule, and as noted therein, we also
analyzed Medwatch reports obtained
from the FDA. Medwatch is the FDA’s
program for reporting a serious adverse
event, product quality problem, product
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use error, or therapeutic inequivalence/
failure that may be associated with the
use of an FDA-regulated drug, biologic,
medical device, dietary supplement, or
cosmetic. (See https://www.fda.gov/
Safety/MedWatch/HowToReport/
default.htm.) There may be adverse
events that have occurred and are not
reported in the Medwatch database.
Also, the existence of a report in the
database does not mean necessarily that
the product actually caused the adverse
event.
The FDA gave us 151 distinct
incidents of adverse events associated
with Welchol ® reported through the
Medwatch system. We excluded
incidents where other medications may
have caused the adverse event reported,
resulting in 22 adverse events. Most
adverse events reported to Medwatch
were gastrointestinal or involved muscle
pain, which is to be expected
considering the adverse effects reported
from clinical trials of Welchol.®
We also received reports from the
FDA of 40 distinct incidents of adverse
events associated with Renvela.® We
excluded incidents where other
medications may have caused the
adverse event reported, resulting in five
in-scope incidents. Two of the five
incidents were deaths, which most
likely were related to the underlying
disease and not treatment with
Renvela.® One of the five incidents
involved intestinal obstruction and
perforation, which the patient’s
physician thought were possibly related
to the patient’s treatment with
Renvela.® In the two remaining
incidents, one patient experienced
gastroenteritis, and the other (who had
asthma and chronic obstructive
pulmonary disease) suffered severe
breathing problems while on Renvela.®
Neither of these two results likely was
related to Renvela.®
2. Updated Injury Data
We updated the injury data since
publication of the proposed rule. We
searched the IPII, NEISS, and death
certificate databases from 2000 through
2010, for incidents associated with
Welchol,® Renvela,® and related drugs
(i.e., cholestyramine (Questran ®) and
colestipol (Colestid ®)). We did not
identify any incidents related to
Renvela,® Questran,® or Colestid,® and
identifed only one new Welchol ®related case. This incident occurred in
July 2010, when a 19-month-old boy
was found in his crib with an open
Tylenol ® bottle. The bottle was
previously used for carrying Welchol ®
and other drugs. It was not clear from
the report if any Welchol ® tablets were
in the bottle when the child accessed it.
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The child was taken to the emergency
department, held overnight for
observation, and then released the next
day.
Additionally, we searched
Poisindex ® (a comprehensive database
which identifies the toxicity of
commercial, biological, and
pharmaceutical products), and the
medical literature for updated
information on colesevelam
hydrochloride and sevelamer carbonate
colestipol, and cholestyramine. We
found no incidents of acute poisoning in
humans through this search.
3. Powder Formulations Generally
We also evaluated the likelihood of
children younger than 5 years old
ingesting powdered substances. The
powdered form of these substances
makes them more difficult to ingest than
medicines in other forms and therefore,
likely will keep children from ingesting
significant quantities. It would be
difficult for children under 5 years old
to eat large amounts of powder quickly
without aspirating or coughing. It also
would be difficult for children to mix
powder thoroughly in a liquid, and the
resulting lumpy quality may be
unappealing to children who try to
drink it. Although children are likely to
be able to tear open the non-childresistant packets used for Welchol ® and
Renvela,® they are likely to spill much
of the contents; therefore, they would
have to open a number of packages to
access a significant quantity of the drug.
Most unintentional poisonings among
children occur during short lapses in
direct visual supervision. The difficulty
posed by ingestion of powder
introduces a delay in the poisoning
scenario, and supervision is likely to
resume before a child can take in a
significant quantity.
As noted in the preamble to the
proposed rule (76 FR at 8944), the
packages used with the powder
formulations of Welchol ® and Renvela ®
also reduce the likelihood of child
poisoning. Both drugs are provided in
small, foil-lined packages containing
individual doses. The Renvela ® package
is easy to tear only at the notch. Because
the package must be opened at a precise
location, it is less accessible, especially
to young children. The Welchol ®
package does not have a notch and has
uniform resistance to tearing, which
makes it more difficult to open than
Renvela.® Although both packages tear
easily enough to be opened by children
under 5 years of age, the fine motor
skills of children in this age group are
still developing, and such children are
likely to spill most of the powder.
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43849
D. Response to Comments on the
Proposed Rule
We published a notice of proposed
rulemaking in the Federal Register on
February 16, 2011, to exempt
colesevelam hydrochloride (Welchol ®)
and sevelamer carbonate (Renvela ®)
from the special packaging requirements
of the PPPA. 76 FR 8942. The proposed
rule would amend our existing
regulations at 16 CFR § 1700.14 by
adding a new paragraph (a)(10)(xxii) to
exempt coleselam hydrochloride in
powder form in packages containing not
more than 3.75 grams of the drug. The
proposed rule also would create a new
paragraph (a)(10)(xxiii) to exempt
sevelamer carbonate in powder form in
packages containing not more than 2.4
grams of the drug. We received 27
comments, with 15 supporting the
proposed rule. In general, the comments
did not address the codified text;
instead, they focused on issues relating
to the drugs themselves. The comments
are available at https://
www.regulations.gov/
#!docketDetail;rpp=50;po=0;D=CPSC–
2011–0007. This section summarizes the
issues raised by the comments and
provides responses to those issues. Each
summarized issue is identified below as
a single comment, and the word
‘‘Comment,’’ in parentheses, will appear
before the summary description of all
comments on that issue, and the word
‘‘Response,’’ in parentheses, will appear
before our response to the issue. We also
have numbered each summarized issue
as a separate comment to help
distinguish between the different issues
raised by the commenters and
summarized by us. They are listed in no
particular order.
