8942 Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Proposed Rules 

bodies; (8) simplify or clarify language 

in regulations; (9) revise regulations to 

address changes in technology, 

economic conditions, or other factors; 

(10) determine if matters in an existing 

regulation could be better handled fully 

by the states without Federal 

regulations; (11) reduce burdens by 

incorporating international or industry 

consensus standards into regulations; 

(12) reconsider regulations that were 

based on scientific or other information 

that has been discredited or superseded; 

and (13) expand regulations that are 

insufficient to address their intended 

objectives or to obtain additional 

benefits. 

Comments should focus on 

regulations that have demonstrated 

deficiencies. Comments that rehash 

debates over recently issued rules will 

be less useful. Particularly where 

comments relate to a rule’s costs or 

benefits, comments will be most useful 

if there are data and experience under 

the rule available to ascertain the rule’s 

actual impact. For that reason, we 

encourage the public to emphasize those 

rules that have been in effect for a 

sufficient amount of time to warrant a 

fair evaluation. Furthermore, the public 

should focus on rule changes that will 

achieve a broad public impact, rather 

than an individual personal or corporate 

benefit. Where feasible, comments 

should reference a specific regulation, 

by Code of Federal Regulations (CFR) 

cite, and provide the Department 

information on what needs fixing and 

why. Comments do not necessarily need 

to address how to fix the perceived 

problem, though such comments are 

welcome. Lastly, we also want to stress 

that this review is for existing rules; the 

public should not use this process to 

submit comments on proposed rules. 

The public meeting will begin with a 

discussion of and taking comments on 

the Department’s preliminary plan for 

regulatory review required by Executive 

Order 13563. After that, we plan to 

allow for comments on candidate rules 

for review. The Department’s General 

Counsel will preside over the meeting. 

Other senior officials from the 

Department and its OAs will also 

attend. It is our intent that the public 

meeting will provide an opportunity for 

these officials to interact with 

individuals or stakeholder 

representatives. To enable them to 

effectively participate in the public 

meeting, they will need some 

information in advance. As a result, we 

are establishing the following process. 

1. Suggestions for Discussion at 

Public Meeting: 

a. By March 3, 2011, the Department 

requests that commenters submit their 

suggestions for discussion at the public 

meeting and indicate whether they want 

time allocated to them at the public 

meeting. Commenters are welcome to 

indicate how much time they would 

like to be allocated, but the Department 

reserves the right to allocate time as 

necessary to ensure that as many 

commenters as possible may participate 

in the public meeting in a meaningful 

manner. 

b. The initial comments from those 

intending to participate in the public 

meeting should contain enough details 

to permit DOT officials to sufficiently 

prepare and ask questions. 

c. The initial comments may be 

augmented anytime before the end of 

the full comment period. 

d. Anyone who needs auxiliary aids 

and services, such as sign language 

interpreters, to effectively participate in 

the meeting should contact the 

Department via the ‘‘FOR FURTHER

INFORMATION CONTACT’’ information 

provided above. 

2. Public Meeting: 

a. After receiving this initial round of 

public comment, the Department will 

organize those suggestions by topic and 

OA for discussion during the public 

meeting. 

b. By having the public meeting after 

receiving initial public comment and by 

organizing the discussion around topics 

and OAs, the Department will be better 

positioned to discuss issues regarding a 

particular rule, broad category of rules, 

or affected group or industry, rather 

than merely recording public comment 

for later review. 

c. The Department will hold its public 

meeting beginning at 9:30 a.m. ET on 

March 14, 2011 at the Department of 

Transportation, West Building, Ground 

Floor, DOT Conference Center, 

Oklahoma Room, 1200 New Jersey 

Avenue, SE., Washington, DC. We will 

make a meeting outline available on 

http://regs.dot.gov in advance of the 

meeting. Furthermore, we are exploring 

the use of technology to enable remote 

participation in the meeting. We will 

update http://regs.dot.gov with 

information about opportunities for the 

public to participate remotely. 