1. Concern About Possible Harm to
Children
(Comment 1)—Some commenters
were concerned about what they felt
was a lack of data, and they thought that
these drugs could be harmful to
children (e.g., cause bowel obstruction,
electrolyte/serum glucose imbalance,
and death), particularly if ingested in
large amounts. One commenter also
questioned the use of adverse effect data
from adults and animals in predicting
toxicity from accidental poisoning in
children.
(Response 1)—We typically consider
all available data in toxicity
assessments, with human data taking
precedence over animal data. While
limited data are available on the acute
toxicity of Welchol ® and Renvela ® in
children, the adverse effects reported
are similar to those in adults. Because
these drugs are not absorbed
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systemically, acute adverse effects
typically are limited to the GI tract and
are unlikely to be serious. An extension
of these effects would be expected in an
overdose scenario. Notably, intestinal
obstruction has only been observed
during therapeutic use of these drugs in
patients whose health has been
compromised otherwise (e.g., low birth
weight, chronic kidney disease, and
adhesions). Cases have been
documented in infants and one child
following treatment with a similar drug,
cholestyramine. In addition, a 45-yearold male developed an intestinal
obstruction, perforation, and an
abdominal fistula (abnormal opening in
the stomach or bowel, which allows the
contents to leak) after several months of
treatment with Renvela.® Intestinal
obstruction has occurred very rarely
after treatment with Welchol.® In fact,
Welchol ® has a greater specificity for
bile acids than cholestyramine and
colestipol and has been suggested to
have greater gastrointestinal tolerance
than the other two drugs.
Based on all available information, an
imbalance of electrolytes or glucose
control is unlikely to occur following an
acute exposure to Welchol ® or
Renvela.® No unexpected laboratory
tests were seen following chronic
administration of 3.75 grams g/day of
Welchol ® to pediatric subjects with
heterozygous familial
hypercholesteremia or 15 g/day of
Renvela ® to normal volunteers. Chronic
administration of Welchol ® decreased
fasting glucose levels 3.9–15.9 mg/dl.
Because a blood glucose goal is 100–180
mg/dl for children, it is unlikely that
acute administration of Welchol ®
would cause hypoglycemia (i.e., low
blood sugar) in a child (less than 60 mg/
dl).
Moreover, as discussed in section C of
this preamble, there are no available
poisoning data showing that these drugs
cause serious toxicity following an acute
exposure.
2. Questions About Powder Form
(Comment 2)—Some commenters
argued that: (1) The powder may present
a choking hazard to children; and (2)
there is little support for claims that the
powders are more difficult for children
to ingest, access from the packet without
spilling, and mix thoroughly in a liquid.
(Response 2)—The low acute toxicity
of Welchol® and Renvela® is a key
factor for the exemptions. Additionally,
CPSC’s Human Factors staff considered
relevant data and medical literature to
conclude that powders generally present
a low risk because they are more
difficult to ingest, particularly in large
quantities. Generally, with the
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exception of caustics, the primary
exposure risk associated with powders
is aspiration. Notably, any potential
choking hazard with these drugs could
also occur with any non-pharmaceutical
powder formulation available in the
household, such as soaps, baby powder,
drink mixes, and food products.
We maintain that a child would have
difficulty opening the packet of either of
these drugs and mixing the powder with
a liquid because of the lack of precision
and control required. Moreover, there
are no available poisoning data with
these or similar drugs (colestipol or
cholestyramine) to indicate otherwise.
3. Mixing With Other Substances
(Comment 3)—One commenter stated
that he believes that ‘‘the drug can
potentially be mixed with something to
create an adverse reaction.’’
(Response 3)—The commenter
provided no evidence to suggest that
this is a likely event, and no information
or examples of a substance that would
cause an adverse reaction when mixed
with Welchol® or Renvela®. Although it
is possible that a child might mix the
powder with a liquid in imitation of an
adult, it is highly unlikely that a child
would do so repeatedly because a small
child can drink only a limited amount
of liquid at one time. In addition, the
consistency of incompletely mixed
powder is likely to deter repetition.
4. Benefits of the Exemptions
(Comment 4)—Some commenters
asserted that benefits from the CR
exemptions are limited: increased
profits for the manufacturers of the
drugs; and ease of opening the package.
(Response 4)—Exempting from CR
requirements the powder forms of
Welchol® and Renvela® may increase
patient compliance. Poor adherence to
medication regimens for chronic health
issues is a well-established concern.
Easier access to these drugs could
benefit patients with minimal or no risk
to children.
E. Effective Date
This rule exempts two drugs that
otherwise would be subject to CR
packaging requirements under the
PPPA. Because the rule grants an
exemption, it is not subject to the usual
requirement under the Administrative
Procedure Act (‘‘APA’’) that a rule must
be published 30 days before it takes
effect. 5 U.S.C. 553(d)(1). Therefore, it is
appropriate for the rule to become
effective upon publication in the
Federal Register.
PO 00000
Frm 00048
Fmt 4700
Sfmt 4700
F. Regulatory Flexibility Act
Certification
Under the Regulatory Flexibility Act
(‘‘RFA’’), 5 U.S.C. 601 et seq., an agency
that engages in rulemaking generally
must prepare initial and final regulatory
flexibility analyses describing the
impact of the rule on small businesses
and other small entities. Section 605 of
the RFA provides that an agency is not
required to prepare a regulatory
flexibility analysis if the head of an
agency certifies that the rule will not
have a significant economic impact on
a substantial number of small entities.
As noted in the preamble to the
proposed rule (76 FR at 8945), the
Commission’s Directorate for Economic
Analysis prepared a preliminary
assessment of the impact of a rule to
exempt powder formulations of
Welchol® and Renvela® from special
packaging requirements. Based on this
assessment, we preliminarily concluded
that the proposed amendment
exempting powder formulations of
Welchol® and Renvela® from special
packaging requirements would not have
a significant impact on a substantial
number of small businesses or other
small entities. We received no
comments on this assessment or any
additional information. Therefore, we
conclude that exempting powder
formulations of colesevelam
hydrochloride (currently marketed as
Welchol® and sevelamer carbonate
(currently marketed as Renvela® from
special packaging requirements would
not have a significant impact on a
substantial number of small businesses
or other small entities.
G. Environmental Considerations
Pursuant to the National
Environmental Policy Act, and in
accordance with the Council on
Environmental Quality regulations and
CPSC procedures for environmental
review, we have assessed the possible
environmental effects associated with
the proposed PPPA amendment. As
discussed in the preamble to the
proposed rule, CPSC regulations state
that rules requiring special packaging
for consumer products normally have
little or no potential for affecting the
human environment. 16 CFR
1021.5(c)(3). Nothing in this rule alters
that expectation. Therefore, because the
rule would have no adverse effect on the
environment, neither an environmental
assessment nor an environmental
impact statement is required.
H. Executive Orders
According to Executive Order 12988
(February 5, 1996), agencies must state
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22JYR1
Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Rules and Regulations
in clear language the preemptive effect,
if any, of new regulations.
The PPPA provides that, generally,
when a special packaging standard
issued under the PPPA is in effect, ‘‘no
State or political subdivision thereof
shall have any authority either to
establish or continue in effect, with
respect to such household substance,
any standard for special packaging (and
any exemption therefrom and
requirement related thereto) which is
not identical to the [PPPA] standard.’’
15 U.S.C. 1476(a). A state or local
standard may be excepted from this
preemptive effect if: (1) the state or local
standard provides a higher degree of
protection from the risk of injury or
illness than the PPPA standard; and (2)
the state or political subdivision applies
to the Commission for an exemption
from the PPPA’s preemption clause and
the Commission grants the exemption
through a process specified at 16 CFR
part 1061. 15 U.S.C. 1476(c)(1). In
addition, the Federal government, or a
state or local government, may establish
and continue in effect a nonidentical
special packaging requirement that
provides a higher degree of protection
than the PPPA requirement for a
household substance for the Federal,
state, or local government’s own use. 15
U.S.C. 1476(b).
Thus, with the exceptions noted
above, the rule exempting powder
formulations of Welchol® and Renvela®
from special packaging requirements
preempts nonidentical state or local
special packaging standards for the
substances.
List of Subjects in 16 CFR Part 1700
Consumer protection, Drugs, Infants
and children, Packaging and containers,
Poison prevention, Toxic substances.
For the reasons given above, the
Commission amends 16 CFR part 1700
as follows:
PART 1700—[AMENDED]
1. The authority citation for part 1700
continues to read as follows:
■
Authority: 15 U.S.C. 1471–76. Secs.
1700.1 and 1700.14 also issued under 15
U.S.C. 2079(a).
2. Section 1700.14 is amended by
adding paragraphs (a)(10)(xxii) and
(xxiii) to read as follows:
emcdonald on DSK2BSOYB1PROD with RULES
■
§ 1700.14 Substances requiring special
packaging.
(a) * * *
(10) * * *
(xxii) Colesevelam hydrochloride in
powder form in packages containing not
more than 3.75 grams of the drug.
VerDate Mar<15>2010
18:10 Jul 21, 2011
Jkt 223001
(xxiii) Sevelamer carbonate in powder
form in packages containing not more
than 2.4 grams of the drug.
*
*
*
*
*
Dated: July 18, 2011.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2011–18511 Filed 7–21–11; 8:45 am]
BILLING CODE 6355–01–P
COMMODITY FUTURES TRADING
COMMISSION
17 CFR Parts 15 and 20
RIN 3038–AD17
Large Trader Reporting for Physical
Commodity Swaps
Commodity Futures Trading
Commission.
ACTION: Final rules.