3. Other Written Comments: 

The Department will continue to 

accept written comments through April 

1, 2011. Those who do not wish to 

attend the public meeting may, of 

course, submit comments at any time 

during the comment period. 

4. Follow-up Action by DOT: 

a. We will place a transcript or 

summary of the public meeting in our 

public docket (http:// 

www.regulations.gov) as soon as 

possible after the end of the meeting. 

We note that because the docket is 

Internet accessible, it should allow 

those with Internet access to review 

those proceedings as well as other 

comments. We hope this will further 

improve the interchange of ideas. 

b. This review will provide 

meaningful and significant input to the 

Secretary, the General Counsel, OA 

Administrators, and other DOT senior 

officials. As soon as possible, depending 

on the number of comments we receive 

and the issues raised, the Department 

will publish a report providing at least 

a brief response to the comments we 

have received, including a description 

of any further action we intend to take. 

Regulatory Notices 

Privacy Act: Anyone may search the 

electronic form of comments received 

into any of our dockets by the name of 

the individual submitting the comment 

(or signing the comment, if submitted 

on behalf of an association, business, 

labor union, etc.) You may review 

DOT’s complete Privacy Act Statement 

in the Federal Register published on 

April 11, 2000 (65 FR 19477–78) or you 

may visit http://www.gpoaccess.gov/fr/ 

browse.html and browse under 2000 for 

April 11, looking under Department of 

Transportation. 

Authority: 5 U.S.C. 610; E.O. 13563, 76 FR 

3821, Jan. 21 2011; E.O. 12866, 58 FR 51735, 

Oct. 4, 1993. 

Issued on February 10, 2011, in 

Washington, DC. 

Robert S. Rivkin, 

General Counsel. 

[FR Doc. 2011–3492 Filed 2–11–11; 8:45 am] 

BILLING CODE 4910–9X–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1700 

[CPSC Docket No. CPSC–2011–0007] 

Poison Prevention Packaging 

Requirements; Proposed Exemption of 

Powder Formulations of Colesevelam 

Hydrochloride and Sevelamer 

Carbonate 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The Consumer Product Safety 

Commission (‘‘CPSC,’’ ‘‘Commission,’’ or 

‘‘we’’) is proposing to amend its childresistant packaging requirements to 

exempt powder formulations of two oral 

prescription drugs, colesevelam 

hydrochloride and sevelamer carbonate. 

Colesevelam hydrochloride, currently 


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Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Proposed Rules 8943 

marketed as Welchol®, is available in a 

new 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 available as a 

new powder formulation and is 

indicated for the control of elevated 

serum phosphorus in chronic kidney 

disease patients on dialysis. The 

proposed rule would exempt these 

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: Comments on the proposal 

should be submitted no later than May 

2, 2011. 

ADDRESSES: You may submit comments, 

identified by Docket No. CPSC–2011– 

0007, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

To ensure timely processing of 

comments, the Commission is no longer 

accepting comments submitted by 

electronic mail (e-mail) except through 

http://www.regulations.gov. 

Written Submissions 

Submit written submissions in the 

following way: 

Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions), 

preferably in five copies, to: Office of the 

Secretary, U.S. Consumer Product 

Safety Commission, Room 820, 4330 

East West Highway, Bethesda, MD 

20814; telephone (301) 504–7923. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

comments received may be posted 

without change, including any personal 

identifiers, contact information, or other 

personal information provided, to 

http://www.regulations.gov. Do not 

submit confidential business 

information, trade secret information, or 

other sensitive or protected information 

electronically. Such information should 

be submitted in writing. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Adrienne Layton, PhD, Division of 

Health Sciences, Directorate for Health 

Sciences, Consumer Product Safety 

Commission, Bethesda, MD 20814– 

4408; telephone (301) 504–7576; 

alayton@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 that the 

substance poses to children is such that 

special packaging is not required to 

protect children against serious personal 

injury or serious illness (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, 

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®. Tablets would continue to be 

in CR packaging. 