AGENCY:
The Commission is adopting
reporting regulations (‘‘Reporting
Rules’’) that require physical
commodity swap and swaption (for ease
of reference, collectively ‘‘swaps’’)
reports. The new regulations require
routine position reports from clearing
organizations, clearing members and
swap dealers and also apply to
reportable swap trader positions.
DATES: Effective Dates: This rulemaking
shall become effective September 20,
2011.
FOR FURTHER INFORMATION CONTACT:
Bruce Fekrat, Senior Special Counsel,
Office of the Director, (202) 418–5578,
bfekrat@cftc.gov, or Ali Hosseini,
Attorney-Advisor, Office of the Director,
(202) 418–6144, ahosseini@cftc.gov,
Division of Market Oversight,
Commodity Futures Trading
Commission, Three Lafayette Centre,
1155 21st Street, NW., Washington, DC
20581.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background and Summary of
Comments
A. Background
On November 2, 2010, the
Commission proposed Reporting Rules
that, in addition to establishing
recordkeeping requirements, require
routine swaps position reports from
clearing organizations, clearing
members and swap dealers and apply
non-routine reporting requirements to
large swaps traders.1 The Reporting
1 75 FR 67258, November 2, 2010. Comments and
ex parte communications list available at https://
comments.cftc.gov/PublicComments/
CommentList.aspx?id=889.
PO 00000
Frm 00049
Fmt 4700
Sfmt 4700
43851
Rules, as finalized and adopted herein,
will allow the Commission to
administer its regulatory responsibilities
under the Commodity Exchange Act
(‘‘CEA or Act’’) by implementing and
conducting effective surveillance of
economically equivalent physical
commodity futures, options and swaps.
The Reporting Rules will directly
support the Commission’s transparency
initiatives such as its dissemination of
Commitments of Traders and Index
Investment Data Reports and will allow
the Commission to monitor compliance
with the trading requirements of the
Act.2
The Commission currently receives
and uses for market surveillance and
enforcement purposes, data on large
positions in all physical commodity
futures and option contracts traded on
designated contract markets (‘‘DCMs’’).
Without the Reporting Rules, there
would be no analogous reporting system
in place for economically equivalent
swaps, which until recently were largely
unregulated financial contracts. The
Reporting Rules, as discussed below, are
reasonably necessary for the effective
surveillance of economically equivalent
futures and swaps.
B. Proposed Reporting Rules Summary
of Comments
The Commission received
approximately 130 comment letters, and
engaged in several ex parte
communications, for the proposed
Reporting Rules. The Commission has
carefully reviewed and considered the
submitted comments. Substantive
comments pertinent to specific
provisions in the rulemaking are
summarized and discussed below and
in other sections of this notice.
The National Futures Association
(‘‘NFA’’) submitted a comment 3
suggesting that its issuance of trader
identifications should be a part of the
position reporting process. Although
beyond the scope of this rulemaking as
proposed, the Commission may review
the feasibility of adopting such an
approach as a part of its ongoing
updating and revision of other
transaction and position reporting
requirements.
The Air Transport Association
(‘‘ATA’’), Better Markets Inc. (‘‘Better
Markets’’), the Petroleum Marketers
Association of America (‘‘PMAA’’) and
New England Fuel Institute (‘‘NEFI’’),
and Robert Pollin and James Heintz of
the Political Economy Research Institute
2 See
76 FR 4752, January 26, 2011.
from Thomas W. Sexton, Senior Vice
President and General Counsel, NFA, to David A.
Stawick, Secretary, CFTC (December 2, 2010).
3 Letter
E:\FR\FM\22JYR1.SGM
22JYR1
]]>Agencies
[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Rules and Regulations]
[Pages 43847-43851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18511]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1700
[CPSC Docket No. CPSC-2011-0007]
Poison Prevention Packaging Requirements; Exemption of Powder
Formulations of Colesevelam Hydrochloride and Sevelamer Carbonate
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Consumer Product Safety Commission (``CPSC,''
``Commission,'' or ``we'') is amending its child-resistant packaging
requirements to exempt powder formulations of two oral prescription
drugs, colesevelam hydrochloride and sevelamer carbonate. Colesevelam
hydrochloride, currently marketed as Welchol [supreg], is available in
a powder formulation and is indicated to reduce elevated LDL
cholesterol levels and improve glycemic control in adults with type 2
diabetes mellitus. Sevelamer carbonate, currently marketed as Renvela
[supreg], is also available as a powder formulation and is indicated
for the control of elevated serum phosphorus in chronic kidney disease
patients on dialysis. The rule exempts these
[[Page 43848]]
prescription drug products on the basis that child-resistant packaging
is not needed to protect young children from serious injury or illness
from powder formulations of colesevelam hydrochloride and sevelamer
carbonate because the products are not acutely toxic, lack adverse
human experience associated with acute ingestion, and, in powder form,
are not likely to be ingested in large quantities by children under 5
years of age.
DATES: The rule becomes effective on July 22, 2011.
FOR FURTHER INFORMATION CONTACT: John Boja, Office of Compliance,
Consumer Product Safety Commission, Bethesda, MD 20814-4408; telephone
(301) 504-7300; jboja@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
1. The Poison Prevention Packaging Act of 1970 and Implementing
Regulations
The Poison Prevention Packaging Act of 1970 (``PPPA''), 15 U.S.C.
1471-1476, gives the Commission authority to establish standards for
the ``special packaging'' of household substances, such as drugs, when
child-resistant (``CR'') packaging is necessary to protect children
from serious personal injury or illness due to the substance and the
special packaging is technically feasible, practicable, and appropriate
for such substance. Accordingly, CPSC regulations require that oral
prescription drugs be in CR packaging. 16 CFR 1700.14(a)(10). The
powder forms of cholestyramine and colestipol, two drugs that are
chemically similar to colesevelam hydrochloride and sevelamer
carbonate, currently are exempt from CR packaging. Id.
1700.14(a)(10)(v) and (xv).
CPSC regulations allow companies to petition the Commission for
exemption from CR requirements. 16 CFR part 1702. Among the possible
grounds for granting an exemption are that:
The degree or nature of the hazard to children in the availability
of the substance, by reason of its packaging, is such that special
packaging is not required to protect children from serious personal
injury or serious illness resulting from handling, using or
ingesting the substance.
16 CFR 1702.17.
2. The Products for Which Exemptions Are Sought
a. Welchol [supreg] (Colesevelam Hydrochloride)
On February 24, 2009, Daiichi Sankyo, Inc. (``Daiichi'') petitioned
the Commission to exempt the powdered form of colesevelam
hydrochloride, which it markets as Welchol [supreg], from the special
packaging requirements for oral prescription drugs. The petitioner
stated that the exemption is justified because of lack of toxicity and
lack of adverse human experience with the drug. Welchol [supreg] has
been marketed in tablet form and dispensed in CR packaging. On October
2, 2009, the U.S. Food and Drug Administration (``FDA'') approved a new
powder formulation of the drug. The petition requested an exemption
only for the powder dosage form of Welchol [supreg]. The product, in
tablet form, would continue to be in CR packaging.
Welchol [supreg] is a bile acid sequestrant indicated as an adjunct
to: (1) Reduce elevated low-density lipoprotein cholesterol (LDL-C)
levels; and (2) improve glycemic control in adults with type 2 diabetes
mellitus. The new dosage form of Welchol [supreg] provides 1.875 g or
3.75 g of the powdered drug in unit dose packages to be mixed with
water and taken orally as a suspension. (A unit dose package of Welchol
[supreg] is a pouch that contains an individual dose.)
b. Renvela [supreg] (Sevelamer Carbonate)
On March 6, 2009, Genzyme Corporation (``Genzyme'') petitioned the
Commission to exempt the powdered form of sevelamer carbonate, which it
markets as Renvela, [supreg] from the special packaging requirements
for oral prescription drugs. The petitioner stated that the exemption
is justified because of lack of toxicity and lack of adverse human
experience with the drug.
Renvela [supreg] is a phosphate binder indicated for the control of
serum phosphorus in patients with chronic kidney disease on dialysis.
The tablets are marketed with a pill crusher for patients who have
trouble swallowing the tablets. The company reformulated Renvela
[supreg] as a powder to be taken as an oral suspension, and the FDA
approved this powder formulation on August 12, 2009. The new dosage
form of Renvela [supreg] provides either 0.8 g or 2.4 g of Renvela
[supreg] powder in unit dose packages to be mixed with 2 ounces of
water.
B. Proposed Rule
On February 16, 2011, we published a notice of proposed rulemaking
(``NPR'') proposing to exempt from special packaging the powder forms
of colesevelam hydrochloride (Welchol [supreg]) and sevelamer carbonate
(Renvela [supreg]). 76 FR 8942. As explained in the preamble to the
proposed rule, we considered the two exemption petitions together
because Welchol [supreg] and Renvela [supreg] have similar chemical
structures, biological properties, and powder formulations.
C. Toxicity and Human Experience Data
1. Summary of Data From Proposed Rule
As noted in the preamble to the proposed rule (76 FR at 8943), the
systemic toxicity of colesevelam hydrochloride and sevelamer carbonate
is limited because they are not absorbed from the gastrointestinal (GI)
tract. There is no data indicating that either drug is acutely toxic.
Acute toxicity is the type of toxicity that is of concern when
considering whether CR packaging is appropriate. Even in patients
taking these drugs chronically, the adverse effects are mostly minor,
such as diarrhea, nausea, constipation, flatulence, and dyspepsia.
If a child were to ingest accidentally Welchol [supreg] or Renvela
[supreg], the potential for the occurrence of mild to moderate GI
discomfort, such as indigestion, constipation, nausea, and vomiting
does exist. However, a review of relevant data indicates that an acute
ingestion of these drugs would not result in serious toxicity.
CPSC's CR packaging regulations exempt cholestyramine and
colestipol in powder form, two bile acid sequestrants that are similar
chemically to Welchol [supreg] and Renvela.[supreg] We have not found
any relevant articles in the medical literature describing toxic
effects following the acute ingestion of either cholestyramine or
colestipol from 1975 through 2010.