Welchol® (colesevelam 

hydrochloride) 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® or 

Renvela® 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,® sevelamer carbonate, 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 

received approval from FDA for 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. Toxicity and Human Experience 

Data 

Welchol® and Renvela® have similar 

chemical structures, biological 

properties, and powder formulations. 

Therefore, we are considering the two 

petitions together, and staff reviewed 

related toxicity data together. CPSC staff 

found that colesevelam hydrochloride 

and sevelamer carbonate are not 

absorbed from the gastrointestinal tract. 

This limits the systemic toxicity of the 

drugs. 

No data indicate that either drug is 

acutely toxic, which is the type of 

toxicity 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. 

Generally, chronic studies are not 

useful in determining whether a drug 

should be in CR packaging (because CR 


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8944 Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Proposed Rules 

packaging is intended to protect against 

the child’s access and likely one-time 

use of the drug). Nevertheless, staff 

reviewed such data. Animal studies 

involving 3 to 6 month administration 

of Welchol® and Renvela,® respectively, 

resulted in hemorrhage. However, this 

result was not related directly to the 

mechanism of action of the drugs, but 

rather to a side effect involving the 

inhibition of vitamin K absorption. 

Chronic administration of Welchol® and 

Renvela® can cause an alteration in the 

absorption of vitamins A, D, E, and K. 

Vitamin K is required by the liver to 

produce functional blood clotting 

factors. When vitamin K levels are low, 

nonfunctional blood clotting factors are 

produced, which can lead to 

hemorrhage. This can occur following 

the chronic administration of a drug that 

inhibits vitamin K, but not after the 

acute administration of such a drug. 

Daiichi Sankyo’s submission mentions 

one 4-year-old girl who was prescribed 

Welchol® off-label to treat a skin 

irritation secondary to liver disease. She 

died from an intracranial hemorrhage. 

There are confounding factors in this 

case, and the death occurred after 

chronic, not acute, exposure. Because of 

the confounding factors, the death 

cannot be attributed solely to Welchol®. 

A trial of Renvela® in a limited number 

of pediatric patients (18) for eight weeks 

resulted in primarily minor GI effects. 

(Pieper A.K., Haffner D., Hoppe B., 

Dittrich K., Offner G., Bonzel K.E., John 

U., Frund S., Klaus G., Stubinger A., 

Duker G. and Querfeld U. (2006).) Other 

effects, such as metabolic acidosis, can 

be attributed to the underlying chronic 

kidney disease in these children. These 

effects would occur after chronic, but 

not acute, exposure. 

If a child were to ingest accidentally 

colesevelam hydrochloride (Welchol®) 

or sevelamer carbonate (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. Any serious 

toxicity would result only after chronic 

administration. 

As noted, the CPSC’s CR packaging 

regulations exempt cholestyramine and 

colestipol in powder form, two bile acid 

sequestrants that are similar chemically 

to Welchol® and Renvela®. CPSC staff 

has not found any articles in the 

medical literature describing toxic 

effects following the acute ingestion of 

either cholestyramine or colestipol from 

1975 through 2010. 

CPSC staff 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’’). Staff 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. CPSC staff also searched 

Poisindex®, Pub Med, and Google for 

Welchol®, Renvela®, Colestipol, and 

Cholestyramine, and found no incidents 

of acute poisoning in humans. 

CPSC staff also analyzed Medwatch 

reports obtained from the FDA. 

Medwatch is the FDA’s program for 

reporting a serious adverse event, 

product quality problem, product 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 http://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 provided CPSC staff with 

151 distinct incidents of adverse events 

associated with colesevelam 

hydrochloride (Welchol®) reported 

through the Medwatch system. CPSC 

staff 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®. 

CPSC staff also received reports from 

the FDA of 40 distinct incidents of 

adverse events associated with 

sevelamer carbonate (Renvela®). CPSC 

staff 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 sevelamer carbonate 

(Renvela®) treatment. One of the five 

incidents involved intestinal 

obstruction and perforation, which the 

patient’s physician thought were related 

to the patient’s treatment with 

sevelamer carbonate (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 sevelamer 

carbonate (Renvela®). 

CPSC staff 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. 

CPSC staff believes that it would be 

difficult for children under 5 years old 

to eat large amounts of powder quickly 

without aspirating or coughing. It would 

also 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. 

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 this age group of children are 

still developing, and children age 2 and 

younger are likely to spill most of the 

powder. 

C. Action on the Petition 

After considering the information 

provided by the petitioner and other 

available toxicity and human experience 

data, the Commission concluded 

preliminarily that the degree and nature 

of the hazard to children presented by 

the availability of powder formulations 

of colesevelam hydrochloride (currently 


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Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Proposed Rules 8945 

marketed as Welchol®) and sevelamer 

carbonate (currently marketed as 

Renvela®) do not require special 

packaging to protect children from 

serious personal injury or serious illness 

resulting from handling, using, or 

ingesting the substance. Therefore, the 

Commission voted to grant the petition 

and begin a rulemaking proceeding to 

exempt powder formulations of 

colesevelam hydrochloride containing 

not more than 3.75 grams per package 

and sevelamer carbonate containing not 

more than 2.4 grams per package from 

the special packaging requirements for 

oral prescription drugs. 

D. Regulatory Flexibility Act 

Certification 

Under the Regulatory Flexibility Act, 

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 Act 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. 

The Commission’s Directorate for 

Economic Analysis prepared a 

preliminary assessment of the impact of 

a rule to exempt powder formulations of 

colesevelam hydrochloride (currently 

marketed as Welchol®) and sevelamer 

carbonate (currently marketed as 

Renvela®) from special packaging 

requirements. 

Daiichi Sankyo, Inc., a subsidiary of 

the Japanese firm Daiichi Sankyo Co, 

Ltd, the company that markets 

colesevelam hydrochloride under the 

trade name of Welchol®, employs 

approximately 1,500 people in the 

United States. Net sales of Welchol®

were approximately $243.1 million in 

2008. Genzyme Corporation, the 

company that markets sevelamer 

carbonate under the trade name of 

Renvela®, is a U.S. firm headquartered 

in Cambridge, Mass., with more than 

12,000 employees worldwide. Annual 

revenue for 2008 was $4.6 billion. Given 

that both firms that would be affected by 

a CR packaging exemption for these 

drugs are large, the exemption would 

not have a significant economic effect 

on a substantial number of small 

entities. Moreover, because the action at 

issue is an exemption from special 

packaging requirements, it would allow 

companies to avoid the costs associated 

with CR packaging. 

Based on this assessment, we 

preliminarily conclude that the 

proposed amendment 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. 

E. 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. 

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 proposed 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. 

F. Executive Orders 

According to Executive Order 12988 

(February 5, 1996), agencies must state 

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 proposed rule exempting 

powder formulations of colesevelam 

hydrochloride (currently marketed as 

Welchol®) and sevelamer carbonate 

(currently marketed as Renvela®) from 

special packaging requirements, if 

finalized, would preempt nonidentical 

state or local special packaging 

standards for the substance. 

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 proposes to amend 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 new paragraphs (a)(10)(xxii) and 

(xxiii) to read as follows: 

§ 1700.14 Substances requiring special 

packaging. 

(a) Substances. The Commission has 

determined that the degree or nature of 

the hazard to children in the availability 

of the following substances, by reason of 

their packaging, is such that special 

packaging meeting the requirements of 

§ 1700.20(a) is required to protect 

children from serious personal injury or 

serious illness resulting from handling, 

using, or ingesting such substances, and 

the special packaging herein required is 

technically feasible, practicable, and 

appropriate for these substances: 

* * * * * 

(10) Prescription Drugs. Any drug for 

human use that is in a dosage form 

intended for oral administration and 

that is required by Federal law to be 

dispensed only by or upon an oral or 

written prescription of a practitioner 

licensed by law to administer such drug 

shall be packaged in accordance with 

the provisions of § 1700.15 (a), (b), and 

(c), except for the following: 

* * * * * 

(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: February 10, 2011. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2011–3437 Filed 2–15–11; 8:45 am] 

BILLING CODE 6355–01–P 


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