As discussed in the preamble to the proposed rule (76 FR at 8944),
we searched the following databases for incidents related to Welchol
[supreg] and Renvela [supreg] occurring between 2000 and 2009: the
Injury and Potential Injury Incident database (``IPII''), the National
Electronic Injury Surveillance System database (``NEISS''), and the
Death Certificates database (``DTHS''). We found one incident involving
Welchol [supreg] in the NEISS database. In that incident, 11-month-old
twin boys were taken to the emergency room after they had been playing
with their grandmother's prescription medications. It is not clear how
many, if any, pills the boys ingested, but the children were treated
and released from the hospital. We also searched Poisindex,[supreg] Pub
Med, and Google for Welchol,[supreg] Renvela,[supreg] colestipol, and
cholestyramine, and found no relevant incidents of acute poisoning in
humans.
Before publication of the proposed rule, and as noted therein, we
also analyzed Medwatch reports obtained from the FDA. Medwatch is the
FDA's program for reporting a serious adverse event, product quality
problem, product
[[Page 43849]]
use error, or therapeutic inequivalence/failure that may be associated
with the use of an FDA-regulated drug, biologic, medical device,
dietary supplement, or cosmetic. (See https://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.) There may be adverse events that
have occurred and are not reported in the Medwatch database. Also, the
existence of a report in the database does not mean necessarily that
the product actually caused the adverse event.
The FDA gave us 151 distinct incidents of adverse events associated
with Welchol [supreg] reported through the Medwatch system. We excluded
incidents where other medications may have caused the adverse event
reported, resulting in 22 adverse events. Most adverse events reported
to Medwatch were gastrointestinal or involved muscle pain, which is to
be expected considering the adverse effects reported from clinical
trials of Welchol.[supreg]
We also received reports from the FDA of 40 distinct incidents of
adverse events associated with Renvela.[supreg] We excluded incidents
where other medications may have caused the adverse event reported,
resulting in five in-scope incidents. Two of the five incidents were
deaths, which most likely were related to the underlying disease and
not treatment with Renvela.[supreg] One of the five incidents involved
intestinal obstruction and perforation, which the patient's physician
thought were possibly related to the patient's treatment with
Renvela.[supreg] In the two remaining incidents, one patient
experienced gastroenteritis, and the other (who had asthma and chronic
obstructive pulmonary disease) suffered severe breathing problems while
on Renvela.[supreg] Neither of these two results likely was related to
Renvela.[supreg]
2. Updated Injury Data
We updated the injury data since publication of the proposed rule.
We searched the IPII, NEISS, and death certificate databases from 2000
through 2010, for incidents associated with Welchol,[supreg]
Renvela,[supreg] and related drugs (i.e., cholestyramine (Questran
[supreg]) and colestipol (Colestid [supreg])). We did not identify any
incidents related to Renvela,[supreg] Questran,[supreg] or
Colestid,[supreg] and identifed only one new Welchol [supreg]-related
case. This incident occurred in July 2010, when a 19-month-old boy was
found in his crib with an open Tylenol [supreg] bottle. The bottle was
previously used for carrying Welchol [supreg] and other drugs. It was
not clear from the report if any Welchol [supreg] tablets were in the
bottle when the child accessed it. The child was taken to the emergency
department, held overnight for observation, and then released the next
day.
Additionally, we searched Poisindex [supreg] (a comprehensive
database which identifies the toxicity of commercial, biological, and
pharmaceutical products), and the medical literature for updated
information on colesevelam hydrochloride and sevelamer carbonate
colestipol, and cholestyramine. We found no incidents of acute
poisoning in humans through this search.
3. Powder Formulations Generally
We also evaluated the likelihood of children younger than 5 years
old ingesting powdered substances. The powdered form of these
substances makes them more difficult to ingest than medicines in other
forms and therefore, likely will keep children from ingesting
significant quantities. It would be difficult for children under 5
years old to eat large amounts of powder quickly without aspirating or
coughing. It also would be difficult for children to mix powder
thoroughly in a liquid, and the resulting lumpy quality may be
unappealing to children who try to drink it. Although children are
likely to be able to tear open the non-child-resistant packets used for
Welchol [supreg] and Renvela,[supreg] they are likely to spill much of
the contents; therefore, they would have to open a number of packages
to access a significant quantity of the drug. Most unintentional
poisonings among children occur during short lapses in direct visual
supervision. The difficulty posed by ingestion of powder introduces a
delay in the poisoning scenario, and supervision is likely to resume
before a child can take in a significant quantity.
As noted in the preamble to the proposed rule (76 FR at 8944), the
packages used with the powder formulations of Welchol [supreg] and
Renvela [supreg] also reduce the likelihood of child poisoning. Both
drugs are provided in small, foil-lined packages containing individual
doses. The Renvela [supreg] package is easy to tear only at the notch.
Because the package must be opened at a precise location, it is less
accessible, especially to young children. The Welchol [supreg] package
does not have a notch and has uniform resistance to tearing, which
makes it more difficult to open than Renvela.[supreg] Although both
packages tear easily enough to be opened by children under 5 years of
age, the fine motor skills of children in this age group are still
developing, and such children are likely to spill most of the powder.
D. Response to Comments on the Proposed Rule
We published a notice of proposed rulemaking in the Federal
Register on February 16, 2011, to exempt colesevelam hydrochloride
(Welchol [supreg]) and sevelamer carbonate (Renvela [supreg]) from the
special packaging requirements of the PPPA. 76 FR 8942. The proposed
rule would amend our existing regulations at 16 CFR Sec. 1700.14 by
adding a new paragraph (a)(10)(xxii) to exempt coleselam hydrochloride
in powder form in packages containing not more than 3.75 grams of the
drug. The proposed rule also would create a new paragraph
(a)(10)(xxiii) to exempt sevelamer carbonate in powder form in packages
containing not more than 2.4 grams of the drug. We received 27
comments, with 15 supporting the proposed rule. In general, the
comments did not address the codified text; instead, they focused on
issues relating to the drugs themselves. The comments are available at
https://www.regulations.gov/#!docketDetail;rpp=50;po=0;D=CPSC-2011-0007.
This section summarizes the issues raised by the comments and provides
responses to those issues. Each summarized issue is identified below as
a single comment, and the word ``Comment,'' in parentheses, will appear
before the summary description of all comments on that issue, and the
word ``Response,'' in parentheses, will appear before our response to
the issue. We also have numbered each summarized issue as a separate
comment to help distinguish between the different issues raised by the
commenters and summarized by us. They are listed in no particular
order.
1. Concern About Possible Harm to Children
(Comment 1)--Some commenters were concerned about what they felt
was a lack of data, and they thought that these drugs could be harmful
to children (e.g., cause bowel obstruction, electrolyte/serum glucose
imbalance, and death), particularly if ingested in large amounts. One
commenter also questioned the use of adverse effect data from adults
and animals in predicting toxicity from accidental poisoning in
children.
(Response 1)--We typically consider all available data in toxicity
assessments, with human data taking precedence over animal data. While
limited data are available on the acute toxicity of Welchol [supreg]
and Renvela [supreg] in children, the adverse effects reported are
similar to those in adults. Because these drugs are not absorbed
[[Page 43850]]
systemically, acute adverse effects typically are limited to the GI
tract and are unlikely to be serious. An extension of these effects
would be expected in an overdose scenario. Notably, intestinal
obstruction has only been observed during therapeutic use of these
drugs in patients whose health has been compromised otherwise (e.g.,
low birth weight, chronic kidney disease, and adhesions). Cases have
been documented in infants and one child following treatment with a
similar drug, cholestyramine. In addition, a 45-year-old male developed
an intestinal obstruction, perforation, and an abdominal fistula
(abnormal opening in the stomach or bowel, which allows the contents to
leak) after several months of treatment with Renvela.[supreg]
Intestinal obstruction has occurred very rarely after treatment with
Welchol.[supreg] In fact, Welchol [supreg] has a greater specificity
for bile acids than cholestyramine and colestipol and has been
suggested to have greater gastrointestinal tolerance than the other two
drugs.
Based on all available information, an imbalance of electrolytes or
glucose control is unlikely to occur following an acute exposure to
Welchol [supreg] or Renvela.[supreg] No unexpected laboratory tests
were seen following chronic administration of 3.75 grams g/day of
Welchol [supreg] to pediatric subjects with heterozygous familial
hypercholesteremia or 15 g/day of Renvela [supreg] to normal
volunteers. Chronic administration of Welchol [supreg] decreased
fasting glucose levels 3.9-15.9 mg/dl. Because a blood glucose goal is
100-180 mg/dl for children, it is unlikely that acute administration of
Welchol [supreg] would cause hypoglycemia (i.e., low blood sugar) in a
child (less than 60 mg/dl).
Moreover, as discussed in section C of this preamble, there are no
available poisoning data showing that these drugs cause serious
toxicity following an acute exposure.
2. Questions About Powder Form
(Comment 2)--Some commenters argued that: (1) The powder may
present a choking hazard to children; and (2) there is little support
for claims that the powders are more difficult for children to ingest,
access from the packet without spilling, and mix thoroughly in a
liquid.
(Response 2)--The low acute toxicity of Welchol[supreg] and
Renvela[supreg] is a key factor for the exemptions. Additionally,
CPSC's Human Factors staff considered relevant data and medical
literature to conclude that powders generally present a low risk
because they are more difficult to ingest, particularly in large
quantities. Generally, with the exception of caustics, the primary
exposure risk associated with powders is aspiration. Notably, any
potential choking hazard with these drugs could also occur with any
non-pharmaceutical powder formulation available in the household, such
as soaps, baby powder, drink mixes, and food products.
We maintain that a child would have difficulty opening the packet
of either of these drugs and mixing the powder with a liquid because of
the lack of precision and control required. Moreover, there are no
available poisoning data with these or similar drugs (colestipol or
cholestyramine) to indicate otherwise.
3. Mixing With Other Substances
(Comment 3)--One commenter stated that he believes that ``the drug
can potentially be mixed with something to create an adverse
reaction.''
(Response 3)--The commenter provided no evidence to suggest that
this is a likely event, and no information or examples of a substance
that would cause an adverse reaction when mixed with Welchol[supreg] or
Renvela[supreg]. Although it is possible that a child might mix the
powder with a liquid in imitation of an adult, it is highly unlikely
that a child would do so repeatedly because a small child can drink
only a limited amount of liquid at one time. In addition, the
consistency of incompletely mixed powder is likely to deter repetition.
4. Benefits of the Exemptions
(Comment 4)--Some commenters asserted that benefits from the CR
exemptions are limited: increased profits for the manufacturers of the
drugs; and ease of opening the package.
(Response 4)--Exempting from CR requirements the powder forms of
Welchol[supreg] and Renvela[supreg] may increase patient compliance.
Poor adherence to medication regimens for chronic health issues is a
well-established concern. Easier access to these drugs could benefit
patients with minimal or no risk to children.
E. Effective Date
This rule exempts two drugs that otherwise would be subject to CR
packaging requirements under the PPPA. Because the rule grants an
exemption, it is not subject to the usual requirement under the
Administrative Procedure Act (``APA'') that a rule must be published 30
days before it takes effect. 5 U.S.C. 553(d)(1). Therefore, it is
appropriate for the rule to become effective upon publication in the
Federal Register.
F. Regulatory Flexibility Act Certification
Under the Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601 et
seq., an agency that engages in rulemaking generally must prepare
initial and final regulatory flexibility analyses describing the impact
of the rule on small businesses and other small entities. Section 605
of the RFA provides that an agency is not required to prepare a
regulatory flexibility analysis if the head of an agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities.
As noted in the preamble to the proposed rule (76 FR at 8945), the
Commission's Directorate for Economic Analysis prepared a preliminary
assessment of the impact of a rule to exempt powder formulations of
Welchol[supreg] and Renvela[supreg] from special packaging
requirements. Based on this assessment, we preliminarily concluded that
the proposed amendment exempting powder formulations of Welchol[supreg]
and Renvela[supreg] from special packaging requirements would not have
a significant impact on a substantial number of small businesses or
other small entities. We received no comments on this assessment or any
additional information. Therefore, we conclude that exempting powder
formulations of colesevelam hydrochloride (currently marketed as
Welchol[supreg] and sevelamer carbonate (currently marketed as
Renvela[supreg] from special packaging requirements would not have a
significant impact on a substantial number of small businesses or other
small entities.
G. Environmental Considerations
Pursuant to the National Environmental Policy Act, and in
accordance with the Council on Environmental Quality regulations and
CPSC procedures for environmental review, we have assessed the possible
environmental effects associated with the proposed PPPA amendment. As
discussed in the preamble to the proposed rule, CPSC regulations state
that rules requiring special packaging for consumer products normally
have little or no potential for affecting the human environment. 16 CFR
1021.5(c)(3). Nothing in this rule alters that expectation. Therefore,
because the rule would have no adverse effect on the environment,
neither an environmental assessment nor an environmental impact
statement is required.
H. Executive Orders
According to Executive Order 12988 (February 5, 1996), agencies
must state
[[Page 43851]]
in clear language the preemptive effect, if any, of new regulations.
The PPPA provides that, generally, when a special packaging
standard issued under the PPPA is in effect, ``no State or political
subdivision thereof shall have any authority either to establish or
continue in effect, with respect to such household substance, any
standard for special packaging (and any exemption therefrom and
requirement related thereto) which is not identical to the [PPPA]
standard.'' 15 U.S.C. 1476(a). A state or local standard may be
excepted from this preemptive effect if: (1) the state or local
standard provides a higher degree of protection from the risk of injury
or illness than the PPPA standard; and (2) the state or political
subdivision applies to the Commission for an exemption from the PPPA's
preemption clause and the Commission grants the exemption through a
process specified at 16 CFR part 1061. 15 U.S.C. 1476(c)(1). In
addition, the Federal government, or a state or local government, may
establish and continue in effect a nonidentical special packaging
requirement that provides a higher degree of protection than the PPPA
requirement for a household substance for the Federal, state, or local
government's own use. 15 U.S.C. 1476(b).
Thus, with the exceptions noted above, the rule exempting powder
formulations of Welchol[supreg] and Renvela[supreg] from special
packaging requirements preempts nonidentical state or local special
packaging standards for the substances.
List of Subjects in 16 CFR Part 1700
Consumer protection, Drugs, Infants and children, Packaging and
containers, Poison prevention, Toxic substances.
For the reasons given above, the Commission amends 16 CFR part 1700
as follows:
PART 1700--[AMENDED]
0
1. The authority citation for part 1700 continues to read as follows:
Authority: 15 U.S.C. 1471-76. Secs. 1700.1 and 1700.14 also
issued under 15 U.S.C. 2079(a).
0
2. Section 1700.14 is amended by adding paragraphs (a)(10)(xxii) and
(xxiii) to read as follows:
Sec. 1700.14 Substances requiring special packaging.
(a) * * *
(10) * * *
(xxii) Colesevelam hydrochloride in powder form in packages
containing not more than 3.75 grams of the drug.
(xxiii) Sevelamer carbonate in powder form in packages containing
not more than 2.4 grams of the drug.
* * * * *
Dated: July 18, 2011.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2011-18511 Filed 7-21-11; 8:45 am]
BILLING CODE 6355-01-P
